H.R. 1014House110th Congress (2007-2009)Passed House

HEART for Women Act

Sponsored by Lois CappsRep. Lois Capps (D-CA)
Introduced February 13, 2007

Legislative Activity

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16 earlier actions
SenateIntro Referral Latest Action

Received in the Senate.

September 26, 2008

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HouseIntro Referral

Introduced in House

February 13, 2007

HouseIntro Referral

Referred to the House Committee on Energy and Commerce.

February 13, 2007

HouseCommittee

Referred to the Subcommittee on Health.

February 14, 2007

HouseCommittee

Subcommittee Hearings Held.

May 1, 2007

HouseCommittee

Committee Consideration and Mark-up Session Held.

September 17, 2008

HouseCommittee

Ordered to be Reported (Amended) by Voice Vote.

September 17, 2008

HouseCommittee

Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 110-874.

September 23, 2008

HouseCalendars

Placed on the Union Calendar, Calendar No. 570.

September 23, 2008

HouseFloor

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

September 23, 2008 • 9:23 PM

HouseFloor

Considered under suspension of the rules. (consideration: CR H8688-8691)

September 23, 2008 • 9:23 PM

HouseFloor

DEBATE - The House proceeded with forty minutes of debate on H.R. 1014.

September 23, 2008 • 9:23 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 The point of no quorum was withdrawn.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 23, 2008 • 9:30 PM

HouseFloor

Considered as unfinished business. (consideration: CR H9927)

September 25, 2008 • 5:15 PM

HouseFloor

Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by recorded vote (2/3 required): 418 - 4 (Roll no. 642).(text: CR 9/23/2008 H8689)

September 25, 2008 • 5:43 PM

HouseFloor

On motion to suspend the rules and pass the bill, as amended Agreed to by recorded vote (2/3 required): 418 - 4 (Roll no. 642). (text: CR 9/23/2008 H8689)

September 25, 2008 • 5:43 PM

HouseFloor

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

September 25, 2008 • 5:43 PM

SenateIntro Referral

Received in the Senate.

September 26, 2008

Floor Debate

15 members

What members said about H.R. 1014 on the floor

8 Republicans7 Democrats
Lois Capps
Rep. Lois CappsD-CA-23 · Feb 13, 2008

Mr. Speaker, I move to suspend the rules and agree to the resolution (H. Res. 972) supporting the goals and ideals of American Heart Month and National Wear Red Day. Mr. Speaker, I ask unanimous…

Janice D. Schakowsky
Rep. Janice D. SchakowskyD-IL-9 · Sep 25, 2008

Madam Speaker, I rise today in support of a number of bipartisan public health bills to come before this body. These bills are the products of the Energy and Commerce Committee, where my colleagues…

Frank Pallone, Jr.
Rep. Frank Pallone, Jr.D-NJ-6 · Sep 23, 2008

Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 1014) to amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to improve the prevention, diagnosis, and…

Lois Capps
Rep. Lois CappsD-CA-23 · May 14, 2008

Mr. Speaker, I move to suspend the rules and agree to the concurrent resolution (H. Con. Res. 331) supporting the goals and ideals of National Women's Health Week, and for other purposes. Mr.…

Rosa L. DeLauro
Rep. Rosa L. DeLauroD-CT-3 · Sep 28, 2008

Mr. Speaker, I rise in support of the HEART for Women Act (H.R. 1014) to help improve the prevention, diagnosis, and treatment of heart disease in women, which often manifests itself differently in…

Show 8 more
Eddie Bernice Johnson
Rep. Eddie Bernice JohnsonD-TX-30 · Mar 6, 2008

Madam Speaker, in order to attend a funeral in my congressional district, I missed 17 votes on March 5 and March 6. Had I been present I would have voted: ``Yea'' on rollcall 91, On Motion to Suspend…

Maurice D. Hinchey
Rep. Maurice D. HincheyD-NY-22 · May 14, 2008

Mr. Speaker, as the initiator of this resolution, I would first like to take a moment to thank Chairman Dingell for supporting the resolution and for bringing, being instrumental, rather, in bringing…

Marsha Blackburn
Rep. Marsha BlackburnR-TN-7 · May 14, 2008

Mr. Speaker, I thank the gentleman from Pennsylvania (Mr. Tim Murphy) for the leadership that he brings to our Health Subcommittee. I also want to thank the gentlewoman from California (Mrs. Capps)…

Sue Wilkins Myrick
Rep. Sue Wilkins MyrickR-NC-9 · Feb 13, 2008

Mr. Speaker, I thank the gentlelady, my friend from California, for all of the hard work she has put into this issue for the last several years, not just this year. It has been a real passion with…

