[Federal Register: March 18, 2004 (Volume 69, Number 53)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D-0124]
Guidance for Industry: Animal Drug User Fees and Fee Waivers and
AGENCY: Food and Drug Administration, HHS.
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: firstname.lastname@example.org.
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
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.
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.
Assistant Commissioner for Policy.
[FR Doc. 04-6182 Filed 3-16-04; 11:10 am]
BILLING CODE 4160-01-S