HR 5249 · 107th Congress 2001–2003, ended

Safe Overseas Human Testing Act

Introduced Jul 26, 2002 Originated House Sponsor Tom Lantos D-CA

Latest action · Jul 26, 2002 Referred to the House Committee on International Relations.

Progress

Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.

IntroducedJul 26, 2002
Passed HouseNot reached
Passed SenateNot reached
To the PresidentNot reached
Became lawNot reached

Summary

Safe Overseas Human Testing Act - Declares it is the policy of Congress to control the export of drugs and other test articles intended for overseas clinical investigations involving human participants in order to foster public health and safety, prevent injury to U.S. foreign policy, and preserve the credibility of the United States as a responsible trading partner.

Requires a license approved by the President for the export of such test articles. Sets forth certain export license requirements, including that the license applicant shall: (1) identify each clinical investigation for which the test article is intended; and (2) submit proof that each of the protocols for every clinical investigation has been reviewed by an institutional review board and has, at a minimum, met substantially the same standards for the protection of the rights and welfare of human subjects as that required for Institutional Review Boards approval of protocols for clinical investigations (in the United States) of test articles pursuant to the Federal Food, Drug, and Cosmetic Act.

Cosponsors 21

Members who signed on, in the order they did. Signatures ran from Jul 26, 2002 to Sep 26, 2002; 18 are original cosponsors, there from the day it was introduced.

Seat	Cosponsor		Signed on
D-CA	Barbara Lee	Original	Jul 26, 2002
D-MI	Bart Stupak	Original	Jul 26, 2002
D-CA	Brad Sherman	Original	Jul 26, 2002
R-NJ	Christopher H. Smith	Original	Jul 26, 2002
D-GA	Cynthia A. McKinney	Original	Jul 26, 2002
D-CA	Diane E. Watson	Original	Jul 26, 2002
D-NJ	Donald M. Payne	Original	Jul 26, 2002
D-AL	Earl F. Hilliard	Original	Jul 26, 2002
D-NJ	Frank Pallone, Jr.	Original	Jul 26, 2002
D-NY	Gary L. Ackerman	Original	Jul 26, 2002
D-CA	Grace F. Napolitano	Original	Jul 26, 2002
D-NY	Gregory W. Meeks	Original	Jul 26, 2002
D-CA	Howard L. Berman	Original	Jul 26, 2002
R-FL	Ileana Ros-Lehtinen	Original	Jul 26, 2002
D-PA	Joseph M. Hoeffel	Original	Jul 26, 2002
D-CA	Lynn C. Woolsey	Original	Jul 26, 2002
D-NV	Shelley Berkley	Original	Jul 26, 2002
D-OH	Sherrod Brown	Original	Jul 26, 2002
I-VT	Bernard Sanders		Sep 4, 2002
D-ME	Thomas H. Allen		Sep 4, 2002
D-PA	Michael F. Doyle		Sep 26, 2002

Committees 1

Where it was sent and what each committee and subcommittee did with it, in order.

Chamber	Committee	What it did
House	Foreign Affairs Committee	Referred Jul 26, 2002

Actions 2

Everything that happened, newest first.

Jul 26, 2002Introduced in House
Jul 26, 2002Referred to the House Committee on International Relations.

Titles 2

Every title it has carried, official and short, at each stage.

Official Title as Introduced: To promote safe and ethical clinical trials of drugs and other test articles on people overseas.
Short Titles as Introduced: Safe Overseas Human Testing Act

Subjects

Assigned by the Library of Congress. Policy area: International Affairs.

Text 1

Each version as it was printed, newest first.

Jul 26, 2002Introduced in House

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Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov; cost estimates are the Congressional Budget Office's, and the hearings are the printed hearings GovInfo publishes, which can appear months after the hearing.