[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 965 Introduced in House (IH)]

114th CONGRESS
  1st Session
                                H. R. 965

 To require the issuance of guidance on the application of the Federal 
 policy for the protection of human subjects with respect to clinical 
                            data registries.


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                    IN THE HOUSE OF REPRESENTATIVES

                           February 13, 2015

 Mr. Pascrell (for himself and Mr. Boustany) introduced the following 
    bill; which was referred to the Committee on Energy and Commerce

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                                 A BILL


 
 To require the issuance of guidance on the application of the Federal 
 policy for the protection of human subjects with respect to clinical 
                            data registries.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Facilitating Participation in 
Clinical Data Registries Act of 2015''.

SEC. 2. GUIDANCE ON APPLICATION OF COMMON RULE TO CLINICAL DATA 
              REGISTRIES.

    Not later than one year after the date of the enactment of this 
Act, the Secretary of Health and Human Services, through the Office for 
Human Research Protections of the Department of Health and Human 
Services, shall issue guidance on the application with respect to 
clinical data registries of the provisions of subpart A of part 46 of 
title 45, Code of Federal Regulations, or equivalent Federal 
regulations for the protection of human subjects in research.
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