Second Annual Animal Drug User Fee Educational Conference; Public Meeting

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <DEPDOC>[Docket No. FDA-2024-N-2602]</DEPDOC> <SUBJECT>Second Annual Animal Drug User Fee Educational Conference; Public Meeting</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Notice of public meeting. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA, the Agency, or we) is announcing the following educational conference (public meeting) entitled “Second Annual Animal Drug User Fee Educational Conference.” This is the second 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. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> The second educational conference will be held on July 15, 2025, from 9 a.m. to 5 p.m. Eastern Time. See the <E T="02">SUPPLEMENTARY INFORMATION</E> 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. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> The second 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. Participants must be REAL ID compliant to access federal facilities. For additional information regarding REAL ID, refer to <E T="03">https://www.dhs.gov/real-id/real-id-faqs.</E> For parking and security information, please refer to <E T="03">https://www.fda.gov/about-fda/visitor-information.</E> Persons interested in attending this educational conference must register at: <E T="03">https://www.surveymonkey.com/r/ADUFAV_2025.</E> You may submit comments as follows. <HD SOURCE="HD2">Electronic Submissions</HD> Submit electronic comments in the following way: • <E T="03">Federal eRulemaking Portal: https://www.regulations.gov.</E> Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to <E T="03">https://www.regulations.gov</E> 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 <E T="03">https://www.regulations.gov.</E> • 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”). <HD SOURCE="HD2">Written/Paper Submissions</HD> Submit written/paper submissions as follows: • <E T="03">Mail/Hand Delivery/Courier (for written/paper submissions):</E> 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.” <E T="03">Instructions:</E> All submissions received must include the Docket No. FDA-2024-N-2602 for “Second 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 <E T="03">https://www.regulations.gov</E> 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 on <E T="03">https://www.regulations.gov.</E> 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: <E T="03">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.</E> <E T="03">Docket:</E> For access to the docket to read background documents or the electronic and written/paper comments received, go to <E T="03">https://www.regulations.gov</E> 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. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Walter Ellenberg, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-796-0885, <E T="03">adufa_v_edu_conference@fda.hhs.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> 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 second of these annual Animal Drug User Fee Educational Conferences. These conferences are open to the public. <HD SOURCE="HD1">II. Topics for Discussion at the Educational Conference</HD> 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 <E T="02">ADDRESSES</E> ). This second conference will focus on the following topics: <FP SOURCE="FP-2">(1) Overview of User Fees and Waivers</FP> <FP SOURCE="FP-2">(2) Foreign Data</FP> <FP SOURCE="FP-2">(3) Real World Data/Evidence</FP> <FP SOURCE="FP-2">(4) What Makes a High-Quality Submission?</FP> <FP SOURCE="FP-2">(5) Adaptive Study Designs</FP> 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. Questions and comments received during each annual conference and comments submitted to the docket will inform the conversation and topics considered in subsequent conferences. <HD SOURCE="HD1">III. Participating in the Educational Conference</HD> <E T="03">Registration:</E> 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. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 11k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━