21 U.S.C. § 387u — Studies of progress and effectiveness

FEDERAL · 21 U.S.C. · Chapter 9

Studies of progress and effectiveness

Current through Pub. L. 119-102

Title 21 — Food and Drugs·Ch. 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT·Subch. IX

(a)FDA report Not later than 3 years after June 22, 2009, 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)data on the number of new product applications received under section 387j of this title and modifie

Free access — add to your briefcase to read the full text and ask questions with AI

(a) FDA report
Not later than 3 years after June 22, 2009, 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) data on the number of new product applications received under section 387j of this title and modified risk product applications received under section 387k of this title, 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 June 22, 2009, 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
The Secretary of Health and Human Services and the Comptroller General of the United States, respectively, shall make the reports required under subsection 1 (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.

21 U.S.C. § 387u (Studies of progress and effectiveness) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.

Source Credit

History

(Pub. L. 111–31, div. A, title I, §106, June 22, 2009, 123 Stat. 1841.)

Editorial Notes

Editorial Notes

References in Text
This division, referred to in subsecs. (a)(1), (2), (4) and (b)(1), is div. A of Pub. L. 111–31, June 22, 2009, 123 Stat. 1776, 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 section 301 of this title 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
With respect to any time periods specified in div. A of Pub. L. 111–31 that begin on June 22, 2009, 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 section 387s of this title, 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 section 6 of Pub. L. 111–31, set out as a note under section 387 of this title.