II

104TH CONGRESS

2D SESSION S. 2024

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 SENATE OF THE UNITED STATES

AUGUST 2, 1996

Ms. SNOWE (for herself and Mrs. FEINSTEIN) introduced the following bill;

which was read twice and referred to the Committee on Labor and

Human Resources

A BILL

To amend the Public Health Service Act to provide a onestop shopping information service for individuals with

serious or life-threatening diseases.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. INFORMATION PROGRAM ON DRUGS FOR SERI4 OUS OR LIFE-THREATENING DISEASES.

5 Section 402 of the Public Health Service Act (42

6 U.S.C. 282) is amended—

7 (1) by redesignating subsections (j) and (k) as

8 subsections (k) and (l), respectively; and
2

•S 2024 IS

1 (2) by inserting after subsection (i), the follow2 ing new subsection:

3 ‘‘(j)(1) The Secretary, acting through the Director of

4 the National Institutes of Health, shall establish, main5 tain, and operate a program with respect to information

6 on research, treatment, detection, and prevention activities

7 relating to serious or life-threatening diseases and condi8 tions. The program shall, with respect to the agencies of

9 the Department of Health and Human Services, be inte10 grated and coordinated, and, to the extent practicable, co11 ordinated with other data banks containing similar infor12 mation.

13 ‘‘(2)(A) After consultation with the Commissioner of

14 Food and Drugs, the directors of the appropriate agencies

15 of the National Institutes of Health (including the Na16 tional Library of Medicine), and the Director of the Cen17 ters for Disease Control and Prevention, the Secretary

18 shall, in carrying out paragraph (1), establish a data bank

19 of information on clinical trials and treatments (including

20 drugs, biologicals, devices, and other therapies) with re21 spect to serious or life-threatening diseases and conditions.

22 ‘‘(B) In carrying out subparagraph (A), the Secretary

23 shall collect, catalog, store and disseminate the informa24 tion described in such subparagraph. The Secretary shall

25 disseminate such information through information sys-
3

•S 2024 IS

1 tems, which shall include toll-free telephone communica2 tions, available to individuals with serious or life-threaten3 ing diseases and conditions, to other members of the pub4 lic, to health care providers, and to researchers.

5 ‘‘(3) The Data Bank shall include the following:

6 ‘‘(A) A registry of clinical trials (whether Fed7 erally or privately funded) of experimental treat8 ments (including drugs, biologicals, devices, and

9 other therapies) for serious or life-threatening dis10 eases and conditions under regulations promulgated

11 pursuant to sections 505 and 515 of the Federal

12 Food, Drug, and Cosmetic Act that provides a de13 scription of the purpose of each experimental drug

14 protocol, either with the consent of the protocol

15 sponsor, or when a trial to test efficacy begins. In16 formation provided shall include eligibility criteria, a

17 description of the location of trial sites, and a point

18 of contact for those wanting to enroll in the trial,

19 and shall be in a form that can be readily under20 stood by members of the public. Such information

21 must be forwarded to the Data Bank by the sponsor

22 of the trial not later than 21 days after approval by

23 the Food and Drug Administration.
4

•S 2024 IS

1 ‘‘(B) Information pertaining to experimental

2 treatments for serious or life-threatening diseases

3 and conditions that may be available—

4 ‘‘(i) under a treatment investigational new

5 drug application that has been submitted to the

6 Food and Drug Administration pursuant to

7 part 312 of title 21, Code of Federal Regula8 tions;

9 ‘‘(ii) as a Group C cancer drug; or

10 ‘‘(iii) under an exemption for devices

11 for investigational use pursuant to part

12 812 of title 21, Code of Federal Regula13 tions.

14 The Data Bank shall also include information

15 pertaining to the results of clinical trials of

16 such treatments, with the consent of the spon17 sor, including information concerning potential

18 toxicities or adverse effects associated with the

19 use or administration of such experimental

20 treatment.

21 ‘‘(4) For the purpose of carrying out this subsection

22 there are authorized to be appropriated such sums as may

23 be necessary.’’.

Æ