This site displays a prototype of a “Web 2.0” version of the daily Federal Register. It is not an official legal edition of the Federal Register, and does not replace the official print version or the official electronic version on GPO’s govinfo.gov.
The documents posted on this site are XML renditions of published Federal Register documents. Each document posted on the site includes a link to the corresponding official PDF file on govinfo.gov. This prototype edition of the daily Federal Register on FederalRegister.gov will remain an unofficial informational resource until the Administrative Committee of the Federal Register (ACFR) issues a regulation granting it official legal status. For complete information about, and access to, our official publications and services, go to About the Federal Register on NARA's archives.gov.
The OFR/GPO partnership is committed to presenting accurate and reliable regulatory information on FederalRegister.gov with the objective of establishing the XML-based Federal Register as an ACFR-sanctioned publication in the future. While every effort has been made to ensure that the material on FederalRegister.gov is accurately displayed, consistent with the official SGML-based PDF version on govinfo.gov, those relying on it for legal research should verify their results against an official edition of the Federal Register. Until the ACFR grants it official status, the XML rendition of the daily Federal Register on FederalRegister.gov does not provide legal notice to the public or judicial notice to the courts.
FederalRegister.gov retrieves relevant information about this document from Regulations.gov to provide users with additional context. This information is not part of the official Federal Register document.
Food and Drug Administration, HHS.
Notice of public workshop; request for comments.
The Food and Drug Administration (FDA or the Agency) is announcing the following public workshop entitled “Fiscal Year 2026 Generic Drug Science and Research Initiatives Workshop.” The purpose of the public workshop is to provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives. FDA is seeking this input from a variety of interested parties—industry, academia, patient advocates, professional societies, and other interested parties—as it fulfills its commitment under the Generic Drug User Fee Amendments of 2022 (GDUFA III) to develop an annual list of science and research initiatives specific to generic drugs. FDA will take the information it obtains from the public workshop into account in developing its fiscal year (FY) 2027 Generic Drug User Fee Amendments (GDUFA) science and research initiatives.
The public workshop will be held on June 8 and 9, 2026. Either electronic or written comments on this public workshop must be submitted by July 10, 2026. See the SUPPLEMENTARY INFORMATION section for additional information.
The public workshop will be held in person and will be accessible virtually (See Streaming Webcast of the Public Workshop below). The public workshop will be held at the FDA White Oak Campus, 10903 New Hampshire Avenue, Building 31 Conference Center, the Great Room (Room 1503), Silver Spring, MD 20993. Entrance for the public workshop 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.
The procedures to submit comments are outlined below. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of July 10, 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.
Submit electronic comments in the following way:
Submit written/paper submissions as follows:
Instructions: All submissions received must include the Docket No. FDA-2023-N-0119 for “Fiscal Year 2026 Generic Drug Science and Research Initiatives Workshop; Public Workshop; Request for Comments.” Received comments, those filed in a timely manner (see ADDRESSES ), 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.
Sam Raney, Ph.D., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4732, Silver Spring, MD 20993, 240-402-7967, Sameersingh.Raney@fda.hhs.gov; or Robert Lionberger, Ph.D., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4722, Silver Spring, MD 20993, 240-402-7957, Robert.Lionberger@fda.hhs.gov.
In July 2012, Congress passed the Generic Drug User Fee Amendments of 2012 (GDUFA I) (Pub. L. 112-144). GDUFA I was designed to enhance public access to safe, high-quality generic drugs and to modernize the generic drug program. To support this goal, FDA agreed in the Generic Drug User Fee Act Program Performance Goals and Procedures (GDUFA I commitment letter) to work with industry and interested parties on identifying science and research initiatives specific to generic drugs for each fiscal year covered by GDUFA I.
In August 2017, GDUFA was reauthorized until September 2022 through the Generic Drug User Fee Amendments of 2017 (GDUFA II) (Pub. L. 115-52), and in September 2022, GDUFA was reauthorized until September 2027 through GDUFA III (Pub. L. 117-180, 136 Stat. 2155). In the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027 (GDUFA III commitment letter),[1] FDA agreed to conduct annual public workshops to solicit input from industry and interested parties for inclusion in an annual list of GDUFA III regulatory science initiatives. This public workshop scheduled for June 8 and 9, 2026, seeks to fulfill this agreement.
