- October 26, 2022
- 2:00 PM - 4:00 PM ET
- Organized By:
On this Page:
- Public Meeting Information
- Requests for Oral Presentations
- Submitting Electronic or Written Comments
- Recording and Transcript
- Event Materials
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.
Section 742(d)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)(21 U.S.C. 379j-13(d)(4)) requires that, after holding negotiations with regulated industry and periodic consultations with stakeholders, and before transmitting the Agency’s final recommendation to Congress for the reauthorized program (AGDUFA IV), we do the following: (1) present the recommendation to the relevant congressional committees, (2) publish such recommendations in the Federal Register, (3) provide for a period of 30 days for the public to provide written comments on such recommendations, (4) hold a meeting at which the public may present its views on such recommendations, and (5) consider such public views and comments and revise such recommendations as necessary. This notice, the 30-day comment period, and the public meeting will satisfy certain of these requirements. After the public meeting, we will revise the draft recommendations as necessary. In addition, the Agency will present the draft recommendations to the congressional committees.
The FDA considers the timely review of abbreviated new animal drug applications (ANADAs) to be central to the Agency’s mission to protect and promote human and animal health. For more information about the AGDUFA authorizations and enhancements towards supporting that mission, please see the Federal Register notice announcing the public meeting. The FDA has published a number of reports that provide useful background on AGDUFA I, AGDUFA II, and AGDUFA III. AGDUFA-related Federal Register notices, guidances, legislation, performance reports, and financial reports can be found at: Animal Generic Drug User Fee Act (AGDUFA).
Public Meeting Information
The proposed enhancements in AGDUFA IV will address priorities identified by stakeholders, regulated industry, and the FDA. The full description of these proposed recommendations can be found in the proposed AGDUFA IV Performance Goals and Procedures Letter.
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.
Requests for Oral Presentations
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: Notice of Public Meeting; Animal Generic Drug User Fee Act; Request for Comments.
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.
Submitting Electronic or Written Comments
Public comments will be accepted through 11:59 Eastern Time at the end of Monday, November 14, 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:
Recording and Transcript
To view the recording of the virtual public meeting, please visit the following links:
To view the AGDUFA IV Public Meeting Presentation, visit the following link:
|Animal Generic Drug User Fee Act Reauthorization Performance Goals and Procedures – Fiscal Years 2024 Through 2028||pdf (186.93 KB)|
|Agenda for the 2022 AGDUFA IV Public Meeting||pdf (96.42 KB)|