[Federal Register: December 28, 2005 (Volume 70, Number 248)]
[Proposed Rules]
[Page 76732]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28de05-26]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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: Andrew.Beaulieu@fda.gov.
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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