Document

Third Annual Animal Drug User Fee Educational Conference; Public Meeting

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following educational conference (public meeting) entitled "Third Annual Animal Drug User Fee Educati...

PDF version FederalRegister.gov

Department of Health and Human Services

Food and Drug Administration

[Docket No. FDA-2024-N-2602]

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public meeting.

SUMMARY:

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following educational conference (public meeting) entitled “Third Annual Animal Drug User Fee Educational Conference.” This is the third of five annual educational conferences FDA will host as described in the “Animal Drug User Fee Act Reauthorization Performance Goals and Procedures Fiscal Years 2024 Through 2028.” The purpose of this series of conferences is to provide educational sessions for stakeholders who are interested in the new animal drug approval process.

( printed page 33177)

DATES:

The third educational conference will be held on July 7, 2026, from 9 a.m. to 1 p.m. Eastern Time. See the SUPPLEMENTARY INFORMATION section for registration dates and information. You may submit comments at any time for this series of educational conferences. We request that you submit either electronic or written comments within 90 days after each annual educational conference to ensure that the Agency considers your comment on a topic discussed at that conference.

ADDRESSES:

The third educational conference will be available in person and virtually. The in-person conference will be held at the Harvey W. Wiley Federal Building, 5001 Campus Drive, Room 1A-001, College Park, MD 20740. Routine security check procedures will be performed at the entrance to the building. Participants must be REAL ID compliant to access federal facilities. For additional information regarding REAL ID, refer to https://www.dhs.gov/real-id/real-id-faqs. Persons interested in attending this educational conference must register at: https://events.gcc.teams.microsoft.com/event/8a5f6cc5-9964-48f3-8ae6-b8041bdef77e@7d2fdb41-339c-4257-87f2-a665730b31fc.

You may submit comments as follows.

Electronic Submissions

Submit electronic comments in the following way:

Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2024-N-2602 for “Third Annual Animal Drug User Fee Educational Conference.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.

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. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted onhttps://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT:

Krystyna Reign, Center for Veterinary Medicine, Food and Drug Administration, 5001 Campus Drive, College Park, MD 20740, 240-402-0631, adufa_v_edu_conference@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

The Animal Drug User Fee Act (Pub. L. 108-130) (ADUFA or the Act) was originally signed into law in 2003 and was subsequently reauthorized by Congress in 2008, 2013, 2018, and 2023. ADUFA authorizes FDA to collect fees for certain new animal drug applications, products, establishments, and sponsors. Resources generated under ADUFA supplement the Agency's funding to enhance the performance of the drug review process, ensuring that new animal drug products are safe and effective for animals, and that food derived from treated animals will be safe for consumption. FDA considers the timely review of the safety and effectiveness of new animal drug applications to be central to the Agency's mission to protect and promote human and animal health.

The Animal Drug User Fee Amendments of 2023 (ADUFA V), the most recent reauthorization of the Act, authorizes FDA to collect user fees through fiscal year 2028. “The Animal Drug User Fee Act Reauthorization Performance Goals and Procedures Fiscal Years 2024 Through 2028” (Performance Goals Letter) sets forth the Agency's performance goals for the period covered by ADUFA V. Among other goals, the document commits the Agency to hosting triannual meetings (three meetings per calendar year) with Animal Health Institute (AHI) members, one of which will consist of an educational conference of up to 8 hours for the animal drug industry. This notice announces the third of these annual Animal Drug User Fee Educational Conferences. These conferences are open to the public.

II. Topics for Discussion at the Educational Conference

As described in the Performance Goals Letter, FDA will plan a series of topics for the educational conferences during the 5 years of ADUFA V. While the agenda for each educational conference is determined by the Agency with input from AHI, all stakeholders ( printed page 33178) are welcome to submit comments to the docket requesting topics to be included for future educational conferences (see ADDRESSES ).

This third conference will focus on the following topics:

(1) Overview of Available Regulatory Pathways

(2) Conditional Approval and Indexing for Minor Use/Minor Species (MUMS)

(3) Expanded Conditional Approval and Reasonable Expectation of Effectiveness

(4) Real World Example of Regulatory Flexibility During a Public Health Emergency

(5) Animal Biotechnology Products and the Veterinary Innovation Program (VIP)

(6) Protocol Quality and Best Practices

The conference will also contain a Q&A session during which FDA will address specific questions from the in-person and virtual audience as time allows. Questions and comments received during each annual conference and comments submitted to the docket will inform the conversation and topics considered in subsequent conferences.

III. Participating in the Educational Conference

Registration: This educational conference is open to the public and will be available virtually and in-person. When registering, please provide complete contact information for each attendee, including name, title, affiliation (if any), address, and email. Also, please self-identify as a member of one of the stakeholder categories: regulated industry, scientific or academic experts, veterinary professionals, consumer advocacy groups, press/media relations, FDA, other government/congress, or other.

Early registration is recommended for persons who wish to attend in person. Registrants will receive confirmation when their registration has been received, and they will be provided the webcast link. Persons interested in attending this conference virtually may register until the start time of the conference. Persons interested in attending this conference in person are encouraged to register online at https://events.gcc.teams.microsoft.com/event/8a5f6cc5-9964-48f3-8ae6-b8041bdef77e@7d2fdb41-339c-4257-87f2-a665730b31fc no later than June 25, 2026.

If you need special accommodations due to a disability, please contact Krystyna Reign (see FOR FURTHER INFORMATION CONTACT ) no later than June 25, 2026.

Grace R. Graham,

Deputy Commissioner for Policy, Legislation, and International Affairs.

[FR Doc. 2026-11101 Filed 6-2-26; 8:45 am]

BILLING CODE P

Legal Citation

Federal Register Citation

Use this for formal legal and research references to the published document.

91 FR 33176

Web Citation

Suggested Web Citation

Use this when citing the archival web version of the document.

“Third Annual Animal Drug User Fee Educational Conference; Public Meeting,” thefederalregister.org (June 3, 2026), https://thefederalregister.org/documents/2026-11101/third-annual-animal-drug-user-fee-educational-conference-public-meeting.