[Federal Register Volume 67, Number 113 (Wednesday, June 12, 2002)]
[Notices]
[Pages 40317-40318]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-14840]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0276]


Guidance for Industry: Channels of Trade Policy for Commodities 
With Vinclozolin Residues; 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 final guidance document for industry entitled 
``Channels of Trade Policy for Commodities With Vinclozolin Residues.'' 
This guidance presents FDA's policy for implementing, for the pesticide 
chemical vinclozolin, the channels of trade provision in the Federal 
Food, Drug, and Cosmetic Act (the act), as amended by the Food Quality 
Protection Act (FQPA) of 1996. The guidance is intended to assist firms 
in understanding FDA's planned approach to the enforcement of this 
provision of the FQPA with regard to residues of vinclozolin in food.

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

ADDRESSES: Submit written comments concerning the 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 entitled ``Channels 
of Trade Policy for Commodities With Vinclozolin Residues'' to the 
Office of Plant and Dairy Foods and Beverages (HFS-305), Center for 
Food Safety and Applied Nutrition, Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740-3835. Send two self-
addressed adhesive labels to assist that office in processing your 
request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to this document.

FOR FURTHER INFORMATION CONTACT: Michael E. Kashtock, Center for Food 
Safety and Applied Nutrition (HFS-305), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-2022, FAX 
301-436-2651, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In a notice published in the Federal Register of July 10, 2001 (66 
FR 35990), FDA announced the availability of a draft guidance document 
entitled ``Channels of Trade Policy for Commodities With Vinclozolin 
Residues.'' The agency has finalized the draft guidance after receiving 
no comments on the document. In a notice published in the Federal 
Register of October 23, 2001 (66 FR 53614), FDA announced that it was 
submitting to the Office of Management and Budget (OMB) for review and 
clearance under the Paperwork Reduction Act of 1995 the collection of 
information entitled ``Suggested Documentation for Demonstrating 
Compliance With the Channels of Trade Provision for Foods With 
Vinclozolin Residues.'' In the October notice, FDA estimated that the 
guidance entitled ``Channels of Trade Policy for Commodities With 
Vinclozolin Residues'' would create an estimated annual reporting 
burden of 921 hours and an estimated annual recordkeeping burden of 496 
hours. The October notice also requested comments on these burden 
estimates. On March 25, 2002, OMB informed FDA that it had approved the 
information collection until March 31, 2005.

II. Guidance Document

    This final guidance document is being issued as level 1 guidance 
consistent with FDA's good guidance practices regulation (21 CFR 
10.115). The guidance represents the agency's current thinking on the 
channels of trade provision and how this provision relates to FDA-
regulated products with residues of vinclozolin. It 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.

III. Electronic Access

    Copies of this guidance also may be downloaded to a personal 
computer with access to the Internet. The final guidance document may 
be accessed at http://www.cfsan.fda.gov under ``How to Obtain FDA Food 
& Cosmetic Guidance Documents.''

[[Page 40318]]

IV. Comments

    Interested persons may, at any time, submit written comments 
concerning the guidance entitled ``Channels of Trade Policy for 
Commodities With Vinclozolin Residues'' to the Dockets Management 
Branch (see ADDRESSES). 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. A copy of the guidance is available for public 
examination in the Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: May 31, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-14840 Filed 6-11-02; 8:45 am]
BILLING CODE 4160-01-S