[Federal Register: March 18, 2004 (Volume 69, Number 53)]
[Page 12863-12864]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2004D-0124]

Guidance for Industry: Animal Drug User Fees and Fee Waivers and 
Reductions; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance document for industry (170) 
entitled ``Animal Drug User Fees and Fee Waivers and Reductions.'' The 
purpose of this document is to provide guidance to industry on the fee 
waiver provisions of the Animal Drug User Fee Act of 2003 (ADUFA). The 
guidance document is immediately in effect, but it remains subject to 
comment in accordance with the agency's good guidance practices (GGPs).

DATES: Submit written or electronic comments on agency guidances at any 

ADDRESSES: 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 brackets in the heading of this document. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the guidance 
    Submit written requests for single copies of the 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.

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.


I. Background

    On November 18, 2003, ADUFA (Public Law 108-130) was enacted. ADUFA 
amends the Federal Food, Drug, and Cosmetic Act and requires 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 fees in certain circumstances.
    The purpose of the guidance document is to provide guidance on the 
types of fees FDA is authorized to collect and how to request waivers 
and reductions from FDA's animal drug user fees. It describes the types 
of fees and fee waivers and reductions, what information FDA recommends 
you submit in support of a request for a fee waiver or reduction, how 
to submit such a request, and FDA's process for reviewing requests.
    FDA is making this guidance document immediately available because 
prior public participation was not feasible or appropriate. ADUFA's 
user fee provisions are already in effect, and it is essential for the 
agency to provide guidance on how to request fee waivers and reductions 
as quickly as possible. Although it was not feasible or appropriate to 
obtain comments before issuing the guidance, in accordance with this 
agency's procedures, FDA will accept comments on the guidance at any 

II. Paperwork Reduction Act of 1995

    FDA is announcing that a collection of information entitled 
``Guidance for Industry: Animal Drug User Fees and Fee Waivers and 
Reductions'' has been approved by the Office of Management and Budget 
(OMB) under the emergency processing provisions of the Paperwork 
Reduction Act of 1995 (the PRA). According to the PRA, a collection of 
information should display a valid OMB control number. The valid OMB 
control number for this information collection is 0910-0540. It expires 
on September 30, 2004. A copy of the supporting statement for this 
information collection is available on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets

III. Significance of Guidance

    This level 1 guidance is being issued consistent with FDA's GGPs 
regulation (21 CFR 10.115). The guidance represents the agency's 
current thinking on the fee waiver provisions of ADUFA. It does not 
create or confer any rights for

[[Page 12864]]

or on any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statutes and regulations.

IV. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this 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 brackets 
in the heading of this document. A copy of the guidance and received 
comments may be seen 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 this guidance from 
the CVM home page at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cvm.

    Dated: March 15, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-6182 Filed 3-16-04; 11:10 am]