21 USC 387u - Studies of progress and effectiveness

U.S Code last checked for updates: Apr 17, 2024

§ 387u.

Studies of progress and effectiveness

(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

 So in original. Probably should be plural.

(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, § 106, June 22, 2009, 123 Stat. 1841.)

cite as: 21 USC 387u