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HR 2031 113th Congress House

TEST Act

Official title: To amend title IV of the Public Health Service Act to expand the clinical trial registry data bank, and for other purposes.

Introduced: May 16, 2013 Introduced by: Markey, Edward J. Democratic · Massachusetts See on congress.gov
Health Administrative law and regulatory proceduresDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationFood and Drug Administration (FDA)
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Government information and archivesHealth information and medical recordsHealth technology, devices, suppliesMedical research
This bill died when the 113th Congress ended
It never became law before the 113th Congress (2013–2014) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
May 17, 2013
Referred to the Subcommittee on Health.
May 16, 2013
Referred to the House Committee on Energy and Commerce.
May 16, 2013
Introduced in House
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 Latest action May 17, 2013

Referred to the Subcommittee on Health.

 Plain-English summary Congressional Research Service

Trial and Experimental Studies Transparency Act of 2012 [sic] 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.

 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
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APA
U.S. Congress. (2026). H.R. 2031: TEST Act. 113th Congress. Open America. https://openamerica.io/bill/113-HR-2031/
MLA
"H.R. 2031: TEST Act." 113th Congress, 2026, Open America, https://openamerica.io/bill/113-HR-2031/.
Bluebook (legal)
H.R. 2031, 113th Cong. (2026), https://openamerica.io/bill/113-HR-2031/.
Markdown link
[H.R. 2031: TEST Act](https://openamerica.io/bill/113-HR-2031/)
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