[Title 21 CFR ]
[Code of Federal Regulations (annual edition) - April 1, 2012 Edition]
[From the U.S. Government Printing Office]
[[Page i]]
Title 21
Food and Drugs
________________________
Parts 1 to 99
Revised as of April 1, 2012
Containing a codification of documents of general
applicability and future effect
As of April 1, 2012
Published by the Office of the Federal Register
National Archives and Records Administration as a
Special Edition of the Federal Register
[[Page ii]]
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[[Page iii]]
Table of Contents
Page
Explanation................................................. v
Title 21:
Chapter I--Food and Drug Administration, Department
of Health and Human Services 3
Finding Aids:
Table of CFR Titles and Chapters........................ 469
Alphabetical List of Agencies Appearing in the CFR...... 489
List of CFR Sections Affected........................... 499
[[Page iv]]
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Cite this Code: CFR
To cite the regulations in
this volume use title,
part and section number.
Thus, 21 CFR 1.1 refers to
title 21, part 1, section
1.
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[[Page v]]
EXPLANATION
The Code of Federal Regulations is a codification of the general and
permanent rules published in the Federal Register by the Executive
departments and agencies of the Federal Government. The Code is divided
into 50 titles which represent broad areas subject to Federal
regulation. Each title is divided into chapters which usually bear the
name of the issuing agency. Each chapter is further subdivided into
parts covering specific regulatory areas.
Each volume of the Code is revised at least once each calendar year
and issued on a quarterly basis approximately as follows:
Title 1 through Title 16.................................as of January 1
Title 17 through Title 27..................................as of April 1
Title 28 through Title 41...................................as of July 1
Title 42 through Title 50................................as of October 1
The appropriate revision date is printed on the cover of each
volume.
LEGAL STATUS
The contents of the Federal Register are required to be judicially
noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie
evidence of the text of the original documents (44 U.S.C. 1510).
HOW TO USE THE CODE OF FEDERAL REGULATIONS
The Code of Federal Regulations is kept up to date by the individual
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To determine whether a Code volume has been amended since its
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EFFECTIVE AND EXPIRATION DATES
Each volume of the Code contains amendments published in the Federal
Register since the last revision of that volume of the Code. Source
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OMB CONTROL NUMBERS
The Paperwork Reduction Act of 1980 (Pub. L. 96-511) requires
Federal agencies to display an OMB control number with their information
collection request.
[[Page vi]]
Many agencies have begun publishing numerous OMB control numbers as
amendments to existing regulations in the CFR. These OMB numbers are
placed as close as possible to the applicable recordkeeping or reporting
requirements.
OBSOLETE PROVISIONS
Provisions that become obsolete before the revision date stated on
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appropriate numerical list of sections affected. For the period before
January 1, 2001, consult either the List of CFR Sections Affected, 1949-
1963, 1964-1972, 1973-1985, or 1986-2000, published in eleven separate
volumes. For the period beginning January 1, 2001, a ``List of CFR
Sections Affected'' is published at the end of each CFR volume.
``[RESERVED]'' TERMINOLOGY
The term ``[Reserved]'' is used as a place holder within the Code of
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INCORPORATION BY REFERENCE
What is incorporation by reference? Incorporation by reference was
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This material, like any other properly issued regulation, has the force
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What is a proper incorporation by reference? The Director of the
Federal Register will approve an incorporation by reference only when
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approval is based are:
(a) The incorporation will substantially reduce the volume of
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(b) The matter incorporated is in fact available to the extent
necessary to afford fairness and uniformity in the administrative
process.
(c) The incorporating document is drafted and submitted for
publication in accordance with 1 CFR part 51.
What if the material incorporated by reference cannot be found? If
you have any problem locating or obtaining a copy of material listed as
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CFR INDEXES AND TABULAR GUIDES
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this volume.
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that volume.
[[Page vii]]
The Federal Register Index is issued monthly in cumulative form.
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the revision dates of the 50 CFR titles.
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Michael L. White,
Acting Director,
Office of the Federal Register.
April 1, 2012.
[[Page ix]]
THIS TITLE
Title 21--Food and Drugs is composed of nine volumes. The parts in
these volumes are arranged in the following order: Parts 1-99, 100-169,
170-199, 200-299, 300-499, 500-599, 600-799, 800-1299 and 1300 to end.
The first eight volumes, containing parts 1-1299, comprise Chapter I--
Food and Drug Administration, Department of Health and Human Services.
The ninth volume, containing part 1300 to end, includes Chapter II--Drug
Enforcement Administration, Department of Justice, and Chapter III--
Office of National Drug Control Policy. The contents of these volumes
represent all current regulations codified under this title of the CFR
as of April 1, 2012.
For this volume, Jonn V. Lilyea was Chief Editor. The Code of
Federal Regulations publication program is under the direction of
Michael L. White, assisted by Ann Worley.
[[Page 1]]
TITLE 21--FOOD AND DRUGS
(This book contains parts 1 to 99)
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Part
chapter i--Food and Drug Administration, Department of
Health and Human Services................................. 1
[[Page 3]]
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
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Editorial Note: Nomenclature changes to chapter I appear at 66 FR
56035, Nov. 6, 2001, 69 FR 13717, Mar. 24, 2004, and 69 FR 18803, Apr.
9, 2004.
SUBCHAPTER A--GENERAL
Part Page
1 General enforcement regulations............. 5
2 General administrative rulings and decisions 50
3 Product jurisdiction........................ 56
5 Organization................................ 60
7 Enforcement policy.......................... 67
10 Administrative practices and procedures..... 77
11 Electronic records; electronic signatures... 111
12 Formal evidentiary public hearing........... 115
13 Public hearing before a public board of
inquiry................................. 133
14 Public hearing before a public advisory
committee............................... 137
15 Public hearing before the Commissioner...... 165
16 Regulatory hearing before the Food and Drug
Administration.......................... 167
17 Civil money penalties hearings.............. 174
19 Standards of conduct and conflicts of
interest................................ 188
20 Public information.......................... 191
21 Protection of privacy....................... 222
25 Environmental impact considerations......... 238
26 Mutual recognition of pharmaceutical good
manufacturing practice reports, medical
device quality system audit reports, and
certain medical device product
evaluation reports: United States and
the European Community.................. 250
50 Protection of human subjects................ 283
54 Financial disclosure by clinical
investigators........................... 295
56 Institutional Review Boards................. 298
58 Good laboratory practice for nonclinical
laboratory studies...................... 308
60 Patent term restoration..................... 321
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70 Color additives............................. 329
71 Color additive petitions.................... 336
73 Listing of color additives exempt from
certification........................... 343
74 Listing of color additives subject to
certification........................... 395
80 Color additive certification................ 435
81 General specifications and general
restrictions for provisional color
additives for use in foods, drugs, and
cosmetics............................... 441
82 Listing of certified provisionally listed
colors and specifications............... 448
83-98 [Reserved]
99 Dissemination of information on unapproved/
new uses for marketed drugs, biologics,
and devices............................. 453
[[Page 5]]
SUBCHAPTER A_GENERAL
PART 1_GENERAL ENFORCEMENT REGULATIONS--Table of Contents
Subpart A_General Provisions
Sec.
1.1 General.
1.3 Definitions.
1.4 Authority citations.
Subpart B_General Labeling Requirements
1.20 Presence of mandatory label information.
1.21 Failure to reveal material facts.
1.23 Procedures for requesting variations and exemptions from required
label statements.
1.24 Exemptions from required label statements.
Subparts C-D [Reserved]
Subpart E_Imports and Exports
1.83 Definitions.
1.90 Notice of sampling.
1.91 Payment for samples.
1.94 Hearing on refusal of admission.
1.95 Application for authorization to relabel and recondition.
1.96 Granting of authorization to relabel and recondition.
1.97 Bonds.
1.99 Costs chargeable in connection with relabeling and reconditioning
inadmissible imports.
1.101 Notification and recordkeeping.
Subparts F-G [Reserved]
Subpart H_Registration of Food Facilities
General Provisions
1.225 Who must register under this subpart?
1.226 Who does not have to register under this subpart?
1.227 What definitions apply to this subpart?
Procedures for Registration of Food Facilities
1.230 When must you register?
1.231 How and where do you register?
1.232 What information is required in the registration?
1.233 What optional items are included in the registration form?
1.234 How and when do you update your facility's registration
information?
1.235 How and when do you cancel your facility's registration
information?
Additional Provisions
1.240 What other registration requirements apply?
1.241 What are the consequences of failing to register, update, or
cancel your registration?
1.242 What does assignment of a registration number mean?
1.243 Is food registration information available to the public?
Subpart I_Prior Notice of Imported Food
General Provisions
1.276 What definitions apply to this subpart?
1.277 What is the scope of this subpart?
Requirements to Submit Prior Notice of Imported Food
1.278 Who is authorized to submit prior notice?
1.279 When must prior notice be submitted to FDA?
1.280 How must you submit prior notice?
1.281 What information must be in a prior notice?
1.282 What must you do if information changes after you have received
confirmation of a prior notice from FDA?
Consequences
1.283 What happens to food that is imported or offered for import
without adequate prior notice?
1.284 What are the other consequences of failing to submit adequate
prior notice or otherwise failing to comply with this subpart?
1.285 What happens to food that is imported or offered for import from
unregistered facilities that are required to register under
subpart H of this part?
Subpart J_Establishment, Maintenance, and Availability of Records
General Provisions
1.326 Who is subject to this subpart?
1.327 Who is excluded from all or part of the regulations in this
subpart?
1.328 What definitions apply to this subpart?
1.329 Do other statutory provisions and regulations apply?
1.330 Can existing records satisfy the requirements of this subpart?
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Requirements for Nontransporters To Establish and Maintain Records To
Identify the Nontransporter and Transporter Immediate Previous Sources
of Food
1.337 What information must nontransporters establish and maintain to
identify the nontransporter and transporter immediate previous
sources of food?
Requirements for Nontransporters To Establish and Maintain Records To
Identify the Nontransporter and Transporter Immediate Subsequent
Recipients of Food
1.345 What information must nontransporters establish and maintain to
identify the nontransporter and transporter immediate
subsequent recipients of food?
Requirements for Transporters To Establish and Maintain Records
1.352 What information must transporters establish and maintain?
General Requirements
1.360 What are the record retention requirements?
1.361 What are the record availability requirements?
1.362 What records are excluded from this subpart?
1.363 What are the consequences of failing to establish or maintain
records or make them available to FDA as required by this
subpart?
Compliance Dates
1.368 What are the compliance dates for this subpart?
Subpart K_Administrative Detention of Food for Human or Animal
Consumption
General Provisions
1.377 What definitions apply to this subpart?
1.378 What criteria does FDA use to order a detention?
1.379 How long may FDA detain an article of food?
1.380 Where and under what conditions must the detained article of food
be held?
1.381 May a detained article of food be delivered to another entity or
transferred to another location?
1.382 What labeling or marking requirements apply to a detained article
of food?
1.383 What expedited procedures apply when FDA initiates a seizure
action against a detained perishable food?
1.384 When does a detention order terminate?
How does FDA order a detention?
1.391 Who approves a detention order?
1.392 Who receives a copy of the detention order?
1.393 What information must FDA include in the detention order?
What is the appeal process for a detention order?
1.401 Who is entitled to appeal?
1.402 What are the requirements for submitting an appeal?
1.403 What requirements apply to an informal hearing?
1.404 Who serves as the presiding officer for an appeal, and for an
informal hearing?
1.405 When does FDA have to issue a decision on an appeal?
1.406 How will FDA handle classified information in an informal hearing?
Authority: 15 U.S.C. 1453, 1454, 1455; 19 U.S.C. 1490, 1491; 21
U.S.C. 321, 331, 333, 334, 335a, 343, 350c, 350d, 352, 355, 360b, 362,
371, 374, 381, 382, 387, 387a, 393; 42 U.S.C. 216, 241, 243, 262, 264.
Effective Date Note: At 77 FR 5176, Feb. 2, 2012, the authority
citation for part 1 was revised, effective April 2, 2012. For the
convenience of the user, the revised text is set forth as follows:
Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 1490,
1491; 21 U.S.C. 321, 331, 333, 334, 335a, 343, 350c, 350d, 352, 355,
360b, 362, 371, 374, 381, 382, 387, 387a, 387c, 393; 42 U.S.C. 216, 241,
243, 262, 264.
Source: 42 FR 15553, Mar. 22, 1977, unless otherwise noted.
Subpart A_General Provisions
Sec.1.1 General.
(a) The provisions of regulations promulgated under the Federal
Food, Drug, and Cosmetic Act with respect to the doing of any act shall
be applicable also to the causing of such act to be done.
(b) The definitions and interpretations of terms contained in
sections 201 and 900 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321 and 387) shall be applicable also to such terms when used in
regulations promulgated under that act.
(c) The definition of principal display panel in Sec. Sec.101.1,
201.60, 501.1, 701.10 and 801.60 of this chapter; and the requirements
pertaining to uniform location, lack of qualification, and separation of
the net quantity declaration in Sec. Sec.101.105(f), 201.62(e),
501.105(f), 701.13(f)
[[Page 7]]
and 801.62(e) of this chapter to type size requirements for net quantity
declaration in Sec. Sec.101.105(i), 201.62(h), 501.105(i), 701.13(i)
and 801.62(h) of this chapter, to initial statement of ounces in the
dual declaration of net quantity in Sec. Sec.101.105(j) and (m),
201.62(i) and (k), 501.105(j) and (m), 701.13(j) and (m) and 801.62(i)
and (k) of this chapter, to initial statement of inches in declaration
of net quantity in Sec. Sec.201.62(m), 701.13(o) and 801.62(m) of this
chapter, to initial statement of square inches in declaration of net
quantity in Sec. Sec.201.62(n), 701.13(p) and 801.62(n) of this
chapter, to prohibition of certain supplemental net quantity statements
in Sec. Sec.101.105(o), 201.62(o), 501.105(o), 701.13(q) and 801.62(o)
of this chapter, and to servings representations in Sec.501.8 of this
chapter are provided for solely by the Fair Packaging and Labeling Act.
The other requirements of this part are issued under both the Fair
Packaging and Labeling Act and the Federal Food, Drug, and Cosmetic Act,
or by the latter act solely, and are not limited in their application by
section 10 of the Fair Packaging and Labeling Act.
[42 FR 15553, Mar. 22, 1977, as amended at 58 FR 17085, Apr. 1, 1993; 75
FR 73953, Nov. 30, 2010]
Sec.1.3 Definitions.
(a) Labeling includes all written, printed, or graphic matter
accompanying an article at any time while such article is in interstate
commerce or held for sale after shipment or delivery in interstate
commerce.
(b) Label means any display of written, printed, or graphic matter
on the immediate container of any article, or any such matter affixed to
any consumer commodity or affixed to or appearing upon a package
containing any consumer commodity.
Sec.1.4 Authority citations.
(a) For each part of its regulations, the Food and Drug
Administration includes a centralized citation of all of the statutory
provisions that provide authority for any regulation that is included in
that part.
(b) The agency may rely on any one or more of the authorities that
are listed for a particular part in implementing or enforcing any
section in that part.
(c) All citations of authority in this chapter will list the
applicable sections in the organic statute if the statute is the Federal
Food, Drug, and Cosmetic Act, the Public Health Service Act, or the Fair
Packaging and Labeling Act. References to an act or a section thereof
include references to amendments to that act or section. These citations
will also list the corresponding United States Code (U.S.C.) sections.
For example, a citation to section 701 of the Federal Food, Drug, and
Cosmetic Act would be listed: Sec. 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 371).
(d) If the organic statute is one other than those specified in
paragraph (c) of this section, the citations of authority in this
chapter generally will list only the applicable U.S.C. sections. For
example, a citation to section 552 of the Administrative Procedure Act
would be listed: 5 U.S.C. 552. The agency may, where it determines that
such measures are in the interest of clarity and public understanding,
list the applicable sections in the organic statute and the
corresponding U.S.C. section in the same manner set out in paragraph (c)
of this section. References to an act or a section thereof include
references to amendments to that act or section.
(e) Where there is no U.S.C. provision, the agency will include a
citation to the U.S. Statutes at Large. Citations to the U.S. Statutes
at Large will refer to volume and page.
(f) The authority citations will include a citation to executive
delegations (i.e., Executive Orders), if any, necessary to link the
statutory authority to the agency.
[54 FR 39630, Sept. 27, 1989]
Subpart B_General Labeling Requirements
Sec.1.20 Presence of mandatory label information.
Except as otherwise provided by section 900(13) of the Family
Smoking Prevention and Tobacco Control Act (21 U.S.C. 387(13)) defining
``package,'' the term package means any container or wrapping in which
any food, drug,
[[Page 8]]
device, or cosmetic is enclosed for use in the delivery or display of
such commodities to retail purchasers, but does not include:
(a) Shipping containers or wrappings used solely for the
transportation of any such commodity in bulk or in quantity to
manufacturers, packers, processors, or wholesale or retail distributors;
(b) Shipping containers or outer wrappings used by retailers to ship
or deliver any such commodity to retail customers if such containers and
wrappings bear no printed matter pertaining to any particular commodity;
or
(c) Containers subject to the provisions of the Act of August 3,
1912 (37 Stat. 250, as amended; 15 U.S.C. 231-233), the Act of March 4,
1915 (38 Stat. 1186, as amended; 15 U.S.C. 234-236), the Act of August
31, 1916 (39 Stat. 673, as amended; 15 U.S.C. 251-256), or the Act of
May 21, 1928 (45 Stat. 635, as amended; 15 U.S.C. 257-257i).
(d) Containers used for tray pack displays in retail establishments.
(e) Transparent wrappers or containers which do not bear written,
printed, or graphic matter obscuring the label information required by
this part.
A requirement contained in this part that any word, statement, or other
information appear on the label shall not be considered to be complied
with unless such word, statement, or information also appears on the
outer container or wrapper of the retail package of the article, or, as
stated in paragraph (e) of this section, such information is easily
legible by virtue of the transparency of the outer wrapper or container.
Where a consumer commodity is marketed in a multiunit retail package
bearing the mandatory label information as required by this part and the
unit containers are not intended to be sold separately, the net weight
placement requirement of Sec.101.105(f) applicable to such unit
containers is waived if the units are in compliance with all the other
requirements of this part.
[42 FR 15553, Mar. 22, 1977, as amended at 75 FR 73953, Nov. 30, 2010]
Sec.1.21 Failure to reveal material facts.
(a) Labeling of a food, drug, device, or cosmetic shall be deemed to
be misleading if it fails to reveal facts that are:
(1) Material in light of other representations made or suggested by
statement, word, design, device or any combination thereof; or
(2) Material with respect to consequences which may result from use
of the article under: (i) The conditions prescribed in such labeling or
(ii) such conditions of use as are customary or usual.
(b) Affirmative disclosure of material facts pursuant to paragraph
(a) of this section may be required, among other appropriate regulatory
procedures, by
(1) Regulations in this chapter promulgated pursuant to section
701(a) of the act; or
(2) Direct court enforcement action.
(c) Paragraph (a) of this section does not:
(1) Permit a statement of differences of opinion with respect to
warnings (including contraindications, precautions, adverse reactions,
and other information relating to possible product hazards) required in
labeling for food, drugs, devices, or cosmetics under the act.
(2) Permit a statement of differences of opinion with respect to the
effectiveness of a drug unless each of the opinions expressed is
supported by substantial evidence of effectiveness as defined in
sections 505(d) and 512(d) of the act.
Effective Date Note: At 77 FR 5176, Feb. 2, 2012, Sec.1.21 was
amended by revising paragraph (a) introductory text and paragraph
(c)(1), effective April 2, 2012. For the convenience of the user, the
revised text is set forth as follows:
Sec.1.21 Failure to reveal material facts.
(a) Labeling of a food, drug, device, cosmetic, or tobacco product
shall be deemed to be misleading if it fails to reveal facts that are:
* * * * *
(c) * * *
(1) Permit a statement of differences of opinion with respect to
warnings (including contraindications, precautions, adverse reactions,
and other information relating to possible product hazards) required in
labeling
[[Page 9]]
for food, drugs, devices, cosmetics, or tobacco products under the
Federal Food, Drug, and Cosmetic Act.
* * * * *
Sec.1.23 Procedures for requesting variations and exemptions from required
label statements.
Section 403(e) of the act (in this part 1, the term act means the
Federal Food, Drug, and Cosmetic Act) provides for the establishment by
regulation of reasonable variations and exemptions for small packages
from the required declaration of net quantity of contents. Section
403(i) of the act provides for the establishment by regulation of
exemptions from the required declaration of ingredients where such
declaration is impracticable, or results in deception or unfair
competition. Section 502(b) of the act provides for the establishment by
regulation of reasonable variations and exemptions for small packages
from the required declaration of net quantity of contents. Section
602(b) of the act provides for the establishment by regulation of
reasonable variations and exemptions for small packages from the
required declaration of net quantity of contents. Section 5(b) of the
Fair Packaging and Labeling Act provides for the establishment by
regulation of exemptions from certain required declarations of net
quantity of contents, identity of commodity, identity and location of
manufacturer, packer, or distributor, and from declaration of net
quantity of servings represented, based on a finding that full
compliance with such required declarations is impracticable or not
necessary for the adequate protection of consumers, and a further
finding that the nature, form, or quantity of the packaged consumer
commodity or other good and sufficient reasons justify such exemptions.
The Commissioner, on his own initiative or on petition of an interested
person, may propose a variation or exemption based upon any of the
foregoing statutory provisions, including proposed findings if section
5(b) of the Fair Packaging and Labeling Act applies, pursuant to parts
10, 12, 13, 14, 15, 16, and 19 of this chapter.
Sec.1.24 Exemptions from required label statements.
The following exemptions are granted from label statements required
by this part:
(a) Foods. (1) While held for sale, a food shall be exempt from the
required declaration of net quantity of contents specified in this part
if said food is received in bulk containers at a retail establishment
and is accurately weighed, measured, or counted either within the view
of the purchaser or in compliance with the purchaser's order.
(2) Random food packages, as defined in Sec.101.105(j) of this
chapter, bearing labels declaring net weight, price per pound or per
specified number of pounds, and total price shall be exempt from the
type size, dual declaration, and placement requirements of Sec.101.105
of this chapter if the accurate statement of net weight is presented
conspicuously on the principal display panel of the package. In the case
of food packed in random packages at one place for subsequent shipment
and sale at another, the price sections of the label may be left blank
provided they are filled in by the seller prior to retail sale. This
exemption shall also apply to uniform weight packages of cheese and
cheese products labeled in the same manner and by the same type of
equipment as random food packages exempted by this paragraph (a)(2)
except that the labels shall bear a declaration of price per pound and
not price per specified number of pounds.
(3) Individual serving-size packages of foods containing less than
\1/2\ ounce or less than \1/2\ fluid ounce for use in restaurants,
institutions, and passenger carriers, and not intended for sale at
retail, shall be exempt from the required declaration of net quantity of
contents specified in this part.
(4) Individually wrapped pieces of penny candy and other
confectionery of less than one-half ounce net weight per individual
piece shall be exempt from the labeling requirements of this part when
the container in which such confectionery is shipped is in conformance
with the labeling requirements of this part. Similarly, when such
confectionery items are sold in bags or boxes,
[[Page 10]]
such items shall be exempt from the labeling requirements of this part,
including the required declaration of net quantity of contents specified
in this part when the declaration on the bag or box meets the
requirements of this part.
(5)(i) Soft drinks packaged in bottles shall be exempt from the
placement requirements for the statement of identity prescribed by Sec.
101.3 (a) and (d) of this chapter if such statement appears
conspicuously on the bottle closure. When such soft drinks are marketed
in a multiunit retail package, the multiunit retail package shall be
exempt from the statement of identity declaration requirements
prescribed by Sec.101.3 of this chapter if the statement of identity
on the unit container is not obscured by the multiunit retail package.
(ii) A multiunit retail package for soft drinks shall be exempt from
the declaration regarding name and place of business required by Sec.
101.5 of this chapter if the package does not obscure the declaration on
unit containers or if it bears a statement that the declaration can be
found on the unit containers and the declaration on the unit containers
complies with Sec.101.5 of this chapter. The declaration required by
Sec.101.5 of this chapter may appear on the top or side of the closure
of bottled soft drinks if the statement is conspicuous and easily
legible.
(iii) Soft drinks packaged in bottles which display other required
label information only on the closure shall be exempt from the placement
requirements for the declaration of contents prescribed by Sec.
101.105(f) of this chapter if the required content declaration is blown,
formed, or molded into the surface of the bottle in close proximity to
the closure.
(iv) Where a trademark on a soft drink package also serves as, or
is, a statement of identity, the use of such trademark on the package in
lines not parallel to the base on which the package rests shall be
exempted from the requirement of Sec.101.3(d) of this chapter that the
statement be in lines parallel to the base so long as there is also at
least one statement of identity in lines generally parallel to the base.
(v) A multiunit retail package for soft drinks in cans shall be
exempt from the declaration regarding name and place of business
required by Sec.101.5 of this chapter if the package does not obscure
the declaration on unit containers or if it bears a statement that the
declaration can be found on the unit containers and the declaration on
the unit containers complies with Sec.101.5 of this chapter. The
declaration required by Sec.101.5 of this chapter may appear on the
top of soft drinks in cans if the statement is conspicuous and easily
legible, provided that when the declaration is embossed, it shall appear
in type size at least one-eighth inch in height, or if it is printed,
the type size shall not be less than one-sixteenth inch in height. The
declaration may follow the curvature of the lid of the can and shall not
be removed or obscured by the tab which opens the can.
(6)(i) Ice cream, french ice cream, ice milk, fruit sherbets, water
ices, quiescently frozen confections (with or without dairy
ingredients), special dietary frozen desserts, and products made in
semblance of the foregoing, when measured by and packaged in \1/2\-
liquid pint and \1/2\-gallon measure-containers, as defined in the
``Measure Container Code of National Bureau of Standards Handbook 44,''
Specifications, Tolerances, and Other Technical Requirements for
Weighing and Measuring Devices, Sec. 4.45 ``Measure-Containers,'' which
is incorporated by reference, are exempt from the requirements of Sec.
101.105(b)(2) of this chapter to the extent that net contents of 8-fluid
ounces and 64-fluid ounces (or 2 quarts) may be expressed as \1/2\ pint
and \1/2\ gallon, respectively. Copies are available from the Center for
Food Safety and Applied Nutrition (HFS-150), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or at
the National Archives and Records Administration (NARA). For information
on the availability of this material at NARA, call 202-741-6030, or go
to: http://www.archives.gov/federal--register/code--of--federal--
regulations/ibr--locations.html.
(ii) The foods named in paragraph (a)(6)(i) of this section, when
measured by and packaged in 1-liquid pint, 1-liquid quart, and \1/2\-
gallon measure-containers, as defined in the ``Measure Container Code of
National Bureau of
[[Page 11]]
Standards Handbook 44,'' Specifications, Tolerances, and Other Technical
Requirements for Weighing and Measuring Devices, Sec. 4.45 ``Measure-
Containers,'' which is incorporated by reference, are exempt from the
dual net-contents declaration requirement of Sec.101.105(j) of this
chapter. Copies are available from the Center for Food Safety and
Applied Nutrition (HFS-150), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740, or at the National Archives and
Records Administration (NARA). For information on the availability of
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal--register/code--of--federal--regulations/ibr--
locations.html.
(iii) The foods named in paragraph (a)(6)(i) of this section, when
measured by and packaged in \1/2\-liquid pint, 1-liquid pint, 1-liquid
quart, \1/2\-gallon, and 1-gallon measured-containers, as defined in the
``Measure Container Code of National Bureau of Standards Handbook 44,''
Specifications, Tolerances, and Other Technical Requirements for
Weighing and Measuring Devices, Sec. 4.45 ``Measure-Containers,'' which
is incorporated by reference, are exempt from the requirement of Sec.
101.105(f) of this chapter that the declaration of net contents be
located within the bottom 30 percent of the principal display panel.
Copies are available from the Center for Food Safety and Applied
Nutrition (HFS-150), Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, or at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal--register/code--of--federal--regulations/ibr--locations.html.
(7)(i) Milk, cream, light cream, coffee or table cream, whipping
cream, light whipping cream, heavy or heavy whipping cream, sour or
cultured sour cream, half-and-half, sour or cultured half-and-half,
reconstituted or recombined milk and milk products, concentrated milk
and milk products, skim or skimmed milk, vitamin D milk and milk
products, fortified milk and milk products, homogenized milk, flavored
milk and milk products, buttermilk, cultured buttermilk, cultured milk
or cultured whole buttermilk, low-fat milk (0.5 to 2.0 percent
butterfat), and acidified milk and milk products, when packaged in
containers of 8- and 64-fluid-ounce capacity, are exempt from the
requirements of Sec.101.105(b)(2) of this chapter to the extent that
net contents of 8 fluid ounces and 64 fluid ounces (or 2 quarts) may be
expressed as \1/2\ pint and \1/2\ gallon, respectively.
(ii) The products listed in paragraph (a)(7)(i) of this section,
when packaged in glass or plastic containers of \1/2\-pint, 1-pint, 1-
quart, \1/2\-gallon, and 1-gallon capacities are exempt from the
placement requirement of Sec.101.105(f) of this chapter that the
declaration of net contents be located within the bottom 30 percent of
the principal display panel, provided that other required label
information is conspicuously displayed on the cap or outside closure and
the required net quantity of contents declaration is conspicuously
blown, formed, or molded into or permanently applied to that part of the
glass or plastic container that is at or above the shoulder of the
container.
(iii) The products listed in paragraph (a)(7)(i) of this section,
when packaged in containers of 1-pint, 1-quart, and \1/2\-gallon
capacities are exempt from the dual net-contents declaration requirement
of Sec.101.105(j) of this chapter.
(8) Wheat flour products, as defined by Sec. Sec.137.105, 137.155,
137.160, 137.165, 137.170, 137.175, 137.180, 137.185, 137.200, and
137.205 of this chapter, packaged:
(i) In conventional 2-, 5-, 10-, 25-, 50-, and 100-pound packages
are exempt from the placement requirement of Sec.101.105(f) of this
chapter that the declaration of net contents be located within the
bottom 30 percent of the area of the principal display panel of the
label; and
(ii) In conventional 2-pound packages are exempt from the dual net-
contents declaration requirement of Sec.101.105(j) of this chapter
provided the quantity of contents is expressed in pounds.
(9)(i) Twelve shell eggs packaged in a carton designed to hold 1
dozen eggs and designed to permit the division of such carton by the
retail customer at the place of purchase into two portions
[[Page 12]]
of one-half dozen eggs each are exempt from the labeling requirements of
this part with respect to each portion of such divided carton if the
carton, when undivided, is in conformance with the labeling requirements
of this part.
(ii) Twelve shell eggs packaged in a carton designed to hold 1 dozen
eggs are exempt from the placement requirements for the declaration of
contents prescribed by Sec.101.105(f) of this chapter if the required
content declaration is otherwise placed on the principal display panel
of such carton and if, in the case of such cartons designed to permit
division by retail customers into two portions of one-half dozen eggs
each, the required content declaration is placed on the principal
display panel in such a manner that the context of the content
declaration is destroyed upon division of the carton.
(10) Butter as defined in 42 Stat. 1500 (excluding whipped butter):
(i) In 8-ounce and in 1-pound packages is exempt from the
requirements of Sec.101.105(f) of this chapter that the net contents
declaration be placed within the bottom 30 percent of the area of the
principal display panel;
(ii) In 1-pound packages is exempt from the requirements of Sec.
101.105(j)(1) of this chapter that such declaration be in terms of
ounces and pounds, to permit declaration of ``1-pound'' or ``one
pound''; and
(iii) In 4-ounce, 8-ounce, and 1-pound packages with continuous
label copy wrapping is exempt from the requirements of Sec. Sec.101.3
and 101.105(f) of this chapter that the statement of identity and net
contents declaration appear in lines generally parallel to the base on
which the package rests as it is designed to be displayed, provided that
such statement and declaration are not so positioned on the label as to
be misleading or difficult to read as the package is customarily
displayed at retail.
(11) Margarine as defined in Sec.166.110 of this chapter and
imitations thereof in 1-pound rectangular packages, except for packages
containing whipped or soft margarine or packages that contain more than
four sticks, are exempt from the requirement of Sec.101.105(f) of this
chapter that the declaration of the net quantity of contents appear
within the bottom 30 percent of the principal display panel and from the
requirement of Sec.101.105(j)(1) of this chapter that such declaration
be expressed both in ounces and in pounds to permit declaration of ``1-
pound'' or ``one pound,'' provided an accurate statement of net weight
appears conspicuously on the principal display panel of the package.
(12) Corn flour and related products, as they are defined by
Sec. Sec.137.211, 137.215, and Sec. Sec.137.230 through 137.290 of
this chapter, packaged in conventional 5-, 10-, 25-, 50-, and 100-pound
bags are exempt from the placement requirement of Sec.101.105(f) of
this chapter that the declaration of net contents be located within the
bottom 30 percent of the area of the principal display panel of the
label.
(13)(i) Single strength and less than single strength fruit juice
beverages, imitations thereof, and drinking water when packaged in glass
or plastic containers of \1/2\-pint, 1-pint, 1-quart, \1/2\-gallon, and
1-gallon capacities are exempt from the placement requirement of Sec.
101.105(f) of this chapter that the declaration of net contents be
located within the bottom 30 percent of the principal display panel:
Provided, That other required label information is conspicuously
displayed on the cap or outside closure and the required net quantity of
contents declaration is conspicuously blown, formed, or molded into or
permanently applied to that part of the glass or plastic container that
is at or above the shoulder of the container.
(ii) Single strength and less than single strength fruit juice
beverages, imitations thereof, and drinking water when packaged in
glass, plastic, or paper (fluid milk type) containers of 1-pint, 1-
quart, and \1/2\-gallon capacities are exempt from the dual net-contents
declaration requirement of Sec.101.105(j) of this chapter.
(iii) Single strength and less than single strength fruit juice
beverages, imitations thereof, and drinking water when packaged in
glass, plastic, or paper (fluid milk type) containers of 8- and 64-
fluid-ounce capacity, are exempt from the requirements of Sec.
101.105(b)(2) of this chapter to the extent that net contents of 8 fluid
ounces and 64 fluid ounces (or 2 quarts) may be
[[Page 13]]
expressed as \1/2\ pint (or half pint) and \1/2\ gallon (or half
gallon), respectively.
(14) The unit containers in a multiunit or multicomponent retail
food package shall be exempt from regulations of section 403 (e)(1),
(g)(2), (i)(2), (k), and (q) of the act with respect to the requirements
for label declaration of the name and place of business of the
manufacturer, packer, or distributor; label declaration of ingredients;
and nutrition information when:
(i) The multiunit or multicomponent retail food package labeling
meets all the requirements of this part;
(ii) The unit containers are securely enclosed within and not
intended to be separated from the retail package under conditions of
retail sale; and
(iii) Each unit container is labeled with the statement ``This Unit
Not Labeled For Retail Sale'' in type size not less than one-sixteenth
of an inch in height. The word ``Individual'' may be used in lieu of or
immediately preceding the word ``Retail'' in the statement.
(b) Drugs. Liquid over-the-counter veterinary preparations intended
for injection shall be exempt from the declaration of net quantity of
contents in terms of the U.S. gallon of 231 cubic inches and quart,
pint, and fluid-ounce subdivisions thereof as required by Sec.201.62
(b), (i), and (j) of this chapter, and from the dual declaration
requirements of Sec.201.62(i) of this chapter, if such declaration of
net quantity of contents is expressed in terms of the liter and
milliliter, or cubic centimeter, with the volume expressed at 68 [deg]F
(20 [deg]C).
(c) Cosmetics. Cosmetics in packages containing less than one-fourth
ounce avoirdupois or one-eighth fluid ounce shall be exempt from
compliance with the requirements of section 602(b)(2) of the Federal
Food, Drug, and Cosmetic Act and section 4(a)(2) of the Fair Packaging
and Labeling Act:
(1) When such cosmetics are affixed to a display card labeled in
conformance with all labeling requirements of this part; or
(2) When such cosmetics are sold at retail as part of a cosmetic
package consisting of an inner and outer container and the inner
container is not for separate retail sale and the outer container is
labeled in conformance with all labeling requirements of this part.
[42 FR 15553, Mar. 22, 1977, as amended at 47 FR 946, Jan. 8, 1982; 47
FR 32421, July 27, 1982; 49 FR 13339, Apr. 4, 1984; 54 FR 9033, Mar. 3,
1989; 58 FR 2174, Jan. 6, 1993; 61 FR 14478, Apr. 2, 1996; 66 FR 56035,
Nov. 6, 2001]
Subparts C-D [Reserved]
Subpart E_Imports and Exports
Sec.1.83 Definitions.
For the purposes of regulations prescribed under section 801(a),
(b), and (c) of the Federal Food, Drug, and Cosmetic Act:
(a) The term owner or consignee means the person who has the rights
of a consignee under the provisions of sections 483, 484, and 485 of the
Tariff Act of 1930, as amended (19 U.S.C. 1483, 1484, 1485).
(b) The term district director means the director of the district of
the Food and Drug Administration having jurisdiction over the port of
entry through which an article is imported or offered for import, or
such officer of the district as he may designate to act in his behalf in
administering and enforcing the provisions of section 801 (a), (b), and
(c).
Sec.1.90 Notice of sampling.
When a sample of an article offered for import has been requested by
the district director, the collector of customs having jurisdiction over
the article shall give to the owner or consignee prompt notice of
delivery of, or intention to deliver, such sample. Upon receipt of the
notice, the owner or consignee shall hold such article and not
distribute it until further notice from the district director or the
collector of customs of the results of examination of the sample.
Sec.1.91 Payment for samples.
The Food and Drug Administration will pay for all import samples
which are found to be in compliance with the requirements of the Federal
Food, Drug, and Cosmetic Act. Billing for reimbursement should be made
by the owner or consignee to the Food and
[[Page 14]]
Drug Administration district headquarters in whose territory the
shipment was offered for import. Payment for samples will not be made if
the article is found to be in violation of the act, even though
subsequently brought into compliance under the terms of an authorization
to bring the article into compliance or rendered not a food, drug,
device, or cosmetic as set forth in Sec.1.95.
Sec.1.94 Hearing on refusal of admission.
(a) If it appears that the article may be subject to refusal of
admission, the district director shall give the owner or consignee a
written notice to that effect, stating the reasons therefor. The notice
shall specify a place and a period of time during which the owner or
consignee shall have an opportunity to introduce testimony. Upon timely
request giving reasonable grounds therefor, such time and place may be
changed. Such testimony shall be confined to matters relevant to the
admissibility of the article, and may be introduced orally or in
writing.
(b) If such owner or consignee submits or indicates his intention to
submit an application for authorization to relabel or perform other
action to bring the article into compliance with the act or to render it
other than a food, drug, device, or cosmetic, such testimony shall
include evidence in support of such application. If such application is
not submitted at or prior to the hearing, the district director shall
specify a time limit, reasonable in the light of the circumstances, for
filing such application.
Sec.1.95 Application for authorization to relabel and recondition.
Application for authorization to relabel or perform other action to
bring the article into compliance with the act or to render it other
than a food, drug, device or cosmetic may be filed only by the owner or
consignee, and shall:
(a) Contain detailed proposals for bringing the article into
compliance with the act or rendering it other than a food, drug, device,
or cosmetic.
(b) Specify the time and place where such operations will be carried
out and the approximate time for their completion.
Sec.1.96 Granting of authorization to relabel and recondition.
(a) When authorization contemplated by Sec.1.95 is granted, the
district director shall notify the applicant in writing, specifying:
(1) The procedure to be followed;
(2) The disposition of the rejected articles or portions thereof;
(3) That the operations are to be carried out under the supervision
of an officer of the Food and Drug Administration or the U.S. Customs
Service, as the case may be;
(4) A time limit, reasonable in the light of the circumstances, for
completion of the operations; and
(5) Such other conditions as are necessary to maintain adequate
supervision and control over the article.
(b) Upon receipt of a written request for extension of time to
complete such operations, containing reasonable grounds therefor, the
district director may grant such additional time as he deems necessary.
(c) An authorization may be amended upon a showing of reasonable
grounds therefor and the filing of an amended application for
authorization with the district director.
(d) If ownership of an article covered by an authorization changes
before the operations specified in the authorization have been
completed, the original owner will be held responsible, unless the new
owner has executed a bond and obtained a new authorization. Any
authorization granted under this section shall supersede and nullify any
previously granted authorization with respect to the article.
[42 FR 15553, Mar. 22, 1977, as amended at 54 FR 9033, Mar. 3, 1989]
Sec.1.97 Bonds.
(a) The bonds required under section 801(b) of the act may be
executed by the owner or consignee on the appropriate form of a customs
single-entry or term bond, containing a condition for the redelivery of
the merchandise or any part thereof upon demand of the collector of
customs and containing a provision for the performance of conditions as
may legally be imposed for the
[[Page 15]]
relabeling or other action necessary to bring the article into
compliance with the act or rendering it other than a food, drug, device,
or cosmetic, in such manner as is prescribed for such bond in the
customs regulations in force on the date of request for authorization.
The bond shall be filed with the collector of customs.
(b) The collector of customs may cancel the liability for liquidated
damages incurred under the above-mentioned provisions of such a bond, if
he receives an application for relief therefrom, upon the payment of a
lesser amount or upon such other terms and conditions as shall be deemed
appropriate under the law and in view of the circumstances, but the
collector shall not act under this regulation in any case unless the
district director is in full agreement with the action.
Sec.1.99 Costs chargeable in connection with relabeling and reconditioning
inadmissible imports.
The cost of supervising the relabeling or other action in connection
with an import of food, drugs, devices, or cosmetics which fails to
comply with the Federal Food, Drug, and Cosmetic Act shall be paid by
the owner or consignee who files an application requesting such action
and executes a bond, pursuant to section 801(b) of the act, as amended.
The cost of such supervision shall include, but not be restricted to,
the following:
(a) Travel expenses of the supervising officer.
(b) Per diem in lieu of subsistence of the supervising officer when
away from his home station, as provided by law.
(c) The charge for the services of the supervising officer, which
shall include administrative support, shall be computed at a rate per
hour equal to 266 percent of the hourly rate of regular pay of a grade
GS-11/4 employee, except that such services performed by a customs
officer and subject to the provisions of the act of February 13, 1911,
as amended (sec. 5, 36 Stat. 901, as amended (19 U.S.C. 267)), shall be
calculated as provided in that act.
(d) The charge for the service of the analyst, which shall include
administrative and laboratory support, shall be computed at a rate per
hour equal to 266 percent of the hourly rate of regular pay of a grade
GS-12/4 employee. The rate per hour equal to 266 percent of the
equivalent hourly rate of regular pay of the supervising officer (GS-11/
4) and the analyst (GS-12/4) is computed as follows:
Hours
Gross number of working hours in 52 40-hr weeks................ 2,080
Less:
9 legal public holidays--New Years Day, Washington's 72
Birthday, Memorial Day, Independence Day, Labor Day,
Columbus Day, Veterans Day, Thanksgiving Day, and Christmas
Day.........................................................
Annual leave--26 d........................................... 208
Sick leave--13 d............................................. 104
--------
Total.................................................... 384
Net number of working hours.............................. 1,696
Gross number of working hours in 52 40-hr weeks................ 2,080
Working hour equivalent of Government contributions for 176
employee retirement, life insurance, and health benefits
computed at 8\1/2\ pct. of annual rate of pay of employee.....
--------
Equivalent annual working hours.......................... 2,256
--------
Support required to equal to 1 man-year........................ 2,256
Equivalent gross annual working hours charged to Food and 4,512
Drug appropriation......................................
Note: Ratio of equivalent gross annual number of working hours
charged to Food and Drug appropriation to net number of annual working
hours 4,512/1,696=266 pct.
(e) The minimum charge for services of supervising officers and of
analysts shall be not less than the charge for 1 hour, and time after
the first hour shall be computed in multiples of 1 hour, disregarding
fractional parts less than \1/2\ hour.
Sec.1.101 Notification and recordkeeping.
(a) Scope. This section pertains to notifications and records
required for human drug, biological product, device, animal drug, food,
and cosmetic exports under sections 801 or 802 of the Federal Food,
Drug, and Cosmetic Act (the act) or (21 U.S.C. 381 and 382) or section
351 of the Public Health Service Act (42 U.S.C. 262).
(b) Recordkeeping requirements for human drugs, biological products,
devices, animal drugs, foods, and cosmetics exported under or subject to
section 801(e)(1) of the act. Persons exporting an article under section
801(e)(1) of the act or an article otherwise subject to section
801(e)(1) of the act shall maintain records as enumerated in paragraphs
[[Page 16]]
(b)(1) through (b)(4) of this section demonstrating that the product
meets the requirements of section 801(e)(1) of the act. Such records
shall be maintained for the same period of time as required for records
subject to good manufacturing practice or quality systems regulations
applicable to the product, except that records pertaining to the export
of foods and cosmetics under section 801(e)(1) of the act shall be kept
for 3 years after the date of exportation. The records shall be made
available to the Food and Drug Administration (FDA), upon request,
during an inspection for review and copying by FDA.
(1) Records demonstrating that the product meets the foreign
purchaser's specifications: The records must contain sufficient
information to match the foreign purchaser's specifications to a
particular export;
(2) Records demonstrating that the product does not conflict with
the laws of the importing country: This may consist of either a letter
from an appropriate foreign government agency, department, or other
authorized body stating that the product has marketing approval from the
foreign government or does not conflict with that country's laws, or a
notarized certification by a responsible company official in the United
States that the product does not conflict with the laws of the importing
country and that includes a statement acknowledging that he or she is
subject to the provisions of 18 U.S.C. 1001;
(3) Records demonstrating that the product is labeled on the outside
of the shipping package that it is intended for export: This may consist
of copies of any labels or labeling statements, such as ``For export
only,'' that are placed on the shipping packages or, if the exported
product does not have a shipping package or container, on shipping
invoices or other documents accompanying the exported product; and
(4) Records demonstrating that the product is not sold or offered
for sale in the United States: This may consist of production and
shipping records for the exported product and promotional materials.
(c) Additional recordkeeping requirements for partially processed
biological products exported under section 351(h) of the Public Health
Service Act. In addition to the requirements in paragraph (b) of this
section, persons exporting a partially processed biological product
under section 351(h) of the Public Health Service Act shall maintain,
for the same period of time as required for records subject to good
manufacturing practice or quality systems regulations applicable to the
product, and make available to FDA, upon request, during an inspection
for review and copying by FDA, the following records:
(1) Records demonstrating that the product for export is a partially
processed biological product and not in a form applicable to the
prevention, treatment, or cure of diseases or injuries of man;
(2) Records demonstrating that the partially processed biological
product was manufactured in conformity with current good manufacturing
practice requirements;
(3) Records demonstrating the distribution of the exported partially
processed biological products; and
(4) Copies of all labeling that accompanies the exported partially
processed biological product and other records demonstrating that the
exported partially processed biological product is intended for further
manufacture into a final dosage form outside the United States; this may
include a container label with the statement, ``Caution: For Further
Manufacturing Use Only'' and any package insert.
(d) Notification requirements for drugs, biological products, and
devices exported under section 802 of the act. (1) Persons exporting a
human drug, biological product, or device under section 802 of the act,
other than a drug, biological product, or device for investigational use
exported under section 802(c) of the act, or a drug, biological product,
or device exported in anticipation of marketing authorization under
section 802(d) of the act, shall provide written notification to FDA.
The notification shall identify:
(i) The product's trade name;
(ii) If the product is a drug or biological product, the product's
abbreviated or proper name or, if the product is a device, the type of
device;
[[Page 17]]
(iii) If the product is a drug or biological product, a description
of the product's strength and dosage form or, if the product is a
device, the product's model number; and
(iv) If the export is to a country not listed in section 802(b)(1)
of the act, the country that is to receive the exported article. The
notification may, but is not required to, identify countries listed in
section 802(b)(1) of the act or state that the export is intended for a
listed country without identifying the listed country.
(2) The notification shall be sent to the following addresses:
(i) For biological products and devices regulated by the Center for
Biologics Evaluation and Research--Division of Case Management (HFM-
610), Office of Compliance and Biologics Quality, Center for Biologics
Evaluation and Research, Food and Drug Administration, 1401 Rockville
Pike, suite 200N, Rockville, MD 20852-1448.
(ii) For human drug products, biological products, and devices
regulated by the Center for Drug Evaluation and Research--Division of
New Drugs and Labeling Compliance, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver
Spring, MD 20993-0002.
(iii) For devices--Food and Drug Administration, Center for Devices
and Radiological Health, Division of Program Operations, 10903 New
Hampshire Ave., Bldg. 66, rm. 5429, Silver Spring, MD 20993-0002.
(e) Recordkeeping requirements for products subject to section
802(g) of the act. (1) Any person exporting a product under any
provision of section 802 of the act shall maintain records of all drugs,
biological products, and devices exported and the countries to which the
products were exported. In addition to the requirements in paragraph (b)
of this section, such records include, but are not limited to, the
following:
(i) The product's trade name;
(ii) If the product is a drug or biological product, the product's
abbreviated or proper name or, if the product is a device, the type of
device;
(iii) If the product is a drug or biological product, a description
of its strength and dosage form and the product's lot or control number
or, if the product is a device, the product's model number;
(iv) The consignee's name and address; and
(v) The date on which the product was exported and the quantity of
product exported.
(2) These records shall be kept at the site from which the products
were exported or manufactured, and be maintained for the same period of
time as required for records subject to good manufacturing practice or
quality systems regulations applicable to the product. The records shall
be made available to FDA, upon request, during an inspection for review
and copying by FDA.
[66 FR 65447, Dec. 19, 2001, as amended at 69 FR 48774, Aug. 11, 2004;
70 FR 14980, Mar. 24, 2005; 74 FR 13112, Mar. 26, 2009; 75 FR 20914,
Apr. 22, 2010]
Effective Date Note: At 77 FR 5176, Feb. 2, 2012, Sec.1.101 was
amended by revising paragraph (a) and the heading of paragraph (b),
effective Apr. 2, 2012. For the convenience of the user, the revised
text is set forth as follows:
Sec.1.101 Notification and recordkeeping.
(a) Scope. This section pertains to notifications and records
required for human drug, biological product, device, animal drug, food,
cosmetic, and tobacco product exports under sections 801 or 802 of the
Federal Food, Drug, and Cosmetic Act or (21 U.S.C. 381 and 382) or
section 351 of the Public Health Service Act (42 U.S.C. 262).
(b) Recordkeeping requirements for human drugs, biological products,
devices, animal drugs, foods, cosmetics, and tobacco products exported
under or subject to section 801(e)(1) of the Federal Food, Drug, and
Cosmetic Act. * * *
* * * * *
Subparts F-G [Reserved]
Subpart H_Registration of Food Facilities
Source: 68 FR 58960, Oct. 10, 2003, unless otherwise noted.
[[Page 18]]
General Provisions
Sec.1.225 Who must register under this subpart?
(a) You must register your facility under this subpart if you are
the owner, operator, or agent in charge of either a domestic or foreign
facility, as defined in this subpart, and your facility is engaged in
the manufacturing/processing, packing, or holding of food for
consumption in the United States, unless your facility qualifies for one
of the exemptions in Sec.1.226.
(b) If you are an owner, operator, or agent in charge of a domestic
facility, you must register your facility whether or not the food from
the facility enters interstate commerce.
(c) If you are the owner, operator, or agent in charge of a
facility, you may authorize an individual to register your facility on
your behalf.
Sec.1.226 Who does not have to register under this subpart?
This subpart does not apply to the following facilities:
(a) A foreign facility, if food from such facility undergoes further
manufacturing/processing (including packaging) by another facility
outside the United States. A facility is not exempt under this provision
if the further manufacturing/processing (including packaging) conducted
by the subsequent facility consists of adding labeling or any similar
activity of a de minimis nature;
(b) Farms;
(c) Retail food establishments;
(d) Restaurants;
(e) Nonprofit food establishments in which food is prepared for, or
served directly to, the consumer;
(f) Fishing vessels, including those that not only harvest and
transport fish but also engage in practices such as heading,
eviscerating, or freezing intended solely to prepare fish for holding on
board a harvest vessel. However, those fishing vessels otherwise engaged
in processing fish are subject to this subpart. For the purposes of this
section, ``processing'' means handling, storing, preparing, shucking,
changing into different market forms, manufacturing, preserving,
packing, labeling, dockside unloading, holding, or heading,
eviscerating, or freezing other than solely to prepare fish for holding
on board a harvest vessel;
(g) Facilities that are regulated exclusively, throughout the entire
facility, by the U.S. Department of Agriculture under the Federal Meat
Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection
Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21
U.S.C. 1031 et seq.);
Sec.1.227 What definitions apply to this subpart?
(a) The act means the Federal Food, Drug, and Cosmetic Act.
(b) In addition, for the purposes of this subpart:
(1) Calendar day means every day shown on the calendar.
(2) Facility means any establishment, structure, or structures under
one ownership at one general physical location, or, in the case of a
mobile facility, traveling to multiple locations, that manufactures/
processes, packs, or holds food for consumption in the United States.
Transport vehicles are not facilities if they hold food only in the
usual course of business as carriers. A facility may consist of one or
more contiguous structures, and a single building may house more than
one distinct facility if the facilities are under separate ownership.
