Reauthorization of the Generic Drug User Fee Amendments; Public Meeting; Request for Comments

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <DEPDOC>[Docket No. FDA-2025-N-0873]</DEPDOC> <SUBJECT>Reauthorization of the Generic Drug User Fee Amendments; 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 public meeting on the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for fiscal years (FYs) 2028 to 2032. At the end of September 2027, new legislation will be required for FDA to continue to collect generic drug user fees for future FYs. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that before FDA begins negotiations with the regulated industry on GDUFA reauthorization, we publish a notice in the <E T="04">Federal Register</E> requesting public input on the reauthorization; 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 the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027 ( <E T="03">i.e.,</E> the GDUFA III Commitment Letter) ( <E T="03">https://www.fda.gov/industry/generic-drug-user-fee-amendments/gdufa-iii-reauthorization</E> ); provide a period of 30 days after the public meeting to obtain written comments from the public; and publish the comments on FDA's website. FDA invites public comment on the GDUFA program and suggestions regarding the features FDA should propose for the next GDUFA program cycle. These comments will be published and available on FDA's website. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> The hybrid public meeting will be held in person and virtually on July 11, 2025, from 9 a.m. to 2 p.m. Either electronic or written comments on this public meeting must be submitted by August 11, 2025. 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., Bldg. 31 Conference Center, the 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. For parking and security information, please refer to <E T="03">https://www.fda.gov/about-fda/visitor-information.</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 on August 11, 2025. 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: Federal eRulemaking Portal: <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: 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.” <E T="03">Instructions:</E> All submissions received must include the Docket No. FDA-2025-N-0873 for “Reauthorization of the Generic Drug User Fee Amendments; 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> Dat Doan, Center for Drug Evaluation and Research, Food and Drug Administration, <E T="03">GDUFAReauthorization@fda.hhs.gov,</E> 240-402-8926. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> On July 9, 2012, the Food and Drug Administration Safety and Innovation Act, which included GDUFA (Pub. L. 112-144, Title III), was signed into law by the President. The GDUFA program was reauthorized two times since then, most recently in the Generic Drug User Fee Amendments of 2022 (GDUFA III), which authorizes FDA to collect fees for certain generic human drug applications, drug master files, and facilities. Designed to facilitate timely access to safe and effective generic drugs for the public, GDUFA III requires that generic drug manufacturers and other relevant entities pay user fees to finance critical and measurable generic drug program enhancements. As described in the GDUFA III Commitment Letter, FDA committed to achieve certain performance goals, and to provide enhancements designed to maximize the efficiency and utility of each assessment cycle, with the intent to reduce the number of assessment cycles for abbreviated new drug applications, and to foster the development, assessment, and approval of complex generic products. Additional information concerning GDUFA, including the text of the law, the GDUFA III Commitment Letter, key <E T="04">Federal Register</E> documents, GDUFA-related guidances, performance reports, and financial reports may be found on the FDA website at <E T="03">https://www.fda.gov/gdufa.</E> <HD SOURCE="HD1">II. Topics for Discussion at the Public Meeting</HD> FDA is interested in responses to the following general questions: • What is your assessment of the overall performance of the GDUFA program to date? • What aspects of GDUFA should be retained, changed, or discontinued to further strengthen and improve the program? • What new features, if any, should FDA consider adding to the program to enhance efficiency and effectiveness of the generic drug 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? FDA welcomes any other relevant information the public would like to share as it relates to the GDUFA program. In general, the public meeting's format will include presentations by FDA and other interested parties, which may include scientific and academic experts, health care professionals, representatives of patient and consumer advocacy groups, the generic drug industry, and the general public. The amount of time available for public testimony will be determined by the number of persons w ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 13k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━