21 U.S.C. § 379j–73: Reauthorization…

Summary

The Secretary must send a yearly progress report to two Congressional committees within 120 calendar days after any fiscal year when fees are collected. The report must say how the FDA is doing on its OTC monograph goals and what it plans to do next. Starting in fiscal year 2026, the report must also include counts of proposed and final orders for four request types (Tier 1, Tier 2, specified safety, and GRAS/E finalization), average processing times overall and by type, postmarket safety work (collecting and reviewing safety data and adverse events, improved analytics and IT including outside databases, and activities under section 379aa), which facilities registered and whether they paid fees, how testing and evidence standards for topical nonprescription drugs are being used and how many active-ingredient requests were reviewed under those standards, and progress on non-animal testing alternatives for sunscreen ingredients. The report must not include information barred from disclosure under section 331(j), section 1905 of title 18, or section 552(b)(4) of title 5. Within the same 120 days the Secretary must also send a fiscal report about fee authority and how the fees were used. Both reports must be posted on the FDA website. For reauthorization covering the five fiscal years after fiscal year 2030, the Secretary must consult with the named Congressional committees, experts, clinicians, patient and consumer groups, and industry; negotiate with industry; publish recommendations in the Federal Register; allow 30 calendar days for public written comments and hold a public meeting; then revise the recommendations and send the final recommendations and a summary of comments to Congress by January 15, 2030. The FDA must post detailed minutes of negotiation meetings on its website within 30 days showing substantive proposals, major disagreements, and how they were resolved.

Title 21, §379j–73

Food and Drugs, Source: USLM XML via OLRC

(a)Performance report

(1)In general

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)Additional information

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)Confidentiality

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)Fiscal report

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)Public availability

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)Reauthorization

(1)Consultation

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)Public review of recommendations

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)Transmittal of recommendations

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)Minutes of negotiation meetings

(A)Public availability

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)Content

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.

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.”

§379j–73 Reauthorization; Reporting Requirements

Summary

Title 21, §379j–73

Notes & Related Subsidiaries

Editorial Notes

References in Text

Amendments

Amendments

Amendments

Statutory Notes and Related Subsidiaries

Effective Date

Citations & Metadata