Agency Information Collection Activities; Proposals, Submissions, and Approvals: Reporting Associated with Animal Drug and Animal Generic Drug User Fees

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

DATES:

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

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 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, 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 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 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 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.

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:

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.