[Federal Register: April 11, 2002 (Volume 67, Number 70)]
[Notices]
[Page 17703-17704]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11ap02-68]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 99D-4575 and 99D-4576]
Guidance for Industry: Food Contact Substance Notification
System; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of two final guidance documents entitled: ``Preparation of
Food Contact Notifications and Food Additive Petitions for Food Contact
Substances: Chemistry Recommendations'' and ``Preparation of Food
Contact Notifications for Food Contact Substances: Toxicology
Recommendations.'' These guidance documents are intended to provide
guidance for industry regarding the preparation of food contact
notifications (FCNs) and petitions for food contact substances (FCSs).
FDA is providing these guidance documents as part of its implementation
of the FCN process established by the Food and Drug Administration
Modernization Act of 1997 (FDAMA).
DATES: Submit written or electronic comments on these guidance
documents at any time.
ADDRESSES: Submit written requests for single copies of the guidance
documents to the Office of Food Additive Safety (HFS-275), Food and
Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-
3835. Send one self-addressed adhesive label to assist that office in
processing your requests. Submit written comments on these guidance
documents to the Dockets Management Branch (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to http://www.fda.gov/dockets/ecomments. You
also may request a copy of the guidance documents by electronic mail at
OPAPMN@CFSAN.FDA.GOV, or by telephone to the Office of Food Additive
Safety at 202-418-3087 (voice) or FAX
[[Page 17704]]
202-418-3131. All requests should identify the guidance documents by
the titles listed in the SUMMARY section. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance documents.
FOR FURTHER INFORMATION CONTACT: Mitchell Cheeseman, Center for Food
Safety and Applied Nutrition (HFS-205), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 202-418-3083.
SUPPLEMENTARY INFORMATION:
I. Background
The FDAMA amended section 409 of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 348) to establish the FCN process as
the primary method for authorizing new uses of food additives that are
FCSs. An FCS is defined in section 409(h)(6) of the act as ``any
substance intended for use as a component of materials used in
manufacturing, packing, packaging, transporting, or holding food if
such use is not intended to have any technical effect in such food.''
FDA expects most new uses of FCSs that previously would have been
regulated by issuance of a listing regulation in response to a food
additive petition or would have been exempted from the requirement of a
regulation under the threshold of regulation process will be the
subject of FCNs. FDA is announcing the availability of two final
guidance documents entitled: ``Preparation of Food Contact
Notifications and Food Additive Petitions for Food Contact Substances:
Chemistry Recommendation'' (Docket No. 99D-4575) and ``Preparation of
Food Contact Notifications for Food Contact Substances: Toxicology
Recommendations'' (Docket No. 99D-4576). These documents are intended
to provide guidance for industry regarding the preparation of FCNs. FDA
is providing these final guidance documents as part of its
implementation of the FCN process established by FDAMA.
II. Significance of Guidance
These two final guidance documents represent the agency's current
thinking on the data and information that should be submitted in an
FCN. These guidance documents do not create or confer any rights for or
on any person and do not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statute and regulations. These two
guidance documents are level 1 guidance under the agency's good
guidance practices (GGPs) regulation (21 CFR 10.115).
Because they are level 1 guidance under the agency's GGPs, FDA
announced the availability of these two guidance documents entitled:
``Preparation of Premarket Notifications for Food Contact Substances:
Chemistry Recommendations'' and ``Preparation of Premarket
Notifications for Food Contact Substances: Toxicology Recommendations''
in draft form for comment in a notice published in the Federal Register
of November 12, 1999 (64 FR 61648). The comment period for these two
draft guidance documents closed on February 14, 2000. FDA received two
comments on the draft guidance documents which it has addressed in the
final guidance documents being made available by this notice. Thus, in
accordance with its GGPs, FDA is now reissuing these two guidance
documents in final form. The final guidance documents have different
titles than the draft guidance documents made available in the November
12, 1999, notice.
III. Comments
Interested persons may, at any time, submit written comments
regarding the guidance documents to the Dockets Management Branch (see
ADDRESSES section for address). Two copies of any comments are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the appropriate docket numbers found in brackets in
the heading of this document. The guidance documents and received
comments may be examined in the office above between 9 a.m. and 4 p.m.,
Monday through Friday.
IV. Electronic Access
The guidance also may be accessed on the Internet site for the
Center for Food Safety and Applied Nutrition (CFSAN) listing all CFSAN
guidances at http://www.cfsan.fda.gov/ndms/guidance.html.
Dated: March 29, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-8745 Filed 4-10-02; 8:45 am]
BILLING CODE 4160-01-S