21 USC 379j-73 - Reauthorization; reporting requirements

U.S Code last checked for updates: Nov 24, 2024

§ 379j–73.

Reauthorization; reporting requirements

(a)

Performance report

(b)

Fiscal report

(c)

Public availability

(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 2025, 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

(June 25, 1938, ch. 675, § 744N, as added Pub. L. 116–136, div. A, title III, § 3862, Mar. 27, 2020, 134 Stat. 468.)

cite as: 21 USC 379j-73