Page:United States Statutes at Large Volume 121.djvu/938

This page needs to be proofread.
[121 STAT. 917]
[121 STAT. 917]
PUBLIC LAW 110-000—MMMM. DD, 2007

PUBLIC LAW 110–85—SEPT. 27, 2007

121 STAT. 917

dkrause on GSDDPC44 with PUBLAW

clinical trial information during the preceding 12month period; ‘‘(II) shall include identification of the dates of any such changes; ‘‘(III) not later than 30 days after the recruitment status of such clinical trial changes, shall include an update of the recruitment status; and ‘‘(IV) not later than 30 days after the completion date of the clinical trial, shall include notification to the Director that such clinical trial is complete. ‘‘(ii) PUBLIC AVAILABILITY OF UPDATES.—The Director of NIH shall make updates submitted under clause (i) publicly available in the registry data bank. Except with regard to overall recruitment status, individual site status, location, and contact information, the Director of NIH shall ensure that updates to elements required under subclauses (I) to (V) of paragraph (2)(A)(ii) do not result in the removal of any information from the original submissions or any preceding updates, and information in such databases is presented in a manner that enables users to readily access each original element submission and to track the changes made by the updates. The Director of NIH shall provide a link from the table of primary and secondary outcomes required under paragraph (3)(C)(ii) to the tracked history required under this clause of the primary and secondary outcome measures submitted under paragraph (2)(A)(ii)(I)(ll). ‘‘(5) COORDINATION AND COMPLIANCE.— ‘‘(A) CLINICAL TRIALS SUPPORTED BY GRANTS FROM FEDERAL AGENCIES.— ‘‘(i) GRANTS FROM CERTAIN FEDERAL AGENCIES.— If an applicable clinical trial is funded in whole or in part by a grant from any agency of the Department of Health and Human Services, including the Food and Drug Administration, the National Institutes of Health, or the Agency for Healthcare Research and Quality, any grant or progress report forms required under such grant shall include a certification that the responsible party has made all required submissions to the Director of NIH under paragraphs (2) and (3). ‘‘(ii) VERIFICATION BY FEDERAL AGENCIES.—The heads of the agencies referred to in clause (i), as applicable, shall verify that the clinical trial information for each applicable clinical trial for which a grantee is the responsible party has been submitted under paragraphs (2) and (3) before releasing any remaining funding for a grant or funding for a future grant to such grantee. ‘‘(iii) NOTICE AND OPPORTUNITY TO REMEDY.—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), such agency head shall provide notice to such grantee of such non-compliance and allow such grantee 30 days

VerDate Aug 31 2005

13:52 Jan 23, 2009

Jkt 059194

PO 00001

Frm 00915

Fmt 6580

Sfmt 6581





PsN: 59194PT1