82 FR 32827 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Drug User Fee Act Waivers and Reductions

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 136 (July 18, 2017)

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.

[Federal Register Volume 82, Number 136 (Tuesday, July 18, 2017)]
[Notices]
[Pages 32827-32828]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-14998]


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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 August 
17, 2017.

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 [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: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[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 (Pub. L. 
108-130) amended the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act) by adding section 740 of the FD&C Act (21 U.S.C 379j-12), which 
requires that FDA assess and collect user fees with respect to new 
animal drug applications 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. FDA uses the 
information submitted by respondents to determine whether to grant the 
requested fee waiver or reduction.
    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 October 17, 2016 (81 FR 71506), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received no comments.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 32828]]



                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                   Number of
  FD&C act section/activity       Number of      responses per    Total annual    Average burden    Total hours
                                 respondents      respondent        responses      per response
----------------------------------------------------------------------------------------------------------------
740(d)(1)(A); significant                  55  1 time for each               55  2..............             110
 barrier to innovation.                         application.
740(d)(1)(B); fees exceed                   8  3.75............              30  .5 (30 minutes)              15
 cost.
740(d)(1)(C); free choice                   5  1 time for each                5  2..............              10
 feeds.                                         application.
740(d)(1)(D); minor use or                 69  1 time for each               69  2..............             138
 minor species.                                 application.
740(d)(1)(E); small business.               1  1 time for each                1  2..............               2
                                                application.
Request for reconsideration                 1  1 time for each                1  2..............               2
 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) 2014 to 2016 
there were an estimated 177 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 2014 to 
2016. The burden has not changed since the last OMB approval.

    Dated: July 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-14998 Filed 7-17-17; 8:45 am]
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