This electronic document was downloaded from the GPO web site, November 2003,
and is provided for information purposes only. The Code of Federal Regulations,
Title 21, is updated April 1 of each year.
The most current version of the regulations may be found at the
GPO web site.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR10]
[Page 86-87]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
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 Dockets Management Branch; 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.
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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.
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.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR10.115]
[Page 113-117]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 10--ADMINISTRATIVE PRACTICES AND PROCEDURES--Table of Contents
Subpart B--General Administrative Procedures
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?
[[Page 114]]
(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 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 Dockets Management Branch (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
[[Page 115]]
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:
(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.
[[Page 116]]
(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 Dockets
Management Branch (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. 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 Dockets Management
Branch 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.
[[Page 117]]
(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
Office of the Chief Mediator and Ombudsman to become involved.
[65 FR 56477, Sept. 19, 2000]
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