2021 FDA Public and Stakeholder Meetings on Reauthorization of Two Animal Drug User Fee Programs

The U.S. Food and Drug Administration will hold public meetings to offer opportunity for discussion on the proposed reauthorization of the Animal Drug User Fee Act (ADUFA) and Animal Generic Drug User Fee Act (AGDUFA). The FDA is also providing the opportunity for the public to comment on the user fee programs and make suggestions regarding features that the FDA should propose for the next ADUFA and AGDUFA programs. 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 and AGDUFA give the FDA the authority to collect user fees that provide funding to support the new animal drug and generic new animal drug review processes, respectively. These resources support the FDA’s responsibility to review these drugs for safety and effectiveness and to enhance the timeliness and predictability of application reviews. These programs expire on September 30, 2023. Without new legislation reauthorizing these programs, the FDA will no longer have the authority to collect user fees to help fund the new animal drug and generic new animal drug review processes.

Date and Time

May 20, 2021
11 a.m. – 1 p.m.: AGDUFA public meeting
2 p.m. – 4 p.m.: ADUFA public meeting

Location

The public meetings will be held virtually.

Registration and Public Comment

Registration to attend these public meetings is free and available on a first-come, first-served basis. Early registration is recommended. If you wish to attend and/or present at the public meetings, please submit notification by email to: [email protected] for the ADUFA public meeting and/or [email protected] for the AGDUFA public meeting by May 18, 2021. Your email should contain complete contact information for each attendee, including name, title, affiliation, address, email address, telephone number, and notice of any special accommodations required due to a disability (e.g., Closed Captioning). Registrants will receive confirmation when their registration has been received and will be provided the webcast link. Additional information about registration is available at the following links:

Public comments will be accepted through December 1, 2022, 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 20952. All comment submissions received must reference Docket No. FDA-2011-N-0656 for ADUFA, and Docket No. FDA-2011-N-0655 for AGDUFA. Comments received by June 21, 2021, will be published online.

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:

Stakeholder Meeting Registration

We are also issuing two notices to request that public stakeholders notify the FDA of their intent to participate in periodic consultation meetings on reauthorization of the ADUFA and AGDUFA programs. After signing up, registrants will be informed when the stakeholders meetings are scheduled to take place. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that the FDA consult with a range of stakeholders--including patient and consumer advocacy groups, veterinary professionals, and scientific and academic experts--in developing recommendations for the next ADUFA and AGDUFA programs, and hold discussions with these stakeholders at least once every 4 months during FDA's negotiations with the regulated industry. The purpose of these requests for notification is to ensure continuity and progress in these regular discussions by establishing consistent stakeholder representation.

If you intend to participate in continued periodic stakeholder consultation meetings regarding AGDUFA reauthorization, please submit notification by email to: [email protected] by May 18, 2021. If you intend to participate in continued periodic stakeholder consultation meetings regarding ADUFA reauthorization, please submit notification by email to: [email protected] by May 18, 2021. Your email should contain complete contact information for each attendee, including name, title, affiliation, address, email address, telephone number, and notice of any special accommodations required due to a disability. Stakeholders will receive confirmation and additional information about the first meeting after FDA receives this notification.

Additional Information

Contact FDA

Lisa Kable, Program Analyst
Email: [email protected]
Phone: 240-402-6888