[Federal Register Volume 76, Number 24 (Friday, February 4, 2011)]
[Notices]
[Pages 6475-6476]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-2441]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0603]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Animal Drug User Fees 
and Fee Waivers and Reductions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by March 
7, 2011.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or e-mailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0540. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Johnny Vilela, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-7651, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Animal Drug User Fees and Fee Waivers and Reductions--(OMB Control 
Number 0910-0540)--Extension

    Enacted on November 18, 2003, the Animal Drug User Fee Act (ADUFA) 
(Pub. L. 108-130) amended the Federal Food, Drug, and Cosmetic Act (the 
FD&C 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 those fees in 
certain circumstances. Thus, to implement this statutory provision of 
ADUFA, FDA developed a guidance entitled

[[Page 6476]]

``Guidance for Industry: Animal Drug User Fees and Fee Waivers and 
Reductions.'' This document provides guidance on the types of fees FDA 
is authorized to collect under ADUFA, and how to request waivers and 
reductions from FDA's animal drug user fees. The guidance also 
describes the types of fees and fee waivers and reductions, the 
information FDA recommends respondents submit in support of a request 
for a fee waiver or reduction, how respondents may submit such a 
request, and FDA's process for reviewing requests.
    Respondents to this collection of information are new animal drug 
sponsors. Requests for waivers or reductions may be submitted by a 
person paying any of the animal drug user fees assessed--application 
fees, product fees, establishment fees, or sponsor fees.
    In the Federal Register of December 2, 2010 (75 FR 75175), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                      Annual
        FD&C Act section             Number of     frequency per   Total annual      Hours per      Total hours
                                    respondents      response        responses       response
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740(d)(1)(A) Significant barrier              22               1              22               2              44
 to innovation..................
740(d)(1)(B) Fees exceed cost...               0               1               0               2               0
740(d)(1)(C) Free choice feeds..               2               1               2               2               4
740(d)(1)(D) Minor use or minor               52               1              52               2             104
 species........................
740(d)(1)(E) Small business.....               0               1               0               0               0
Request for reconsideration of a               5               1               5               2              10
 decision.......................
Request for review--(user fee                  2               1               2               2               4
 appeal officer)................
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    Total.......................  ..............  ..............  ..............  ..............             166
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on FDA's database system, there are an estimated 250 sponsors 
of products subject to ADUFA. However, not all sponsors will have any 
submissions in a given year and some may have multiple submissions. The 
total number of waiver requests is based on the number of submission 
types received by FDA in fiscal year 2008.

    Dated: January 31, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-2441 Filed 2-3-11; 8:45 am]
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