Political Quotes

“I ask unanimous consent that the reading of the amendment be dispensed with. The PRESIDING OFFICER. Without objection, it is so ordered. The amendment is as follows: (Purpose: 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) 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).…”