21 U.S.C. § 387u: Studies of progress and…

Summary

Within 3 years after June 22, 2009, and at least every 2 years after that, the Secretary of Health and Human Services must send a report to the Senate Committee on Health, Education, Labor, and Pensions and the House Committee on Energy and Commerce. The report must describe the FDA’s progress implementing the law, note major accomplishments and measurable results, point out unfinished parts and obstacles or delays, give counts of new-product applications under section 387j and modified-risk applications under section 387k and how many were acted on, and report the number of full-time equivalent staff involved. Within 5 years after June 22, 2009, the Comptroller General must study and report to the same committees whether the Secretary has enough authority and resources to meet the law’s goals and recommend ways to strengthen that authority to better protect public health for tobacco manufacture, marketing, and distribution. Both reports must be made public, including by posting them on the FDA and GAO websites.

Title 21, §387u

Food and Drugs, Source: USLM XML via OLRC

(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 (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.

Notes & Related Subsidiaries

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 ActionWith 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.

§387u Studies of Progress and Effectiveness