[Federal Register Volume 65, Number 135 (Thursday, July 13, 2000)]
[Notices]
[Page 43377]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-17654]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1360]


Draft Guidance for Industry: Food-Contact Substance Notification 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availability of a draft guidance document entitled ``Preparation of 
Premarket Notifications for Food Contact Substances: Administrative.'' 
This document is intended to provide guidance for industry regarding 
the preparation of premarket notifications for food-contact substances 
(FCS). FDA is providing this draft guidance as part of its 
implementation of the premarket notification process for FCS 
established by the Food and Drug Administration Modernization Act of 
1997 (FDAMA).

DATES: Submit written comments on this draft guidance by September 26, 
2000 to ensure their adequate consideration in the preparation of the 
final document.

ADDRESSES: Submit written requests for single copies of the draft 
guidance entitled ``Preparation of Premarket Notifications for Food 
Contact Substances: Administrative'' to the Office of Premarket 
Approval (HFS-200), Food and Drug Administration, 200 C St. SW., 
Washington, DC 20204. The document may also be obtained by calling the 
Office of Premarket Approval at 202-418-3080 or by fax at 202-418-3131. 
See the SUPPLEMENTARY INFORMATION section for electronic access to this 
guidance.
    Submit written comments concerning this draft guidance to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Comments should be 
identified with the docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Mitchell Cheeseman, Center for Food 
Safety and Applied Nutrition (HFS-215), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 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 a 
premarket notification (PMN) process as the primary method for 
authorizing new uses of food additives that are FCS. 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 FCS 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 (21 CFR 170.39) 
will be the subject of PMN's. FDA is announcing the availability of a 
draft guidance document entitled ``Preparation of Premarket 
Notifications for Food Contact Substances: Administrative.'' This 
document is intended to provide guidance for industry regarding the 
preparation of premarket notifications for FCS. FDA is providing this 
draft guidance as part of its implementation of the premarket 
notification process for FCS established by FDAMA. Elsewhere in this 
issue of the Federal Register FDA is proposing regulations necessary to 
implement the notification process for FCS.

II. Significance of Guidance

    This draft guidance document represents the agency's current 
thinking on the data and information that should be submitted in a 
premarket notification for the use of a FCS. This draft 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 draft guidance document is a level 1 guidance under the 
agency's good guidance practices (62 FR 8961, February 27, 1997).

III. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding the draft guidance document 
by September 26, 2000. 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 draft guidance and received comments are available 
for public examination in the Dockets Management Branch between 9 a.m. 
and 4 p.m., Monday through Friday. Such comments will be considered 
when determining whether to amend the draft guidance.

VI. Electronic Access

    The draft guidance may also be accessed on the Internet site for 
the Center for Food Safety and Applied Nutrition at http://www.cfsan.fda.gov.

    Dated: June 27, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-17654 Filed 7-12-00; 8:45 am]
BILLING CODE 4160-01-F