[Federal Register Volume 67, Number 98 (Tuesday, May 21, 2002)]
[Notices]
[Page 35826]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-12663]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1360]


Guidance for Industry on Preparation of Food Contact 
Notifications: Administrative; 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 the guidance document entitled "Preparation of 
Food Contact Notifications: Administrative." This guidance 
document is intended to provide guidance for industry regarding the 
preparation of food contact notifications (FCNs). FDA is providing this 
guidance as part of its implementation of the premarket notification 
process for food contact substances (FCSs) established by the Food and 
Drug Administration Modernization Act of 1997 (FDAMA).

DATES: Submit written or electronic comments concerning this guidance 
document at any time.

ADDRESSES: Submit written comments concerning this guidance document 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. 
Submit written requests for single copies of the guidance document 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. You also may request a copy of the 
guidance document by electronic mail at [email protected], or by 
telephone to the Office of Food Additive Safety at 
202-418-3087 (voice) or FAX 202-418-3131. All 
requests should be identified with the guidance document by its title. 
See the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.

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

    FDAMA (Public Law 105-115) amended section 409 of the Federal 
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 348) to establish an 
FCN process as the primary method for authorizing new uses of food 
additives that are FCSs. A "food contact substance" 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 the 
guidance document entitled "Preparation of Food Contact 
Notifications: Administrative." This guidance document is 
intended to provide guidance for industry regarding the preparation of 
FCNs. FDA is providing this guidance document as part of its 
implementation of the premarket notification process for FCSs 
established by FDAMA.

II. Significance of Guidance

    This guidance document represents the agency's current thinking on 
the data and information that should be submitted in an FCN and the 
plan for administration of the FCN program. This guidance document does 
not create or confer any rights for or on any person and does 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. This guidance document is a level 1 guidance under the 
agency's good guidance practices (GGPs) regulations (21 CFR 10.115).
    Because it is a level 1 guidance under the agency's GGPs, FDA 
announced the availability for comment of a draft of the guidance 
document "Preparation of Food Contact Notifications: 
Administrative" in a notice published in the Federal Register of 
July 13, 2000 (65 FR 43377). The comment period for the guidance 
document closed on September 26, 2000. FDA received no comments on the 
guidance document. However, FDA did receive three comments on the 
proposed rule published simultaneously with the July 13, 2000, notice 
of availability. Portions of these three comments are relevant to the 
guidance document and FDA has addressed the relevant portions of the 
comments in the guidance document announced by this notice. Thus, in 
accordance with its GGPs, FDA now is reissuing this guidance document 
in final form.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance 
document at http://www.cfsan.fda.gov/ï¿½7Edms/guidance.html.

IV. Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written and electronic comments regarding the guidance 
document at any time. Two copies of any comments are to be submitted, 
except that individuals may submit one copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. The guidance document and received comments may be seen 
in the office above between 9 a.m. and 4 p.m., Monday through Friday. 
Such comments will be considered when determining whether to amend the 
guidance.

    Dated: May 6, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-12663 Filed 5-20-02; 8:45 am]
BILLING CODE 4160-01-S