[Federal Register Volume 70, Number 248 (Wednesday, December 28, 2005)]
[Proposed Rules]
[Page 76732]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-24512]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 20, 510, 514, and 516

[Docket No. 2005N-0329]
RIN 0910-AF60


Designation of New Animal Drugs for Minor Uses or Minor Species; 
Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; reopening of the comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening until 
January 27, 2006, the comment period for the proposed rule published in 
the Federal Register of September 27, 2005 (70 FR 56394), proposing 
implementing regulations for designation of new animal drugs for minor 
uses and minor species under section 573 of the Federal Food, Drug, and 
Cosmetic Act (the act). FDA is reopening the comment period to update 
comments and to receive any new information.

DATES: Submit written or electronic comments by January 27, 2006.

ADDRESSES: Submit written comments to the Division of Dockets 
Management (HFA-305), 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: Andrew Beaulieu, Center for Veterinary 
Medicine (HFV-50), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-276-9090, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of September 27, 2005 (70 FR 56394), FDA 
proposed implementing regulations for designation of new animal drugs 
for minor uses and minor species under section 573 of the act (21 
U.S.C. 360ccc-2). Interested persons were originally given until 
December 12, 2005, to comment.

II. Request for Comments

    Following publication of the September 27, 2005, proposed rule, FDA 
received requests to allow interested persons additional time to 
comment. The requesters asserted that the time period of 75 days was 
insufficient to respond fully to FDA's specific requests for comments 
and to allow potential respondents to thoroughly evaluate and address 
pertinent issues.

III. How to Submit Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments to http://www.fda.gov/dockets/ecomments or two paper copies of any mailed comments, except 
that individuals may submit one paper 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 Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: December 21, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-24512 Filed 12-27-05; 8:45 am]
BILLING CODE 4160-01-S