H.R. 1014 (110th): Heart Disease Education, Analysis Research, and Treatment for Women Act

Introduced:
Feb 13, 2007 (110th Congress, 2007–2009)
Sponsor:
Rep. Lois Capps [D-CA23]
Status:
Died (Passed House)
See Instead:
This bill was re-introduced as H.R. 1032 (111th) on Feb 12, 2009.

The bill’s title was written by the bill’s sponsor. H.R. stands for House of Representatives bill.

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Status

This bill was introduced in a previous session of Congress and was passed by the House on September 25, 2008 but was never passed by the Senate.

Progress
Introduced Feb 13, 2007
Reported by Committee Sep 17, 2008
Passed House Sep 25, 2008
Votes

House Vote on Passage
Sep 25, 2008 5:42 p.m.
Passed 418/4

Cosponsors
238 cosponsors (171D, 67R) (show)
Committees

House Energy and Commerce

The committee chair determines whether a bill will move past the committee stage.

Full Title

To amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to improve the prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women.

Summary

No summaries available.

Text

Read Bill Text »

Last updated Sep 26, 2008.
10 pages

Primary Source

View on THOMAS (The Library of Congress)

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Citation

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GovTrack’s Bill Summary

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Library of Congress Summary

The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress.

9/25/2008--Passed House amended. Heart Disease Education, Analysis Research, and Treatment for Women Act or the HEART for Women Act -
Section 2 -
Amends the Federal Food, Drug, and Cosmetic Act to allow the Secretary of Health and Human Services to deny a new drug application if the application fails to include required information on clinical investigations.
Directs the Secretary to require that a new drug application include any clinical data possessed by the applicant that relates to the safety and effectiveness of the drug involved by gender, age, and racial subgroup. (Currently, this is required by regulation.)
Requires the Secretary to develop guidance for the staff of the Food and Drug Administration (FDA) to ensure that new drug applications are adequately reviewed to determine whether they include the required clinical data.
Authorizes the Secretary to place a clinical hold on an investigation under an investigational new drug application if the sponsor of the investigation fails to meet the requirements of an annual report on the status of each study in progress. Applies provisions relating to clinical data submission for new drug applications to an investigational new drug application, an application for a biologics license for a biological product, an application for premarket approval for a class III device, and an application for investigational use of a device.
Section 3 -
Amends the Public Health Service Act to require the Secretary to provide that all nonidentifiable patient safety work product reported to and among the network of patient safety databases be identified by sex.
Directs that analyses of national and regional statistics of information reported to and among the network of patient safety databases take into account data that specifically relates to women and any disparities between treatment and the quality of care between males and females.
Section 4 -
Requires the Director of the Agency for Healthcare Research and Quality to conduct and support research and support demonstrations to identify and evaluate clinical and organizational strategies to improve the quality of and access to care for women with heart disease, stroke, and other cardiovascular diseases.
Section 5 -
Requires the Secretary to develop and distribute to females who are age 65 or older, physicians, and other appropriate health care professionals educational materials relating to the prevention diagnosis and treatment of heart disease, stroke, and cardiovascular diseases in women. Requires the Secretary, acting through the Bureau of Health Professions of the Health Resources and Services Administration, to conduct an education and awareness campaign for physicians and other health care professionals relating to the prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women.
Section 6 -
Expands the grant program authorizing the Secretary, acting through the Director of the Centers for Disease Control and Prevention (CDC), to award grants for preventive health services to all states. (Currently, only three grants may be awarded). Authorizes appropriations for FY2009-FY2013.

House Republican Conference Summary

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No summary available.

House Democratic Caucus Summary

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The bill contains the following citations to other parts of U.S. law:

United States Code

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