Document ID: FDA-2007-N-0037-0005
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Animal Drug User
Fee Act Waivers and Reductions
Posted Date: 2014-05-16T04:00Z

[Federal Register Volume 79, Number 95 (Friday, May 16, 2014)]
[Notices]
[Pages 28525-28526]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-11322]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Animal Drug User Fee 
Act 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 June 
16, 2014.

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 emailed to oira_submission@omb.eop.gov. 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@fda.hhs.gov.

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 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 for 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.
    In the Federal Register of February 25, 2014 (79 FR 10532) FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden for this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                    Number of                         Average
   21 CFR section; activity        Number of      responses per    Total annual     burden per      Total hours
                                  respondents      respondent        responses       response
----------------------------------------------------------------------------------------------------------------
740(d)(1)(A); significant                   45  1 time for each               45               2              90
 barrier to innovation.                          application.
740(d)(1)(B); fees exceed cost               8  3.75............              30         \2\ 0.5              15
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 of               2  1 time for each                2               2               4
 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.
\2\ 30 minutes.

    Based on FDA's database system, from fiscal years 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 fiscal years 
2010 to 2012.

[[Page 28526]]

    Dated: May 12, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-11322 Filed 5-15-14; 8:45 am]
BILLING CODE 4160-01-P