21 USC 379 - Reauthorization; reporting requirements

View all text of Subpart 10 [§ 379j-71 - § 379j-73]

§ 379j–73. Reauthorization; reporting requirements

(a) Performance report

(1) In general

(2) Additional informationBeginning 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

(b) Fiscal report

(d) Reauthorization

(1) ConsultationIn 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;

(D) health care professionals;

(E) representatives of patient and consumer advocacy groups; and

(F) the regulated industry.

(2) Public review of recommendationsAfter 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;

(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

(4) Minutes of negotiation meetings

(A) Public availability

(B) Content

(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.)