[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]
BILLING CODE 4160-01-S