[House Report 111-639]
[From the U.S. Government Publishing Office]
111th Congress Report
HOUSE OF REPRESENTATIVES
2d Session 111-639
======================================================================
HEART DISEASE EDUCATION, ANALYSIS RESEARCH, AND TREATMENT FOR WOMEN ACT
_______
September 28, 2010.--Committed to the Committee of the Whole House on
the State of the Union and ordered to be printed
_______
Mr. Waxman, from the Committee on Energy and Commerce, submitted the
following
R E P O R T
[To accompany H.R. 1032]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
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 treatment of heart disease, stroke,
and other cardiovascular diseases in women, having considered
the same, report favorably thereon with amendments and
recommend that the bill as amended do pass.
CONTENTS
Page
Amendment........................................................ 2
Purpose and Summary.............................................. 3
Background and Need for Legislation.............................. 3
Committee Consideration.......................................... 3
Committee Votes.................................................. 4
Committee Oversight Findings and Recommendations................. 4
New Budget Authority, Entitlement Authority, and Tax Expenditures 4
Statement of General Performance Goals and Objectives............ 4
Constitutional Authority Statement............................... 4
Earmarks and Tax and Tariff Benefits............................. 4
Federal Advisory Committee Statement............................. 4
Applicability of Law to the Legislative Branch................... 5
Federal Mandates Statement....................................... 5
Committee Cost Estimate.......................................... 5
Congressional Budget Office Cost Estimate........................ 5
Section-by-Section Analysis of the Legislation................... 7
Explanation of Amendments........................................ 7
Changes in Existing Law Made by the Bill, as Reported............ 7
Amendment
The amendments are as follows:
Strike all after the enacting clause and insert the
following:
SECTION 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''.
SEC. 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)).
SEC. 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:
``SEC. 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.''.
SEC. 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.''.
Amend the title so as to read:
A bill to amend the Public Health Service Act to improve
the prevention, diagnosis, and treatment of heart disease,
stroke, and other cardiovascular diseases in women.
Purpose and Summary
H.R. 1032, the ``Heart Disease Education, Analysis,
Research, and Treatment for Women Act'' or ``HEART for Women
Act'', was introduced on February 12, 2009, by Rep. Lois Capps
(D-CA) and referred to the Committee on Energy and Commerce.
The goal of H.R. 1032 is to improve the prevention,
diagnosis, and treatment of heart disease, stroke, and other
cardiovascular diseases in women. H.R. 1032 extends the Centers
for Disease Control and Prevention (CDC) WISEWOMAN program and
contains other provisions addressing the quality of and access
to care for women with heart disease, stroke, and other
cardiovascular diseases.
Background and Need for Legislation
Heart disease is the number one killer of women in the
United States today. H.R. 1032 is designed to support efforts
to improve prevention and treatment of heart disease within
this population by strengthening data collection efforts and
extending and expanding the WISEWOMAN program. Administered by
the CDC, this program provides important preventive services to
uninsured and underinsured women who may be at risk for heart
disease.
Committee Consideration
H.R. 1032, the ``Heart Disease Education, Analysis,
Research, and Treatment for Women Act'', was introduced by Mrs.
Capps of California on February 12, 2009, and referred to the
Committee on Energy and Commerce. The bill was subsequently
referred to the Subcommittee on Health on February 13, 2009. On
September 15, 2010, the Subcommittee held a legislative hearing
on the bill. The Subcommittee met in open markup session to
consider H.R. 1032 on September 16, 2010. An amendment in the
nature of a substitute (manager's amendment) by Mrs. Capps was
adopted by a voice vote. Subsequently, H.R. 1032 was favorably
forwarded to the full Committee, amended, by a voice vote.
On September 23, 2010, the Committee on Energy and Commerce
met in open markup session and considered H.R. 1032 as approved
by the Subcommittee. There were no amendments offered in full
Committee and subsequently the Committee ordered H.R. 1032
favorably reported to the House, as amended by the Subcommittee
on Health, by a voice vote.
Committee Votes
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list each record vote
on the motion to report legislation and amendments thereto. A
motion by Mr. Waxman ordering H.R. 1032 reported to the House,
as amended, was approved by a voice vote. There were no record
votes taken during consideration of this bill.
Committee Oversight Findings and Recommendations
In compliance with clause 3(c)(1) of rule XIII and clause
(2)(b)(1) of rule X of the Rules of the House of
Representatives, the oversight findings and recommendations of
the Committee are reflected in the descriptive portions of this
report, including the finding that the WISEWOMAN program
provides important preventive services to uninsured and
underinsured women who may be at risk for heart disease.
