SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing a hybrid public meeting to discuss proposed recommendations for the reauthorization of GDUFA, which authorizes FDA to assess and collect user fees to support human generic drug activities, which are defined under the FD&C Act ^[1] to include the activities necessary for the review (also called “assessment”) of generic human drug applications and Type II active pharmaceutical ingredient (API) drug master files (DMFs),^[2] and for conducting ( printed page 51720) inspections related to generic drugs, and to engage in other related activities. The current authorization of the program (GDUFA III) expires at the end of September 2027. Without new legislation, FDA will no longer be able to assess and collect user fees to help fund human generic drug activities for future fiscal years.

Section 744C(f)(5) of the FD&C Act (21 U.S.C. 379j-43(f)(5)) requires that after FDA negotiates with the regulated industry,^[3] we do the following:

(1) Present recommendations to the relevant Congressional committees, (2) publish such recommendations in the Federal Register , (3) provide for a period of 30 days for the public to provide written comments on such recommendations, (4) hold a meeting at which the public may present its views on such recommendations, and (5) after consideration of such public views and comments, revise such recommendations as necessary.

This notice, the 30-day comment period, and the public meeting described in this notice will satisfy certain of these statutory requirements. After the public meeting, we will revise the recommendations as necessary and present the proposed recommendations to the appropriate Congressional committees.

The purpose of the public meeting announced in this Federal Register notice is to obtain the public's views on the proposed recommendations for the reauthorized program (GDUFA IV). The following information is provided to help potential meeting participants better understand the history and evolution of the GDUFA program and the proposed GDUFA IV recommendations.

II. What is GDUFA and what does it do?

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 with respect to certain generic human drug applications, drug master files, and drug manufacturing facilities for fiscal years 2023 through 2027. GDUFA fees support the Agency's human generic drug activities and facilitate timely access to safe and effective generic drugs for the public. As described in the GDUFA III Commitment Letter, FDA committed to achieve certain performance goals and measurable generic drug program 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 Federal Register documents, GDUFA-related guidances, performance reports, and financial reports may be found on the FDA website at www.fda.gov/​gdufa.

III. Proposed GDUFA IV Recommendations

In preparing the proposed recommendations to Congress for GDUFA reauthorization for GDUFA IV, FDA conducted discussions with the regulated industry and consulted with patient and consumer advocacy groups, as required by the law, among other stakeholders. FDA began the GDUFA reauthorization process by publishing a notice in the Federal Register requesting public input on the reauthorization and announcing a public meeting, which was held on July 11, 2025 (90 FR 21313, May 19, 2025). The meeting included presentations by FDA and different stakeholder groups, including patient and consumer advocacy groups, health professionals, and academic researchers. The materials from the meeting, including the agenda, presentations, and transcript can be found at www.fda.gov/​drugs/​news-events-human-drugs/​public-meeting-reauthorization-generic-drug-user-fee-amendments-gdufa-07112025.

Following the July 2025 public meeting, FDA conducted negotiations with the regulated industry and held monthly consultations with other stakeholders from October 2025 through March 2026. As directed by Congress, FDA posted minutes of these meetings on its website “GDUFA IV: Fiscal Years 2028-2032”, available at www.fda.gov/​industry/​generic-drug-user-fee-amendments/​gdufa-iv-fiscal-years-2028-2032. The proposed enhancements for GDUFA IV address many of the top priorities identified by FDA, the regulated industry, and other stakeholders.

These include proposed program enhancements to stabilize fee revenue, advance approvals in fewer review cycles, improve program efficiency, enhance processes around complex data issues, and provide mechanisms to facilitate onshoring of generic drug manufacturing. The full descriptions of these proposed recommendations can be found in the proposed GDUFA IV Commitment Letter (Proposed Commitment Letter), which will be posted prior to the public meeting on FDA's website “GDUFA IV: Fiscal Years 2028-2032, available at www.fda.gov/​industry/​generic-drug-user-fee-amendments/​gdufa-iv-fiscal-years-2028-2032.

Each significant new or modified enhancement is described briefly below with references to the relevant section of the Proposed Commitment Letter where more detailed information can be found.