The private residence of an individual is not a facility. Nonbottled
water drinking water collection and distribution establishments and
their structures are not facilities.
(i) Domestic facility means any facility located in any State or
Territory of the United States, the District of Columbia, or the
Commonwealth of Puerto Rico that manufactures/processes, packs, or holds
food for consumption in the United States.
(ii) Foreign facility means a facility other than a domestic
facility that manufactures/processes, packs, or holds food for
consumption in the United States.
(3) Farm means a facility in one general physical location devoted
to the growing and harvesting of crops, the raising of animals
(including seafood), or both. Washing, trimming of outer leaves of, and
cooling produce are considered part of harvesting. The term ``farm''
includes:
[[Page 19]]
(i) Facilities that pack or hold food, provided that all food used
in such activities is grown, raised, or consumed on that farm or another
farm under the same ownership; and
(ii) Facilities that manufacture/process food, provided that all
food used in such activities is consumed on that farm or another farm
under the same ownership.
(4) Food has the meaning given in section 201(f) of the act (21
U.S.C. 321(f)),
(i) Except for purposes of this subpart, it does not include:
(A) Food contact substances as defined in section 409(h)(6) of the
act (21 U.S.C. 348(h)(6)), or
(B) Pesticides as defined in 7 U.S.C. 136(u).
(ii) Examples of food include fruits, vegetables, fish, dairy
products, eggs, raw agricultural commodities for use as food or as
components of food, animal feed (including pet food), food and feed
ingredients, food and feed additives, dietary supplements and dietary
ingredients, infant formula, beverages (including alcoholic beverages
and bottled water), live food animals, bakery goods, snack foods, candy,
and canned foods.
(5) Holding means storage of food. Holding facilities include
warehouses, cold storage facilities, storage silos, grain elevators, and
liquid storage tanks.
(6) Manufacturing/processing means making food from one or more
ingredients, or synthesizing, preparing, treating, modifying or
manipulating food, including food crops or ingredients. Examples of
manufacturing/processing activities are cutting, peeling, trimming,
washing, waxing, eviscerating, rendering, cooking, baking, freezing,
cooling, pasteurizing, homogenizing, mixing, formulating, bottling,
milling, grinding, extracting juice, distilling, labeling, or packaging.
(7) Nonprofit food establishment means a charitable entity that
prepares or serves food directly to the consumer or otherwise provides
food or meals for consumption by humans or animals in the United States.
The term includes central food banks, soup kitchens, and nonprofit food
delivery services. To be considered a nonprofit food establishment, the
establishment must meet the terms of section 501(c)(3) of the U.S.
Internal Revenue Code (26 U.S.C. 501(c)(3)).
(8) Packaging (when used as a verb) means placing food into a
container that directly contacts the food and that the consumer
receives.
(9) Packing means placing food into a container other than packaging
the food.
(10) Restaurant means a facility that prepares and sells food
directly to consumers for immediate consumption. ``Restaurant'' does not
include facilities that provide food to interstate conveyances, central
kitchens, and other similar facilities that do not prepare and serve
food directly to consumers.
(i) Entities in which food is provided to humans, such as
cafeterias, lunchrooms, cafes, bistros, fast food establishments, food
stands, saloons, taverns, bars, lounges, catering facilities, hospital
kitchens, day care kitchens, and nursing home kitchens are restaurants;
and
(ii) Pet shelters, kennels, and veterinary facilities in which food
is provided to animals are restaurants.
(11) Retail food establishment means an establishment that sells
food products directly to consumers as its primary function. A retail
food establishment may manufacture/process, pack, or hold food if the
establishment's primary function is to sell from that establishment
food, including food that it manufactures/processes, packs, or holds,
directly to consumers. A retail food establishment's primary function is
to sell food directly to consumers if the annual monetary value of sales
of food products directly to consumers exceeds the annual monetary value
of sales of food products to all other buyers. The term ``consumers''
does not include businesses. A ``retail food establishment'' includes
grocery stores, convenience stores, and vending machine locations.
(12) Trade name means the name or names under which the facility
conducts business, or additional names by which the facility is known. A
trade name is associated with a facility, and a brand name is associated
with a product.
[[Page 20]]
(13) U.S. agent means a person (as defined in section 201(e) of the
act (21 U.S.C. 321(e))) residing or maintaining a place of business in
the United States whom a foreign facility designates as its agent for
purposes of this subpart. A U.S. agent cannot be in the form of a
mailbox, answering machine or service, or other place where an
individual acting as the foreign facility's agent is not physically
present.
(i) The U.S. agent acts as a communications link between FDA and the
foreign facility for both emergency and routine communications. The U.S.
agent will be the person FDA contacts when an emergency occurs, unless
the registration specifies under Sec.1.233(e) another emergency
contact.
(ii) FDA will treat representations by the U.S. agent as those of
the foreign facility, and will consider information or documents
provided to the U.S. agent the equivalent of providing the information
or documents to the foreign facility.
(iii) Having a single U.S. agent for the purposes of this subpart
does not preclude facilities from having multiple agents (such as
foreign suppliers) for other business purposes. A firm's commercial
business in the United States need not be conducted through the U.S.
agent designated for purposes of this subpart.
(14) You or registrant means the owner, operator, or agent in charge
of a facility that manufactures/processes, packs, or holds food for
consumption in the United States.
Procedures for Registration of Food Facilities
Sec.1.230 When must you register?
The owner, operator, or agent in charge of a facility that
manufactures/processes, packs or holds food for consumption in the
United States must register the facility no later than December 12,
2003. The owner, operator, or agent in charge of a facility that begins
to manufacture/process, pack, or hold food for consumption in the United
States on or after December 12, 2003, must register before the facility
begins such activities. An owner, operator, or agent in charge of a
facility may authorize an individual to register the facility on its
behalf.
Sec.1.231 How and where do you register?
(a) Electronic registration. (1) To register electronically, you
must register at http://www.fda.gov/furls, which is available for
registration 24 hours a day, 7 days a week. This website is available
from wherever the Internet is accessible, including libraries, copy
centers, schools, and Internet cafes. An individual authorized by the
owner, operator, or agent in charge of a facility may also register a
facility electronically.
(2) FDA strongly encourages electronic registration for the benefit
of both FDA and the registrant.
(3) Once you complete your electronic registration, FDA will
automatically provide you with an electronic confirmation of
registration and a permanent registration number.
(4) You will be considered registered once FDA electronically
transmits your confirmation and registration number.
(b) Registration by mail or fax. If, for example, you do not have
reasonable access to the Internet through any of the methods described
in paragraph (a) of this section, you may register by mail or fax.
(1) You must register using Form 3537. You may obtain a copy of this
form by writing to the U.S. Food and Drug Administration (HFS-681), 5600
Fishers Lane, Rockville, MD 20857 or by requesting a copy of this form
by phone at 1-800-216-7331 or 301-575-0156.
(2) When you receive the form, you must fill it out completely and
legibly and either mail it to the address in paragraph (b)(1) of this
section or fax it to 301-436-2804 or 1-800-573-0846.
(3) If any required information on the form is incomplete or
illegible when FDA receives it, FDA will return the form to you for
revision, provided that your mailing address or fax number is legible
and valid. When returning a registration form for revision, FDA will use
the means by which the form was received by the agency (i.e., by mail or
fax).
[[Page 21]]
(4) FDA will enter complete and legible mailed and faxed
registration submissions into its registration system, along with CD-ROM
submissions, as soon as practicable, in the order FDA receives them.
(5) FDA will then mail to the address or fax to the fax number on
the registration form a copy of the registration as entered,
confirmation of registration, and your registration number. When
responding to a registration submission, FDA will use the means by which
the registration was received by the agency (i.e., by mail or fax).
(6) If any information you previously submitted was incorrect at the
time of submission, you must immediately update your facility's
registration as specified in Sec.1.234.
(7) Your facility is considered registered once FDA enters your
facility's registration data into the registration system and the system
generates a registration number.
(c) Registration by CD-ROM for multiple submissions. If, for
example, you do not have reasonable access to the Internet through any
of the methods provided under paragraph (a) of this section, you may
register by CD-ROM.
(1) Registrants submitting their registrations in CD-ROM format must
use ISO 9660 (CD-R or CD-RW) data format.
(2) These files must be submitted on a portable document format
(PDF) rendition of the registration form (Form 3537) and be accompanied
by one signed copy of the certification statement that appears on the
registration form (Form 3537).
(3) Each submission on the CD-ROM must contain the same preferred
mailing address in the appropriate block on Form 3537.
(4) A CD-ROM may contain registrations for as many facilities as
needed up to the CD-ROM's capacity.
(5) The registration on the CD-ROM for each separate facility must
have a unique file name up to 32 characters long, the first part of
which may be used to identify the parent company.
(6) You must mail the CD-ROM to the U.S. Food and Drug
Administration (HFS-681), 5600 Fishers Lane, Rockville, MD 20857.
(7) If FDA receives a CD-ROM that does not comply with these
specifications, it will return the CD-ROM to the submitter unprocessed.
(8) FDA will enter CD-ROM submissions that comply with these
specifications into its registration system, along with the complete and
legible mailed and faxed submissions, as soon as practicable, in the
order FDA receives them.
(9) For each facility on the CD-ROM, FDA will mail to the preferred
mailing address a copy of the registration(s) as entered, confirmation
of registration, and each facility's assigned registration number.
(10) If any information you previously submitted was incorrect at
the time of submission, you must immediately update your facility's
registration as specified in Sec.1.234.
(11) Your facility is considered registered once FDA enters your
facility's registration data into the registration system and the system
generates a registration number.
(d) Fees. No registration fee is required.
(e) Language. You must submit all registration information in the
English language except an individual's name, the name of a company, the
name of a street, and a trade name may be submitted in a foreign
language. All information, including these items, must be submitted
using the Latin (Roman) alphabet.
[68 FR 58960, Oct. 10, 2003, as amended at 69 FR 29428, May 24, 2004; 73
FR 15883, Mar. 26, 2008]
Sec.1.232 What information is required in the registration?
Each registrant must submit the following information through one of
the methods described in Sec.1.231:
(a) The name, full address, and phone number of the facility;
(b) The name, address, and phone number of the parent company, if
the facility is a subsidiary of the parent company;
(c) For domestic and foreign facilities, the names, addresses, and
phone numbers of the owner, operator, and agent in charge.
(d) For a foreign facility, the name, address, phone number, and, if
no emergency contact is designated under Sec.1.233(e), the emergency
contact phone
[[Page 22]]
number of the foreign facility's U.S. agent;
(e) For a domestic facility, an emergency contact phone number;
(f) All trade names the facility uses;
(g) Applicable food product categories as identified in Sec.170.3
of this chapter, unless you check either ``most/all human food product
categories,'' according to Sec.1.233(j), or ``none of the above
mandatory categories'' because your facility manufactures/processes,
packs, or holds a food that is not identified in Sec.170.3 of this
chapter;
(h) The name, address, and phone number for the owner, operator, or
agent in charge;
(i) A statement in which the owner, operator, or agent in charge
certifies that the information submitted is true and accurate. If the
individual submitting the form is not the owner, operator, or agent in
charge of the facility, the registration must also include a statement
in which the individual certifies that the information submitted is true
and accurate, certifies that he/she is authorized to submit the
registration, and identifies by name, address, and telephone number, the
individual who authorized submission of the registration. Each
registration must include the name of the individual registering the
facility submitting the registration, and the individual's signature
(for the paper and CD-ROM options).
[68 FR 58960, Oct. 10, 2003, as amended at 69 FR 29428, May 24, 2004]
Sec.1.233 What optional items are included in the registration form?
FDA encourages, but does not require, you to submit the following
items in your facility's registration. These data will enable FDA to
communicate more quickly with facilities that may be the target of a
terrorist threat or attack, or otherwise affected by an outbreak of
foodborne illness. This information includes:
(a) Fax number and e-mail address of the facility;
(b) Preferred mailing address, if different from that of the
facility;
(c) Fax number and e-mail address of the parent company, if the
facility is a subsidiary of the parent company;
(d) For a domestic facility, emergency contact name, title, and e-
mail address;
(e) For a foreign facility, an emergency contact name, title, phone
number and e-mail address. FDA will consider the facility's U.S. agent
the facility's emergency contact unless the facility chooses to
designate another person to serve as an emergency contact under this
section;
(f) For a foreign facility, title, fax number, and e-mail address of
the U.S. agent;
(g) Type of activity conducted at the facility (e.g., manufacturing/
processing or holding);
(h) Food categories not identified in Sec.170.3 of this chapter,
which are provided in Form 3537 sections 11a (e.g., infant formula,
animal byproducts and extracts) and 11b (e.g., grain products, amino
acids);
(i) Type of storage, if the facility is primarily a holding
facility;
(j) A food product category of ``most/all human food product
categories,'' if the facility manufactures/processes, packs, or holds
foods in most or all of the categories identified in Sec.170.3 of this
chapter;
(k) Approximate dates of operation, if the facility's business is
seasonal;
(l) The fax number and e-mail address of the owner, operator, or
agent in charge; and
(m) The fax number and e-mail address of the individual who
authorized submission of the registration.
Sec.1.234 How and when do you update your facility's registration
information?
(a) Update requirements. The owner, operator, or agent in charge
must submit an update to a facility's registration within 60 calendar
days of any change to any of the information previously submitted under
Sec.1.232 (e.g., change of operator, agent in charge, or U.S. agent),
except a change of the owner. The owner, operator, or agent in charge
may authorize an individual to update a facility's registration.
(b) Cancellation due to ownership changes. If the reason for the
update is that the facility has a new owner, the former owner must
cancel the facility's
[[Page 23]]
registration as specified in Sec.1.235 within 60 calendar days of the
change and the new owner must re-register the facility as specified in
Sec.1.231. The former owner may authorize an individual to cancel a
facility's registration.
(c) Electronic update. (1) To update your registration
electronically, you must update at http://www.fda.gov/furls.
(2) Once you complete your electronic update, FDA will automatically
provide you with an electronic confirmation of your update.
(3) Your registration will be considered updated once FDA transmits
your update confirmation, unless notified otherwise.
(d) Update by mail or fax. If, for example, you do not have
reasonable access to the Internet through any of the methods described
in Sec.1.231(a)), you may update your facility's registration by mail
or by fax:
(1) You must update your registration using Form 3537. You may
obtain a copy of this form by writing to the U.S. Food and Drug
Administration (HFS-681), 5600 Fishers Lane, Rockville, MD 20857 or by
requesting the form by phone at 1-877-FDA-3882 (1-877-332-3882).
(2) When you receive the form, you must legibly fill out the
sections of the form reflecting your updated information and either mail
it to the address in paragraph (d)(1) of this section or fax it to 301-
436-2804 or
1-800-573-0846.
(3) If the information on the form is incomplete or illegible when
FDA receives it, FDA will return the form to you for revision, provided
that your mailing address or fax number is legible and valid. When
returning a registration form for revision, FDA will use the means by
which the registration was received by the agency (i.e., by mail or
fax).
(4) FDA will enter complete and legible updates into its
registration system, along with CD-ROM submissions, as soon as
practicable, in the order FDA receives them.
(5) FDA will then mail to the address or fax to the fax number on
the registration form a copy of the update as entered and confirmation
of the update. When responding to an update submission, FDA will use the
means by which the form was received by the agency (i.e., by mail or
fax).
(6) If any update information you previously submitted was incorrect
at the time of submission, you must immediately resubmit your update.
(7) Your registration will be considered updated once FDA enters
your facility's update data into the registration system and the system
generates an update confirmation.
(e) Update by CD-ROM for multiple submissions. If, for example, you
do not have reasonable access to the Internet through any of the methods
provided under Sec.1.231(a), you may update your facilities'
registrations by CD-ROM.
(1) Registrants submitting their updates in CD-ROM format must use
ISO 9660 (CD-R or CD-RW) data format.
(2) Update files must be submitted on a PDF rendition of FDA's
registration form (Form 3537) and be accompanied by one signed copy of
the certification statement on the registration form (Form 3537).
(3) Each submission on the CD-ROM must contain the same preferred
mailing address in the appropriate block on Form 3537.
(4) The CD-ROM may contain updates for as many facilities as needed
up to the CD-ROM's capacity.
(5) The update for each facility on the CD-ROM must have a unique
file name up to 32 characters long, the first part of which may be used
to identify the parent company.
(6) You must mail the CD-ROM to U.S. Food and Drug Administration
(HFS-681), 5600 Fishers Lane, Rockville, MD 20857.
(7) If FDA receives an update CD-ROM that does not comply with these
specifications, it will return the CD-ROM to the registrant unprocessed.
(8) FDA will enter CD-ROM update submissions into its registration
system, along with the complete and legible mailed and faxed update
submissions, as soon as practicable, in the order FDA receives them.
(9) For each facility on the CD-ROM, FDA will mail to the preferred
mailing address a copy of the update(s) as entered and confirmation of
the update.
(10) If any update information you previously submitted was
incorrect at
[[Page 24]]
the time of submission, you must immediately resubmit your update.
(11) Your registration will be considered updated once FDA enters
your facility's update data into the registration system and the system
generates an update confirmation.
[68 FR 58960, Oct. 10, 2003 as amended at 73 FR 15883, Mar. 26, 2008]
Sec.1.235 How and when do you cancel your facility's registration
information?
(a) Notification of registration cancellation. A facility canceling
its registration must do so within 60 calendar days of the reason for
cancellation (e.g., facility ceases operations, ceases providing food
for consumption in the United States, or the facility is sold to a new
owner).
(b) Cancellation requirements. The cancellation of a facility's
registration must include the following information:
(1) The facility's registration number;
(2) Whether the facility is domestic or foreign;
(3) The facility name and address;
(4) The name, address, and e-mail address (if available) of the
individual submitting the cancellation; and
(5) A statement certifying that the information submitted is true
and accurate, and that the person submitting the cancellation is
authorized by the facility to cancel its registration.
(c) Electronic cancellation. (1) To cancel your registration
electronically, you must cancel at http://www.fda.gov/furls.
(2) Once you complete your electronic cancellation, FDA will
automatically provide you with an electronic confirmation of your
cancellation.
(3) Your registration will be considered cancelled once FDA
transmits your cancellation confirmation.
(d) Cancellation by mail or fax. If, for example, you do not have
reasonable access to the Internet through any of the methods described
in Sec.1.231(a), you may cancel your facility's registration by mail
or fax.
(1) You must cancel your registration using Form 3537a. You may
obtain a copy of this form by writing to the U.S. Food and Drug
Administration (HFS-681), 5600 Fishers Lane, Rockville, MD 20857, or by
requesting the form by phone at 1-877-FDA-3882 (1-877-332-3882).
(2) When you receive the form, you must completely and legibly fill
out the form and either mail it to the address in paragraph (d)(1) of
this section or fax it to 301-436-2804 or 1-800-573-0846.
(3) If the information on the form is incomplete or illegible when
FDA receives it, FDA will return the form to you for revision, provided
that your mailing address or fax number is legible and valid. When
returning a cancellation form for revision, FDA will use the means by
which the cancellation was received by the agency (i.e., by mail or
fax).
(4) FDA will enter complete and legible mailed and faxed
cancellations into its registration system, along with CD-ROM
cancellations, as soon as practicable, in the order FDA receives them.
(5) FDA will then mail to the address or fax to the fax number on
the cancellation form a copy of the cancellation as entered and
confirmation of the cancellation. When responding to a cancellation, FDA
will use the means by which the form was received by the agency (i.e.,
by mail or fax).
(6) If any information you previously submitted was incorrect at the
time of submission, you must immediately resubmit your cancellation.
(7) Your registration will be considered cancelled once FDA enters
your facility's cancellation data into the registration system and the
system generates a confirmation.
(e) Cancellation by CD-ROM for multiple submissions. If, for
example, you do not have reasonable access to the Internet through any
of the methods described in Sec.1.231(a), you may cancel your
facilities' registrations using a CD-ROM.
(1) Registrants submitting their cancellations in CD-ROM format must
use ISO 9660 (CD-R or CD-RW) data format.
(2) Cancellation files must be submitted on a PDF rendition of the
cancellation form (Form 3537a) and be accompanied by one signed copy of
the
[[Page 25]]
certification statement on the cancellation form.
(3) Each submission on the CD-ROM must contain the same preferred
mailing address in the appropriate block on Form 3537.
(4) The CD-ROM may contain cancellations for as many facilities as
needed up to the CD-ROM's capacity.
(5) The cancellation for each facility on the CD-ROM must have a
unique file name up to 32 characters long, the first part of which may
be used to identify the parent company.
(6) You must mail the CD-ROM to U.S. Food and Drug Administration
(HFS-681), 5600 Fishers Lane, Rockville, MD 20857.
(7) If FDA receives a CD-ROM that does not comply with these
specifications, it will return the CD-ROM to the registrant unprocessed.
(8) FDA will enter CD-ROM submissions that meet the specifications
into its registration system, along with complete and legible mailed and
faxed submissions, as soon as practicable, in the order FDA receives
them.
(9) For each facility on the CD-ROM, FDA will mail to the preferred
mailing address a copy of the cancellation(s) as entered and
confirmation of the cancellation.
(10) If any information you previously submitted was incorrect at
the time of submission, you must immediately resubmit your cancellation.
(11) Your registration will be considered cancelled once FDA enters
your facility's cancellation data into the registration system and the
system generates a confirmation.
[68 FR 58960, Oct. 10, 2003 as amended at 73 FR 15883, Mar. 26, 2008]
Additional Provisions
Sec.1.240 What other registration requirements apply?
In addition to the requirements of this subpart, you must comply
with the registration regulations found in part 108 of this chapter,
related to emergency permit control, and any other Federal, State, or
local registration requirements that apply to your facility.
Sec.1.241 What are the consequences of failing to register, update, or cancel
your registration?
(a) Section 301 of the act (21 U.S.C. 331) prohibits the doing of
certain acts or causing such acts to be done. Under section 302 of the
act (21 U.S.C. 332), the United States can bring a civil action in
Federal court to enjoin a person who commits a prohibited act. Under
section 303 of the act (21 U.S.C. 333), the United States can bring a
criminal action in Federal court to prosecute a person who is
responsible for the commission of a prohibited act. Under section 306 of
the act (21 U.S.C. 335a), FDA can seek debarment of any person who has
been convicted of a felony relating to importation of food into the
United States. Failure of an owner, operator, or agent in charge of a
domestic or foreign facility to register its facility, to update
required elements of it's facility's registration, or to cancel its
registration in accordance with the requirements of this subpart is a
prohibited act under section 301(dd) of the act.
(b) FDA will cancel a registration if the agency independently
verifies that the facility is no longer in business or has changed
owners, and the owner, operator, or agent in charge of the facility
fails to cancel the registration, or if FDA determines that the
registration is for a facility that does not exist. If FDA cancels a
facility's registration, FDA will mail a confirmation of the
cancellation to the facility at the address provided in the facility's
registration.
(c) If an article of food is imported or offered for import into the
United States and a foreign facility that manufactured/processed,
packed, or held that article of food has not registered in accordance
with this subpart, the disposition of the article of food shall be
governed by the procedures set out in subpart I of this part.
Sec.1.242 What does assignment of a registration number mean?
Assignment of a registration number to a facility means that the
facility is registered with FDA. Assignment of a registration number
does not in any way convey FDA's approval or endorsement of a facility
or its products.
[[Page 26]]
Sec.1.243 Is food registration information available to the public?
(a) The list of registered facilities and registration documents
submitted under this subpart are not subject to disclosure under 5
U.S.C. 552 (the Freedom of Information Act). In addition, any
information derived from such list or registration documents that would
disclose the identity or location of a specific registered person, is
not subject to disclosure under 5 U.S.C. 552 (the Freedom of Information
Act).
(b) Paragraph (a) of this section does not apply to any information
obtained by other means or that has previously been disclosed to the
public as defined in Sec.20.81 of this chapter.
Subpart I_Prior Notice of Imported Food
Source: 73 FR 66402, Nov. 7, 2008, unless otherwise noted.
General Provisions
Sec.1.276 What definitions apply to this subpart?
(a) The act means the Federal Food, Drug, and Cosmetic Act.
(b) The definitions of terms in section 201 of the act (21 U.S.C.
321) apply when the terms are used in this subpart, unless defined in
this section.
(1) Calendar day means every day shown on the calendar.
(2) Country from which the article originates means FDA Country of
Production.
(3) Country from which the article is shipped means the country in
which the article of food is loaded onto the conveyance that brings it
to the United States or, in the case of food sent by international mail,
the country from which the article is mailed.
(4) FDA Country of Production means: (i) For an article of food that
is in its natural state, the country where the article of food was
grown, including harvested or collected and readied for shipment to the
United States. If an article of food is wild fish, including seafood
that was caught or harvested outside the waters of the United States by
a vessel that is not registered in the United States, the FDA Country of
Production is the country in which the vessel is registered. If an
article of food that is in its natural state was grown, including
harvested or collected and readied for shipment, in a Territory, the FDA
Country of Production is the United States.
(ii) For an article of food that is no longer in its natural state,
the country where the article was made; except that, if an article of
food is made from wild fish, including seafood, aboard a vessel, the FDA
Country of Production is the country in which the vessel is registered.
If an article of food that is no longer in its natural state was made in
a Territory, the FDA Country of Production is the United States.
(5) Food has the meaning given in section 201(f) of the act, except
as provided in paragraph (b)(5)(i) of this section.
(i) For purposes of this subpart, food does not include:
(A) Food contact substances as defined in section 409(h)(6) of the
act (21 U.S.C. 348(h)(6)); or
(B) Pesticides as defined in 7 U.S.C. 136(u).
(ii) Examples of food include fruits, vegetables, fish, including
seafood, dairy products, eggs, raw agricultural commodities for use as
food or as components of food, animal feed (including pet food), food
and feed ingredients, food and feed additives, dietary supplements and
dietary ingredients, infant formula, beverages (including alcoholic
beverages and bottled water), live food animals, bakery goods, snack
foods, candy, and canned foods.
(6) Full address means the facility's street name and number; suite/
unit number, as appropriate; city; Province or State as appropriate;
mail code as appropriate; and country.
(7) Grower means a person who engages in growing and harvesting or
collecting crops (including botanicals), raising animals (including
fish, which includes seafood), or both.
(8) International mail means foreign national mail services.
International mail does not include express consignment operators or
carriers or other private delivery services unless such service is
operating under contract as an agent or extension of a foreign mail
service.
[[Page 27]]
(9) Manufacturer means the last facility, as that word is defined in
Sec.1.227(b)(2), that manufactured/processed the food. A facility is
considered the last facility even if the food undergoes further
manufacturing/processing that consists of adding labeling or any similar
activity of a de minimis nature. If the food undergoes further
manufacturing/processing that exceeds an activity of a de minimis
nature, then the subsequent facility that performed the additional
manufacturing/processing is considered the manufacturer.
(10) No longer in its natural state means that an article of food
has been made from one or more ingredients or synthesized, prepared,
treated, modified, or manipulated. Examples of activities that render
food no longer in its natural state are cutting, peeling, trimming,
washing, waxing, eviscerating, rendering, cooking, baking, freezing,
cooling, pasteurizing, homogenizing, mixing, formulating, bottling,
milling, grinding, extracting juice, distilling, labeling, or packaging.
Crops that have been cleaned (e.g., dusted, washed), trimmed, or cooled
attendant to harvest or collection or treated against pests, or polished
are still in their natural state for purposes of this subpart. Whole
fish headed, eviscerated, or frozen attendant to harvest are still in
their natural state for purposes of this subpart.
(11) Port of arrival means the water, air, or land port at which the
article of food is imported or offered for import into the United
States. For an article of food arriving by water or air, this is the
port of unloading. For an article of food arriving by land, this is the
port where the article of food first crosses the border into the United
States. The port of arrival may be different than the port where
consumption or warehouse entry or foreign trade zone admission
documentation is presented to the U.S. Customs and Border Protection
(CBP).
(12) Port of entry, in section 801(m) and (l) of the act (21 U.S.C.
381(m) and (l)), means the port of entry as defined in 19 CFR 101.1.
(13) Registration number means the registration number assigned to a
facility by FDA under section 415 of the act (21 U.S.C. 350d) and
subpart H of this part.
(14) Shipper means the owner or exporter of the article of food who
consigns and ships the article from a foreign country or the person who
sends an article of food by international mail or express consignment
operators or carriers or other private delivery service to the United
States.
(15) United States means the Customs territory of the United States
(i.e., the 50 States, the District of Columbia, and the Commonwealth of
Puerto Rico), but not the Territories.
(16) You means the person submitting the prior notice, i.e., the
submitter or the transmitter, if any.
Sec.1.277 What is the scope of this subpart?
(a) This subpart applies to all food for humans and other animals
that is imported or offered for import into the United States for use,
storage, or distribution in the United States, including food for gifts
and trade and quality assurance/quality control samples, food for
transshipment through the United States to another country, food for
future export, and food for use in a U.S. Foreign Trade Zone.
(b) Notwithstanding paragraph (a) of this section, this subpart does
not apply to:
(1) Food for an individual's personal use when it is carried by or
otherwise accompanies the individual when arriving in the United States;
(2) Food that was made by an individual in his/her personal
residence and sent by that individual as a personal gift (i.e., for
nonbusiness reasons) to an individual in the United States;
(3) Food that is imported then exported without leaving the port of
arrival until export;
(4) Meat food products that at the time of importation are subject
to the exclusive jurisdiction of the U.S. Department of Agriculture
(USDA) under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.);
(5) Poultry products that at the time of importation are subject to
the exclusive jurisdiction of USDA under the Poultry Products Inspection
Act (21 U.S.C. 451 et seq.);
[[Page 28]]
(6) Egg products that at the time of importation are subject to the
exclusive jurisdiction of USDA under the Egg Products Inspection Act (21
U.S.C. 1031 et seq.); and
(7) Articles of food subject to Article 27(3) of The Vienna
Convention on Diplomatic Relations (1961), i.e., shipped as baggage or
cargo constituting the diplomatic bag.
Requirements To Submit Prior Notice of Imported Food
Sec.1.278 Who is authorized to submit prior notice?
A prior notice for an article of food may be submitted by any person
with knowledge of the required information. This person is the
submitter. The submitter also may use another person to transmit the
required information on his/her behalf. The person who transmits the
information is the transmitter. The submitter and transmitter may be the
same person.
Sec.1.279 When must prior notice be submitted to FDA?
(a) Except as provided in paragraph (c) of this section, you must
submit the prior notice to FDA and the prior notice submission must be
confirmed by FDA for review as follows:
(1) If the article of food is arriving by land by road, no less than
2 hours before arriving at the port of arrival;
(2) If the article of food is arriving by land by rail, no less than
4 hours before arriving at the port of arrival;
(3) If the article of food is arriving by air, no less than 4 hours
before arriving at the port of arrival; or
(4) If the article of food is arriving by water, no less than 8
hours before arriving at the port of arrival.
(b) Except in the case of an article of food imported or offered for
import by international mail:
(1) If prior notice is submitted via Automated Broker Interface/
Automated Commercial System (ABI/ACS), you may not submit prior notice
more than 30-calendar days before the anticipated date of arrival.
(2) If prior notice is submitted via the FDA Prior Notice System
Interface (FDA PNSI), you may not submit prior notice more than 15-
calendar days before the anticipated date of arrival.
(c) Notwithstanding paragraphs (a) and (b) of this section, if the
article of food is arriving by international mail, you must submit the
prior notice before the article of food is sent to the United States.
(d) FDA will notify you that your prior notice has been confirmed
for review with a reply message that contains a Prior Notice (PN)
Confirmation Number. Your prior notice will be considered submitted and
the prior notice time will start when FDA has confirmed your prior
notice for review.
(e) The PN Confirmation Number must accompany any article of food
arriving by international mail. The PN Confirmation Number must appear
on the Customs Declaration (e.g., CN22 or CN23 or U.S. equivalent) that
accompanies the package.
(f) A copy of the confirmation, including the PN Confirmation
Number, must accompany any article of food that is subject to this
subpart when it is carried by or otherwise accompanies an individual
when arriving in the United States. The copy of the confirmation must be
provided to U.S. Customs and Border Protection (CBP) or FDA upon
arrival.
(g) The PN Confirmation Number must accompany any article of food
for which the prior notice was submitted through the FDA PNSI when the
article arrives in the United States and must be provided to CBP or FDA
upon arrival.
Sec.1.280 How must you submit prior notice?
(a) You must submit the prior notice electronically to FDA. You must
submit all prior notice information in the English language, except that
an individual's name, the name of a company, and the name of a street
may be submitted in a foreign language. All information, including the
items listed in the previous sentence, must be submitted using the Latin
(Roman) alphabet. Unless paragraph (c) of this section applies, you must
submit prior notice through:
[[Page 29]]
(1) The U.S. Customs and Border Protection (CBP) Automated Broker
Interface of the Automated Commercial System (ABI/ACS); or
(2) The FDA PNSI at http://www.access.fda.gov. You must submit prior
notice through the FDA Prior Notice System Interface (FDA PNSI) for
articles of food imported or offered for import by international mail,
and other transaction types that cannot be made through ABI/ACS. Prior
notice for articles that have been refused under section 801(m)(1) of
the act and under this subpart must be submitted through the FDA PNSI
until such time as FDA and CBP issue a determination that ACS or its
successor system can accommodate such transactions.
(b) If a customhouse broker's or self-filer's system is not working
or if the ABI/ACS interface is not working, prior notice must be
submitted through the FDA PNSI.
(c) If FDA determines that FDA PNSI or the Operational and
Administration System for Import Support (OASIS) is not working, FDA
will post prominent notification and instructions at http://www.fda.gov.
FDA will accept prior notice submissions in the format it deems
appropriate during the system(s) outage.
Sec.1.281 What information must be in a prior notice?
(a) General. For each article of food that is imported or offered
for import into the United States, except by international mail, you
must submit the information for the article that is required in
paragraphs (a)(1) through (a)(17) of this section:
(1) The name of the individual submitting the prior notice and his/
her business address, phone number, and e-mail address, and the name and
address of the submitting firm, if applicable. If the business address
of the individual submitting the prior notice is a registered facility,
then the facility's registration number, city, and country may be
provided instead of the facility's full address;
(2) If different from the submitter, the name of the individual and
firm, if applicable, transmitting the prior notice on behalf of the
submitter and his/her business address, phone number, and e-mail
address. If the business address of the individual transmitting the
prior notice is a registered facility, then the facility's registration
number, city, and country may be provided instead of the facility's full
address;
(3) The entry type;
(4) The U.S. Customs and Border Protection (CBP) entry identifier
(e.g., CBP entry number or in-bond number), if available;
(5) The identity of the article of food being imported or offered
for import, as follows:
(i) The complete FDA product code;
(ii) The common or usual name or market name;
(iii) The estimated quantity of food that will be shipped, described
from largest container to smallest package size; and
(iv) The lot or code numbers or other identifier of the food if
required by the act or FDA regulations, e.g., low-acid canned foods, by
Sec.113.60(c) of this chapter; acidified foods, by Sec.114.80(b) of
this chapter; and infant formula, by Sec.106.90 of this chapter;
(6) For an article of food that is no longer in its natural state,
the identity of the manufacturer, as follows:
(i) The name of the manufacturer; and
(ii) Either the registration number, city, and country of the
manufacturer or both the full address of the manufacturer and the reason
the registration number is not provided;
(7) For an article of food that is in its natural state, the name
and growing location address of the grower, if known. If the submitter
does not know the identity of the grower or, if the article has been
consolidated and the submitter does not know the identity of any of the
growers, you may provide the name and address of the firm that has
consolidated the articles of food from different growers or different
growing locations;
(8) The FDA Country of Production;
(9) If the shipper is different from the manufacturer, the identity
of the shipper, as follows:
(i) The name of the shipper; and
(ii) The full address of the shipper. If the address of the shipper
is a registered facility, you also may submit
[[Page 30]]
the registration number of the shipper's registered facility;
(10) The country from which the article is shipped;
(11) Anticipated arrival information about the article of food being
imported or offered for import, as follows:
(i) The anticipated port of arrival;
(ii) The anticipated date on which the article of food will arrive
at the anticipated port of arrival;
(iii) The anticipated time of that arrival; and
(iv) Notwithstanding paragraphs (a)(11)(i) through (a)(11)(iii) of
this section, if the article of food is arriving by express consignment
operator or carrier, and neither the submitter nor transmitter is the
express consignment operator or carrier, and prior notice is submitted
via the FDA PNSI, the express consignment operator or carrier tracking
number may be submitted in lieu of the information required in
paragraphs (a)(11)(i) through (a)(11)(iii) of this section. Until such
time as FDA and CBP issue a determination that ACS or its successor
system can accommodate such transactions, the tracking number may not be
submitted in lieu of information required in paragraphs (a)(11)(i)
through (a)(11)(iii) of this section, if the prior notice is submitted
via ABI/ACS.
(12) The name and full address of the importer. If the business
address of the importer is a registered facility, you also may submit
the registration number of the importer's registered facility. The
identity of the importer is not required for an article of food that is
imported or offered for import for transshipment through the United
States under a Transportation and Exportation entry;
(13) The name and full address of the owner if different from the
importer or ultimate consignee. If the business address of the owner is
a registered facility, you also may submit the registration number of
the owner's registered facility. The identity of the owner is not
required for an article of food that is imported or offered for import
for transshipment through the United States under a Transportation and
Exportation entry;
(14) The name and full address of the ultimate consignee. If the
business address of the ultimate consignee is a registered facility, you
also may submit the registration number of the ultimate consignee's
registered facility. The identity of the ultimate consignee is not
required for an article of food that is imported or offered for import
for transshipment through the United States under a Transportation and
Exportation entry;
(15) The mode of transportation;
(16) The Standard Carrier Abbreviation Code (SCAC) or International
Air Transportation Association (IATA) code of the carrier which is, or
will be, carrying the article of food from the country from which the
article is shipped to the United States to the port of arrival, or if
this code is not applicable, then the name of the carrier. If the
carrier is a privately owned vehicle, the license plate number of the
vehicle and the State or Province that issued the license plate number;
(17) Planned shipment information, as applicable to the mode of
transportation and when it exists:
(i) The Airway Bill number(s) or Bill of Lading number(s), as
applicable. This information is not required for an article of food when
carried by or otherwise accompanying an individual when entering the
United States. If the article of food is arriving by express consignment
operator or carrier, and neither the submitter nor transmitter is the
express consignment operator or carrier, and the prior notice is
submitted via the FDA PNSI, the express consignment operator or carrier
tracking number may be submitted in lieu of the Airway Bill number(s) or
Bill of Lading number(s), as applicable. Until such time as FDA and CBP
issue a determination that ACS or its successor system can accommodate
such transactions, the tracking number may not be submitted in lieu of
the Airway Bill number(s) or Bill of Lading number(s), if the prior
notice is submitted via ABI/ACS;
(ii) For food arriving by ocean vessel, the vessel name and voyage
number;
(iii) For food arriving by air carrier, the flight number. If the
article of food is arriving by express consignment operator or carrier,
and neither the submitter nor transmitter is the express consignment
operator or carrier, and
[[Page 31]]
the prior notice is submitted via the FDA PNSI, the express consignment
operator or carrier tracking number may be submitted in lieu of the
flight number. Until such time as FDA and CBP issue a determination that
ACS or its successor system can accommodate such transactions, the
tracking number may not be submitted in lieu of the flight number, if
the prior notice is submitted via ABI/ACS;
(iv) For food arriving by truck, bus, or rail, the trip number;
(v) For food arriving as containerized cargo by water, air, or land,
the container number(s). This information is not required for an article
of food when carried by or otherwise accompanying an individual when
entering the United States; and
(vi) For food arriving by rail, the car number. This information is
not required for an article of food when carried by or otherwise
accompanying an individual.
(18) Any country to which the article has been refused entry.
(b) Articles arriving by international mail. For each article of
food that is imported or offered for import into the United States by
international mail, you must submit the information for the article that
is required in paragraphs (b)(1) through (b)(11) of this section:
(1) The name of the individual submitting the prior notice and his/
her business address, phone number, and e-mail address, and the name and
address of the submitting firm, if applicable. If the business address
of the individual submitting the prior notice is a registered facility,
then the facility's registration number, city, and country may be
provided instead of the facility's full address;
(2) If different from the submitter, the name of the individual and
firm, if applicable, transmitting the prior notice on behalf of the
submitter and his/her business address, phone number, and e-mail
address. If the business address of the individual transmitting the
prior notice is a registered facility, then the facility's registration
number, city, and country may be provided instead of the facility's full
address;
(3) The entry type (which will be a mail entry);
(4) The identity of the article of food being imported or offered
for import, as follows:
(i) The complete FDA product code;
(ii) The common or usual name or market name;
(iii) The estimated quantity of food that will be shipped, described
from largest container to smallest package size; and
(iv) The lot or code numbers or other identifier of the food if
required by the act or FDA regulations, e.g., low-acid canned foods, by
Sec.113.60(c) of this chapter; acidified foods, by Sec.114.80(b) of
this chapter; and infant formula, Sec.106.90 of this chapter;
(5) For an article of food that is no longer in its natural state,
the identity of the manufacturer, as follows:
(i) The name of the manufacturer; and
(ii) Either the registration number, city, and country of the
manufacturer or both the full address of the manufacturer and the reason
the registration number is not provided;
(6) For an article of food that is in its natural state, the name
and growing location address of the grower, if known. If the submitter
does not know the identity of the grower or, if the article has been
consolidated and the submitter does not know the identity of any of the
growers, you may provide the name and address of the firm that has
consolidated the articles of food from different growers or different
growing locations;
(7) The FDA Country of Production;
(8) If the shipper is different from the manufacturer, the identity
of the shipper, as follows:
(i) The name of the shipper; and
(ii) The full address of the shipper. If the address of the shipper
is a registered facility, you also may submit the registration number of
the shipper's registered facility;
(9) The country from which the article is shipped (i.e., mailed);
(10) The anticipated date of mailing; and
(11) The name and address of the U.S. recipient.
(12) Any country to which the article has been refused entry.
(c) Refused articles. If the article of food has been refused under
section
[[Page 32]]
801(m)(1) of the act and under this subpart, you must submit the
information for the article that is required in paragraphs (c)(1)
through (c)(18) of this section. However, if the refusal is based on
Sec.1.283(a)(1)(iii) (Untimely Prior Notice), you do not have to
resubmit any information previously submitted unless it has changed or
the article has been exported and the original prior notice was
submitted through ABI/ACS. If the refusal is based on Sec.
1.283(a)(1)(ii), you should cancel the previous submission per Sec.
1.282(b) and (c).
(1) The name of the individual submitting the prior notice and his/
her business address, phone number, and e-mail address, and the name and
address of the submitting firm, if applicable. If the business address
of the individual submitting the prior notice is a registered facility,
then the facility's registration number, city, and country may be
provided instead of the facility's full address;
(2) If different from the submitter, the name of the individual and
firm, if applicable, transmitting the prior notice on behalf of the
submitter and his/her business address, phone number, and e-mail
address. If the business address of the individual transmitting the
prior notice is a registered facility, then the facility's registration
number, city, and country may be provided instead of the facility's full
address;
(3) The entry type;
(4) The CBP entry identifier (e.g., CBP entry number or in-bond
number), if available;
(5) The identity of the article of food being imported or offered
for import, as follows:
(i) The complete FDA product code;
(ii) The common or usual name or market name;
(iii) The quantity of food that was shipped, described from largest
container to smallest package size; and
(iv) The lot or code numbers or other identifier of the food if
required by the act or FDA regulations, e.g., low-acid canned foods, by
Sec.113.60(c) of this chapter; acidified foods, by Sec.114.80(b) of
this chapter; and infant formula, by Sec.106.90 of this chapter;
(6) For an article of food that is no longer in its natural state,
the identity of the manufacturer, as follows:
(i) The name of the manufacturer; and
(ii) Either the registration number, city, and country of the
manufacturer or both the full address of the manufacturer and the reason
the registration number is not provided;
(7) For an article of food that is in its natural state, the name
and growing location address of the grower, if known. If the submitter
does not know the identity of the grower or, if the article has been
consolidated and the submitter does not know any of the growers, you may
provide the name and address of the firm that has consolidated the
articles of food from different growers or different growing locations;
(8) The FDA Country of Production;
(9) If the shipper is different from the manufacturer, the identity
of the shipper, as follows:
(i) The name of the shipper; and
(ii) The full address of the shipper. If the address of the shipper
is a registered facility, you also may submit the registration number of
the shipper's registered facility;
(10) The country from which the article is shipped;
(11) Arrival information about the article of food being imported or
offered for import, as follows:
(i) The port of arrival; and
(ii) The date on which the article of food arrived at the port of
arrival.
(iii) Notwithstanding paragraph (c)(11) of this section, if the
article of food arrived by express consignment operator or carrier, and
neither the submitter nor transmitter is the express consignment
operator or carrier, and the prior notice is submitted via the FDA PNSI,
the express consignment operator or carrier tracking number may be
submitted in lieu of the information required in paragraph (c)(11) of
this section. Until such time as FDA and CBP issue a determination that
ACS or its successor system can accommodate such transactions, the
tracking number may not be submitted in lieu of information required in
paragraph (c)(11) of this section, if the prior notice is submitted via
ABI/ACS;
[[Page 33]]
(12) The name and full address of the importer. If the business
address of the importer is a registered facility, you also may submit
the registration number of the importer's registered facility. The
identity of the importer is not required for an article of food that is
imported or offered for import for transshipment through the United
States under a Transportation and Exportation entry;
(13) The name and full address of the owner, if different from the
importer or ultimate consignee. If the business address of the owner is
a registered facility, you also may submit the registration number of
the importer's registered facility. The identity of the owner is not
required for an article of food that is imported or offered for import
for transshipment through the United States under a Transportation and
Exportation entry;
(14) The name and full address of the ultimate consignee. If the
business address of the ultimate consignee is a registered facility, you
also may submit the registration number of the ultimate consignee's
registered facility. The identity of the ultimate consignee is not
required for an article of food that is imported or offered for import
for transshipment through the United States under a Transportation and
Exportation entry;
(15) The mode of transportation;
(16) The SCAC or IATA code of the carrier which carried the article
of food from the country from which the article is shipped to the United
States to the port of arrival, or if this code is not applicable, then
the name of the carrier. If the carrier is a privately owned vehicle,
the license plate number of the vehicle and the State or Province that
issued the license plate number;
(17) Shipment information, as applicable to the mode of
transportation and when it exists:
(i) The Airway Bill number(s) or Bill of Lading number(s), as
applicable; however, this information is not required for an article of
food when carried by or otherwise accompanying an individual when
entering the United States. If the article of food arrived by express
consignment operator or carrier, and neither the submitter nor
transmitter is the express consignment operator or carrier, and the
prior notice is submitted via the FDA PNSI, the express consignment
operator or carrier tracking number may be submitted in lieu of the
Airway Bill number(s) or Bill of Lading number(s), as applicable. Until
such time as FDA and CBP issue a determination that ACS or its successor
system can accommodate such transactions, the tracking number may not be
submitted in lieu of the Airway Bill number(s) or Bill of Lading
number(s), if the prior notice is submitted via ABI/ACS;
(ii) For food that arrived by ocean vessel, the vessel name and
voyage number;
(iii) For food that arrived by air carrier, the flight number. If
the article of food arrived by express consignment operator or carrier,
and neither the submitter nor transmitter is the express consignment
operator or carrier, and the prior notice is submitted via the FDA PNSI,
the express consignment operator or carrier tracking number may be
submitted in lieu of the flight number. Until such time as FDA and CBP
issue a determination that ACS or its successor system can accommodate
such transactions, the tracking number may not be submitted in lieu of
the flight number, if the prior notice is submitted via ABI/ACS;
(iv) For food that arrived by truck, bus, or rail, the trip number;
(v) For food that arrived as containerized cargo by water, air, or
land, the container number(s); however, this information is not required
for an article of food when carried by or otherwise accompanying an
individual when entering the United States; and
(vi) For food that arrived by rail, the car number; however, this
information is not required for an article of food when carried by or
otherwise accompanying an individual;
(18) The location and address where the article of refused food will
be or is being held, the date the article has arrived or will arrive at
that location, and identification of a contact at that location.
(19) Any country to which the article has been refused entry.
[73 FR 66402, Nov. 7, 2008, as amended at 76 FR 25545, May 5, 2011]
[[Page 34]]
Sec.1.282 What must you do if information changes after you have received
confirmation of a prior notice from FDA?
(a)(1) If any of the information required in Sec.1.281(a), except
the information required in:
(i) Section 1.281(a)(5)(iii) (quantity),
(ii) Section 1.281(a)(11) (anticipated arrival information), or
(iii) Section 1.281(a)(17) (planned shipment information), changes
after you receive notice that FDA has confirmed your prior notice
submission for review, you must resubmit prior notice in accordance with
this subpart unless the article of food will not be offered for import
or imported into the United States.
(2) If any of the information required in Sec.1.281(b), except the
information required in Sec.1.281(b)(10) (the anticipated date of
mailing), changes after you receive notice that FDA has confirmed your
prior notice submission for review, you must resubmit prior notice in
accordance with this subpart, unless the article of food will not be
offered for import or imported into the United States.
(b) If you submitted the prior notice via the FDA PNSI, you should
cancel the prior notice via the FDA PNSI.
(c) If you submitted the prior notice via ABI/ACS, you should cancel
the prior notice via ACS by requesting that CBP cancel the entry.
Consequences
Sec.1.283 What happens to food that is imported or offered for import without
adequate prior notice?
(a) For each article of food that is imported or offered for import
into the United States, except for food arriving by international mail
or food carried by or otherwise accompanying an individual, the
consequences are:
(1) Inadequate prior notice--(i) No prior notice. If an article of
food arrives at the port of arrival and no prior notice has been
submitted and confirmed by FDA for review, the food is subject to
refusal of admission under section 801(m)(1) of the act (21 U.S.C.
381(m)(1)). If an article of food is refused for lack of prior notice,
unless U.S. Customs and Border Protection (CBP) concurrence is obtained
for export and the article is immediately exported from the port of
arrival under CBP supervision, it must be held within the port of entry
for the article unless directed by CBP or FDA.
(ii) Inaccurate prior notice. If prior notice has been submitted and
confirmed by FDA for review, but upon review of the notice or
examination of the article of food, the notice is determined to be
inaccurate, the food is subject to refusal of admission under section
801(m)(1) of the act. If the article of food is refused due to
inaccurate prior notice, unless CBP concurrence is obtained for export
and the article is immediately exported from the port of arrival under
CBP supervision, it must be held within the port of entry for the
article unless directed by CBP or FDA.
(iii) Untimely prior notice. If prior notice has been submitted and
confirmed by FDA for review, but the full time that applies under Sec.
1.279 for prior notice has not elapsed when the article of food arrives,
the food is subject to refusal of admission under section 801(m)(1) of
the act, unless FDA has already reviewed the prior notice, determined
its response to the prior notice, and advised CBP of that response. If
the article of food is refused due to untimely prior notice, unless CBP
concurrence is obtained for export and the article is immediately
exported from the port of arrival under CBP supervision, it must be held
within the port of entry for the article unless directed by CBP or FDA.
(2) Status and movement of refused food. (i) An article of food that
has been refused under section 801(m)(1) of the act and paragraph (a) of
this section shall be considered general order merchandise as described
in section 490 of the Tariff Act of 1930, as amended (19 U.S.C. 1490).
(ii) Refused food must be moved under appropriate custodial bond
unless immediately exported under CBP supervision. If the food is to be
held at the port, FDA must be notified of the location where the food is
held at that port before the food is moved there. If the food is to be
held at a secure facility outside the port, FDA must be notified of the
location of the secure facility before the food is moved there. The
[[Page 35]]
refused food shall not be entered and shall not be delivered to any
importer, owner, or ultimate consignee. If the food is to be held at a
secure facility outside a port, the food must be taken directly to that
secure facility.
(3) Segregation of refused foods. If an article of food that is
refused is part of a shipment that contains articles of food that have
not been placed under hold or other merchandise not subject to this
subpart, the refused article of food may be segregated from the rest of
the shipment. This segregation must take place where the article is
held. FDA or CBP may supervise segregation. If FDA or CBP determines
that supervision is necessary, segregation must not take place without
supervision.
(4) Costs. Neither FDA nor CBP are liable for transportation,
storage, or other expenses resulting from refusal.
(5) Export after refusal. An article of food that has been refused
under paragraph (a) of this section may be exported with CBP concurrence
and under CBP supervision unless it is seized or administratively
detained by FDA or CBP under other authority. If an article of food that
has been refused admission under paragraph (a) of this section is
exported, the prior notice should be cancelled within 5-business days of
exportation.
(6) No post-refusal submission or request for review. If an article
of food is refused under section 801(m)(1) of the act and no prior
notice is submitted or resubmitted, no request for FDA review is
submitted in accordance with paragraph (d) of this section, or export
has not occurred in accordance with paragraph (a)(5) of this section,
the article of food shall be dealt with as set forth in CBP regulations
relating to general order merchandise (19 CFR part 127), except that,
unless otherwise agreed to by CBP and FDA, the article may only be sold
for export or destroyed.
(b) Food carried by or otherwise accompanying an individual. If food
carried by or otherwise accompanying an individual arriving in the
United States is not for personal use and does not have adequate prior
notice or the individual cannot provide FDA or CBP with a copy of the
prior notice (PN) confirmation, the food is subject to refusal of
admission under section 801(m)(1) of the act. If before leaving the
port, the individual does not arrange to have the food held at the port
or exported, FDA or CBP may destroy the article of food.