New Budget Authority, Entitlement Authority, and Tax Expenditures
Regarding compliance with clause 3(c)(2) of rule XIII of
the Rules of the House of Representatives, the Committee finds
that H.R. 1032 would result in no new budget authority,
entitlement authority, or tax expenditures or revenues.
Statement of General Performance Goals and Objectives
In accordance with clause 3(c)(4) of rule XIII of the Rules
of the House of Representatives, the performance goals and
objectives of the Committee are reflected in the descriptive
portions of this report, including the goal of extending the
WISEWOMAN program.
Constitutional Authority Statement
Pursuant to clause 3(d)(1) of rule XIII of the Rules of the
House of Representatives, the Committee finds that the
constitutional authority for H.R. 1032 is provided under
article I, section 8, clauses 3 and 18 of the Constitution of
the United States.
Earmarks and Tax and Tariff Benefits
H.R. 1032 does not contain any congressional earmarks,
limited tax benefits, or limited tariff benefits as defined in
clause 9 of rule XXI of the Rules of the House of
Representatives.
Federal Advisory Committee Statement
The Committee finds that the legislation does not establish
or authorize the establishment of an advisory committee within
the definition of 5 U.S.C. App., section 5(b) of the Federal
Advisory Committee Act.
Applicability of Law to the Legislative Branch
Section 102(b)(3) of Public Law 104-1 requires a
description of the application of this bill to the legislative
branch where the bill relates to terms and conditions of
employment or access to public services and accommodations.
H.R. 1032 contains no such provisions.
Federal Mandates Statement
Section 423 of the Congressional Budget and Impoundment
Control Act of 1974 (as amended by section 101(a)(2) of the
Unfunded Mandates Reform Act, Public Law 104-4) requires a
statement on whether the provisions of the report include
unfunded mandates. In compliance with this requirement the
Committee adopts as its own the analysis of federal mandates
prepared by the Director of the Congressional Budget Office
regarding H.R. 1032.
Committee Cost Estimate
Pursuant to clause 3(d)(2) of rule XIII of the Rules of the
House of Representatives, the Committee adopts as its own the
cost estimate of H.R. 1032 prepared by the Director of the
Congressional Budget Office pursuant to section 402 of the
Congressional Budget Act of 1974.
Congressional Budget Office Cost Estimate
With respect to the requirements of clause (3)(c)(3) of
rule XIII of the Rules of the House of Representatives and
section 402 of the Congressional Budget Act of 1974, the
Committee has received the following cost estimate for H.R.
1032 from the Director of Congressional Budget Office:
U.S. Congress,
Congressional Budget Office,
Washington, DC, September 27, 2010.
Hon. Henry A. Waxman,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for H.R. 1032, the Heart
Disease Education, Analysis Research, and Treatment for Women
Act.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contacts are Ellen
Werble and Stephanie Cameron.
Sincerely,
Douglas W. Elmendorf.
Enclosure.
H.R. 1032--Heart Disease Education, Analysis Research, and Treatment
for Women Act
Summary: H.R. 1032 would amend the Public Health Service
Act to improve the prevention and treatment of cardiovascular
disease in women. H.R. 1032 would extend the Well-Integrated
Screening and Evaluation for Women Across the Nation
(WISEWOMAN) program administered by the Centers for Disease
Control and Prevention (CDC) through fiscal year 2016. In
addition, the bill would require several reports from federal
agencies and a study by the Government Accountability Office
(GAO) on the extent to which sponsors of clinical studies
adhere to requirements and guidelines for the presentation of
clinical study safety and effectiveness data by sex, age, and
racial subgroups.
CBO estimates that implementing H.R. 1032 would cost less
than $500,000 in 2011 and $82 million over the 2011-2015
period. Enacting H.R. 1032 would not affect direct spending or
revenues; therefore, pay-as-you-go procedures do not apply.
H.R. 1032 contains no intergovernmental or private-sector
mandates as defined in the Unfunded Mandates Reform Act (UMRA).
Estimated cost to the Federal Government: The estimated
budgetary impact of H.R. 1032 is shown in the following table.
The costs of this legislation fall primarily within budget
function 550 (health).
----------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
------------------------------------------------------------
2011 2012 2013 2014 2015 2011-2015
----------------------------------------------------------------------------------------------------------------
CHANGES IN SPENDING SUBJECT TO APPROPRIATION
Estimated Authorization Level...................... * 23 25 28 31 107
Estimated Outlays.................................. * 9 20 25 28 82
----------------------------------------------------------------------------------------------------------------
Note: * = less than $500,000.
