---
kind: "section"
citation: "21 U.S.C. § 379j–73"
title: "21"
title_heading: "Food and Drugs"
number: "379j–73"
heading: "Reauthorization; reporting requirements"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/379j-73"
units:
  - "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. Reauthorization; reporting requirements

- (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](/usc/21/321.md?p=d) shall prepare and submit to the Committee on Energy and [Commerce](/usc/21/360hh.md?p=4) 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](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration in achieving the goals identified in the letters described in section 6502 of the Over-the-Counter Monograph [Drug](/usc/21/321.md?p=g-1) User Fee Amendments during such fiscal year and the future plans of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) 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](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration in achieving the goals, and future plans for meeting the goals, including—
      - (i) the number of [Tier 1 OTC monograph order requests](/usc/21/379j–71.md?p=8) 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](/usc/21/379j–71.md?p=9-A) 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](/usc/21/379j–71.md?p=7) 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](/usc/21/321.md?p=u) and effective finalization [OTC monograph order requests](/usc/21/379j–71.md?p=7) 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](/usc/21/379j–71.md?p=7), in the aggregate and by submission type, in the previous fiscal year; and
      - (vi) postmarket safety activities with respect to [OTC monograph drugs](/usc/21/379j–71.md?p=5), including—
        - (I) collecting, developing, and reviewing safety information on [OTC monograph drugs](/usc/21/379j–71.md?p=5), including [adverse event](/usc/21/364.md?p=1) reports;
        - (II) developing and using improved analytical tools, [adverse event](/usc/21/364.md?p=1) 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](/usc/21/379aa.md);
    - (B) information regarding registration of [OTC monograph drug facilities](/usc/21/379j–71.md?p=10-A) and [contract manufacturing organization facilities](/usc/21/379j–71.md?p=2) and payment of registration fees by such [facilities](/usc/21/364.md?p=3-A), including—
      - (i) the [OTC monograph drug facilities](/usc/21/379j–71.md?p=10-A) and [contract manufacturing organization facilities](/usc/21/379j–71.md?p=2) that were first registered under section [360(c)](/usc/21/360.md?p=c) or [360(i)](/usc/21/360.md?p=i) of this title in the fiscal year; and
      - (ii) for each [OTC monograph drug facility](/usc/21/379j–71.md?p=10-A) and [contract manufacturing organization facility](/usc/21/379j–71.md?p=2) that was assessed a [facility](/usc/21/364.md?p=3-A) fee under [section 379j–72(a) of this title](/usc/21/379j–72.md?p=a) in the fiscal year, whether the [facility](/usc/21/364.md?p=3-A) paid such fee;
    - (C) the status of implementation of evidence and testing standards under [section 355h(r) of this title](/usc/21/355h.md?p=r) for [nonprescription](/usc/21/360fff.md?p=5) [drugs](/usc/21/321.md?p=g-1) intended for topical administration, including—
      - (i) the application of evidence or testing standards; and
      - (ii) the number of active ingredient requests for [nonprescription](/usc/21/360fff.md?p=5) [drugs](/usc/21/321.md?p=g-1) intended for topical administration reviewed using the standards under [section 355h(b) of this title](/usc/21/355h.md?p=b); and
    - (D) the progress of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration in allowing nonclinical testing alternatives to animal testing for the consideration of [sunscreen active ingredients](/usc/21/360fff.md?p=10).
  - (3) **Confidentiality—** Nothing in [paragraph (2)](#a-2) shall be construed to authorize the disclosure of information that is prohibited from disclosure under [section 331(j) of this title](/usc/21/331.md?p=j) or [section 1905 of title 18](/usc/18/1905.md) or that is subject to withholding under [section 552(b)(4) of title 5](/usc/5/552.md?p=b-4).
- (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](/usc/21/321.md?p=d) shall prepare and submit to the Committee on Energy and [Commerce](/usc/21/360hh.md?p=4) 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](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration, of the fees collected for such fiscal year.
- (c) **Public availability—** The [Secretary](/usc/21/321.md?p=d) shall make the reports required under subsections [(a)](#a) and [(b)](#b) available to the public on the internet website of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration.
- (d) **Reauthorization—**
  - (1) **Consultation—** In developing recommendations to present to the Congress with respect to the goals described in [subsection (a)](#a), and plans for meeting the goals, for [OTC monograph drug activities](/usc/21/379j–71.md?p=6) for the first 5 fiscal years after fiscal year 2030, and for the reauthorization of this subpart for such fiscal years, the [Secretary](/usc/21/321.md?p=d) shall consult with—
    - (A) the Committee on Energy and [Commerce](/usc/21/360hh.md?p=4) 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](/usc/21/321.md?p=d) shall—
    - (A) present the recommendations developed under [paragraph (1)](#d-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](/usc/21/321.md?p=d) shall transmit to the Congress the revised recommendations under [paragraph (2)](#d-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](/usc/21/321.md?p=d) shall make publicly available, on the public website of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration, robust written minutes of all negotiation meetings conducted under this subsection between the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) 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)](#d-4-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.

## Source credit

(June 25, 1938, ch. 675, § 744N, as added Pub. L. 116–136, div. A, title III, § 3862, Mar. 27, 2020, 134 Stat. 468; amended Pub. L. 119–37, div. F, title V, § 6505(a), Nov. 12, 2025, 139 Stat. 642.)

## Notes

### Termination of Section

For 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 Amendment

Amendment 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.”