[Federal Register Volume 69, Number 187 (Tuesday, September 28, 2004)]
[Notices]
[Pages 57941-57942]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-21677]


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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availability of a draft guidance (173) entitled ``Guidance For 
Industry: Animal Drug Sponsor Fees Under the Animal Drug User Fee Act 
(ADUFA).'' This draft guidance describes how FDA intends to implement 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DATES: Submit written or electronic comments on the draft guidance by 
October 28, 2004, 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ADDRESSES: Submit written requests for single copies of the draft 
guidance document to the Communications Staff (HFV-12), Center for 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    Submit written comments on the draft guidance document to the 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. Comments should be 
identified with the full title of the draft guidance document and the 
docket number found in the heading of this document. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.

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

    The Animal Drug User Fee Act of 2003 (ADUFA), enacted on November 
18, 2003, amends the act by adding sections 739 and 740 (21 U.S.C. 
379j-11 and 379j-12). Section 740 requires FDA to assess and collect 
user fees for certain applications, products, establishments, and 
sponsors. This draft guidance represents FDA's current thinking on how 
it intends to implement the animal drug sponsor fee provision of ADUFA.

II. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this draft 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 draft guidance is being issued as a level 1 guidance 
consistent with our good guidance practices regulation (21 CFR 10.115). 
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 the applicable statutes and 
regulations.

III. Comments

    This draft guidance 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 draft guidance document. 
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. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

IV. Electronic Access

    Electronic comments may be submitted on the Internet at http://www.fda.gov/dockets/ecomments. Once on this site, select [2004D-0422]

[[Page 57942]]

 ``Guidance for Industry: Animal Drug Sponsor Fees Under the Animal 
Drug User Fee Act'' and follow the directions. Copies of this guidance 
may be obtained on the Internet from the CVM home page at http://www.fda.gov/cvm.

    Dated: September 21, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-21677 Filed 9-27-04; 8:45 am]
BILLING CODE 4160-01-S