Basis of estimate: For this estimate, CBO assumes that H.R.
1032 will be enacted near the beginning of fiscal year 2011,
that the necessary amounts will be appropriated each year, and
that outlays will follow historical patterns for similar
activities of the Department of Health and Human Services. CBO
estimates that implementing H.R. 1032 would cost less than
$500,000 in 2011 and $82 million over the 2011-2015 period.
The WISEWOMAN program provides chronic disease screening
and educational services to low-income women between the ages
of 40 and 64. H.R. 1032 would authorize the appropriation of
$107 million over the 2012-2015 period and an additional $34
million for fiscal year 2016 to the CDC to extend the WISEWOMAN
program. Assuming the appropriation of the specified amounts,
CBO estimates that provision would cost $82 million over the
2012-2015 period and an additional $57 million after 2015. In
addition, H.R. 1032 would require several reports from federal
agencies on quality and access to care for women with
cardiovascular disease and from the GAO on adherence to
requirements and guidelines for the presentation of data in
clinical studies. CBO estimates that these provisions would
cost less than $500,000 over the 2011-2015 period.
Pay-As-You-Go considerations: None.
Estimated impact on state, local, and tribal governments:
H.R. 1032 contains no intergovernmental mandates as defined in
UMRA. Grant funds authorized in the bill would benefit states
that provide blood pressure and cholesterol screening and
education services to women.
Estimated impact on the private sector: This bill contains
no private-sector mandates as defined in UMRA.
Estimate prepared by: Federal costs: Stephanie Cameron and
Ellen Werble; Impact on state, local, and tribal governments:
Lisa Ramirez-Branum; Impact on the private sector: Jimmy Jin.
Estimate approved by: Holly Harvey, Deputy Assistant
Director for Budget Analysis.
Section-by-Section Analysis of the Legislation
Section 1. Short title
Section 1 designates that the Act may be cited as the
``Heart Disease Education, Analysis Research, and Treatment for
Women Act'' or the ``HEART for Women Act''.
Section 2. Report by the Government Accountability Office
Section 2 requires the Government Accountability Office
(GAO) to conduct a review of the effectiveness of the Food and
Drug Administration (FDA) in enforcing regulations that require
sponsors of applications for approval of certain FDA-regulated
products to stratify the data submitted in support of such
applications by gender. This section also requires HHS to
respond to the GAO report, including a corrective action plan
as needed to respond to the recommendations in the report.
Section 3. Reporting on quality of and access to care for women with
cardiovascular disease
Section 3 amends the Public Health Service Act to require
HHS to submit an annual report to Congress on the quality of
and access to care for women with heart disease, stroke, and
other cardiovascular diseases.
Section 4. Extension of WISEWOMAN program
Section 4 extends the CDC WISEWOMAN program for an
additional five fiscal years and authorizes the following sums
in each such year: $23 million for FY2012; $25.3 million for
FY2013; $27.8 million for FY2014; $30.8 million for FY2015; and
$34 million for FY2016.
Explanation of Amendments
During the Subcommittee on Health markup of H.R. 1032, Mrs.
Capps of California offered an amendment in the nature of a
substitute (manager's amendment), which was adopted by a voice
vote. The substance of the substitute amendment is reflected in
the section-by-section analysis contained in this report.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italic, existing law in which no change is
proposed is shown in roman):
PUBLIC HEALTH SERVICE ACT
* * * * * * *
TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE
* * * * * * *
PART P--ADDITIONAL PROGRAMS
* * * * * * *
SEC. 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.
* * * * * * *
TITLE XV--PREVENTIVE HEALTH MEASURES WITH RESPECT TO BREAST AND
CERVICAL CANCERS
* * * * * * *
SEC. 1509. SUPPLEMENTAL GRANTS FOR ADDITIONAL PREVENTIVE HEALTH
SERVICES.
(a) [Demonstration Projects] In General.--In the case of
States receiving grants under section 1501, the Secretary,
acting through the Director of the Centers for Disease Control
and Prevention, [may make grants to not more than 3 such States
to carry out demonstration projects for the purpose] may make
grants to such States for the purpose of--
(1) * * *
* * * * * * *
(d) Funding.--
(1) In general.--Subject to paragraph (2), for the
purpose of carrying out this section, [there are
authorized to be appropriated $3,000,000 for fiscal
year 1994, and such sums as may be necessary for each
of the fiscal years 1995 through 2003.] 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.
* * * * * * *