Update: On October 19, 2022, the FDA announced it would extend the comment period announced in the notice of public meeting and request for comments published September 30, 2022. Either electronic or written comments on the notice must be submitted by November 14, 2022, to ensure that the Agency considers your comments regarding this public meeting and request for comments. The FDA is taking this action due to a delay in the posting of the AGDUFA IV Performance Goals and Procedures Letter. This extension will provide the public 30 days to comment.
October 12, 2022
The U.S. Food and Drug Administration will hold a public meeting on October 26, 2022, to offer opportunity for discussion on the proposed recommendations for reauthorization of the Animal Generic Drug User Fee Act (AGDUFA). Interested parties can share their comments at the meeting or by submitting them to the public docket electronically or by mail as described below.
AGDUFA gives the FDA the authority to collect user fees that provide funding to support the generic new animal drug review process. These resources support the FDA’s responsibility to ensure these drugs are safe and effective and to enhance the timeliness and predictability of application review for generic animal drugs needed by various animal populations. Reauthorization of this program includes an annual revenue of at least $25 million in user fees, supplementing budget authority funding, for the generic new animal drug program. The program expires on September 30, 2023.
Date and Time
October 26, 2022
2 p.m. to 4 p.m. Eastern Time
The public meeting will be hosted via a live virtual webcast.
Registration and Oral Public Comment
Stakeholders interested in attending this public meeting must register online at https://fda.zoomgov.com/meeting/register/vJItcuCtqD4pGPe2DNgbbQZYaRswsTm9iRM no later than October 24, 2022. Early registration is recommended. Registrants will receive confirmation when their registration has been received and will be provided the webcast link.
During online registration you may indicate if you wish to present during the public comment session, and which topic(s) you wish to address. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to participate. The FDA will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and we will notify participants by October 24, 2022. All requests to make oral presentations must be received by October 20, 2022, 11:59 p.m. Eastern Time. If selected for presentation, any presentation materials must be emailed to Lisa Kable at Lisa.Kable@fda.hhs.gov no later than October 24, 2022.
Additional information about registration is available at the following link:
If attendees need special accommodations due to a disability, please contact Lisa Kable at Lisa.Kable@fda.hhs.gov or 240-402-6888 no later than October 20, 2022.
Electronic and Written Comments
Public comments will be accepted through 11:59 Eastern Time at the end of Wednesday, November 9, 2022. Comments can be submitted electronically via the Federal eRulemaking Portal, or in writing to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm 1061, Rockville, MD 20952. All comment submissions received must reference Docket No. FDA-2011-N-0655.
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. For detailed instructions, refer to:
- Animal Generic Drug User Fee Act Virtual Public Meeting
- Federal Register Notice: Animal Generic Drug User Fee Act; Public Meeting; Request for Comments
- Animal Generic Drug User Fee Act Reauthorization Performance Goals and Procedures – Fiscal Years 2024 Through 2028
- Background - Animal Generic Drug User Fee Act (AGDUFA)
- FDA Announces FY 2023 Animal Drug User Fee Rates for ADUFA and AGDUFA
- FDA: User Fees Explained
Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.