[Federal Register Volume 67, Number 70 (Thursday, April 11, 2002)]
[Notices]
[Pages 17703-17704]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-8745]


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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.

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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 
[email protected], 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