I

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 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

9 (2) by inserting after subsection (i), the follow10 ing new subsection:
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1 ‘‘(j)(1) The Secretary, acting through the Director of

2 the National Institutes of Health, shall establish, main3 tain, and operate a program with respect to information

4 on research, treatment, detection, and prevention activities

5 relating to serious or life-threatening diseases and condi6 tions. The program shall, with respect to the agencies of

7 the Department of Health and Human Services, be inte8 grated and coordinated, and, to the extent practicable, co9 ordinated with other data banks containing similar infor10 mation.

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

12 Food and Drugs, the directors of the appropriate agencies

13 of the National Institutes of Health (including the Na14 tional Library of Medicine), and the Director of the Cen15 ters for Disease Control and Prevention, the Secretary

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

17 of information on clinical trials and treatments (including

18 drugs, biologicals, devices, and other therapies) with re19 spect to serious or life-threatening diseases and conditions.

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

21 shall collect, catalog, store and disseminate the informa22 tion described in such subparagraph. The Secretary shall

23 disseminate such information through information sys24 tems, which shall include toll-free telephone communica25 tions, available to individuals with serious or life-threaten-
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1 ing diseases and conditions, to other members of the pub2 lic, to health care providers, and to researchers.

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

4 ‘‘(A) A registry of clinical trials (whether Fed5 erally or privately funded) of experimental treat6 ments (including drugs, biologicals, devices, and

7 other therapies) for serious or life-threatening dis8 eases and conditions under regulations promulgated

9 pursuant to sections 505 and 515 of the Federal

10 Food, Drug, and Cosmetic Act that provides a de11 scription of the purpose of each experimental drug

12 protocol, either with the consent of the protocol

13 sponsor, or when a trial to test efficacy begins. In14 formation provided shall include eligibility criteria, a

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

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

17 and shall be in a form that can be readily under18 stood by members of the public. Such information

19 must be forwarded to the Data Bank by the sponsor

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

21 the Food and Drug Administration.

22 ‘‘(B) Information pertaining to experimental

23 treatments for serious or life-threatening diseases

24 and conditions that may be available—
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1 ‘‘(i) under a treatment investigational new

2 drug application that has been submitted to the

3 Food and Drug Administration pursuant to

4 part 312 of title 21, Code of Federal Regula5 tions;

6 ‘‘(ii) as a Group C cancer drug; or

7 ‘‘(iii) under an exemption for devices for

8 investigational use pursuant to part 812 of title

9 21, Code of Federal Regulations.

10 The Data Bank shall also include information per11 taining to the results of clinical trials of such treat12 ments, with the consent of the sponsor, including in13 formation concerning potential toxicities or adverse

14 effects associated with the use or administration of

15 such experimental treatment.

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

17 there are authorized to be appropriated such sums as may

18 be necessary.’’.

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