A. Controlled Correspondence

FDA proposes that Abbreviated New Drug Application (ANDA) applicants will use a pre-assigned ANDA number or ANDA number when submitting controlled correspondences to allow linkages between ANDA applications and these communications. FDA also proposes a new 90-day timeline for controlled correspondences for specific topics. Details can be found in the Proposed Commitment Letter, section I.E.

B. ANDA Assessment Transparency and Communications Enhancements

FDA proposes updates to review timelines and other efficiency enhancements for some steps of the ANDA assessment process and increased communications throughout the process, including inclusion of a new goal date extension option for applicants to select at the time of application submission. FDA proposes a new 120-day goal extension for a Potential Official Action Indicated (pOAI) alert, in certain circumstances, to allow time for FDA to finalize the inspection classification and take appropriate action within the same review cycle. Details can be found in the Proposed Commitment Letter, section II.A and B.

FDA proposes a new post pre-approval inspection meeting, when needed, to discuss inspection findings that may impact application approval and corrective actions that may address issues identified. Details can be found in the Proposed Commitment Letter, Section II.B. and section VI.D.

Lastly, FDA proposes improved management of applications with complex data issues, to help ensure efficient use of review resources. FDA proposes that if FDA identifies a complex data issue which cannot be fully assessed and resolved for ( printed page 51721) appropriate action by the goal date, FDA will assign a new goal date of 6 months after the original goal date. FDA proposes that if the new goal date is not met, FDA will contact the applicant and the relevant site or facility for which a complex data issue has been identified and offer an opportunity for a meeting with the agency. Details can be found in the Proposed Commitment Letter, sections II and IX. FDA proposes similar enhancements for original applications for which the goal date will be missed by more than 60 days due to a complex regulatory issue or other reason. For these applications FDA proposes assigning a new goal date of 6 months after the original goal date, and proposes that if the new goal date is not met, FDA will contact the applicant and offer an opportunity for a meeting with the agency. Details can be found in the Proposed Commitment Letter, section II.B.9.

C. Application-Related Meetings

FDA proposes a new more streamlined and efficient meeting structure for application-related meetings, specifies the types of questions to be addressed and outlines processes for each of the updated meeting types. These proposed enhancements will also support complex generic development by facilitating new or faster meeting opportunities for companies developing complex generics. Details can be found in the Proposed Commitment Letter, section III.C.

D. Additional Program Enhancements

FDA proposes continuing to update the Inactive Ingredient Database (IID) on an ongoing basis and posting quarterly notices of such updates made. Proposed new updates include adding inactive ingredients newly and accurately identified in labeling approved by FDA on or after October 1, 2027, or adding upon request ingredients accurately identified in labeling approved by FDA before October 1, 2027. FDA also proposes to continue the transition in the IID from providing maximum potency to maximum daily exposure (MDE) information. Details can be found in the Proposed Commitment Letter, section IV.A.

FDA proposes to establish a public Maximum Daily Dose (MDD) database populated with at least 500 MDD values for reference listed drugs (RLDs) by the end of FY 2028 and to continue to populate that database with MDD values. FDA also proposes seeking public input on the utility of the MDD database. Details can be found in the Proposed Commitment Letter, section IV.B.

FDA proposes providing or updating standard tables and format information for applicants to use when submitting certain data in ANDAs and providing external training on best practices. Once updated, industry would aspire to provide data in the updated formats. Details can be found in the Proposed Commitment Letter, section IV.C.

E. DMF Assessment Program

FDA proposes expanding the eligibility criteria for DMF prior assessments to include complex API and prior approval supplements seeking to add a new API source located in the U.S., and to expand eligibility for DMF prior assessment requests related to ANDAs submitted within a certain timeframe of the date all patents and exclusivities for the RLD will expire. FDA also proposes enhancing submission procedures for these DMF assessment requests to add a cover letter template signed by the ANDA applicant and Form FDA 3938. Details can be found in the Proposed Commitment Letter, section V.E.

