Document ID: FDA-2011-N-0655-0003
Agency: fda
Document Type: Notice
Title: Animal Generic Drug User Fee Act; Reopening of Comment Period
Posted Date: 2011-12-21T05:00Z

[Federal Register Volume 76, Number 245 (Wednesday, December 21, 2011)]
[Notices]
[Pages 79195-79196]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-32565]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0655]

Animal Generic Drug User Fee Act; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of the comment period.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is extending 
to January 15, 2013, the comment period for the notice of public 
meeting; request for public comments, published in the Federal Register 
of September 20, 2011 (76 FR 58277). In that notice, FDA requested 
comments on the Animal Generic Drug User Fee Act (AGDUFA) program to 
date and solicited suggestions regarding the features FDA should 
propose for the next AGDUFA program. The Agency is taking this action 
to ensure that interested persons have the option of submitting 
comments throughout the reauthorization of AGDUFA.

DATES: Submit either electronic or written comments by January 15, 
2013.

ADDRESSES: Submit electronic comments to: http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Identify comments with the docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Donal Parks, Center for Veterinary 
Medicine (HFV-010), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, (240) 276-8688, AGDUFAReauthorization@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of September 20, 2011, FDA published a 
notice of

[[Page 79196]]

public meeting; request for comments, to solicit input from the public 
on what FDA should consider including in the reauthorization of AGDUFA. 
FDA is interested in responses from the public on the following two 
general questions and welcomes other pertinent information that 
stakeholders would like to share:
    1. What is your assessment of the overall performance of the AGDUFA 
program thus far?
    2. What aspects of AGDUFA should be retained, changed, or 
discontinued to further strengthen and improve the program?
    Additional background materials, including the transcript of the 
public meeting, are available on the FDA's Web site.
    The Agency is reopening the comment period to allow members of the 
general public or of stakeholder groups the opportunity to provide 
comments throughout the process of reauthorizing AGDUFA.

II. How to Submit Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments on 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: December 15, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-32565 Filed 12-20-11; 8:45 am]
BILLING CODE 4160-01-P