# 2026-16353: FDA Seeks Input on Generic Drug Fees Through 2032

2026-16353, Reauthorization of the Generic Drug User Fee Amendments; Public Meeting; Request for Comments, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2026-08-11, effective The hybrid public meeting will be held on September 17, 2026, from 9:00 a.m. to 2:00 p.m. Either electronic or written comments on this public meeting must be submitted by October 17, 2026.; PRIA reads it as touching household money (as of 2026-08-18).

- Canonical: https://policyrisk.com/federal-register/2026-16353
- As of: 2026-08-18
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-16353
- Title: Reauthorization of the Generic Drug User Fee Amendments; Public Meeting; Request for Comments
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 91 FR 51718
- Published: 2026-08-11
- Effective: The hybrid public meeting will be held on September 17, 2026, from 9:00 a.m. to 2:00 p.m. Either electronic or written comments on this public meeting must be submitted by October 17, 2026.
- Comments close: 2026-10-17
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-08-18

## In one line

FDA Seeks Input on Generic Drug Fees Through 2032

## Summary

The Food and Drug Administration (FDA, the Agency, or we) is hosting a public meeting to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for fiscal years (FYs) 2028 to 2032. GDUFA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to authorize FDA to assess and collect fees to support human generic drug activities. The current legislative authority for GDUFA expires at the end of September 2027. At that time, new legislation will be required for FDA to continue to assess and collect generic drug user fees for future fiscal years. The FD&C Act directs FDA, following negotiations with the regulated industry and periodic consultations with other stakeholders, to present recommendations for reauthorization of the GDUFA program to the relevant Congressional committees, publish the recommendations in the Federal Register, provide for a period of 30 days for the public to provide written comments on such recommendations, and hold a meeting at which the public may present its views on such recommendations. FDA will then consider such public views and comments and revise such recommendations as necessary.

## Effects PRIA read

- Foreign Facility Fee Jump to $25,000: cost, high. FDA proposes to increase the foreign fee differential from $15,000 to $25,000 starting in FY 2028 for all foreign API, finished dosage form (FDF), and contract manufacturing organization (CMO) facilities. If adopted, companies using foreign facilities would face an additional $10,000 fee per affect…
- One-Time ANDA Fee Waiver for U.S.-Only Applicants: benefit, medium. FDA proposes a one-time waiver of the original ANDA application fee if an applicant’s submission identifies only U.S.-located FDF manufacturers and U.S.-located API suppliers. This waiver would apply to qualifying domestic applicants for an original ANDA submission under the proposed GDUFA IV terms.
- Shift in Fee Revenue Allocation (26% ANDA Share): mixed, medium. FDA proposes changing the statutory allocation so ANDA submission fees would make up 26% of total GDUFA fee revenues (down from 33%), with the difference shifted to program fees. This is a statutory reallocation of how fee revenue is sourced under GDUFA IV.
- Advance Inspection Requests for U.S. Facilities: benefit, low. FDA proposes to let existing U.S. generic API and FDF facilities without recent inspection history request an inspection in advance of a planned DMF or ANDA submission that will include the facility. This gives such U.S. facilities an opportunity to obtain inspections ahead of submitting regulatory…
- Expanded DMF Prior-Assessment Eligibility: benefit, medium. FDA proposes expanding DMF prior-assessment eligibility to include complex APIs, prior approval supplements adding a new U.S. API source, and certain DMF requests related to ANDAs submitted near the RLD patent/exclusivity expiry date. This broadens what types of DMF requests may receive prior asses…
- New ANDA Review Timeline Options and Extensions: benefit, medium. FDA proposes review-process changes including a new 120-day goal extension option for certain pOAI alerts, a new 6‑month re-assigned goal date for complex data issues (with a meeting offer if missed), and a post pre-approval inspection meeting option. Applicants may also select a goal-date extensio…
- Public Maximum Daily Dose (MDD) Database: benefit, low. 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 adding values thereafter. FDA will also seek public input on the database's utility.
- Inactive Ingredient Database (IID) Updates and MDE Transition: benefit, low. FDA proposes to continue updating the Inactive Ingredient Database (IID) on an ongoing basis, post quarterly notices of updates, add ingredients newly and accurately identified in labeling approved on or after October 1, 2027, and continue the IID transition from maximum potency to maximum daily ex…

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## Sources
- [2026-16353 on federalregister.gov](https://www.federalregister.gov/documents/2026/08/11/2026-16353/reauthorization-of-the-generic-drug-user-fee-amendments-public-meeting-request-for-comments)
- [2026-16353 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-08-11/pdf/2026-16353.pdf)

## Related
- [Previous: 2026-16352, Agency Information Collection Activities: Submission for OMB Review; Comment Re…](https://policyrisk.com/federal-register/2026-16352)
- [Next: 2026-16355, Foreign-Trade Zone (FTZ) 153; Withdrawal of Notification of Proposed Production…](https://policyrisk.com/federal-register/2026-16355)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2026-16353 (as of 2026-08-18).