[Federal Register Volume 88, Number 81 (Thursday, April 27, 2023)]
[Notices]
[Pages 25658-25660]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-08946]


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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: Either electronic or written comments on the collection of 
information must be submitted by June 26, 2023.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of June 26, 2023. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are received 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'').

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 ``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, 240-402-7500.

[[Page 25659]]

     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, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

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.

Animal Drug and Animal Generic Drug User Fee Programs

OMB Control Number 0910-0540--Extension

    This information collection helps support implementation of the 
Animal Drug User Fee Act of 2003 (ADUFA) (Pub. L. 108-130) and Animal 
Generic Drug User Fee Act of 2008 (AGDUFA) (Pub. L. 110-316), 
established in sections 740 and 741 of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 379j-12 and 21 U.S.C. 379j-21), 
respectively. Under ADUFA, FDA assesses and collects user fees for 
certain new animal drug applications and supplements, products, 
establishments, and sponsors of new animal drug applications and/or 
investigational new animal drug file submissions. The ADUFA program is 
currently reauthorized through September 30, 2023, and FDA efforts to 
engage interested stakeholders in the 2023 reauthorization is ongoing. 
More information regarding the ADUFA program can be found at https://www.fda.gov/industry/fda-user-fee-programs/animal-drug-user-fee-act-adufa, including current user fee rates applicable to animal drug 
submissions. Under AGDUFA, FDA assesses and collects user fees for 
certain abbreviated (generic) new animal drug applications and 
supplements, products, and sponsors of generic new animal drug 
applications and/or generic investigational new animal drug file 
submissions. The AGDUFA program is currently reauthorized through 
September 30, 2023, and FDA efforts to engage interested stakeholders 
in the 2023 reauthorization is ongoing. More information regarding the 
AGDUFA program can be found at https://www.fda.gov/industry/fda-user-fee-programs/animal-generic-drug-user-fee-act-agdufa, including current 
user fee rates applicable to generic animal drug submissions.
    These user fee program resources support FDA's responsibilities to 
ensure that new animal drugs are safe and effective for animals, as 
well as ensuring the safety of food from treated animals.
    Sponsors of new animal drug applications complete a user fee cover 
sheet and submit it through CVM's eSubmitter. 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, the Center) to initiate the administrative screening of new 
animal drug applications and supplements.
    Similarly, sponsors of abbreviated new animal drug applications 
also complete a user fee cover sheet and submit it through CVM's 
eSubmitter. The AGDUFA cover sheet (Form FDA 3728) is also 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.
    Both sections 740 and 741 of the FD&C Act provide for waivers, 
reductions, and exemptions of fees. To assist respondents with 
submitting

[[Page 25660]]

requests for waivers or reductions of ADUFA user fees, we developed 
guidance for industry (GFI) #170 entitled ``Animal Drug User Fees and 
Fee Waivers and Reductions'' (April 2023), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-170-animal-drug-user-fees-and-fee-waivers-and-reductions. This 
document discusses the types of fees FDA is authorized to collect under 
section 740 of the FD&C Act, and how to request waivers or 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, a request for reconsideration of denial of a fee waiver or 
reduction request, or an appeal of the denial decision in accordance 
with 21 CFR 10.75; how to submit such a request or appeal; and FDA's 
process for reviewing such requests or appeals.
    Similarly, we developed guidance for industry (GFI) #199 entitled 
``Animal Generic Drug User Fees and Fee Waivers and Reductions'' (May 
2009), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-199-animal-generic-drug-user-fees-and-fee-waivers-and-reductions. This document discusses the types of fees 
FDA is authorized to collect under section 741(a)(1) of the FD&C Act, 
and how to request waivers or 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, a request for 
reconsideration of denial of a fee waiver or reduction request, or an 
appeal of the denial decision in accordance with 21 CFR 10.75; how to 
submit such a request or appeal; and FDA's process for reviewing such 
requests or appeals.
    We use the information submitted by respondents to determine 
whether requests for waiver or reduction of user fees, reconsideration 
requests, or appeals may be granted.
    We estimate 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 response    Total hours
                                                               respondents     respondent       responses
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                                                             User fee cover sheets, by type
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740(a)(1); Animal Drug User Fee      FDA 3546..............              15               1              15  1..........................              15
 cover sheet.
741(a)(1); Animal Generic Drug User  FDA 3728..............              22               2              44  .08 (5 minutes)............             3.5
 Fee cover sheet.
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                                                           Waiver and other requests, by type
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740(d)(1)(A); significant barrier    N/A...................              65               1              65  2..........................             130
 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...................               4               1               4  2..........................               8
740(d)(1)(D); minor use or minor     N/A...................              73               1              73  2..........................             146
 species.
740(d)(1)(E); small business.......  N/A...................               1               1               1  2..........................               2
741(d)(1); minor use or minor        N/A...................               2               1               2  2..........................               4
 species.
Request for reconsideration of a     N/A...................               1               1               1  2..........................               2
 decision.
21 CFR 10.75; Appeal of a decision.  N/A...................               1               1               1  2..........................               2
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    Total..........................  ......................  ..............  ..............  ..............  ...........................           327.5
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Our estimated burden for the information collection reflects an 
overall increase. We attribute this adjustment to an increase in the 
number of submissions we have received since our last evaluation. The 
total number of annual responses is based on the average number of 
submissions received by FDA in fiscal years 2019 to 2021. The estimated 
time we attribute to the hours per response is based on our experience 
with the various submissions and reflects the average burden we 
attribute to all respondents.

    Dated: April 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-08946 Filed 4-26-23; 8:45 am]
BILLING CODE 4164-01-P