(c) Post-Refusal prior notice submissions. (1) If an article of food
is refused under paragraph (a)(1)(i) of this section (no prior notice)
and the food is not exported, prior notice must be submitted in
accordance with Sec. Sec.1.280 and 1.281(c).
(2) If an article of food is refused under paragraph (a)(1)(ii) of
this section (inaccurate prior notice) and the food is not exported, the
prior notice should be canceled in accordance with Sec.1.282 and you
must resubmit prior notice in accordance with Sec. Sec.1.280 and
1.281(c).
(3) Once the prior notice has been submitted or resubmitted and
confirmed by FDA for review, FDA will endeavor to review and respond to
the prior notice submission within the timeframes set out in Sec.
1.279.
(d) FDA review after refusal. (1) If an article of food has been
refused admission under section 801(m)(1) of the act, a request may be
submitted asking FDA to review whether the article is subject to the
requirements of this subpart under Sec.1.277, or whether the
information submitted in a prior notice is complete and accurate. A
request for review may not be used to submit prior notice or to resubmit
an inaccurate prior notice.
(2) A request may be submitted only by the carrier, submitter,
importer, owner, or ultimate consignee. A request must identify which
one the requester is.
(3) A request must be submitted in writing to FDA and delivered by
fax or e-mail. The location for receipt of a request is listed at http:/
/www.fda.gov--see Prior Notice. A request must include all factual and
legal information necessary for FDA to conduct its review. Only one
request for review may be submitted for each refused article.
(4) The request must be submitted within 5-calendar days of the
refusal. FDA will review and respond within 5-calendar days of receiving
the request.
(5) If FDA determines that the article is not subject to the
requirements of this subpart under Sec.1.277 or that the prior notice
submission is complete
[[Page 36]]
and accurate, it will notify the requester, the transmitter, and CBP
that the food is no longer subject to refusal under section 801(m)(1) of
the act.
(e) International mail. If an article of food arrives by
international mail with inadequate prior notice or the PN confirmation
number is not affixed as required, the parcel will be held by CBP for 72
hours for FDA inspection and disposition. If FDA refuses the article
under section 801(m)(1) of the act and there is a return address, the
parcel may be returned to sender marked ``No Prior Notice--FDA
Refused.'' If the article is refused and there is no return address or
FDA determines that the article of food in the parcel appears to present
a hazard, FDA may dispose of or destroy the parcel at its expense. If
FDA does not respond within 72 hours of the CBP hold, CBP may return the
parcel to the sender or, if there is no return address, destroy the
parcel, at FDA expense.
(f) Prohibitions on delivery and transfer. (1) Notwithstanding
section 801(b) of the act, an article of food refused under section
801(m)(1) of the act may not be delivered to the importer, owner, or
ultimate consignee until prior notice is submitted to FDA in accordance
with this subpart, FDA has examined the prior notice, FDA has determined
that the prior notice is adequate, and FDA has notified CBP and the
transmitter that the article of food is no longer refused admission
under section 801(m)(1) of the act.
(2) During the time an article of food that has been refused under
section 801(m)(1) of the act is held, the article may not be transferred
by any person from the port or other designated secure facility until
prior notice is submitted to FDA in accordance with this subpart, FDA
has examined the prior notice, FDA has determined that the prior notice
is adequate, and FDA has notified CBP and the transmitter that the
article of food no longer is refused admission under section 801(m)(1)
of the act. After this notification by FDA to CBP and transmitter, entry
may be made in accordance with law and regulation.
(g) Relationship to other admissibility decisions. A determination
that an article of food is no longer refused under section 801(m)(1) of
the act is different than, and may come before, determinations of
admissibility under other provisions of the act or other U.S. laws. A
determination that an article of food is no longer refused under section
801(m)(1) of the act does not mean that it will be granted admission
under other provisions of the act or other U.S. laws.
Sec.1.284 What are the other consequences of failing to submit adequate prior
notice or otherwise failing to comply with this subpart?
(a) The importing or offering for import into the United States of
an article of food in violation of the requirements of section 801(m) of
the act, including the requirements of this subpart, is a prohibited act
under section 301(ee) of the act (21 U.S.C. 331(ee)).
(b) Section 301 of the act prohibits the doing of certain acts or
causing such acts to be done.
(1) Under section 302 of the act (21 U.S.C. 332), the United States
can bring a civil action in Federal court to enjoin persons who commit a
prohibited act.
(2) Under sections 301 and 303 of the act (21 U.S.C. 331 and 333),
the United States can bring a criminal action in Federal court to
prosecute persons who are responsible for the commission of a prohibited
act.
(c) Under section 306 of the act (21 U.S.C. 335a), FDA can seek
debarment of any person who has been convicted of a felony relating to
importation of food into the United States or any person who has engaged
in a pattern of importing or offering for import adulterated food that
presents a threat of serious adverse health consequences or death to
humans or animals.
Sec.1.285 What happens to food that is imported or offered for import from
unregistered facilities that are required to register under subpart H of this
part?
(a) Consequences. If an article of food from a foreign facility that
is not registered as required under section 415 of the act (21 U.S.C.
350d) and subpart H of this part is imported or offered for import into
the United States, the food is subject to being held under section
801(l) of the act (21 U.S.C. 381(l)).
[[Page 37]]
(b) Hold. Unless CBP concurrence is obtained for export and the
article is immediately exported from the port of arrival, if an article
of food has been placed under hold under section 801(l) of the act, it
must be held within the port of entry for the article unless directed by
CBP or FDA.
(c) Status and movement of held food. (1) An article of food that
has been placed under hold under section 801(l) of the act shall be
considered general order merchandise as described in section 490 of the
Tariff Act of 1930, as amended (19 U.S.C. 1490).
(2) Food under hold under section 801(l) of the act must be moved
under appropriate custodial bond unless immediately exported under CBP
supervision. If the food is to be held at the port, FDA must be notified
of the location where the food is held at the port before the food is
moved there. If the food is to be held at a secure facility outside the
port, FDA must be notified of the location of the secure facility before
the food is moved there. The food subject to hold shall not be entered
and shall not be delivered to any importer, owner, or ultimate
consignee. If the food is to be held at a secure facility outside a
port, the food must be taken directly to that secure facility.
(d) Segregation of held foods. If an article of food that has been
placed under hold under section 801(l) of the act is part of a shipment
that contains articles that have not been placed under hold, the food
under hold may be segregated from the rest of the shipment. This
segregation must take place where the article is held. FDA or CBP may
supervise segregation. If FDA or CBP determine that supervision is
necessary, segregation must not take place without supervision.
(e) Costs. Neither FDA nor CBP will be liable for transportation,
storage, or other expenses resulting from any hold.
(f) Export after hold. An article of food that has been placed under
hold under section 801(l) of the act may be exported with CBP
concurrence and under CBP supervision unless it is seized or
administratively detained by FDA or CBP under other authority.
(g) No registration or request for review. If an article of food is
placed under hold under section 801(l) of the act and no registration
number or request for FDA review is submitted in accordance with
paragraph (j) of this section or export has not occurred in accordance
with paragraph (f) of this section, the food shall be dealt with as set
forth in CBP regulations relating to general order merchandise, except
that, unless otherwise agreed to by CBP and FDA, the article may only be
sold for export or destroyed.
(h) Food carried by or otherwise accompanying an individual. If an
article of food carried by or otherwise accompanying an individual
arriving in the United States is not for personal use and is placed
under hold under section 801(l) of the act because it is from a foreign
facility that is not registered as required under section 415 of the act
and subpart H of this part, the individual may arrange to have the food
held at the port or exported. If such arrangements cannot be made, the
article of food may be destroyed.
(i) Post-hold submissions. (1) To resolve a hold, if an article of
food is held under paragraph (b) of this section because it is from a
foreign facility that is not registered, the facility must be registered
and a registration number must be obtained.
(2) The FDA Prior Notice Center must be notified of the applicable
registration number in writing. The notification must provide the name
and contact information for the person submitting the information. The
notification may be delivered to FDA by fax or e-mail. The contact
information for these delivery methods is listed at http://www.fda.gov--
see Prior Notice. The notification should include the applicable CBP
entry identifier.
(3) If FDA determines that the article is no longer subject to hold,
it will notify the person who provided the registration information and
CBP that the food is no longer subject to hold under section 801(l) of
the act.
(j) FDA review after hold. (1) If an article of food has been placed
under hold under section 801(l) of the act, a request may be submitted
asking FDA to review whether the facility associated with the article is
subject to the requirements of section 415 of the act. A
[[Page 38]]
request for review may not be submitted to obtain a registration number.
(2) A request may be submitted only by the carrier, submitter,
importer, owner, or ultimate consignee of the article. A request must
identify which one the requestor is.
(3) A request must be submitted in writing to FDA and delivered by
fax or e-mail. The location for receipt of a request is listed at http:/
/www.fda.gov--see Prior Notice. A request must include all factual and
legal information necessary for FDA to conduct its review. Only one
request for review may be submitted for each article under hold.
(4) The request must be submitted within 5-calendar days of the
hold. FDA will review and respond within 5-calendar days of receiving
the request.
(5) If FDA determines that the article is not from a facility
subject to the requirements of section 415 of the act, it will notify
the requestor and CBP that the food is no longer subject to hold under
section 801(l) of the act.
(k) International mail. If an article of food that arrives by
international mail is from a foreign facility that is not registered as
required under section 415 of the act and subpart H of this part, the
parcel will be held by CBP for 72 hours for FDA inspection and
disposition. If the article is placed under hold under section 801(l) of
the act and there is a return address, the parcel may be returned to
sender marked ``No Registration--No Admission Permitted.'' If the
article is under hold and there is no return address or FDA determines
that the article of food in the parcel appears to present a hazard, FDA
may dispose of or destroy the parcel at its expense. If FDA does not
respond within 72 hours of the CBP hold, CBP may return the parcel to
the sender marked ``No Registration--No Admission Permitted'' or, if
there is no return address, destroy the parcel, at FDA expense.
(l) Prohibitions on delivery and transfer. Notwithstanding section
801(b) of the act, while an article of food is under hold under section
801(l) of the act, it may not be delivered to the importer, owner, or
ultimate consignee. If an article of food is no longer subject to hold
under section 801(l) of the act, entry may be made in accordance with
law and regulation.
(m) Relationship to other admissibility provisions. A determination
that an article of food is no longer subject to hold under section
801(l) of the act is different than, and may come before, determinations
of admissibility under other provisions of the act or other U.S. laws. A
determination that an article of food is no longer under hold under
section 801(l) of the act does not mean that it will be granted
admission under other provisions of the act or other U.S. laws.
Subpart J_Establishment, Maintenance, and Availability of Records
Source: 69 FR 71651, Dec. 9, 2004, unless otherwise noted.
General Provisions
Sec.1.326 Who is subject to this subpart?
(a) Persons who manufacture, process, pack, transport, distribute,
receive, hold, or import food in the United States are subject to the
regulations in this subpart, unless you qualify for one of the
exclusions in Sec.1.327. If you conduct more than one type of activity
at a location, you are required to keep records with respect to those
activities covered by this subpart, but are not required by this subpart
to keep records with respect to activities that fall within one of the
exclusions in Sec.1.327.
(b) Persons subject to the regulations in this subpart must keep
records whether or not the food is being offered for or enters
interstate commerce.
Sec.1.327 Who is excluded from all or part of the regulations in this
subpart?
(a) Farms are excluded from all of the requirements in this subpart.
(b) Restaurants are excluded from all of the requirements in this
subpart. A restaurant/retail facility is excluded from all of the
requirements in this subpart if its sales of food it prepares and sells
to consumers for immediate consumption are more than 90 percent of its
total food sales.
[[Page 39]]
(c) Fishing vessels, including those that not only harvest and
transport fish but also engage in practices such as heading,
eviscerating, or freezing intended solely to prepare fish for holding on
board a harvest vessel, are excluded from all of the requirements in
this subpart, except Sec. Sec.1.361 and 1.363. However, those fishing
vessels otherwise engaged in processing fish are subject to all of the
requirements in this subpart. For the purposes of this section,
``processing'' means handling, storing, preparing, shucking, changing
into different market forms, manufacturing, preserving, packing,
labeling, dockside unloading, holding or heading, eviscerating, or
freezing other than solely to prepare fish for holding on board a
harvest vessel.
(d) Persons who distribute food directly to consumers are excluded
from the requirements in Sec.1.345 to establish and maintain records
to identify the nontransporter and transporter immediate subsequent
recipients as to those transactions. The term ``consumers'' does not
include businesses.
(e) Persons who operate retail food establishments that distribute
food to persons who are not consumers are subject to all of the
requirements in this subpart. However, the requirements in Sec.1.345
to establish and maintain records to identify the nontransporter and
transporter immediate subsequent recipients that are not consumers
applies as to those transactions only to the extent the information is
reasonably available.
(1) For purposes of this section, retail food establishment is
defined to mean an establishment that sells food products directly to
consumers as its primary function. The term ``consumers'' does not
include businesses.
(2) A retail food establishment may manufacture/process, pack, or
hold food if the establishment's primary function is to sell from that
establishment food, including food that it manufactures/processes,
packs, or holds, directly to consumers.
(3) A retail food establishment's primary function is to sell food
directly to consumers if the annual monetary value of sales of food
products directly to consumers exceeds the annual monetary value of
sales of food products to all other buyers.
(4) A ``retail food establishment'' includes grocery stores,
convenience stores, and vending machine locations.
(f) Retail food establishments that employ 10 or fewer full-time
equivalent employees are excluded from all of the requirements in this
subpart, except Sec. Sec.1.361 and 1.363. The exclusion is based on
the number of full-time equivalent employees at each retail food
establishment and not the entire business, which may own numerous retail
stores.
(g) Persons who manufacture, process, pack, transport, distribute,
receive, hold, or import food in the United States that is within the
exclusive jurisdiction of the U.S. Department of Agriculture (USDA)
under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the
Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg
Products Inspection Act (21 U.S.C. 1031 et seq.) are excluded from all
of the requirements in this subpart with respect to that food while it
is under the exclusive jurisdiction of USDA.
(h) Foreign persons, except for foreign persons who transport food
in the United States, are excluded from all of the requirements of this
subpart.
(i) Persons who manufacture, process, pack, transport, distribute,
receive, hold, or import food are subject to Sec. Sec.1.361 and 1.363
with respect to its packaging (the outer packaging of food that bears
the label and does not contact the food). All other persons who
manufacture, process, pack, transport, distribute, receive, hold, or
import packaging are excluded from all of the requirements of this
subpart.
(j) Persons who manufacture, process, pack, transport, distribute,
receive, hold, or import food contact substances other than the finished
container that directly contacts food are excluded from all of the
requirements of this subpart, except Sec. Sec.1.361 and 1.363.
(k) Persons who place food directly in contact with its finished
container are subject to all of the requirements of this subpart as to
the finished container that directly contacts that food. All other
persons who manufacture,
[[Page 40]]
process, pack, transport, distribute, receive, hold, or import the
finished container that directly contacts the food are excluded from the
requirements of this subpart as to the finished container, except
Sec. Sec.1.361 and 1.363.
(l) Nonprofit food establishments are excluded from all of the
requirements in this subpart, except Sec. Sec.1.361 and 1.363.
(m) Persons who manufacture, process, pack, transport, distribute,
receive, hold, or import food for personal consumption are excluded from
all of the requirements of this subpart.
(n) Persons who receive or hold food on behalf of specific
individual consumers and who are not also parties to the transaction and
who are not in the business of distributing food are excluded from all
of the requirements of this subpart.
Sec.1.328 What definitions apply to this subpart?
The definitions of terms in section 201 of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C. 321) apply to such terms when used
in this subpart. In addition, for the purposes of this subpart:
Act means the Federal Food, Drug, and Cosmetic Act.
Farm means a facility in one general physical location devoted to
the growing and harvesting of crops, the raising of animals (including
seafood), or both. Washing, trimming of outer leaves, and cooling
produce are considered part of harvesting. The term ``farm'' includes:
(1) Facilities that pack or hold food, provided that all food used
in such activities is grown, raised, or consumed on that farm or another
farm under the same ownership; and
(2) Facilities that manufacture/process food, provided that all food
used in such activities is consumed on that farm or another farm under
the same ownership.
Food has the meaning given in section 201(f) of the act. Examples of
food include, but are not limited to fruits; vegetables; fish; dairy
products; eggs; raw agricultural commodities for use as food or as
components of food; animal feed, including pet food; food and feed
ingredients and additives, including substances that migrate into food
from the finished container and other articles that contact food;
dietary supplements and dietary ingredients; infant formula; beverages,
including alcoholic beverages and bottled water; live food animals;
bakery goods; snack foods; candy; and canned foods.
Full-time equivalent employee means all individuals employed by the
person claiming the exemption. The number of full-time equivalent
employees is determined by dividing the total number of hours of salary
or wages paid directly to employees of the person and of all of its
affiliates by the number of hours of work in 1 year, 2,080 hours (i.e.,
40 hours x 52 weeks).
Holding means storage of food. Holding facilities include
warehouses, cold storage facilities, storage silos, grain elevators, and
liquid storage tanks.
Manufacturing/processing means making food from one or more
ingredients, or synthesizing, preparing, treating, modifying, or
manipulating food, including food crops or ingredients. Examples of
manufacturing/processing activities are cutting, peeling, trimming,
washing, waxing, eviscerating, rendering, cooking, baking, freezing,
cooling, pasteurizing, homogenizing, mixing, formulating, bottling,
milling, grinding, extracting juice, distilling, labeling, or packaging.
Nonprofit food establishment means a charitable entity that prepares
or serves food directly to the consumer or otherwise provides food or
meals for consumption by humans or animals in the United States. The
term includes central food banks, soup kitchens, and nonprofit food
delivery services. To be considered a nonprofit food establishment, the
establishment must meet the terms of section 501(c)(3) of the U.S.
Internal Revenue Code (26 U.S.C. 501(c)(3)).
Nontransporter means a person who owns food or who holds,
manufactures, processes, packs, imports, receives, or distributes food
for purposes other than transportation.
Nontransporter immediate previous source means a person that last
had food before transferring it to another nontransporter.
Nontransporter immediate subsequent recipient means a nontransporter
that acquires food from another nontransporter.
[[Page 41]]
Packaging means the outer packaging of food that bears the label and
does not contact the food. Packaging does not include food contact
substances as they are defined in section 409(h)(6) of the act (21
U.S.C. 348(h)(6)).
Person includes individual, partnership, corporation, and
association.
Recipe means the formula, including ingredients, quantities, and
instructions, necessary to manufacture a food product. Because a recipe
must have all three elements, a list of the ingredients used to
manufacture a product without quantity information and manufacturing
instructions is not a recipe.
Restaurant means a facility that prepares and sells food directly to
consumers for immediate consumption. ``Restaurant'' does not include
facilities that provide food to interstate conveyances, central
kitchens, and other similar facilities that do not prepare and serve
food directly to consumers.
(1) Facilities in which food is directly provided to humans, such as
cafeterias, lunchrooms, cafes, bistros, fast food establishments, food
stands, saloons, taverns, bars, lounges, catering facilities, hospital
kitchens, day care kitchens, and nursing home kitchens, are restaurants.
(2) Pet shelters, kennels, and veterinary facilities in which food
is directly provided to animals are restaurants.
Transporter means a person who has possession, custody, or control
of an article of food in the United States for the sole purpose of
transporting the food, whether by road, rail, water, or air. Transporter
also includes a foreign person that transports food in the United
States, regardless of whether that foreign person has possession,
custody, or control of that food for the sole purpose of transporting
that food.
Transporter's immediate previous source means a person from whom a
transporter received food. This source can be either another transporter
or a nontransporter.
Transporter's immediate subsequent recipient means a person to whom
a transporter delivered food. This recipient can be either another
transporter or a nontransporter.
You means a person subject to this subpart under Sec.1.326.
Sec.1.329 Do other statutory provisions and regulations apply?
(a) In addition to the regulations in this subpart, you must comply
with all other applicable statutory provisions and regulations related
to the establishment and maintenance of records for foods except as
described in paragraph (b) of this section. For example, the regulations
in this subpart are in addition to existing recordkeeping regulations
for low acid canned foods, juice, seafood, infant formula, color
additives, bottled water, animal feed, and medicated animal feed.
(b) Records established or maintained to satisfy the requirements of
this subpart that meet the definition of electronic records in Sec.
11.3(b)(6) (21 CFR 11.3 (b)(6)) of this chapter are exempt from the
requirements of part 11 of this chapter. Records that satisfy the
requirements of this subpart but that are also required under other
applicable statutory provisions or regulations remain subject to part 11
of this chapter.
Sec.1.330 Can existing records satisfy the requirements of this subpart?
The regulations in this subpart do not require duplication of
existing records if those records contain all of the information
required by this subpart. If a covered person keeps records of all of
the information as required by this subpart to comply with other
Federal, State, or local regulations, or for any other reason, then
those records may be used to meet these requirements. Moreover, persons
do not have to keep all of the information required by this rule in one
set of records. If they have records containing some of the required
information, they may keep those existing records and keep, either
separately or in a combined form, any new information required by this
rule. There is no obligation to create an entirely new record or
compilation of records containing both existing and new information,
even if the records containing some of the required information were not
created at the time the food was received or released.
[[Page 42]]
Requirements for Nontransporters To Establish and Maintain Records To
Identify the Nontransporter and Transporter Immediate Previous Sources
of Food
Sec.1.337 What information must nontransporters establish and maintain to
identify the nontransporter and transporter immediate previous sources of
food?
(a) If you are a nontransporter, you must establish and maintain the
following records for all food you receive:
(1) The name of the firm, address, telephone number and, if
available, the fax number and e-mail address of the nontransporter
immediate previous source, whether domestic or foreign;
(2) An adequate description of the type of food received, to include
brand name and specific variety (e.g., brand x cheddar cheese, not just
cheese; or romaine lettuce, not just lettuce);
(3) The date you received the food;
(4) For persons who manufacture, process, or pack food, the lot or
code number or other identifier of the food (to the extent this
information exists);
(5) The quantity and how the food is packaged (e.g., 6 count
bunches, 25 pound (lb) carton, 12 ounce (oz) bottle, 100 gallon (gal)
tank); and
(6) The name of the firm, address, telephone number, and, if
available, the fax number and e-mail address of the transporter
immediate previous source (the transporter who transported the food to
you).
Requirements for Nontransporters To Establish and Maintain Records To
Identify the Nontransporter and Transporter Immediate Subsequent
Recipients of Food
Sec.1.345 What information must nontransporters establish and maintain to
identify the nontransporter and transporter immediate subsequent recipients of
food?
(a) If you are a nontransporter, you must establish and maintain the
following records for food you release:
(1) The name of the firm, address, telephone number, and, if
available, the fax number and e-mail address of the nontransporter
immediate subsequent recipient, whether domestic or foreign;
(2) An adequate description of the type of food released, to include
brand name and specific variety (e.g., brand x cheddar cheese, not just
cheese; or romaine lettuce, not just lettuce);
(3) The date you released the food;
(4) For persons who manufacture, process, or pack food, the lot or
code number or other identifier of the food (to the extent this
information exists);
(5) The quantity and how the food is packaged (e.g., 6 count
bunches, 25 lb carton, 12 oz bottle, 100 gal tank);
(6) The name of the firm, address, telephone number, and, if
available, the fax number and e-mail address of the transporter
immediate subsequent recipient (the transporter who transported the food
from you); and
(b) Your records must include information reasonably available to
you to identify the specific source of each ingredient used to make
every lot of finished product.
Requirements for Transporters To Establish and Maintain Records
Sec.1.352 What information must transporters establish and maintain?
If you are a transporter, you must establish and maintain the
following records for each food you transport in the United States. You
may fulfill this requirement by either:
(a) Establishing and maintaining the following records:
(1) Names of the transporter's immediate previous source and
transporter's immediate subsequent recipient;
(2) Origin and destination points;
(3) Date shipment received and date released;
(4) Number of packages;
(5) Description of freight;
(6) Route of movement during the time you transported the food; and
(7) Transfer point(s) through which shipment moved; or
(b) Establishing and maintaining records containing the following
information currently required by the Department of Transportation's
Federal Motor Carrier Safety Administration (of roadway interstate
transporters (49 CFR 373.101 and 373.103) as of December 9, 2004:
(1) Names of consignor and consignee;
(2) Origin and destination points;
(3) Date of shipment;
[[Page 43]]
(4) Number of packages;
(5) Description of freight;
(6) Route of movement and name of each carrier participating in the
transportation; and
(7) Transfer points through which shipment moved; or
(c) Establishing and maintaining records containing the following
information currently required by the Department of Transportation's
Surface Transportation Board of rail and water interstate transporters
(49 CFR 1035.1 and 1035.2) as of December 9, 2004:
(1) Date received;
(2) Received from;
(3) Consigned to;
(4) Destination;
(5) State of;
(6) County of;
(7) Route;
(8) Delivering carrier;
(9) Car initial;
(10) Car no;
(11) Trailer initials/number;
(12) Container initials/number;
(13) No. packages; and
(14) Description of articles; or
(d) Establishing and maintaining records containing the following
information currently required by the Warsaw Convention of international
air transporters on air waybills:
(1) Shipper's name and address;
(2) Consignee's name and address;
(3) Customs reference/status;
(4) Airport of departure and destination;
(5) First carrier; and
(6) Description of goods; or
(e) Entering into an agreement with the nontransporter immediate
previous source located in the United States and/or the nontransporter
immediate subsequent recipient located in the United States to
establish, maintain, or establish and maintain, the information in Sec.
1.352(a), (b), (c), or (d). The agreement must contain the following
elements:
(1) Effective date;
(2) Printed names and signatures of authorized officials;
(3) Description of the records to be established and/or maintained;
(4) Provision for the records to be maintained in compliance with
Sec.1.360, if the agreement provides for maintenance of records;
(5) Provision for the records to be available to FDA as required by
Sec.1.361, if the agreement provides for maintenance of records;
(6) Acknowledgement that the nontransporter assumes legal
responsibility under Sec.1.363 for establishing and/or maintaining the
records as required by this subpart; and
(7) Provision that if the agreement is terminated in writing by
either party, responsibility for compliance with the applicable
establishment, maintenance, and access provisions of this subpart
reverts to the transporter as of the date of termination.
General Requirements
Sec.1.360 What are the record retention requirements?
(a) You must create the required records when you receive and
release food, except to the extent that the information is contained in
existing records.
(b) If you are a nontransporter, you must retain for 6 months after
the dates you receive and release the food all required records for any
food having a significant risk of spoilage, loss of value, or loss of
palatability within 60 days after the date you receive or release the
food.
(c) If you are a nontransporter, you must retain for 1 year after
the dates you receive and release the food all required records for any
food for which a significant risk of spoilage, loss of value, or loss of
palatability occurs only after a minimum of 60 days, but within 6
months, after the date you receive or release the food.
(d) If you are a nontransporter, you must retain for 2 years after
the dates you receive and release the food all required records for any
food for which a significant risk of spoilage, loss of value, or loss of
palatability does not occur sooner than 6 months after the date you
receive or release the food, including foods preserved by freezing,
dehydrating, or being placed in a hermetically sealed container.
(e) If you are a nontransporter, you must retain for 1 year after
the dates you receive and release the food all required records for
animal food, including pet food.
[[Page 44]]
(f) If you are a transporter or nontransporter retaining records on
behalf of a transporter, you must retain for 6 months after the dates
you receive and release the food all required records for any food
having a significant risk of spoilage, loss of value, or loss of
palatability within 60 days after the date the transporter receives or
releases the food. If you are a transporter, or nontransporter retaining
records on behalf of a transporter, you must retain for 1 year after the
dates you receive and release the food, all required records for any
food for which a significant risk of spoilage, loss of value, or loss of
palatability occurs only after a minimum of 60 days after the date the
transporter receives or releases the food.
(g) You must retain all records at the establishment where the
covered activities described in the records occurred (onsite) or at a
reasonably accessible location.
(h) The maintenance of electronic records is acceptable. Electronic
records are considered to be onsite if they are accessible from an
onsite location.
Sec.1.361 What are the record availability requirements?
When FDA has a reasonable belief that an article of food, and any
other article of food that FDA reasonably believes is likely to be
affected in a similar manner, is adulterated and presents a threat of
serious adverse health consequences or death to humans or animals, or
when FDA believes that there is a reasonable probability that the use of
or exposure to an article of food, and any other article of food that
FDA reasonably believes is likely to be affected in a similar manner,
will cause serious adverse health consequences or death to humans or
animals, any records and other information accessible to FDA under
section 414 or 704(a) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 350c and 374(a)) must be made readily available for inspection
and photocopying or other means of reproduction. Such records and other
information must be made available as soon as possible, not to exceed 24
hours from the time of receipt of the official request, from an officer
or employee duly designated by the Secretary of Health and Human
Services who presents appropriate credentials and a written notice.
[77 FR 10662, Feb. 23, 2012]
Sec.1.362 What records are excluded from this subpart?
The establishment and maintenance of records as required by this
subpart does not extend to recipes for food as defined in Sec.1.328;
financial data, pricing data, personnel data, research data, or sales
data (other than shipment data regarding sales).
Sec.1.363 What are the consequences of failing to establish or maintain
records or make them available to FDA as required by this subpart?
(a) The failure to establish or maintain records as required by
section 414(b) of the act and this regulation or the refusal to permit
access to or verification or copying of any such required record is a
prohibited act under section 301 of the act.
(b) The failure of a nontransporter immediate previous source or a
nontransporter immediate subsequent recipient who enters an agreement
under Sec.1.352(e) to establish, maintain, or establish and maintain,
records required under Sec.1.352(a), (b), (c), or (d), or the refusal
to permit access to or verification or copying of any such required
record, is a prohibited act under section 301 of the act.
(c) The failure of any person to make records or other information
available to FDA as required by section 414 or 704(a) of the act and
this regulation is a prohibited act under section 301 of the act.
[69 FR 71651, Dec. 9, 2004, as amended at 70 FR 8726, Feb. 23, 2005]
Compliance Dates
Sec.1.368 What are the compliance dates for this subpart?
The compliance date for the requirements in this subpart is December
9, 2005. However, the compliance dates for small and very small
businesses are contained in paragraphs (a) and (b) of this section. The
size of the business is determined using the total number of full-time
equivalent employees in the
[[Page 45]]
entire business, not each individual location or establishment. A full-
time employee counts as one full-time equivalent employee. Two part-time
employees, each working half time, count as one full-time equivalent
employee.
(a) The compliance date for the requirements in this subpart is June
9, 2006, for small businesses employing fewer that 500, but more than 10
full-time equivalent employees.
(b) The compliance date for the requirements in this subpart is
December 11, 2006, for very small businesses that employ 10 or fewer
full-time equivalent employees.
[69 FR 71651, Dec. 9, 2004, as amended at 70 FR 8727, Feb. 23, 2005]
Subpart K_Administrative Detention of Food for Human or Animal
Consumption
Source: 69 FR 31701, June 4, 2004, unless otherwise noted.
General Provisions
Sec.1.377 What definitions apply to this subpart?
The definitions of terms that appear in section 201 of the act (21
U.S.C. 321) apply when the terms are used in this subpart. In addition,
for the purposes of this subpart:
Act means the Federal Food, Drug, and Cosmetic Act.
Authorized FDA representative means an FDA District Director in
whose district the article of food involved is located or an FDA
official senior to such director.
Calendar day means every day shown on the calendar.
Food has the meaning given in section 201(f) of the act (21 U.S.C.
321(f)). Examples of food include, but are not limited to, fruits,
vegetables, fish, dairy products, eggs, raw agricultural commodities for
use as food or components of food, animal feed, including pet food, food
and feed ingredients and additives, including substances that migrate
into food from food packaging and other articles that contact food,
dietary supplements and dietary ingredients, infant formula, beverages,
including alcoholic beverages and bottled water, live food animals,
bakery goods, snack foods, candy, and canned foods.
Perishable food means food that is not heat-treated; not frozen; and
not otherwise preserved in a manner so as to prevent the quality of the
food from being adversely affected if held longer than 7 calendar days
under normal shipping and storage conditions.
We means the U.S. Food and Drug Administration (FDA).
Working day means any day from Monday through Friday, excluding
Federal holidays.
You means any person who received the detention order or that
person's representative.
Sec.1.378 What criteria does FDA use to order a detention?
An officer or qualified employee of FDA may order the detention of
any article of food that is found during an inspection, examination, or
investigation under the act if the officer or qualified employee has
reason to believe that the article of food is adulterated or misbranded.
[76 FR 25541, May 5, 2011]
Sec.1.379 How long may FDA detain an article of food?
(a) FDA may detain an article of food for a reasonable period that
may not exceed 20 calendar days after the detention order is issued.
However, an article may be detained for 10 additional calendar days if a
greater period of time is required to institute a seizure or injunction
action. The authorized FDA representative may approve the additional 10-
calendar day detention period at the time the detention order is issued,
or at any time within the 20-calendar day period by amending the
detention order.
(b) The entire detention period may not exceed 30 calendar days.
(c) An authorized FDA representative may, in accordance with Sec.
1.384, terminate a detention order before the expiration of the
detention period.
Sec.1.380 Where and under what conditions must the detained article of food
be held?
(a) You must hold the detained article of food in the location and
under
[[Page 46]]
the conditions specified by FDA in the detention order.
(b) If FDA determines that removal to a secure facility is
appropriate, the article of food must be removed to a secure facility. A
detained article of food remains under detention before, during, and
after movement to a secure facility. FDA will also state in the
detention order any conditions of transportation applicable to the
detained article.
(c) If FDA directs you to move the detained article of food to a
secure facility, you must receive a modification of the detention order
under Sec.1.381(c) before you move the detained article of food to a
secure facility.
(d) You must ensure that any required tags or labels under Sec.
1.382 accompany the detained article during and after movement. The tags
or labels must remain with the article of food until FDA terminates the
detention order or the detention period expires, whichever occurs first,
unless otherwise permitted by the authorized FDA representative.
(e) The movement of an article of food in violation of a detention
order issued under Sec.1.393 is a prohibited act under section 301 of
the act (21 U.S.C. 331).
Sec.1.381 May a detained article of food be delivered to another entity or
transferred to another location?
(a) An article of food subject to a detention order under this
subpart may not be delivered under the execution of a bond.
Notwithstanding section 801(b) of the act (21 U.S.C. 381(b)), while any
article of food is subject to a detention order under section 304(h) of
the act (21 U.S.C. 334(h)), it may not be delivered to any of its
importers, owners, or consignees. This section does not preclude
movement at FDA's direction of imported food to a secure facility under
an appropriate Customs' bond when that bond is required by Customs' law
and regulation.
(b) Except as provided in paragraph (c) of this section, no person
may transfer a detained article of food within or from the place where
it has been ordered detained, or from the place to which it was removed,
until an authorized FDA representative releases the article of food
under Sec.1.384 or the detention period expires under Sec.1.379,
whichever occurs first.
(c) The authorized FDA representative may approve, in writing, a
request to modify a detention order to permit movement of a detained
article of food for any of the following purposes:
(1) To destroy the article of food,
(2) To move the detained article of food to a secure facility under
the terms of a detention order,
(3) To maintain or preserve the integrity or quality of the article
of food, or
(4) For any other purpose that the authorized FDA representative
believes is appropriate in the case.
(d) You must submit your request for modification of the detention
order in writing to the authorized FDA representative who approved the
detention order. You must state in your request the reasons for
movement; the exact address of and location in the new facility (or the
new location within the same facility) where the detained article of
food will be transferred; an explanation of how the new address and
location will be secure, if FDA has directed that the article be
detained in a secure facility; and how the article will be held under
any applicable conditions described in the detention order. If you are
requesting modification of a detention order for the purpose of
destroying the detained article of food, you also must submit a verified
statement identifying the ownership or proprietary interest you have in
the detained article of food, in accordance with Supplemental Rule C to
the ``Federal Rules of Civil Procedure.''
(e) If FDA approves a request for modification of a detention order,
the article may be transferred but remains under detention before,
during, and after the transfer. FDA will state any conditions of
transportation applicable to the detained article. You may not transfer
a detained article of food without FDA supervision unless FDA has
declined in writing to supervise the transfer. If FDA has declined in
writing to supervise the transfer of a detained article, you must
immediately notify
[[Page 47]]
in writing the authorized FDA representative who approved the
modification of the detention order that the article of food has reached
its new location, and the specific location of the detained article
within the new location. Such written notification may be in the form of
a fax, e-mail, or other form as agreed to by the authorized FDA
representative.
(f) You must ensure that any required tags or labels under Sec.
1.382 accompany the detained article during and after movement. The tags
or labels must remain with the article of food until FDA terminates the
detention order or the detention period expires, whichever occurs first,
unless otherwise permitted by the authorized FDA representative who
approves the modification of a detention order under this section.
(g) The transfer of an article of food in violation of a detention
order issued under Sec.1.393 is a prohibited act under section 301 of
the act.
Sec.1.382 What labeling or marking requirements apply to a detained article
of food?
The officer or qualified employee of FDA issuing a detention order
under Sec.1.393 may label or mark the detained article of food with
official FDA tags or labels that include the following information:
(a) A statement that the article of food is detained by FDA in
accordance with section 304(h) of the act;
(b) A statement that the article of food must not be consumed,
moved, altered, or tampered with in any manner for the period shown,
without the written permission of an authorized FDA representative;
(c) A statement that the violation of a detention order or the
removal or alteration of the tag or label is a prohibited act,
punishable by fine or imprisonment or both; and
(d) The detention order number, the date and hour of the detention
order, the detention period, and the name of the officer or qualified
employee of FDA who issued the detention order.
Sec.1.383 What expedited procedures apply when FDA initiates a seizure action
against a detained perishable food?
If FDA initiates a seizure action under section 304(a) of the act
against a perishable food subject to a detention order under this
subpart, FDA will send the seizure recommendation to the Department of
Justice (DOJ) within 4 calendar days after the detention order is
issued, unless extenuating circumstances exist. If the fourth calendar
day is not a working day, FDA will advise the DOJ of its plans to
recommend a seizure action on the last working day before the fourth
calendar day and send the recommendation as soon as practicable on the
first working day that follows. For purposes of this section, an
extenuating circumstance includes, but is not limited to, instances when
the results of confirmatory testing or other evidentiary development
requires more than 4 calendar days to complete.
Sec.1.384 When does a detention order terminate?
If FDA terminates a detention order or the detention period expires,
an authorized FDA representative will issue a detention termination
notice releasing the article of food to any person who received the
detention order or that person's representative and will remove, or
authorize in writing the removal of, the required labels or tags. If FDA
fails to issue a detention termination notice and the detention period
expires, the detention is deemed to be terminated.
How Does FDA Order a Detention?
Sec.1.391 Who approves a detention order?
An authorized FDA representative, i.e., the FDA District Director in
whose district the article of food involved is located or an FDA
official senior to such director, must approve a detention order. If
prior written approval is not feasible, prior oral approval must be
obtained and confirmed in writing as soon as possible.
[[Page 48]]
Sec.1.392 Who receives a copy of the detention order?
(a) FDA must issue the detention order to the owner, operator, or
agent in charge of the place where the article of food is located. If
the owner of the article of food is different from the owner, operator,
or agent in charge of the place where the article is detained, FDA must
provide a copy of the detention order to the owner of the article of
food if the owner's identity can be determined readily.
(b) If FDA issues a detention order for an article of food located
in a vehicle or other carrier used to transport the detained article of
food, FDA also must provide a copy of the detention order to the shipper
of record and the owner and operator of the vehicle or other carrier, if
their identities can be determined readily.
Sec.1.393 What information must FDA include in the detention order?
(a) FDA must issue the detention order in writing, in the form of a
detention notice, signed and dated by the officer or qualified employee
of FDA who has reason to believe that such article of food is
adulterated or misbranded.
(b) The detention order must include the following information:
(1) The detention order number;
(2) The date and hour of the detention order;
(3) Identification of the detained article of food;
(4) The period of the detention;
(5) A statement that the article of food identified in the order is
detained for the period shown;
(6) A brief, general statement of the reasons for the detention;
(7) The address and location where the article of food is to be
detained and the appropriate storage conditions;
(8) Any applicable conditions of transportation of the detained
article of food;
(9) A statement that the article of food is not to be consumed,
moved, altered, or tampered with in any manner during the detention
period, unless the detention order is first modified under Sec.
1.381(c);
(10) The text of section 304(h) of the act and Sec. Sec.1.401 and
1.402;
(11) A statement that any informal hearing on an appeal of a
detention order must be conducted as a regulatory hearing under part 16
of this chapter, with certain exceptions described in Sec.1.403;
(12) The mailing address, telephone number, e-mail address, and fax
number of the FDA district office and the name of the FDA District
Director in whose district the detained article of food is located;
(13) A statement indicating the manner in which approval of the
detention order was obtained, i.e., verbally or in writing; and
(14) The name and the title of the authorized FDA representative who
approved the detention order.
[69 FR 31701, June 4, 2004, as amended at 76 FR 25541, May 5, 2011]
What Is the Appeal Process for a Detention Order?
Sec.1.401 Who is entitled to appeal?
Any person who would be entitled to be a claimant for the article of
food, if seized under section 304(a) of the act, may appeal a detention
order as specified in Sec.1.402. Procedures for establishing
entitlement to be a claimant for purposes of section 304(a) of the act
are governed by Supplemental Rule C to the ``Federal Rules of Civil
Procedure.''
Sec.1.402 What are the requirements for submitting an appeal?
(a) If you want to appeal a detention order, you must submit your
appeal in writing to the FDA District Director, in whose district the
detained article of food is located, at the mailing address, e-mail
address, or fax number identified in the detention order according to
the following applicable timeframes:
(1) Perishable food: If the detained article is a perishable food,
as defined in Sec.1.377, you must file an appeal within 2 calendar
days of receipt of the detention order.
(2) Nonperishable food: If the detained article is not a perishable
food, as defined in Sec.1.377, you must file a notice of an intent to
request a hearing within 4 calendar days of receipt of the detention
order. If the notice of intent is not filed within 4 calendar days, you
will
[[Page 49]]
not be granted a hearing. If you have not filed a timely notice of
intent to request a hearing, you may file an appeal without a hearing
request. Whether or not it includes a request for hearing, your appeal
must be filed within 10 calendar days of receipt of the detention order.
(b) Your request for appeal must include a verified statement
identifying your ownership or proprietary interest in the detained
article of food, in accordance with Supplemental Rule C to the ``Federal
Rules of Civil Procedure.''
(c) The process for the appeal of a detention order under this
section terminates if FDA institutes either a seizure action under
section 304(a) of the act or an injunction under section 302 of the act
(21 U.S.C. 276) regarding the article of food involved in the detention
order.
(d) As part of the appeals process, you may request an informal
hearing. Your request for a hearing must be in writing and must be
included in your request for an appeal specified in paragraph (a) of
this section. If you request an informal hearing, and FDA grants your
request, the hearing will be held within 2 calendar days after the date
the appeal is filed.
Sec.1.403 What requirements apply to an informal hearing?
If FDA grants a request for an informal hearing on an appeal of a
detention order, FDA must conduct the hearing in accordance with part 16
of this chapter, except that:
(a) The detention order under Sec.1.393, rather than the notice
under Sec.16.22(a) of this chapter, provides notice of opportunity for
a hearing under this section and is part of the administrative record of
the regulatory hearing under Sec.16.80(a) of this chapter;
(b) A request for a hearing under this section must be addressed to
the FDA District Director in whose district the article of food involved
is located;
(c) The provision in Sec.16.22(b) of this chapter, providing that
a person not be given less than 3 working days after receipt of notice
to request a hearing, does not apply to a hearing under this subpart;
(d) The provision in Sec.16.24(e) of this chapter, stating that a
hearing may not be required to be held at a time less than 2 working
days after receipt of the request for a hearing, does not apply to a
hearing under this subpart;
(e) Section 1.406, rather than Sec.16.24(f) of this chapter,
describes the statement that will be provided to an appellant where a
detention order is based on classified information;
(f) Section 1.404, rather than Sec.16.42(a) of this chapter,
describes the FDA employees, e.g., Regional Food and Drug Directors or
other officials senior to a District Director, who preside at hearings
under this subpart;
(g) The presiding officer may require that a hearing conducted under
this section be completed within 1 calendar day, as appropriate;
(h) Section 16.60(e) and (f) of this chapter does not apply to a
hearing under this subpart. The presiding officer must prepare a written
report of the hearing. All written material presented at the hearing
will be attached to the report. The presiding officer must include as
part of the report of the hearing a finding on the credibility of
witnesses (other than expert witnesses) whenever credibility is a
material issue, and must include a proposed decision, with a statement
of reasons. The hearing participant may review and comment on the
presiding officer's report within 4 hours of issuance of the report. The
presiding officer will then issue the final agency decision.
(i) Section 16.80(a)(4) of this chapter does not apply to a
regulatory hearing under this subpart. The presiding officer's report of
the hearing and any comments on the report by the hearing participant
under Sec.1.403(h) are part of the administrative record.
(j) No party shall have the right, under Sec.16.119 of this
chapter to petition the Commissioner of Food and Drugs for
reconsideration or a stay of the presiding officer's final agency
decision.
(k) If FDA grants a request for an informal hearing on an appeal of
a detention order, the hearing must be conducted as a regulatory hearing
pursuant to regulation in accordance with part 16 of this chapter,
except that Sec.16.95(b) does not apply to a hearing under this
subpart. With respect to a regulatory hearing under this subpart, the
administrative record of the hearing specified in Sec. Sec.
16.80(a)(1), (a)(2),
[[Page 50]]
(a)(3), and (a)(5), and 1.403(i) constitutes the exclusive record for
the presiding officer's final decision on an administrative detention.
For purposes of judicial review under Sec.10.45 of this chapter, the
record of the administrative proceeding consists of the record of the
hearing and the presiding officer's final decision.
Sec.1.404 Who serves as the presiding officer for an appeal, and for an
informal hearing?
The presiding officer for an appeal, and for an informal hearing,
must be an FDA Regional Food and Drug Director or another FDA official
senior to an FDA District Director.
Sec.1.405 When does FDA have to issue a decision on an appeal?
(a) The presiding officer must issue a written report that includes
a proposed decision confirming or revoking the detention by noon on the
fifth calendar day after the appeal is filed; after your 4 hour
opportunity for submitting comments under Sec.1.403(h), the presiding
officer must issue a final decision within the 5-calendar day period
after the appeal is filed. If FDA either fails to provide you with an
opportunity to request an informal hearing, or fails to confirm or
terminate the detention order within the 5-calendar day period, the
detention order is deemed terminated.
(b) If you appeal the detention order, but do not request an
informal hearing, the presiding officer must issue a decision on the
appeal confirming or revoking the detention within 5 calendar days after
the date the appeal is filed. If the presiding officer fails to confirm
or terminate the detention order during such 5-calendar day period, the
detention order is deemed terminated.
(c) If you appeal the detention order and request an informal
hearing and your hearing request is denied, the presiding officer must
issue a decision on the appeal confirming or revoking the detention
within 5 calendar days after the date the appeal is filed. If the
presiding officer fails to confirm or terminate the detention order
during such 5-calendar day period, the detention order is deemed
terminated.
(d) If the presiding officer confirms a detention order, the article
of food continues to be detained until we terminate the detention under
Sec.1.384 or the detention period expires under Sec.1.379, whichever
occurs first.
(e) If the presiding officer terminates a detention order, or the
detention period expires, FDA must terminate the detention order as
specified under Sec.1.384.
(f) Confirmation of a detention order by the presiding officer is
considered a final agency action for purposes of 5 U.S.C. 702.
Sec.1.406 How will FDA handle classified information in an informal hearing?
Where the credible evidence or information supporting the detention
order is classified under the applicable Executive order as requiring
protection from unauthorized disclosure in the interest of national
security (``classified information''), FDA will not provide you with
this information. The presiding officer will give you notice of the
general nature of the information and an opportunity to offer opposing
evidence or information, if he or she may do so consistently with
safeguarding the information and its source. If classified information
was used to support the detention, then any confirmation of such
detention will state whether it is based in whole or in part on that
classified information.
PART 2_GENERAL ADMINISTRATIVE RULINGS AND DECISIONS--Table of Contents
Subpart A_General Provisions
Sec.
2.5 Imminent hazard to the public health.
2.10 Examination and investigation samples.
2.19 Methods of analysis.
Subpart B_Human and Animal Foods
2.25 Grain seed treated with poisonous substances; color identification
to prevent adulteration of human and animal food.
2.35 Use of secondhand containers for the shipment or storage of food
and animal feed.
Subparts C-E [Reserved]
[[Page 51]]
Subpart F_Caustic Poisons
2.110 Definition of ammonia under Federal Caustic Poison Act.
Subpart G_Provisions Applicable to Specific Products Subject to the
Federal Food, Drug, and Cosmetic Act
2.125 Use of ozone-depleting substances in foods, drugs, devices, or
cosmetics.
Authority: 15 U.S.C. 402, 409; 21 U.S.C. 321, 331, 335, 342, 343,
346a, 348, 351, 352, 355, 360b, 361, 362, 371, 372, 374; 42 U.S.C. 7671
et seq.
Source: 42 FR 15559, Mar. 22, 1977, unless otherwise noted.
Subpart A_General Provisions
Sec.2.5 Imminent hazard to the public health.
(a) Within the meaning of the Federal Food, Drug, and Cosmetic Act
an imminent hazard to the public health is considered to exist when the
evidence is sufficient to show that a product or practice, posing a
significant threat of danger to health, creates a public health
situation (1) that should be corrected immediately to prevent injury and
(2) that should not be permitted to continue while a hearing or other
formal proceeding is being held. The imminent hazard may be declared at
any point in the chain of events which may ultimately result in harm to
the public health. The occurrence of the final anticipated injury is not
essential to establish that an imminent hazard of such occurrence
exists.
(b) In exercising his judgment on whether an imminent hazard exists,
the Commissioner will consider the number of injuries anticipated and
the nature, severity, and duration of the anticipated injury.
Sec.2.10 Examination and investigation samples.
(a)(1) When any officer or employee of the Department collects a
sample of a food, drug, or cosmetic for analysis under the act, the
sample shall be designated as an official sample if records or other
evidence is obtained by him or any other officer or employee of the
Department indicating that the shipment or other lot of the article from
which such sample was collected was introduced or delivered for
introduction into interstate commerce, or was in or was received in
interstate commerce, or was manufactured within a Territory. Only
samples so designated by an officer or employee of the Department shall
be considered to be official samples.
(2) For the purpose of determining whether or not a sample is
collected for analysis, the term analysis includes examinations and
tests.
(3) The owner of a food, drug, or cosmetic of which an official
sample is collected is the person who owns the shipment or other lot of
the article from which the sample is collected.
(b) When an officer or employee of the Department collects an
official sample of a food, drug, or cosmetic for analysis under the act,
he shall collect at least twice the quantity estimated by him to be
sufficient for analysis, unless:
(1) The amount of the article available and reasonably accessible
for sampling is less than twice the quantity so estimated, in which case
he shall collect as much as is available and reasonably accessible.
(2) The cost of twice the quantity so estimated exceeds $150.
(3) The sample cannot by diligent use of practicable preservation
techniques available to the Food and Drug Administration be kept in a
state in which it could be readily and meaningfully analyzed in the same
manner and for the same purposes as the Food and Drug Administration's
analysis.
(4) The sample is collected from a shipment or other lot which is
being imported or offered for import into the United States.
(5) The sample is collected from a person named on the label of the
article or his agent, and such person is also the owner of the article.
(6) The sample is collected from the owner of the article, or his
agent, and such article bears no label or, if it bears a label, no
person is named thereon.
In addition to the quantity of sample set forth in this paragraph, the
officer or employee shall, if practicable, collect such further amount
as he estimates will be sufficient for use as trial exhibits.
[[Page 52]]
(c) After the Food and Drug Administration has completed such
analysis of an official sample of a food, drug, or cosmetic as it
determines, in the course of analysis and interpretation of analytical
results, to be adequate to establish the respects, if any, in which the
article is adulterated or misbranded within the meaning of the act, or
otherwise subject to the prohibitions of the act, and has reserved an
amount of the article it estimates to be adequate for use as exhibits in
the trial of any case that may arise under the act based on the sample,
a part of the sample, if any remains available, shall be provided for
analysis, upon written request, by any person named on the label of the
article, or the owner thereof, or the attorney or agent of such person
or owner, except when:
(1) After collection, the sample or remaining part thereof has
become decomposed or otherwise unfit for analysis, or
(2) The request is not made within a reasonable time before the
trial of any case under the act, based on the sample to which such
person or owner is a party. The person, owner, attorney, or agent who
requests the part of sample shall specify the amount desired. A request
from an owner shall be accompanied by a showing of ownership, and a
request from an attorney or agent by a showing of authority from such
person or owner to receive the part of sample. When two or more requests
for parts of the same sample are received the requests shall be complied
with in the order in which they were received so long as any part of the
sample remains available therefor.
(d) When an official sample of food, drug, or cosmetic is the basis
of a notice given under section 305 of the act, or of a case under the
act, and the person to whom the notice was given, or any person who is a
party to the case, has no right under paragraph (c) of this section to a
part of the sample, such person or his attorney or agent may obtain a
part of the sample upon request accompanied by a written waiver of right
under such paragraph (c) from each person named on the label of the
article and owner thereof, who has not exercised his right under such
paragraph (c). The operation of this paragraph shall be subject to the
exceptions, terms, and conditions prescribed in paragraph (c) of this
section.
