[Federal Register: May 21, 2002 (Volume 67, Number 98)]
[&thnsp;Notices]
[Page 35826]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21my02-63]
 
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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 OPAPMN@CFSAN.FDA.GOV, 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/˜dms/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
 

Preparation of Food Contact Notifications: Administrative May 21, 2002

Food Contact Substance Notification System; Final Rule May 21, 2002