[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Draft Guidance for Industry; Animal Drug User Fees: Fees Exceed 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availability of the draft guidance for industry (183) entitled 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The draft guidance explains the procedures FDA expects to use to 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DATES: Submit written or electronic comments on the draft guidance by 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ADDRESSES: Submit written requests for single copies of the draft 
guidance document to the Communications Staff (HFV-12), Center for 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draft guidance document to the Division of Dockets Management (HFA-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electronic access to the draft guidance document.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    The draft guidance explains the procedures FDA expects to use to 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]
BILLING CODE 4160-01-S