H.R. 1032House111th Congress (2009-2011)Passed House

HEART for Women Act

Sponsored by Lois CappsRep. Lois Capps (D-CA)
Introduced February 12, 2009

Legislative Activity

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19 earlier actions
SenateIntro Referral Latest Action

Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

November 15, 2010

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HouseIntro Referral

Introduced in House

February 12, 2009

HouseIntro Referral

Referred to the House Committee on Energy and Commerce.

February 12, 2009

HouseCommittee

Referred to the Subcommittee on Health.

February 13, 2009

HouseCommittee

Subcommittee Hearings Held.

September 15, 2010

HouseCommittee

Subcommittee Consideration and Mark-up Session Held.

September 16, 2010

HouseCommittee

Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .

September 16, 2010

HouseCommittee

Committee Consideration and Mark-up Session Held.

September 23, 2010

HouseCommittee

Ordered to be Reported (Amended) by Voice Vote.

September 23, 2010

HouseCommittee

Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 111-639.

September 28, 2010

HouseCalendars

Placed on the Union Calendar, Calendar No. 379.

September 28, 2010

HouseFloor

Mr. Pallone moved to suspend the rules and pass the bill, as amended.

September 28, 2010 • 10:19 PM

HouseFloor

Considered under suspension of the rules. (consideration: CR H7189-7190)

September 28, 2010 • 10:19 PM

HouseFloor

DEBATE - The House proceeded with forty minutes of debate on H.R. 1032.

September 28, 2010 • 10:19 PM

HouseFloor

At the conclusion of debate, the chair put the question on the motion to suspend the rules. Mr. Burgess objected to the vote on the grounds that a quorum was not present. Further proceedings on the motion were postponed. The point of no quorum was withdrawn.

September 28, 2010 • 10:22 PM

HouseFloor

Considered as unfinished business. (consideration: CR H7380)

September 30, 2010 • 12:43 AM

HouseFloor

Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.(text: CR 9/28/2010 H7189-7190)

September 30, 2010 • 12:43 AM

HouseFloor

On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR 9/28/2010 H7189-7190)

September 30, 2010 • 12:43 AM

HouseFloor

Motion to reconsider laid on the table Agreed to without objection.

September 30, 2010 • 12:43 AM

HouseFloor

The title of the measure was amended. Agreed to without objection.

September 30, 2010 • 12:43 AM

SenateIntro Referral

Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

November 15, 2010

Floor Debate

4 members

What members said about H.R. 1032 on the floor

1 Republican3 Democrats
Maxine Waters
Rep. Maxine WatersD-CA-35 · Sep 22, 2009

Madam Speaker, yesterday was World Alzheimer's Day--a day to call attention to and raise awareness of this fatal, neurodegenerative disease afflicting over 5 million Americans. In this country,…

Lois Capps
Rep. Lois CappsD-CA-23 · Sep 28, 2010

Mr. Speaker, I rise in strong support of H.R. 1032, the HEART for Women Act. As you may know, heart disease is the number one killer of American women, claiming the lives of over 400,000 women…

Michael C. Burgess
Rep. Michael C. BurgessR-TX-26 · Sep 28, 2010

Mr. Speaker, I yield myself such time as I may consume. H.R. 1032, the Heart Disease Education, Analysis, Research, and Treatment for Women Act, would take several important steps in the fight…

Frank Pallone, Jr.
Rep. Frank Pallone, Jr.D-NJ-6 · Sep 28, 2010

Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 1032) to amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to improve the prevention, diagnosis, and…

Bill Text

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Referred in SenateIssued November 15, 2010

IIB

111th CONGRESS

2d Session

H. R. 1032

IN THE SENATE OF THE UNITED STATES

November 15, 2010

Received; read twice and referred to the Committee on Health, Education, Labor, and Pensions

AN ACT

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

1.

Short title

This Act may be cited as the Heart Disease Education, Analysis Research, and Treatment for Women Act or the HEART for Women Act.

2.

Report by Government Accountability Office

(a)

In General

The Comptroller General of the United States shall conduct a study investigating the extent to which sponsors of clinical studies of investigational drugs, biologics, and devices and sponsors of applications for approval or licensure of new drugs, biologics, and devices comply with Food and Drug Administration requirements and follow guidance for presentation of clinical study safety and effectiveness data by sex, age, and racial subgroups.

(b)

Report by GAO

(1)

Submission

Not later than 12 months after the date of the enactment of this Act, the Comptroller General shall complete the study under subsection (a) and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the results of such study.

(2)

Contents

The report required by paragraph (1) shall include each of the following:

(A)

A description of the extent to which the Food and Drug Administration assists sponsors in complying with the requirements and following the guidance referred to in subsection (a).

(B)

A description of the effectiveness of the Food and Drug Administration’s enforcement of compliance with such requirements.

(C)

An analysis of the extent to which females, racial and ethnic minorities, and adults of all ages are adequately represented in Food and Drug Administration-approved clinical studies (at all phases) so that product safety and effectiveness data can be evaluated by gender, age, and racial subgroup.

(D)

An analysis of the extent to which a summary of product safety and effectiveness data disaggregated by sex, age, and racial subgroup is readily available to the public in a timely manner by means of the product label or the Food and Drug Administration’s Website.

(E)

Appropriate recommendations for—

(i)

modifications to the requirements and guidance referred to in subsection (a); or

(ii)

oversight by the Food and Drug Administration of such requirements.

(c)

Report by HHS

Not later than 6 months after the submission by the Comptroller General of the report required under subsection (b), the Secretary of Health and Human Services shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a response to that report, including a corrective action plan as needed to respond to the recommendations in that report.

(d)

Definitions

In this section:

(1)

The term biologic has the meaning given to the term biological product in section 351(i) of the Public Health Service Act (42 U.S.C. 262(i)).

(2)

The term device has the meaning given to such term in section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)).

(3)

The term drug has the meaning given to such term in section 201(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)).

3.

Reporting on quality of and access to care for women with cardiovascular diseases

Part P of title III of the Public Health Service Act (42 U.S.C. 280g et seq.) is amended by adding at the end the following:

399V–5.

Reporting on quality of and access to care for women with cardiovascular diseases

Not later than September 30, 2013, and annually thereafter, the Secretary of Health and Human Services shall prepare and submit to the Congress a report on the quality of and access to care for women with heart disease, stroke, and other cardiovascular diseases. The report shall contain recommendations for eliminating disparities in, and improving the treatment of, heart disease, stroke, and other cardiovascular diseases in women.

.

4.

Extension of WISEWOMAN program

Section 1509 of the Public Health Service Act (42 U.S.C. 300n–4a) is amended—

(1)

in subsection (a)—

(A)

by striking the heading and inserting In general.—; and

(B)

in the matter preceding paragraph (1), by striking may make grants and all that follows through purpose and inserting the following: may make grants to such States for the purpose; and

(2)

in subsection (d)(1), by striking there are authorized and all that follows through the period and inserting there are authorized to be appropriated $23,000,000 for fiscal year 2012, $25,300,000 for fiscal year 2013, $27,800,000 for fiscal year 2014, $30,800,000 for fiscal year 2015, and $34,000,000 for fiscal year 2016..

Passed the House of Representatives September 30 (legislative day September 29), 2010.

Lorraine C. Miller,

Clerk