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

submitted 17 years ago by Pub. L. 111-31 to r/title-21-FOOD-AND-DRUGS · 308 words · no verdicts yet

in plain englishAI-generated · not legal advice

The FDA must report to Congress on its tobacco program progress every two years, starting within three years. The Government Accountability Office must study the FDA's authority and resources within five years. Both reports must be posted publicly online.

(a) FDA report: Starting no later than 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's Health, Education, Labor, and Pensions Committee and the House's Energy and Commerce Committee. The report must cover: (1) how the FDA is doing implementing this division — major achievements, measurable progress, and any areas not yet done; (2) obstacles the FDA has found to making progress or meeting deadlines; (3) data on how many new tobacco product applications (under section 387j) and modified risk applications (under section 387k) were received, and how many were acted on in each category; and (4) data on how many full-time staff are working on this division. (b) GAO report: No later than 5 years after June 22, 2009, the Comptroller General must study and report to the same committees on: (1) whether the Secretary has enough legal authority and resources to meet this division's goals; and (2) recommendations for strengthening that authority to better protect public health around making, marketing, and distributing tobacco products. (c) Public availability: Both the Secretary and the Comptroller General must make their reports public, including by posting them on the FDA's and the GAO's websites.

the actual law source: uscode.house.gov ↗public domain

(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.

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.

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

history & why it existsrecord from the source credit

2009Enacted · Pub. L. 111-31 · 123 Stat. 1841

A history note hasn’t been published yet. The record shows enactment by Pub. L. 111-31 on 2009-06-22.

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