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H.R.3196 / 109th Congress

Fair Access to Clinical Trials Act

Referred to the Subcommittee on Health.

Official summary

Version 00 · Introduced in House · Jun 30, 2005

Fair Access to Clinical Trials 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 Secretary to collect, catalog, store, and disseminate such information.

Specifies information required for registration of clinical trials, including the purpose and results of the trial. Requires the responsible person to submit clinical trial information to the Secretary. Sets forth provisions regarding periodic updates of data bank information, compliance with requirements, and violations of this Act. Allows the Secretary to identify any false or misleading information in the data bank and include an accurate version of the information.

Requires the Secretary to: (1) disseminate data bank information through an Internet site and through other appropriate means; (2) establish procedures to allow voluntary submission of clinical trial information not required by this Act; and (3) enter into a contract with the Institute of Medicine to study the extent to which data submitted to the data bank has impacted the public health.

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Who introduced it

Rep. Waxman, Henry A. [D-CA-30] · D–CA

Committees

  • Energy and Commerce Committee
42 cosponsorship records, including any withdrawals

Actions

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  1. Referred to the Subcommittee on Health.

  2. Referred to the House Committee on Energy and Commerce.

  3. Introduced in House

  4. Introduced in House

Bill text & related measures

Text links open the official source. We currently store references to these documents.

Related bills identified by Congress.gov

No related bills are listed in this snapshot. This does not establish whether the proposal has appeared in earlier Congresses.

Source last updated: Aug 15, 2025. Consult Congress.gov for the current record.

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Objective

Analyze H.R.3196 as objectively as possible. Explain its main provisions, who would be affected, possible benefits and harms, implementation, exceptions, and uncertainties. Present the strongest arguments for and against it, and identify evidence needed to assess its public impact.

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Fairness and public impact

Progressive lens

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Institutions and government scope

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Individual rights and government power

Liberty lens

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