Document ID: FDA-2012-N-0447-0006
Agency: fda
Document Type: Proposed Rule
Title: Antimicrobial Animal Drug Sales and Distribution Reporting: Extension of Comment Period
Posted Date: 2012-09-26T04:00Z

[Federal Register Volume 77, Number 187 (Wednesday, September 26, 2012)]
[Proposed Rules]
[Page 59156]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-23740]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 514

[Docket No. FDA-2012-N-0447]

Antimicrobial Animal Drug Sales and Distribution Reporting; 
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 the 
comment period for the advance notice of proposed rulemaking that 
appeared in the Federal Register of July 27, 2012. In the advance 
notice of proposed rulemaking, FDA requested comments regarding 
potential changes to its regulations relating to records and reports 
for approved antimicrobial new animal drugs. The Agency is taking this 
action in response to requests for an extension to allow interested 
persons additional time to submit comments.

DATES: The comment period for the advance notice of proposed rulemaking 
that published July 27, 2012 (77 FR 44177) is extended. Submit written 
or electronic comments by November 26, 2012.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2012-
N-0447, 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 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-2012-N-0447 for this rulemaking. 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: Neal Bataller, Center for Veterinary 
Medicine (HFV-210), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-276-9062, email: neal.bataller@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 27, 2012 (77 FR 44177), FDA 
published an advance notice of proposed rulemaking with a 60-day 
comment period to request comments regarding potential changes to its 
regulations relating to records and reports for approved new animal 
drugs. FDA is considering revisions to this regulation to incorporate 
the requirements of section 105 of the Animal Drug User Fee Amendments 
of 2008 (ADUFA 105). The Agency is also seeking public comment on how 
best to compile and present the summary information as directed by 
ADUFA 105, and on alternative methods available to the Agency for 
obtaining additional data and information about the extent of 
antimicrobial drug use in food-producing animals.
    The Agency has received requests for a 60-day extension of the 
comment period for the advance notice of proposed rulemaking. The 
requests conveyed concern that the current 60-day comment period does 
not allow sufficient time to develop a meaningful or thoughtful 
response to the advance notice of proposed rulemaking.
    FDA has considered the requests and is extending the comment period 
for the advance notice of proposed rulemaking for 60 days, until 
November 26, 2012. The Agency believes that a 60-day extension allows 
adequate time for interested persons to submit comments without 
significantly delaying rulemaking on these important issues.

II. Request for Comments

    Interested persons may submit either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. It is only necessary 
to send one set of 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, and will be posted to the docket at http://www.regulations.gov.

    Dated: September 20, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-23740 Filed 9-21-12; 4:15 pm]
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