I 112th CONGRESS 2d Session H. R. 5283 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.

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. .