Clinical Trial Cancer Mission 2020 Act

Bill: 114-hr-617
Sponsor: full_name: Rep. Reed, Tom [R-NY-23]
Introduced: 2015-01-28
Policy area: Health
Subjects: Drug safety, medical device, and laboratory regulation

Government information and archives

Health information and medical records

Health programs administration and funding

Medical research

Military medicine
Latest action: action_date: 2015-01-30
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2015-01-28
action_desc: Introduced in House
text: <p><b>Clinical Trial Cancer Mission 2020 Act</b></p> <p>Amends the Public Health Service Act to revise clinical trial registry data bank provisions to specify that a device or drug clinical trial must be included in the clinical trial registry data bank regardless of whether it results in a positive or negative outcome.</p> <p>Requires the responsible party of any clinical trials funded in whole or in part by the Department of Defense (DOD) to certify in all required grant or progress forms that the required submissions to the clinical trial registry data bank have been made. Requires DOD to verify that the clinical trial information has been submitted before releasing any remaining grant funds or funding future grants. </p> <p>Makes a clinical trial grantee of the Department of Health and Human Services or DOD who fails to submit the required information to the data bank ineligible for the remaining grant funds or future funds. Makes the grantee liable for repayment of grant amounts already provided.</p>

tv_txt: I 114th CONGRESS 1st Session H. R. 617 IN THE HOUSE OF REPRESENTATIVES January 28, 2015 Mr. Reed (for himself and Ms. Slaughter ) 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. Short title This Act may be cited as the Clinical Trial Cancer Mission 2020 Act . 2. 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. .