[Federal Register Volume 79, Number 37 (Tuesday, February 25, 2014)]
[Notices]
[Pages 10532-10534]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-04013]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-N-0037]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Animal Drug User Fee Act Waivers and Reductions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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[[Page 10533]]

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the paperwork burden of 
requesting a waiver or reduction of fees under Animal Drug User Fee Act 
(ADUFA).

DATES: Submit either electronic or written comments on the collection 
of information by April 28, 2014.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, [email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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 (Pub. L. 
108-130) amended 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 those fees in certain circumstances. 
Thus, to implement this statutory provision of ADUFA, FDA developed a 
guidance entitled, ``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. 
Further, this guidance also describes the types of fees and fee waivers 
and reductions; what information FDA recommends be submitted in support 
of a request for a fee waiver or reduction; how to submit such a 
request; and FDA's process for reviewing requests.
    Respondents to this collection of information are new animal drug 
sponsors. Requests or waivers or reductions may be submitted by a 
person paying any of the animal drug user fees assessed including 
application fees, product fees, establishment fees, or sponsor fees.
    FDA estimates the burden for this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                   Number of
   21 CFR section; activity       Number of      responses per    Total annual    Average burden    Total hours
                                 respondents      respondent        responses      per response
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740(d)(1)(A); significant                  45  1 time for each               45  2..............              90
 barrier to innovation.                         application.
740(d)(1)(B); fees exceed                   8  3.75............              30  0.5 (30                      15
 cost.                                                                            minutes).
740(d)(1)(C); free choice                   5  1 time for each                5  2..............              10
 feeds.                                         application.
740(d)(1)(D); minor use or                 76  1 time for each               76  2..............             152
 minor species.                                 application.
740(d)(1)(E); small business.               3  1 time for each                3  2..............               6
                                                application.
Request for reconsideration                 2  1 time for each                2  2..............               4
 of a decision.                                 application.
Request for review (user fee                0  1 time for each                0  0..............               0
 appeal officer).                               application.
                              ----------------------------------------------------------------------------------
    Total....................  ..............  ................  ..............  ...............             277
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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, from fiscal year (FY) 2010 to 2012 
there were an estimated 173 sponsors 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 average number of submission types received by FDA in FY 2010-2012.


[[Page 10534]]


    Dated: February 20, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-04013 Filed 2-24-14; 8:45 am]
BILLING CODE 4160-01-P