Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reporting Associated With Animal Drug and Animal Generic Drug User Fees

Issuing agencies

Abstract

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.

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<title>Federal Register, Volume 91 Issue 166 (Friday, August 28, 2026)</title>
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[Federal Register Volume 91, Number 166 (Friday, August 28, 2026)]
[Notices]
[Pages 55606-55608]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-17601]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2026-N-2365]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Reporting Associated 
With Animal Drug and Animal Generic Drug User Fees

AGENCY: Food and Drug Administration, HHS.

[[Page 55607]]


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: Submit written comments (including recommendations) on the 
collection of information by September 28, 2026.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0540. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Kelly Covington, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 240-402-5661, 
<a href="/cdn-cgi/l/email-protection#5c0c0e1d0f283d3a3a1c3a383d7234342f723b332a"><span class="__cf_email__" data-cfemail="154547544661747373557371743b7d7d663b727a63">[email&#160;protected]</span></a>.

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 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 files. The ADUFA program is currently 
reauthorized through September 30, 2028, and FDA efforts to engage 
interested stakeholders in the 2028 reauthorization is ongoing. More 
information regarding the ADUFA program can be found at <a href="https://www.fda.gov/industry/fda-user-fee-programs/animal-drug-user-fee-act-adufa">https://www.fda.gov/industry/fda-user-fee-programs/animal-drug-user-fee-act-adufa</a>, 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, 
supplements, and generic investigational new animal drug file 
submissions, products, and sponsors of generic new animal drug 
applications and/or generic investigational new animal drug files. The 
AGDUFA program is currently reauthorized through September 30, 2028, 
and FDA efforts to engage interested stakeholders in the 2028 
reauthorization is ongoing. More information regarding the AGDUFA 
program can be found at <a href="https://www.fda.gov/industry/fda-user-fee-programs/animal-generic-drug-user-fee-act-agdufa">https://www.fda.gov/industry/fda-user-fee-programs/animal-generic-drug-user-fee-act-agdufa</a>, 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 the 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 FDA's Center for Veterinary Medicine's 
(CVM, the Center) 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 CVM to initiate the administrative screening of 
new animal drug applications and supplements.
    Similarly, sponsors of abbreviated new animal drug applications and 
certain generic investigational new animal drug file submissions 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 or submission to an investigational file, 
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 or generic investigational new 
animal drug file submission 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 and certain generic 
investigational new animal drug file submissions.
    Both sections 740 and 741 of the FD&C Act provide for waivers, 
reductions, and exemptions of fees. To assist respondents with 
submitting 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 
<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-170-animal-drug-user-fees-and-fee-waivers-and-reductions">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-170-animal-drug-user-fees-and-fee-waivers-and-reductions</a>. 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 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-199-animal-generic-drug-user-fees-and-fee-waivers-and-reductions">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-199-animal-generic-drug-user-fees-and-fee-waivers-and-reductions</a>. 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.

[[Page 55608]]

    In the Federal Register of March 23, 2026 (91 FR 13854), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                  Number of       Total
      FD&C act section; activity             FDA Form No.          Number of    responses per     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 cover  FDA 3546................             7               2           14  0.5 (30 minutes)...............            7
 sheet.
741(a)(1); Animal Generic Drug User    FDA 3728................            22             2.4           53  0.5 (30 minutes)...............         26.5
 Fee cover sheet.
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                                                           Waiver and other requests, by type
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740(d)(1)(A); significant barrier to   N/A.....................            65               1           65  2..............................          130
 innovation.
740(d)(1)(B); fees exceed cost.......  N/A.....................             4               2            8  0.5 (30 minutes)...............            4
740(d)(1)(C); free choice feeds......  N/A.....................             4               1            4  2..............................            8
740(d)(1)(D); minor use or minor       N/A.....................            78               1           78  2..............................          156
 species.
740(d)(1)(E); small business.........  N/A.....................             4               1            4  2..............................            8
741(d)(1); minor use or minor species  N/A.....................             3               1            3  2..............................            6
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
                                                                ----------------------------------------------------------------------------------------
    Total............................  ........................  ............  ..............  ...........  ...............................        349.5
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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 2022 to 2024. 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.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-17601 Filed 8-27-26; 8:45 am]
BILLING CODE 4164-01-P


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