(e) The Food and Drug Administration is authorized to destroy:
(1) Any official sample when it determines that no analysis of such
sample will be made;
(2) Any official sample or part thereof when it determines that no
notice under section 305 of the act, and no case under the act, is or
will be based on such sample;
(3) Any official sample or part thereof when the sample was the
basis of a notice under section 305 of the act, and when, after
opportunity for presentation of views following such notice, it
determines that no other such notice, and no case under the act, is or
will be based on such sample;
(4) Any official sample or part thereof when the sample was the
basis of a case under the act which has gone to final judgment, and when
it determines that no other such case is or will be based on such
sample;
(5) Any official sample or part thereof if the article is
perishable;
(6) Any official sample or part thereof when, after collection, such
sample or part has become decomposed or otherwise unfit for analysis;
(7) That part of any official sample which is in excess of three
times the quantity it estimates to be sufficient for analysis.
[42 FR 15559, Mar. 22, 1977, as amended at 63 FR 51299, Sept. 25, 1998]
Sec.2.19 Methods of analysis.
Where the method of analysis is not prescribed in a regulation, it
is the policy of the Food and Drug Administration in its enforcement
programs to utilize the methods of analysis of the AOAC INTERNATIONAL
(AOAC) as published in the latest edition (13th Ed., 1980) of their
publication ``Official Methods of Analysis of the Association of
Official Analytical Chemists,'' and the supplements thereto (``Changes
in Methods'' as published in the March issues of the ``Journal of the
Association of Official Analytical Chemists''), which are incorporated
by reference, when available and applicable. Copies are available from
the AOAC INTERNATIONAL, 481 North Frederick Ave.,
[[Page 53]]
suite 500, Gaithersburg, MD 20877, or at the National Archives and
Records Administration (NARA). For information on the availability of
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal--register/code--of--federal--regulations/ibr--
locations.html. In the absence of an AOAC method, the Commissioner will
furnish a copy of the particular method, or a reference to the published
method, that the Food and Drug Administration will use in its
enforcement program. Other methods may be used for quality control,
specifications, contracts, surveys, and similar nonregulatory functions,
but it is expected that they will be calibrated in terms of the method
which the Food and Drug Administration uses in its enforcement program.
Use of an AOAC method does not relieve the practioner of the
responsibility to demonstrate that he can perform the method properly
through the use of positive and negative controls and recovery and
reproducibility studies.
[42 FR 15559, Mar. 22, 1977, as amended at 47 FR 946, Jan. 8, 1982; 54
FR 9034, Mar. 3, 1989; 70 FR 40880, July 15, 2005; 70 FR 67651, Nov. 8,
2005]
Subpart B_Human and Animal Foods
Sec.2.25 Grain seed treated with poisonous substances; color identification
to prevent adulteration of human and animal food.
(a) In recent years there has developed increasing use of poisonous
treatments on seed for fungicidal and other purposes. Such treated seed,
if consumed, presents a hazard to humans and livestock. It is not
unusual for stocks of such treated food seeds to remain on hand after
the planting season has passed. Despite the cautions required by the
Federal Seed Act (53 Stat. 1275, as amended 72 Stat. 476, 7 U.S.C. 1551
et seq.) in the labeling of the treated seed, the Food and Drug
Administration has encountered many cases where such surplus stocks of
treated wheat, corn, oats, rye, barley, and sorghum seed had been mixed
with untreated seed and sent to market for food or feed use. This has
resulted in livestock injury and in legal actions under the Federal
Food, Drug, and Cosmetic Act against large quantities of food
adulterated through such admixture of poisonous treated seeds with good
food. Criminal cases were brought against some firms and individuals.
Where the treated seeds are prominently colored, buyers and users or
processors of agricultural food seed for food purposes are able to
detect the admixture of the poisonous seed and thus reject the lots; but
most such buyers, users, and processors do not have the facilities or
scientific equipment to determine the presence of the poisonous chemical
at the time crops are delivered, in cases where the treated seeds have
not been so colored. A suitable color for this use is one that is in
sufficient contrast to the natural color of the food seed as to make
admixture of treated, denatured seeds with good food easily apparent,
and is so applied that it is not readily removed.
(b) On and after December 31, 1964, the Food and Drug Administration
will regard as adulterated any interstate shipment of the food seeds
wheat, corn, oats, rye, barley, and sorghum bearing a poisonous
treatment in excess of a recognized tolerance or treatment for which no
tolerance or exemption from tolerance is recognized in regulations
promulgated pursuant to section 408 of the Federal Food, Drug, and
Cosmetic Act, unless such seeds have been adequately denatured by a
suitable color to prevent their subsequent inadvertent use as food for
man or feed for animals.
(c) Attention is called to the labeling requirements of the Federal
Hazardous Substances Act, where applicable to denatured seeds in
packages suitable for household use.
Sec.2.35 Use of secondhand containers for the shipment or storage of food and
animal feed.
(a) Investigations by the Food and Drug Administration, the National
Communicable Disease Center of the U.S. Public Health Service, the
Consumer and Marketing Service of the U.S. Department of Agriculture,
and by various State public health agencies have revealed practices
whereby food and animal feed stored or shipped in
[[Page 54]]
secondhand containers have been rendered dangerous to health. Such
contamination has been the result of the original use of these
containers for the storage and shipment of articles containing or
bearing disease organisms or poisonous or deleterious substances.
(b) The Commissioner concludes that such dangerous or potentially
dangerous practices include, but are not limited to, the following:
(1) Some vegetable growers and packers employ used poultry crates
for shipment of fresh vegetables, including cabbage and celery.
Salmonella organisms are commonly present on dressed poultry and in
excreta and fluid exudates from dressed birds. Thus wooden crates in
which dressed poultry has been iced and packed are potential sources of
Salmonella or other enteropathogenic microorganisms that may contaminate
fresh vegetables which are frequently consumed without heat treatment.
(2) Some potato growers and producers of animal feeds use secondhand
bags for shipment of these articles. Such bags may have originally been
used for shipping or storing pesticide-treated seed or other articles
bearing or containing poisonous substances. Thus these secondhand bags
are potential sources of contamination of the food or animal feed stored
or shipped therein.
(c) In a policy statement issued April 11, 1968, the Food and Drug
Administration declared adulterated within the meaning of section 402(a)
of the Federal Food, Drug, and Cosmetic Act shipments of vegetables or
other edible food in used crates or containers that may render the
contents injurious to health. This policy statement is extended so that
the Food and Drug Administration will regard as adulterated within the
meaning of section 402(a) of the act shipments of vegetables, other
edible food, or animal feed in used crates, bags, or other containers
that may render the contents injurious to health.
Subparts C-E [Reserved]
Subpart F_Caustic Poisons
Sec.2.110 Definition of ammonia under Federal Caustic Poison Act.
For the purpose of determining whether an article containing ammonia
is subject to the Federal Caustic Poison Act, the ammonia content is to
be calculated as NH3.
Subpart G_Provisions Applicable to Specific Products Subject to the
Federal Food, Drug, and Cosmetic Act
Sec.2.125 Use of ozone-depleting substances in foods, drugs, devices, or
cosmetics.
(a) As used in this section, ozone-depleting substance (ODS) means
any class I substance as defined in 40 CFR part 82, appendix A to
subpart A, or class II substance as defined in 40 CFR part 82, appendix
B to subpart A.
(b) Except as provided in paragraph (c) of this section, any food,
drug, device, or cosmetic that is, consists in part of, or is contained
in an aerosol product or other pressurized dispenser that releases an
ODS is not an essential use of the ODS under the Clean Air Act.
(c) A food, drug, device, or cosmetic that is, consists in part of,
or is contained in an aerosol product or other pressurized dispenser
that releases an ODS is an essential use of the ODS under the Clean Air
Act if paragraph (e) of this section specifies the use of that product
as essential. For drugs, including biologics and animal drugs, and for
devices, an investigational application or an approved marketing
application must be in effect, as applicable.
(d) [Reserved]
(e) The use of ODSs in the following products is essential:
(1) Metered-dose corticosteroid human drugs for oral inhalation.
Oral pressurized metered-dose inhalers containing the following active
moieties:
(i)-(v) [Reserved]
(2) Metered-dose short-acting adrenergic bronchodilator human drugs
for oral inhalation. Oral pressurized metered-dose inhalers containing
the following active moieties:
(i)-(iii) [Reserved]
[[Page 55]]
(iv) Pirbuterol.
(v) [Reserved]
(3) [Reserved]
(4) Other essential uses. (i)-(ii) [Reserved]
(iii) Anesthetic drugs for topical use on accessible mucous
membranes of humans where a cannula is used for application.
(iv)-(v) [Reserved]
(vi) Metered-dose atropine sulfate aerosol human drugs administered
by oral inhalation.
(vii) [Reserved]
(viii) Metered-dose ipratropium bromide and albuterol sulfate, in
combination, administered by oral inhalation for human use.
(ix) Sterile aerosol talc administered intrapleurally by
thoracoscopy for human use.
(f) Any person may file a petition under part 10 of this chapter to
request that FDA initiate rulemaking to amend paragraph (e) of this
section to add an essential use. FDA may initiate notice-and-comment
rulemaking to add an essential use on its own initiative or in response
to a petition, if granted.
(1) If the petition is to add use of a noninvestigational product,
the petitioner must submit compelling evidence that:
(i) Substantial technical barriers exist to formulating the product
without ODSs;
(ii) The product will provide an unavailable important public health
benefit; and
(iii) Use of the product does not release cumulatively significant
amounts of ODSs into the atmosphere or the release is warranted in view
of the unavailable important public health benefit.
(2) If the petition is to add use of an investigational product, the
petitioner must submit compelling evidence that:
(i) Substantial technical barriers exist to formulating the
investigational product without ODSs;
(ii) A high probability exists that the investigational product will
provide an unavailable important public health benefit; and
(iii) Use of the investigational product does not release
cumulatively significant amounts of ODSs into the atmosphere or the
release is warranted in view of the high probability of an unavailable
important public health benefit.
(g) Any person may file a petition under part 10 of this chapter to
request that FDA initiate rulemaking to amend paragraph (e) of this
section to remove an essential use. FDA may initiate notice-and-comment
rulemaking to remove an essential use on its own initiative or in
response to a petition, if granted. If the petition is to remove an
essential use from paragraph (e) of this section, the petitioner must
submit compelling evidence of any one of the following criteria:
(1) The product using an ODS is no longer being marketed; or
(2) After January 1, 2005, FDA determines that the product using an
ODS no longer meets the criteria in paragraph (f) of this section after
consultation with a relevant advisory committee(s) and after an open
public meeting; or
(3) For individual active moieties marketed as ODS products and
represented by one new drug application (NDA):
(i) At least one non-ODS product with the same active moiety is
marketed with the same route of administration, for the same indication,
and with approximately the same level of convenience of use as the ODS
product containing that active moiety;
(ii) Supplies and production capacity for the non-ODS product(s)
exist or will exist at levels sufficient to meet patient need;
(iii) Adequate U.S. postmarketing use data is available for the non-
ODS product(s); and
(iv) Patients who medically required the ODS product are adequately
served by the non-ODS product(s) containing that active moiety and other
available products; or
(4) For individual active moieties marketed as ODS products and
represented by two or more NDAs:
(i) At least two non-ODS products that contain the same active
moiety are being marketed with the same route of delivery, for the same
indication, and with approximately the same level of convenience of use
as the ODS products; and
[[Page 56]]
(ii) The requirements of paragraphs (g)(3)(ii), (g)(3)(iii), and
(g)(3)(iv) of this section are met.
[67 FR 48384, July 24, 2002, as amended at 71 FR 70873, Dec. 7, 2006; 70
FR 17192, Apr. 4, 2005; 73 FR 69552, Nov. 19, 2008; 75 FR 19241, Apr.
14, 2010]
Effective Date Note: At 75 FR 19241, Apr. 14, 2010, Sec.2.125 was
amended by removing and reserving paragraphs (e)(2)(iv) and
(e)(4)(viii), effective Dec. 31, 2013.
PART 3_PRODUCT JURISDICTION--Table of Contents
Subpart A_Assignment of Agency Component for Review of Premarket
Applications
Sec.
3.1 Purpose.
3.2 Definitions.
3.3 Scope.
3.4 Designated agency component.
3.5 Procedures for identifying the designated agency component.
3.6 Product jurisdiction officer.
3.7 Request for designation.
3.8 Letter of designation.
3.9 Effect of letter of designation.
3.10 Stay of review time.
Subpart B [Reserved]
Authority: 21 U.S.C. 321, 351, 353, 355, 360, 360c-360f, 360h-360j,
360gg-360ss, 360bbb-2, 371(a), 379e, 381, 394; 42 U.S.C. 216, 262, 264.
Source: 56 FR 58756, Nov. 21, 1991, unless otherwise noted.
Subpart A_Assignment of Agency Component for Review of Premarket
Applications
Sec.3.1 Purpose.
This regulation relates to agency management and organization and
has two purposes. The first is to implement section 503(g) of the act,
as added by section 16 of the Safe Medical Devices Act of 1990 (Public
Law 101-629) and amended by section 204 of the Medical Device User Fee
and Modernization Act of 2002 (Public Law 107-250), by specifying how
FDA will determine the organizational component within FDA designated to
have primary jurisdiction for the premarket review and regulation of
products that are comprised of any combination of a drug and a device; a
device and a biological; a biological and a drug; or a drug, a device
and a biological. This determination will eliminate, in most cases, the
need to receive approvals from more than one FDA component for such
combination products. The second purpose of this regulation is to
enhance the efficiency of agency management and operations by providing
procedures for determining which agency component will have primary
jurisdiction for any drug, device, or biological product where such
jurisdiction is unclear or in dispute. Nothing in this section prevents
FDA from using any agency resources it deems necessary to ensure
adequate review of the safety and effectiveness of any product, or the
substantial equivalence of any device to a predicate device.
[56 FR 58756, Nov. 21, 1991, as amended by 68 FR 37077, June 23, 2003]
Sec.3.2 Definitions.
For the purpose of this part:
(a) Act means the Federal Food, Drug, and Cosmetic Act.
(b) Agency component means the Center for Biologics Evaluation and
Research, the Center for Devices and Radiological Health, the Center for
Drug Evaluation and Research, or alternative organizational component of
the agency.
(c) Applicant means any person who submits or plans to submit an
application to the Food and Drug Administration for premarket review.
For purposes of this section, the terms ``sponsor'' and ``applicant''
have the same meaning.
(d) Biological product has the meaning given the term in section
351(a) of the Public Health Service Act (42 U.S.C. 262(a)).
(e) Combination product includes:
(1) A product comprised of two or more regulated components, i.e.,
drug/device, biologic/device, drug/biologic, or drug/device/biologic,
that are physically, chemically, or otherwise combined or mixed and
produced as a single entity;
(2) Two or more separate products packaged together in a single
package or as a unit and comprised of drug and device products, device
and biological products, or biological and drug products;
[[Page 57]]
(3) A drug, device, or biological product packaged separately that
according to its investigational plan or proposed labeling is intended
for use only with an approved individually specified drug, device, or
biological product where both are required to achieve the intended use,
indication, or effect and where upon approval of the proposed product
the labeling of the approved product would need to be changed, e.g., to
reflect a change in intended use, dosage form, strength, route of
administration, or significant change in dose; or
(4) Any investigational drug, device, or biological product packaged
separately that according to its proposed labeling is for use only with
another individually specified investigational drug, device, or
biological product where both are required to achieve the intended use,
indication, or effect.
(f) Device has the meaning given the term in section 201(h) of the
act.
(g) Drug has the meaning given the term in section 201(g)(1) of the
act.
(h) FDA means Food and Drug Administration.
(i) Letter of designation means the written notice issued by the
product jurisdiction officer specifying the agency component with
primary jurisdiction for a combination product.
(j) Letter of request means an applicant's written submission to the
product jurisdiction officer seeking the designation of the agency
component with primary jurisdiction.
(k) Mode of action is the means by which a product achieves an
intended therapeutic effect or action. For purposes of this definition,
``therapeutic'' action or effect includes any effect or action of the
combination product intended to diagnose, cure, mitigate, treat, or
prevent disease, or affect the structure or any function of the body.
When making assignments of combination products under this part, the
agency will consider three types of mode of action: The actions provided
by a biological product, a device, and a drug. Because combination
products are comprised of more than one type of regulated article
(biological product, device, or drug), and each constituent part
contributes a biological product, device, or drug mode of action,
combination products will typically have more than one identifiable mode
of action.
(1) A constituent part has a biological product mode of action if it
acts by means of a virus, therapeutic serum, toxin, antitoxin, vaccine,
blood, blood component or derivative, allergenic product, or analogous
product applicable to the prevention, treatment, or cure of a disease or
condition of human beings, as described in section 351(i) of the Public
Health Service Act.
(2) A constituent part has a device mode of action if it meets the
definition of device contained in section 201(h)(1) to (h)(3) of the
act, it does not have a biological product mode of action, and it does
not achieve its primary intended purposes through chemical action within
or on the body of man or other animals and is not dependent upon being
metabolized for the achievement of its primary intended purposes.
(3) A constituent part has a drug mode of action if it meets the
definition of drug contained in section 201(g)(1) of the act and it does
not have a biological product or device mode of action.
(l) Premarket review includes the examination of data and
information in an application for premarket review described in sections
505, 510(k), 513(f), 515, or 520(g) or 520(l) of the act or section 351
of the Public Health Service Act of data and information contained in
any investigational new drug (IND) application, investigational device
exemption (IDE), new drug application (NDA), biologics license
application, device premarket notification, device reclassification
petition, and premarket approval application (PMA).
(m) Primary mode of action is the single mode of action of a
combination product that provides the most important therapeutic action
of the combination product. The most important therapeutic action is the
mode of action expected to make the greatest contribution to the overall
intended therapeutic effects of the combination product.
(n) Product means any article that contains any drug as defined in
section 201(g)(1) of the act; any device as defined in section 201(h) of
the act; or any
[[Page 58]]
biologic as defined in section 351(a) of the Public Health Service Act
(42 U.S.C. 262(a)).
(o) Product jurisdiction officer is the person or persons
responsible for designating the component of FDA with primary
jurisdiction for the premarket review and regulation of a combination
product or any product requiring a jurisdictional designation under this
part.
(p) Sponsor means ``applicant'' (see Sec.3.2(c)).
[56 FR 58756, Nov. 21, 1991 as amended at 64 FR 398, Jan. 5, 1999; 64 FR
56447, Oct. 20, 1999; 68 FR 37077, June 23, 2003; 70 FR 49861, Aug. 25,
2005]
Sec.3.3 Scope.
This section applies to:
(a) Any combination product, or
(b) Any product where the agency component with primary jurisdiction
is unclear or in dispute.
Sec.3.4 Designated agency component.
(a) To designate the agency component with primary jurisdiction for
the premarket review and regulation of a combination product, the agency
shall determine the primary mode of action of the product. Where the
primary mode of action is that of:
(1) A drug (other than a biological product), the agency component
charged with premarket review of drugs shall have primary jurisdiction;
(2) A device, the agency component charged with premarket review of
devices shall have primary jurisdiction;
(3) A biological product, the agency component charged with
premarket review of biological products shall have primary jurisdiction.
(b) In some situations, it is not possible to determine, with
reasonable certainty, which one mode of action will provide a greater
contribution than any other mode of action to the overall therapeutic
effects of the combination product. In such a case, the agency will
assign the combination product to the agency component that regulates
other combination products that present similar questions of safety and
effectiveness with regard to the combination product as a whole. When
there are no other combination products that present similar questions
of safety and effectiveness with regard to the combination product as a
whole, the agency will assign the combination product to the agency
component with the most expertise related to the most significant safety
and effectiveness questions presented by the combination product.
(c) The designation of one agency component as having primary
jurisdiction for the premarket review and regulation of a combination
product does not preclude consultations by that component with other
agency components or, in appropriate cases, the requirement by FDA of
separate applications.
[56 FR 58756, Nov. 21, 1991, as amended at 70 FR 49861, Aug. 25, 2005]
Sec.3.5 Procedures for identifying the designated agency component.
(a)(1) The Center for Biologics Evaluation and Research, the Center
for Devices and Radiological Health, and the Center for Drug Evaluation
and Research have entered into agreements clarifying product
jurisdictional issues. These guidance documents are on display in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and are entitled
``Intercenter Agreement Between the Center for Drug Evaluation and
Research and the Center for Devices and Radiological Health;''
``Intercenter Agreement Between the Center for Devices and Radiological
Health and the Center for Biologics Evaluation and Research;''
``Intercenter Agreement Between the Center for Drug Evaluation and
Research and the Center for Biologics Evaluation and Research.'' The
availability of any amendments to these intercenter agreements will be
announced by Federal Register notice.
(2) These guidance documents describe the allocation of
responsibility for categories of products or specific products. These
intercenter agreements, and any amendments thereto, are nonbinding
determinations designed to provide useful guidance to the public.
(3) The sponsor of a premarket application or required
investigational filing for a combination or other product
[[Page 59]]
covered by these guidance documents may contact the designated agency
component identified in the intercenter agreement before submitting an
application of premarket review or to confirm coverage and to discuss
the application process.
(b) For a combination product not covered by a guidance document or
for a product where the agency component with primary jurisdiction is
unclear or in dispute, the sponsor of an application for premarket
review should follow the procedures set forth in Sec.3.7 to request a
designation of the agency component with primary jurisdiction before
submitting the application.
[56 FR 58756, Nov. 21, 1991, as amended at 68 FR 24879, May 9, 2003]
Sec.3.6 Product jurisdiction officer.
The Office of Combination Products (Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32, rm. 5129, Silver Spring, MD 20993-
0002, 301-796-8930,, e-mail: combination@fda.gov, is the designated
product jurisdiction officer.
[68 FR 37077, June 23, 2003, as amended at 71 FR 16033, Mar. 30, 2006;
75 FR 13678, Mar. 23, 2010]
Sec.3.7 Request for designation.
(a) Who should file: the sponsor of:
(1) Any combination product the sponsor believes is not covered by
an intercenter agreement; or
(2) Any product where the agency component with primary jurisdiction
is unclear or in dispute.
(b) When to file: a sponsor should file a request for designation
before filing any application for premarket review, whether an
application for marketing approval or a required investigational notice.
Sponsors are encouraged to file a request for designation as soon as
there is sufficient information for the agency to make a determination.
(c) What to file: an original and two copies of the request for
designation must be filed. The request for designation must not exceed
15 pages, including attachments, and must set forth:
(1) The identity of the sponsor, including company name and address,
establishment registration number, company contact person and telephone
number.
(2) A description of the product, including:
(i) Classification, name of the product and all component products,
if applicable;
(ii) Common, generic, or usual name of the product and all component
products;
(iii) Proprietary name of the product;
(iv) Identification of any component of the product that already has
received premarket approval, is marketed as not being subject to
premarket approval, or has received an investigational exemption, the
identity of the sponsors, and the status of any discussions or
agreements between the sponsors regarding the use of this product as a
component of a new combination product.
(v) Chemical, physical, or biological composition;
(vi) Status and brief reports of the results of developmental work,
including animal testing;
(vii) Description of the manufacturing processes, including the
sources of all components;
(viii) Proposed use or indications;
(ix) Description of all known modes of action, the sponsor's
identification of the single mode of action that provides the most
important therapeutic action of the product, and the basis for that
determination.
(x) Schedule and duration of use;
(xi) Dose and route of administration of drug or biologic;
(xii) Description of related products, including the regulatory
status of those related products; and
(xiii) Any other relevant information.
(3) The sponsor's recommendation as to which agency component should
have primary jurisdiction based on the mode of action that provides the
most important therapeutic action of the combination product. If the
sponsor cannot determine with reasonable certainty which mode of action
provides the most important therapeutic action of the combination
product, the sponsor's recommendation must be based on the assignment
algorithm set forth
[[Page 60]]
in Sec.3.4(b) and an assessment of the assignment of other combination
products the sponsor wishes FDA to consider during the assignment of its
combination product.
(d) Where to file: all communications pursuant to this subpart shall
be addressed to the attention of the product jurisdiction officer. Such
a request, in its mailing cover should be plainly marked ``Request for
Designation.'' Concurrent submissions of electronic copies of Requests
for Designation may be addressed to combination@fda.gov.
[56 FR 58756, Nov. 21, 1991, as amended at 68 FR 37077, June 23, 2003;
70 FR 49861, Aug. 25, 2005]
Sec.3.8 Letter of designation.
(a) Each request for designation will be reviewed for completeness
within 5 working days of receipt. Any request for designation determined
to be incomplete will be returned to the applicant with a request for
the missing information. The sponsor of an accepted request for
designation will be notified of the filing date.
(b) Within 60 days of the filing date of a request for designation,
the product jurisdiction officer will issue a letter of designation to
the sponsor, with copies to the centers, specifying the agency component
designated to have primary jurisdiction for the premarket review and
regulation of the product at issue, and any consulting agency
components. The product jurisdiction officer may request a meeting with
the sponsor during the review period to discuss the request for
designation. If the product jurisdiction officer has not issued a letter
of designation within 60 days of the filing date of a request for
designation, the sponsor's recommendation of the center with primary
jurisdiction, in accordance with Sec.3.7(c)(3), shall become the
designated agency component.
(c) Request for reconsideration by sponsor: If the sponsor disagrees
with the designation, it may request the product jurisdiction officer to
reconsider the decision by filing, within 15 days of receipt of the
letter of designation, a written request for reconsideration not
exceeding 5 pages. No new information may be included in a request for
reconsideration. The product jurisdiction officer shall review and act
on the request in writing within 15 days of its receipt.
Sec.3.9 Effect of letter of designation.
(a) The letter of designation constitutes an agency determination
that is subject to change only as provided in paragraph (b) of this
section.
(b) The product jurisdiction officer may change the designated
agency component with the written consent of the sponsor, or without its
consent to protect the public health or for other compelling reasons. A
sponsor shall be given 30 days written notice of any proposed
nonconsensual change in designated agency component. The sponsor may
request an additional 30 days to submit written objections, not to
exceed 15 pages, to the proposed change, and shall be granted, upon
request, a timely meeting with the product jurisdiction officer and
appropriate center officials. Within 30 days of receipt of the sponsor's
written objections, the product jurisdiction officer shall issue to the
sponsor, with copies to appropriate center officials, a written
determination setting forth a statement of reasons for the proposed
change in designated agency component. A nonconsensual change in the
designated agency component requires the concurrence of the Principal
Associate Commissioner.
[56 FR 58756, Nov. 21, 1991, as amended at 68 FR 37077, June 23, 2003]
Sec.3.10 Stay of review time.
Any filing with or review by the product jurisdiction officer stays
the review clock or other established time periods for agency action for
an application for marketing approval or required investigational notice
during the pendency of the review by the product jurisdiction officer.
Subpart B [Reserved]
PART 5_ORGANIZATION--Table of Contents
Subparts A-L [Reserved]
Subpart M_Organization
Sec.
5.1100 Headquarters.
[[Page 61]]
5.1105 Chief Counsel, Food and Drug Administration.
5.1110 FDA public information offices.
Authority: 5 U.S.C. 552; 21 U.S.C. 301-397.
Source: 77 FR 15962, Mar. 19, 2012, unless otherwise noted.
Subparts A-L [Reserved]
Subpart M_Organization
Sec.5.1100 Headquarters.
The Food and Drug Administration consists of the following:
Office of the Commissioner.
Office of Executive Secretariat.
Office of the Chief Counsel.
Office of the Counselor to the Commissioner.
Office of Crisis Management.
Office of Emergency Operations.
Office of Policy and Planning.
Office of Policy.
Policy Development and Coordination Staff.
Regulations Policy and Management Staff.
Regulations Editorial Section.
Office of Planning.
Planning Staff.
Program Evaluation and Process Improvement Staff.
Economics Staff.
Risk Communications Staff.
Office of Legislation.
Office of External Affairs.
Web Communications Staff.
Office of External Relations.
Communications Staff.
Office of Public Affairs.
Office of Special Health Issues.
Office of Minority Health.
Office of Women's Health.
Office of the Chief Scientist.
Office of Counter-Terrorism and Emerging Threats.
Office of Scientific Integrity.
Office of Regulatory Science and Innovation.
Division of Science Innovation and Critical Path.
Division of Scientific Computing and Medical Information.
Office of Scientific Professional Development.
National Center for Toxicological Research.
Office of the Center Director.
Office of Management.
Office of Scientific Coordination.
Office of Research.
Division of Biochemical Toxicology.
Division of Genetic and Molecular Toxicology.
Division of Personalized Nutrition and Medicine.
Biometry Branch.
Pharmacogenomics Branch.
Division of Microbiology.
Division of Neurotoxicology.
Division of Systems Biology.
Office of Operations.
Office of Equal Employment Opportunity.
Conflict Prevention and Resolution Staff.
Compliance Staff.
Diversity Staff.
Office of Finance, Budget, and Acquisitions.
Office of Budget.
Office of Acquisitions and Grants Services.
Division of Acquisition Operations.
Division of Acquisition Support and Grants.
Division of Acquisition Programs.
Division of Information Technology.
Office of Financial Operations.
Office of Financial Management.
User Fees Staff.
Division of Accounting.
Division of Budget Execution and Control.
Office of Financial Services.
Payroll Staff.
Division of Payment Services.
Division of Travel Services.
Office of Information Management.
Division of Business Partnership and Support.
Division of Chief Information Officer Support.
Division of Systems Management.
Division of Infrastructure Operations.
Division of Technology.
Office of Management.
Ethics and Integrity Staff.
Office of Management Programs.
Office of Security Operations.
Office of Facilities, Engineering and Mission Support Services.
Jefferson Lab Complex Staff.
Business Operations and Initiatives Staff.
Division of Operations Management and Community Relations.
Auxiliary Program Management Branch.
Logistics and Transportation Management Branch.
Facilities Maintenance and Operations Branch.
Division of Planning, Engineering, and Space Management.
Planning and Space Management Branch.
Employee Safety and Environmental Management Branch.
Engineering Management Branch.
Office of Library and Employee Services.
Employee Resource and Information Center.
FDA Biosciences Library.
Public Services Branch.
Technical Services Branch.
FDA History Office.
Division of Freedom of Information.
Division of Dockets Management.
Office of Foods.
Center for Food Safety and Applied Nutrition.
Office of the Center Director.
Executive Operations Staff.
International Staff.
[[Page 62]]
Office of Management.
Safety Staff.
Division of Planning and Budget and Planning.
Division of Program Services.
Office of Food Defense, Communication and Emergency Response.
Division of Education and Communication.
Division of Public Health and Biostatistics.
Office of Food Safety.
Retail Food and Cooperative Program Support Staff.
Division of Seafood Science and Technology.
Chemical Hazard Branch.
Microbiological Hazard Branch.
Division of Food Processing Science and Technology.
Process Engineering Branch.
Food Technology Branch.
Division of Plant and Dairy Food Safety.
Plant Products Branch.
Dairy and Egg Branch.
Division of Seafood Safety.
Shellfish and Aquaculture Policy Branch.
Seafood Processing and Technology Policy Branch.
Office of Cosmetics and Colors.
Cosmetic Staff.
Division of Color Certification and Technology.
Office of Regulatory Science.
Division of Analytical Chemistry.
Methods Branch.
Spectroscopy and Mass Spectrometry Branch.
Division of Microbiology.
Microbial Methods and Development Branch.
Molecular Methods and Subtyping Branch.
Division of Bioanalytical Chemistry.
Bioanalytical Methods Branch.
Chemical Contaminants Branch.
Office of Food Additive Safety.
Division of Food Contact Notifications.
Division of Biotechnology and GRAS Notice Review.
Division of Petition Review.
Office of Compliance.
Division of Enforcement.
Division of Field Programs and Guidance.
Office of Applied Research and Safety Assessment.
Division of Molecular Biology.
Division of Virulence Assessment.
Division of Toxicology.
Office of Regulations, Policy, and Social Sciences.
Regulations and Special Government Employees Management Staff.
Division of Social Sciences.
Office of Nutrition, Labeling, and Dietary Supplements.
Nutrition Programs Staff.
Division of Dietary Supplement Programs.
Center for Veterinary Medicine.
Office of the Center Director.
Office of Management.
Management Logistics Staff.
Human Capital Management Staff.
Program and Resource Management Staff.
Talent Development Staff.
Budget Planning and Evaluation Staff.
Office of New Animal Drug Evaluation.
Division of Therapeutic Drugs for Non-Food Animals.
Division of Biometrics and Production Drugs.
Division of Therapeutic Drugs for Food Animals.
Division of Human Food Safety.
Division of Manufacturing Technologies.
Division of Scientific Support.
Division of Generic Animal Drugs.
Office of Surveillance and Compliance.
Division of Surveillance.
Division of Animal Feeds.
Division of Compliance.
Division of Veterinary Product Safety.
Office of Research.
Division of Residue Chemistry.
Division of Animal Research.
Division of Animal and Food Microbiology.
Office of Minor Use and Minor Species Animal Drug Development.
Office of Medical Products and Tobacco.
Office of Special Medical Programs.
Advisory Committee Oversight and Management Staff.
Good Clinical Practice Staff.
Office of Combination Products.
Office of Orphan Products Development.
Office of Pediatric Therapeutics.
Center for Biologics Evaluation and Research.
Office of the Center Director.
Regulations Policy Staff.
Quality Assurance Staff.
Office of Management.
Regulatory Information Management Staff.
Division of Planning, Evaluation, and Budget.
Division of Veterinary Services.
Division of Program Services.
Division of Scientific Advisors and Consultants.
Building Operations Staff.
Office of Compliance and Biologics Quality.
Division of Case Management.
Division of Inspections and Surveillance.
Division of Manufacturing and Product Quality.
Office of Biostatistics and Epidemiology.
Division of Biostatistics.
Division of Epidemiology.
Office of Information Management.
Division of Information Operations.
Division of Information Development.
Office of Blood Research and Review.
Policy and Publications Staff.
Division of Emerging and Transfusion Transmitted Diseases.
Division of Hematology.
[[Page 63]]
Division of Blood Applications.
Office of Vaccines Research and Review.
Program Operation Staff.
Division of Product Quality.
Division of Bacterial, Parasitic, and Allergenic Products.
Division of Viral Products.
Division of Vaccines and Related Product Applications.
Office of Cellular, Tissue, and Gene Therapies.
Regulatory Management Staff.
Division of Cellular and Gene Therapies.
Division of Clinical Evaluation and Pharmacology/Toxicology.
Division of Human Tissues.
Office of Communication, Outreach and Development.
Division of Disclosure and Oversight Management.
Division of Manufacturers Assistance and Training.
Division of Communication and Consumer Affairs.
Center for Devices and Radiological Health.
Office of the Center Director.
Regulations Staff.
Office of Management Operations.
Division of Ethics and Management Operations.
Human Resource and Administrative Management Branch.
Integrity, Conference and Committee Management Branch.
Division of Planning, Analysis and Finance.
Planning Branch.
Financial Management Branch.
Office of Compliance.
Promotion and Advertising Policy Staff.
Program Management Staff.
Quality Management Program Staff.
Division of Bioresearch Monitoring.
Program Enforcement Branch A.
Program Enforcement Branch B.
Special Investigations Branch.
Division of Risk Management Operations.
Field Programs Branch.
Recall Branch.
Regulatory Policy Branch.
Division of Enforcement.
General Surgery Devices Branch.
Dental Ear, Nose, Throat and Ophthalmic Devices Branch.
Gastroenterology and Urology Branch.
General Hospital Devices Branch.
Division of Enforcement B.
Radiology, Anesthesiology, and Neurology Devices Branch.
Cardiac Rhythm and Electrophysiology Devices Branch.
Vascular and Circulatory Support Devices Branch.
Orthopedic and Physical Medicine Devices Branch.
Office of Device Evaluation.
Program Management Staff.
Program Operations Staff.
Pre-Market Approval Staff.
Investigational Device Exemption Staff.
Pre-Market Notification Section.
Division of Cardiovascular Devices.
Circulatory Support and Prosthetic Branch.
Interventional Cardiology Devices Branch.
Pacing, Defibrillators, and Leads Branch.
Cardiac Electrophysiology and Monitoring Devices Branch.
Peripheral Scads Vascular Devices Branch.
Division of Reproductive, Gastro-Renal, and Urological Devices.
Gynecology Devices Branch.
Urology and Lithotripsy Devices Branch.
Gastroenterology and Renal Devices Branch.
Division of Surgical, Orthopedic, and Restorative Devices.
General Surgery Devices Branch.
Restorative Devices Branch.
Plastic and Reconstructive Surgery Devices Branch.
Orthopedic Joint Devices Branch.
Orthopedic Spine Devices Branch.
Division of Ophthalmic, Neurological, and Ear, Nose, and Throat
Devices.
Intraocular, Corneal, and Neuromaterial Devices Branch.
Ophthalmic Laser, Neuromuscular Stimulators, and Diagnostic Devices
Branch.
Neurodiagnostic and Neurotherapeutic Devices Branch.
Ear, Nose, and Throat Devices Branch.
Division of Anesthesiology, General Hospital, Infection Control, and
Dental Devices.
General Hospital Devices Branch.
Infection Control Devices Branch.
Dental Devices Branch.
Anesthesiology and Respiratory Devices Branch.
Office of Science and Engineering Laboratories.
Management Support Staff.
Division of Biology.
Division of Chemistry and Materials Science.
Division of Solid and Fluid Mechanics.
Division of Physics.
Division of Imaging and Applied Mathematics.
Division of Solid and Fluid Mechanics.
Division of Electrical and Software Engineering.
Office of Communication, Education and Radiation Programs.
Program Operations Staff.
Staff College.
Division of Health Communication.
Web Communication Branch.
Risk Communication Branch.
Division of Small Manufacturers International and Consumer
Assistance.
Technical Assistance Branch.
[[Page 64]]
International Relations and External Affairs Staff.
Regulatory Assistance Branch.
Division of Mammography Quality and Radiation Programs.
Inspection and Compliance Branch.
Information Management Branch.
Diagnostic Devices Branch.
Electronic Devices Branch.
Division of Communication Media.
Television Design and Development Branch.
Division of Freedom of Information.
Freedom of Information Branch A.
Freedom of Information Branch B.
Office of Surveillance and Biometrics.
Program Management Staff.
Division of Biostatistics.
Cardiovascular and Ophthalmic Devices Branch.
Diagnostic Devices Branch.
General and Surgical Devices Branch.
Division of Postmarket Surveillance.
Product Evaluation Branch 1.
Product Evaluation Branch 2.
Information Analysis Branch.
MDR Policy Branch.
Division of Patient Safety Partnership.
Patient Safety Branch 1.
Patient Safety Branch 2.
Division of Epidemiology.
Epidemiology Evaluation and Research Branch 1.
Epidemiology Evaluation and Research Branch 2.
Office of In Vitro Diagnostic Device Evaluation and Safety.
Division of Chemistry and Toxicology Devices.
Division of Immunology and Hematology Devices.
Division of Microbiology Devices.
Division of Radiological Devices.
Center for Drug Evaluation and Research.
Office of the Center Director.
Controlled Substances Staff.
Safe Use Staff.
Office of Regulatory Policy.
Division of Regulatory Policy I.
Division of Regulatory Policy II.
Division of Regulatory Policy III.
Division of Information Disclosure Policy.
Office of Management.
Division of Management and Budget.
Planning and Resource Management Branch.
Management Analysis Branch.
Division of Management Services.
Program Management Services Branch.
Interface Management Branch.
Office of Communications.
Division of Online Communications.
Division of Health Communications.
Division of Drug Information.
Office of Surveillance and Epidemiology.
Regulatory Science Staff.
Regulatory Affairs Staff.
Executive Operations and Strategic Planning Staff.
Technical Information Staff.
Program Management and Analysis Staff.
Project Management Staff.
Office of Medication Error Prevention.
Division of Medication Error Prevention and Analysis.
Division of Risk Management.
Office of Pharmacovigilance and Epidemiology.
Division of Epidemiology I.
Division of Epidemiology II.
Division of Pharmacovigilance I.
Division of Pharmacovigilance II.
Office of Compliance.
Office of Drug Security, Integrity, and Recalls.
Division of Import Operations and Recalls.
Recall Coordination Branch.
Import Operations Branch.
Division of Supply Chain Integrity.
Office of Unapproved Drugs and Labeling Compliance.
Division of Prescription Drugs.
Prescription Drugs Branch.
Compounding and Pharmacy Practice Branch.
Division of Non-Prescription Drugs and Health Fraud.
Over-the-Counter Drugs Branch.
Health Fraud and Consumer Outreach Branch.
Office of Manufacturing and Product Quality.
Division of International Drug Quality.
International Compliance Branch I.
International Compliance Branch II.
Division of Domestic Drug Quality.
Domestic Compliance Branch 1.
Domestic Compliance Branch 2.
Division of Policy, Collaboration, and Data Operations.
Regulatory Policy and Communications Branch.
Drug Surveillance and Data Reporting Branch.
Division of GMP Assessment.
Biotech Manufacturing Assessment Branch.
New Drug Manufacturing Assessment Branch.
Generic Drug Manufacturing Assessment Branch.
Office of Scientific Investigations.
Division of Bioequivalence and Good Laboratory Practice Compliance.
Good Laboratory Practice Branch.
Bioequivalence Branch.
Division of Good Clinical Practice Compliance.
Good Clinical Practice Enforcement Branch
Good Clinical Practice Assessment Branch
Division of Safety Compliance.
Post Market Safety Branch.
Human Subject Protection Branch.
[[Page 65]]
Office of New Drugs.
Pediatric and Maternal Health Staff.
Program Management Analysis Staff.
Office of Drug Evaluation I.
Division of Cardiovascular and Renal Products.
Division of Neurology Products.
Division of Psychiatry Products.
Office of Drug Evaluation II.
Division of Metabolism and Endocrinology Products.
Division of Pulmonary, Allergy, and Rheumatology Products.
Division of Anesthesia, Analgesia, and Addiction Products.
Office of Drug Evaluation III.
Division of Gastroenterology and Inborn Effects Products.
Division of Reproductive and Urologic Products.
Division of Dermatology and Dental Products.
Office of Antimicrobial Products.
Division of Anti-Infective Products.
Division of Anti-Viral Products.
Division of Transplant and Ophthalmology Products.
Office of Drug Evaluation IV.
Division of Nonprescription Clinical Evaluation.
Division of Nonprescription Regulation Development.
Division of Medical Imaging Products.
Office of Hematology and Oncology Drug Products.
Division of Oncology Products 1.
Division of Oncology Products 2.
Division of Hematology Products.
Division of Hematology Oncology Toxicology.
Office of Pharmaceutical Science.
Program Activities Review Staff.
Operations Staff.
Science and Research Staff.
New Drug Microbiology Staff.
Office of Generic Drugs.
Division of Bioequivalence 1.
Division of Bioequivalence 2.
Division of Labeling and Program Support.
Labeling Review Branch.
Regulatory Branch.
Review Support Branch.
Division of Chemistry I.
Division of Chemistry II.
Division of Chemistry III.
Division of Chemistry IV.
Division of Clinical Review.
Division of Microbiology.
Office of New Drug Quality Assessment.
Division of New Drug Quality Assessment I.
Branch I.
Branch II.
Branch III.
Division of New Drug Quality Assessment II.
Branch IV.
Branch V.
Branch VI.
Division of New Drug Quality Assessment III.
Branch VII.
Branch VIII.
Branch IX.
Office of Testing and Research.
Division of Drug Safety Research.
Division of Pharmaceutical Analysis.
Division of Product Quality Research.
Office of Biotechnology Products.
Division of Monoclonal Antibodies.
Division of Therapeutic Protein.
Office of Medical Policy.
Office of Prescription Drug Promotion.
Division of Consumer Drug Promotion.
Division of Professional Drug Promotion.
Office of Medical Policy Initiatives.
Division of Medical Policy Development.
Division of Medical Policy Programs.
Office of Executive Programs.
Division of Training and Development.
Training and Development Branch I.
Training and Development Branch II.
Division of Executive Operations.
Division of Advisory Committee and Consultant Management.
Office of Translational Science.
Office of Biostatistics.
Division of Biometrics I.
Division of Biometrics II.
Division of Biometrics III.
Division of Biometrics IV.
Division of Biometrics V.
Division of Biometrics VI.
Division of Biometrics VII.
Office of Clinical Pharmacology.
Division of Clinical Pharmacology I.
Division of Clinical Pharmacology II.
Division of Clinical Pharmacology III.
Division of Clinical Pharmacology IV.
Division of Clinical Pharmacology V.
Division of Pharmacometrics.
Office of Counter-Terrorism and Emergency Coordination.
Office of Planning and Informatics.
Office of Planning and Analysis.
Office of Business Informatics.
Division of Records Management.
Division of Regulatory Review Support.
Division of Business Analysis and Reporting.
Division of Project Development.
Center for Tobacco Products.
Office of the Center Director.
Office of Management.
Office of Policy.
Office of Regulations.
Office of Science.
Office of Health Communication and Education.
Office of Compliance and Enforcement.
Office of Global Regulatory Operations and Policy.
Office of International Programs.
Office of Regulatory Affairs.
[[Page 66]]
Office of Resource Management.
Division of Planning, Evaluation, and Management.
Program Planning and Workforce Management Branch.
Program Evaluation Branch.
Division of Human Resource Development.
Division of Management Operations.
Office of Enforcement.
Division of Compliance Management and Operations.
Division of Compliance Policy.
Division of Compliance Information and Quality Assurance.
Office of Regional Operations.
Division of Federal-State Relations.
State Contracts Staff.
State Information Staff.
Public Affairs and Health Fraud Staff.
Division of Field Science.
FERN National Program Branch.
Scientific Compliance and Regulatory Review Branch.
Laboratory Operations Branch.
Division of Import Operations and Policy.
Systems Branch.
Operations and Policy Branch.
Division of Foreign Field Investigations.
International Operations Branch.
Foreign Food Branch.
Foreign Drug Branch.
Foreign Devices Branch.
Division of Domestic Field Investigations.
Team Biologics Staff.
National Expert Staff.
Domestic Operations Branch.
Division of Food Defense Targeting.
Office of Criminal Investigations.
Mid-Atlantic Area Office.
Midwest Area Office.
Northeast Area Office.
Pacific Area Office.
Southeast Area Office.
Southwest Area Office.
Regional Food and Drug Directors.
Regional Field Office, Central Region, Chicago, IL.
State Cooperative Programs Staff I.
State Cooperative Programs Staff II.
Regional Operations Staff.
District Office, Baltimore, MD.
Compliance Branch.
Investigations Branch.
District Office, Cincinnati, OH.
Compliance Branch.
Investigations Branch.
Forensic Chemistry Center.
Inorganic Chemistry Branch.
Organic Chemistry Branch.
District Office, Parsippany, NJ
Compliance Branch.
Investigations Branch.
District Office, Philadelphia, PA.
Compliance Branch.
Investigations Branch.
Laboratory Branch.
District Office, Chicago, IL.
Compliance Branch.
Investigations Branch.
District Office, Minneapolis, MN.
Compliance Branch.
Investigations Branch.
District Office, Detroit, MI.
Compliance Branch.
Investigations Branch.
Laboratory Branch.
Regional Field Office, Northeast Region, Jamaica, NY.
Operations Staff.
Intergovernmental Affairs Staff.
District Office, New York.
Domestic Compliance Branch.
Domestic Investigations Branch.
Import Operations Branch (Downstate).
Import Operations Branch (Upstate).
Northeast Regional Laboratory.
Microbiological Science Branch.
Food Chemistry Branch.
Drug Chemistry Branch.
District Office New England.
Compliance Branch.
Investigations Branch.
Winchester Engineering and Analytical Center.
Analytical Branch.
Engineering Branch.
Regional Field Office, Pacific Region, Oakland, CA.
District Office, San Francisco, CA
Compliance Branch.
Investigations Branch.
Laboratory Branch.
District Office, Los Angeles, CA.
Compliance Branch.
Domestic Investigations Branch.
Import Operations Branch.
District Office, Seattle, WA.
Compliance Branch.
Investigations Branch.
Pacific Regional Laboratory Southwest Los Angeles, CA.
Food Chemistry Branch.
Drug Chemistry Branch.
Microbiology Branch.
Pacific Regional Laboratory Northwest Bothell, WA.
Chemistry Branch.
Microbiology Branch.
Seafood Products Research Center.
Regional Field Office, Southeast Region, Atlanta, GA.
District Office, Atlanta, GA.
Compliance Branch.
Investigations Branch.
District Office, FL.
Compliance Branch.
Investigations Branch.
District Office, New Orleans, LA.
Compliance Branch.
Investigations Branch.
Nashville Branch.
District Office, San Juan, PR.
Compliance Branch.
Investigations Branch.
[[Page 67]]
Laboratory Branch.
Southeast Regional Laboratory, Atlanta, GA.
Chemistry Branch I.
Microbiology Branch.
Atlanta Center for Nutrient Analysis.
Chemistry Branch II.
Regional Field Office, Southwest Region.
District Office, Dallas, TX.
Compliance Branch.
Investigations Branch.
District Office, Kansas City, MO.
Compliance Branch.
Investigations Branch.
Science Operations Branch.
Total Diet and Pesticide Research Center.
District Office, Denver, CO.
Compliance Branch.
Investigations Branch.
Laboratory Branch.
Arkansas Regional Laboratory.
General Chemistry Branch.
Pesticide Chemistry Branch.
Microbiology Branch.
Southwest Import District Office, Dallas, TX.
Compliance Branch.
Investigations Branch.
Sec.5.1105 Chief Counsel, Food and Drug Administration.
The Office of the Chief Counsel's mailing address is White Oak Bldg.
1, 10903 New Hampshire Ave., Silver Spring, MD 20993.
Sec.5.1110 FDA public information offices.
(a) Division of Dockets Management. The Division of Dockets
Management public room is located in rm. 1061, 5630 Fishers Lane,
Rockville, MD 20852, Telephone: 301-827-6860.
(b) Division of Freedom of Information. The Division of Freedom of
Information public room is located in rm. 1050, Element Bldg., 12420
Parklawn Dr., Rockville, MD 20857, Telephone: 301-796-3900.
(c) Press Relations Staff. Press offices are located in White Oak
Bldg. 1, 10903 New Hampshire Ave., Silver Spring, MD 20993, Telephone:
301-827-6242; and at 5100 Paint Branch Pkwy., College Park, MD 20740,
Telephone: 301-436-2335.
PART 7_ENFORCEMENT POLICY--Table of Contents
Subpart A_General Provisions
Sec.
7.1 Scope.
7.3 Definitions.
7.12 Guaranty.
7.13 Suggested forms of guaranty.
Subpart B [Reserved]
Subpart C_Recalls (Including Product Corrections)_Guidance on Policy,
Procedures, and Industry Responsibilities
7.40 Recall policy.
7.41 Health hazard evaluation and recall classification.
7.42 Recall strategy.
7.45 Food and Drug Administration-requested recall.
7.46 Firm-initiated recall.
7.49 Recall communications.
7.50 Public notification of recall.
7.53 Recall status reports.
7.55 Termination of a recall.
7.59 General industry guidance.
Subpart D [Reserved]
Subpart E_Criminal Violations
7.84 Opportunity for presentation of views before report of criminal
violation.
7.85 Conduct of a presentation of views before report of criminal
violation.
7.87 Records related to opportunities for presentation of views
conducted before report of criminal violation.
Authority: 21 U.S.C. 321-393; 42 U.S.C. 241, 262, 263b-263n, 264.
Source: 42 FR 15567, Mar. 22, 1977, unless otherwise noted.
Subpart A_General Provisions
Sec.7.1 Scope.
This part governs the practices and procedures applicable to
regulatory enforcement actions initiated by the Food and Drug
Administration pursuant to the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.) and other laws that it administers. This part also
provides guidance for manufacturers and distributors to follow with
respect to their voluntary removal or correction of marketed violative
products. This part is promulgated to clarify and explain the regulatory
practices and procedures of the Food and Drug Administration, enhance
public understanding, improve consumer protection, and assure uniform
and
[[Page 68]]
consistent application of practices and procedures throughout the
agency.
[43 FR 26218, June 16, 1978, as amended at 65 FR 56476, Sept. 19, 2000]
Sec.7.3 Definitions.
(a) Agency means the Food and Drug Administration.
(b) Citation or cite means a document and any attachments thereto
that provide notice to a person against whom criminal prosecution is
contemplated of the opportunity to present views to the agency regarding
an alleged violation.
(c) Respondent means a person named in a notice who presents views
concerning an alleged violation either in person, by designated
representative, or in writing.
(d) Responsible individual includes those in positions of power or
authority to detect, prevent, or correct violations of the Federal Food,
Drug, and Cosmetic Act.
(e) [Reserved]
(f) Product means an article subject to the jurisdiction of the Food
and Drug Administration, including any food, drug, and device intended
for human or animal use, any cosmetic and biologic intended for human
use, and any item subject to a quarantine regulation under part 1240 of
this chapter. Product does not include an electronic product that emits
radiation and is subject to parts 1003 and 1004 of this chapter.
(g) Recall means a firm's removal or correction of a marketed
product that the Food and Drug Administration considers to be in
violation of the laws it administers and against which the agency would
initiate legal action, e.g., seizure. Recall does not include a market
withdrawal or a stock recovery.
