42 U.S.C. § 300cc–11: Clinical evaluation…

Summary

The Secretary must set up a clinical evaluation unit at the NIH Clinical Center for both the National Cancer Institute and the National Institute of Allergy and Infectious Diseases, using their directors to run them. Each unit must test experimental treatments for acquired immune deficiency syndrome that come from the preclinical drug development program. They must also study ways to diagnose immune deficiency and to predict, diagnose, prevent, and treat opportunistic cancers and infections. The units may also test experimental treatments made by other NIH institutes or other organizations. The NIH Director must give each unit enough staff, admin help, and other services. Each unit must have at least 50 beds or outpatient capacity equal to at least twice the outpatient AIDS capacity the Clinical Center had on June 1, 1988. These resources must be added on top of the Clinical Center’s usual care resources. Money needed to do this may be appropriated.

Title 42, §300cc–11

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

(a)In general

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)Personnel and administrative support

(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)Authorization of appropriations

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