[Federal Register Volume 88, Number 154 (Friday, August 11, 2023)]
[Notices]
[Pages 54620-54621]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17260]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Animal Drug and 
Animal Generic Drug User Fee Submissions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) 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 11, 2023.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. 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: 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: 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 Submissions

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 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 the Center for Veterinary Medicine (CVM) 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 CVM 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 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

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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.
    In the Federal Register of April 27, 2023 (88 FR 25658), we 
published a 60-day notice soliciting public comment on the proposed 
information collection. One general comment was received encouraging 
FDA in its mission to promote and protect animal health.
    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:
    740(a)(1); Animal Drug User Fee cover             3546              15               1              15  1...........................              15
     sheet.
    741(a)(1); Animal Generic Drug User               3728              22               2              44  0.08 (5 minutes)............             3.5
     Fee cover sheet.
Waiver and other requests, by type:
    740(d)(1)(A); Significant barrier to               N/A              65               1              65  2...........................             130
     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 species.             N/A               2               1               2  2...........................               4
    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.............................  ..............  ..............  ..............  ..............  ............................           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: August 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17260 Filed 8-10-23; 8:45 am]
BILLING CODE 4164-01-P