(h) Correction means repair, modification, adjustment, relabeling,
destruction, or inspection (including patient monitoring) of a product
without its physical removal to some other location.
(i) Recalling firm means the firm that initiates a recall or, in the
case of a Food and Drug Administration-requested recall, the firm that
has primary responsibility for the manufacture and marketing of the
product to be recalled.
(j) Market withdrawal means a firm's removal or correction of a
distributed product which involves a minor violation that would not be
subject to legal action by the Food and Drug Administration or which
involves no violation, e.g., normal stock rotation practices, routine
equipment adjustments and repairs, etc.
(k) Stock recovery means a firm's removal or correction of a product
that has not been marketed or that has not left the direct control of
the firm, i.e., the product is located on premises owned by, or under
the control of, the firm and no portion of the lot has been released for
sale or use.
(l) Recall strategy means a planned specific course of action to be
taken in conducting a specific recall, which addresses the depth of
recall, need for public warnings, and extent of effectiveness checks for
the recall.
(m) Recall classification means the numerical designation, i.e., I,
II, or III, assigned by the Food and Drug Administration to a particular
product recall to indicate the relative degree of health hazard
presented by the product being recalled.
(1) Class I is a situation in which there is a reasonable
probability that the use of, or exposure to, a violative product will
cause serious adverse health consequences or death.
(2) Class II is a situation in which use of, or exposure to, a
violative product may cause temporary or medically reversible adverse
health consequences or where the probability of serious adverse health
consequences is remote.
(3) Class III is a situation in which use of, or exposure to, a
violative product is not likely to cause adverse health consequences.
(n) Consignee means anyone who received, purchased, or used the
product being recalled.
[42 FR 15567, Mar. 22, 1977, as amended at 43 FR 26218, June 16, 1978;
44 FR 12167, Mar. 6, 1979]
Effective Date Note: At 77 FR 5176, Feb. 2, 2012, Sec.7.3 was
amended by revising the first sentence of paragraph (f), effective Apr.
2, 2012. For the convenience of the user, the revised text is set forth
as follows:
[[Page 69]]
Sec.7.3 Definitions.
* * * * *
(f) Product means an article subject to the jurisdiction of the Food
and Drug Administration, including any food, drug, and device intended
for human or animal use, any cosmetic and biologic intended for human
use, any tobacco product intended for human use, and any item subject to
a quarantine regulation under part 1240 of this chapter. * * *
* * * * *
Sec.7.12 Guaranty.
In case of the giving of a guaranty or undertaking referred to in
section 303(c)(2) or (3) of the act, each person signing such guaranty
or undertaking shall be considered to have given it.
Sec.7.13 Suggested forms of guaranty.
(a) A guaranty or undertaking referred to in section 303(c)(2) of
the act may be:
(1) Limited to a specific shipment or other delivery of an article,
in which case it may be a part of or attached to the invoice or bill of
sale covering such shipment or delivery, or
(2) General and continuing, in which case, in its application to any
shipment or other delivery of an article, it shall be considered to have
been given at the date such article was shipped or delivered by the
person who gives the guaranty or undertaking.
(b) The following are suggested forms of guaranty or undertaking
under section 303(c)(2) of the act:
(1) Limited form for use on invoice or bill of sale.
(Name of person giving the guaranty or undertaking) hereby
guarantees that no article listed herein is adulterated or misbranded
within the meaning of the Federal Food, Drug, and Cosmetic Act, or is an
article which may not, under the provisions of section 404, 505, or 512
of the act, be introduced into interstate commerce.
(Signature and post-office address of person giving the guaranty or
undertaking.)
(2) General and continuing form.
The article comprising each shipment or other delivery hereafter
made by (name of person giving the guaranty or undertaking) to, or in
the order of (name and post-office address of person to whom the
guaranty or undertaking is given) is hereby guaranteed, as of the date
of such shipment or delivery, to be, on such date, not adulterated or
misbranded within the meaning of the Federal Food, Drug, and Cosmetic
Act, and not an article which may not, under the provisions of section
404, 505, or 512 of the act, be introduced into interstate commerce.
(Signature and post-office address of person giving the guaranty of
undertaking.)
(c) The application of a guaranty or undertaking referred to in
section 303(c)(2) of the act to any shipment or other delivery of an
article shall expire when such article, after shipment or delivery by
the person who gave such guaranty or undertaking, becomes adulterated or
misbranded within the meaning of the act, or becomes an article which
may not, under the provisions of section 404, 505, or 512 of the act, be
introduced into interstate commerce.
(d) A guaranty or undertaking referred to in section 303(c)(3) of
the act shall state that the shipment or other delivery of the color
additive covered thereby was manufactured by a signer thereof. It may be
a part of or attached to the invoice or bill of sale covering such
color. If such shipment or delivery is from a foreign manufacturer, such
guaranty or undertaking shall be signed by such manufacturer and by an
agent of such manufacturer who resides in the United States.
(e) The following are suggested forms of guaranty or undertaking
under section 303(c)(3) of the act:
(1) For domestic manufacturers:
(Name of manufacturer) hereby guarantees that all color additives
listed herein were manufactured by him, and (where color additive
regulations require certification) are from batches certified in
accordance with the applicable regulations promulgated under the Federal
Food, Drug, and Cosmetic Act.
(Signature and post-office address of manufacturer.)
(2) For foreign manufacturers:
(Name of manufacturer and agent) hereby severally guarantee that all
color additives listed herein were manufactured by (name of
manufacturer), and (where color additive regulations require
certification) are from batches certified in accordance with the
applicable regulations promulgated under the Federal Food, Drug, and
Cosmetic Act.
(Signature and post-office address of manufacturer.)
(Signature and post-office address of agent.)
[[Page 70]]
(f) For the purpose of a guaranty or undertaking under section
303(c)(3) of the act the manufacturer of a shipment or other delivery of
a color additive is the person who packaged such color.
(g) A guaranty or undertaking, if signed by two or more persons,
shall state that such persons severally guarantee the article to which
it applies.
(h) No representation or suggestion that an article is guaranteed
under the act shall be made in labeling.
Subpart B [Reserved]
Subpart C_Recalls (Including Product Corrections)_Guidance on Policy,
Procedures, and Industry Responsibilities
Source: 43 FR 26218, June 16, 1978, unless otherwise noted.
Sec.7.40 Recall policy.
(a) Recall is an effective method of removing or correcting consumer
products that are in violation of laws administered by the Food and Drug
Administration. Recall is a voluntary action that takes place because
manufacturers and distributors carry out their responsibility to protect
the public health and well-being from products that present a risk of
injury or gross deception or are otherwise defective. This section and
Sec. Sec.7.41 through 7.59 recognize the voluntary nature of recall by
providing guidance so that responsible firms may effectively discharge
their recall responsibilities. These sections also recognize that recall
is an alternative to a Food and Drug Administration-initiated court
action for removing or correcting violative, distributed products by
setting forth specific recall procedures for the Food and Drug
Administration to monitor recalls and assess the adequacy of a firm's
efforts in recall.
(b) Recall may be undertaken voluntarily and at any time by
manufacturers and distributors, or at the request of the Food and Drug
Administration. A request by the Food and Drug Administration that a
firm recall a product is reserved for urgent situations and is to be
directed to the firm that has primary responsibility for the manufacture
and marketing of the product that is to be recalled.
(c) Recall is generally more appropriate and affords better
protection for consumers than seizure, when many lots of product have
been widely distributed. Seizure, multiple seizure, or other court
action is indicated when a firm refuses to undertake a recall requested
by the Food and Drug Administration, or where the agency has reason to
believe that a recall would not be effective, determines that a recall
is ineffective, or discovers that a violation is continuing.
[43 FR 26218, June 16, 1978, as amended at 65 FR 56476, Sept. 19, 2000]
Sec.7.41 Health hazard evaluation and recall classification.
(a) An evaluation of the health hazard presented by a product being
recalled or considered for recall will be conducted by an ad hoc
committee of Food and Drug Administration scientists and will take into
account, but need not be limited to, the following factors:
(1) Whether any disease or injuries have already occurred from the
use of the product.
(2) Whether any existing conditions could contribute to a clinical
situation that could expose humans or animals to a health hazard. Any
conclusion shall be supported as completely as possible by scientific
documentation and/or statements that the conclusion is the opinion of
the individual(s) making the health hazard determination.
(3) Assessment of hazard to various segments of the population,
e.g., children, surgical patients, pets, livestock, etc., who are
expected to be exposed to the product being considered, with particular
attention paid to the hazard to those individuals who may be at greatest
risk.
(4) Assessment of the degree of seriousness of the health hazard to
which the populations at risk would be exposed.
(5) Assessment of the likelihood of occurrence of the hazard.
(6) Assessment of the consequences (immediate or long-range) of
occurrence of the hazard.
[[Page 71]]
(b) On the basis of this determination, the Food and Drug
Administration will assign the recall a classification, i.e., Class I,
Class II, or Class III, to indicate the relative degree of health hazard
of the product being recalled or considered for recall.
Sec.7.42 Recall strategy.
(a) General. (1) A recall strategy that takes into account the
following factors will be developed by the agency for a Food and Drug
Administration-requested recall and by the recalling firm for a firm-
initiated recall to suit the individual circumstances of the particular
recall:
(i) Results of health hazard evaluation.
(ii) Ease in identifying the product.
(iii) Degree to which the product's deficiency is obvious to the
consumer or user.
(iv) Degree to which the product remains unused in the market-place.
(v) Continued availability of essential products.
(2) The Food and Drug Administration will review the adequacy of a
proposed recall strategy developed by a recalling firm and recommend
changes as appropriate. A recalling firm should conduct the recall in
accordance with an approved recall strategy but need not delay
initiation of a recall pending review of its recall strategy.
(b) Elements of a recall strategy. A recall strategy will address
the following elements regarding the conduct of the recall:
(1) Depth of recall. Depending on the product's degree of hazard and
extent of distribution, the recall strategy will specify the level in
the distribution chain to which the recall is to extend, as follows:
(i) Consumer or user level, which may vary with product, including
any intermediate wholesale or retail level; or
(ii) Retail level, including any intermediate wholesale level; or
(iii) Wholesale level.
(2) Public warning. The purpose of a public warning is to alert the
public that a product being recalled presents a serious hazard to
health. It is reserved for urgent situations where other means for
preventing use of the recalled product appear inadequate. The Food and
Drug Administration in consultation with the recalling firm will
ordinarily issue such publicity. The recalling firm that decides to
issue its own public warning is requested to submit its proposed public
warning and plan for distribution of the warning for review and comment
by the Food and Drug Administration. The recall strategy will specify
whether a public warning is needed and whether it will issue as:
(i) General public warning through the general news media, either
national or local as appropriate, or
(ii) Public warning through specialized news media, e.g.,
professional or trade press, or to specific segments of the population
such as physicians, hospitals, etc.
(3) Effectiveness checks. The purpose of effectiveness checks is to
verify that all consignees at the recall depth specified by the strategy
have received notification about the recall and have taken appropriate
action. The method for contacting consignees may be accomplished by
personal visits, telephone calls, letters, or a combination thereof. A
guide entitled ``Methods for Conducting Recall Effectiveness Checks''
that describes the use of these different methods is available upon
request from the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. The
recalling firm will ordinarily be responsible for conducting
effectiveness checks, but the Food and Drug Administration will assist
in this task where necessary and appropriate. The recall strategy will
specify the method(s) to be used for and the level of effectiveness
checks that will be conducted, as follows:
(i) Level A--100 percent of the total number of consignees to be
contacted;
(ii) Level B--Some percentage of the total number of consignees to
be contacted, which percentage is to be determined on a case-by-case
basis, but is greater that 10 percent and less than 100 percent of the
total number of consignees;
(iii) Level C--10 percent of the total number of consignees to be
contacted;
[[Page 72]]
(iv) Level D--2 percent of the total number of consignees to be
contacted; or
(v) Level E--No effectiveness checks.
[43 FR 26218, June 16, 1978, as amended at 46 FR 8455, Jan. 27, 1981; 59
FR 14363, Mar. 28, 1994; 68 FR 24879, May 9, 2003]
Sec.7.45 Food and Drug Administration-requested recall.
(a) The Commissioner of Food and Drugs or designee may request a
firm to initiate a recall when the following determinations have been
made:
(1) That a product that has been distributed presents a risk of
illness or injury or gross consumer deception.
(2) That the firm has not initiated a recall of the product.
(3) That an agency action is necessary to protect the public health
and welfare.
(b) The Commissioner or his designee will notify the firm of this
determination and of the need to begin immediately a recall of the
product. Such notification will be by letter or telegram to a
responsible official of the firm, but may be preceded by oral
communication or by a visit from an authorized representative of the
local Food and Drug Administration district office, with formal, written
confirmation from the Commissioner or his designee afterward. The
notification will specify the violation, the health hazard
classification of the violative product, the recall strategy, and other
appropriate instructions for conducting the recall.
(c) Upon receipt of a request to recall, the firm may be asked to
provide the Food and Drug Administration any or all of the information
listed in Sec.7.46(a). The firm, upon agreeing to the recall request,
may also provide other information relevant to the agency's
determination of the need for the recall or how the recall should be
conducted.
[43 FR 26218, June 16, 1978, as amended at 69 FR 17290, Apr. 2, 2004]
Sec.7.46 Firm-initiated recall.
(a) A firm may decide of its own volition and under any
circumstances to remove or correct a distributed product. A firm that
does so because it believes the product to be violative is requested to
notify immediately the appropriate Food and Drug Administration district
office listed in Sec.5.115 of this chapter. Such removal or correction
will be considered a recall only if the Food and Drug Administration
regards the product as involving a violation that is subject to legal
action, e.g., seizure. In such cases, the firm will be asked to provide
the Food and Drug Administration the following information:
(1) Identity of the product involved.
(2) Reason for the removal or correction and the date and
circumstances under which the product deficiency or possible deficiency
was discovered.
(3) Evaluation of the risk associated with the deficiency or
possible deficiency.
(4) Total amount of such products produced and/or the timespan of
the production.
(5) Total amount of such products estimated to be in distribution
channels.
(6) Distribution information, including the number of direct
accounts and, where necessary, the identity of the direct accounts.
(7) A copy of the firm's recall communication if any has issued, or
a proposed communication if none has issued.
(8) Proposed strategy for conducting the recall.
(9) Name and telephone number of the firm official who should be
contacted concerning the recall.
(b) The Food and Drug Administration will review the information
submitted, advise the firm of the assigned recall classification,
recommend any appropriate changes in the firm's strategy for the recall,
and advise the firm that its recall will be placed in the weekly FDA
Enforcement Report. Pending this review, the firm need not delay
initiation of its product removal or correction.
(c) A firm may decide to recall a product when informed by the Food
and Drug Administration that the agency has determined that the product
in question violates the law, but the agency has not specifically
requested a recall. The firm's action also is considered a firm-
initiated recall and is subject to paragraphs (a) and (b) of this
section.
[[Page 73]]
(d) A firm that initiates a removal or correction of its product
which the firm believes is a market withdrawal should consult with the
appropriate Food and Drug Administration district office when the reason
for the removal or correction is not obvious or clearly understood but
where it is apparent, e.g., because of complaints or adverse reactions
regarding the product, that the product is deficient in some respect. In
such cases, the Food and Drug Administration will assist the firm in
determining the exact nature of the problem.
Sec.7.49 Recall communications.
(a) General. A recalling firm is responsible for promptly notifying
each of its affected direct accounts about the recall. The format,
content, and extent of a recall communication should be commensurate
with the hazard of the product being recalled and the strategy developed
for that recall. In general terms, the purpose of a recall communication
is to convey:
(1) That the product in question is subject to a recall.
(2) That further distribution or use of any remaining product should
cease immediately.
(3) Where appropriate, that the direct account should in turn notify
its customers who received the product about the recall.
(4) Instructions regarding what to do with the product.
(b) Implementation. A recall communication can be accomplished by
telegrams, mailgrams, or first class letters conspicuously marked,
preferably in bold red type, on the letter and the envelope: ``drug [or
food, biologic, etc.] recall [or correction]''. The letter and the
envelope should be also marked: ``urgent'' for class I and class II
recalls and, when appropriate, for class III recalls. Telephone calls or
other personal contacts should ordinarily be confirmed by one of the
above methods and/or documented in an appropriate manner.
(c) Contents. (1) A recall communication should be written in
accordance with the following guidelines:
(i) Be brief and to the point;
(ii) Identify clearly the product, size, lot number(s), code(s) or
serial number(s) and any other pertinent descriptive information to
enable accurate and immediate identification of the product;
(iii) Explain concisely the reason for the recall and the hazard
involved, if any;
(iv) Provide specific instructions on what should be done with
respect to the recalled products; and
(v) Provide a ready means for the recipient of the communication to
report to the recalling firm whether it has any of the product, e.g., by
sending a postage-paid, self-addressed postcard or by allowing the
recipient to place a collect call to the recalling firm.
(2) The recall communication should not contain irrelevant
qualifications, promotional materials, or any other statement that may
detract from the message. Where necessary, followup communications
should be sent to those who fail to respond to the initial recall
communication.
(d) Responsibility of recipient. Consignees that receive a recall
communication should immediately carry out the instructions set forth by
the recalling firm and, where necessary, extend the recall to its
consignees in accordance with paragraphs (b) and (c) of this section.
Sec.7.50 Public notification of recall.
The Food and Drug Administration will promptly make available to the
public in the weekly FDA Enforcement Report a descriptive listing of
each new recall according to its classification, whether it was Food and
Drug Administration-requested or firm-initiated, and the specific action
being taken by the recalling firm. The Food and Drug Administration will
intentionally delay public notification of recalls of certain drugs and
devices where the agency determines that public notification may cause
unnecessary and harmful anxiety in patients and that initial
consultation between patients and their physicians is essential. The
report will not include a firm's product removals or corrections which
the agency determines to be market withdrawals or stock recoveries. The
report, which also includes other Food and Drug Administration
regulatory
[[Page 74]]
actions, e.g., seizures that were effected and injunctions and
prosecutions that were filed, is available upon request from the Office
of Public Affairs (HFI-1), Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857.
Sec.7.53 Recall status reports.
(a) The recalling firm is requested to submit periodic recall status
reports to the appropriate Food and Drug Administration district office
so that the agency may assess the progress of the recall. The frequency
of such reports will be determined by the relative urgency of the recall
and will be specified by the Food and Drug Administration in each recall
case; generally the reporting interval will be between 2 and 4 weeks.
(b) Unless otherwise specified or inappropriate in a given recall
case, the recall status report should contain the following information:
(1) Number of consignees notified of the recall, and date and method
of notification.
(2) Number of consignees responding to the recall communication and
quatity of products on hand at the time it was received.
(3) Number of consignees that did not respond (if needed, the
identity of nonresponding consignees may be requested by the Food and
Drug Administration).
(4) Number of products returned or corrected by each consignee
contacted and the quantity of products accounted for.
(5) Number and results of effectiveness checks that were made.
(6) Estimated time frames for completion of the recall.
(c) Recall status reports are to be discontinued when the recall is
terminated by the Food and Drug Administration.
Sec.7.55 Termination of a recall.
(a) A recall will be terminated when the Food and Drug
Administration determines that all reasonable efforts have been made to
remove or correct the product in accordance with the recall strategy,
and when it is reasonable to assume that the product subject to the
recall has been removed and proper disposition or correction has been
made commensurate with the degree of hazard of the recalled product.
Written notification that a recall is terminated will be issued by the
appropriate Food and Drug Administration district office to the
recalling firm.
(b) A recalling firm may request termination of its recall by
submitting a written request to the appropriate Food and Drug
Adminstration district office stating that the recall is effective in
accordance with the criteria set forth in paragraph (a) of this section,
and by accompanying the request with the most current recall status
report and a description of the disposition of the recalled product.
Sec.7.59 General industry guidance.
A recall can be disruptive of a firm's operation and business, but
there are several steps a prudent firm can take in advance to minimize
this disruptive effect. Notwithstanding similar specific requirements
for certain products in other parts of this chapter, the following is
provided by the Food and Drug Administration as guidance for a firm's
consideration:
(a) Prepare and maintain a current written contingency plan for use
in initiating and effecting a recall in accordance with Sec. Sec.7.40
through 7.49, 7.53, and 7.55.
(b) Use sufficient coding of regulated products to make possible
positive lot identification and to facilitate effective recall of all
violative lots.
(c) Maintain such product distribution records as are necessary to
facilitate location of products that are being recalled. Such records
should be maintained for a period of time that exceeds the shelf life
and expected use of the product and is at least the length of time
specified in other applicable regulations concerning records retention.
Subpart D [Reserved]
Subpart E_Criminal Violations
Sec.7.84 Opportunity for presentation of views before report of criminal
violation.
(a)(1) Except as provided in paragraph (a) (2) and (3) of this
section, a
[[Page 75]]
person against whom criminal prosecution under the Federal Food, Drug,
and Cosmetic Act is contemplated by the Commissioner of Food and Drugs
shall be given appropriate notice and an opportunity to present
information and views to show cause why criminal prosecution should not
be recommended to a United States attorney.
(2) Notice and opportunity need not be provided if the Commissioner
has reason to believe that they may result in the alteration or
destruction of evidence or in the prospective defendant's fleeing to
avoid prosecution.
(3) Notice and opportunity need not be provided if the Commissioner
contemplates recommending further investigation by the Department of
Justice.
(b) If a statute enforced by the Commissioner does not contain a
provision for an opportunity to present views, the Commissioner need
not, but may in the Commissioner's discretion, provide notice and an
opportunity to present views.
(c) If an apparent violation of the Federal Food, Drug, and Cosmetic
Act also constitutes a violation of any other Federal statute(s), and
the Commissioner contemplates recommending prosecution under such other
statute(s) as well, the notice of opportunity to present views will
include all violations.
(d) Notice of an opportunity to present views may be by letter,
standard form, or other document(s) identifying the products and/or
conduct alleged to violate the law. The notice shall--
(1) Be sent by registered or certified mail, telegram, telex,
personal delivery, or any other appropriate mode of written
communication;
(2) Specify the time and place where those named may present their
views;
(3) Summarize the violations that constitute the basis of the
contemplated prosecution;
(4) Describe the purpose and procedure of the presentation; and
(5) Furnish a form on which the legal status of any person named in
the notice may be designated.
(e) If more than one person is named in a notice, a separate
opportunity for presentation of views shall be scheduled on request.
Otherwise, the time and place specified in a notice may be changed only
upon a showing of reasonable grounds. A request for any change shall be
addressed to the Food and Drug Administration office that issued the
notice and shall be received in that office at least 3 working days
before the date set in the notice.
(f) A person who has received a notice is under no legal obligation
to appear or answer in any manner. A person choosing to respond may
appear personally, with or without a representative, or may designate a
representative to appear for him or her. Alternatively, a person may
respond in writing. If a person elects not to respond on or before the
time scheduled, the Commissioner will, without further notice, decide
whether to recommend criminal prosecution to a United States attorney on
the basis of the information available.
(g) If a respondent chooses to appear solely by designated
representative, that representative shall present a signed statement of
authorization. If a representative appears for more than one respondent,
the representative shall submit independent documentation of authority
to act for each respondent. If a representative appears without written
authorization, the opportunity to present views with respect to that
respondent may be provided at that time only if the authenticity of the
representative's authority is first verified by telephone or other
appropriate means.
[44 FR 12167, Mar. 6, 1979]
Sec.7.85 Conduct of a presentation of views before report of criminal
violation.
(a) The presentation of views shall be heard by a designated Food
and Drug Administration employee. Other Food and Drug Administration
employees may be present.
(b) A presentation of views shall not be open to the public. The
agency employee designated to receive views will permit participation of
other persons only if they appear with the respondent or the
respondent's designated representative, and at the request of, and on
behalf of, the respondent.
(c) A respondent may present any information of any kind bearing on
the
[[Page 76]]
Commissioner's determination to recommend prosecution. Information may
include statements of persons appearing on the respondent's behalf,
letters, documents, laboratory analyses, if applicable, or other
relevant information or arguments. The opportunity to present views
shall be informal. The rules of evidence shall not apply. Any
information given by a respondent, including statements by the
respondent, shall become part of the agency's records concerning the
matter and may be used for any official purpose. The Food and Drug
Administration is under no obligation to present evidence or witnesses.
(d) If the respondent holds a ``guaranty or undertaking'' as
described in section 303(c) of the act (21 U.S.C. 333(c)) that is
applicable to the notice, that document, or a verified copy of it, may
be presented by the respondent.
(e) A respondent may have an oral presentation recorded and
transcribed at his or her expense, in which case a copy of the
transcription shall be furnished to the Food and Drug Administration
office from which the notice issued. The employee designated to receive
views may order a presentation of views recorded and transcribed at
agency expense, in which case a copy of such transcription shall be
provided to each respondent.
(f) If an oral presentation is not recorded and transcribed, the
agency employee designated to receive views shall dictate a written
summary of the presentation. A copy of the summary shall be provided to
each respondent.
(g) A respondent may comment on the summary or may supplement any
response by additional written or documentary evidence. Any comment or
addition shall be furnished to the Food and Drug Administration office
where the respondent's views were presented. If materials are submitted
within 10 calendar days after receipt of the copy of the summary or
transcription of the presentation, as applicable, they will be
considered before a final decision as to whether or not to recommend
prosecution. Any materials received after the supplemental response
period generally will be considered only if the final agency decision
has not yet been made.
(h)(1) When consideration of a criminal prosecution recommendation
involving the same violations is closed by the Commissioner with respect
to all persons named in the notice, the Commissioner will so notify each
person in writing.
(2) When it is determined that a person named in a notice will not
be included in the Commissioner's recommendation for criminal
prosecution, the Commissioner will so notify that person, if and when
the Commissioner concludes that notification will not prejudice the
prosecution of any other person.
(3) When a United States attorney informs the agency that no persons
recommended will be prosecuted, the Commissioner will so notify each
person in writing, unless the United States attorney has already done
so.
(4) When a United States attorney informs the agency of intent to
prosecute some, but not all, persons who had been provided an
opportunity to present views and were subsequently named in the
Commissioner's recommendation for criminal prosecution, the
Commissioner, after being advised by the United States attorney that the
notification will not prejudice the prosecution of any other person,
will so notify those persons eliminated from further consideration,
unless the United States attorney has already done so.
[44 FR 12168, Mar. 6, 1979]
Sec.7.87 Records related to opportunities for presentation of views conducted
before report of criminal violation.
(a) Records related to a section 305 opportunity for presentation of
views constitute investigatory records for law enforcement purposes and
may include inter- and intra-agency memorandums.
(1) Notwithstanding the rule established in Sec.20.21 of this
chapter, no record related to a section 305 presentation is available
for public disclosure until consideration of criminal prosecution has
been closed in accordance with paragraph (b) of this section, except as
provided in Sec.20.82 of this chapter. Only very rarely and only under
circumstances that demonstrate a compelling public interest will the
[[Page 77]]
Commissioner exercise, in accordance with Sec.20.82 of this chapter,
the authorized discretion to disclose records related to a section 305
presentation before the consideration of criminal prosecution is closed.
(2) After consideration of criminal prosecution is closed, the
records are available for public disclosure in response to a request
under the Freedom of Information Act, except to the extent that the
exemptions from disclosure in subpart D of part 20 of this chapter are
applicable. No statements obtained through promises of confidentiality
shall be available for public disclosure.
(b) Consideration of criminal prosecution based on a particular
section 305 notice of opportunity for presentation of views shall be
deemed to be closed within the meaning of this section and Sec.7.85
when a final decision has been made not to recommend criminal
prosecution to a United States attorney based on charges set forth in
the notice and considered at the presentation, or when such a
recommendation has been finally refused by the United States attorney,
or when criminal prosecution has been instituted and the matter and all
related appeals have been concluded, or when the statute of limitations
has run.
(c) Before disclosure of any record specifically reflecting
consideration of a possible recommendation for criminal prosecution of
any individual, all names and other information that would identify an
individual whose prosecution was considered but not recommended, or who
was not prosecuted, shall be deleted, unless the Commissioner concludes
that there is a compelling public interest in the disclosure of the
names.
(d) Names and other information that would identify a Food and Drug
Administration employee shall be deleted from records related to a
section 305 presentation of views before public disclosure only under
Sec.20.32 of this chapter.
[44 FR 12168, Mar. 6, 1979]
PART 10_ADMINISTRATIVE PRACTICES AND PROCEDURES--Table of Contents
Subpart A_General Provisions
Sec.
10.1 Scope.
10.3 Definitions.
10.10 Summaries of administrative practices and procedures.
10.19 Waiver, suspension, or modification of procedural requirements.
Subpart B_General Administrative Procedures
10.20 Submission of documents to Division of Dockets Management;
computation of time; availability for public disclosure.
10.25 Initiation of administrative proceedings.
10.30 Citizen petition.
10.33 Administrative reconsideration of action.
10.35 Administrative stay of action.
10.40 Promulgation of regulations for the efficient enforcement of the
law.
10.45 Court review of final administrative action; exhaustion of
administrative remedies.
10.50 Promulgation of regulations and orders after an opportunity for a
formal evidentiary public hearing.
10.55 Separation of functions; ex parte communications.
10.60 Referral by court.
10.65 Meetings and correspondence.
10.70 Documentation of significant decisions in administrative file.
10.75 Internal agency review of decisions.
10.80 Dissemination of draft Federal Register notices and regulations.
10.85 Advisory opinions.
10.90 Food and Drug Administration regulations, recommendations, and
agreements.
10.95 Participation in outside standard-setting activities.
10.100 Public calendar.
10.105 Representation by an organization.
10.110 Settlement proposals.
10.115 Good guidance practices.
Subpart C_Electronic Media Coverage of Public Administrative
Proceedings; Guideline on Policy and Procedures
10.200 Scope.
10.203 Definitions.
10.204 General.
10.205 Electronic media coverage of public administrative proceedings.
10.206 Procedures for electronic media coverage of agency public
administrative proceedings.
[[Page 78]]
Authority: 5 U.S.C. 551-558, 701-706; 15 U.S.C. 1451-1461; 21 U.S.C.
141-149, 321-397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201,
262, 263b, 264.
Source: 44 FR 22323, Apr. 13, 1979, unless otherwise noted.
Editorial Note: Nomenclature changes to part 10 appear at 68 FR
24879, May 9, 2003.
Subpart A_General Provisions
Sec.10.1 Scope.
(a) Part 10 governs practices and procedures for petitions,
hearings, and other administrative proceedings and activities conducted
by the Food and Drug Administration under the Federal Food, Drug, and
Cosmetic Act, the Public Health Service Act, and other laws which the
Commissioner of Food and Drugs administers.
(b) If a requirement in another part of title 21 differs from a
requirement in this part, the requirements of this part apply to the
extent that they do not conflict with the other requirements.
(c) References in this part and parts 12, 13, 14, 15, and 16 to
regulatory sections of the Code of Federal Regulations are to chapter I
of title 21 unless otherwise noted.
(d) References in this part and parts 12, 13, 14, 15, and 16 to
publication, or to the day or date of publication, or use of the phrase
to publish, refer to publication in the Federal Register unless
otherwise noted.
[44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9034, Mar. 3, 1989; 69
FR 17290, Apr. 2, 2004]
Sec.10.3 Definitions.
(a) The following definitions apply in this part and parts 12, 13,
14, 15, 16, and 19:
Act means the Federal Food, Drug, and Cosmetic Act unless otherwise
indicated.
Administrative action includes every act, including the refusal or
failure to act, involved in the administration of any law by the
Commissioner, except that it does not include the referral of apparent
violations to U.S. attorneys for the institution of civil or criminal
proceedings or an act in preparation of a referral.
Administrative file means the file or files containing all documents
pertaining to a particular administrative action, including internal
working memoranda, and recommendations.
Administrative record means the documents in the administrative file
of a particular administrative action on which the Commissioner relies
to support the action.
Agency means the Food and Drug Administration.
Chief Counsel means the Chief Counsel of the Food and Drug
Administration.
Commissioner means the Commissioner of Food and Drugs, Food and Drug
Administration, U.S. Department of Health and Human Services, or the
Commissioner's designee.
Department means the U.S. Department of Health and Human Services.
Division of Dockets Management means the Division of Dockets
Management, Office of Management and Operations of the Food and Drug
Administration, U.S. Department of Health and Human Services, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852.
Ex parte communication means an oral or written communication not on
the public record for which reasonable prior notice to all parties is
not given, but does not include requests for status reports on a matter.
FDA means the Food and Drug Administration.
Food and Drug Administration employee or Food and Drug
Administration representative includes members of the Food and Drug
Division of the office of the General Counsel of the Department of
Health and Human Services.
Formal evidentiary public hearing means a hearing conducted under
part 12.
Interested person or any person who will be adversely affected means
a person who submits a petition or comment or objection or otherwise
asks to participate in an informal or formal administrative proceeding
or court action.
Meeting means any oral discussion, whether by telephone or in
person.
Office of the Commissioner includes the offices of the Associate
Commissioners but not the centers or the regional or district offices.
Order means the final agency disposition, other than the issuance of
a regulation, in a proceeding concerning any
[[Page 79]]
matter and includes action on a new drug application, new animal drug
application, or biological license.
Participant means any person participating in any proceeding,
including each party and any other interested person.
Party means the center of the Food and Drug Administration
responsible for a matter involved and every person who either has
exercised a right to request or has been granted the right by the
Commissioner to have a hearing under part 12 or part 16 or who has
waived the right to a hearing to obtain the establishment of a Public
Board of Inquiry under part 13 and as a result of whose action a hearing
or a Public Board of Inquiry has been established.
Person includes an individual, partnership, corporation,
association, or other legal entity.
Petition means a petition, application, or other document requesting
the Commissioner to establish, amend, or revoke a regulation or order,
or to take or not to take any other form of administrative action, under
the laws administered by the Food and Drug Administration.
Presiding officer means the Commissioner or the Commissioner's
designee or an administrative law judge appointed as provided in 5
U.S.C. 3105.
Proceeding and administrative proceeding means any undertaking to
issue, amend, or revoke a regulation or order, or to take or refrain
from taking any other form of administrative action.
Public advisory committee or advisory committee means any committee,
board, commission, council, conference, panel, task force, or other
similar group, or any subcommittee or other subgroup of an advisory
committee, that is not composed wholly of full-time employees of the
Federal Government and is established or utilized by the Food and Drug
Administration to obtain advice or recommendations.
Public Board of Inquiry or Board means an administrative law
tribunal constituted under part 13.
Public hearing before a public advisory committee means a hearing
conducted under part 14.
Public hearing before a Public Board of Inquiry means a hearing
conducted under part 13.
Public hearing before the Commissioner means a hearing conducted
under part 15.
Regulations means an agency rule of general or particular
applicability and future effect issued under a law administered by the
Commissioner or relating to administrative practices and procedures. In
accordance with Sec.10.90(a), each agency regulation will be published
in the Federal Register and codified in the Code of Federal Regulations.
Regulatory hearing before the Food and Drug Administration means a
hearing conducted under part 16.
Secretary means the Secretary of Health and Human Services.
The laws administered by the Commissioner or the laws administered
by the Food and Drug Administration means all the laws that the
Commissioner is authorized to administer.
(b) A term that is defined in section 201 of the Federal Food, Drug,
and Cosmetic Act or part 1 has the same definition in this part.
(c) Words in the singular form include the plural, words in the
masculine form include the feminine, and vice versa.
(d) Whenever a reference is made in this part to a person in FDA,
e.g., the director of a center, the reference includes all persons to
whom that person has delegated the specific function involved.
[44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 50
FR 8994, Mar. 6, 1985; 54 FR 6886, Feb. 15, 1989; 54 FR 9034, Mar. 3,
1989; 59 FR 14363, Mar. 28, 1994; 69 FR 17290, Apr. 2, 2004]
Sec.10.10 Summaries of administrative practices and procedures.
To encourage public participation in all agency activities, the
Commissioner will prepare for public distribution summaries of FDA
administrative practices and procedures in readily understandable terms.
[[Page 80]]
Sec.10.19 Waiver, suspension, or modification of procedural requirements.
The Commissioner or a presiding officer may, either voluntarily or
at the request of a participant, waive, suspend, or modify any provision
in parts 12 through 16 applicable to the conduct of a public hearing by
announcement at the hearing or by notice in advance of the hearing if no
participant will be prejudiced, the ends of justice will thereby be
served, and the action is in accordance with law.
Subpart B_General Administrative Procedures
Sec.10.20 Submission of documents to Division of Dockets Management;
computation of time; availability for public disclosure.
(a) A submission to the Division of Dockets Management of a
petition, comment, objection, notice, compilation of information, or any
other document is to be filed in four copies except as otherwise
specifically provided in a relevant Federal Register notice or in
another section of this chapter. The Division of Dockets Management is
the agency custodian of these documents.
(b) A submission is to be signed by the person making it, or by an
attorney or other authorized representative of that person. Submissions
by trade associations are also subject to the requirements of Sec.
10.105(b).
(c) Information referred to or relied upon in a submission is to be
included in full and may not be incorporated by reference, unless
previously submitted in the same proceeding.
(1) A copy of an article or other reference or source cited must be
included, except where the reference or source is:
(i) A reported Federal court case;
(ii) A Federal law or regulation;
(iii) An FDA document that is routinely publicly available; or
(iv) A recognized medical or scientific textbook that is readily
available to the agency.
(2) If a part of the material submitted is in a foreign language, it
must be accompanied by an English translation verified to be complete
and accurate, together with the name, address, and a brief statement of
the qualifications of the person making the translation. A translation
of literature or other material in a foreign language is to be
accompanied by copies of the original publication.
(3) Where relevant information is contained in a document also
containing irrelevant information, the irrelevant information is to be
deleted and only the relevant information is to be submitted.
(4) Under Sec.20.63 (a) and (b), the names and other information
that would identify patients or research subjects are to be deleted from
any record before it is submitted to the Division of Dockets Management
in order to preclude a clearly unwarranted invasion of personal privacy.
(5) Defamatory, scurrilous, or intemperate matter is to be deleted
from a record before it is submitted to the Division of Dockets
Management.
(6) The failure to comply with the requirements of this part or with
Sec.12.80 or Sec.13.20 will result in rejection of the submission
for filing or, if it is filed, in exclusion from consideration of any
portion that fails to comply. If a submission fails to meet any
requirement of this section and the deficiency becomes known to the
Division of Dockets Management, the Division of Dockets Management shall
not file the submission but return it with a copy of the applicable
regulations indicating those provisions not complied with. A deficient
submission may be corrected or supplemented and subsequently filed. The
office of the Division of Dockets Management does not make decisions
regarding the confidentiality of submitted documents.
(d) The filing of a submission means only that the Division of
Dockets Management has identified no technical deficiencies in the
submission. The filing of a petition does not mean or imply that it
meets all applicable requirements or that it contains reasonable grounds
for the action requested or that the action requested is in accordance
with law.
(e) All submissions to the Division of Dockets Management will be
considered as submitted on the date they are postmarked or, if delivered
in person during regular business hours, on the
[[Page 81]]
date they are delivered, unless a provision in this part, an applicable
Federal Register notice, or an order issued by an administrative law
judge specifically states that the documents must be received by a
specified date, e.g., Sec.10.33(g) relating to a petition for
reconsideration, in which case they will be considered submitted on the
date received.
(f) All submissions are to be mailed or delivered in person to the
Division of Dockets Management, Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852.
(g) FDA ordinarily will not acknowledge or give receipt for
documents, except:
(1) Documents delivered in person or by certified or registered mail
with a return receipt requested; and
(2) Petitions for which acknowledgment of receipt of filing is
provided by regulation or by customary practice, e.g., Sec.10.30(c)
relating to a citizen petition.
(h) Saturdays, Sundays, and Federal legal holidays are included in
computing the time allowed for the submission of documents, except that
when the time for submission expires on a Saturday, Sunday, or Federal
legal holiday, the period will be extended to include the next business
day.
(i) All submissions to the Division of Dockets Management are
representations that, to the best of the knowledge, information, and
belief of the person making the submission, the statements made in the
submission are true and accurate. All submissions are subject to the
False Reports to the Government Act (18 U.S.C. 1001) under which a
willfully false statement is a criminal offense.
(j) The availability for public examination and copying of
submissions to the Division of Dockets Management is governed by the
following rules:
(1) Except to the extent provided in paragraphs (j)(2) and (3) of
this section, the following submissions, including all supporting
material, will be on public display and will be available for public
examination between 9 a.m. and 4 p.m., Monday through Friday. Requests
for copies of submissions will be filed and handled in accordance with
subpart C of part 20:
(i) Petitions.
(ii) Comments on petitions, on documents published in the Federal
Register, and on similar public documents.
(iii) Objections and requests for hearings filed under part 12.
(iv) Material submitted at a hearing under Sec.12.32(a)(2) and
parts 12, 13, and 15.
(v) Material placed on public display under the regulations in this
chapter, e.g., agency guidance documents developed under Sec.10.115.
(2)(i) Material prohibited from public disclosure under Sec.20.63
(clearly unwarranted invasion of personal privacy) and, except as
provided in paragraph (j)(3) of this section, material submitted with
objections and requests for hearing filed under part 12, or at a hearing
under part 12 or part 13, or an alternative form of public hearing
before a public advisory committee or a hearing under Sec.12.32(a) (2)
or (3), of the following types will not be on public display, will not
be available for public examination, and will not be available for
copying or any other form of verbatim transcription unless it is
otherwise available for public disclosure under part 20:
(a) Safety and effectiveness information, which includes all studies
and tests of an ingredient or product on animals and humans and all
studies and tests on the ingredient or product for identity, stability,
purity, potency, bioavailability, performance, and usefulness.
(b) A protocol for a test or study.
(c) Manufacturing methods or processes, including quality control
procedures.
(d) Production, sales distribution, and similar information, except
any compilation of information aggregated and prepared in a way that
does not reveal confidential information.
(e) Quantitative or semiquantitative formulas.
(f) Information on product design or construction.
(ii) Material submitted under paragraph (j)(2) of this section is to
be segregated from all other submitted material and clearly so marked. A
person who does not agree that a submission is properly subject to
paragraph (j)(2)
[[Page 82]]
may request a ruling from the Associate Commissioner for Public Affairs
whose decision is final, subject to judicial review under Sec.20.48.
(3) Material listed in paragraph (j)(2)(i) (a) and (b) of this
section may be disclosed under a protective order issued by the
administrative law judge or other presiding officer at a hearing
referenced in paragraph (j)(2)(i). The administrative law judge or
presiding officer shall permit disclosure of the data only in camera and
only to the extent necessary for the proper conduct of the hearing. The
administrative law judge or presiding officer shall direct to whom the
information is to be made available (e.g., to parties or participants,
or only to counsel for parties or participants), and persons not
specifically permitted access to the data will be excluded from the in
camera part of the proceeding. The administrative law judge or other
presiding officer may impose other conditions or safeguards. The limited
availability of material under this paragraph does not constitute prior
disclosure to the public as defined in Sec.20.81, and no information
subject to a particular order is to be submitted to or received or
considered by FDA in support of a petition or other request from any
other person.
[44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 49
FR 7363, Feb. 29, 1984; 54 FR 9034, Mar. 3, 1989; 59 FR 14363, Mar. 28,
1994; 64 FR 69190, Dec. 10, 1999; 65 FR 56477, Sept. 19, 2000; 66 FR
56035, Nov. 6, 2001; 66 FR 66742, Dec. 27, 2001; 68 FR 25285, May 12,
2003]
Sec.10.25 Initiation of administrative proceedings.
An administrative proceeding may be initiated in the following three
ways:
(a) An interested person may petition the Commissioner to issue,
amend, or revoke a regulation or order, or to take or refrain from
taking any other form of administrative action. A petition must be
either:
(1) In the form specified in other applicable FDA regulations, e.g.,
the form for a color additive petition in Sec.71.1, for a food
additive petition in Sec.171.1, for a new drug application in Sec.
314.50, for a new animal drug application in Sec.514.1, or
(2) in the form for a citizen petition in Sec.10.30.
(b) The Commissioner may initiate a proceeding to issue, amend, or
revoke a regulation or order or take or refrain from taking any other
form of administrative action. FDA has primary jurisdiction to make the
initial determination on issues within its statutory mandate, and will
request a court to dismiss, or to hold in abeyance its determination of
or refer to the agency for administrative determination, any issue which
has not previously been determined by the agency or which, if it has
previously been determined, the agency concluded should be reconsidered
and subject to a new administrative determination. The Commissioner may
utilize any of the procedures established in this part in reviewing and
making a determination on any matter initiated under this paragraph.
(c) The Commissioner will institute a proceeding to determine
whether to issue, amend, or revoke a regulation or order, or take or
refrain from taking any other form of administrative action whenever any
court, on its own initiative, holds in abeyance or refers any matter to
the agency for an administrative determination and the Commissioner
concludes that an administrative determination is feasible within agency
priorities and resources.
[44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9034, Mar. 3, 1989]
Sec.10.30 Citizen petition.
(a) This section applies to any petition submitted by a person
(including a person who is not a citizen of the United States) except to
the extent that other sections of this chapter apply different
requirements to a particular matter.
(b) A petition (including any attachments) must be submitted in
accordance with Sec.10.20 and in the following form:
(Date)__________________________________________________________________
Division of Dockets Management, Food and Drug Administration,
Department of Health and Human Services, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
Citizen Petition
The undersigned submits this petition under ------ (relevant
statutory sections, if
[[Page 83]]
known) of the ------ (Federal Food, Drug, and Cosmetic Act or the Public
Health Service Act or any other statutory provision for which authority
has been delegated to the Commissioner of Food and Drugs under 21 CFR
5.10) to request the Commissioner of Food and Drugs to ------ (issue,
amend, or revoke a regulation or order or take or refrain from taking
any other form of administrative action).
A. Action requested
((1) If the petition requests the Commissioner to issue, amend, or
revoke a regulation, the exact wording of the existing regulation (if
any) and the proposed regulation or amendment requested.)
((2) If the petition requests the Commissioner to issue, amend, or
revoke an order, a copy of the exact wording of the citation to the
existing order (if any) and the exact wording requested for the proposed
order.)
((3) If the petition requests the Commissioner to take or refrain
from taking any other form of administrative action, the specific action
or relief requested.)
B. Statement of grounds
(A full statement, in a well organized format, of the factual and
legal grounds on which the petitioner relies, including all relevant
information and views on which the petitioner relies, as well as
representative information known to the petitioner which is unfavorable
to the petitioner's position.)
C. Environmental impact
(A) Claim for categorical exclusion under Sec. Sec.25.30, 25.31,
25.32, 25.33, or Sec.25.34 of this chapter or an environmental
assessment under Sec.25.40 of this chapter.)
D. Economic impact
(The following information is to be submitted only when requested by
the Commissioner following review of the petition: A statement of the
effect of requested action on: (1) Cost (and price) increases to
industry, government, and consumers; (2) productivity of wage earners,
businesses, or government; (3) competition; (4) supplies of important
materials, products, or services; (5) employment; and (6) energy supply
or demand.)
E. Certification
The undersigned certifies, that, to the best knowledge and belief of
the undersigned, this petition includes all information and views on
which the petition relies, and that it includes representative data and
information known to the petitioner which are unfavorable to the
petition.
(Signature)_____________________________________________________________
(Name of petitioner)____________________________________________________
(Mailing address)_______________________________________________________
(Telephone number)______________________________________________________
(c) A petition which appears to meet the requirements of paragraph
(b) of this section and Sec.10.20 will be filed by the Division of
Dockets Management, stamped with the date of filing, and assigned a
docket number. The docket number identifies the file established by the
Division of Dockets Management for all submissions relating to the
petition, as provided in this part. Subsequent submissions relating to
the matter must refer to the docket number and will be filed in the
docket file. Related petitions may be filed together and given the same
docket number. The Division of Dockets Management will promptly notify
the petitioner in writing of the filing and docket number of a petition.
(d) An interested person may submit written comments to the Division
of Dockets Management on a filed petition, which comments become part of
the docket file. The comments are to specify the docket number of the
petition and may support or oppose the petition in whole or in part. A
request for alternative or different administrative action must be
submitted as a separate petition.
(e)(1) The Commissioner shall, in accordance with paragraph (e)(2),
rule upon each petition filed under paragraph (c) of this section,
taking into consideration (i) available agency resources for the
category of subject matter, (ii) the priority assigned to the petition
considering both the category of subject matter involved and the overall
work of the agency, and (iii) time requirements established by statute.
(2) Except as provided in paragraph (e)(4) of this section, the
Commissioner shall furnish a response to each petitioner within 180 days
of receipt of the petition. The response will either:
(i) Approve the petition, in which case the Commissioner shall
concurrently take appropriate action (e.g., publication of a Federal
Register notice) implementing the approval;
(ii) Deny the petition; or
(iii) Provide a tentative response, indicating why the agency has
been unable to reach a decision on the petition, e.g., because of the
existence of other agency priorities, or a need for additional
information. The tentative
[[Page 84]]
response may also indicate the likely ultimate agency response, and may
specify when a final response may be furnished.
(3) The Commissioner may grant or deny such a petition, in whole or
in part, and may grant such other relief or take other action as the
petition warrants. The petitioner is to be notified in writing of the
Commissioner's decision. The decision will be placed in the public
docket file in the office of the Division of Dockets Management and may
also be in the form of a notice published in the Federal Register.
(4) The Commissioner shall furnish a response to each petitioner
within 90 days of receipt of a petition filed under section 505(j)(2)(C)
of the act. The response will either approve or disapprove the petition.
Agency action on a petition shall be governed by Sec.314.93 of this
chapter.
(f) If a petition filed under paragraph (c) of this section requests
the Commissioner to issue, amend, or revoke a regulation, Sec.10.40 or
Sec.10.50 also apply.
(g) A petitioner may supplement, amend, or withdraw a petition in
writing without agency approval and without prejudice to resubmission at
anytime until the Commissioner rules on the petition, unless the
petition has been referred for a hearing under parts 12, 13, 14, or 15.
After a ruling or referral, a petition may be supplemented, amended, or
withdrawn only with the approval of the Commissioner. The Commissioner
may approve withdrawal, with or without prejudice against resubmission
of the petition.
(h) In reviewing a petition the Commissioner may use the following
procedures:
(1) Conferences, meetings, discussions, and correspondence under
Sec.10.65.
(2) A hearing under parts 12, 13, 14, 15, or 16.
(3) A Federal Register notice requesting information and views.
(4) A proposal to issue, amend, or revoke a regulation, in
accordance with Sec.10.40 or Sec.12.20.
(5) Any other specific public procedure established in this chapter
and expressly applicable to the matter.
(i) The record of the administrative proceeding consists of the
following:
(1) The petition, including all information on which it relies,
filed by the Division of Dockets Management.
(2) All comments received on the petition, including all information
submitted as a part of the comments.
(3) If the petition resulted in a proposal to issue, amend, or
revoke a regulation, all of the documents specified in Sec.10.40(g).
(4) The record, consisting of any transcripts, minutes of meetings,
reports, Federal Register notices, and other documents resulting from
the optional procedures specified in paragraph (h) of this section,
except a transcript of a closed portion of a public advisory committee
meeting.
(5) The Commissioner's decision on the petition, including all
information identified or filed by the Commissioner with the Division of
Dockets Management as part of the record supporting the decision.
(6) All documents filed with the Division of Dockets Management
under Sec.10.65(h).
(7) If a petition for reconsideration or for a stay of action is
filed under paragraph (j) of this section, the administrative record
specified in Sec.10.33(k) or Sec.10.35(h).
(j) The administrative record specified in paragraph (i) of this
section is the exclusive record for the Commissioner's decision. The
record of the administrative proceeding closes on the date of the
Commissioner's decision unless some other date is specified. Thereafter
any interested person may submit a petition for reconsideration under
Sec.10.33 or a petition for stay of action under Sec.10.35. A person
who wishes to rely upon information or views not included in the
administrative record shall submit them to the Commissioner with a new
petition to modify the decision in accordance with this section.
(k) This section does not apply to the referral of a matter to a
United States attorney for the initiation of court enforcement action
and related correspondence, or to requests, suggestions, and
recommendations made informally in routine correspondence received by
FDA. Routine correspondence does not constitute a petition
[[Page 85]]
within the meaning of this section unless it purports to meet the
requirements of this section. Action on routine correspondence does not
constitute final administrative action subject to judicial review under
Sec.10.45.
(l) The Division of Dockets Management will maintain a chronological
list of each petition filed under this section and Sec.10.85, but not
of petitions submitted elsewhere in the agency under Sec.10.25(a)(1),
showing:
(1) The docket number;
(2) The date the petition was filed by the Division of Dockets
Management;
(3) The name of the petitioner;
(4) The subject matter involved; and
(5) The disposition of the petition.
[44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 50
16656, Apr. 26, 1985; 54 FR 9034, Mar. 3, 1989; 57 FR 17980, Apr. 28,
1992; 59 FR 14364, Mar. 28, 1994; 62 FR 40592, July 29, 1997; 66 FR
6467, Jan. 22, 2001; 66 FR 12848, Mar. 1, 2001]
Sec.10.33 Administrative reconsideration of action.
(a) The Commissioner may at any time reconsider a matter, on the
Commissioner's own initiative or on the petition of an interested
person.
(b) An interested person may request reconsideration of part or all
of a decision of the Commissioner on a petition submitted under Sec.
