To provide deadlines for the issuance of certain regulations and to require a GAO report on the implementation of the clinical trial registration and reporting requirements under the Public Health Service Act.

1. Adds SEC. 11__. REGULATIONS ON CLINICAL TRIAL REGISTRATION; GAO STUDY OF CLINICAL TRIAL REGISTRATION AND REPORTING REQUIREMENTS at the end of title XI

   Adds a section

   In S. 3187 · Placed on Calendar Senate

   "(b) Financial Interest.--In this section, the term 'financial interest' means a financial interest under section 208(a) of title 18, United States Code.".

   Inserted: SEC. 11__. REGULATIONS ON CLINICAL TRIAL REGISTRATION; GAO STUDY OF CLINICAL TRIAL REGISTRATION AND REPORTING REQUIREMENTS.

   Inserted: (a) Definitions.--In this section--

   Inserted: (1) the term "applicable clinical trial" has the meaning given such term under section 402(j) of the Public Health Service Act (42 U.S.C. 282(j));

   Inserted: (2) the term "Director" means the Director of the National Institutes of Health;

   Inserted: (3) the term "responsible party" has the meaning given such term under such section 402(j); and

   Inserted: (4) the term "Secretary" means the Secretary of Health and Human Services.

   Inserted: (b) Required Regulations.--

   Inserted: (1) Proposed rulemaking.--Not later than 180 days after the date of enactment of this Act, the Secretary, acting through the Director, shall issue a notice of proposed rulemaking for a proposed rule on the registration of applicable clinical trials by responsible parties under section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)) (as amended by section 801 of the Food and Drug Administration Amendments Act of 2007).

   Inserted: (2) Final rule.--Not later than 180 days after the issuance of the notice of proposed rulemaking under paragraph (1), the Secretary, acting through the Director, shall issue the final rule on the registration of applicable clinical trials by responsible parties under such section 402(j).

   Inserted: (3) Letter to congress.--If the final rule described in paragraph (2) is not issued by the date required under such paragraph, the Secretary shall submit to Congress a letter that describes the reasons why such final rule has not been issued.

   Inserted: (c) Report by GAO.--

   Inserted: (1) In general.--Not later than 2 years after the issuance of the final rule under subsection (b), the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the implementation of the registration and reporting requirements for applicable drug and device clinical trials under section 402(j) the Public Health Service Act (42 U.S.C. 282(j)) (as amended by section 801 of the Food and Drug Administration Amendments Act of 2007).

   Show 7 more inserted paragraphsShow less

   Inserted: (2) Content.--The report under paragraph (1) shall include--

   Inserted: (A) information on the rate of compliance and non-compliance (by category of sponsor, category of trial (phase II, III, or IV), whether the applicable clinical trial is conducted domestically, in foreign sites, or a combination of sites, and such other categories as the Comptroller General determines useful) with the requirements of--

   Inserted: (i) registering applicable clinical trials under such section 402(j);

   Inserted: (ii) reporting the results of such trials under such section; and

   Inserted: (iii) the completeness of the reporting of the required data under such section; and

   Inserted: (B) information on the promulgation of regulations for the registration of applicable clinical trials by the responsible parties under such section 402(j).

   Inserted: (3) Recommendations.--If the Comptroller General finds problems with timely compliance or completeness of the data being reported under such section 402(j), or finds that the implementation of registration and reporting requirements under such section 402(j) for applicable drug and device clinical trials could be improved, the Comptroller General shall, after consulting with the Commissioner of Food and Drugs, applicable stakeholders, and experts in the conduct of clinical trials, make recommendations for administrative or legislative actions to increase the compliance with the requirements of such section 402(j).

   Original wording

   At the end of title XI, add the following:

Read automatically from the Congressional Record. Check the original before relying on it.

As printed