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[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.

           *       *       *       *       *       *       *