10.25. Each request for reconsideration must be submitted in accordance
with Sec.10.20 and in the following form no later than 30 days after
the date of the decision involved. The Commissioner may, for good cause,
permit a petition to be filed after 30 days. In the case of a decision
published in the Federal Register, the day of publication is the day of
decision.
(Date)__________________________________________________________________
Division of Dockets Management, Food and Drug Administration,
Department of Health and Human Services, rm. 1-23, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.
Petition for Reconsideration
[Docket No.]
The undersigned submits this petition for reconsideration of the
decision of the Commissioner of Food and Drugs in Docket No. ----.
A. Decision involved
(A concise statement of the decision of the Commissioner which the
petitioner wishes to have reconsidered.)
B. Action requested
(The decision which the petitioner requests the Commissioner to make
upon reconsideration of the matter.)
C. Statement of grounds
(A full statement, in a well-organized format, of the factual and
legal grounds upon which the petitioner relies. The grounds must
demonstrate that relevant information and views contained in the
administrative record were not previously or not adequately considered
by the Commissioner.
(No new information or views may be included in a petition for
reconsideration.)
(Signature)_____________________________________________________________
(Name of petitioner)____________________________________________________
(Mailing address)_______________________________________________________
(Telephone number)______________________________________________________
(c) A petition for reconsideration relating to a petition submitted
under Sec.10.25(a)(2) is subject to the requirements of Sec.10.30
(c) and (d), except that it is filed in the same docket file as the
petition to which it relates.
(d) The Commissioner shall promptly review a petition for
reconsideration. The Commissioner may grant the petition when the
Commissioner determines it is in the public interest and in the interest
of justice. The Commissioner shall grant a petition for reconsideration
in any proceeding if the Commissioner determines all of the following
apply:
(1) The petition demonstrates that relevant information or views
contained in the administrative record were not previously or not
adequately considered.
(2) The petitioner's position is not frivolous and is being pursued
in good faith.
(3) The petitioner has demonstrated sound public policy grounds
supporting reconsideration.
(4) Reconsideration is not outweighed by public health or other
public interests.
(e) A petition for reconsideration may not be based on information
and views not contained in the administrative record on which the
decision was made. An interested person who wishes
[[Page 86]]
to rely on information or views not included in the administrative
record shall submit them with a new petition to modify the decision
under Sec.10.25(a).
(f) The decision on a petition for reconsideration is to be in
writing and placed on public display as part of the docket file on the
matter in the office of the Division of Dockets Management. A
determination to grant reconsideration will be published in the Federal
Register if the Commissioner's original decision was so published. Any
other determination to grant or deny reconsideration may also be
published in the Federal Register.
(g) The Commissioner may consider a petition for reconsideration
only before the petitioner brings legal action in the courts to review
the action, except that a petition may also be considered if the
Commissioner has denied a petition for stay of action and the petitioner
has petitioned for judicial review of the Commissioner's action and
requested the reviewing court to grant a stay pending consideration of
review. A petition for reconsideration submitted later than 30 days
after the date of the decision involved will be denied as untimely
unless the Commissioner permits the petition to be filed after 30 days.
A petition for reconsideration will be considered as submitted on the
day it is received by the Division of Dockets Management.
(h) The Commissioner may initiate the reconsideration of all or part
of a matter at any time after it has been decided or action has been
taken. If review of the matter is pending in the courts, the
Commissioner may request that the court refer the matter back to the
agency or hold its review in abeyance pending administrative
reconsideration. The administrative record of the proceeding is to
include all additional documents relating to such reconsideration.
(i) After determining to reconsider a matter, the Commissioner shall
review and rule on the merits of the matter under Sec.10.30(e). The
Commissioner may reaffirm, modify, or overrule the prior decision, in
whole or in part, and may grant such other relief or take such other
action as is warranted.
(j) The Commissioner's reconsideration of a matter relating to a
petition submitted under Sec.10.25(a)(2) is subject to Sec.10.30 (f)
through (h), (j), and (k).
(k) The record of the administrative proceeding consists of the
following:
(1) The record of the original petition specified in Sec.10.30(i).
(2) The petition for reconsideration, including all information on
which it relies, filed by the Division of Dockets Management.
(3) All comments received on the petition, including all information
submitted as a part of the comments.
(4) The Commissioner's decision on the petition under paragraph (f)
of this section, including all information identified or filed by the
Commissioner with the Division of Dockets Management as part of the
record supporting the decision.
(5) Any Federal Register notices or other documents resulting from
the petition.
(6) All documents filed with the Division of Dockets Management
under Sec.10.65(h).
(7) If the Commissioner reconsiders the matter, the administrative
record relating to reconsideration specified in Sec.10.30(i).
[44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 59
FR 14364, Mar. 28, 1994; 66 FR 6467, Jan. 22, 2001; 66 FR 12848, Mar. 1,
2001]
Sec.10.35 Administrative stay of action.
(a) The Commissioner may at any time stay or extend the effective
date of an action pending or following a decision on any matter.
(b) An interested person may request the Commissioner to stay the
effective date of any administrative action. A stay may be requested for
a specific time period or for an indefinite time period. A request for
stay must be submitted in accordance with Sec.10.20 and in the
following form no later than 30 days after the date of the decision
involved. The Commissioner may, for good cause, permit a petition to be
filed after 30 days. In the case of a decision published in the Federal
Register, the day of publication is the date of decision.
(Date)__________________________________________________________________
Division of Dockets Management, Food and Drug Administration,
Department of
[[Page 87]]
Health and Human Services, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852.
Petition for Stay of Action
The undersigned submits this petition requesting that the
Commissioner of Food and Drugs stay the effective date of the following
matter.
A. Decision involved
(The specific administrative action being taken by the Commissioner
for which a stay is requested, including the docket number or other
citation to the action involved.)
B. Action requested
(The length of time for which the stay is requested, which may be
for a specific or indefinite time period.)
C. Statement of grounds
(A full statement, in a well-organized format, of the factual and
legal grounds upon which the petitioner relies for the stay.)
(Signature)_____________________________________________________________
(Name of petitioner)____________________________________________________
(Mailing address)_______________________________________________________
(Telephone number)______________________________________________________
(c) A petition for stay of action relating to a petition submitted
under Sec.10.25(a)(2) is subject to the requirements of Sec.10.30
(c) and (d), except that it will be filed in the same docket file as the
petition to which it relates.
(d) Neither the filing of a petition for a stay of action nor action
taken by an interested person in accordance with any other
administrative procedure in this part or in any other section of this
chapter, e.g., the filing of a citizen petition under Sec.10.30 or a
petition for reconsideration under Sec.10.33 or a request for an
advisory opinion under Sec.10.85, will stay or otherwise delay any
administrative action by the Commissioner, including enforcement action
of any kind, unless one of the following applies:
(1) The Commissioner determines that a stay or delay is in the
public interest and stays the action.
(2) A statute requires that the matter be stayed.
(3) A court orders that the matter be stayed.
(e) The Commissioner shall promptly review a petition for stay of
action. The Commissioner may grant or deny a petition, in whole or in
part; and may grant such other relief or take such other action as is
warranted by the petition. The Commissioner may grant a stay in any
proceeding if it is in the public interest and in the interest of
justice. The Commissioner shall grant a stay in any proceeding if all of
the following apply:
(1) The petitioner will otherwise suffer irreparable injury.
(2) The petitioner's case is not frivolous and is being pursued in
good faith.
(3) The petitioner has demonstrated sound public policy grounds
supporting the stay.
(4) The delay resulting from the stay is not outweighted by public
health or other public interests.
(f) The Commissioner's decision on a petition for stay of action is
to be in writing and placed on public display as part of the file on the
matter in the office of the Division of Dockets Management. A
determination to grant a stay will be published in the Federal Register
if the Commissioner's original decision was so published. Any other
determination to grant or to deny a stay may also be published in the
Federal Register.
(g) A petition for a stay of action submitted later than 30 days
after the date of the decision involved will be denied as untimely
unless the Commissioner permits the petition to be filed after 30 days.
A petition for a stay of action is considered submitted on the day it is
received by the Division of Dockets Management.
(h) The record of the administrative proceeding consists of the
following:
(1) The record of the proceeding to which the petition for stay of
action is directed.
(2) The petition for stay of action, including all information on
which it relies, filed by the Division of Dockets Management.
(3) All comments received on the petition, including all information
submitted as a part of the comments.
(4) The Commissioner's decision on the petition under paragraph (e)
of this section, including all information identified or filed by the
Commissioner with the Division of Dockets Management as part of the
record supporting the decision.
(5) Any Federal Register notices or other documents resulting from
the petition.
[[Page 88]]
(6) All documents filed with the Division of Dockets Management
under Sec.10.65(h).
[44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 54
FR 9034, Mar. 3, 1989; 59 FR 14364, Mar. 28, 1994; 66 FR 6468, Jan. 22,
2001; 66 FR 12848, Mar. 1, 2001]
Sec.10.40 Promulgation of regulations for the efficient enforcement of the
law.
(a) The Commissioner may propose and promulgate regulations for the
efficient enforcement of the laws administered by FDA whenever it is
necessary or appropriate to do so. The issuance, amendment, or
revocation of a regulation may be initiated in any of the ways specified
in Sec.10.25.
(1) This section applies to any regulation: (i) Not subject to Sec.
10.50 and part 12, or (ii) if it is subject to Sec.10.50 and part 12,
to the extent that those provisions make this section applicable.
(2) A regulation proposed by an interested person in a petition
submitted under Sec.10.25(a) will be published in the Federal Register
as a proposal if:
(i) The petition contains facts demonstrating reasonable grounds for
the proposal; and
(ii) The petition substantially shows that the proposal is in the
public interest and will promote the objectives of the act and the
agency.
(3) Two or more alternative proposed regulations may be published on
the same subject to obtain comment on the different alternatives.
(4) A regulation proposed by an interested person in a petition
submitted under Sec.10.25(a) may be published together with the
Commissioner's preliminary views on the proposal and any alternative
proposal.
(b) Except as provided in paragraph (e) of this section, each
regulation must be the subject of a notice of proposed rulemaking
published in the Federal Register. (1) The notice will contain:
(i) The name of the agency;
(ii) The nature of the action, e.g., proposed rule, or notice;
(iii) A summary in the first paragraph describing the substance of
the document in easily understandable terms;
(iv) Relevant dates, e.g., comment closing date, and proposed
effective date(s);
(v) The name, business address, and phone number of an agency
contact person who can provide further information to the public about
the notice;
(vi) An address for submitting written comments;
(vii) Supplementary information about the notice in the form of a
preamble that summarizes the proposal and the facts and policy
underlying it, includes references to all information on which the
Commissioner relies for the proposal (copies or a full list of which are
a part of the docket file on the matter in the office of the Division of
Dockets Management), and cites the authority under which the regulation
is proposed;
(viii) Either the terms or substance of the proposed regulation or a
description of the subjects and issues involved;
(ix) A reference to the existence or lack of need for an
environmental impact statement under Sec.25.52 of this chapter; and
(x) The docket number of the matter, which identifies the docket
file established by the Division of Dockets Management for all relevant
submissions.
(2) The proposal will provide 60 days for comment, although the
Commissioner may shorten or lengthen this time period for good cause. In
no event is the time for comment to be less than 10 days.
(3) After publication of the proposed rule, any interested person
may request the Commissioner to extend the comment period for an
additional specified period by submitting a written request to the
Division of Dockets Management stating the grounds for the request. The
request is submitted under Sec.10.35 but should be headed ``REQUEST
FOR EXTENSION OF COMMENT PERIOD.''
(i) A request must discuss the reason comments could not feasibly be
submitted within the time permitted, or that important new information
will shortly be available, or that sound public policy otherwise
supports an extension of the time for comment. The Commissioner may
grant or deny the request or may grant an extension for
[[Page 89]]
a time period different from that requested. An extension may be limited
to specific persons who have made and justified the request, but will
ordinarily apply to all interested persons.
(ii) A comment time extension of 30 days or longer will be published
in the Federal Register and will be applicable to all interested
persons. A comment time extension of less than 30 days will be the
subject either of a letter or memorandum filed with the Division of
Dockets Management or of a notice published in the Federal Register.
(4) A notice of proposed rulemaking will request that four copies of
all comments be submitted to the Division of Dockets Management, except
that individuals may submit single copies. Comments will be stamped with
the date of receipt and will be numbered chronologically.
(5) Persons submitting comments critical of a proposed regulation
are encouraged to include their preferred alternative wording.
(c) After the time for comment on a proposed regulation has expired,
the Commissioner will review the entire administrative record on the
matter, including all comments and, in a notice published in the Federal
Register, will terminate the proceeding, issue a new proposal, or
promulgate a final regulation.
(1) The quality and persuasiveness of the comments will be the basis
for the Commissioner's decision. The number or length of comments will
not ordinarily be a significant factor in the decision unless the number
of comments is material where the degree of public interest is a
legitimate factor for consideration.
(2) The decision of the Commissioner on the matter will be based
solely upon the administrative record.
(3) A final regulation published in the Federal Register will have a
preamble stating: (i) The name of the agency, (ii) the nature of the
action e.g., final rule, notice, (iii) a summary first paragraph
describing the substance of the document in easily understandable terms,
(iv) relevant dates, e.g., the rule's effective date and comment closing
date, if an opportunity for comment is provided, (v) the name, business
address, and phone number of an agency contact person who can provide
further information to the public about the notice, (vi) an address for
the submission of written comments when they are permitted, (vii)
supplementary information about the regulation in the body of the
preamble that contains references to prior notices relating to the same
matter and a summary of each type of comment submitted on the proposal
and the Commissioner's conclusions with respect to each. The preamble is
to contain a thorough and comprehensible explanation of the reasons for
the Commissioner's decision on each issue.
(4) The effective date of a final regulation may not be less than 30
days after the date of publication in the Federal Register, except for:
(i) A regulation that grants an exemption or relieves a restriction;
or
(ii) A regulation for which the Commissioner finds, and states in
the notice good cause for an earlier effective date.
(d) The provisions for notice and comment in paragraphs (b) and (c)
of this section apply only to the extent required by the Administrative
Procedure Act (5 U.S.C. 551, 552, and 553). As a matter of discretion,
however, the Commissioner may voluntarily follow those provisions in
circumstances in which they are not required by the Administrative
Procedure Act.
(e) The requirements of notice and public procedure in paragraph (b)
of this section do not apply in the following situations:
(1) When the Commissioner determines for good cause that they are
impracticable, unnecessary, or contrary to the public interest. In these
cases, the notice promulgating the regulation will state the reasons for
the determination, and provide an opportunity for comment to determine
whether the regulation should subsequently be modified or revoked. A
subsequent notice based on those comments may, but need not, provide
additional opportunity for public comment.
(2) Food additive and color additive petitions, which are subject to
the provisions of Sec.12.20(b)(2).
[[Page 90]]
(3) New animal drug regulations, which are promulgated under section
512(i) of the act.
(f) In addition to the notice and public procedure required under
paragraph (b) of this section, the Commissioner may also subject a
proposed or final regulation, before or after publication in the Federal
Register, to the following additional procedures:
(1) Conferences, meetings, discussions, and correspondence under
Sec.10.65.
(2) A hearing under parts 12, 13, 14, or 15.
(3) A notice published in the Federal Register requesting
information and views before the Commissioner determines whether to
propose a regulation.
(4) A draft of a proposed regulation placed on public display in the
office of the Division of Dockets Management. If this procedure is used,
the Commissioner shall publish an appropriate notice in the Federal
Register stating that the document is available and specifying the time
within which comments on the draft proposal may be submitted orally or
in writing.
(5) A revised proposal published in the Federal Register, which
proposal is subject to all the provisions in this section relating to
proposed regulations.
(6) A tentative final regulation or tentative revised final
regulation placed on public display in the office of the Division of
Dockets Management and, if deemed desirable by the Commissioner,
published in the Federal Register. If the tentative regulation is placed
on display only, the Commissioner shall publish an appropriate notice in
the Federal Register stating that the document is available and
specifying the time within which comments may be submitted orally or in
writing on the tentative final regulation. The Commissioner shall mail a
copy of the tentative final regulation and the Federal Register notice
to each person who submitted comments on the proposed regulation if one
has been published.
(7) A final regulation published in the Federal Register that
provides an opportunity for the submission of further comments, in
accordance with paragraph (e)(1) of this section.
(8) Any other public procedure established in this chapter and
expressly applicable to the matter.
(g) The record of the administrative proceeding consists of all of
the following:
(1) If the regulation was initiated by a petition, the
administrative record specified in Sec.10.30(i).
(2) If a petition for reconsideration or for a stay of action is
filed, the administrative record specified in Sec. Sec.10.33(k) and
10.35(h).
(3) The proposed rule published in the Federal Register, including
all information identified or filed by the Commissioner with the
Division of Dockets Management on the proposal.
(4) All comments received on the proposal, including all information
submitted as a part of the comments.
(5) The notice promulgating the final regulation, including all
information identified or filed by the Commissioner with the Division of
Dockets Management as part of the administrative record of the final
regulation.
(6) The transcripts, minutes of meetings, reports, Federal Register
notices, and other documents resulting from the procedures specified in
paragraph (f) of this section, but not the transcript of a closed
portion of a public advisory committee meeting.
(7) All documents submitted to the Division of Dockets Management
under Sec.10.65(h).
(h) The record of the administrative proceeding closes on the date
of publication of the final regulation in the Federal Register unless
some other date is specified. Thereafter, any interested person may
submit a petition for reconsideration under Sec.10.33 or a petition
for stay of action under Sec.10.35. A person who wishes to rely upon
information or views not included in the administrative record shall
submit it to the Commissioner with a new petition to modify the final
regulation.
(i) The Division of Dockets Management shall maintain a
chronological list of all regulations proposed and promulgated under
this section and Sec.10.50 (which list will not include regulations
resulting from petitions filed and assigned a docket number under Sec.
10.30) showing--
[[Page 91]]
(1) The docket number (for a petition submitted directly to a
center, the list also includes the number or other designation assigned
by the center, e.g., the number assigned to a food additive petition);
(2) The name of the petitioner, if any;
(3) The subject matter involved; and
(4) The disposition of the petition.
[44 FR 22323, Apr. 13, 1979, as amended at 52 FR 36401, Sept. 29, 1987;
54 FR 9034, Mar. 3, 1989; 56 FR 13758, Apr. 4, 1991; 62 FR 40592, July
29, 1997; 66 FR 6468, Jan. 22, 2001; 66 FR 12848, Mar. 1, 2001]
Sec.10.45 Court review of final administrative action; exhaustion of
administrative remedies.
(a) This section applies to court review of final administrative
action taken by the Commissioner, including action taken under
Sec. Sec.10.25 through 10.40 and Sec.16.1(b), except action subject
to Sec.10.50 and part 12.
(b) A request that the Commissioner take or refrain from taking any
form of administrative action must first be the subject of a final
administrative decision based on a petition submitted under Sec.
10.25(a) or, where applicable, a hearing under Sec.16.1(b) before any
legal action is filed in a court complaining of the action or failure to
act. If a court action is filed complaining of the action or failure to
act before the submission of the decision on a petition under Sec.
10.25(a) or, where applicable, a hearing under Sec.16.1(b), the
Commissioner shall request dismissal of the court action or referral to
the agency for an initial administrative determination on the grounds of
a failure to exhaust administrative remedies, the lack of final agency
action as required by 5 U.S.C. 701 et seq., and the lack of an actual
controversy as required by 28 U.S.C. 2201.
(c) A request that administrative action be stayed must first be the
subject of an administrative decision based upon a petition for stay of
action submitted under Sec.10.35 before a request is made that a court
stay the action. If a court action is filed requesting a stay of
administrative action before the Commissioner's decision on a petition
submitted in a timely manner pursuant to Sec.10.35, the Commissioner
shall request dismissal of the court action or referral to the agency
for an initial determination on the grounds of a failure to exhaust
administrative remedies, the lack of final agency action as required by
5 U.S.C. 701 et seq., and the lack of an actual controversy as required
by 28 U.S.C. 2201. If a court action is filed requesting a stay of
administrative action after a petition for a stay of action is denied
because it was submitted after expiration of the time period provided
under Sec.10.35, or after the time for submitting such a petition has
expired, the Commissioner will request dismissal of the court action on
the ground of a failure to exhaust administrative remedies.
(d) Unless otherwise provided, the Commissioner's final decision
constitutes final agency action (reviewable in the courts under 5 U.S.C.
701 et seq. and, where appropriate, 28 U.S.C. 2201) on a petition
submitted under Sec.10.25(a), on a petition for reconsideration
submitted under Sec.10.33, on a petition for stay of action submitted
under Sec.10.35, on an advisory opinion issued under Sec.10.85, on a
matter involving administrative action which is the subject of an
opportunity for a hearing under Sec.16.1(b) of this chapter, or on the
issuance of a final regulation published in accordance with Sec.10.40,
except that the agency's response to a petition filed under section
505(j)(2)(C) of the act (21 U.S.C. 355(j)(2)(C)) and Sec.314.93 of
this chapter will not constitute final agency action until any petition
for reconsideration submitted by the petitioner is acted on by the
Commissioner.
(1) It is the position of FDA except as otherwise provided in
paragraph (d)(2) of this section, that:
(i) Final agency action exhausts all administrative remedies and is
ripe for preenforcement judicial review as of the date of the final
decision, unless applicable law explicitly requires that the petitioner
take further action before judicial review is available;
(ii) An interested person is affected by, and thus has standing to
obtain judicial review of final agency action; and
(iii) It is not appropriate to move to dismiss a suit for
preenforcement judicial review of final agency action on the ground that
indispenable parties
[[Page 92]]
are not joined or that it is an unconsented suit against the United
States if the defect could be cured by amending the complaint.
(2) The Commissioner shall object to judicial review of a matter if:
(i) The matter is committed by law to the discretion of the
Commissioner, e.g., a decision to recommend or not to recommend civil or
criminal enforcement action under sections 302, 303, and 304 of the act;
or
(ii) Review is not sought in a proper court.
(e) An interested person may request judicial review of a final
decision of the Commissioner in the courts without first petitioning the
Commissioner for reconsideration or for a stay of action, except that in
accordance with paragraph (c) of this section, the person shall request
a stay by the Commissioner under Sec.10.35 before requesting a stay by
the court.
(f) The Commissioner shall take the position in an action for
judicial review under 5 U.S.C. 701 et seq., whether or not it includes a
request for a declaratory judgment under 28 U.S.C. 2201, or in any other
case in which the validity of administrative action is properly
challenged, that the validity of the action must be determined solely on
the basis of the administrative record specified in Sec. Sec.10.30(i),
10.33(k), 10.35(h), 10.40(g), and 16.80(a) or the administrative record
applicable to any decision or action under the regulations referenced in
Sec.16.1(b), and that additional information or views may not be
considered. An interested person who wishes to rely upon information or
views not included in the administrative record shall submit them to the
Commissioner with a new petition to modify the action under Sec.
10.25(a).
(g) The Commissioner requests that all petitions for judicial review
of a particular matter be filed in a single U.S. District court. If
petitions are filed in more than one jurisdiction, the Commissioner will
take appropriate action to prevent a multiplicity of suits in various
jurisdictions, such as:
(1) A request for transfer of one or more suits to consolidate
separate actions, under 28 U.S.C. 1404(a) or 28 U.S.C. 2112(a);
(2) A request that actions in all but one jurisdiction be stayed
pending the conclusion of one proceeding;
(3) A request that all but one action be dismissed pending the
conclusion of one proceeding, with the suggestion that the other
plaintiffs intervene in that one suit; or
(4) A request that one of the suits be maintained as a class action
in behalf of all affected persons.
(h)(1) For the purpose of 28 U.S.C. 2112(a), a copy of any petition
filed in any U.S. Court of Appeals challenging a final action of the
Commissioner shall be sent by certified mail, return receipt requested,
or by personal delivery to the Chief Counsel of FDA. The petition copy
shall be time-stamped by the clerk of the court when the original is
filed with the court. The petition copy should be addressed to: Office
of the Chief Counsel (GCF-1), Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857. The Chief Counsel requests that the purpose
of all petitions mailed or delivered to the Office of Chief Counsel to
satisfy 28 U.S.C. 2112(a) be clearly identified in a cover letter.
(2) If the Chief Counsel receives two or more petitions filed in two
or more U.S. Courts of Appeals for review of any agency action within 10
days of the effective date of that action for the purpose of judicial
review, the Chief Counsel will notify the U.S. Judicial Panel on
Multidistrict Litigation of any petitions that were received within the
10-day period, in accordance with the applicable rule of the panel.
(3) For the purpose of determining whether a petition for review has
been received within the 10-day period under paragraph (h)(2) of this
section, the petition shall be considered to be received on the date of
delivery, if personally delivered. If the delivery is accomplished by
mail, the date of receipt shall be the date noted on the return receipt
card.
(i) Upon judicial review of administrative action under this
section:
(1) If a court determines that the administrative record is
inadequate to support the action, the Commissioner shall determine
whether to proceed
[[Page 93]]
with such action. (i) If the Commissioner decides to proceed with the
action, the court will be requested to remand the matter to the agency
to reopen the administrative proceeding and record, or on the
Commissioner's own initiative the administrative proceeding and record
may be reopened upon receipt of the court determination. A reopened
administrative proceeding will be conducted under the provisions of this
part and in accordance with any directions of the court.
(ii) If the Commissioner concludes that the public interest requires
that the action remain in effect pending further administrative
proceedings, the court will be requested not to stay the matter in the
interim and the Commissioner shall expedite the further administrative
proceedings.
(2) If a court determines that the administrative record is
adequate, but the rationale for the action must be further explained:
(i) The Commissioner shall request either that further explanation
be provided in writing directly to the court without further
administrative proceedings, or that the administrative proceeding be
reopened in accordance with paragraph (i)(1)(i) of this section; and
(ii) If the Commissioner concludes that the public interest requires
that the action remain in effect pending further court or administrative
proceedings, the court will be requested not to stay the matter in the
interim and the Commissioner shall expedite the further proceedings.
[44 FR 22323, Apr. 13, 1979, as amended at 54 FR 6886, Feb. 15, 1989; 54
FR 9034, Mar. 3, 1989; 57 FR 17980, Apr. 28, 1992; 65 FR 56477, Sept.
19, 2000; 69 FR 31705, June 4, 2004]
Sec.10.50 Promulgation of regulations and orders after an opportunity for a
formal evidentiary public hearing.
(a) The Commissioner shall promulgate regulations and orders after
an opportunity for a formal evidentiary public hearing under part 12
whenever all of the following apply:
(1) The subject matter of the regulation or order is subject by
statute to an opportunity for a formal evidentiary public hearing.
(2) The person requesting the hearing has a right to an opportunity
for a hearing and submits adequate justification for the hearing as
required by Sec. Sec.12.20 through 12.22 and other applicable
provisions in this chapter, e.g., Sec. Sec.314.200, 514.200, and
601.7(a).
(b) The Commissioner may order a formal evidentiary public hearing
on any matter whenever it would be in the public interest to do so.
(c) The provisions of the act, and other laws, that afford a person
who would be adversely affected by administrative action an opportunity
for a formal evidentiary public hearing as listed below. The list
imparts no right to a hearing where the statutory section provides no
opportunity for a hearing.
(1) Section 401 on any action for the amendment or repeal of any
definition and standard of identity for any dairy product (including
products regulated under parts 131, 133, and 135 of this chapter) or
maple sirup (regulated under Sec.168.140 of this chapter).
(2) Section 403(j) on regulations for labeling of foods for special
dietary uses.
(3) Section 404(a) on regulations for emergency permit control.
(4) Section 406 on tolerances for poisonous substances in food.
(5) Section 409 (c), (d), and (h) on food additive regulations.
(6) Section 501(b) on tests or methods of assay for drugs described
in official compendia.
(7) [Reserved]
(8) Section 502(h) on regulations designating requirements for drugs
liable to deterioration.
(9) Section 502(n) on prescription drug advertising regulations.
(10)-(11) [Reserved]
(12) Section 512(n)(5) on regulations for animal antibiotic drugs
and certification requirements.
(13) Section 721 (b) and (c) on regulations for color additive
listing and certification.
(14) Section 4(a) of the Fair Packaging and Labeling Act on food,
drug, device, and cosmetic labeling.
(15) Section 5(c) of the Fair Packaging and Labeling Act on
additional economic regulations for food, drugs, devices, and cosmetics.
[[Page 94]]
(16) Section 505 (d) and (e) on new drug applications.
(17) Section 512 (d), (e) and (m) (3) and (4) on new animal drug
applications.
(18) Section 515(g) on device premarket approval applications and
product development protocols.
(19) Section 351(a) of the Public Health Service Act on a biologics
license for a biological product.
(20) Section 306 on debarment, debarment period and considerations,
termination of debarment under section 306(d)(3), suspension, and
termination of suspension.
[44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9034, Mar. 3, 1989; 58
FR 49190, Sept. 22, 1993; 60 FR 38626, July 27, 1995; 63 FR 26697, May
13, 1998; 64 FR 398, Jan. 5, 1999; 64 FR 56448, Oct. 20, 1999; 67 FR
4906, Feb. 1, 2002]
Sec.10.55 Separation of functions; ex parte communications.
(a) This section applies to any matter subject by statute to an
opportunity for a formal evidentiary public hearing, as listed in Sec.
10.50(c), and any matter subject to a hearing before a Public Board of
Inquiry under part 13.
(b) In the case of a matter listed in Sec.10.50(c) (1) through
(10) and (12) through (15):
(1) An interested person may meet or correspond with any FDA
representative concerning a matter prior to publication of a notice
announcing a formal evidentiary public hearing or a hearing before a
Public Board of Inquiry on the matter; the provisions of Sec.10.65
apply to the meetings and correspondence; and
(2) Upon publication of a notice announcing a formal evidentiary
public hearing or a hearing before a Public Board of Inquiry, the
following separation of functions apply:
(i) The center responsible for the matter is, as a party to the
hearing, responsible for all investigative functions and for
presentation of the position of the center at the hearing and in any
pleading or oral argument before the Commissioner. Representatives of
the center may not participate or advise in any decision except as
witness or counsel in public proceedings. There is to be no other
communication between representatives of the center and representatives
of the office of the Commissioner concerning the matter before the
decision of the Commissioner. The Commissioner may, however, designate
representatives of a center to advise the office of the Commissioner, or
designate members of that office to advise a center. The designation
will be in writing and filed with the Division of Dockets Management no
later than the time specified in paragraph (b)(2) of this section for
the application of separation of functions. All members of FDA other
than representatives of the involved center (except those specifically
designated otherwise) shall be available to advise and participate with
the office of the Commissioner in its functions relating to the hearing
and the final decision.
(ii) The Chief Counsel for FDA shall designate members of the office
of General Counsel to advise and participate with the center in its
functions in the hearing and members who are to advise the office of the
Commissioner in its functions related to the hearing and the final
decision. The members of the office of General Counsel designated to
advise the center may not participate or advise in any decision of the
Commissioner except as counsel in public proceedings. The designation is
to be in the form of a memorandum filed with the Division of Dockets
Management and made a part of the administrative record in the
proceeding. There may be no other communication between those members of
the office of General Counsel designated to advise the office of the
Commissioner and any other persons in the office of General Counsel or
in the involved center with respect to the matter prior to the decision
of the Commissioner. The Chief Counsel may assign new attorneys to
advise either the center or the office of the Commissioner at any stage
of the proceedings. The Chief Counsel will ordinarily advise and
participate with the office of the Commissioner in its functions
relating to the hearing and the final decision.
(iii) The office of the Commissioner is responsible for the agency
review and final decision of the matter, with the advice and
participation of anyone in FDA other than representatives of the
involved center and those members
[[Page 95]]
of the office of General Counsel designated to assist in the center's
functions in the hearing.
(c) In a matter listed in Sec.10.50(c) (11) and (16) through (19),
the provisions relating to separation of functions set forth in
Sec. Sec.314.200(f), 514.200, and 601.7(a) are applicable before
publication of a notice announcing a formal evidentiary public hearing
or a hearing before a Public Board of Inquiry. Following publication of
the notice of hearing, the rules in paragraph (b)(2) of this section
apply.
(d) Except as provided in paragraph (e) of this section, between the
date that separation of functions applies under paragraph (b) or (c) of
this section and the date of the Commissioner's decision on the matter,
communication concerning the matter involved in the hearing will be
restricted as follows:
(1) No person outside the agency may have an ex parte communication
with the presiding officer or any person representing the office of the
Commissioner concerning the matter in the hearing. Neither the presiding
officer nor any person representing the office of the Commissioner may
have any ex parte communication with a person outside the agency
concerning the matter in the hearing. All communications are to be
public communications, as witness or counsel, under the applicable
provisions of this part.
(2) A participant in the hearing may submit a written communication
to the office of the Commissioner with respect to a proposal for
settlement. These communications are to be in the form of pleadings,
served on all other participants, and filed with the Division of Dockets
Management like any other pleading.
(3) A written communication contrary to this section must be
immediately served on all other participants and filed with the Division
of Dockets Management by the presiding officer at the hearing, or by the
Commissioner, depending on who received the communication. An oral
communication contrary to this section must be immediately recorded in a
written memorandum and similarly served on all other participants and
filed with the Division of Dockets Management. A person, including a
representative of a participant in the hearing, who is involved in an
oral communication contrary to this section, must, if possible, be made
available for cross-examination during the hearing with respect to the
substance of that conversation. Rebuttal testimony pertinent to a
written or oral communication contrary to this section will be
permitted. Cross-examination and rebuttal testimony will be transcribed
and filed with the Division of Dockets Management.
(e) The prohibitions specified in paragraph (d) of this section
apply to a person who knows of a notice of hearing in advance of its
publication from the time the knowledge is acquired.
(f) The making of a communication contrary to this section may,
consistent with the interests of justice and the policy of the
underlying statute, result in a decision adverse to the person knowingly
making or causing the making of such a communication.
[44 FR 22323, Apr. 13, 1979, as amended at 50 FR 8994, Mar. 6, 1985; 54
FR 9035, Mar. 3, 1989; 64 FR 398, Jan. 5, 1999]
Sec.10.60 Referral by court.
(a) This section applies when a Federal, State, or local court holds
in abeyance, or refers to the Commissioner, any matter for an initial
administrative determination under Sec.10.25(c) or Sec.10.45(b).
(b) The Commissioner shall promptly agree or decline to accept a
court referral. Whenever feasible in light of agency priorities and
resources, the Commissioner shall agree to accept a referral and shall
proceed to determine the matter referred.
(c) In reviewing the matter, the Commissioner may use the following
procedures:
(1) Conferences, meetings, discussions, and correspondence under
Sec.10.65.
(2) A hearing under parts 12, 13, 14, 15, or 16.
(3) A notice published in the Federal Register requesting
information and views.
(4) Any other public procedure established in other sections of this
chapter and expressly applicable to the matter under those provisions.
(d) If the Commissioner's review of the matter results in a proposed
rule,
[[Page 96]]
the provisions of Sec.10.40 or Sec.10.50 also apply.
Sec.10.65 Meetings and correspondence.
(a) In addition to public hearings and proceedings established under
this part and other sections of this chapter, meetings may be held and
correspondence may be exchanged between representatives of FDA and an
interested person outside FDA on a matter within the jurisdiction of the
laws administered by the Commissioner. Action on meetings and
correspondence does not constitute final administrative action subject
to judicial review under Sec.10.45.
(b) The Commissioner may conclude that it would be in the public
interest to hold an open public meeting to discuss a matter (or class of
matters) pending before FDA, in which any interested person may
participate.
(1) The Commissioner shall inform the public of the time and place
of the meeting and of the matters to be discussed.
(2) The meeting will be informal, i.e., any interested person may
attend and participate in the discussion without prior notice to the
agency unless the notice of the meeting specifies otherwise.
(c) Every person outside the Federal Government may request a
private meeting with a representative of FDA in agency offices to
discuss a matter. FDA will make reasonable efforts to accommodate such
requests.
(1) The person requesting a meeting may be accompanied by a
reasonable number of employees, consultants, or other persons with whom
there is a commercial arrangement within the meaning of Sec.20.81(a)
of this chapter. Neither FDA nor any other person may require the
attendance of a person who is not an employee of the executive branch of
the Federal Government without the agreement of the person requesting
the meeting. Any person may attend by mutual consent of the person
requesting the meeting and FDA.
(2) FDA will determine which representatives of the agency will
attend the meeting. The person requesting the meeting may request, but
not require or preclude, the attendance of a specific FDA employee.
(3) A person who wishes to attend a private meeting, but who is not
invited to attend either by the person requesting the meeting or by FDA,
or who otherwise cannot attend the meeting, may request a separate
meeting with FDA to discuss the same matter or an additional matter.
(d) FDA employees have a responsibility to meet with all segments of
the public to promote the objectives of the laws administered by the
agency. In pursuing this responsibility, the following general policy
applies where agency employees are invited by persons outside the
Federal Government to attend or participate in meetings outside agency
offices as representatives of the agency.
(1) A person outside the executive branch may invite an agency
representative to attend or participate in a meeting outside agency
offices. The agency representative is not obligated to attend or
participate, but may do so where it is in the public interest and will
promote the objectives of the act.
(2) The agency representative may request that the meeting be open
if that would be in the public interest. The agency representative may
decline to participate in a meeting held as a private meeting if that
will best serve the public interest.
(3) An agency representative may not knowingly participate in a
meeting that is closed on the basis of gender, race, or religion.
(e) An official transcript, recording, or memorandum summarizing the
substance of any meeting described in this section will be prepared by a
representative of FDA when the agency determines that such documentation
will be useful.
(f) FDA promptly will file in the appropriate administrative file
memoranda of meetings prepared by FDA representatives and all
correspondence, including any written summary of a meeting from a
participant, that relate to a matter pending before the agency.
(g) Representatives of FDA may initiate a meeting or correspondence
on any matter concerning the laws administered by the Commissioner.
Unless otherwise required by law, meetings may be public or private at
FDA's discretion.
[[Page 97]]
(h) A meeting of an advisory committee is subject to the
requirements of part 14 of this chapter.
[66 FR 6468, Jan. 22, 2001]
Sec.10.70 Documentation of significant decisions in administrative file.
(a) This section applies to every significant FDA decision on any
matter under the laws administered by the Commissioner, whether it is
raised formally, for example, by a petition or informally, for example,
by correspondence.
(b) FDA employees responsible for handling a matter are responsible
for insuring the completeness of the administrative file relating to it.
The file must contain:
(1) Appropriate documentation of the basis for the decision,
including relevant evaluations, reviews, memoranda, letters, opinions of
consultants, minutes of meetings, and other pertinent written documents;
and
(2) The recommendations and decisions of individual employees,
including supervisory personnel, responsible for handling the matter.
(i) The recommendations and decisions are to reveal significant
controversies or differences of opinion and their resolution.
(ii) An agency employee working on a matter and, consistent with the
prompt completion of other assignments, an agency employee who has
worked on a matter may record individual views on that matter in a
written memorandum, which is to be placed in the file.
(c) A written document placed in an administrative file must:
(1) Relate to the factual, scientific, legal or related issues under
consideration;
(2) Be dated and signed by the author;
(3) Be directed to the file, to appropriate supervisory personnel,
and to other appropriate employees, and show all persons to whom copies
were sent;
(4) Avoid defamatory language, intemperate remarks, undocumented
charges, or irrelevant matters (e.g., personnel complaints);
(5) If it records the views, analyses, recommendations, or decisions
of an agency employee in addition to the author, be given to the other
employees; and
(6) Once completed (i.e., typed in final form, dated, and signed)
not be altered or removed. Later additions to or revisions of the
document must be made in a new document.
(d) Memoranda or other documents that are prepared by agency
employees and are not in the administrative file have no status or
effect.
(e) FDA employees working on a matter have access to the
administrative file on that matter, as appropriate for the conduct of
their work. FDA employees who have worked on a matter have access to the
administrative file on that matter so long as attention to their
assignments is not impeded. Reasonable restrictions may be placed upon
access to assure proper cataloging and storage of documents, the
availability of the file to others, and the completeness of the file for
review.
Sec.10.75 Internal agency review of decisions.
(a) A decision of an FDA employee, other than the Commissioner, on a
matter, is subject to review by the employee's supervisor under the
following circumstances:
(1) At the request of the employee.
(2) On the initiative of the supervisor.
(3) At the request of an interested person outside the agency.
(4) As required by delegations of authority.
(b)(1) The review will be made by consultation between the employee
and the supervisor or by review of the administrative file on the
matter, or both. The review will ordinarily follow the established
agency channels of supervision or review for that matter.
(2) A sponsor, applicant, or manufacturer of a drug or device
regulated under the act or the Public Health Service Act (42 U.S.C.
262), may request review of a scientific controversy by an appropriate
scientific advisory panel as described in section 505(n) of the act, or
an advisory committee as described in section 515(g)(2)(B) of the act.
The reason(s) for any denial of a request for such review shall be
briefly set forth in writing to the requester. Persons who receive a
Center denial of their request
[[Page 98]]
under this section may submit a request for review of the denial. The
request should be sent to the Chief Mediator and Ombudsman.
(c) An interested person outside the agency may request internal
agency review of a decision through the established agency channels of
supervision or review. Personal review of these matters by center
directors or the office of the Commissioner will occur for any of the
following purposes:
(1) To resolve an issue that cannot be resolved at lower levels
within the agency (e.g., between two parts of a center or other
component of the agency, between two centers or other components of the
agency, or between the agency and an interested person outside the
agency).
(2) To review policy matters requiring the attention of center or
agency management.
(3) In unusual situations requiring an immediate review in the
public interest.
(4) As required by delegations of authority.
(d) Internal agency review of a decision must be based on the
information in the administrative file. If an interested person presents
new information not in the file, the matter will be returned to the
appropriate lower level in the agency for reevaluation based on the new
information.
[44 FR 22323, Apr. 13, 1979, as amended at 50 FR 8994, Mar. 6, 1985; 63
FR 63982, Nov. 18, 1998]
Sec.10.80 Dissemination of draft Federal Register notices and regulations.
(a) A representative of FDA may discuss orally or in writing with an
interested person ideas and recommendations for notices or regulations.
FDA welcomes assistance in developing ideas for, and in gathering the
information to support, notices and regulations.
(b) Notices and proposed regulations. (1) Once it is determined that
a notice or proposed regulation will be prepared, the general concepts
may be discussed by a representative of FDA with an interested person.
Details of a draft of a notice or proposed regulation may be discussed
with a person outside the executive branch only with the specific
permission of the Commissioner. The permission must be in writing and
filed with the Division of Dockets Management.
(2) A draft of a notice or proposed regulation or its preamble, or a
portion of either, may be furnished to an interested person outside the
executive branch only if it is made available to all interested persons
by a notice published in the Federal Register. A draft of a notice or
proposed regulation made available in this manner may, without the prior
permission of the Commissioner, be discussed with an interested person
to clarify and resolve questions raised and concerns expressed about the
draft.
(c) After publication of a notice or proposed regulation in the
Federal Register, and before preparation of a draft of the final notice
or regulation, a representative of FDA may discuss the proposal with an
interested person as provided in paragraph (b)(2) of this section.
(d) Final notices and regulations. (1) Details of a draft of a final
notice or regulation may be discussed with an interested person outside
the executive branch only with the specific permission of the
Commissioner. The permission must be in writing and filed with the
Division of Dockets Management.
(2) A draft of a final notice or regulation or its preamble, or any
portion of either, may be furnished to an interested person outside the
executive branch only if it is made available to all interested persons
by a notice published in the Federal Register, except as otherwise
provided in paragraphs (g) and (j) of this section. A draft of a final
notice or regulation made available to an interested person in this
manner may, without the prior permission of the Commissioner, be
discussed as provided in paragraph (b)(2) of this section.
(i) The final notice or regulation and its preamble will be prepared
solely on the basis of the administrative record.
(ii) If additional technical information from a person outside the
executive branch is necessary to draft the final notice or regulation or
its preamble, it will be requested by FDA in general terms and furnished
directly to the Division of Dockets Management
[[Page 99]]
to be included as part of the administrative record.
(iii) If direct discussion by FDA of a draft of a final notice or
regulation or its preamble is required with a person outside the
executive branch, appropriate protective procedures will be undertaken
to make certain that a full and impartial administrative record is
established. Such procedures may include either:
(a) The scheduling of an open public meeting under Sec.10.65(b) at
which interested persons may participate in review of and comment on the
draft document; or
(b) The preparation of a tentative final regulation or tentative
revised final regulation under Sec.10.40(f)(6), on which interested
persons will be given an additional period of time for oral and written
comment.
(e) After a final regulation is published, an FDA representative may
discuss any aspect of it with an interested person.
(f) In addition to the requirements of this section, the provisions
of Sec.10.55 apply to the promulgation of a regulation subject to
Sec.10.50 and part 12.
(g) A draft of a final food additive color additive, or new animal
drug regulation may be furnished to the petitioner for comment on the
technical accuracy of the regulation. Every meeting with a petitioner
relating to the draft will be recorded in a written memorandum, and all
memoranda and correspondence will be filed with the Division of Dockets
Management as part of the administrative record of the regulation under
the provisions of Sec.10.65.
(h) In accordance with 42 U.S.C 263f, the Commissioner shall consult
with interested persons and with the Technical Electronic Product
Radiation Safety Standards Committee (TEPRSSC) before prescribing any
performance standard for an electronic product. Accordingly, the
Commissioner shall publish in the Federal Register an announcement when
a proposed or final performance standard, including any amendment, is
being considered for an electronic product, and any draft of any
proposed or final standard will be furnished to an interested person
upon request and may be discussed in detail.
(i) The provisions of Sec.10.65 apply to meetings and
correspondence relating to draft notices and regulations.
(j) The provisions of this section restricting discussion and
disclosure of draft notices and regulations do not apply to situations
covered by Sec. Sec.20.83 through 20.89.
[44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989; 64
FR 398, Jan. 5, 1999]
Sec.10.85 Advisory opinions.
(a) An interested person may request an advisory opinion from the
Commissioner on a matter of general applicability.
(1) The request will be granted whenever feasible.
(2) The request may be denied if:
(i) The request contains incomplete information on which to base an
informed advisory opinion;
(ii) The Commissioner concludes that an advisory opinion cannot
reasonably be given on the matter involved;
(iii) The matter is adequately covered by a prior advisory opinion
or a regulation;
(iv) The request covers a particular product or ingredient or label
and does not raise a policy issue of broad applicability; or
(v) The Commissioner otherwise concludes that an advisory opinion
would not be in the public interest.
(b) A request for an advisory opinion is to be submitted in
accordance with Sec.10.20, is subject to the provisions of Sec.10.30
(c) through (l), and must be in the following form:
(Date)__________________________________________________________________
Division of Dockets Management, Food and Drug Administration,
Department of Health and Human Services, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
Request for Advisory Opinion
The undersigned submits this request for an advisory opinion of the
Commissioner of Food and Drugs with respect to ------ (the general
nature of the matter involved).
A. Issues involved.
(A concise statement of the issues and questions on which an opinion
is requested.)
B. Statement of facts and law.
(A full statement of all facts and legal points relevant to the
request.)
[[Page 100]]
The undersigned certifies that, to the best of his/her knowledge and
belief, this request includes all data, information, and views relevant
to the matter, whether favorable or unfavorable to the position of the
undersigned, which is the subject of the request.
(Signature)_____________________________________________________________
(Person making request)_________________________________________________
(Mailing address)_______________________________________________________
(Telephone number)______________________________________________________
(c) The Commissioner may respond to an oral or written request to
the agency as a request for an advisory opinion, in which case the
request will be filed with the Division of Dockets Management and be
subject to this section.
(d) A statement of policy or interpretation made in the following
documents, unless subsequently repudiated by the agency or overruled by
a court, will constitute an advisory opinion:
(1) Any portion of a Federal Register notice other than the text of
a proposed or final regulation, e.g., a notice to manufacturers or a
preamble to a proposed or final regulation.
(2) Trade Correspondence (T.C. Nos. 1-431 and 1A-8A) issued by FDA
between 1938 and 1946.
(3) Compliance policy guides issued by FDA beginning in 1968 and
codified in the Compliance Policy Guides manual.
(4) Other documents specifically identified as advisory opinions,
e.g., advisory opinions on the performance standard for diagnostic X-ray
systems, issued before July 1, 1975, and filed in a permanent public
file for prior advisory opinions maintained by the Division of Freedom
of Information (ELEM-1029).
(e) An advisory opinion represents the formal position of FDA on a
matter and except as provided in paragraph (f) of this section,
obligates the agency to follow it until it is amended or revoked. The
Commissioner may not recommend legal action against a person or product
with respect to an action taken in conformity with an advisory opinion
which has not been amended or revoked.
(f) In unusual situations involving an immediate and significant
danger to health, the Commissioner may take appropriate civil
enforcement action contrary to an advisory opinion before amending or
revoking the opinion. This action may be taken only with the approval of
the Commissioner, who may not delegate this function. Appropriate
amendment or revocation of the advisory opinion involved will be
expedited.
(g) An advisory opinion may be amended or revoked at any time after
it has been issued. Notice of amendment or revocation will be given in
the same manner as notice of the advisory opinion was originally given
or in the Federal Register, and will be placed on public display as part
of the file on the matter in the office of the Division of Dockets
Management. The Division of Dockets Management shall maintain a separate
chronological index of all advisory opinions filed. The index will
specify the date of the request for the advisory opinion, the date of
the opinion, and identification of the appropriate file.
(h) Action undertaken or completed in conformity with an advisory
opinion which has subsequently been amended or revoked is acceptable to
FDA unless the Commissioner determines that substantial public interest
considerations preclude continued acceptance. Whenever possible, an
amended or revoked advisory opinion will state when action previously
undertaken or completed does not remain acceptable, and any transition
period that may be applicable.
(i) An interested person may submit written comments on an advisory
opinion or modified advisory opinion. Four copies of any comments are to
be sent to the Division of Dockets Management for inclusion in the
public file on the advisory opinion. Individuals may submit only one
copy. Comments will be considered in determining whether further
modification of an advisory opinion is warranted.
(j) An advisory opinion may be used in administrative or court
proceedings to illustrate acceptable and unacceptable procedures or
standards, but not as a legal requirement.
(k) A statement made or advice provided by an FDA employee
constitutes an advisory opinion only if it is issued in writing under
this section. A statement or advice given by an FDA employee orally, or
given in writing but not under this section or Sec.10.90, is an
[[Page 101]]
informal communication that represents the best judgment of that
employee at that time but does not constitute an advisory opinion, does
not necessarily represent the formal position of FDA, and does not bind
or otherwise obligate or commit the agency to the views expressed.
[44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 59
FR 14364, Mar. 28, 1994; 65 FR 56477, Sept. 19, 2000; 76 FR 31469, June
1, 2011]
Sec.10.90 Food and Drug Administration regulations, recommendations, and
agreements.
(a) Regulations. FDA regulations are issued in the Federal Register
under Sec.10.40 or Sec.10.50 and codified in the Code of Federal
Regulations. Regulations may contain provisions that will be enforced as
legal requirements, or which are intended only as guidance documents and
recommendations, or both. The dissemination of draft notices and
regulations is subject to Sec.10.80.
(b) [Reserved]
(c) Recommendations. In addition to the guidance documents subject
to Sec.10.115, FDA often formulates and disseminates recommendations
about matters which are authorized by, but do not involve direct
regulatory action under, the laws administered by the Commissioner,
e.g., model State and local ordinances, or personnel practices for
reducing radiation exposure, issued under 42 U.S.C. 243 and 21 U.S.C.
360ii. These recommendations may, in the discretion of the Commissioner,
be handled under the procedures established in Sec.10.115, except that
the recommendations will be included in a separate public file of
recommendations established by the Division of Dockets Management and
will be separated from the guidance documents in the notice of
availability published in the Federal Register, or be published in the
Federal Register as regulations under paragraph (a) of this section.
(d) Agreements. Formal agreements, memoranda of understanding, or
other similar written documents executed by FDA and another person will
be included in the public file on agreements established by the Division
of Freedom of Information (ELEM-1029) under Sec.20.108. A document not
included in the public file is deemed to be rescinded and has no force
or effect whatever.
[44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989; 65
FR 56477, Sept. 19, 2000; 75 FR 16346, Apr. 1, 2010; 76 FR 31469, June
1, 2011]
Sec.10.95 Participation in outside standard-setting activities.
(a) General. This section applies to participation by FDA employees
in standard-setting activities outside the agency. Standard-setting
activities include matters such as the development of performance
characteristics, testing methodology, manufacturing practices, product
standards, scientific protocols, compliance criteria, ingredient
specifications, labeling, or other technical or policy criteria. FDA
encourages employee participation in outside standard-setting activities
that are in the public interest.
(b) Standard-setting activities by other Federal Government
agencies. (1) An FDA employee may participate in these activities after
approval of the activity under procedures specified in the current
agency Staff Manual Guide.
(2) Approval forms and all pertinent background information
describing the activity will be included in the public file on standard-
setting activities established by the Division of Freedom of Information
(ELEM-1029).
(3) If a member of the public is invited by FDA to present views to,
or to accompany, the FDA employee at a meeting, the invitations will be
extended to a representative sampling of the public, including consumer
groups, industry associations, professional societies, and academic
institutions.
(4) An FDA employee appointed as the liaison representative to an
activity shall refer all requests for information about or participation
in the activity to the group or organization responsible for the
activity.