Tim Murphy
Rep. Tim MurphyR-PA-18 · May 14, 2008

Mr. Speaker, I also thank the gentlewoman from California (Mrs. Capps) for her thoughts and input on this bill, which I'm pleased to be a cosponsor today. Appropriately, National Women's Health Week…

Lois Capps
Rep. Lois CappsD-CA-23 · Sep 23, 2008

Mr. Speaker, I rise in strong support of H.R. 1014, the HEART for Women Act. I thank my colleague for yielding to me, and I thank the lead co-sponsor of this bill, Congresswoman Barbara Cubin of…

Mary Fallin
Rep. Mary FallinR-OK-5 · Feb 13, 2008

Mr. Speaker, I appreciate both of my fine colleagues here and their sponsorship of this great resolution to honor women and, of course, the American Heart Association Go Red for Women Month. It is a…

George Radanovich
Rep. George RadanovichR-CA-19 · Sep 23, 2008

Mr. Speaker, I would like to thank my colleagues Mrs. Capps and Mrs. Cubin for sponsoring H.R. 1014, the Heart Disease Education, Analysis Research and Treatment, or HEART, for Women Act. I lend my…

Show 5 more
Lynn C. Woolsey
Rep. Lynn C. WoolseyD-CA-6 · Mar 6, 2008

Madam Speaker, on March 5, 2008, I was unavoidably detained and was not able to record my votes for Rollcall No. 91-102. Had I been present I would have voted: Rollcall No. 91--``Yes''--To…

Michael C. Burgess
Rep. Michael C. BurgessR-TX-26 · Sep 23, 2008

Mr. Speaker, in deference to the primary sponsor of the bill, I will reserve the balance of my time. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I rise in support of H.R.…

Jeff Miller
Rep. Jeff MillerR-FL-1 · Sep 28, 2008

Madam Speaker, I would like to offer a personal explanation of the reason I missed rollcall votes 637-644 on September 25, 2008. I was in my congressional district attending a funeral for a fallen…

Marsha Blackburn
Rep. Marsha BlackburnR-TN-7 · Feb 13, 2008

Mr. Speaker, we are all joining together to sponsor this resolution. Before I speak, I want to commend both the gentlelady from California and the gentlelady from North Carolina for the exceptional…

Nathan Deal
Rep. Nathan DealR-GA-9 · Sep 25, 2008

Madam Speaker, I demand a recorded vote.

Bill Text

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Received in SenateIssued September 26, 2008

II

110th CONGRESS

2d Session

H. R. 1014

IN THE SENATE OF THE UNITED STATES

September 26 (legislative day, September 17), 2008

Received

AN ACT

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.

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.

Reporting of data in applications for drugs, biologics, and devices

(a)

Drugs

(1)

New drug applications

Section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) is amended—

(A)

in paragraph (1), in the second sentence—

(i)

by striking drug, and (G) and inserting drug; (G); and

(ii)

by inserting before the period the following: ; and (H) the information required under paragraph (7); and

(B)

by adding at the end the following:

(7)
(A)

With respect to clinical data in an application under this subsection, the Secretary may deny such an application if the application fails to meet the requirements of sections 314.50(d)(5)(v) and 314.50(d)(5)(vi)(a) of title 21, Code of Federal Regulations.

(B)

The Secretary shall modify the sections referred to in subparagraph (A) to require that an application under this subsection include any clinical data possessed by the applicant that relates to the safety or effectiveness of the drug involved by gender, age, and racial subgroup.

(C)

Promptly after approving an application under this subsection, the Secretary shall, through an Internet site of the Department of Health and Human Services, make available to the public the information submitted to the Secretary pursuant to subparagraphs (A) and (B), subject to sections 301(j) and 520(h)(4) of this Act, subsection (b)(4) of section 552 of title 5, United States Code (commonly referred to as the Freedom of Information Act), and other provisions of law that relate to trade secrets or confidential commercial information.

(D)

The Secretary shall develop guidance for staff of the Food and Drug Administration to ensure that applications under this subsection are adequately reviewed to determine whether the applications include the information required pursuant to subparagraphs (A) and (B).

.

(2)

Investigational new drug applications

Section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) is amended—

(A)

in paragraph (2), by striking Subject to paragraph (3), and inserting Subject to paragraphs (3) and (5), ; and

(B)

by adding at the end the following:

(5)
(A)

The Secretary may place a clinical hold (as described in paragraph (3)) on an investigation if the sponsor of the investigation fails to meet the requirements of section 312.33(a) of title 21, Code of Federal Regulations.

