Document ID: FDA-2010-N-0528-0144
Agency: fda
Document Type: Notice
Title: Unapproved Animal Drugs; Extension of Comment Period
Posted Date: 2011-02-18T05:00Z

[Federal Register Volume 76, Number 34 (Friday, February 18, 2011)]
[Notices]
[Page 9584]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-3712]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0528]

Unapproved Animal Drugs; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Request for comments; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending to April 
19, 2011, the comment period for the notice that appeared in the 
Federal Register of December 20, 2010 (75 FR 79383). In the notice FDA 
requested comments on strategies to address the prevalence of animal 
drug products marketed in the United States without approval or other 
legal marketing status. The Agency is taking this action in response to 
requests for an extension to allow interested persons additional time 
to submit comments.

DATES: Submit electronic or written comments by April 19, 2011.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2010-
N-0528 by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name 
and Docket No. FDA-2010-N-0528. All comments received may be posted 
without change to http://www.regulations.gov, including any personal 
information provided. For additional information on submitting 
comments, see the ``Request for Comments'' heading of the SUPPLEMENTARY 
INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Tracey H. Forfa, Center for Veterinary 
Medicine (HFV-1), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-276-9000, e-mail: Tracey.Forfa@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of December 20, 2010 (75 FR 79383), FDA 
published a notice with a 60-day comment period to request comments 
from stakeholders on strategies to address the prevalence of animal 
drug products marketed in the United States without approval or other 
legal marketing status. The notice expressed FDA's interest in 
receiving comments on strategies that utilize FDA's existing regulatory 
framework for addressing this issue as well as on novel strategies not 
currently employed by the Agency.
    The Agency has received requests for a 60-day extension of the 
comment period. The requests conveyed concern that the current 60-day 
comment period does not allow respondents sufficient time to address 
fully the many important issues FDA raised in the notice.
    FDA has considered the requests and is extending the comment period 
for the notice for 60 days, until April 19, 2011. The Agency believes 
that a 60-day extension allows adequate time for interested persons to 
submit comments without significantly delaying the Agency's 
consideration of these important issues.

II. Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments 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: February 15, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-3712 Filed 2-17-11; 8:45 am]
BILLING CODE 4160-01-P