(c) Standard-setting activities by State and local government
agencies and by United Nations organizations and other international
organizations and foreign governments pursuant to treaty. (1) An FDA
employee may participate in these activities after approval of the
activity under procedures specified in
[[Page 102]]
the current agency Staff Manual Guide.
(2) Approval forms and all pertinent background information
describing the activity will be included in the public file on standard-
setting activities established by the Division of Freedom of Information
(ELEM-1029).
(3) The availability for public disclosure of records relating to
the activity will be governed by part 20.
(4) If a member of the public is invited by FDA to present views to,
or to accompany, the FDA employee at a meeting, the invitation will be
extended to a representative sampling of the public, including consumer
groups, industry associations, professional societies, and academic
institutions.
(5) An FDA employee appointed as the liaison representative to an
activity shall refer all requests for information about or participation
in the activity to the group or organization responsible for the
activity.
(d) Standard-setting activities by private groups and organizations.
(1) An FDA employee may engage in these activities after approval of the
activity under procedures specified in the current agency Staff Manual
Guide. A request for official participation must be made by the group or
organization in writing, must describe the scope of the activity, and
must demonstrate that the minimum standards set out in paragraph (d)(5)
of this section are met. Except as provided in paragraph (d)(7) of this
section, a request that is granted will be the subject of a letter from
the Commissioner or the center director to the organization stating--
(i) Whether participation by the individual will be as a voting or
nonvoting liaison representative;
(ii) That participation by the individual does not connote FDA
agreement with, or endorsement of, any decisions reached; and
(iii) That participation by the individual precludes service as the
deciding official on the standard involved if it should later come
before FDA. The deciding official is the person who signs a document
ruling upon the standard.
(2) The letter requesting official FDA participation, the approval
form, and the Commissioner's or center director's letter, together with
all pertinent background information describing the activities involved,
will be included in the public file on standard-setting activities
established by the Division of Freedom of Information (ELEM-1029).
(3) The availability for public disclosure of records relating to
the activities will be governed by part 20.
(4) An FDA employee appointed as the liaison representative to an
activity shall refer all requests for information about or participation
in the activity to the group or organization responsible for the
activity.
(5) The following minimum standards apply to an outside private
standard-setting activity in which FDA employees participate:
(i) The activity will be based upon consideration of sound
scientific and technological information, will permit revision on the
basis of new information, and will be designed to protect the public
against unsafe, ineffective, or deceptive products or practices.
(ii) The activity and resulting standards will not be designed for
the economic benefit of any company, group, or organization, will not be
used for such antitrust violations as fixing prices or hindering
competition, and will not involve establishment of certification or
specific approval of individual products or services.
(iii) The group or organization responsible for the standard-setting
activity must have a procedure by which an interested person will have
an opportunity to provide information and views on the activity and
standards involved, without the payment of fees, and the information and
views will be considered. How this is accomplished, including whether
the presentation will be in person or in writing, will be decided by the
group or organization responsible for the activity.
(6) Membership of an FDA employee in an organization that also
conducts a standard-setting activity does not invoke the provisions of
this section unless the employee participates in the standard-setting
activity. Participation in a standard-setting activity is subject to
this section.
(7) The Commissioner may determine in writing that, because direct
involvement by FDA in a particular standard-
[[Page 103]]
setting activity is in the public interest and will promote the
objectives of the act and the agency, the participation is exempt from
the requirements of paragraph (d)(1) (ii) and/or (iii) of this section.
This determination will be included in the public file on standard-
setting activities established by the Division of Freedom of Information
(ELEM-1029) and in any relevant administrative file. The activity may
include the establishment and validation of analytical methods for
regulatory use, drafting uniform laws and regulations, and the
development of recommendations concerning public health and preventive
medicine practices by national and international organizations.
(8) Because of the close daily cooperation between FDA and the
associations of State and local government officials listed below in
this paragraph, and the large number of agency employees who are members
of or work with these associations, participation in the activities of
these associations is exempt from paragraphs (d)(1) through (7) of this
section, except that a list of the committees and other groups of these
associations will be included in the public file on standard-setting
activities established by the Division of Freedom of Information (ELEM-
1029).
(i) American Association of Food Hygiene Veterinarians (AAFHV).
(ii) American Public Health Association (APHA).
(iii) Association of American Feed Control Officials, Inc. (AAFCO).
(iv) Association of Food and Drug Officials (AFDO).
(v) AOAC INTERNATIONAL (AOAC).
(vi) Association of State and Territorial Health Officials (ASTHO).
(vii) Conference for Food Protection (CFP).
(viii) Conference of State Health and Environmental Managers
(COSHEM).
(ix) Conference of Radiation Control Program Directors (CRCPD).
(x) International Association of Milk, Food, and Environmental
Sanitation, Inc. (IAMFES).
(xi) Interstate Shellfish Sanitation Conference (ISSC).
(xii) National Association of Boards of Pharmacy (NABP).
(xiii) National Association of Departments of Agriculture (NADA).
(xiv) National Conference on Interstate Milk Shipments (NCIMS).
(xv) National Conference of Local Environmental Health
Administrators (NCLEHA).
(xvi) National Conference on Weights and Measures (NCWW).
(xvii) National Environmental Health Association (NEHA).
(xviii) National Society of Professional Sanitarians (NSPS).
[44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 52
FR 35064, Sept. 17, 1987; 54 FR 9035, Mar. 3, 1989; 70 FR 40880, July
15, 2005; 70 FR 67651, Nov. 8, 2005; 76 FR 31469, June 1, 2011]
Sec.10.100 Public calendar.
(a) Public calendar. A public calendar will be prepared and made
publicly available by FDA each week showing, to the extent feasible,
significant events of the previous week, including significant meetings
with persons outside the executive branch, that involve the
representatives of FDA designated under paragraph (c) of this section.
(1) Public calendar entries will include:
(i) Significant meetings with members of the judiciary,
representatives of Congress, or staffs of congressional committees when
the meeting relates to a pending court case, administrative hearing, or
other regulatory action or decision;
(ii) Significant meetings, conferences, seminars, and speeches; and
(iii) Social events sponsored by the regulated industry.
(2) The public calendar will not include reports of meetings that
would prejudice law enforcement activities (e.g., a meeting with an
informant) or invade privacy (e.g., a meeting with a candidate for
possible employment at FDA), meetings with members of the press, or
meetings with onsite contractors.
(b) Calendar entries. The calendar will specify for each entry the
date, person(s), and subject matter involved. If a large number of
persons are in attendance, the name of each individual need not be
specified. When more than one FDA representative is in attendance, the
most senior agency official
[[Page 104]]
will report the meeting on the public calendar.
(c) Affected persons. The following FDA representatives are subject
to the requirements of this section:
(1) Commissioner of Food and Drugs.
(2) Senior Associate Commissioners.
(3) Deputy Commissioners.
(4) Associate Commissioner for Regulatory Affairs.
(5) Center Directors.
(6) Chief Counsel for the Food and Drug Administration.
(d) Public display. The public calendar will be placed on public
display at the following locations:
(1) Division of Dockets Management.
(2) Office of the Associate Commissioner for Public Affairs.
(3) The FDA home page, to the extent feasible.
[66 FR 6468, Jan. 22, 2001]
Sec.10.105 Representation by an organization.
(a) An organization may represent its members by filing petitions,
comments, and objections, and otherwise participating in an
administrative proceeding subject to this part.
(b) A petition, comment, objection, or other representation by an
organization will not abridge the right of a member to take individual
action of a similar type, in the member's own name.
(c) It is requested that each organization participating in FDA
administrative proceedings file annually with the Division of Dockets
Management a current list of all of the members of the organization.
(d) The filing by an organization of an objection or request for
hearing under Sec. Sec.12.20 through 12.22 does not provide a member a
legal right with respect to the objection or request for hearing that
the member may individually exercise. A member of an organization
wishing to file an objection or request for hearing must do so
individually.
(e) In a court proceeding in which an organization participates, the
Commissioner will take appropriate legal measures to have the case
brought or considered as a class action or otherwise as binding upon all
members of the organization except those specifically excluded by name.
Regardless of whether the case is brought or considered as a class
action or as otherwise binding upon all members of the organization
except those specifically excluded by name, the Commissioner will take
the position in any subsequent suit involving the same issues and a
member of the organization that the issues are precluded from further
litigation by the member under the doctrines of collateral estoppel or
res judicata.
Sec.10.110 Settlement proposals.
At any time in the course of a proceeding subject to this part, a
person may propose settlement of the issues involved. A participant in a
proceeding will have an opportunity to consider a proposed settlement.
Unaccepted proposals of settlement and related matters, e.g., proposed
stipulations not agreed to, will not be admissible in evidence in an FDA
administrative proceeding. FDA will oppose the admission in evidence of
settlement information in a court proceeding or in another
administrative proceeding.
Sec.10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices
(GGP's) are FDA's policies and procedures for developing, issuing, and
using guidance documents.
(b) What is a guidance document? (1) Guidance documents are
documents prepared for FDA staff, applicants/sponsors, and the public
that describe the agency's interpretation of or policy on a regulatory
issue.
(2) Guidance documents include, but are not limited to, documents
that relate to: The design, production, labeling, promotion,
manufacturing, and testing of regulated products; the processing,
content, and evaluation or approval of submissions; and inspection and
enforcement policies.
(3) Guidance documents do not include: Documents relating to
internal FDA procedures, agency reports, general information documents
provided to consumers or health professionals, speeches, journal
articles and editorials, media interviews, press materials, warning
letters, memoranda of
[[Page 105]]
understanding, or other communications directed to individual persons or
firms.
(c) What other terms have a special meaning? (1) ``Level 1 guidance
documents'' include guidance documents that:
(i) Set forth initial interpretations of statutory or regulatory
requirements;
(ii) Set forth changes in interpretation or policy that are of more
than a minor nature;
(iii) Include complex scientific issues; or
(iv) Cover highly controversial issues.
(2) ``Level 2 guidance documents'' are guidance documents that set
forth existing practices or minor changes in interpretation or policy.
Level 2 guidance documents include all guidance documents that are not
classified as Level 1.
(3) ``You'' refers to all affected parties outside of FDA.
(d) Are you or FDA required to follow a guidance document? (1) No.
Guidance documents do not establish legally enforceable rights or
responsibilities. They do not legally bind the public or FDA.
(2) You may choose to use an approach other than the one set forth
in a guidance document. However, your alternative approach must comply
with the relevant statutes and regulations. FDA is willing to discuss an
alternative approach with you to ensure that it complies with the
relevant statutes and regulations.
(3) Although guidance documents do not legally bind FDA, they
represent the agency's current thinking. Therefore, FDA employees may
depart from guidance documents only with appropriate justification and
supervisory concurrence.
(e) Can FDA use means other than a guidance document to communicate
new agency policy or a new regulatory approach to a broad public
audience? The agency may not use documents or other means of
communication that are excluded from the definition of guidance document
to informally communicate new or different regulatory expectations to a
broad public audience for the first time. These GGP's must be followed
whenever regulatory expectations that are not readily apparent from the
statute or regulations are first communicated to a broad public
audience.
(f) How can you participate in the development and issuance of
guidance documents? (1) You can provide input on guidance documents that
FDA is developing under the procedures described in paragraph (g) of
this section.
(2) You can suggest areas for guidance document development. Your
suggestions should address why a guidance document is necessary.
(3) You can submit drafts of proposed guidance documents for FDA to
consider. When you do so, you should mark the document ``Guidance
Document Submission'' and submit it to Division of Dockets Management
(HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
(4) You can, at any time, suggest that FDA revise or withdraw an
already existing guidance document. Your suggestion should address why
the guidance document should be revised or withdrawn and, if applicable,
how it should be revised.
(5) Once a year, FDA will publish, both in the Federal Register and
on the Internet, a list of possible topics for future guidance document
development or revision during the next year. You can comment on this
list (e.g., by suggesting alternatives or making recommendations on the
topics that FDA is considering).
(6) To participate in the development and issuance of guidance
documents through one of the mechanisms described in paragraphs (f)(1),
(f)(2), or (f)(4) of this section, you should contact the center or
office that is responsible for the regulatory activity covered by the
guidance document.
(7) If FDA agrees to draft or revise a guidance document, under a
suggestion made under paragraphs (f)(1), (f)(2), (f)(3) or (f)(4) of
this section, you can participate in the development of that guidance
document under the procedures described in paragraph (g) of this
section.
(g) What are FDA's procedures for developing and issuing guidance
documents? (1) FDA's procedures for the development and issuance of
Level 1 guidance documents are as follows:
[[Page 106]]
(i) Before FDA prepares a draft of a Level 1 guidance document, FDA
can seek or accept early input from individuals or groups outside the
agency. For example, FDA can do this by participating in or holding
public meetings and workshops.
(ii) After FDA prepares a draft of a Level 1 guidance document, FDA
will:
(A) Publish a notice in the Federal Register announcing that the
draft guidance document is available;
(B) Post the draft guidance document on the Internet and make it
available in hard copy; and
(C) Invite your comment on the draft guidance document. Paragraph
(h) of this section tells you how to submit your comments.
(iii) After FDA prepares a draft of a Level 1 guidance document, FDA
also can:
(A) Hold public meetings or workshops; or
(B) Present the draft guidance document to an advisory committee for
review.
(iv) After providing an opportunity for public comment on a Level 1
guidance document, FDA will:
(A) Review any comments received and prepare the final version of
the guidance document that incorporates suggested changes, when
appropriate;
(B) Publish a notice in the Federal Register announcing that the
guidance document is available;
(C) Post the guidance document on the Internet and make it available
in hard copy; and
(D) Implement the guidance document.
(v) After providing an opportunity for comment, FDA may decide that
it should issue another draft of the guidance document. In this case,
FDA will follow the steps in paragraphs (g)(1)(ii), (g)(1)(iii), and
(g)(1)(iv) of this section.
(2) FDA will not seek your comment before it implements a Level 1
guidance document if the agency determines that prior public
participation is not feasible or appropriate.
(3) FDA will use the following procedures for developing and issuing
Level 1 guidance documents under the circumstances described in
paragraph (g)(2) of this section:
(i) After FDA prepares a guidance document, FDA will:
(A) Publish a notice in the Federal Register announcing that the
guidance document is available;
(B) Post the guidance document on the Internet and make it available
in hard copy;
(C) Immediately implement the guidance document; and
(D) Invite your comment when it issues or publishes the guidance
document. Paragraph (h) of this section tells you how to submit your
comments.
(ii) If FDA receives comments on the guidance document, FDA will
review those comments and revise the guidance document when appropriate.
(4) FDA will use the following procedures for developing and issuing
Level 2 guidance documents:
(i) After it prepares a guidance document, FDA will:
(A) Post the guidance document on the Internet and make it available
in hard copy;
(B) Immediately implement the guidance document, unless FDA
indicates otherwise when the document is made available; and
(C) Invite your comment on the Level 2 guidance document. Paragraph
(h) of this section tells you how to submit your comments.
(ii) If FDA receives comments on the guidance document, FDA will
review those comments and revise the document when appropriate. If a
version is revised, the new version will be placed on the Internet.
(5) You can comment on any guidance document at any time. Paragraph
(h) of this section tells you how to submit your comments. FDA will
revise guidance documents in response to your comments when appropriate.
(h) How should you submit comments on a guidance document? (1) If
you choose to submit comments on any guidance document under paragraph
(g) of this section, you must send them to the Division of Dockets
Management (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
(2) Comments should identify the docket number on the guidance
document, if such a docket number exists.
[[Page 107]]
For documents without a docket number, the title of the guidance
document should be included.
(3) Comments will be available to the public in accordance with
FDA's regulations on submission of documents to the Division of Dockets
Management specified in Sec.10.20(j).
(i) What standard elements must FDA include in a guidance document?
(1) A guidance document must:
(i) Include the term ``guidance,''
(ii) Identify the center(s) or office(s) issuing the document,
(iii) Identify the activity to which and the people to whom the
document applies,
(iv) Prominently display a statement of the document's nonbinding
effect,
(v) Include the date of issuance,
(vi) Note if it is a revision to a previously issued guidance and
identify the document that it replaces, and
(vii) Contain the word ``draft'' if the document is a draft
guidance.
(2) Guidance documents must not include mandatory language such as
``shall,'' ``must,'' ``required,'' or ``requirement,'' unless FDA is
using these words to describe a statutory or regulatory requirement.
(3) When issuing draft guidance documents that are the product of
international negotiations (e.g., guidances resulting from the
International Conference on Harmonisation), FDA need not apply
paragraphs (i)(1) and (i)(2) of this section. However, any final
guidance document issued according to this provision must contain the
elements in paragraphs (i)(1) and (i)(2) of this section.
(j) Who, within FDA, can approve issuance of guidance documents?
Each center and office must have written procedures for the approval of
guidance documents. Those procedures must ensure that issuance of all
documents is approved by appropriate senior FDA officials.
(k) How will FDA review and revise existing guidance documents? (1)
The agency will periodically review existing guidance documents to
determine whether they need to be changed or withdrawn.
(2) When significant changes are made to the statute or regulations,
the agency will review and, if appropriate, revise guidance documents
relating to that changed statute or regulation.
(3) As discussed in paragraph (f)(3) of this section, you may at any
time suggest that FDA revise a guidance document.
(l) How will FDA ensure that FDA staff are following GGP's? (1) All
current and new FDA employees involved in the development, issuance, or
application of guidance documents will be trained regarding the agency's
GGP's.
(2) FDA centers and offices will monitor the development and
issuance of guidance documents to ensure that GGP's are being followed.
(m) How can you get copies of FDA's guidance documents? FDA will
make copies available in hard copy and, as feasible, through the
Internet.
(n) How will FDA keep you informed of the guidance documents that
are available? (1) FDA will maintain on the Internet a current list of
all guidance documents. New documents will be added to this list within
30 days of issuance.
(2) Once a year, FDA will publish in the Federal Register its
comprehensive list of guidance documents. The comprehensive list will
identify documents that have been added to the list or withdrawn from
the list since the previous comprehensive list.
(3) FDA's guidance document lists will include the name of the
guidance document, issuance and revision dates, and information on how
to obtain copies of the document.
(o) What can you do if you believe that someone at FDA is not
following these GGP's? If you believe that someone at FDA did not follow
the procedures in this section or that someone at FDA treated a guidance
document as a binding requirement, you should contact that person's
supervisor in the center or office that issued the guidance document. If
the issue cannot be resolved, you should contact the next highest
supervisor. You can also contact the center or office ombudsman for
assistance in resolving the issue. If you are unable to resolve the
issue at the center or office level or if you feel that you are not
making progress by going through the chain of command, you may ask the
[[Page 108]]
Office of the Chief Mediator and Ombudsman to become involved.
[65 FR 56477, Sept. 19, 2000]
Subpart C_Electronic Media Coverage of Public Administrative
Proceedings; Guideline on Policy and Procedures
Source: 49 FR 14726, Apr. 13, 1984, unless otherwise noted.
Sec.10.200 Scope.
This guideline describes FDA's policy and procedures applicable to
electronic media coverage of agency public administrative proceedings.
It is a guideline intended to clarify and explain FDA's policy on the
presence and operation of electronic recording equipment at such
proceedings and to assure uniform and consistent application of
practices and procedures throughout the agency.
Sec.10.203 Definitions.
(a) Public administrative proceeding as used in this guideline means
any FDA proceeding which the public has a right to attend. This includes
a formal evidentiary public hearing as set forth in part 12, a public
hearing before a Public Board of Inquiry as set forth in part 13, a
public hearing before a Public Advisory Committee as set forth in part
14, a public hearing before the Commissioner as set forth in part 15, a
regulatory hearing before FDA as set forth in part 16, consumer exchange
meetings, and Commissioner's public meetings with health professionals.
(b) Advance notice as used in this guideline means written or
telephone notification to FDA's Office of Public Affairs (Press
Relations Staff) of intent to electronically record an agency public
administrative proceeding.
(c) Electronic recording as used in this guideline means any visual
or audio recording made by videotape recording equipment or moving film
camera, and/or other electronic recording equipment.
[49 FR 14726, Apr. 13, 1984, as amended at 54 FR 9035, Mar. 3, 1989]
Sec.10.204 General.
(a) FDA has for many years willingly committed itself to a policy of
openness. In many instances FDA has sought to make the open portions of
agency public administrative proceedings more accessible to public
participation. Similarly, FDA has sought, wherever possible, to allow
full written media access to its proceedings, so that members of the
press would have the opportunity to provide first-hand reports. However,
because electronic media coverage presents certain difficulties that are
easier to resolve with advance notice to the agency and all
participants, FDA believes that codification of its policy will
facilitate and further increase media access to its public
administrative proceedings. The agency intends to refer to this
guideline when notices of hearing, or individual advisory committee
meetings, are published in the Federal Register. Thus, all parties to a
proceeding will be on notice that the proceeding may be recorded
electronically and any person interested in videotaping or otherwise
recording the proceeding will be notified that there are established
procedures to be followed.
(b) The designated presiding officer of a public administrative
proceeding retains the existing discretionary authority set forth in
specific regulations pertaining to each type of administrative
proceeding to regulate the conduct of the proceeding over which he or
she presides. The responsibilities of the presiding officer, established
elsewhere in parts 10 through 16, include an obligation to be concerned
with the timely conduct of a hearing, the limited availability of
certain witnesses, and reducing disruptions to the proceeding which may
occur. Each proceeding varies, and the presiding officer cannot
anticipate all that might occur. Discretionary authority to regulate
conduct at a proceeding has traditionally been granted to presiding
officers to enable them to fulfill their responsibility to maintain a
fair and orderly hearing conducted in an expeditious manner.
(c) This guideline provides the presiding officer with a degree of
flexibility in that it sets forth the agency's policy as well as the
procedures that
[[Page 109]]
presiding officers should ordinarily follow, but from which they may
depart in particular situations if necessary, subject to the presumption
of openness of public proceedings to electronic media coverage. The
presiding officer's discretion to establish additional procedures or to
limit electronic coverage is to be exercised only in the unusual
circumstances defined in this guideline. Even though a presiding officer
may establish additional procedures or limits as may be required in a
particular situation, he or she will be guided by the policy expressed
in this guideline in establishing these conditions. The presiding
officer may also be less restrictive, taking into account such factors
as the duration of a hearing and the design of the room.
(d) If a portion or all of a proceeding is closed to the public
because material is to be discussed that is not disclosable to the
public under applicable laws, the proceeding also will be closed to
electronic media coverage.
(e) The agency requests advance notice of intent to record a
proceeding electronically to facilitate the orderly conduct of the
proceeding. Knowledge of anticipated media coverage will allow the
presiding officer to make any special arrangements required by the
circumstances of the proceeding. The agency believes that this guideline
establishes sufficiently specific criteria to promote uniformity.
(f) The agency would like to allow all interested media
representatives to videotape a proceeding in which they have an
interest. However, should space limitations preclude a multitude of
cameras, the presiding officer may require pool sharing. In such a case,
pool sharing arrangements of the resulting videotape should be made
between those allowed to film and those who were excluded. Arrangements
for who is designated to present the pool and a method of distributing
the resulting film or tape may be determined by the established
networks' pooling system. However, the agency has a strong commitment to
ensuring that media representatives other than the major networks also
be able to obtain a copy of the tape at cost. FDA is concerned that if
the network pool representative wishes to record only a short portion of
a proceeding, but an excluded party wishes to record the entire
proceeding, confusion will result. The agency expects the interested
media representatives to negotiate a suitable agreement among themselves
before commencement of the proceeding. For example, the network pool
representatives might agree to record a portion of the proceeding up to
a break in the proceeding, at which time, while the network
representative is disassembling equipment, another media representative
might set up to continue recording. If an agreement cannot be reached
before the proceeding, the agency will use the time of receipt of any
advance notice to determine the representation for each category of
media, e.g., one network reporter, one independent reporter. The agency
recommends that parties intending to videotape provide as much advance
notice as possible, so that the agency may best respond to the needs of
the electronic media.
(g) To ensure the timely conduct of agency hearings and to prevent
disruptions, equipment is to be stationary during a proceeding and
should be set up and taken down when the proceeding is not in progress.
As noted previously, the presiding officer may, at his or her
discretion, be less restrictive if appropriate.
(h) The agency recognizes that electronic media representatives may
desire only short footage of a proceeding, a facsimile of the
proceeding, and/or interview opportunities and may be unnecessarily
restricted by requirements for setting up before a proceeding and then
waiting until a break in the proceeding before being permitted to take
down their equipment. To accommodate this possibility, FDA's Press
Relations Staff will attempt to make arrangements to respond to such
needs by, for example, requesting that the presiding officer provide a
break shortly after commencement of the proceeding to permit take down
of equipment.
(i) The agency is making a full commitment to allowing, whenever
possible, electronic coverage of its public administrative proceedings
subject to the limited restrictions established in this guideline.
[[Page 110]]
Sec.10.205 Electronic media coverage of public administrative proceedings.
(a) A person may record electronically any open public
administrative proceeding, subject to the procedures specified in this
guideline. The procedures include a presumption that agency public
proceedings are open to the electronic media. Whenever possible, FDA
will permit all interested persons access to record agency public
administrative proceedings. Restrictions other than those listed in
Sec.10.206 will be imposed only under exceptional circumstances.
(b) A videotape recording of an FDA public administrative proceeding
is not an official record of the proceeding. The only official record is
the written transcript of the proceeding, which is taken by the official
reporter.
Sec.10.206 Procedures for electronic media coverage of agency public
administrative proceedings.
(a) To facilitate the agency's response to media needs, a person
intending to videotape an FDA public administrative proceeding should,
whenever possible, provide advance notice to the Press Relations Staff
(HFI-20), Office of Public Affairs, Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, in writing or by telephone (telephone
301-443-4177), at least 48 hours in advance of the proceeding. The Press
Relations Staff will inform the presiding officer that the proceeding
will be attended by representatives of the electronic media, and
ascertain whether any special provisions in addition to those set forth
in this subpart are required by the presiding officer. If so, the Press
Relations Staff will function as a liaison between the presiding officer
and the person intending to record the proceeding in facilitating any
procedures in addition to those outlined in this subpart. The presiding
officer will not deny access for failure to provide a 48-hour advance
notice. Any advance notice may describe the intended length of recording
if known, the amount and type of equipment to be used, and any special
needs such as interviews.
(b) Cameras should be completely set up before a proceeding is
scheduled to begin or during a break in the proceeding and should remain
standing in the area designated for electronic media equipment. Cameras
may be taken down only during breaks or after the hearing is over.
Roving cameras will not be permitted during the proceeding. Any
artificial lighting should be unobtrusive. Microphones, like cameras,
should be in place before the start of a proceeding and may be taken
down as indicated in this paragraph.
(c) When space in the hearing room is limited, the presiding officer
may restrict the number of cameras or the equipment present. Should such
a restriction become necessary, the pool arrangements are the
responsibility of the participating media. The agency encourages the
network pool to make copies of the tape, film, or other product
available at cost to nonpool participants. However, if this is not
possible, the agency may need to use the time of receipt of any advance
notice to determine the representation for each category, e.g., one
network reporter, one independent reporter, etc.
(d) Off the record portions of a proceeding may not be videotaped.
(e) Before or during the proceeding, the presiding officer may
establish other conditions specific to the proceeding for which the
request is being made. These conditions may be more or less restrictive
than those stated in this guideline, except that the presiding officer
shall observe the agency's presumption of openness of its public
proceedings to the electronic media. Only a substantial and clear threat
to the agency's interests in order, fairness, and timeliness authorizes
the presiding officer to impose additional restrictions. This threat
must outweigh the public interest in electronic media coverage of agency
proceedings. Additional restrictions shall be narrowly drawn to the
particular circumstances. The following factors are listed to assist
presiding officers in determining whether the agency's interest is
sufficiently compelling to call for the unusual step of imposing
additional restrictions. Generally this step is justified when one of
the following factors is met:
(1) Electronic recording would result in a substantial likelihood of
disruption that clearly cannot be contained
[[Page 111]]
by the procedures established in paragraphs (a) through (d) of this
section.
(2) Electronic recording would result in a substantial likelihood of
prejudicial impact on the fairness of the proceeding or the substantive
discussion in a proceeding.
(3) There is a substantial likelihood that a witness' ability to
testify may be impaired due to unique personal circumstances such as the
age or psychological state of the witness or the particularly personal
or private nature of the witness' testimony, if the witness' testimony
were electronically recorded.
(f) Before the proceeding, the Press Relations Staff will, upon
request, provide written copies of any additional conditions imposed by
the presiding officer (as described in paragraph (e) of this section) to
requesting members of the media. Any appeals should be made in
accordance with paragraph (h) of this section.
(g) The presiding officer retains authority to restrict or
discontinue videotaping or other recording of a proceeding, or parts of
a proceeding, should such a decision become necessary. The presiding
officer's responsibility to conduct the hearing includes the right and
duty to remove a source of substantial disruption. In exercising his or
her authority, the presiding officer shall observe the presumption that
agency public proceedings are open to the electronic media. The
presiding officer shall exercise his or her discretion to restrict or
discontinue electronic coverage of a public proceeding, or portions of a
public proceeding, only if he or she determines that the agency's
interest in the fair and orderly administrative process is substantially
threatened. A clear and substantial threat to the integrity of agency
proceedings must clearly outweigh the public interest in electronic
media coverage of the proceedings before additional restrictions are
imposed on the electronic media during the course of the proceedings.
The factors noted in paragraph (e) of this section indicate the kind of
substantial threat to the agency interests that may require imposing
additional restrictions during the course of the proceedings. If
additional requirements are established during the hearing, the
presiding officer shall notify immediately the Deputy Commissioner of
Food and Drugs of that fact by telephone and submit a written
explanation of the circumstances that necessitated such an action within
24 hours or sooner if requested by the Deputy Commissioner. In the
absence or unavailability of the Deputy Commissioner, the presiding
officer shall notify the Associate Commissioner for Regulatory Affairs.
(h) A decision by a presiding officer, made either before the
proceeding or during the course of a proceeding, to establish
requirements in addition to the minimum standards set forth in this
guideline may be appealed by any adversely affected person who intends
to record the proceeding electronically. Appeals may be made in writing
or by phone to the Deputy Commissioner or, in his or her absence, to the
Associate Commissioner for Regulatory Affairs. The filing of an appeal,
whether before or during a proceeding, does not require the presiding
officer to interrupt the proceeding. However, the Deputy Commissioner
or, in his or her absence, the Associate Commissioner for Regulatory
Affairs will resolve an appeal as expeditiously as possible so as to
preserve, to the extent possible, the reporters' opportunity to record
the proceedings.
[49 FR 14726, Apr. 13, 1984, as amended at 54 FR 9035, Mar. 3, 1989]
PART 11_ELECTRONIC RECORDS; ELECTRONIC SIGNATURES--Table of Contents
Subpart A_General Provisions
Sec.
11.1 Scope.
11.2 Implementation.
11.3 Definitions.
Subpart B_Electronic Records
11.10 Controls for closed systems.
11.30 Controls for open systems.
11.50 Signature manifestations.
11.70 Signature/record linking.
Subpart C_Electronic Signatures
11.100 General requirements.
11.200 Electronic signature components and controls.
11.300 Controls for identification codes/passwords.
[[Page 112]]
Authority: 21 U.S.C. 321-393; 42 U.S.C. 262.
Source: 62 FR 13464, Mar. 20, 1997, unless otherwise noted.
Subpart A_General Provisions
Sec.11.1 Scope.
(a) The regulations in this part set forth the criteria under which
the agency considers electronic records, electronic signatures, and
handwritten signatures executed to electronic records to be trustworthy,
reliable, and generally equivalent to paper records and handwritten
signatures executed on paper.
(b) This part applies to records in electronic form that are
created, modified, maintained, archived, retrieved, or transmitted,
under any records requirements set forth in agency regulations. This
part also applies to electronic records submitted to the agency under
requirements of the Federal Food, Drug, and Cosmetic Act and the Public
Health Service Act, even if such records are not specifically identified
in agency regulations. However, this part does not apply to paper
records that are, or have been, transmitted by electronic means.
(c) Where electronic signatures and their associated electronic
records meet the requirements of this part, the agency will consider the
electronic signatures to be equivalent to full handwritten signatures,
initials, and other general signings as required by agency regulations,
unless specifically excepted by regulation(s) effective on or after
August 20, 1997.
(d) Electronic records that meet the requirements of this part may
be used in lieu of paper records, in accordance with Sec.11.2, unless
paper records are specifically required.
(e) Computer systems (including hardware and software), controls,
and attendant documentation maintained under this part shall be readily
available for, and subject to, FDA inspection.
(f) This part does not apply to records required to be established
or maintained by Sec. Sec.1.326 through 1.368 of this chapter. Records
that satisfy the requirements of part 1, subpart J of this chapter, but
that also are required under other applicable statutory provisions or
regulations, remain subject to this part.
[62 FR 13464, Mar. 20, 1997, as amended at 69 FR 71655, Dec. 9, 2004]
Sec.11.2 Implementation.
(a) For records required to be maintained but not submitted to the
agency, persons may use electronic records in lieu of paper records or
electronic signatures in lieu of traditional signatures, in whole or in
part, provided that the requirements of this part are met.
(b) For records submitted to the agency, persons may use electronic
records in lieu of paper records or electronic signatures in lieu of
traditional signatures, in whole or in part, provided that:
(1) The requirements of this part are met; and
(2) The document or parts of a document to be submitted have been
identified in public docket No. 92S-0251 as being the type of submission
the agency accepts in electronic form. This docket will identify
specifically what types of documents or parts of documents are
acceptable for submission in electronic form without paper records and
the agency receiving unit(s) (e.g., specific center, office, division,
branch) to which such submissions may be made. Documents to agency
receiving unit(s) not specified in the public docket will not be
considered as official if they are submitted in electronic form; paper
forms of such documents will be considered as official and must
accompany any electronic records. Persons are expected to consult with
the intended agency receiving unit for details on how (e.g., method of
transmission, media, file formats, and technical protocols) and whether
to proceed with the electronic submission.
Sec.11.3 Definitions.
(a) The definitions and interpretations of terms contained in
section 201 of the act apply to those terms when used in this part.
(b) The following definitions of terms also apply to this part:
(1) Act means the Federal Food, Drug, and Cosmetic Act (secs. 201-
903 (21 U.S.C. 321-393)).
[[Page 113]]
(2) Agency means the Food and Drug Administration.
(3) Biometrics means a method of verifying an individual's identity
based on measurement of the individual's physical feature(s) or
repeatable action(s) where those features and/or actions are both unique
to that individual and measurable.
(4) Closed system means an environment in which system access is
controlled by persons who are responsible for the content of electronic
records that are on the system.
(5) Digital signature means an electronic signature based upon
cryptographic methods of originator authentication, computed by using a
set of rules and a set of parameters such that the identity of the
signer and the integrity of the data can be verified.
(6) Electronic record means any combination of text, graphics, data,
audio, pictorial, or other information representation in digital form
that is created, modified, maintained, archived, retrieved, or
distributed by a computer system.
(7) Electronic signature means a computer data compilation of any
symbol or series of symbols executed, adopted, or authorized by an
individual to be the legally binding equivalent of the individual's
handwritten signature.
(8) Handwritten signature means the scripted name or legal mark of
an individual handwritten by that individual and executed or adopted
with the present intention to authenticate a writing in a permanent
form. The act of signing with a writing or marking instrument such as a
pen or stylus is preserved. The scripted name or legal mark, while
conventionally applied to paper, may also be applied to other devices
that capture the name or mark.
(9) Open system means an environment in which system access is not
controlled by persons who are responsible for the content of electronic
records that are on the system.
Subpart B_Electronic Records
Sec.11.10 Controls for closed systems.
Persons who use closed systems to create, modify, maintain, or
transmit electronic records shall employ procedures and controls
designed to ensure the authenticity, integrity, and, when appropriate,
the confidentiality of electronic records, and to ensure that the signer
cannot readily repudiate the signed record as not genuine. Such
procedures and controls shall include the following:
(a) Validation of systems to ensure accuracy, reliability,
consistent intended performance, and the ability to discern invalid or
altered records.
(b) The ability to generate accurate and complete copies of records
in both human readable and electronic form suitable for inspection,
review, and copying by the agency. Persons should contact the agency if
there are any questions regarding the ability of the agency to perform
such review and copying of the electronic records.
(c) Protection of records to enable their accurate and ready
retrieval throughout the records retention period.
(d) Limiting system access to authorized individuals.
(e) Use of secure, computer-generated, time-stamped audit trails to
independently record the date and time of operator entries and actions
that create, modify, or delete electronic records. Record changes shall
not obscure previously recorded information. Such audit trail
documentation shall be retained for a period at least as long as that
required for the subject electronic records and shall be available for
agency review and copying.
(f) Use of operational system checks to enforce permitted sequencing
of steps and events, as appropriate.
(g) Use of authority checks to ensure that only authorized
individuals can use the system, electronically sign a record, access the
operation or computer system input or output device, alter a record, or
perform the operation at hand.
(h) Use of device (e.g., terminal) checks to determine, as
appropriate, the validity of the source of data input or operational
instruction.
(i) Determination that persons who develop, maintain, or use
electronic record/electronic signature systems have the education,
training, and experience to perform their assigned tasks.
[[Page 114]]
(j) The establishment of, and adherence to, written policies that
hold individuals accountable and responsible for actions initiated under
their electronic signatures, in order to deter record and signature
falsification.
(k) Use of appropriate controls over systems documentation
including:
(1) Adequate controls over the distribution of, access to, and use
of documentation for system operation and maintenance.
(2) Revision and change control procedures to maintain an audit
trail that documents time-sequenced development and modification of
systems documentation.
Sec.11.30 Controls for open systems.
Persons who use open systems to create, modify, maintain, or
transmit electronic records shall employ procedures and controls
designed to ensure the authenticity, integrity, and, as appropriate, the
confidentiality of electronic records from the point of their creation
to the point of their receipt. Such procedures and controls shall
include those identified in Sec.11.10, as appropriate, and additional
measures such as document encryption and use of appropriate digital
signature standards to ensure, as necessary under the circumstances,
record authenticity, integrity, and confidentiality.
Sec.11.50 Signature manifestations.
(a) Signed electronic records shall contain information associated
with the signing that clearly indicates all of the following:
(1) The printed name of the signer;
(2) The date and time when the signature was executed; and
(3) The meaning (such as review, approval, responsibility, or
authorship) associated with the signature.
(b) The items identified in paragraphs (a)(1), (a)(2), and (a)(3) of
this section shall be subject to the same controls as for electronic
records and shall be included as part of any human readable form of the
electronic record (such as electronic display or printout).
Sec.11.70 Signature/record linking.
Electronic signatures and handwritten signatures executed to
electronic records shall be linked to their respective electronic
records to ensure that the signatures cannot be excised, copied, or
otherwise transferred to falsify an electronic record by ordinary means.
Subpart C_Electronic Signatures
Sec.11.100 General requirements.
(a) Each electronic signature shall be unique to one individual and
shall not be reused by, or reassigned to, anyone else.
(b) Before an organization establishes, assigns, certifies, or
otherwise sanctions an individual's electronic signature, or any element
of such electronic signature, the organization shall verify the identity
of the individual.
(c) Persons using electronic signatures shall, prior to or at the
time of such use, certify to the agency that the electronic signatures
in their system, used on or after August 20, 1997, are intended to be
the legally binding equivalent of traditional handwritten signatures.
(1) The certification shall be submitted in paper form and signed
with a traditional handwritten signature, to the Office of Regional
Operations (HFC-100), 5600 Fishers Lane, Rockville, MD 20857.
(2) Persons using electronic signatures shall, upon agency request,
provide additional certification or testimony that a specific electronic
signature is the legally binding equivalent of the signer's handwritten
signature.
Sec.11.200 Electronic signature components and controls.
(a) Electronic signatures that are not based upon biometrics shall:
(1) Employ at least two distinct identification components such as
an identification code and password.
(i) When an individual executes a series of signings during a
single, continuous period of controlled system access, the first signing
shall be executed using all electronic signature components; subsequent
signings shall be executed using at least one electronic signature
component that is only executable by, and designed to be used only by,
the individual.
(ii) When an individual executes one or more signings not performed
during
[[Page 115]]
a single, continuous period of controlled system access, each signing
shall be executed using all of the electronic signature components.
(2) Be used only by their genuine owners; and
(3) Be administered and executed to ensure that attempted use of an
individual's electronic signature by anyone other than its genuine owner
requires collaboration of two or more individuals.
(b) Electronic signatures based upon biometrics shall be designed to
ensure that they cannot be used by anyone other than their genuine
owners.
Sec.11.300 Controls for identification codes/passwords.
Persons who use electronic signatures based upon use of
identification codes in combination with passwords shall employ controls
to ensure their security and integrity. Such controls shall include:
(a) Maintaining the uniqueness of each combined identification code
and password, such that no two individuals have the same combination of
identification code and password.
(b) Ensuring that identification code and password issuances are
periodically checked, recalled, or revised (e.g., to cover such events
as password aging).
(c) Following loss management procedures to electronically
deauthorize lost, stolen, missing, or otherwise potentially compromised
tokens, cards, and other devices that bear or generate identification
code or password information, and to issue temporary or permanent
replacements using suitable, rigorous controls.
(d) Use of transaction safeguards to prevent unauthorized use of
passwords and/or identification codes, and to detect and report in an
immediate and urgent manner any attempts at their unauthorized use to
the system security unit, and, as appropriate, to organizational
management.
(e) Initial and periodic testing of devices, such as tokens or
cards, that bear or generate identification code or password information
to ensure that they function properly and have not been altered in an
unauthorized manner.
PART 12_FORMAL EVIDENTIARY PUBLIC HEARING--Table of Contents
Subpart A_General Provisions
Sec.
12.1 Scope.
Subpart B_Initiation of Proceedings
12.20 Initiation of a hearing involving the issuance, amendment, or
revocation of a regulation.
12.21 Initiation of a hearing involving the issuance, amendment, or
revocation of an order.
12.22 Filing objections and requests for a hearing on a regulation or
order.
12.23 Notice of filing of objections.
12.24 Ruling on objections and requests for hearing.
12.26 Modification or revocation of regulation or order.
12.28 Denial of hearing in whole or in part.
12.30 Judicial review after waiver of hearing on a regulation.
12.32 Request for alternative form of hearing.
12.35 Notice of hearing; stay of action.
12.37 Effective date of a regulation.
12.38 Effective date of an order.
Subpart C_Appearance and Participation
12.40 Appearance.
12.45 Notice of participation.
12.50 Advice on public participation in hearings.
Subpart D_Presiding Officer
12.60 Presiding officer.
12.62 Commencement of functions.
12.70 Authority of presiding officer.
12.75 Disqualification of presiding officer.
12.78 Unavailability of presiding officer.
Subpart E_Hearing Procedures
12.80 Filing and service of submissions.
12.82 Petition to participate in forma pauperis.
12.83 Advisory opinions.
12.85 Disclosure of data and information by the participants.
12.87 Purpose; oral and written testimony; burden of proof.
12.89 Participation of nonparties.
12.90 Conduct at oral hearings or conferences.
12.91 Time and place of prehearing conference.
12.92 Prehearing conference procedure.
12.93 Summary decisions.
12.94 Receipt of evidence.
12.95 Official notice.
12.96 Briefs and argument.
[[Page 116]]
12.97 Interlocutory appeal from ruling of presiding officer.
12.98 Official transcript.
12.99 Motions.
Subpart F_Administrative Record
12.100 Administrative record of a hearing.
12.105 Examination of record.
Subpart G_Initial and Final Decisions
12.120 Initial decision.
12.125 Appeal from or review of initial decision.
12.130 Decision by Commissioner on appeal or review of initial decision.
12.139 Reconsideration and stay of action.
Subpart H_Judicial Review
12.140 Review by the courts.
12.159 Copies of petitions for judicial review.
Authority: 21 U.S.C. 141-149, 321-393, 467f, 679, 821, 1034; 42
U.S.C. 201, 262, 263b-263n, 264; 15 U.S.C. 1451-1461; 5 U.S.C. 551-558,
701-721; 28 U.S.C. 2112.
Source: 44 FR 22339, Apr. 13, 1979, unless otherwise noted.
Subpart A_General Provisions
Sec.12.1 Scope.
The procedures in this part apply when--
(a) A person has a right to an opportunity for a hearing under the
laws specified in Sec.10.50; or
(b) The Commissioner concludes that it is in the public interest to
hold a formal evidentiary public hearing on any matter before FDA.
Subpart B_Initiation of Proceedings
Sec.12.20 Initiation of a hearing involving the issuance, amendment, or
revocation of a regulation.
(a) A proceeding under section 409(f), 502(n), 512(n)(5), 701(e), or
721(d) of the act or section 4 or 5 of the Fair Packaging and Labeling
Act may be initiated--
(1) By the Commissioner on the Commissioner's own initiative, e.g.,
as provided in Sec.170.15 for food additives; or
(2) By a petition--
(i) In the form specified elsewhere in this chapter, e.g., the form
for a color additive petition in Sec.71.1; or
(ii) If no form is specified, by a petition under Sec.10.30.
(b) If the Commissioner receives a petition under paragraph (a)(2)
of this section, the Commissioner will--
(1) If it involves any matter subject to section 701(e) of the act
or section 4 or 5 of the Fair Packaging and Labeling Act, and meets the
requirements for filing, follow the provisions of Sec.10.40 (b)
through (f);
(2) If it involves a color additive or food additive, and meets the
requirements for filing in Sec. Sec.71.1 and 71.2, or in Sec. Sec.
171.1, 171.6, 171.7, and 171.100, publish a notice of filing of the
petition within 30 days after the petition is filed instead of a notice
of proposed rulemaking.
(c) [Reserved]
(d) The notice promulgating the regulation will describe how to
submit objections and requests for hearing.
(e) On or before the 30th day after the date of publication of a
final regulation, or of a notice withdrawing a proposal initiated by a
petition under Sec.10.25(a), a person may submit to the Commissioner
written objections and a request for a hearing. The 30-day period may
not be extended except that additional information supporting an
objection may be received after 30 days upon a showing of inadvertent
omission and hardship, and if review of the objection and request for
hearing will not thereby be impeded. If, after a final color additive
regulation is published, a petition or proposal relating to the
regulation is referred to an advisory committee in accordance with
section 721(b)(5)(C) of the act, objections and requests for a hearing
may be submitted on or before the 30th day after the date on which the
order confirming or modifying the Commissioner's previous order is
published.
[44 FR 22339, Apr. 13, 1979, as amended at 64 FR 399, Jan. 5, 1999]
Sec.12.21 Initiation of a hearing involving the issuance, amendment, or
revocation of an order.
(a) A proceeding under section 505 (d) or (e), 512 (d), (e), (m) (3)
or (4), of section 515(g)(1) of the act, or section 351(a) of the Public
Health Service Act, may be initiated--
[[Page 117]]
(1) By the Commissioner on the Commissioner's own initiative;
(2) By a petition in the form specified elsewhere in this chapter,
e.g., Sec.314.50 for new drug applications, Sec.514.1 for new animal
drug applications, Sec.514.2 for applications for animal feeds, or
Sec.601.3 for licenses for biologic products; or
(3) By a petition under Sec.10.30.
(b) A notice of opportunity for hearing on a proposal to deny or
revoke approval of all or part of an order will be published together
with an explanation of the grounds for the proposed action. The notice
will describe how to submit requests for hearing. A person subject to
the notice has 30 days after its issuance to request a hearing. The 30-
day period may not be extended.
(c) The Commissioner may use an optional procedure specified in
Sec.10.30(h) to consider issuing, amending, or revoking an order.
(d) In a proceeding under sections 505(e), 512(e) or (m), or 515(e)
of the act in which a party wishes to apply for reimbursement of certain
expenses under the Equal Access to Justice Act (5 U.S.C. 504 and 504
note), FDA will follow the Department of Health and Human Services'
regulations in 45 CFR part 13.
[44 FR 22339, Apr. 13, 1979, as amended at 47 FR 25734, June 15, 1982;
54 FR 9035, Mar. 3, 1989]
Sec.12.22 Filing objections and requests for a hearing on a regulation or
order.
(a) Objections and requests for a hearing under Sec.12.20(d) must
be submitted to the Division of Dockets Management and will be accepted
for filing if they meet the following conditions:
(1) They are submitted within the time specified in Sec.12.20(e).
(2) Each objection is separately numbered.
(3) Each objection specifies with particularity the provision of the
regulation or proposed order objected to.
(4) Each objection on which a hearing is requested specifically so
states. Failure to request a hearing on an objection constitutes a
waiver of the right to a hearing on that objection.
(5) Each objection for which a hearing is requested includes a
detailed description and analysis of the factual information to be
presented in support of the objection. Failure to include a description
and analysis for an objection constitutes a waiver of the right to a
hearing on that objection. The description and analysis may be used only
for the purpose of determining whether a hearing has been justified
under Sec.12.24, and do not limit the evidence that may be presented
if a hearing is granted.
(i) A copy of any report, article, survey, or other written document
relied upon must be submitted, except if the document is--
(a) An FDA document that is routinely publicly available; or
(b) A recognized medical or scientific textbook that is readily
available to the agency.
(ii) A summary of the nondocumentary testimony to be presented by
any witnesses relied upon must be submitted.
(b) Requests for hearing submitted under Sec.12.21 will be
submitted to the Division of Dockets Management and will be accepted for
filing if they meet the following conditions:
(1) They are submitted on or before the 30th day after the date of
publication of the notice of opportunity for hearing.
(2) They comply with Sec. Sec.314.200, 514.200, or 601.7(a).
(c) If an objection or request for a public hearing fails to meet
the requirements of this section and the deficiency becomes known to the
Division of Dockets Management, the Division of Dockets Management shall
return it with a copy of the applicable regulations, indicating those
provisions not complied with. A deficient objection or request for a
hearing may be supplemented and subsequently filed if submitted within
the 30-day time period specified in Sec.12.20(e) or Sec.12.21(b).
(d) If another person objects to a regulation issued in response to
a petition submitted under Sec.12.20(a)(2), the petitioner may submit
a written reply to the Division of Dockets Management.
[44 FR 22339, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989; 64
FR 69190, Dec. 10, 1999]
[[Page 118]]
Sec.12.23 Notice of filing of objections.
As soon as practicable after the expiration of the time for filing
objections to and requests for hearing on agency action involving the
issuance, amendment, or revocation of a regulation under sections
502(n), 701(e), or 721(d) of the act or sections 4 or 5 of the Fair
Packaging and Labeling Act, the Commissioner shall publish a notice in
the Federal Register specifying those parts of the regulation that have
been stayed by the filing of proper objections and, if no objections
have been filed, stating that fact. The notice does not constitute a
determination that a hearing is justified on any objections or requests
for hearing that have been filed. When to do so will cause no undue
delay, the notice required by this section may be combined with the
notices described in Sec. Sec.12.28 and 12.35.
Sec.12.24 Ruling on objections and requests for hearing.
(a) As soon as possible the Commissioner will review all objections
and requests for hearing filed under Sec.12.22 and determine--
(1) Whether the regulation should be modified or revoked under Sec.
12.26;
(2) Whether a hearing has been justified; and
(3) Whether, if requested, a hearing before a Public Board of
Inquiry under part 13 or before a public advisory committee under part
14 or before the Commissioner under part 15 has been justified.
(b) A request for a hearing will be granted if the material
submitted shows the following:
(1) There is a genuine and substantial issue of fact for resolution
at a hearing. A hearing will not be granted on issues of policy or law.
(2) The factual issue can be resolved by available and specifically
identified reliable evidence. A hearing will not be granted on the basis
of mere allegations or denials or general descriptions of positions and
contentions.
(3) The data and information submitted, if established at a hearing,
would be adequate to justify resolution of the factual issue in the way
sought by the person. A hearing will be denied if the Commissioner
concludes that the data and information submitted are insufficient to
justify the factual determination urged, even if accurate.
(4) Resolution of the factual issue in the way sought by the person
is adequate to justify the action requested. A hearing will not be
granted on factual issues that are not determinative with respect to the
action requested, e.g., if the Commissioner concludes that the action
would be the same even if the factual issue were resolved in the way
sought, or if a request is made that a final regulation include a
provision not reasonably encompassed by the proposal. A hearing will be
granted upon proper objection and request when a food standard or other
regulation is shown to have the effect of excluding or otherwise
affecting a product or ingredient.
(5) The action requested is not inconsistent with any provision in
the act or any regulation in this chapter particularizing statutory
standards. The proper procedure in those circumstances is for the person
requesting the hearing to petition for an amendment or waiver of the
regulation involved.
(6) The requirements in other applicable regulations, e.g.,
Sec. Sec.10.20, 12.21, 12.22, 314.200, 514.200, and 601.7(a), and in
the notice promulgating the final regulation or the notice of
opportunity for hearing are met.
(c) In making the determination in paragraph (a) of this section,
the Commissioner may use any of the optional procedures specified in
Sec.10.30(h) or in other applicable regulations, e.g., Sec. Sec.
314.200, 514.200, and 601.7(a).
(d) If it is uncertain whether a hearing has been justified under
the principles in paragraph (b) of this section, and the Commissioner
concludes that summary decision against the person requesting a hearing
should be considered, the Commissioner may serve upon the person by
registered mail a proposed order denying a hearing. The person has 30
days after receipt of the proposed order to demonstrate that the
submission justifies a hearing.
