
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-18]

 
                 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-18. Development of model protocols for clinical care 
        of infected individuals
        

(a) In general

    (1) The Secretary, acting through the Director of the National 
Institutes of Health and after consultation with the Director of the 
Agency for Healthcare Research and Quality, may make grants to public 
and nonprofit private entities for the establishment of projects to 
develop model protocols for the clinical care of individuals infected 
with the etiologic agent for acquired immune deficiency syndrome, 
including treatment and prevention of HIV infection and related 
conditions among women.
    (2) The Secretary may not make a grant under paragraph (1) unless--
        (A) the applicant for the grant is a provider of comprehensive 
    primary care; or
        (B) the applicant for the grant agrees, with respect to the 
    project carried out pursuant to paragraph (1), to enter into a 
    cooperative arrangement with an entity that is a provider of 
    comprehensive primary care.

(b) Requirement of provision of certain services

    The Secretary may not make a grant under subsection (a) of this 
section unless the applicant for the grant agrees that, with respect to 
patients participating in the project carried out with the grant, 
services provided pursuant to the grant will include--
        (1) monitoring, in clinical laboratories, of the condition of 
    such patients;
        (2) clinical intervention for infection with the etiologic agent 
    for acquired immune deficiency syndrome, including measures for the 
    prevention of conditions arising from the infection;
        (3) information and counseling on the availability of treatments 
    for such infection approved by the Commissioner of Food and Drugs, 
    on the availability of treatments for such infection not yet 
    approved by the Commissioner, and on the reports issued by the AIDS 
    Research Advisory Committee under section 300cc-3(c)(2)(B) of this 
    title;
        (4) support groups; and
        (5) information on, and referrals to, entities providing 
    appropriate social support services.

(c) Limitation on imposition of charges for services

    The Secretary may not make a grant under subsection (a) of this 
section unless the applicant for the grant agrees that, if the applicant 
will routinely impose a charge for providing services pursuant to the 
grant, the applicant will not impose the charge on any individual 
seeking such services who is unable to pay the charge.

(d) Evaluation and reports

    (1) The Secretary may not make a grant under subsection (a) of this 
section unless the applicant for the grant agrees, with respect to the 
project carried out pursuant to subsection (a) of this section, to 
submit to the Secretary--
        (A) information sufficient to assist in the replication of the 
    model protocol developed pursuant to the project; and
        (B) such reports as the Secretary may require.

    (2) The Secretary shall provide for evaluations of projects carried 
out pursuant to subsection (a) of this section and shall annually submit 
to the Congress a report describing such projects. The report shall 
include the findings made as a result of such evaluations and may 
include any recommendations of the Secretary for appropriate 
administrative and legislative initiatives with respect to the program 
established in this section.

(e) Authorization of appropriations

    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 1989 through 1991, and such sums as may be necessary for each of 
the fiscal years 1994 through 1996.

(July 1, 1944, ch. 373, title XXIII, Sec. 2318, as added Pub. L. 100-
607, title II, Sec. 201(4), Nov. 4, 1988, 102 Stat. 3073; amended Pub. 
L. 103-43, title XVIII, Sec. 1811(4), title XX, Sec. 2008(d)(5), June 
10, 1993, 107 Stat. 199, 212; Pub. L. 106-129, Sec. 2(b)(2), Dec. 6, 
1999, 113 Stat. 1670.)


                               Amendments

    1999--Subsec. (a)(1). Pub. L. 106-129 substituted ``Director of the 
Agency for Healthcare Research and Quality'' for ``Administrator for 
Health Care Policy and Research''.
    1993--Subsec. (a)(1). Pub. L. 103-43, Sec. 1811(4)(A), inserted ``, 
acting through the Director of the National Institutes of Health and 
after consultation with the Administrator for Health Care Policy and 
Research,'' after ``The Secretary'' and ``, including treatment and 
prevention of HIV infection and related conditions among women'' after 
``syndrome''.
    Subsec. (b)(3). Pub. L. 103-43, Sec. 2008(d)(5), substituted ``AIDS 
Research Advisory Committee'' for ``Clinical Research Review 
Committee''.
    Subsec. (e). Pub. L. 103-43, Sec. 1811(4)(B), inserted before period 
at end ``, and such sums as may be necessary for each of the fiscal 
years 1994 through 1996''.
