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.
What it does: Adds SEC. 11__. REGULATIONS ON CLINICAL TRIAL REGISTRATION; GAO STUDY OF CLINICAL TRIAL REGISTRATION AND REPORTING REQUIREMENTS at the end of title XI
Sen. Chuck Grassley (R-IA)What it changes
1 change to S. 3187 · shown in the bill's text
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 sectionIn 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).
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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
SA 2129. Mr. GRASSLEY submitted an amendment intended to be proposed by him to the bill S. 3187, to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes; which was ordered to lie on the table; as follows:
At the end of title XI, add the following:
SEC. 11__. REGULATIONS ON CLINICAL TRIAL REGISTRATION; GAO STUDY OF CLINICAL TRIAL REGISTRATION AND REPORTING REQUIREMENTS.
(a) Definitions.--In this section--
(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));
(2) the term “Director” means the Director of the National Institutes of Health;
(3) the term “responsible party” has the meaning given such term under such section 402(j); and
(4) the term “Secretary” means the Secretary of Health and Human Services.
(b) Required Regulations.--
(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).
(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).
(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.
(c) Report by GAO.--
(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).
(2) Content.--The report under paragraph (1) shall include--
(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--
(i) registering applicable clinical trials under such section 402(j);
(ii) reporting the results of such trials under such section; and
(iii) the completeness of the reporting of the required data under such section; and
(B) information on the promulgation of regulations for the registration of applicable clinical trials by the responsible parties under such section 402(j).
(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).
Legislative Activity
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Senate amendment proposed (on the floor): Amendment SA 2129 proposed by Senator Grassley.(consideration: CR S3490-3491, S3507; text: CR S3490-3491)
May 23, 2012
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Senate amendment proposed (on the floor): Amendment SA 2129 proposed by Senator Grassley.(consideration: CR S3490-3491, S3507; text: CR S3490-3491)
May 23, 2012
Senate amendment agreed to: Amendment SA 2129 agreed to in Senate by Unanimous Consent.
May 23, 2012
Amendment SA 2129 proposed by Senator Grassley. (consideration: CR S3490-3491, S3507; text: CR S3490-3491) 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.
May 23, 2012
Amendment SA 2129 agreed to in Senate by Unanimous Consent.
May 23, 2012
Senate amendment submitted
May 22, 2012