SEC. 113 INFORMATION PROGRAM ON CLINICAL TRIALS FOR SERIOUS OR 
LIFE-THREATENING DISEASES.

    (a) In General.--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:

<<NOTE: Establishment>> ``(j)(1)(A) The Secretary, acting through 
the Director of NIH, shall establish, maintain, and operate a data bank 
of information on clinical trials for drugs for serious or life-
threatening diseases and conditions (in this subsection referred to as 
the `data bank'). The activities of the data bank shall be integrated 
and coordinated with related activities of other agencies of the 
Department of Health and Human Services, and to the extent practicable, 
coordinated with other data banks containing similar information.

    ``(B) The Secretary shall establish the data bank 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.
    ``(2) In carrying out paragraph (1), the Secretary shall collect, 
catalog, store, and disseminate the information described in such 
paragraph. 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 for serious or 
        life-threatening diseases and conditions under regulations 
        promulgated pursuant to section 505(i) of the Federal Food, 
        Drug, and Cosmetic Act, which provides a description of the 
        purpose of each experimental drug, either with the consent of 
        the protocol sponsor, or when a trial to test effectiveness 
        begins. Information provided shall consist of eligibility 
        criteria for participation in the clinical trials, 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 
        shall be forwarded to the data bank by the sponsor of the trial 
        not later than 21 days after the approval of the protocol.
            ``(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 Secretary 
                under section 561(c) of the Federal Food, Drug, and 
                Cosmetic Act; or
                    ``(ii) as a Group C cancer drug (as defined by the 
                National Cancer Institute).
        The data bank may 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 treatments.

    ``(4) The data bank shall not include information relating to an 
investigation if the sponsor has provided a detailed certification to 
the Secretary that disclosure of such information would substantially 
interfere with the timely enrollment of subjects in the investigation, 
unless the Secretary, after the receipt of the certification, provides 
the sponsor with a detailed written determination that such disclosure
would not substantially interfere with such enrollment.
     <<NOTE: Appropriation authorization.>> ``(5) For the purpose of 
carrying out this subsection, there are authorized to be appropriated 
such sums as may be necessary. Fees collected under section 736 of the 
Federal Food, Drug, and Cosmetic Act shall not be used in carrying out 
this subsection.''.

     <<NOTE: 42 USC 282 note.>> (b) Collaboration and Report.--
            (1) In general.--The Secretary of Health and Human Services, 
        the Director of the National Institutes of Health, and the 
        Commissioner of Food and Drugs shall collaborate to determine 
        the feasibility of including device investigations within the 
        scope of the data bank under section 402(j) of the Public Health 
        Service Act.
            (2) Report.--Not later than two years after the date of 
        enactment of this section, the Secretary of Health and Human 
        Services shall prepare and submit to the Committee on Labor and 
        Human Resources of the Senate and the Committee on Commerce of 
        the House of Representatives a report--
                    (A) of the public health need, if any, for inclusion 
                of device investigations within the scope of the data 
                bank under section 402(j) of the Public Health Service 
                Act;
                    (B) on the adverse impact, if any, on device 
                innovation and research in the United States if 
                information relating to such device investigations is 
                required to be publicly disclosed; and
                    (C) on such other issues relating to such section 
                402(j) as the Secretary determines to be appropriate.