[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4135 Introduced in House (IH)]







105th CONGRESS
  2d Session
                                H. R. 4135

   To amend the Public Health Service Act to direct the Secretary of 
Health and Human Services to establish a program for the collection of 
information relating to the use of children and individuals with mental 
    disabilities as subjects in biomedical and behavioral research.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             June 24, 1998

Mr. Towns (for himself, Mr. Shays, Mr. Barrett of Wisconsin, Mr. Burton 
 of Indiana, and Mr. Waxman) introduced the following bill; which was 
                 referred to the Committee on Commerce

_______________________________________________________________________

                                 A BILL


 
   To amend the Public Health Service Act to direct the Secretary of 
Health and Human Services to establish a program for the collection of 
information relating to the use of children and individuals with mental 
    disabilities as subjects in biomedical and behavioral research.

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

SECTION 1. AMENDMENT TO ESTABLISH A PROGRAM FOR THE COLLECTION OF 
              INFORMATION RELATING TO THE USE OF CHILDREN AND 
              INDIVIDUALS WITH MENTAL DISABILITIES AS SUBJECTS IN 
              BIOMEDICAL AND BEHAVIORAL RESEARCH.

    Section 491(a) of the Public Health Service Act (42 U.S.C. 289(a)) 
is amended--
            (1) by inserting ``(1)'' after ``(a)''; and
            (2) by inserting at the end the following:
    ``(2) The Secretary shall establish a program for the collection of 
information relating to the use of children and individuals with mental 
disabilities (including mental retardation and mental illnesses) in 
biomedical or behavioral research subject to paragraph (1), or subject 
to chapter V of the Food, Drug, and Cosmetic Act, or otherwise subject 
to regulation by any Federal department or agency. The program may, 
pursuant to such paragraph, such chapter, or other applicable law, 
include the establishment of requirements for the submission of reports 
by Institutional Review Boards. Information collected under the program 
shall include information relating to--
            ``(A) description of the research subjects;
            ``(B) the nature of the research;
            ``(C) the objective of the research;
            ``(D) the reasons for the use of such subjects; and
            ``(E) the source of funding for the research.
The Secretary shall ensure that information collected under the program 
is made available to the public on a regular basis including in the 
form of an annual report.''.
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