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 onestop 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
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1 disseminate such information through information sys2 tems, which shall include toll-free telephone communica3 tions, available to individuals with serious or life-threaten4 ing diseases and conditions, to other members of the pub5 lic, to health care providers, and to researchers.

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

7 ‘‘(A) A registry of clinical trials (whether Fed8 erally or privately funded) of experimental treat9 ments (including drugs, biologicals, devices, and

10 other therapies) for serious or life-threatening dis11 eases and conditions under regulations promulgated

12 pursuant to sections 505 and 515 of the Federal

13 Food, Drug, and Cosmetic Act that provides a de14 scription of the purpose of each experimental drug

15 protocol, either with the consent of the protocol

16 sponsor, or when a trial to test efficacy begins. In17 formation provided shall include eligibility criteria, a

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

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

20 and shall be in a form that can be readily under21 stood by members of the public. Such information

22 must be forwarded to the Data Bank by the sponsor

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

24 the Food and Drug Administration.
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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 for

11 investigational use pursuant to part 812 of title

12 21, Code of Federal Regulations.

13 The Data Bank shall also include information per14 taining to the results of clinical trials of such treat15 ments, with the consent of the sponsor, including in16 formation concerning potential toxicities or adverse

17 effects associated with the use or administration of

18 such experimental treatment.

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

20 there are authorized to be appropriated such sums as may

21 be necessary.’’.

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