PRIA, Government Policy, Made Personal

Summary

The Secretary must set up a clinical evaluation unit at the NIH Clinical Center for the National Cancer Institute and another for the National Institute of Allergy and Infectious Diseases, working through each Institute’s director. Each unit must run clinical tests of experimental AIDS treatments developed in the preclinical drug program, including tests of ways to diagnose immune problems and to predict, prevent, or treat opportunistic cancers and infections. They may also test experimental AIDS treatments made by other NIH institutes or outside groups. Each unit must have at least 50 beds or outpatient space equal to at least twice the outpatient capacity the Clinical Center had for AIDS on June 1, 1988, plus the staff and support services needed. These resources must be extra to what the Clinical Center would otherwise have. Money may be appropriated as needed to carry this out.

Title 42, §300cc–11

The Public Health and Welfare, Source: USLM XML via OLRC

(a)The Secretary, acting through the Director of the National Cancer Institute and the Director of the National Institute of Allergy and Infectious Diseases, shall for each such Institute establish a clinical evaluation unit at the Clinical Center at the National Institutes of Health. Each of the clinical evaluation units—

(1)shall conduct clinical evaluations of experimental treatments for acquired immune deficiency syndrome developed within the preclinical drug development program, including evaluations of methods of diagnosing immune deficiency and evaluations of methods of predicting, diagnosing, preventing, and treating opportunistic cancers and infectious diseases; and

(2)may conduct clinical evaluations of experimental treatments for such syndrome that are developed by any other national research institute of the National Institutes of Health or by any other entity.

(b)(1)For the purposes described in subsection (a), the Secretary, acting through the Director of the National Institutes of Health, shall provide each of the clinical evaluation units required in such subsection—

(A)(i)with not less than 50 beds; or

(ii)with an outpatient clinical capacity equal to not less than twice the outpatient clinical capacity, with respect to acquired immune deficiency syndrome, possessed by the Clinical Center of the National Institutes of Health on June 1, 1988; and

(B)with such personnel, such administrative support, and such other support services as may be necessary.

(2)Facilities, personnel, administrative support, and other support services provided pursuant to paragraph (1) shall be in addition to the number or level of facilities, personnel, administrative support, and other support services that otherwise would be available at the Clinical Center at the National Institutes of Health for the provision of clinical care for individuals with diseases or disorders.

(c)For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary.

Notes & Related Subsidiaries

Editorial Notes

Prior Provisions

A prior section 300cc–11, act July 1, 1944, § 2312, was successively renumbered by subsequent acts and transferred, see section 238i of this title.

Amendments

1993—Subsec. (a)(1). Pub. L. 103–43 inserted before semicolon at end “, including evaluations of methods of diagnosing immune deficiency and evaluations of methods of predicting, diagnosing, preventing, and treating opportunistic cancers and infectious diseases”.

§300cc–11 Clinical Evaluation Units at National Institutes of Health