Public Law 119-73 (01/23/2026)

21 U.S.C. § 387u

Studies of progress and effectiveness

(a)

FDA report

Not later than 3 years after , and not less than every 2 years thereafter, the Secretary of Health and Human Services shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report concerning—
(1)
the progress of the Food and Drug Administration in implementing this division, including major accomplishments, objective measurements of progress, and the identification of any areas that have not been fully implemented;
(2)
impediments identified by the Food and Drug Administration to progress in implementing this division and to meeting statutory timeframes;
(3)
section 387j of this titlesection 387k of this title data on the number of new product applications received under and modified risk product applications received under , and the number of applications acted on under each category; and
(4)
data on the number of full time equivalents engaged in implementing this division.
(b)

GAO report

Not later than 5 years after , the Comptroller General of the United States shall conduct a study of, and submit to the Committees described in subsection (a) a report concerning—
(1)
the adequacy of the authority and resources provided to the Secretary of Health and Human Services for this division to carry out its goals and purposes; and
(2)
any recommendations for strengthening that authority to more effectively protect the public health with respect to the manufacture, marketing, and distribution of tobacco products.
(c)

Public availability

1

1 So in original. Probably should be plural.
The Secretary of Health and Human Services and the Comptroller General of the United States, respectively, shall make the reports required under subsection  (a) and (b) available to the public, including by posting such reports on the respective Internet websites of the Food and Drug Administration and the Government Accountability Office.

Pub. L. 111–31, div. A, title I, § 106123 Stat. 1841(, , .)

Editorial Notes

References in Text

Pub. L. 111–31123 Stat. 1776section 301 of this titleThis division, referred to in subsecs. (a)(1), (2), (4) and (b)(1), is div. A of , , , known as Family Smoking Prevention and Tobacco Control Act. For complete classification of division A to the Code, see Short Title of 2009 Amendment note set out under and Tables.

Codification

Section was enacted as part of the Family Smoking Prevention and Tobacco Control Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

Statutory Notes and Related Subsidiaries

Modification of Deadlines for Secretarial Action

Pub. L. 111–31section 387s of this titlesection 6 of Pub. L. 111–31section 387 of this titleWith respect to any time periods specified in div. A of that begin on , within which the Secretary of Health and Human Services is required to carry out and complete specified activities, with certain limitations, the calculation of such time periods shall commence on the first day of the first fiscal quarter following the initial 2 consecutive fiscal quarters of fiscal year 2010 for which the Secretary has collected fees under , and the Secretary may extend or reduce the duration of one or more such time periods, except that no such period shall be extended for more than 90 days, see , set out as a note under .