Document ID: FDA-2009-D-0189-0001
Agency: fda
Document Type: Notice
Title: Guidance for Industry: Animal Generic Drug User Fees and Fee Waivers and Reductions; Availability
Posted Date: 2009-05-14T04:00Z

[Federal Register: May 14, 2009 (Volume 74, Number 92)]
[Notices]               
[Page 22752-22753]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14my09-45]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0189]

 
Guidance for Industry: Animal Generic Drug User Fees and Fee 
Waivers and Reductions; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance document for industry (199) 
entitled ``Animal Generic Drug User Fees and Fee Waivers and 
Reductions.'' The purpose of this document is to provide guidance to 
industry on the Animal Generic Drug User Fee Act of 2008 (AGDUFA). FDA 
is issuing this final guidance document for immediate implementation 
consistent with the agency's good guidance practices (GGPs). Interested 
persons may submit comments on agency guidances at any time.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of the guidance 
document to the Communications Staff (HFV-12), Center for Veterinary 
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, 
MD 20855. Send one self-addressed adhesive label to assist that office 
in processing your requests.
    Submit written comments on the guidance document 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.regulations.gov. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: David Newkirk, Center for Veterinary 
Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-276-8307, e-mail: dnewkirk@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    On August 14, 2008, AGDUFA (Public Law 110-316) was enacted. AGDUFA 
amends the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and 
requires FDA to assess and collect user fees for certain applications, 
products, and sponsors. It also requires the agency to grant a waiver 
from or a reduction of fees in certain circumstances. Under section 
741(d) of the FD&C Act, when certain conditions are met, FDA will waive 
or reduce fees for generic new animal drugs intended solely to provide 
for a minor use or minor species indication.
    The purpose of the guidance document is to provide guidance on the 
types of fees FDA is authorized to collect under AGDUFA and how to 
request waivers and reductions of these fees. It describes the types of 
fees, the type of fee waiver or reduction

[[Page 22753]]

available, what information FDA recommends you submit in support of a 
request for a fee waiver or reduction, how to submit such a request, 
and FDA's process for reviewing requests.
    FDA is issuing this level 1 final guidance document for immediate 
implementation consistent with FDA's GGPs regulation (21 CFR 10.115). 
Prior public participation is not feasible because the guidance 
concerns statutory requirements that FDA must implement immediately. 
AGDUFA's user fee provisions are already in effect, and it is essential 
for the agency to provide guidance on how to request fee waivers and 
reductions as quickly as possible. If FDA receives comments on this 
final guidance, it will review the comments and revise the guidance if 
appropriate.

II. Significance of Guidance

    This level 1 guidance is being issued consistent with FDA's GGPs 
regulation (21 CFR 10.115). The guidance represents the agency's 
current thinking on the fee waiver provisions of AGDUFA. It does not 
create or confer any rights for or on any person and will not operate 
to bind FDA or the public. Alternative methods may be used as long as 
they satisfy the requirements of the applicable statutes and 
regulations.

III. Paperwork Reduction Act of 1995

    FDA concludes that there are no collections of information under 
the Paperwork Reduction Act of 1995.

IV. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this guidance. 
Submit a single copy of electronic comments 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. A copy of the guidance and received 
comments are available for public examination in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

V. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either http://www.fda.gov/cvm or http://www.regulations.gov.

    Dated: May 7, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-11218 Filed 5-13-09; 8:45 am]

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