I
105TH CONGRESS
1ST SESSION
H. R. 482
To amend the Public Health Service Act to provide a one-stop information
service for individuals with serious or life-threatening diseases.
IN THE HOUSE OF REPRESENTATIVES
JANUARY 21, 1997
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 information service for individuals with serious or
life-threatening diseases.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. INFORMATION PROGRAM ON DRUGS FOR SERI-
OUS 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 follow-
ing new subsection:
‘‘(j)(1) The Secretary, acting through the Director of
the National Institutes of Health, shall establish, main-
tain, and operate a program with respect to information
on research, treatment, detection, and prevention activities
relating to serious or life-threatening diseases and condi-
tions. The program shall, with respect to the agencies of
the Department of Health and Human Services, be inte-
grated and coordinated, and, to the extent practicable, co-
ordinated with other data banks containing similar infor-
mation.
‘‘(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 Na-
tional Library of Medicine), and the Director of the Cen-
ters 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 re-
spect to serious or life-threatening diseases and conditions.
‘‘(B) In carrying out subparagraph (A), the Secretary
shall collect, catalog, store and disseminate the informa-
tion described in such subparagraph. The Secretary shall
disseminate such information through information sys-
tems, which shall include toll-free telephone communica-
tions, available to individuals with serious or life-threaten-
ing diseases and conditions, to other members of the pub-
lic, to health care providers, and to researchers.
‘‘(3) The Data Bank shall include the following:
‘‘(A) A registry of clinical trials (whether Fed-
erally or privately funded) of experimental treat-
ments (including drugs, biologicals, devices, and
other therapies) for serious or life-threatening dis-
eases and conditions under regulations promulgated
pursuant to sections 505 and 515 of the Federal
Food, Drug, and Cosmetic Act that provides a de-
scription of the purpose of each experimental drug
protocol, either with the consent of the protocol
sponsor, or when a trial to test efficacy begins. In-
formation 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 under-
stood 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 Regula-
tions;
‘‘(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 per-
taining to the results of clinical trials of such treat-
ments, with the consent of the sponsor, including in-
formation 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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