Bill113th Congress

H.R. 2031

TEST Act

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Introduced
May 16, 2013
Origin Chamber
House
Policy Area
Health
Latest Action
May 17, 2013

Sponsor

Rep. Markey, Edward J. [D-MA-5]

Democrat·MA-5
Bioguide ID: M000133
First Name: Edward
Middle Name: J.
Last Name: Markey
By Request: N
3
Cosponsors
1
Committees
4
Actions
0
Amendments
0
Related Bills
8
Subjects
1
Summaries
4
Titles
1
Text Versions

Bill Details

Update Date
Nov 15, 2022
Origin Chamber
House
Bill Type
HR
Bill Number
2,031
Congress
113
Introduced Date
May 16, 2013
Policy Area
Health
Is Law
No
May 17, 2013Committee

Referred to the Subcommittee on Health.

Source: House committee actions

May 16, 2013IntroReferralH11100

Referred to the House Committee on Energy and Commerce.

Source: House floor actions

May 16, 2013IntroReferralIntro-H

Introduced in House

Source: Library of Congress

May 16, 2013IntroReferral1000

Introduced in House

Source: Library of Congress

Introduced in House· May 16, 20130

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.

Energy and Commerce Committee

House· Standing
Administrative law and regulatory proceduresDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationFood and Drug Administration (FDA)Government information and archivesHealth information and medical recordsHealth technology, devices, suppliesMedical research

Introduced in House

May 16, 2013

TEST Act — Informed