§284i — Title 42 The Public Health and Welfare | U.S. Code

Summary

The NIH must step up and coordinate research and other work on autoimmune diseases. The NIH Director must share money for this work among the institutes doing it. The law says “autoimmune disease” means diseases that show autoimmune activity, as the Secretary decides. The Secretary must make sure an Autoimmune Diseases Coordinating Committee works across the NIH and with other federal health programs. The Committee includes directors (or their designees) of the research institutes and representatives from other health agencies like the CDC and FDA. The Committee’s chair is the main adviser to the Secretary, the Assistant Secretary for Health, and the NIH Director and reports to the NIH Director. No later than 1 year after October 17, 2000, the Committee had to write a plan for research and education and update it as needed. The plan must cover a wide range of biomedical, social, and rehab research, study the heavier impact on women, set NIH priorities, and include input from scientists, patients, and advocacy groups. It must include work on why the diseases happen, basic causes, who gets them and how often, better screening, clinical studies of new treatments (including biological drugs), and information and education for doctors and the public. The NIH must carry out its programs according to that plan.

Title 42, §284i

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

(a)(1)The Director of NIH shall expand, intensify, and coordinate research and other activities of the National Institutes of Health with respect to autoimmune diseases.

(2)With respect to amounts appropriated to carry out this section for a fiscal year, the Director of NIH shall allocate the amounts among the national research institutes that are carrying out paragraph (1).

(3)The term “autoimmune disease” includes, for purposes of this section such diseases or disorders with evidence of autoimmune pathogensis 11 So in original. Probably should be “pathogenesis”. as the Secretary determines to be appropriate.

(b)(1)The Secretary shall ensure that the Autoimmune Diseases Coordinating Committee (referred to in this section as the “Coordinating Committee”) coordinates activities across the National Institutes and with other Federal health programs and activities relating to such diseases.

(2)The Coordinating Committee shall be composed of the directors or their designees of each of the national research institutes involved in research with respect to autoimmune diseases and representatives of all other Federal departments and agencies whose programs involve health functions or responsibilities relevant to such diseases, including the Centers for Disease Control and Prevention and the Food and Drug Administration.

(3)(A)With respect to autoimmune diseases, the Chair of the Committee shall serve as the principal advisor to the Secretary, the Assistant Secretary for Health, and the Director of NIH, and shall provide advice to the Director of the Centers for Disease Control and Prevention, the Commissioner of Food and Drugs, and other relevant agencies.

(B)The Chair of the Committee shall be directly responsible to the Director of NIH.

(c)(1)Not later than 1 year after October 17, 2000, the Coordinating Committee shall develop a plan for conducting and supporting research and education on autoimmune diseases through the national research institutes and shall periodically review and revise the plan. The plan shall—

(A)provide for a broad range of research and education activities relating to biomedical, psychosocial, and rehabilitative issues, including studies of the disproportionate impact of such diseases on women;

(B)identify priorities among the programs and activities of the National Institutes of Health regarding such diseases; and

(C)reflect input from a broad range of scientists, patients, and advocacy groups.

(2)The plan under paragraph (1) shall, with respect to autoimmune diseases, provide for the following as appropriate:

(A)Research to determine the reasons underlying the incidence and prevalence of the diseases.

(B)Basic research concerning the etiology and causes of the diseases.

(C)Epidemiological studies to address the frequency and natural history of the diseases, including any differences among the sexes and among racial and ethnic groups.

(D)The development of improved screening techniques.

(E)Clinical research for the development and evaluation of new treatments, including new biological agents.

(F)Information and education programs for health care professionals and the public.

(3)The Director of NIH shall ensure that programs and activities of the National Institutes of Health regarding autoimmune diseases are implemented in accordance with the plan under paragraph (1).

Notes & Related Subsidiaries

Editorial Notes

Amendments

2007—Subsec. (d). Pub. L. 109–482, § 104(b)(1)(E), struck out heading and text of subsec. (d). Text read as follows: “The Coordinating Committee under subsection (b)(1) of this section shall biennially submit to the Committee on Commerce of the House of Representatives, and the Committee on Health, Education, Labor and Pensions of the Senate, a report that describes the research, education, and other activities on autoimmune diseases being conducted or supported through the national research institutes, and that in addition includes the following: “(1) The plan under subsection (c)(1) of this section (or revisions to the plan, as the case may be). “(2) Provisions specifying the amounts expended by the National Institutes of Health with respect to each of the autoimmune diseases included in the plan. “(3) Provisions identifying particular projects or types of projects that should in the future be considered by the national research institutes or other entities in the field of research on autoimmune diseases.” Subsec. (e). Pub. L. 109–482, § 103(b)(11), struck out heading and text of subsec. (e). Text read as follows: “For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005. The authorization of appropriations established in the preceding sentence is in addition to any other authorization of appropriations that is available for conducting or supporting through the National Institutes of Health research and other activities with respect to autoimmune diseases.”

Statutory Notes and Related Subsidiaries

Effective Date

of 2007 AmendmentAmendment by Pub. L. 109–482 applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of Pub. L. 109–482, set out as a note under section 281 of this title.

§284i Autoimmune diseases