November 18, 2022
The U.S. Food and Drug Administration will hold a public meeting on December 7, 2022, to offer opportunity for comment on the proposed recommendations for reauthorization of the Animal Drug User Fee Act (ADUFA). Interested parties can share their comments at the meeting or by submitting them to the public docket electronically or by mail as described below.
ADUFA gives the FDA the authority to collect user fees that provide supplemental funding to support the new animal drug review process. The FDA’s responsibility is to ensure these drugs are safe and effective and these resources enhance the timeliness and predictability of application review for animal drugs needed by various animal populations. Reauthorization of this program includes an annual revenue of at least $32 million in user fees, supplementing budget authority funding, for the new animal drug program. The user fee program expires on September 30, 2023.
Date and Time
December 7, 2022
1 p.m. to 3 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/webinar/register/WN_DBPaDGi5QXaakCoxkJKX7g no later than December 5, 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. All requests to make oral presentations must be received by December 1, 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 December 5, 2022. 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 December 5, 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 December 1, 2022.
Electronic and Written Comments
Public comments will be accepted through 11:59 Eastern Time at the end of December 19, 2022. Comments can be submitted electronically via the Federal eRulemaking Portal https://www.regulations.gov, or in writing to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm 1061, Rockville, MD 20852. All comment submissions received must reference Docket No. FDA-2011-N-0656.
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 Drug User Fee Act Virtual Public Meeting
- Federal Register Notice: Animal Drug User Fee Act; Public Meeting; Request for Comments
- Animal Drug User Fee Act (ADUFA)
- 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.