[Federal Register: March 9, 2007 (Volume 72, Number 46)]
[Notices]
[Page 10767-10768]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09mr07-83]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D-0301]
Guidance for Industry: Animal Drug User Fees; Fees Exceed Costs
Waiver/Reduction; 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 guidance for industry (183) entitled
``Guidance for Industry: Animal Drug User Fees; Fees Exceed Costs
Waiver/Reduction.'' This 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 (ADUFA).
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 (CVM), 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http:///www.fda.gov/dockets/ecomments.
Comments should be identified with the full title of the
guidance document and the docket number found in the heading of this
document. See the SUPPLEMENTARY INFORMATION section for electronic
access to the 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: david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of August 17, 2006 (71 FR 47502), FDA
published the notice of availability of the draft guidance entitled
``Guidance for Industry: Animal Drug User Fees; Fees Exceed Costs
Waiver and Reductions'' giving interested persons until October 31,
2006, to submit comments. FDA received no comments.
ADUFA (Public Law 108-130) amended the Federal Food, Drug, and
Cosmetic Act (the act) and requires the FDA to 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.
This 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, a written request to the
agency for a waiver/reduction, including under the fees exceed costs
waiver provision, 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 guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The guidance represents
the agency's current thinking on the topic. The document does not
create or confer any rights for or on any person and does 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.
[[Page 10768]]
III. Paperwork Reduction Act of 1995
This 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 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
Interested persons may, at any time, submit to the Division of
Dockets Management (see ADDRESSES) written or electronic comments
regarding the 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 the 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 CVM home page (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cvm) or the Division of Dockets Management Web site http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/
default.htm.
Dated: March 1, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-4322 Filed 3-8-07; 8:45 am]
BILLING CODE 4160-01-S