
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-17]

 
                 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-17. Information services


(a) Establishment of program

    The Secretary shall establish, maintain, and operate a program with 
respect to information on research, treatment, and prevention activities 
relating to infection with the etiologic agent for acquired immune 
deficiency syndrome. The program shall, with respect to the agencies of 
the Department of Health and Human Services, be integrated and 
coordinated.

(b) Toll-free telephone communications for health care entities

    (1) After consultation with the Director of the Office of AIDS 
Research, the Administrator of the Health Resources and Services 
Administration, and the Director of the Centers for Disease Control and 
Prevention, the Secretary shall provide for toll-free telephone 
communications to provide medical and technical information with respect 
to acquired immune deficiency syndrome to health care professionals, 
allied health care providers, and to professionals providing emergency 
health services.
    (2) Information provided pursuant to paragraph (1) shall include--
        (A) information on prevention of exposure to, and the 
    transmission of, the etiologic agent for acquired immune deficiency 
    syndrome; and
        (B) information contained in the data banks established in 
    subsections (c) and (d) of this section.

(c) Data bank on research information

    (1) After consultation with the Director of the Office of AIDS 
Research, the Director of the Centers for Disease Control and 
Prevention, and the National Library of Medicine, the Secretary shall 
establish a data bank of information on the results of research with 
respect to acquired immune deficiency syndrome conducted in the United 
States and other countries.
    (2) In carrying out paragraph (1), the Secretary shall collect, 
catalog, store, and disseminate the information described in such 
paragraph. To the extent practicable, the Secretary shall make such 
information available to researchers, physicians, and other appropriate 
individuals, of countries other than the United States.

(d) Data bank on clinical trials and treatments

    (1) After consultation with the Commissioner of Food and Drugs, the 
AIDS Research Advisory Committee established under section 300cc-3 of 
this title, and the Director of the Office of AIDS Research, the 
Secretary shall, in carrying out subsection (a) of this section, 
establish a data bank of information on clinical trials and treatments 
with respect to infection with the etiologic agent for acquired immune 
deficiency syndrome (hereafter in this section referred to as the ``Data 
Bank'').
    (2) In carrying out paragraph (1), the Secretary shall collect, 
catalog, store, and disseminate the information described in such 
paragraph. The Secretary shall disseminate such information through 
information systems available to individuals infected with the etiologic 
agent for acquired immune deficiency syndrome, to other members of the 
public, to health care providers, and to researchers.

(e) Requirements with respect to data bank on clinical trials and 
        treatments

    The Data Bank shall include the following:
        (1) A registry of clinical trials of experimental treatments for 
    acquired immune deficiency syndrome and related illnesses conducted 
    under regulations promulgated pursuant to section 355 of title 21 
    that provides a description of the purpose of each experimental drug 
    protocol either with the consent of the protocol sponsor, or when a 
    trial to test efficacy begins. Information provided shall include 
    eligibility criteria and the location of trial sites, and must be 
    forwarded to the Data Bank by the sponsor of the trial not later 
    than 21 days after the approval by the Food and Drug Administration.
        (2) Information pertaining to experimental treatments for 
    acquired immune deficiency syndrome that may be available under a 
    treatment investigational new drug application that has been 
    submitted to the Food and Drug Administration pursuant to part 312 
    of title 21, Code of Federal Regulations. The Data Bank shall also 
    include information pertaining to the results of clinical trials of 
    such treatments, with the consent of the sponsor, of such 
    experimental treatments, including information concerning potential 
    toxicities or adverse effects associated with the use or 
    administration of such experimental treatment.

(July 1, 1944, ch. 373, title XXIII, Sec. 2317, as added Pub. L. 100-
607, title II, Sec. 201(4), Nov. 4, 1988, 102 Stat. 3071; amended Pub. 
L. 100-690, title II, Sec. 2617(c), Nov. 18, 1988, 102 Stat. 4240; Pub. 
L. 102-531, title III, Sec. 312(d)(19), Oct. 27, 1992, 106 Stat. 3505; 
Pub. L. 103-43, title XX, Sec. 2008(d)(4), June 10, 1993, 107 Stat. 
212.)


                               Amendments

    1993--Subsec. (d)(1). Pub. L. 103-43 substituted ``AIDS Research 
Advisory Committee established under section 300cc-3 of this title'' for 
``Clinical Research Review Committee''.
    1992--Subsecs. (b)(1), (c)(1). Pub. L. 102-531 substituted ``Centers 
for Disease Control and Prevention'' for ``Centers for Disease 
Control''.
    1988--Subsec. (e). Pub. L. 100-690 substituted ``data bank on 
clinical trials and treatments'' for ``data bank'' in heading.


                    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.
