[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4257 Introduced in House (IH)]







104th CONGRESS
  2d Session
                                H. R. 4257

 To amend the Public Health Service Act to provide a one-stop shopping 
 information service for individuals with serious or life-threatening 
                               diseases.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           September 27, 1996

Mr. Lazio of New York introduced the following bill; which was referred 
                      to the Committee on Commerce

_______________________________________________________________________

                                 A BILL


 
 To amend the Public Health Service Act to provide a one-stop shopping 
 information service for individuals with serious or life-threatening 
                               diseases.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. INFORMATION PROGRAM ON DRUGS FOR SERIOUS OR LIFE-THREATENING 
              DISEASES.

    Section 402 of the Public Health Service Act (42 U.S.C. 282) is 
amended--
            (1) by redesignating subsections (j) and (k) as subsections 
        (k) and (l), respectively; and
            (2) by inserting after subsection (i), the following new 
        subsection:
    ``(j)(1) The Secretary, acting through the Director of the National 
Institutes of Health, shall establish, maintain, and operate a program 
with respect to information on research, treatment, detection, and 
prevention activities relating to serious or life-threatening diseases 
and conditions. The program shall, with respect to the agencies of the 
Department of Health and Human Services, be integrated and coordinated, 
and, to the extent practicable, coordinated with other data banks 
containing similar information.
    ``(2)(A) After consultation with the Commissioner of Food and 
Drugs, the directors of the appropriate agencies of the National 
Institutes of Health (including the National Library of Medicine), and 
the Director of the Centers for Disease Control and Prevention, the 
Secretary shall, in carrying out paragraph (1), establish a data bank 
of information on clinical trials and treatments (including drugs, 
biologicals, devices, and other therapies) with respect to serious or 
life-threatening diseases and conditions.
    ``(B) In carrying out subparagraph (A), the Secretary shall 
collect, catalog, store and disseminate the information described in 
such subparagraph. The Secretary shall disseminate such information 
through information systems, which shall include toll-free telephone 
communications, available to individuals with serious or life-
threatening diseases and conditions, to other members of the public, to 
health care providers, and to researchers.
    ``(3) The Data Bank shall include the following:
            ``(A) A registry of clinical trials (whether Federally or 
        privately funded) of experimental treatments (including drugs, 
        biologicals, devices, and other therapies) for serious or life-
        threatening diseases and conditions under regulations 
        promulgated pursuant to sections 505 and 515 of the Federal 
        Food, Drug, and Cosmetic Act 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, a description of the location of trial sites, and a 
        point of contact for those wanting to enroll in the trial, and 
        shall be in a form that can be readily understood by members of 
        the public. Such information must be forwarded to the Data Bank 
        by the sponsor of the trial not later than 21 days after 
        approval by the Food and Drug Administration.
            ``(B) Information pertaining to experimental treatments for 
        serious or life-threatening diseases and conditions that may be 
        available--
                    ``(i) 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;
                    ``(ii) as a Group C cancer drug; or
                    ``(iii) under an exemption for devices for 
                investigational use pursuant to part 812 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, including information concerning potential 
        toxicities or adverse effects associated with the use or 
        administration of such experimental treatment.
    ``(4) For the purpose of carrying out this subsection there are 
authorized to be appropriated such sums as may be necessary.''.
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