F. Supporting Domestic Manufacturing

FDA is committed to encouraging domestic manufacturing to reduce supply chain risk. FDA proposes statutory changes to increase the foreign fee differential from $15,000 to $25,000 starting in FY 2028 for all foreign Active Pharmaceutical Ingredient (API), Finished Dosage Form (FDF) and Contract Manufacturing Organization (CMO) facilities. FDA also proposes statutory amendments for a one-time application fee waiver for an original ANDA submission fee if a domestic applicant satisfies the proposed requirements of having the application identify only facilities located in the U.S. as both the FDF manufacturer(s) and the API supplier(s). In addition to these statutory changes, FDA proposes an opportunity for existing U.S. generic API and FDF facilities without recent inspection history the opportunity to request an inspection in advance of a planned DMF or ANDA submission that will include the facility. Details can be found in the Proposed Commitment Letter, section VI.E.

G. User Fee Resource Management

FDA is committed to ensuring the sustainability of GDUFA program resources and to enhancing the operational agility of the generic drugs program. FDA will continue activities to promote transparency of the use of GDUFA financial resources in support of the generic drugs program through publication of a GDUFA 5-year financial plan (along with annual updates). FDA proposes to update the topics included in the financial plan, as well as in the annual GDUFA Financial Report submitted to Congress. FDA will also offer one technical staff meeting per year with industry focused on program finances, and FDA will publish minutes from these meetings on its public website. FDA also proposes to make cover sheets for annual fees available on August 15th or the following business day of each year and to add language to the GDUFA website explaining payment timelines. Details can be found in the Proposed Commitment Letter, section VII.C.

In addition, FDA proposes to amend the statute to modify the date used to establish liability for annual fees for the upcoming fiscal year, to improve predictability. FDA also proposes statutory language for GDUFA IV to change the percentage of total fee revenues to be derived from ANDA submission fees to 26% (from 33%) and shift allocation of the difference to the percentage derived from program fees. FDA also proposes allocating a portion of fees for restaffing the generic drugs program.

IV. Public Meeting Information

A. Purpose and Scope of the Meeting

The meeting will include presentations by FDA and a series of panels with FDA and regulated industry representatives to present and discuss the agreed-upon proposed enhancements. The meeting will also include verbal comments on the proposed enhancements from other interested parties, which may include scientific and academic experts, healthcare professionals, representatives of patient and consumer advocacy groups, and the general public. A draft agenda and other background information for the public meeting will be posted at: www.fda.gov/​industry/​generic-drug-user-fee-amendments/​gdufa-iv-fiscal-years-2028-2032.

B. Participating in the Public Meeting

Registration: Information about how to register for the public meeting is available on FDA's web page for this public meeting: www.fda.gov/​industry/​generic-drug-user-fee-amendments/​gdufa-iv-fiscal-years-2028-2032. Registration is free for both in person and virtual attendance. In person attendance is based on space availability, with priority given to early registrants. Early registration is recommended because seating is ( printed page 51722) limited; therefore, FDA may limit the number of in person participants from each organization. If you need special accommodation due to a disability, please contact GDUFAReauthorization@fda.hhs.gov no later than September 3, 2026.

Opportunity for Public Comment: If you wish to speak during the public comment session, complete the request form on www.fda.gov/​industry/​generic-drug-user-fee-amendments/​gdufa-iv-fiscal-years-2028-2032 and identify which topic(s) you wish to address. All requests to make a public comment during the meeting must be received by September 3, 2026, 11:59 p.m. Eastern Time. We will do our best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their comments and request time jointly. FDA we will determine the amount of time allotted to each commenter, the approximate time each comment is to begin, and will select and notify participants by September 10, 2026. No commercial or promotional material will be permitted to be presented at the public meeting.

Streaming Webcast of the Public Meeting: When available, the virtual link to the hybrid public meeting will be posted on FDA's public web page at www.fda.gov/​industry/​generic-drug-user-fee-amendments/​gdufa-iv-fiscal-years-2028-2032. FDA will also distribute the link via email to registered attendees.

Transcripts: Please be advised that as soon as a transcript of the public meeting is available, it will be accessible at www.regulations.gov. It may be viewed at the Dockets Management Staff (see ADDRESSES ). A link to the transcript will also be available on the internet at www.fda.gov/​industry/​generic-drug-user-fee-amendments/​gdufa-iv-fiscal-years-2028-2032.

91 FR 51718