[Federal Register Volume 85, Number 15 (Thursday, January 23, 2020)]
[Notices]
[Pages 3929-3931]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01082]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0145]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Reporting Associated With Animal Drug and Animal 
Generic Drug User Fees

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 information collection provisions of 
FDA's animal drug and animal generic drug user fee programs.

DATES: Submit either electronic or written comments on the collection 
of information by March 23, 2020.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before March 23, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of March 23, 2020. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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'').

[[Page 3930]]

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2020-N-0145 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Reporting Associated with Animal 
Drug and Animal Generic Drug User Fees.'' Received comments, those 
filed in a timely manner (see ADDRESSES), will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff 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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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.

Reporting Associated With Animal Drug and Animal Generic Drug User 
Fees--21 U.S.C. 379j-12 and 379j-21

OMB Control Numbers 0910-0540--Extension

    This information collection supports FDA's animal drug and animal 
generic drug user fee programs. The Animal Drug User Fee Act of 2003 
(ADUFA) (Pub. L. 108-130) amended the Federal Food, Drug, and Cosmetic 
Act (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. 
The Animal Generic Drug User Fee Act of 2008 (AGDUFA) (Pub. L. 110-316) 
added section 741 of the FD&C Act (21 U.S.C. 379j-21), which 
establishes three different kinds of user fees: (1) Fees for certain 
types of abbreviated applications for generic new animal drugs; (2) 
annual fees for certain generic new animal drug products; and (3) 
annual fees for certain sponsors of abbreviated applications for 
generic new animal drugs and/or investigational submissions for generic 
new animal drugs (21 U.S.C. 379j-21(a)). On August 14, 2018, H.R. 5554, 
the Animal Drug and Animal Generic Drug User Fee Amendments of 2018, 
was signed into law to reauthorize the ADUFA and AGDUFA programs 
administered by FDA.
    Sponsors of new animal drug applications prepare and submit user 
fee cover sheets. The Animal Drug User Fee cover sheet (Form FDA 3546) 
is designed to collect the minimum necessary information to determine 
whether a fee is required for the review of an application or 
supplement or whether an application fee waiver was granted, to 
determine the amount of the fee required, and to ensure that each 
animal drug user fee payment is appropriately linked to the animal drug 
application for which payment is made. The form, when completed 
electronically, results in the generation of a unique payment 
identification number used by FDA to track the payment. The information 
collected is used by FDA's Center for Veterinary Medicine (CVM) to 
initiate the administrative screening of new animal drug applications 
and supplements. The information collection associated with the Animal 
Drug User Fee cover sheet currently is approved under OMB control 
number 0910-0539.
    Sponsors of abbreviated new animal drug applications also prepare 
and

[[Page 3931]]

submit user fee cover sheets. The Animal Generic Drug User Fee cover 
sheet (Form FDA 3728) similarly is designed to collect the minimum 
necessary information to determine whether a fee is required for review 
of an application, to determine the amount of the fee required, and to 
ensure that each animal generic drug user fee payment is appropriately 
linked to the abbreviated new animal drug application for which payment 
is made. The form, when completed electronically, results in the 
generation of a unique payment identification number used by FDA to 
track the payment. The information collected is used by CVM to initiate 
the administrative screening of abbreviated new animal drug 
applications. The information collection associated with the Animal 
Generic Drug User Fee cover sheet currently is approved under OMB 
control number 0910-0632.
    FDA has also developed a guidance for industry (GFI) #170 entitled 
``Animal Drug User Fees and Fee Waivers and Reductions.'' This document 
provides guidance on the types of fees FDA is authorized to collect 
under section 740 of the FD&C Act, and how to request waivers and 
reductions from these fees. Further, this guidance also describes 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. The information collection associated with GFI #170 
currently is approved under OMB control number 0910-0540.
    The information collection provisions approved under OMB control 
numbers 0910-0539, 0910-0540, and 0910-0632 are similar in that they 
support FDA's animal drug and animal generic drug user fee programs. 
Thus, with this notice, FDA proposes to consolidate these collections 
of information into one OMB control number for government efficiency 
and to allow the public to look to one OMB control number for all 
reporting associated with FDA's animal drug and animal generic drug 
user fee programs. Because we are proposing to combine all reporting 
associated with FDA's animal drug user fees into one collection, we are 
consolidating the burden under OMB control number 0910-0540 and 
discontinuing OMB control numbers 0910-0539 and 0910-0632.
    Description of Respondents: Respondents to this collection of 
information are new animal drug applicants and abbreviated new animal 
drug applicants. In addition, requests for waivers or reductions of 
user fees may be submitted by a person responsible for paying or 
potentially responsible for paying any of the animal drug user fees 
assessed, including application fees, product fees, establishment fees, 
or sponsor fees.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                   Number of
     FD&C Act Section; Activity             FDA form No.           Number of     responses per   Total annual      Average  burden per      Total hours
                                                                  respondents     respondent       responses            response
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User fee cover sheets, by type:
    740(a)(1); Animal Drug User Fee  FDA 3546.................              21               1              21  1.......................              21
     cover sheet.
    741; Animal Generic Drug User    FDA 3728.................              20               2              40  0.08 (5 minutes)........               3
     Fee cover sheet.
Waiver and other requests, by type:
    740(d)(1)(A); significant        N/A......................              55               1              55  2.......................             110
     barrier to innovation.
    740(d)(1)(B); fees exceed cost.  N/A......................               8            3.75              30  0.5 (30 minutes)........              15
    740(d)(1)(C); free-choice feeds  N/A......................               5               1               5  2.......................              10
    740(d)(1)(D); minor use or       N/A......................              69               1              69  2.......................             138
     minor species.
    740(d)(1)(E); small business...  N/A......................               1               1               1  2.......................               2
    Request for reconsideration of   N/A......................               1               1               1  2.......................               2
     a decision.
    Request for review (user fee     N/A......................               1               1               1  2.......................               2
     appeal officer).
                                    --------------------------------------------------------------------------------------------------------------------
        Total......................  .........................  ..............  ..............  ..............  ........................             303
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    For the purpose of this consolidation, we rely on our previous 
estimates of the number of user fee cover sheet and waiver and other 
request submissions. We estimate 21 respondents will each submit 1 
Animal Drug User Fee cover sheet (Form FDA 3546) for a total of 21 
responses. We estimate 20 respondents will each submit 2 Animal Generic 
Drug User Fee cover sheets (Form FDA 3728) for a total of 40 responses. 
Our estimate of the number of waiver and other request submissions is 
detailed in table 1. These estimates are consistent with our previous 
estimates except for the row labeled, Request for review (user fee 
appeal officer), for which we have increased the estimated number of 
respondents from zero to one and the average burden per response from 0 
to 2 hours to correct the error in our previous submission. We base our 
estimates of the average burden per response on our experience with the 
submission of similar cover sheets and waiver and other requests.
    The information collection reflects an increase in burden by an 
additional 26 hours and 62 responses due to the consolidation of the 
information collections covered by OMB control numbers 0910-0539, 
``Animal Drug User Fee Cover Sheet,'' and 0910-0632, ``Animal Generic 
Drug User Fee Cover Sheet'' and the correction of the error in our 
previous submission.

    Dated: January 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-01082 Filed 1-22-20; 8:45 am]
 BILLING CODE 4164-01-P


