Virtual | Virtual

Event Title

Animal Drug User Fee Act Virtual Public Meeting

December 7, 2022

Date:: December 7, 2022
Time:: 1:00 p.m. - 3:00 p.m. ET

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.

Background

Section 740A(d)(4) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 379j-13(d)(4)) requires that, after holding negotiations with regulated industry and periodic consultations with stakeholder, and before transmitting the Agency's final recommendation to Congress for the reauthorized program (ADUFA V), 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 the safety and effectiveness of new animal drug applications (NADAs) to be central to the Agency's mission to protect and promote human and animal health. For more information about the ADUFA authorizations and enhancements toward 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 ADUFA I, II, III, and IV. ADUFA-related Federal Register notices, guidances, legislation, performance reports, and financial reports can be found at: Animal Drug User Fee Act (ADUFA).

Public Meeting Information

The proposed enhancements in ADUFA V will address priorities identified by stakeholders, regulated industry, and FDA. The full description of these proposed recommendations can be found in the proposed ADUFA V Performance Goals and Procedures Letter.

Registration

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. Please self-identify as a member of one of the following stakeholder categories: scientific or academic experts, veterinary professionals, patients and consumer advocacy groups, or the regulated industry, and whether you are requesting a scheduled presentation.

Early registration is recommended. Registrants will receive confirmation when their registration has been received and will be provided the webcast link. Please retain the email with the webcast link for the day of the virtual public meeting. If you do not receive it automatically after registering, please check your spam/junk mail folder.

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. 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: Notice of Public Meeting; Animal 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 December 1, 2022.

Submitting Electronic or 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:

Notice of Public Meeting; Animal Drug User Fee Act; Request for Comments

Recording and Transcript

To view the recording and transcript of the virtual public meeting, please visit the following links:

To view the ADUFA IV Public Meeting Presentation, visit the following link:

ADUFA IV Public Meeting Presentation

U.S. Food and Drug Administration