[Federal Register Volume 70, Number 25 (Tuesday, February 8, 2005)]
[Notices]
[Pages 6696-6697]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-2417]


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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://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: [email protected].

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://www.fda.gov/cvm) and from the 
Division of Dockets Management Web site (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