H.R.3196 - Fair Access to Clinical Trials Act109th Congress (2005-2006)
|Sponsor:||Rep. Waxman, Henry A. [D-CA-30] (Introduced 06/30/2005)|
|Committees:||House - Energy and Commerce|
|Latest Action:||07/29/2005 Referred to the Subcommittee on Health.|
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Summary: H.R.3196 — 109th Congress (2005-2006)All Bill Information (Except Text)
Introduced in House (06/30/2005)
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.