3.0.0 6272 2019-11-15T21:18:14Z 2019-11-15T21:18:14Z House H HR 2012-08-02 112 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. MARKEY:H.R. 6272.Congress has the power to enact this legislation pursuantto the following:Article 1, Section 8[Page H5708]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2012-08-03T14:58:10Z Referred to 2012-08-02T13:00:21Z 2012-08-03 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2012-08-02 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2012-08-02 Introduced in House IntroReferral Intro-H 9 Library of Congress 2012-08-02 Introduced in House IntroReferral 1000 9 Library of Congress M000133 Rep. Markey, Edward J. [D-MA-7] Edward Markey D MA J. 7 N W000215 Rep. Waxman, Henry A. [D-CA-30] HENRY WAXMAN D CA A. 30 2012-08-02 True D000216 Rep. DeLauro, Rosa L. [D-CT-3] ROSA DELAURO D CT 3 2012-08-02 True S001145 Rep. Schakowsky, Janice D. [D-IL-9] JANICE SCHAKOWSKY D IL D. 9 2012-08-02 True Health Administrative law and regulatory procedures Department of Health and Human Services Drug safety, medical device, and laboratory regulation Food and Drug Administration (FDA) Government information and archives Health information and medical records Health technology, devices, supplies Medical research Health 00 2012-08-02 Introduced in House 2012-11-21T15:51:23Z Trial and Experimental Studies Transparency Act of 2012 or TEST Act - Amends the Public Health Service Act to expand the clinical trials that must be reported to the clinical trial registry data bank to include: (1) any interventional study of a drug, device, or biological product conducted outside of the United States the results of which are submitted to the Secretary of Health and Human Services (HHS) as support for approval of an application; and (2) postmarket surveillance of a class II or class III device that involves data collection from human subjects. Defines "interventional study" to mean a study in human beings in which individuals are assigned by an investigator, based on a protocol, to receive specific interventions to evaluate their effects on biomedical health-related outcomes.

Requires submission to the data bank of supporting documents, including protocol documents and consent documents used to enroll subjects into the trial. Requires the responsible party for a clinical trial to submit clinical trial information to the data bank before the first patient is enrolled in the trial.

Requires the Director of the National Institutes of Health (NIH) to post the information submitted to the data bank within 30 days after the submission is determined to meet the quality criteria established by the Director.

Revises time frames for the reporting of results data to the clinical trial registry.

Requires the Director and the Commissioner of Food and Drugs (FDA) to report on the number of clinical trials with information submitted to the registry and steps taken to enforce compliance with such reporting requirements.

]]> TEST Act Short Titles as Introduced TEST Act Short Titles as Introduced Trial and Experimental Studies Transparency Act of 2012 Display Title TEST Act Official Title as Introduced To amend title IV of the Public Health Service Act to expand the clinical trial registry data bank, and for other purposes. Introduced in House 2012-08-02T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-112hr6272ih/xml/BILLS-112hr6272ih.xml 2012-08-03 Referred to the Subcommittee on Health. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.