(B)

The Secretary shall modify the section referred to in subparagraph (A) to require that reports under such section include any clinical data possessed by the sponsor of the investigation that relates to the safety or effectiveness of the drug involved by gender, age, and racial subgroup.

.

(b)

Biologics license applications

Section 351 of the Public Health Service Act (42 U.S.C. 262) is amended by adding at the end the following:

(k)

The provisions of section 505(b)(7) of the Federal Food, Drug, and Cosmetic Act (relating to clinical data submission) apply with respect to an application under subsection (a) of this section to the same extent and in the same manner as such provisions apply with respect to an application under section 505(b) of such Act.

.

(c)

Devices

(1)

Premarket approval

Section 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e) is amended—

(A)

in subsection (c)(1)—

(i)

in subparagraph (G)—

(I)

by moving the margin 2 ems to the left; and

(II)

by striking and after the semicolon at the end;

(ii)

by redesignating subparagraph (H) as subparagraph (I); and

(iii)

by inserting after subparagraph (G) the following subparagraph:

(H)

the information required under subsection (d)(7); and

; and

(B)

in subsection (d), by adding at the end the following paragraph:

(7)

To the extent consistent with the regulation of devices, the provisions of section 505(b)(7) (relating to clinical data submission) apply with respect to an application for premarket approval of a device under subsection (c) of this section to the same extent and in the same manner as such provisions apply with respect to an application for premarket approval of a drug under section 505(b).

.

(2)

Investigational devices

Section 520(g)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(g)(2)) is amended by adding at the end the following subparagraph:

(D)

To the extent consistent with the regulation of devices, the provisions of section 505(i)(5) (relating to individual study information) apply with respect to an application for an exemption pursuant to subparagraph (A) of this paragraph to the same extent and in the same manner as such provisions apply with respect to an application for an exemption under section 505(i).

.

(d)

Rules of construction

This Act and the amendments made by this Act may not be construed—

(1)

as establishing new requirements under the Federal Food, Drug, and Cosmetic Act relating to the design of clinical investigations that were not otherwise in effect on the day before the date of the enactment of this Act; or

(2)

as having any effect on the authority of the Secretary of Health and Human Services to enforce regulations under the Federal Food, Drug, and Cosmetic Act that are not expressly referenced in this Act or the amendments made by this Act.

(e)

Application

This section and the amendments made by this section apply only with respect to applications received under section 505 or 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355, 360e) or section 351 of the Public Health Service Act (42 U.S.C. 262) on or after the date of the enactment of this Act.

3.

Reporting and analysis of patient safety data

(a)

Data standards

Section 923(b) of the Public Health Service Act (42 U.S.C. 299b–23(b)) is amended by adding at the end the following: The Secretary shall provide that all nonidentifiable patient safety work product reported to and among the network of patient safety databases be stratified by sex..

(b)

Use of information

Section 923(c) of the Public Health Service Act (42 U.S.C. 299b–23(c)) is amended by adding at the end the following: Such analyses take into account data that specifically relates to women and any disparities between treatment and the quality of care between males and females..

4.

Quality of care reports by the Agency for Healthcare Research and Quality

Section 903 of the Public Health Service Act (42 U.S.C. 299a–1) is amended—

(1)

in subsection (b)(1)(B), by inserting before the semicolon the following: , including quality of and access to care for women with heart disease, stroke, and other cardiovascular diseases; and

(2)

in subsection (c), by adding at the end the following:

(4)

Annual report on women and heart disease

Not later than September 30, 2009, and annually thereafter, the Secretary, acting through the Director, shall prepare and submit to Congress a report concerning the findings related to 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.

.

5.

Educational campaigns

(a)

Distribution of educational material

The Secretary of Health and Human Services (referred to in this section as the Secretary) shall develop and distribute to females who are age 65 or older, physicians, and other appropriate healthcare professionals, educational materials relating to the prevention, diagnosis, and treatment of heart disease, stroke, and cardiovascular diseases in women. The Secretary may carry out this subsection through contracts with public and private nonprofit entities.

(b)

Healthcare professional educational campaign

The Secretary, acting through the Bureau of Health Professions of the Health Resources and Services Administration, shall conduct an education and awareness campaign for physicians and other healthcare professionals relating to the prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women. The Bureau of Health Professions may carry out this subsection through contracts with public and private nonprofit entities.

6.

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 $37,000,000 for fiscal year 2009, $38,850,000 for fiscal year 2010, $40,792,500 for fiscal year 2011, $42,832,000 for fiscal year 2012, and $44,974,000 for fiscal year 2013..

Passed the House of Representatives September 25, 2008.

Lorraine C. Miller,

Clerk