[Federal Register Volume 71, Number 159 (Thursday, August 17, 2006)]
[Notices]
[Pages 47502-47503]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-13507]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D-0301]
Draft Guidance for Industry; Animal Drug User Fees: Fees Exceed
Costs 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availability of the draft guidance for industry (183) entitled
``Animal Drug User Fees: Fees Exceed Costs Waivers and Reductions.''
The draft guidance explains the procedures FDA expects to use to
evaluate waiver requests under the fees exceed costs waiver provision
of the Animal Drug User Fee Act of 2003.
DATES: Submit written or electronic comments on the draft guidance by
October 31, 2006 to ensure their adequate consideration in preparation
of the final document. General comments on agency guidance documents
are welcome at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance document to the Communications Staff (HFV-12), Center for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
draft guidance document to the Division of Dockets Management (HFA-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.fda.gov/
dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Dave Newkirk, Center for Veterinary
Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-6967, e-mail: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
The Animal Drug User Fee Act of 2003 (ADUFA) (Public Law 108-130)
amended the Federal Food, Drug, and Cosmetic Act (the act) and requires
that FDA assess and collect user fees for certain applications,
products, establishments, and sponsors. It also requires the agency to
grant a waiver from, or a reduction of, those fees in certain
circumstances.
The draft guidance explains the procedures FDA expects to use to
evaluate waiver requests under the fees exceed costs waiver provision
of ADUFA. These procedures may be modified in the future as FDA gains
more experience with waiver requests.
To qualify for waiver consideration for fees due on or after
October 1, 2004, a written request for a fees exceed costs waiver or
reduction must be submitted no later than 180 days after the fee is due
(section 740(i) of the act (21 U.S.C. 379j-12(i))).
II. Significance of Guidance
This level 1 draft guidance is being issued consistent with FDA's
Good Guidance Practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent the agency's current thinking on the
topic. The document does not create or confer any rights for or on any
person and will not operate to bind FDA or the public. Alternative
approaches may be used as long as they satisfy the requirements of the
applicable statutes and regulations.
III. Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information found in Guidance for Industry 170. These
collections of information are subject to review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520) and have been approved under OMB Control No.
0910-0540.
IV. Comments
This draft guidance document is being distributed for comment
purposes only and is not intended for implementation at this time.
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of
[[Page 47503]]
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 full title of the draft guidance document and the
docket number found in brackets in the heading of this document. A copy
of the draft 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
Electronic comments may be submitted on the Internet at http://www.fda.gov/dockets/ecomments. Once on the Internet site, select Docket
No. 2006D-0301, ``Animal Drug User Fees; Fees Exceeds Costs Waivers and
Reductions'' and follow the directions. A copy of this document may be
obtained on the Internet from the CVM home page at http://www.fda.gov/cvm.
Dated: August 10, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-13507 Filed 8-16-06; 8:45 am]
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