
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 23, 2000]
[Document not affected by Public Laws enacted between
  January 23, 2000 and December 4, 2001]
[CITE: 42USC300cc-13]

 
                 TITLE 42--THE PUBLIC HEALTH AND WELFARE
 
                    CHAPTER 6A--PUBLIC HEALTH SERVICE
 
  SUBCHAPTER XXI--RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY 
                                SYNDROME
 
                       Part B--Research Authority
 
Sec. 300cc-13. Terry Beirn Community-Based AIDS Research 
        Initiative
        

(a) In general

    After consultation with the Commissioner of Food and Drugs, the 
Director of the National Institutes of Health, acting through the 
Director of the National Institute of Allergy and Infectious Diseases, 
may make grants to public entities and nonprofit private entities 
concerned with acquired immune deficiency syndrome, and may enter into 
contracts with public and private such \1\ entities, for the purpose of 
planning and conducting, in the community involved, clinical trials of 
experimental treatments for infection with the etiologic agent for such 
syndrome that are approved by the Commissioner of Food and Drugs for 
investigational use under regulations issued under section 355 of title 
21.
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    \1\ So in original.
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(b) Requirement of certain projects

    (1) Financial assistance under subsection (a) of this section shall 
include such assistance to community-based organizations and community 
health centers for the purpose of--
        (A) retaining appropriate medical supervision;
        (B) assisting with administration, data collection and record 
    management; and
        (C) conducting training of community physicians, nurse 
    practitioners, physicians' assistants and other health professionals 
    for the purpose of conducting clinical trials.

    (2)(A) Financial assistance under subsection (a) of this section 
shall include such assistance for demonstration projects designed to 
implement and conduct community-based clinical trials in order to 
provide access to the entire scope of communities affected by infections 
with the etiologic agent for acquired immune deficiency syndrome, 
including minorities, hemophiliacs and transfusion-exposed individuals, 
women, children, users of intravenous drugs, and individuals who are 
asymptomatic with respect to such infection.
    (B) The Director of the National Institutes of Health may not 
provide financial assistance under this paragraph unless the application 
for such assistance is approved--
        (i) by the Commissioner of Food and Drugs;
        (ii) by a duly constituted Institutional Review Board that meets 
    the requirements of part 56 of title 21, Code of Federal 
    Regulations; and
        (iii) by the Director of the National Institute of Allergy and 
    Infectious Diseases.

(c) Participation of private industry, schools of medicine and primary 
        providers

    Programs carried out with financial assistance provided under 
subsection (a) of this section shall be designed to encourage private 
industry and schools of medicine, osteopathic medicine, and existing 
consortia of primary care providers organized to conduct clinical 
research concerning acquired immune deficiency syndrome to participate 
in, and to support, the clinical trials conducted pursuant to the 
programs.

(d) Requirement of application

    The Secretary may not provide financial assistance under subsection 
(a) of this section unless--
        (1) an application for the assistance is submitted to the 
    Secretary;
        (2) with respect to carrying out the purpose for which the 
    assistance is to be made, the application provides assurances of 
    compliance satisfactory to the Secretary; and
        (3) the application otherwise is in such form, is made in such 
    manner, and contains such agreements, assurances, and information as 
    the Secretary determines to be necessary to carry out this section.

(e) Authorization of appropriations

    (1) For the purpose of carrying out subsection (b)(1) of this 
section, there are authorized to be appropriated such sums as may be 
necessary for each of the fiscal years 1989 through 1996.
    (2) For the purpose of carrying out subsection (b)(2) of this 
section, there are authorized to be appropriated such sums as may be 
necessary for each of the fiscal years 1989 through 1996.

(July 1, 1944, ch. 373, title XXIII, Sec. 2313, as added Pub. L. 100-
607, title II, Sec. 201(4), Nov. 4, 1988, 102 Stat. 3068; amended Pub. 
L. 100-690, title II, Sec. 2617(b), Nov. 18, 1988, 102 Stat. 4240; Pub. 
L. 101-93, Sec. 6, Aug. 16, 1989, 103 Stat. 615; Pub. L. 102-96, Sec. 3, 
Aug. 14, 1991, 105 Stat. 481.)


                            Prior Provisions

    A prior section 300cc-13, act July 1, 1944, Sec. 2314, was 
successively renumbered by subsequent acts and transferred, see section 
238k of this title.


                               Amendments

    1991--Pub. L. 102-96, Sec. 3(1), substituted ``Terry Beirn 
Community-Based AIDS Research Initiative'' for ``Community-based 
evaluations of experimental therapies'' in section catchline.
    Subsec. (c). Pub. L. 102-96, Sec. 3(2), substituted ``, schools of 
medicine and primary providers'' for ``and schools of medicine'' in 
heading and substituted ``schools of medicine, osteopathic medicine, and 
existing consortia of primary care providers organized to conduct 
clinical research concerning acquired immune deficiency syndrome'' for 
``schools of medicine and osteopathic medicine''.
    Subsec. (e). Pub. L. 102-96, Sec. 3(3), substituted ``1996'' for 
``1991'' in pars. (1) and (2).
    1989--Subsec. (c). Pub. L. 101-93 inserted ``and osteopathic 
medicine'' after ``schools of medicine''.
    1988--Subsec. (a). Pub. L. 100-690, Sec. 2617(b)(1), which directed 
substitution of ``through the Director of the National Institute of 
Allergy'' for ``through the National Institutes of Allergy'', was 
executed by making substitution for ``through the National Institute of 
Allergy'' as the probable intent of Congress.
    Subsec. (b)(2)(B)(iii). Pub. L. 100-690, Sec. 2617(b)(2), which 
directed substitution of ``Institute'' for ``Institutes'', could not be 
executed because ``Institute'' was singular in original.


                    Effective Date of 1988 Amendment

    Amendment by Pub. L. 100-690 effective immediately after enactment 
of Pub. L. 100-607, which was approved Nov. 4, 1988, see section 2600 of 
Pub. L. 100-690, set out as a note under section 242m of this title.


  Reference to Community, Migrant, Public Housing, or Homeless Health 
              Center Considered Reference to Health Center

    Reference to community health center, migrant health center, public 
housing health center, or homeless health center considered reference to 
health center, see section 4(c) of Pub. L. 104-299, set out as a note 
under section 254b of this title.


                     Findings and Sense of Congress

    Section 2 of Pub. L. 102-96 provided that:
    ``(a) Findings.--Congress finds that--
        ``(1) community-based clinical trials complement the National 
    Institute of Allergy and Infectious Diseases' university-based 
    research in order to provide increased access to experimental 
    therapies;
        ``(2) community-based clinical trials provide an efficient and 
    cost-effective means to develop new HIV-related treatments, 
    benefiting all people living with HIV disease and other illnesses; 
    and
        ``(3) because the community-based clinical trials model has a 
    proven ability to conduct rapid trials that meet the very highest 
    standards of scientific inquiry, this program should be reauthorized 
    and significantly expanded.
    ``(b) Sense of Congress.--It is the sense of Congress that, because 
of Terry Beirn's tireless efforts to foster a partnership among all 
parties invested in AIDS research (including the National Institutes of 
Health university-based research system, primary care physicians 
practicing in the community, and patients), the community-based clinical 
trials program should be renamed as the `Terry Beirn Community-Based 
AIDS Research Initiative' in his honor.''
