[Federal Register: February 8, 2005 (Volume 70, Number 25)]
[Notices]
[Page 6696-6697]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08fe05-74]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D-0422]
Guidance for Industry: Animal Drug Sponsor Fees Under the Animal
Drug User Fee Act; 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 for industry (173) entitled
``Guidance for Industry: Animal Drug Sponsor Fees Under the Animal Drug
User Fee Act (ADUFA).'' This guidance describes how FDA intends to
implement the Federal Food, Drug, and Cosmetic Act (the act) as it
relates to animal drug sponsor fees.
DATES: Comments on agency guidance documents are welcome at any time.
ADDRESSES: Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments on the
guidance via the Internet at 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 and
the docket number found in brackets in the heading of this document.
See the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.
Submit written requests for single copies of the guidance 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.
FOR FURTHER INFORMATION CONTACT: David Newkirk, Center for Veterinary
Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-6967, e-mail: dnewkirk@cvm.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
(173) entitled ``Guidance for Industry: Animal Drug Sponsor
Fees Under the Animal Drug User Fee Act.'' ADUFA requires FDA to assess
and collect user fees for certain applications, products,
establishments, and sponsors. This guidance represents FDA's current
thinking on how it intends to implement the animal drug sponsor fee
provision of ADUFA.
In the Federal Register of September 28, 2004 (69 FR 57941), FDA
published a notice of availability for a draft of the guidance, giving
interested persons until October 28, 2004, to comment. FDA received one
comment on the draft guidance. No substantive changes were made in
finalizing this guidance document.
II. Paperwork Reduction Act of 1995
FDA concludes that this guidance contains no collections of
information. Therefore, clearance by the Office of Management and
Budget under the Paperwork Reduction Act of 1995 is not required.
III. Significance of Guidance
This level 1 guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). This guidance represents
the agency's current thinking on the topic. It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternate method may be used as long as it satisfies
the requirements of applicable statutes and regulations.
IV. Comments
As with all FDA's guidances, the public is encouraged to submit
written or electronic comments with new data or other new information
pertinent to this guidance. FDA periodically will review the comments
in the docket and, where appropriate, will amend the guidance. The
agency will notify the public of any substantive amendments through a
document in the Federal Register.
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the guidance at any
time. Submit a single copy of electronic comments or two paper copies
of any mailed comments, except that individuals may submit one paper
copy. Comments should be identified with the docket number found in
brackets in the heading of this document. A copy of the document 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.
[[Page 6697]]
V. Electronic Access
Copies of the guidance document entitled ``Guidance for Industry:
Animal Drug Sponsor Fees Under the Animal Drug User Fee Act'' may be
obtained from the CVM home page (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cvm) and from 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: January 28, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-2417 Filed 2-7-05; 8:45 am]
BILLING CODE 4160-01-S