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Title 21, Food and DrugsRelease 119-73not60

§379j–73 Reauthorization; Reporting Requirements

Title 21 › Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VII— GENERAL AUTHORITY › Part C— Fees › Subpart 10— fees relating to over-the-counter drugs › § 379j–73

Last updated Apr 5, 2026|Official source

Summary

The Secretary must send a yearly report within 120 calendar days after each fiscal year ends to the House Energy and Commerce Committee and the Senate Health, Education, Labor, and Pensions Committee. The report explains FDA progress and future plans for meeting goals from the OTC monograph user-fee letters. Starting with fiscal year 2026, the report must add counts of proposed and final orders for four types of OTC monograph requests (Tier 1, Tier 2, specified safety, and generally recognized as safe and effective finalizations), the average time to process requests (overall and by submission type), and postmarket safety work (such as collecting and reviewing safety and adverse-event information, using better analytical and IT tools and outside databases, and actions under section 379aa). It must also list facilities newly registered under sections 360(c) or 360(i) and say whether facilities billed a facility fee under section 379j–72(a) paid it. The report must describe how evidence and testing standards for topical nonprescription drugs under section 355h(r) are being applied and how many active ingredient requests were reviewed under section 355h(b). It must also report on progress in finding non-animal testing options for sunscreen ingredients. Confidential information that federal law protects must not be released. Within the same 120-day deadline the Secretary must also report on how the fee authority was used and how collected fees were spent. Both reports must be posted on the FDA website. For planning the first five fiscal years after fiscal year 2030 and for reauthorization, the Secretary must consult with the two congressional committees, experts, health professionals, patient and consumer groups, and industry. After negotiating with industry, the Secretary must send the recommendations to Congress, publish them in the Federal Register, allow 30 calendar days for written public comment, hold a public meeting, consider comments and revise the recommendations, and send the revised recommendations and a summary of comments to Congress by January 15, 2030. The Secretary must also post detailed written minutes of each negotiation meeting within 30 days showing proposals, important disagreements, and how they were resolved.

