Rules and Regulations. Notice of public meeting; request for comments

Agency: Food and Drug Administration, HHS
Action: Notice of public meeting; request for comments
Citation: FR Doc. 2026-07498 · Docket No. FDA-2011-N-0656

Summary

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following virtual public meeting entitled “Animal Drug User Fee Act.” The purpose of the public meeting is to invite public comment on the Animal Drug User Fee Act (ADUFA) program and suggestions regarding the features FDA should consider for the next reauthorization of the ADUFA program. The meeting will be open to the public.

Dates

The public meeting will be held virtually on May 27, 2026, from 2 p.m. to 4 p.m. Eastern Time. See the SUPPLEMENTARY INFORMATION section for registration dates and information. To permit the widest possible opportunity to obtain comments on all aspects of the public meeting, the docket will remain open for comment throughout the reauthorization process of ADUFA, until December 1, 2027. In addition to being publicly viewable at http://www.regulations.gov, comments received by July 1, 2026, suggesting changes to the program, will also be published on https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/adufa-meetings.

Supplementary Information

I. Introduction The authority for ADUFA expires September 30, 2028. Without new legislation, FDA will no longer have the authority to collect user fees to help fund the new animal drug review process for future fiscal years. Prior to beginning negotiations with the regulated industry on ADUFA reauthorization, section 740A(d)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379j-13(d)(2)) requires FDA to: (1) Publish a notice in the Federal Register requesting public input on the reauthorization; (2) hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in section 740A(a) of the FD&C Act; (3) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes; and (4) publish the comments on FDA's website. This notice, the public meeting, the comment period after the meeting, and the posting of the comments on the FDA website will satisfy these requirements. FDA is holding a public meeting to gather information on what FDA should consider including in the reauthorization of ADUFA. FDA is interested in responses from the public on the following two general questions and welcomes other pertinent information that stakeholders would like to share: 1. What is your assessment of the overall performance of the ADUFA program thus far? 2. What aspects of ADUFA should be retained, changed, or discontinued to further strengthen and improve the program? II. Background FDA considers the timely review of new animal drug submissions to be central to the Agency's mission to protect and promote human and animal health. The ADUFA program began in FY 2004 and is currently in the fifth authorization (ADUFA V). FDA has published a number of reports that provide useful background on ADUFA I, ADUFA II, ADUFA III, ADUFA IV and ADUFA V. ADUFA-related Federal Register notices, guidances, legislation, performance reports, and financial reports can be found at: https://www.fda.gov/industry/fda-user-fee-programs/animal-drug-user-fee-act-adufa. III. Participating in the Public Meeting Registration: Persons interested in attending this public meeting must register no later than midnight Eastern time on May 22, 2026, by emailing complete contact information for each attendee, including name, title, affiliation, address, email, telephone number, and if you need reasonable accommodations due to a disability ( e.g., Closed Captioning) to ADUFAReauth@fda.hhs.gov. Registration is free and 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 make an oral presentation during the public meeting. To facilitate agenda development, registrants requesting to present will be asked to provide information regarding which topics they intend to address and the title of their presentation. We will do our best to accommodate requests to make an oral presentation. 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 May 1, 2026. We 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 May 8, 2026. Presenters planning to use an electronic slide deck must email an electronic copy of their presentation to Madeline Faunce at ADUFAReauth@fda.hhs.gov (see FOR FURTHER INFORMATION CONTACT ) with the subject line “ADUFA Public Meeting Presentation” on or before May 15, 2026. If presenters choose not to use a slide deck, they are requested to email a single slide with their name, affiliation, title of their presentation, and contact information. No commercial or promotional material will be permitted to be presented at the public meeting. Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2026-07498 Filed 4-16-26; 8:45 am]