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Food and Drug Administration, HHS.
Notice of public meeting.
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following educational conference (public meeting) entitled “First Annual Animal Drug User Fee Educational Conference.” This is the first 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.
The first educational conference will be held on July 17, 2024, from 9 a.m. to 5 p.m. Eastern Time. See the SUPPLEMENTARY INFORMATION section for registration date 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 by 90 days after each annual educational conference to ensure that the Agency considers your comment on a topic discussed at that conference.
The first educational conference will be available in person and virtually. The in-person conference will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Great Room Conference Center, Silver Spring, MD 20993-0002. Entrance for conference participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to https://www.fda.gov/about-fda/visitor-information. Persons interested in attending this educational conference must register at: https://fda.zoomgov.com/webinar/register/WN_cSFEyfDpQK6RuGrwPznG9A.
You may submit comments as follows.
Submit electronic comments in the following way:
Submit written/paper submissions as follows:
Instructions: All submissions received must include the Docket No. FDA-2024-N-2602 for “First 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.
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.
Walter Ellenberg, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-796-0885, adufa_v_edu_conference@fda.hhs.gov.
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. Each year, during one of these meetings, the Agency will commit up to 8 hours for an educational conference intended for the animal drug industry. This notice announces the first of these annual Animal Drug User Fee Educational Conferences. These conferences are open to the public. The educational conference being announced in this notice is the first annual conference of this series.
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 are welcome to submit comments to the docket requesting topics to be included for future educational conferences (see ADDRESSES ).
This initial conference will provide a high-level overview in the following areas:
(1) Overview of the Approval Process
(2) Communication Pathways with the Center for Veterinary Medicine ( printed page 51533)
(3) Best Practices in the Approval Process
(4) Target Animal Safety Technical Section Overview
(5) Effectiveness Technical Section Overview
(6) Chemistry, Manufacturing, and Controls Technical Section Overview
(7) Human Food Safety Technical Section Overview
(8) Environmental Impact Technical Section Overview
(9) Minor Technical Sections Overview
The conference will also contain Q&A sessions during which FDA will address specific questions from the in-person and virtual audience as time allows. Future educational conferences will take a more in-depth approach to these and other topics based on questions and comments received during this conference, as well as questions and comments submitted to the docket.
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, email, and telephone number. 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 the conference. 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://fda.zoomgov.com/webinar/register/WN_cSFEyfDpQK6RuGrwPznG9A no later than July 10, 2024. Onsite registration will be provided on the day of the conference on a first-come, first-served basis, until the room capacity is reached. Onsite registration will open at the conference site at 8 a.m. on July 17, 2024. If room capacity is reached, individuals will be offered the opportunity to observe the conference from an overflow room located at the conference site.
If you need special accommodations due to a disability, please contact Walter Ellenberg (see FOR FURTHER INFORMATION CONTACT ) no later than July 10, 2024.
Transcript: Transcripts of the educational conference will be available on FDA's website at https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/adufa-meetings approximately 30 days after the conference. Please be advised that as soon as a transcript of the educational conference is available, it will be accessible at https://www.regulations.gov, and may also be viewed at the Dockets Management Staff (see ADDRESSES ). A link to the transcript will also be available at https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/adufa-meetings.
Recording of Conference: Please be advised that as soon as a recording of this conference is available, it will be accessible at https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/adufa-meetings.
Dated: June 11, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-13303 Filed 6-17-24; 8:45 am]
BILLING CODE 4164-01-P