[Federal Register Volume 81, Number 200 (Monday, October 17, 2016)]
[Notices]
[Pages 71506-71508]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25040]


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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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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).

[[Page 71507]]


DATES: Submit either electronic or written comments on the collection 
of information by December 16, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2007-N-0037 for ``Animal Drug User Fee Act Waivers and 
Reductions.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at http://www.regulations.gov or at the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, [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 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.
    FDA estimates the burden for this collection of information as 
follows:

[[Page 71508]]



                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                             Number of      Number of responses per    Total annual
        21 CFR section; activity            respondents           respondent             responses        Average burden per response       Total hours
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740(d)(1)(A); significant barrier to                  55  1 time for each                         55  2.................................             110
 innovation.                                               application.
740(d)(1)(B); fees exceed cost..........               8  3.75......................              30  0.5 (30 minutes)..................              15
740(d)(1)(C); free choice feeds.........               5  1 time for each                          5  2.................................              10
                                                           application.
740(d)(1)(D); minor use or minor species              69  1 time for each                         69  2.................................             138
                                                           application.
740(d)(1)(E); small business............               1  1 time for each                          1  2.................................               2
                                                           application.
Request for reconsideration of a                       1  1 time for each                          1  2.................................               2
 decision.                                                 application.
Request for review (user fee appeal                    0  1 time for each                          0  0.................................               0
 officer).                                                 application.
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    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.

    Dated: October 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25040 Filed 10-14-16; 8:45 am]
 BILLING CODE 4164-01-P