3.0.0 2933 2023-01-14T22:48:35Z 2023-01-14T22:48:35Z Senate S S 2004-10-07 108 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2004-10-07T22:42:16Z 2004-10-07 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2004-10-07 Sponsor introductory remarks on measure. (CR S10728-10730) IntroReferral B00100 9 Library of Congress 2004-10-07 Introduced in Senate IntroReferral 10000 9 Library of Congress D000388 Sen. Dodd, Christopher J. [D-CT] CHRISTOPHER DODD D CT JOHN N K000105 Sen. Kennedy, Edward M. [D-MA] EDWARD KENNEDY D MA MOORE 2004-10-07 True J000177 Sen. Johnson, Tim [D-SD] TIM JOHNSON D SD 2004-10-07 True W000779 Sen. Wyden, Ron [D-OR] Ron Wyden D OR 2004-10-07 True Health Administrative procedure Auditing Clinical trials Commerce Communication in medicine Congress Congressional reporting requirements Data banks Department of Health and Human Services Drug advertising Drug approvals Drug industry Fines (Penalties) Government Operations and Politics Government paperwork Governmental investigations Health information systems Law Medical research Medical supplies National Institutes of Health (NIH) Nonprofit organizations Periodicals Product safety Research centers Science, Technology, Communications Social Welfare Health 00 2004-10-07 Introduced in Senate 2005-02-05T17:55:34Z Fair Access to Clinical Trials Act of 2004 or the FACT Act - Amends the Public Health Service Act to require the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health (NIH), to establish and operate a data bank of registry information on clinical trials for drugs, biological products, and devices.

Requires the principal investigator or a responsible person to submit clinical trial information to the Secretary.

Requires the Secretary to: (1) seek a memorandum of understanding with the heads of other Federal agencies to include in the registry clinical trials sponsored by such agencies; and (2) establish procedures to allow voluntary submission of clinical trial information not involving drugs, biological products, or devices.

Allows the Secretary to: (1) require that information from such other clinical trials be submitted to the registry in cases in which it is in the interest of public health; and (2) correct any information included in the registry that is factually and substantively inaccurate, false, or misleading.

Extends requirements of this Act to clinical trials conducted outside of the United States under certain circumstances.

Requires the responsible person for proposals submitted to the Secretary requesting financial assistance to conduct research to submit registry information to the Secretary.

Prohibits a responsible person or a manufacturer from performing any act that prohibits, limits, or imposes unreasonable delays on the ability of an individual to discuss or publish the results of a clinical trial.

Requires the Secretary to enter into a contract with the Institute of Medicine to study the extent to which data submitted to the registry has impacted the public health.

]]> Fair Access to Clinical Trials Act of 2004 Display Title Fair Access to Clinical Trials Act of 2004 Official Title as Introduced A bill to amend the Public Health Service Act to expand the clinical trials drug data bank. Introduced in Senate IS Short Titles as Introduced Fair Access to Clinical Trials Act of 2004 Short Titles as Introduced FACT Act Introduced in Senate 2004-10-07T04:00:00Z 2004-10-07 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. 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.