[Federal Register Volume 66, Number 236 (Friday, December 7, 2001)]
[Proposed Rules]
[Page 63519]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-30331]



[[Page 63519]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 21 CFR Part 500

[Docket No. 01N-0284]


Import Tolerances; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Advance notice of proposed rulemaking; extension of comment 
period.

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SUMMARY:  The Food and Drug Administration (FDA) is extending to March 
11, 2002, the comment period for the advance notice of proposed 
rulemaking (ANPRM) that appeared in the Federal Register of August 10, 
2001 (66 FR 42167). The ANPRM gave notice that FDA was proposing a 
regulation for establishing import tolerances. The ANPRM was soliciting 
comments on issues related to the implementation of the import 
tolerances provision in section 4 of the Animal Drug Availability Act 
of 1996 (ADAA). The ADAA authorizes FDA to establish drug residue 
tolerances (import tolerances) for imported food products of animal 
origin for drugs that are used in other countries, but that are 
unapproved new animal drugs in the United States. Food products of 
animal origin that are in compliance with the import tolerance will not 
be considered adulterated under the Federal Food, Drug, and Cosmetic 
Act (the act) and may be imported into the United States. FDA is taking 
action because it has rescheduled the public meeting on the issue and 
wishes to allow time for the consideration of comments made after the 
meeting.

DATES:  Submit written or electronic comments by March 11, 2002.

ADDRESSES:  Submit written comments to the Dockets Management Branch 
(HFA-235), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT:  Frances Pell, Center for Veterinary 
Medicine (HFV-235), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0188, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Extension of Comment Period

    In the Federal Register of August 10, 2001 (66 FR 42167), FDA 
published an ANPRM that gave notice that FDA intends to propose a 
regulation for establishing import tolerances. Interested persons were 
given until December 10, 2001, to comment on the ANPRM. The ANPRM is 
available on the Internet at: http://www.fda.gov/OHRMS/DOCKETS/98fr/081001a.htm. Because the agency has rescheduled the meeting of the 
Veterinary Medicine Advisory Committee (VMAC) from September 2001 to 
January 2002 (66 FR 58052, November 21, 2001), the agency is extending 
the comment period 90 days. The VMAC will be asked to discuss answers 
to questions similar to those posed in the ANPRM.

II. Comments

    Interested persons may submit written or electronic comments 
regarding the ANPRM by March 10, 2002. Written or electronic comments 
should be submitted to the Dockets Management Branch (address above). 
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. Received 
comments may be seen in the office above between 9 a.m. and 4 p.m., 
Monday through Friday.
    Comments may also be submitted electronically on the Internet at: 
http://www.fda.gov/dockets/ecomments. Once on the Internet site, select 
01N-0284 Import Tolerances and follow the directions.

    Dated: November 30, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-30331 Filed 12-6-01; 8:45 am]
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