The purpose of this public workshop is to obtain input from industry and other interested parties on identifying generic drug science and research initiatives for FY 2027. FDA is interested in receiving input about regulatory science initiatives for the ongoing years of the GDUFA III science and research program, and particularly for FY 2027.
Topics discussed during the workshop will focus on research that is needed to address scientific knowledge gaps and associated challenges impacting the development and regulatory assessment of generic products, including complex generics. As examples, topics discussed will likely focus on identifying approaches to leverage generic drug industry expertise and insights when advancing GDUFA research, and when prioritizing the development of product-specific guidances. Specific technical discussions will likely explore what new research is needed to address ongoing challenges with impurities such as nitrosamines, to expand regulatory flexibility with bioequivalence standards, to employ artificial intelligence tools in practical ways that reduce barriers for generic drug development and assessment, and to standardize product characterization test methods that support demonstrations of bioequivalence and product quality. Additional topics that can enhance public access to high-quality, safe, and effective generic products may also be discussed. Specific presentations and discussions at this workshop will be announced at a later date and may differ from the topics above. Input about the topics above will help the Agency identify and expand its scientific focus for the next fiscal year.
FDA will consider all comments made at this workshop or received through the docket (see ADDRESSES ) as it develops its FY 2027 science and research initiatives. Information concerning the science and research initiatives for generic drugs can be found on the Science & Research website at https://www.fda.gov/drugs/generic-drugs/science-research.
Registration: Persons interested in attending this public workshop do not need to register in advance. Those interested in attending in-person are encouraged to contact FDA at GDUFARegulatoryScience@fda.hhs.gov to confirm the availability of space prior to making travel arrangements; while there has historically been ample space to accommodate all in-person attendees, seating is limited.
If you need special accommodations due to a disability, please contact FDA via email at GDUFARegulatoryScience@fda.hhs.gov no later than 11:59 p.m. Eastern Time on May 15, 2026.
Requests for Oral Presentations: Requests to provide public comments via a prerecorded presentation or a live presentation, including in-person or virtual presentations, should be submitted via email to GDUFARegulatoryScience@fda.hhs.gov by 11:59 p.m. Eastern Time on April 3, 2026. The request should briefly describe the topic(s) of the comments, and specify whether the comments would be presented in person or as a pre-recorded presentation. FDA will do its best to accommodate requests to make public comments that are within the scope of this public workshop, i.e., those that identify what research is needed to address specific challenges for generic product development or regulatory assessment. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to participate in the workshop. Based on the public comment presentation requests received by April 3, 2026, at 11:59 p.m. Eastern Time, FDA will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin. By April 30, 2026, FDA will select and notify persons who request to present prepared public comment if they are selected for presentation during the workshop. Any presentation materials must then be emailed to GDUFARegulatoryScience@fda.hhs.gov no later than May 20, 2026, 11:59 p.m. Eastern Time. No commercial or promotional material will be permitted to be presented or distributed at the public workshop.
Streaming Webcast of the Public Workshop: This public workshop will be webcast. The link to the streaming webcast of the workshop on June 8, 2026 (Day 1 of the workshop), is: https://teams.microsoft.com/meet/29276529473988?p=3uD9Z7KE. The link to the streaming webcast of the workshop on June 9, 2026 (Day 2 of the workshop), is: https://teams.microsoft.com/meet/29105893294615?p=fZ9hG2BU. Although FDA verified the website addresses in this document, please note that websites are subject to change over time.
Transcripts: Please be advised that as soon as a video recording and audio transcript of the public workshop are available, they will be accessible at https://www.regulations.gov or via the Science & Research FDA website accessible at https://www.fda.gov/drugs/generic-drugs/science-research. They may also be available for viewing at the ( printed page 9872) Dockets Management Staff (see ADDRESSES ).
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
1. The GDUFA III commitment letter is available at https://www.fda.gov/media/153631/download.
Back to Citation[FR Doc. 2026-03961 Filed 2-26-26; 8:45 am]
BILLING CODE 4164-01-P
This document has a comment period that ends in 23 days. (07/10/2026) Submit a public comment