Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <DEPDOC>[Docket No. FDA-2015-N-3326]</DEPDOC> <SUBJECT>Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Notice of public meeting; request for comments. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA, the Agency, or we) is hosting a hybrid public meeting to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2028 through 2032. The BsUFA authorizes FDA to collect user fees to support the process for the review of biosimilar biological products. The current legislative authority for BsUFA expires in September 2027. At that time, new legislation will be required for FDA to continue collecting user fees in future fiscal years. FDA begins the BsUFA reauthorization process by publishing a notice in the <E T="04">Federal Register</E> requesting public input and holding a public meeting where the public may present its views on the reauthorization. FDA invites public comment as the Agency begins the process to reauthorize the program for FYs 2028 through 2032. These comments will be published and available on FDA's website. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> The public meeting will be held on December 3, 2025, from 9 a.m. to 12 p.m. Eastern Time, and will take place in person and virtually. Either electronic or written comments on this public meeting must be submitted by January 2, 2026. See the <E T="02">SUPPLEMENTARY INFORMATION</E> section for registration date and information. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> The public meeting will be held in-person at the FDA White Oak Campus, 10903 New Hampshire Ave., Building Conference Center, the White Oak Great Room, Silver Spring, MD 20993-0002 and virtually using the Microsoft Teams platform. Entrance for the public meeting 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 security and parking information, please refer to <E T="03">https://www.fda.gov/about-fda/visitor-information</E> and <E T="03">https://www.fda.gov/about-fda/visitor-information/visitor-parking-and-campus-map.</E> Any changes to the public meeting location and remote information, as appropriate, will be posted to <E T="03">https://www.fda.gov/industry/public-meeting-reauthorization-biosimilar-user-fee-act-bsufa-12032025.</E> You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The <E T="03">https://www.regulations.gov</E> electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of January 2, 2026. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. <HD SOURCE="HD2">Electronic Submissions</HD> Submit electronic comments in the following way: • <E T="03">Federal eRulemaking Portal:</E> <E T="03">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-2015-N-3326 for “Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments.” Received comments, those filed in a timely manner (see <E T="02">ADDRESSES</E> ), 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> Thamar Bailey, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32 Rm. 4103, Silver Spring, MD 20993-0002, 301-796-6645, <E T="03">BSUFAReauthorization@fda.hhs.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> FDA is announcing a hybrid public meeting to begin the reauthorization process for BsUFA. The authority to collect user fees under BsUFA expires in September 2027. Without new legislation, FDA will no longer be able to collect user fees for future FYs to fund the biosimilar biological product review process. Before FDA begins negotiations with the regulated industry on BsUFA reauthorization, the Agency is holding the public meeting announced in this notice, at which the public may present their views on reauthorization, including any suggestions for changes to the performance goals referred to in the “Biosimilar Biological Product Reauthorization Performance Goals and Procedures Fiscal Years 2023 through 2027” (the BsUFA III Commitment Letter) (available at <E T="03">https://www.fda.gov/media/152279/download?attachment</E> ). In addition, FDA will provide a period of 30 days after the public meeting for the public to submit written comments. The purpose of this public meeting is to hear the public's views on BsUFA as we consider elements to propose, update, or discontinue in the next BsUFA. In addition to any other relevant information the public would like to share, the FDA is interested in responses to the following four general questions: • What is your assessment of the overall performance of the current reauthorization of BsUFA FYs 2023 through 2027 to date? • What current elements of BsUFA should be retained, changed, or discontinued to further strengthen and improve the program? • What new elements, if any, should FDA consider adding to the program to enhance the efficiency and effectiveness of the biosimilar biological product review process? • What changes, if any, could be made to the current fee structures and amounts to better advance the goals of the agreement, including facilitating product development and timely access for consumers? <HD SOURCE="HD1">II. What is BsUFA and what does it do?</HD> FDA provides the following information to help potential meeting participants better understand the history and evolution of BsUFA and its status. BsUFA is a law that authorizes FDA to assess and collect fees from drug companies that submit marketing applications for biosimilar biological products. BsUFA was originally enacted in 201 ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 17k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━