[44 FR 22339, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989; 64
FR 399, Jan. 5, 1999]
Sec.12.26 Modification or revocation of regulation or order.
If the Commissioner determines upon review of an objection or
request for
[[Page 119]]
hearing that the regulation or order should be modified or revoked, the
Commissioner will promptly take such action by notice in the Federal
Register. Further objections to or requests for hearing on the
modification or revocation may be submitted under Sec. Sec.12.20
through 12.22 but no further issue may be taken with other provisions in
the regulation or order. Objections and requests for hearing that are
not affected by the modification or revocation will remain on file and
be acted upon in due course.
Sec.12.28 Denial of hearing in whole or in part.
If the Commissioner determines upon review of the objections or
requests for hearing that a hearing is not justified, in whole or in
part, a notice of the determination will be published.
(a) The notice will state whether the hearing is denied in whole or
in part. If the hearing is denied in part, the notice will be combined
with the notice of hearing required by Sec.12.35, and will specify the
objections and requests for hearing that have been granted and denied.
(1) Any denial will be explained. A denial based on an analysis of
the information submitted to justify a hearing will explain the
inadequacy of the information.
(2) The notice will confirm or modify or stay the effective date of
the regulation or order involved.
(b) The record of the administrative proceeding relating to denial
of a public hearing in whole or in part on an objection or request for
hearing consists of the following:
(1) If the proceeding involves a regulation--
(i) The documents specified in Sec.10.40(g);
(ii) The objections and requests for hearing filed by the Division
of Dockets Management;
(iii) If the proceeding involves a color additive regulation
referred to an advisory committee in accordance with section
721(b)(5)(C) of the act, the committee's report and the record of the
committee's proceeding; and
(iv) The notice denying a formal evidentiary public hearing.
(2) If the proceeding involves an order--
(i) The notice of opportunity for hearing;
(ii) The requests for hearing filed by the Division of Dockets
Management;
(iii) The transcripts, minutes of meetings, reports, Federal
Register notices, and other documents constituting the record of any of
the optional procedures specified in Sec.12.24(c) used by the
Commissioner, but not the transcript of a closed portion of a public
advisory committee meeting; and
(iv) The notice denying the hearing.
(c) The record specified in paragraph (b) of this section is the
exclusive record for the Commissioner's decision on the complete or
partial denial of a hearing. The record of the proceeding will be closed
as of the date of the Commissioner's decision unless another date is
specified. A person who requested and was denied a hearing may submit a
petition for reconsideration under Sec.10.33 or a petition for stay of
action under Sec.10.35. A person who wishes to rely upon information
or views not included in the administrative record shall submit them to
the Commissioner with a petition under Sec.10.25(a) to modify the
final regulation or order.
(d) Denial of a request for a hearing in whole or in part is final
agency action reviewable in the courts, under the statutory provisions
governing the matter involved, as of the date of publication of the
denial in the Federal Register.
(1) Before requesting a court for a stay of action pending review, a
person shall first submit a petition for a stay of action under Sec.
10.35.
(2) Under 28 U.S.C. 2112(a), FDA will request consolidation of all
petitions on a particular matter.
(3) The time for filing a petition for judicial review of a denial
of a hearing on an objection or issue begins on the date the denial is
published in the Federal Register, (i) When an objection or issues
relates to a regulation, if a hearing is denied on all objections and
issues concerning a part of the proposal the effectiveness of which has
not been deferred pending a hearing on other parts of the proposal; or
(ii) when an issue relates to an order, if a hearing is
[[Page 120]]
denied on all issues relating to a particular new drug application, new
animal drug application, device premarket approval application or
product development protocol, or biologics license. The failure to file
a petition for judicial review within the period established in the
statutory provision governing the matter involved constitutes a waiver
of the right to judicial review of the objection or issue, regardless
whether a hearing has been granted on other objections and issues.
Sec.12.30 Judicial review after waiver of hearing on a regulation.
(a) A person with a right to submit objections and a request for
hearing under Sec.12.20(d) may submit objections and waive the right
to a hearing. The waiver may be either an explicit statement, or a
failure to request a hearing, as provided in 12.22(a)(4).
(b) If a person waives the right to a hearing, the Commissioner will
rule upon the person's objections under Sec. Sec.12.24 through 12.28.
As a matter of discretion, the Commissioner may also order a hearing on
the matter under any of the provisions of this part.
(c) If the Commissioner rules adversely on a person's objection, the
person may petition for judicial review in a U.S. Court of Appeals under
the act.
(1) The record for judicial review is the record designated in Sec.
12.28(b)(1).
(2) The time for filing a petition for judicial review begins as of
the date of publication of the Commissioner's ruling on the objections.
Sec.12.32 Request for alternative form of hearing.
(a) A person with a right to request a hearing may waive that right
and request one of the following alternatives:
(1) A hearing before a Public Board of Inquiry under part 13.
(2) A hearing before a public advisory committee under part 14.
(3) A hearing before the Commissioner under part 15.
(b) The request--
(1) May be on the person's own initiative or at the suggestion of
the Commissioner.
(2) Must be submitted in the form of a citizen petition under Sec.
10.30 before publication of a notice of hearing under Sec.12.35 or a
denial of hearing under Sec.12.28; and
(3) Must be--
(i) In lieu of a request for a hearing under this part; or
(ii) If submitted after or with a request for hearing, in the form
of a waiver of the right to request a hearing conditioned on an
alternative form of hearing. Upon acceptance by the Commissioner, the
waiver becomes binding and may be withdrawn only by waiving any right to
any form of hearing unless the Commissioner determines otherwise.
(c) When more than one person requests and justifies a hearing under
this part, an alternative form of hearing may by used only if all the
persons concur and waive their right to request a hearing under this
part.
(d) The Commissioner will determine whether an alternative form of
hearing should be used, and if so, which alternative is acceptable,
after considering the requests submitted and the appropriateness of the
alternatives for the issues raised in the objections. The Commissioner's
acceptance is binding unless, for good cause, the Commissioner
determines otherwise.
(e) The Commissioner will publish a notice of an alternative form of
hearing setting forth the following information:
(1) The regulation or order that is the subject of the hearing.
(2) A statement specifying any part of the regulation or order that
has been stayed by operation of law or in the Commissioner's discretion.
(3) The time, date, and place of the hearing, or a statment that
such information will be contained in a later notice.
(4) The parties to the hearing.
(5) The issues at the hearing. The statement of issues determines
the scope of the hearing.
(6) If the hearing will be conducted by a Public Board of Inquiry,
the time within which--
(i) The parties should submit nominees for the Board under Sec.
13.10(b);
(ii) A notice of participation under Sec.12.45 should be filed;
and
[[Page 121]]
(iii) Participants should submit written information under Sec.
13.25. The notice will list the contents of the portions of the
administrative record relevant to the issues at the hearing before the
Board. The portions listed will be placed on public display in the
office of the Division of Dockets Management before the notice is
published. Additional copies of material already submitted under Sec.
13.25 need not be included with any later submissions.
(f)(1) The decision of a hearing before a Public Board of Inquiry or
a public advisory committee under this section has legal status of and
will be handled as an initial decision under Sec.12.120.
(2) The decision of a public hearing before the Commissioner under
this section will be issued as a final order. The final order will have
the same content as an initial decision, as specified in Sec.12.120
(b) and (c).
(3) Thereafter, the participants in the proceeding may pursue the
administrative and court remedies specified in Sec. Sec.12.120 through
12.159.
(g) If a hearing before a public advisory committee or a hearing
before the Commissioner is used as an alternative form of hearing, all
submissions will be made to the Division of Dockets Management, and
Sec.10.20(j) governs their availability for public examination and
copying.
(h) This section does not affect the right to an opportunity for a
hearing before a public advisory committee under section 515(g)(2) of
the act regarding device premarket approval applications and product
development protocols. Advisory committee hearing procedures are found
in part 14.
Sec.12.35 Notice of hearing; stay of action.
(a) If the Commissioner determines upon review of the objections and
requests for hearing that a hearing is justified on any issue, the
Commissioner will publish a notice setting forth the following:
(1) The regulation or order that is the subject of the hearing.
(2) A statement specifying any part of the regulation or order that
has been stayed by operation of law or in the Commissioner's discretion.
(3) The parties to the hearing.
(4) The issues of fact on which a hearing has been justified.
(5) A statement of any objections or requests for hearing for which
a hearing has not been justified, which are subject to Sec.12.28.
(6) The presiding officer, or a statement that the presiding officer
will be designated in a later notice.
(7) The time within which notices of participation should be filed
under Sec.12.45.
(8) The date, time, and place of the prehearing conference, or a
statement that the date, time, and place will be announced in a later
notice. The pre-hearing conference may not commence until after the time
expires for filing the notice of participation required by Sec.
12.45(a).
(9) The time within which participants should submit written
information and views under Sec.12.85. The notice will list the
contents of the portions of the administrative record relevant to the
issues at the hearing. The portions listed will be placed on public
display in the office of the Division of Dockets Management before the
notice is published. Additional copies of material already submitted
under Sec.12.85 need not be included with any later submissions.
(b) The statement of the issues determines the scope of the hearing
and the matters on which evidence may be introduced. The issues may be
revised by the presiding officer. A participant may obtain interlocutory
review by the Commissioner of a decision by the presiding officer to
revise the issues to include an issue on which the Commissioner has not
granted a hearing or to eliminate an issue on which a hearing has been
granted.
(c) A hearing is deemed to begin on the date of publication of the
notice of hearing.
[44 FR 22339, Apr. 13, 1979, as amended at 47 FR 26375, June 18, 1982]
Sec.12.37 Effective date of a regulation.
(a) If no objections are filed and no hearing is requested on a
regulation under Sec.12.20(e), the regulation is effective on the date
specified in the regulation as promulgated.
(b) The Commissioner shall publish a confirmation of the effective
date of
[[Page 122]]
the regulation. The Federal Register document confirming the effective
date of the regulation may extend the time for compliance with the
regulation.
Sec.12.38 Effective date of an order.
(a) If a person who is subject to a notice of opportunity for
hearing under Sec.12.21(b) does not request a hearing, the
Commissioner will--
(1) Publish a final order denying or withdrawing approval of an NDA,
NADA, device premarket approval application, or biologics license, in
whole or in part, or revoking a device product development protocol or
notice of completion, or declaring that such a protocol has not been
completed, and stating the effective date of the order; and
(2) If the order involves withdrawal of approval of an NADA,
forthwith revoke, in whole or in part, the applicable regulation, under
section 512(i) of the act.
(b) If a person who is subject to a notice of opportunity for
hearing under Sec.12.21(b) requests a hearing and others do not, the
Commissioner may issue a final order covering all the drug or device
products at once or may issue more than one final order covering
different drug or device products at different times.
Subpart C_Appearance and Participation
Sec.12.40 Appearance.
(a) A person who has filed a notice of participation under Sec.
12.45 may appear in person or by counsel or other representative in any
hearing and, subject to Sec.12.89, may be heard concerning all
relevant issues.
(b) The presiding officer may strike a person's appearance for
violation of the rules of conduct in Sec.12.90.
Sec.12.45 Notice of participation.
(a) Within 30 days after publication of the notice of hearing under
Sec.12.35, a person desiring to participate in a hearing is to file
with the Division of Dockets Management under Sec.10.20 a notice of
participation in the following form:
(Date)
Division of Dockets Management, Food and Drug Administration,
Department of Health and Human Services, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
Notice of Participation
Docket No. ----
Under 21 CFR part 12, please enter the participation of:
(Name)_________________________________________________________________
(Street address)_______________________________________________________
(City and State)_______________________________________________________
(Telephone number)_____________________________________________________
Service on the above will be accepted by:
(Name)_________________________________________________________________
(Street address)_______________________________________________________
(City and State)_______________________________________________________
(Telephone number)_____________________________________________________
The following statements are made as part of this notice of
participation:
A. Specific interests. (A statement of the specific interest of the
person in the proceeding, including the specific issues of fact
concerning which the person desires to be heard. This part need not be
completed by a party to the proceeding.)
B. Commitment to participate. (A statement that the person will
present documentary evidence or testimony at the hearing and will comply
with the requirements of 21 CFR 12.85, or, in the case of a hearing
before a Public Board of Inquiry, with the requirements of 21 CFR
13.25.)
(Signed)_______________________________________________________________
(b) An amendment to a notice of participation should be filed with
the Division of Dockets Management and served on all participants.
(c) No person may participate in a hearing who has not filed a
written notice of participation or whose participation has been stricken
under paragraph (e) of this section.
(d) The presiding officer may permit the late filing of a notice of
participation upon a showing of good cause.
(e) The presiding officer may strike the participation of a person
for nonparticipation in the hearing or failure to comply with any
requirement of this subpart, e.g., disclosure of information as required
by Sec.12.85 or the prehearing order issued under Sec.12.92. Any
person whose participation is stricken may petition the Commissioner for
interlocutory review.
[44 FR 22339, Apr. 13, 1979, as amended at 46 FR 8456, Jan. 27, 1981; 59
FR 14364, Mar. 28, 1994; 68 FR 24879, May 9, 2003]
[[Page 123]]
Sec.12.50 Advice on public participation in hearings.
(a) Designated agency contact. All inquiries from the public about
scheduling, location, and general procedures should be addressed to the
Deputy Commissioner for Policy (HF-22), Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20857, or telephone 301-443-3480. The
staff of the Associate Commissioner for Regulatory Affairs will attempt
to respond promptly to all inquiries from members of the public, as well
as to simple requests for information from participants in hearings.
(b) Hearing schedule changes. Requests by hearing participants for
changes in the schedule of a hearing or for filing documents, briefs, or
other pleadings should be made in writing directly to the Administrative
Law Judge (HF-3), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857.
(c) Legal advice to individuals. FDA does not have the resources to
provide legal advice to members of the public concerning participation
in hearings. Furthermore, to do so would compromise the independence of
the Commissioner's office and invite charges of improper interference in
the hearing process. Accordingly, the Deputy Commissioner for Policy
(HF-22) will not answer questions about the strengths or weaknesses of a
party's position at a hearing, litigation strategy, or similar matters.
(d) Role of the office of the Chief Counsel. Under no circumstances
will the office of the Chief Counsel of FDA directly provide advice
about a hearing to any person who is participating or may participate in
the hearing. In every hearing, certain attorneys in the office are
designated to represent the center or centers whose action is the
subject of the hearing. Other members of the office, including
ordinarily the Chief Counsel, are designated to advise the Commissioner
on a final decision in the matter. It is not compatible with these
functions, nor would it be professionally responsible, for the attorneys
in the office of the Chief Counsel also to advise other participants in
a hearing, or for any attorney who may be called on to advise the
Commissioner to respond to inquiries from other participants in the
hearing, for such participants may be urging views contrary to those of
the center involved or to what may ultimately be the final conclusions
of the Commissioner. Accordingly, members of the office of the Chief
Counsel, other than the attorneys responsible for representing the
center whose action is the subject of the hearing, will not answer
questions about the hearing from any participant or potential
participant.
(e) Communication between participants and attorneys. Participants
in a hearing may communicate with the attorneys responsible for
representing the center whose action is the subject of the hearing, in
the same way that they may communicate with counsel for any other party
in interest about the presentation of matters at the hearing. It would
be inappropriate to bar discussion of such matters as stipulations of
fact, joint presentation of witnesses, or possible settlement of hearing
issues. Members of the public, including participants at hearings, are
advised, however, that all such communications, including those by
telephone, will be recorded in memoranda that can be filed with the
Division of Dockets Management.
[44 FR 22329, Apr. 13, 1979, as amended at 50 FR 8994, Mar. 6, 1985; 54
FR 9035, Mar. 3, 1989; 58 FR 17096, Apr. 1, 1993]
Subpart D_Presiding Officer
Sec.12.60 Presiding officer.
The presiding officer in a hearing will be the Commissioner, a
member of the Commissioner's office to whom the responsibility for the
matter involved has been delegated, or an administrative law judge
qualified under 5 U.S.C. 3105.
Sec.12.62 Commencement of functions.
The functions of the presiding officer begin upon designation and
end upon the filing of the initial decision.
Sec.12.70 Authority of presiding officer.
The presiding officer has all powers necessary to conduct a fair,
expeditious, and orderly hearing, including the power to--
[[Page 124]]
(a) Specify and change the date, time, and place of oral hearings
and conferences;
(b) Establish the procedures for use in developing evidentiary
facts, including the procedures in Sec.12.92(b) and to rule on the
need for oral testimony and cross-examination under Sec.12.87(b);
(c) Prepare statements of the areas of factual disagreement among
the participants;
(d) Hold conferences to settle, simplify, or determine the issues in
a hearing or to consider other matters that may expedite the hearing;
(e) Administer oaths and affirmations;
(f) Control the course of the hearing and the conduct of the
participants;
(g) Examine witnesses and strike their testimony if they fail to
respond fully to proper questions;
(h) Rule on, admit, exclude, or limit evidence;
(i) Set the time for filing pleadings;
(j) Rule on motions and other procedural matters;
(k) Rule on motions for summary decision under Sec.12.93;
(l) Conduct the hearing in stages if the number of parties is large
or the issues are numerous and complex;
(m) Waive, suspend, or modify any rule in this subpart under Sec.
10.19 if the presiding officer determines that no party will be
prejudiced, the ends of justice will be served, and the action is in
accordance with law;
(n) Strike the participation of any person under Sec.12.45(e) or
exclude any person from the hearing under Sec.12.90, or take other
reasonable disciplinary action; and
(o) Take any action for the fair, expeditious, and orderly conduct
of the hearing.
Sec.12.75 Disqualification of presiding officer.
(a) A participant may request the presiding officer to disqualify
himself/herself and withdraw from the proceeding. The ruling on any such
request may be appealed in accordance with Sec.12.97(b).
(b) A presiding officer who is aware of grounds for disqualification
shall withdraw from the proceeding.
Sec.12.78 Unavailability of presiding officer.
(a) If the presiding officer is unable to act for any reason, the
Commissioner will assign the powers and duties to another presiding
officer. The substitution will not affect the hearing, except as the new
presiding officer may order.
(b) Any motion based on the substitution must be made within 10
days.
Subpart E_Hearing Procedures
Sec.12.80 Filing and service of submissions.
(a) Submissions, including pleadings in a hearing, are to be filed
with the Division of Dockets Management under Sec.10.20 except that
only two copies need be filed. To determine compliance with filing
deadlines in a hearing, a submission is considered submitted on the date
it is actually received by the Division of Dockets Management. When this
part allows a response to a submission and prescribes a period of time
for the filing of the response, an additional 3 days are allowed for the
filing of the response if the submission is served by mail.
(b) The person making a submission shall serve copies of it on the
other participants. Submissions of documentary data and information are
not required to be served on each participant, but any accompanying
transmittal letter, pleading, summary, statement of position,
certification under paragraph (d) of this section, or similar document
must be served on each participant.
(c) Service is accomplished by mailing a submission to the address
shown in the notice of participation or by personal delivery.
(d) All submissions are to be accompanied by a certificate of
service, or a statement that service is not required.
(e) No written submission or other portion of the administrative
record may be held in confidence, except as provided in Sec.12.105.
Sec.12.82 Petition to participate in forma pauperis.
(a) A participant who believes that compliance with the filing and
service
[[Page 125]]
requirements of this section constitutes an unreasonable financial
burden may submit to the Commissioner a petition to participate in forma
pauperis.
(b) The petition will be in the form specified in Sec.10.30 except
that the heading will be ``Request to Participate in Forma Pauperis,
Docket No. ----.'' Filing and service requirements for the petition are
described in paragraph (c) of this section, whether or not the petition
is granted. The petition must demonstrate that either: (1) The person is
indigent and a strong public interest justifies participation, or (2)
the person's participation is in the public interest because it can be
considered of primary benefit to the general public.
(c) The Commissioner may grant or deny the petition. If the petition
is granted, the participant need file only one copy of each submission
with the Division of Dockets Management. The Division of Dockets
Management will make sufficient additional copies for the administrative
record, and serve a copy on each other participant.
Sec.12.83 Advisory opinions.
Before or during a hearing, a person may, under Sec.10.85, request
the Commissioner for an advisory opinion on whether any regulation or
order under consideration in the proceeding applies to a specific
situation.
Sec.12.85 Disclosure of data and information by the participants.
(a) Before the notice of hearing is published under Sec.12.35, the
director of the center responsible for the matters involved in the
hearing shall submit the following to the Division of Dockets
Management:
(1) The relevant portions of the administrative record of the
proceeding. Portions of the administrative record not relevant to the
issues in the hearing are not part of the administrative record.
(2) All documents in the director's files containing factual
information, whether favorable or unfavorable to the director's
position, which relate to the issues involved in the hearing. Files
means the principal files in the center in which documents relating to
the issues in the hearing are ordinarily kept, e.g., the food additive
master file and the food additive petition in the case of issues
concerning a food additive, or the new drug application in the case of
issues concerning a new drug. Internal memoranda reflecting the
deliberative process, and attorney work product and material prepared
specifically for use in connection with the hearing, are not required to
be submitted.
(3) All other documentary data and information relied upon.
(4) A narrative position statement on the factual issues in the
notice of hearing and the type of supporting evidence the director
intends to introduce.
(5) A signed statement that, to the director's best knowledge and
belief, the submission complies with this section.
(b) Within 60 days of the publication of the notice of hearing or,
if no participant will be prejudiced, within another period of time set
by the presiding officer, each participant shall submit to the Division
of Dockets Management all data and information specified in paragraph
(a)(2) through (5) of this section, and any objections that the
administrative record filed under paragraph (a)(1) of this section is
incomplete. With respect to the data and information specified in
paragraph (a)(2) of this section, participants shall exercise reasonable
diligence in identifying documents in files comparable to those
described in that paragraph.
(c) Submissions required by paragraphs (a) and (b) of this section
may be supplemented later in the proceeding, with the approval of the
presiding officer, upon a showing that the material contained in the
supplement was not reasonably known or available when the submission was
made or that the relevance of the material contained in the supplement
could not reasonably have been forseen.
(d) A participant's failure to comply substantially and in good
faith with this section constitutes a waiver of the right to participate
further in the hearing; failure of a party to comply constitutes a
waiver of the right to a hearing.
[[Page 126]]
(e) Participants may reference each other's submissions. To reduce
duplicative submissions, participants are encouraged to exchange and
consolidate lists of documentary evidence. If a particular document is
bulky or in limited supply and cannot reasonably be reproduced, and it
constitutes relevant evidence, the presiding officer may authorize
submission of a reduced number of copies.
(f) The presiding officer will rule on questions relating to this
section.
[44 FR 22339, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989]
Sec.12.87 Purpose; oral and written testimony; burden of proof.
(a) The objective of a formal evidentiary hearing is the fair
determination of relevant facts consistent with the right of all
interested persons to participate and the public interest in promptly
settling controversial matters affecting the public health and welfare.
(b) Accordingly, the evidence at a hearing is to be developed to the
maximum extent through written submissions, including written direct
testimony, which may be in narrative or in question-and-answer form.
(1) In a hearing, the issues may have general applicability and
depend on general facts that do not concern particular action of a
specific party, e.g., the safety or effectiveness of a class of drug
products, the safety of a food or color additive, or a definition and
standard of identity for a food; or the issues may have specific
applicability to past action and depend upon particular facts concerning
only that party, e.g., the applicability of a grandfather clause to a
particular brand of a drug or the failure of a particular manufacturer
to meet required manufacturing and processing specifications or other
general standards.
(i) If the proceeding involves general issues, direct testimony will
be submitted in writing, except on a showing that written direct
testimony is insufficient for a full and true disclosure of relevant
facts and that the participant will be prejudiced if unable to present
oral direct testimony. If the proceeding involves particular issues,
each party may determine whether, and the extent to which, each wishes
to present direct testimony orally or in writing.
(ii) Oral cross-examination of witnesses will be permitted if it
appears that alternative means of developing the evidence are
insufficient for a full and true disclosure of the facts and that the
party requesting oral cross-examination will be prejudiced by denial of
the request or that oral cross-examination is the most effective and
efficient means to clarify the matters at issue.
(2) Witnesses shall give testimony under oath.
(c) Except as provided in paragraph (d) of this section, in a
hearing involving issuing, amending, or revoking a regulation or order,
the originator of the proposal or petition or of any significant
modification will be, within the meaning of 5 U.S.C. 556(d), the
proponent of the regulation or order, and will have the burden of proof.
A participant who proposes to substitute a new provision for a provision
objected to has the burden of proof in relation to the new provision.
(d) At a hearing involving issuing, amending, or revoking a
regulation or order relating to the safety or effectiveness of a drug,
device, food additive, or color additive, the participant who is
contending that the product is safe or effective or both and who is
requesting approval or contesting withdrawal of approval has the burden
of proof in establishing safety or effectiveness or both and thus the
right to approval. The burden of proof remains on that participant in an
amendment or revocation proceeding.
[44 FR 22339, Apr. 13, 1979 as amended at 64 FR 399, Jan. 5, 1999]
Sec.12.89 Participation of nonparties.
(a) A nonparty participant may--
(1) Attend all conferences (including the prehearing conference),
oral proceedings, and arguments;
(2) Submit written testimony and documentary evidence for inclusion
in the record;
(3) File written objections, briefs, and other pleadings; and
(4) Present oral argument.
(b) A nonparty participant may not--
(1) Submit written interrogatories; and
[[Page 127]]
(2) Conduct cross-examination.
(c) A person whose petition is the subject of the hearing has the
same right as a party.
(d) A nonparty participant will be permitted additional rights if
the presiding officer concludes that the participant's interests would
not be adequately protected otherwise or that broader participation is
required for a full and true disclosure of the facts, but the rights of
a nonparty participant may not exceed the rights of a party.
[44 FR 22339, Apr. 13, 1979, as amended at 48 FR 51770, Nov. 14, 1983]
Sec.12.90 Conduct at oral hearings or conferences.
All participants in a hearing will conduct themselves with dignity
and observe judicial standards of practice and ethics. They may not
indulge in personal attacks, unseemly wrangling, or intemperate
accusations or characterizations. Representatives of parties shall, to
the extent possible, restrain clients from improprieties in connection
with any proceeding. Disrespectful, disorderly, or contumacious language
or conduct, refusal to comply with directions, use of dilatory tactics,
or refusal to adhere to reasonable standards of orderly and ethical
conduct during any hearing, constitute grounds for immediate exclusion
from the proceeding by the presiding officer.
Sec.12.91 Time and place of prehearing conference.
A prehearing conference will commence at the date, time, and place
announced in the notice of hearing, or in a later notice, or as
specified by the presiding officer in a notice modifying a prior notice.
At that conference the presiding officer will establish the methods and
procedures to be used in developing the evidence, determine reasonable
time periods for the conduct of the hearing, and designate the times and
places for the production of witnesses for direct and cross-examination
if leave to conduct oral examination is granted on any issue, as far as
practicable at that time.
Sec.12.92 Prehearing conference procedure.
(a) Participants in a hearing are to appear at the prehearing
conference prepared to discuss and resolve all matters specified in
paragraph (b) of this section.
(1) To expedite the hearing, participants are encouraged to prepare
in advance for the prehearing conference. Participants should cooperate
with each other, and request information and begin preparation of
testimony at the earliest possible time. Failure of a participant to
appear at the prehearing conference or to raise matters that could
reasonably be anticipated and resolved at that time will not delay the
progress of the hearing, and constitutes a waiver of the rights of the
participant regarding such matters as objections to the agreements
reached, actions taken, or rulings issued by the presiding officer and
may be grounds for striking the participation under Sec.12.45.
(2) Participants shall bring to the prehearing conference the
following specific information, which will be filed with the Division of
Dockets Management under Sec.12.80:
(i) Any additional information to supplement the submission filed
under Sec.12.85, which may be filed if approved under Sec.12.85(c).
(ii) A list of all witnesses whose testimony will be offered, orally
or in writing, at the hearing, with a full curriculum vitae for each.
Additional witnesses may later be identified, with the approval of the
presiding officer, on a showing that the witness was not reasonably
available at the time of the prehearing conference or the relevance of
the witness' views could not reasonably have been foreseen at that time.
(iii) All prior written statements including articles and any
written statement signed or adopted, or a recording or transcription of
an oral statement made, by persons identified as witnesses if--
(a) The statement is available without making request of the witness
or any other person;
(b) The statement relates to the subject matter of the witness'
testimony; and
[[Page 128]]
(c) The statement either was made before the time the person agreed
to become a witness or has been made publicly available by the person.
(b) The presiding officer will conduct a prehearing conference for
the following purposes:
(1) To determine the areas of factual disagreement to be considered
at the hearing. The presiding officer may hold conferences off the
record in an effort to reach agreement on disputed factual questions.
(2) To identify the most appropriate techniques for developing
evidence on issues in controversy and the manner and sequence in which
they will be used, including, where oral examination is to be conducted,
the sequence in which witnesses will be produced for, and the time and
place of, oral examination. The presiding officer may consider--
(i) Submission of narrative statements of position on factual issues
in controversy;
(ii) Submission of evidence or identification of previously
submitted evidence to support such statements, such as affidavits,
verified statements of fact, data, studies, and reports;
(iii) Exchange of written interrogatories directed to particular
witnesses;
(iv) Written requests for the production of additional
documentation, data, or other relevant information;
(v) Submission of written questions to be asked by the presiding
officer of a specific witness; and
(vi) Identification of facts for which oral examination and/or
cross-examination is appropriate.
(3) To group participants with substantially like interests for
presenting evidence, making motions and objections, including motions
for summary decision, filing briefs, and presenting oral argument.
(4) To hear and rule on objections to admitting into evidence
information submitted under Sec.12.85.
(5) To obtain stipulations and admissions of facts.
(6) To take other action that may expedite the hearing.
(c) The presiding officer shall issue, orally or in writing, a
prehearing order reciting the actions taken at the prehearing conference
and setting forth the schedule for the hearing. The order will control
the subsequent course of the hearing unless modified by the presiding
officer for good cause.
Sec.12.93 Summary decisions.
(a) After the hearing commences, a participant may move, with or
without supporting affidavits, for a summary decision on any issue in
the hearing. Any other participant may, within 10 days after service of
the motion, which time may be extended for an additional 10 days for
good cause, serve opposing affidavits or countermove for summary
decision. The presiding officer may set the matter for argument and call
for the submission of briefs.
(b) The presiding officer will grant the motion if the objections,
requests for hearing, other pleadings, affidavits, and other material
filed in connection with the hearing, or matters officially noticed,
show that there is no genuine issue as to any material fact and that a
participant is entitled to summary decision.
(c) Affidavits should set forth facts that would be admissible in
evidence and show affirmatively that the affiant is competent to testify
to the matters stated. When a properly supported motion for summary
decision is made, a participant opposing the motion may not rest upon
mere allegations or denials or general descriptions of positions and
contentions; affidavits or other responses must set forth specific facts
showing that there is a genuine issue of fact for the hearing.
(d) Should it appear from the affidavits of a participant opposing
the motion that for sound reasons stated, facts essential to justify the
opposition cannot be presented by affidavit, the presiding officer may
deny the motion for summary decision, order a continuance to permit
affidavits or additional evidence to be obtained, or issue other just
order.
(e) If on motion under this section a summary decision is not
rendered upon the whole case or for all the relief asked. and
evidentiary facts need to be developed, the presiding officer will issue
an order specifying the facts that appear without substantial
controversy
[[Page 129]]
and directing further evidentiary proceedings. The facts so specified
will be deemed established.
(f) A participant may obtain interlocutory review by the
Commissioner of a summary decision of the presiding officer.
Sec.12.94 Receipt of evidence.
(a) A hearing consists of the development of evidence and the
resolution of factual issues as set forth in this subpart and in the
prehearing order.
(b) All orders, transcripts, written statements of position, written
direct testimony, written interrogatories and responses, and any other
written material submitted in the proceeding is a part of the
administrative record of the hearing, and will be promptly placed on
public display in the office of the Division of Dockets Management,
except as provided in Sec.12.105.
(c) Written evidence, identified as such, is admissible unless a
participant objects and the presiding officer excludes it on objection
of a participant or on the presiding officer's own initiative.
(1) The presiding officer may exclude written evidence as
inadmissible only if--
(i) The evidence is irrelevant, immaterial, unreliable, or
repetitive;
(ii) Exclusion of part or all of the written evidence of a
participant is necessary to enforce the requirements of this subpart; or
(iii) The evidence was not submitted as required by Sec.12.85.
(2) Items of written evidence are to be submitted as separate
documents, sequentially numbered, except that a voluminous document may
be submitted in the form of a cross-reference to the documents filed
under Sec.12.85.
(3) Written evidence excluded by the presiding officer as
inadmissible remains a part of the administrative record, as an offer of
proof, for judicial review.
(d) Testimony, whether on direct or on cross-examination, is
admissible as evidence unless a participant objects and the presiding
officer excludes it.
(1) The presiding officer may exclude oral evidence as inadmissible
only if--
(i) The evidence is irrelevant, immaterial, unreliable, or
repetitive; or
(ii) Exclusion of part or all of the evidence is necessary to
enforce the requirements of this part.
(2) If oral evidence is excluded as inadmissible, the participant
may take written exception to the ruling in a brief to the Commissioner,
without taking oral exception at the hearing. Upon review, the
Commissioner may reopen the hearing to permit the evidence to be
admitted if the Commissioner determines that its exclusion was erroneous
and prejudicial.
(e) The presiding officer may schedule conferences as needed to
monitor the program of the hearing, narrow and simplify the issues, and
consider and rule on motions, requests, and other matters concerning the
development of the evidence.
(f) The presiding officer will conduct such proceedings as are
necessary for the taking of oral testimony, for the oral examination of
witnesses by the presiding officer on the basis of written questions
previously submitted by the parties, and for the conduct of cross-
examination of witnesses by the parties. The presiding officer shall
exclude irrelevant or repetitious written questions and limit oral
cross-examination to prevent irrelevant or repetitious examination.
(g) The presiding officer shall order the proceedings closed for the
taking of oral testimony relating to matters specified in Sec.
10.20(j)(2)(i) (a) and (b). Such closed proceedings will be conducted in
accordance with Sec.10.20(j)(3). Participation in closed proceedings
will be limited to the witness, the witness' counsel, and Federal
Government executive branch employees and special government employees.
Closed proceedings will be permitted only for, and will be limited to,
oral testimony directly relating to matters specified in Sec.
10.20(j)(3).
Sec.12.95 Official notice.
(a) Official notice may be taken of such matters as might be
judicially noticed by the courts of the United States or of any other
matter peculiarly within the general knowledge of FDA as an expert
agency.
[[Page 130]]
(b) If official notice is taken of a material fact not appearing in
the evidence of record, a participant, on timely request, will be
afforded an opportunity to show the contrary.
Sec.12.96 Briefs and arguments.
(a) Promptly after the taking of evidence is completed, the
presiding officer will announce a schedule for the filing of briefs.
Briefs are to be filed ordinarily within 45 days of the close of the
hearing. Briefs must include a statement of position on each issue, with
specific and complete citations to the evidence and points of law relied
on. Briefs must contain proposed findings of fact and conclusions of
law.
(b) The presiding officer may, as a matter of discretion, permit
oral argument after the briefs are filed.
(c) Briefs and oral argument are to refrain from disclosing specific
details of written and oral testimony and documents relating to matters
specified in Sec.10.20(j)(2)(i)(a) and (b), except as specifically
authorized in a protective order issued under Sec.10.20(j)(3).
Sec.12.97 Interlocutory appeal from ruling of presiding officer.
(a) Except as provided in paragraph (b) of this section and in
Sec. Sec.12.35(b), 12.45(e), 12.93(f), and 12.99(d), when an
interlocutory appeal is specifically authorized by this subpart, rulings
of the presiding officer may not be appealed to the Commissioner before
the Commissioner's consideration of the entire record of the hearing.
(b) A ruling of the presiding officer is subject to interlocutory
appeal to the Commissioner if the presiding officer certifies on the
record or in writing that immediate review is necessary to prevent
exceptional delay, expense, or prejudice to any participant, or
substantial harm to the public interest.
(c) When an interlocutory appeal is made to the Commissioner, a
participant may file a brief with the Commissioner only if specifically
authorized by the presiding officer or the Commissioner, and if such
authorization is granted, within the period the Commissioner directs. If
a participant is authorized to file a brief, any other participant may
file a brief in opposition, within the period the Commissioner directs.
If no briefs are authorized, the appeal will be presented as an oral
argument to the Commissioner. The oral argument will be transcribed. If
briefs are authorized, oral argument will be heard only at the
discretion of the Commissioner.
Sec.12.98 Official transcript.
(a) The presiding officer will arrange for a verbatim stenographic
transcript of oral testimony and for necessary copies of the transcript.
(b) One copy of the transcript will be placed on public display in
the office of the Division of Dockets Management upon receipt.
(c) Except as provided in Sec.12.105, copies of the transcript may
be obtained by application to the official reporter and payment of costs
thereof or under part 20.
(d) Witnesses, participants, and counsel have 30 days from the time
the transcript becomes available to propose corrections in the
transcript of oral testimony. Corrections are permitted only for
transcription errors. The presiding officer shall promptly order
justified corrections.
Sec.12.99 Motions.
(a) A motion on any matter relating to the proceeding is to be filed
under Sec.12.80, and must include a draft order, except one made in
the course of an oral hearing before the presiding officer.
(b) A response may be filed within 10 days of service of a motion.
The time may be shortened or extended by the presiding officer for good
cause shown.
(c) The moving party has no right to reply, except as permitted by
the presiding officer.
(d) The presiding officer shall rule upon the motion and may certify
that ruling to the Commissioner for interlocutory review.
Subpart F_Administrative Record
Sec.12.100 Administrative record of a hearing.
(a) The record of a hearing consists of--
(1) The order or regulation or notice of opportunity for hearing
that gave rise to the hearing;
[[Page 131]]
(2) All objections and requests for hearing filed by the Division of
Dockets Management under Sec. Sec.12.20 through 12.22;
(3) The notice of hearing published under Sec.12.35;
(4) All notices of participation filed under Sec.12.45;
(5) All Federal Register notices pertinent to the proceeding;
(6) All submissions filed under Sec.12.82, e.g., the submissions
required by Sec.12.85, all other documentary evidence and written
testimony, pleadings, statements of position, briefs, and other similar
documents;
(7) The transcript, written order, and all other documents relating
to the prehearing conference, prepared under Sec.12.92;
(8) All documents relating to any motion for summary decision under
Sec.12.93;
(9) All documents of which official notice is taken under Sec.
12.95;
(10) All pleadings filed under Sec.12.96;
(11) All documents relating to any interlocutory appeal under Sec.
12.97;
(12) All transcripts prepared under Sec.12.98; and
(13) Any other document relating to the hearing and filed with the
Division of Dockets Management by the presiding officer or any
participant;
(b) The record of the administrative proceeding is closed--
(1) With respect to the taking of evidence, when specified by the
presiding officer; and
(2) With respect to pleadings, at the time specified in Sec.
12.96(a) for the filing of briefs.
(c) The presiding officer may reopen the record to receive further
evidence at any time before the filing of the initial decision.
Sec.12.105 Examination of record.
Documents in the record will be publicly available in accordance
with Sec.10.20(j). Documents available for examination or copying will
be placed on public display in the office of the Division of Dockets
Management promptly upon receipt in that office.
Subpart G_Initial and Final Decisions
Sec.12.120 Initial decision.
(a) The presiding officer shall prepare and file an initial decision
as soon as possible after the filing of briefs and oral argument.
(b) The initial decision must contain--
(1) Findings of fact based issued upon relevant, material, and
reliable evidence of record;
(2) Conclusions of law;
(3) A discussion of the reasons for the findings and conclusions,
including a discussion of the significant contentions made by any
participant;
(4) Citations to the record supporting the findings and conclusions;
(5) An appropriate regulation or order supported by substantial
evidence of record and based upon the findings of fact and conclusions
of law; and
(6) An effective date for the regulation or order.
(c) The initial decision must refrain from disclosing specific
details of matters specified in Sec.10.20(j)(2)(i) (a) and (b), except
as specifically authorized in a protective order issued pursuant to
Sec.10.20(j)(3).
(d) The initial decision is to be filed with the Division of Dockets
Management and served upon all participants. Once the initial decision
is filed with the Division of Dockets Management, the presiding officer
has no further jurisdiction over the matter, and any motions or requests
filed with the Division of Dockets Management will be decided by the
Commissioner.
(e) The initial decision becomes the final decision of the
Commissioner by operation of law unless a participant files exceptions
with the Division of Dockets Management under Sec.12.125(a) or the
Commissioner files a notice of review under Sec.12.125(f).
(f) Notice that an initial decision has become the decision of the
Commissioner without appeal to or review by the Commissioner will be
published in the Federal Register, or the Commissioner may publish the
decision when it is of widespread interest.
[[Page 132]]
Sec.12.125 Appeal from or review of initial decision.
(a) A participant may appeal an initial decision to the Commissioner
by filing exceptions with the Division of Dockets Management, and
serving them on the other participants, within 60 days of the date of
the initial decision.
(b) Exceptions must specifically identify alleged errors in the
findings of fact or conclusions of law in the initial decision, and
provide supporting citations to the record. Oral argument before the
Commissioner may be requested in the exceptions.
(c) Any reply to the exceptions is to be filed and served within 60
days of the end of the period for filing exceptions.
(d) The Commissioner may extend the time for filing exceptions under
paragraph (a) of this section or replies to exceptions under paragraph
(c) of this section only upon a showing by a participant of
extraordinary circumstances. Such an extension shall be requested by
filing a written request with the Commissioner's Executive Secretariat
(HF-40) and serving copies of the request on the Division of Dockets
Management (HFA-305), the Chief Counsel (GCF-1), and all hearing
participants.
(e) If the Commissioner decides to hear oral argument, the
participants will be informed of the date, time, and place, the amount
of time allotted to each participant, and the issues to be addressed.
(f) Within 10 days following the expiration of the time for filing
exceptions (including any extensions), the Commissioner may file with
the Division of Dockets Management, and serve on the participants, a
notice of the Commissioner's determination to review the initial
decision. The Commissioner may invite the participants to file briefs or
present oral argument on the matter. The time for filing briefs or
presenting oral argument will be specified in that or a later notice.
[44 FR 22339, Apr. 13, 1979, as amended at 53 FR 29453, Aug. 5, 1988]
Sec.12.130 Decision by Commissioner on appeal or review of initial decision.
(a) On appeal from or review of the initial decision, the
Commissioner has all the powers given to make the initial decision. On
the Commissioner's own initiative or on motion, the Commissioner may
remand the matter to the presiding officer for any further action
necessary for a proper decision.
(b) The scope of the issues on appeal is the same as the scope of
the issues at the public hearing unless the Commissioner specifies
otherwise.
(c) As soon as possible after the filing of briefs and any oral
argument, the Commissioner will issue a final decision in the
proceeding, which meets the requirements established in Sec.12.120 (b)
and (c).
(d) The Commissioner may adopt the initial decision as the final
decision.
(e) Notice of the Commissioner's decision will be published in the
Federal Register, or the Commissioner may publish the decision when it
is of widespread interest.
Sec.12.139 Reconsideration and stay of action.
Following notice or publication of the final decisions, a
participant may petition the Commissioner for reconsideration of any
part or all of the decision under Sec.10.33 or may petition for a stay
of the decision under Sec.10.35.
Subpart H_Judicial Review
Sec.12.140 Review by the courts.
(a) The Commissioner's final decision constitutes final agency
action from which a participant may petition for judicial review under
the statutes governing the matter involved. Before requesting an order
from a court for a stay of action pending review, a participant shall
first submit a petition for a stay of action under Sec.10.35.
(b) Under 28 U.S.C. 2112(a), FDA will request consolidation of all
petitions related to a particular matter.
[[Page 133]]
Sec.12.159 Copies of petitions for judicial review.
The Chief Counsel for FDA has been designated by the Secretary as
the officer on whom copies of petitions of judicial review are to be
served. This officer is responsible for filing the record on which the
final decision is based. The record of the proceeding is certified by
the Commissioner.
PART 13_PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY--Table of Contents
Subpart A_General Provisions
Sec.
13.1 Scope.
13.5 Notice of a hearing before a Board.
13.10 Members of a Board.
13.15 Separation of functions; ex parte communications; administrative
support.
Subpart B_Hearing Procedures
13.20 Submissions to a Board.
13.25 Disclosure of data and information by the participants.
13.30 Proceedings of a Board.
Subpart C_Records of a Hearing Before a Board
13.40 Administrative record of a Board.
13.45 Examination of administrative record.
13.50 Record for administrative decision.
Authority: 5 U.S.C. 551-558, 701-721; 15 U.S.C. 1451-1461; 21 U.S.C.
141-149, 321-393, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201,
262, 263b-263n, 264.
Source: 44 FR 22348, Apr. 13, 1979, unless otherwise noted.
Subpart A_General Provisions
Sec.13.1 Scope.
The procedures in this part apply when--
(a) The Commissioner concludes, as a matter of discretion, that it
is in the public interest to hold a public hearing before a Public Board
of Inquiry (Board) with respect to any matter before FDA;
(b) Under specific sections of this chapter a matter before FDA is
subject to a hearing before a Board; or
(c) Under Sec.12.32, a person who has a right to an opportunity
for a formal evidentiary public hearing waives that opportunity and
requests that a Board act as an administrative law tribunal concerning
the matters involved, and the Commissioner decides to accept this
request.
Sec.13.5 Notice of a hearing before a Board.
If the Commissioner determines that a Board should be established to
conduct a hearing on any matter, a notice of hearing will be published
in the Federal Register setting forth the following information:
(a) If the hearing is under Sec.13.1 (a) or (b), all applicable
information described in Sec.12.32(e).
(1) Any written document that is to be the subject matter of the
hearing will be published as a part of the notice, or the notice will
refer to it if the document has already been published in the Federal
Register or state that the document is available from the Division of
Dockets Management or an agency employee designated in the notice.
(2) For purposes of a hearing under Sec.13.1 (a) or (b), all
participants who file a notice of participation under Sec.
12.32(e)(6)(ii) are deemed to be parties and entitled to participate in
selection of the Board under Sec.13.15(b).
(b) If the hearing is in lieu of a formal evidentiary hearing, as
provided in Sec.13.1(c), all of the information described in Sec.
12.32(e).
[44 FR 22348, Apr. 13, 1979, as amended at 47 FR 26375, June 18, 1982]
Sec.13.10 Members of a Board.
(a) All members of a Board are to have medical, technical,
scientific, or other qualifications relevant to the issues to be
considered, are subject to the conflict of interest rules applicable to
special Government employees, and are to be free from bias or prejudice
concerning the issues involved. A member of a Board may be a full-time
or part-time Federal Government employee or may serve on an FDA advisory
committee but, except with the agreement of all parties, may not
currently be a full-time or part-time employee of FDA or otherwise act
as a special Government employee of FDA.
(b) Within 30 days of publication of the notice of hearing, the
director of the center of FDA responsible for a
[[Page 134]]
matter before a Board, the other parties to the proceeding, and any
person whose petition was granted and is the subject of the hearing,
shall each submit to the Division of Dockets Management the names and
full curricula vitae of five nominees for members of the Board.
Nominations are to state that the nominee is aware of the nomination, is
interested in becoming a member of the Board, and appears to have no
conflict of interest.
(1) Any two or more persons entitled to nominate members may agree
upon a joint list of five qualified nominees.
(2) The lists of nominees must be submitted to the persons entitled
to submit a list of nominees under this paragraph but not to all
participants. Within 10 days of receipt of the lists of nominees, such
persons may submit comments to the Division of Dockets Management on
whether the nominees of the other persons meet the criteria established
in paragraph (a) of this section. A person submitting comments to the
Division of Dockets Management shall submit them to all persons entitled
to submit a list of nominees.
(3) The lists of nominees and comments on them are to be held in
confidence by the Division of Dockets Management as part of the
administrative record of the proceeding and are not to be made available
for public disclosure, and all persons who submit or receive them shall
similarly hold them in confidence. This portion of the administrative
record remains confidential but is available for judicial review in the
event that it becomes relevant to any issue before a court.
(c) After reviewing the lists of nominees and any comments, the
Commissioner will choose three qualified persons as members of a Board.
One member will be from the lists of nominees submitted by the director
of the center and by any person whose petition was granted and is the
subject of the hearing. The second will be from the lists of nominees
submitted by the other parties. The Commissioner may choose the third
member from any source. That member is the Chairman of the Board.
(1) If the Commissioner is unable to find a qualified person with no
conflict of interest from among a list of nominees or if additional
information is needed, the Commissioner will request the submission of
the required additional nominees or information.
(2) If a person fails to submit a list of nominees as required by
paragraph (b) of this section, the Commissioner may choose a qualified
member without further consultation with that person.
(3) The Commissioner will announce the members of a Board by filing
a memorandum in the record of the proceeding and sending a copy to all
participants.
(d) Instead of using the selection method in paragraphs (b) and (c)
of this section, the director of the center, the other parties to the
proceeding, and any person whose petition was granted and is the subject
of the hearing, may, with the approval of the Commissioner, agree that a
standing advisory committee listed in Sec.14.80 constitutes the Board
for a particular proceeding, or that another procedure is to be used for
selection of the members of the Board, or that the Board consists of a
larger number of members.
(e) The members of a Board serve as consultants to the Commissioner
and are special Government employees or Government employees. A Board
functions as an administrative law tribunal in the proceeding and is not
an advisory committee subject to the requirements of the Federal
Advisory Committee Act or part 14.
(f) The Chairman of the Board has the authority of a presiding
officer set out in Sec.12.70.
[44 FR 22348, Apr. 13, 1979, as amended at 50 FR 8994, Mar. 6, 1985]
Sec.13.15 Separation of functions; ex parte communications; administrative
support.
(a) The proceeding of a Board are subject to the provisions of Sec.
10.55 relating to separation of functions and ex parte communications.
Representatives of the participants in any proceeding before a Board,
including any members of the office of the Chief Counsel of FDA assigned
to advise the center responsible for the matter, may have no contact
with the members of the Board, except as participants in the proceeding,
and may not participate in the deliberations of the Board.
[[Page 135]]
(b) Administrative support for a Board is to be provided only by the
office of the Commissioner and the office of the Chief Counsel for FDA.
[44 FR 22348, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989]
Subpart B_Hearing Procedures
Sec.13.20 Submissions to a Board.
(a) Submissions are to be filed with the Division of Dockets
Management under Sec.10.20.
(b) The person making a submission shall serve copies of it on each
participant in the proceeding, except as provided in Sec. Sec.
13.10(b)(2) and 13.45. Submissions of documentary data and information
need not be sent to each participant, but any accompanying transmittal
letter, summary, statement of position, certification under paragraph
(d) of this section, or similar document must be.
(c) A submission must be mailed to the address shown in the notice
of appearance or personally delivered.
(d) All submissions are to be accompanied by a certificate of
service, or a statement that service is not required.
(e) No written submission or other portion of the administrative
record may be held in confidence, except as provided in Sec. Sec.
13.10(b)(2) and 13.45.
(f) A participant who believes that compliance with the requirements
of this section constitutes an unreasonable financial burden may submit
to the Commissioner a petition to participate in forma pauperis in the
form and manner specified in Sec.12.82.
Sec.13.25 Disclosure of data and information by the participants.
(a) Before the notice of hearing is published under Sec.13.5, the
director of the center responsible for the matters involved in the
hearing must submit to the Division of Dockets Management--
(1) The relevant portions of the existing administrative record of
the proceeding. Portions of the administrative record not relevant to
the issues in the hearing are not part of the administrative record;
(2) A list of all persons whose views will be presented orally or in
writing at the hearing;
(3) All documents in the director's files containing factual
information, whether favorable or unfavorable to the director's
position, which relate to the issues involved in the hearing. Files
means the principal files in the center in which documents relating to
the issues in the hearing are ordinarily kept, e.g., the food additive
master file and the food additive petition in the case of issues
concerning a food additive, or the new drug application in the case of
issues concerning a new drug. Internal memoranda reflecting the
deliberative process, and attorney work product and material prepared
specifically for use in connection with the hearing, are not required to
be submitted;
(4) All other documentary information relied on; and
(5) A signed statement that, to the best of the director's knowledge
and belief, the submission complies with this section.
(b) Within the time prescribed in the notice of hearing published
under Sec.13.5, each participant shall submit to the Division of
Dockets Management all information specified in paragraph (a)(2) through
(5) of this section and any objections that the administrative record
filed under paragraph (a)(1) of this section is incomplete. With respect
to the information specified in paragraph (a)(3) of this section,
participants are to exercise reasonable diligence in identifying
documents in files comparable to those described in that paragraph.
(c) The submissions required by paragraphs (a) and (b) of this
section may be supplemented later in the proceeding, with the approval
of the Board, on a showing that the views of the persons or the material
contained in the supplement was not known or reasonably available when
the initial submission was made or that the relevance of the views of
the persons or the material contained in the supplement could not
reasonably have been foreseen.
(d) The failure to comply substantially and in good faith with this
section in the case of a participant constitutes a waiver of the right
to participate further in the hearing and in
[[Page 136]]
the case of a party constitutes a waiver of the right to a hearing.
(e) The Chairman rules on questions relating to this section. Any
participant dissatisfied with a ruling may petition the Commissioner for
interlocutory review.
[44 FR 22348, Apr. 13, 1979, as amended at 50 FR 8994, Mar. 6, 1985; 54
FR 9035, Mar. 3, 1989]