3.0.0 5252 2023-01-14T22:48:41Z 2023-01-14T22:48:41Z House H HR 2004-10-07 108 hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2004-10-08T16:27:17Z Referred to 2004-10-07T14:04:35Z 2004-10-11 Sponsor introductory remarks on measure. (CR E1882-1883) IntroReferral B00100 9 Library of Congress 2004-10-08 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2004-10-07 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2004-10-07 Introduced in House IntroReferral Intro-H 9 Library of Congress 2004-10-07 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 2004-10-07 True F000339 Rep. Frank, Barney [D-MA-4] BARNEY FRANK D MA 4 2004-11-18 False A000357 Rep. Allen, Thomas H. [D-ME-1] THOMAS ALLEN D ME H. 1 2004-11-18 False S001145 Rep. Schakowsky, Janice D. [D-IL-9] JANICE SCHAKOWSKY D IL D. 9 2004-11-18 False Health Administrative procedure Clinical trials Commerce Communication in medicine Communication in science Data banks Demography Department of Health and Human Services Drug advertising Economics and Public Finance Electronic government information Federal aid to research Fines (Penalties) Fraud Government Operations and Politics Government contractors Government paperwork Government publicity Governmental investigations Health information systems Human experimentation in medicine Internet Labeling Law Licenses Medical research Medical statistics Medical supplies Peer review organizations (Medicine) Periodicals Pharmaceutical research Product safety Research grants Science, Technology, Communications Telephone Web sites Health 00 2004-10-07 Introduced in House 2005-01-07T16:50:27Z Fair Access to Clinical Trials Act - Amends the Public Health Service Act to prohibit an entity from receiving an award of a grant, contract, or cooperative agreement to conduct a clinical trial to determine the safety or effectiveness of a use of a drug or device unless the entity agrees to: (1) register the trial; (2) provide the results of such trial to the Secretary of Health and Human Services; (3) disclose specified information regarding the trial to the public; and (4) be subject to audits.

Requires the Secretary, acting through the Director of the National Institutes of Health (NIH), to establish and operate a databank of such clinical trial information provided to the Secretary. Requires the Director to assign to the National Library of Medicine the primary responsibility for operating such databank.

Requires the Secretary to: (1) identify false or misleading information in the databank, correct such information, and make appropriate public notifications; and (2) amend regulations to require institutional review boards to determine the safety or effectiveness of products registered under this Act and deny approval for trials that are not registered.

Specifies information required for registration of clinical trials, including information important to clinicians or researchers.

Sets forth provisions regarding periodic updates of databank information, submission of results of clinical trials, public disclosure of databank information, and violations of this Act.

Amends the Federal Food, Drug and Cosmetic Act to allow exemptions for clinical investigational use of drugs or devices only if such drugs are registered in accordance with this Act.

]]> Fair Access to Clinical Trials Act Display Title Fair Access to Clinical Trials Act Official Title as Introduced To amend the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act with respect to the availability to the public of information on clinical trials to determine the safety and effectiveness of drugs, biological products, and devices, and for other purposes. Introduced in House IH Short Titles as Introduced Fair Access to Clinical Trials Act Introduced in House 2004-10-07T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-108hr5252ih/xml/BILLS-108hr5252ih.xml 2004-10-11 Sponsor introductory remarks on measure. (CR E1882-1883) 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.