[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5283 Introduced in House (IH)]

112th CONGRESS
  2d Session
                                H. R. 5283

 To amend the Public Health Service Act to enhance the clinical trial 
  registry data bank reporting requirements and enforcement measures.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             April 27, 2012

   Mr. Reed introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
 To amend the Public Health Service Act to enhance the clinical trial 
  registry data bank reporting requirements and enforcement measures.

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

SECTION 1. ENHANCING CLINICAL TRIAL REGISTRY DATA BANK REPORTING 
              REQUIREMENTS AND ENFORCEMENT MEASURES.

    (a) Clarification That Clinical Trial Registry Data Bank 
Requirements Apply Regardless of Trial Outcomes.--Section 
402(j)(1)(A)(i) of the Public Health Service Act (42 U.S.C. 
282(j)(1)(A)(i)) is amended by inserting before the period at the end 
the following ``, whether or not such a clinical trial results in a 
positive or negative outcome''.
    (b) Application to Grants From Department of Defense.--Section 
402(j)(5)(A)(i) of such Act (42 U.S.C. 282(j)(5)(A)(i)) is amended by 
inserting ``the Department of Defense or'' after ``agency of''.
    (c) Enhanced Enforcement.--Section 402(j)(5)(A) of such Act (42 
U.S.C. 282(j)(5)(A)) is amended by adding at the end the following new 
clause:
                            ``(v) Enhanced enforcement.--After the 30-
                        day period described in clause (iii), if the 
                        head of an agency referred to in clause (i), as 
                        applicable, verifies that a grantee has not 
                        submitted clinical trial information as 
                        described in clause (ii), with respect to an 
                        applicable clinical trial that is funded in 
                        whole or in part by a grant from the agency, 
                        such grantee--
                                    ``(I) shall not be eligible to 
                                receive any remaining funding for the 
                                grant or funding for a future Federal 
                                grant until such time as the grantee 
                                comes into compliance with all 
                                applicable reporting requirements under 
                                this subsection; and
                                    ``(II) shall be liable to the 
                                United States for repayment of any 
                                amount provided under the grant for the 
                                clinical trial for which the grantee 
                                failed to comply with such reporting 
                                requirements.''.
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