Full Legal Text

Title 21, §379j–73

Food and Drugs, Source: USLM XML via OLRC

(a)(1)Not later than 120 calendar days after the end of each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 6502 of the Over-the-Counter Monograph Drug User Fee Amendments during such fiscal year and the future plans of the Food and Drug Administration for meeting such goals.
(2)Beginning with fiscal year 2026, the annual report under this subsection shall include—
(A)the progress of the Food and Drug Administration in achieving the goals, and future plans for meeting the goals, including—
(i)the number of Tier 1 OTC monograph order requests for which a proposed order was issued, and the number of such requests for which a final order was issued, in the previous fiscal year;
(ii)the number of Tier 2 OTC monograph order requests for which a proposed order was issued, and the number of such requests for which a final order was issued, in the previous fiscal year;
(iii)the number of specified safety OTC monograph order requests for which a proposed order was issued, and the number of such requests for which a final order was issued, in the previous fiscal year;
(iv)the number of generally recognized as safe and effective finalization OTC monograph order requests for which a proposed order was issued, and the number of such requests for which a final order was issued, in the previous fiscal year;
(v)the average timeline for processing OTC monograph order requests, in the aggregate and by submission type, in the previous fiscal year; and
(vi)postmarket safety activities with respect to OTC monograph drugs, including—
(I)collecting, developing, and reviewing safety information on OTC monograph drugs, including adverse event reports;
(II)developing and using improved analytical tools, adverse event data-collection systems, including information technology systems, to assess potential safety problems, including access to external databases; and
(III)activities under section 379aa of this title;
(B)information regarding registration of OTC monograph drug facilities and contract manufacturing organization facilities and payment of registration fees by such facilities, including—
(i)the OTC monograph drug facilities and contract manufacturing organization facilities that were first registered under section 360(c) or 360(i) of this title in the fiscal year; and
(ii)for each OTC monograph drug facility and contract manufacturing organization facility that was assessed a facility fee under section 379j–72(a) of this title in the fiscal year, whether the facility paid such fee;
(C)the status of implementation of evidence and testing standards under section 355h(r) of this title for nonprescription drugs intended for topical administration, including—
(i)the application of evidence or testing standards; and
(ii)the number of active ingredient requests for nonprescription drugs intended for topical administration reviewed using the standards under section 355h(b) of this title; and
(D)the progress of the Food and Drug Administration in allowing nonclinical testing alternatives to animal testing for the consideration of sunscreen active ingredients.
(3)Nothing in paragraph (2) shall be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5.
(b)Not later than 120 calendar days after the end of each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected for such fiscal year.
(c)The Secretary shall make the reports required under subsections (a) and (b) available to the public on the internet website of the Food and Drug Administration.
(d)(1)In developing recommendations to present to the Congress with respect to the goals described in subsection (a), and plans for meeting the goals, for OTC monograph drug activities for the first 5 fiscal years after fiscal year 2030, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with—
(A)the Committee on Energy and Commerce of the House of Representatives;
(B)the Committee on Health, Education, Labor, and Pensions of the Senate;
(C)scientific and academic experts;
(D)health care professionals;
(E)representatives of patient and consumer advocacy groups; and
(F)the regulated industry.
(2)After negotiations with the regulated industry, the Secretary shall—
(A)present the recommendations developed under paragraph (1) to the congressional committees specified in such paragraph;
(B)publish such recommendations in the Federal Register;
(C)provide for a period of 30 calendar days for the public to provide written comments on such recommendations;
(D)hold a meeting at which the public may present its views on such recommendations; and
(E)after consideration of such public views and comments, revise such recommendations as necessary.
(3)Not later than January 15, 2030, the Secretary shall transmit to the Congress the revised recommendations under paragraph (2), a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments.
(4)(A)The Secretary shall make publicly available, on the public website of the Food and Drug Administration, robust written minutes of all negotiation meetings conducted under this subsection between the Food and Drug Administration and the regulated industry, not later than 30 days after each such negotiation meeting.
(B)The robust written minutes described under subparagraph (A) shall contain, in detail, any substantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations and their resolution.

Legislative History

Notes & Related Subsidiaries

Termination of SectionFor termination of section by section 6509(b) of Pub. L. 119–37, see Termination Date note below.

Editorial Notes

References in Text

section 6502 of the Over-the-Counter Monograph Drug User Fee

Amendments

, referred to in subsec. (a)(1), is section 6502 of title V of div. F of Pub. L. 119–37, which is set out as a note under section 379j–71 of this title.

Amendments

2025—Subsec. (a). Pub. L. 119–37, § 6505(a)(1), designated existing provisions as par. (1), inserted heading, substituted “Not later than 120 calendar days after the end of each fiscal year” for “Beginning with fiscal year 2021, and not later than 120 calendar days after the end of each fiscal year thereafter” and “section 6502 of the Over-the-Counter Monograph Drug User Fee

Amendments

” for “section 3861(b) of the CARES Act”, and added pars. (2) and (3). Subsec. (b). Pub. L. 119–37, § 6505(a)(2), substituted “each fiscal year” for “fiscal year 2021 and each subsequent fiscal year”. Subsec. (d)(1), (3). Pub. L. 119–37, § 6505(a)(3)(A), substituted “2030” for “2025”. Subsec. (d)(4). Pub. L. 119–37, § 6505(a)(3)(B), added par. (4).

Statutory Notes and Related Subsidiaries

Effective Date

of 2025 AmendmentAmendment by Pub. L. 119–37 effective Nov. 12, 2025, with fees under this subpart to be assessed beginning Oct. 1, 2025, see section 6510 of Pub. L. 119–37, set out as a note under section 355 of this title. Termination Date Pub. L. 119–37, div. F, title V, § 6509(b), Nov. 12, 2025, 139 Stat. 648, provided that: “section 744N of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–73) shall cease to be effective January 31, 2031.”

Reference

Citations & Metadata

Citation

21 U.S.C. § 379j–73

Title 21, Food and Drugs

Last Updated

Apr 5, 2026

Release point: 119-73not60