[House Report 117-212]
[From the U.S. Government Publishing Office]


117th Congress    }                                    {        Report
                        HOUSE OF REPRESENTATIVES
 1st Session      }                                    {       117-212

======================================================================



 
    CARDIOVASCULAR ADVANCES IN RESEARCH AND OPPORTUNITIES LEGACY ACT

                                _______
                                

December 8, 2021.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

 Mr. Pallone, from the Committee on Energy and Commerce, submitted the 
                               following

                              R E P O R T

                        [To accompany H.R. 1193]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 1193) to amend title IV of the Public Health 
Service Act to direct the Director of the National Institutes 
of Health, in consultation with the Director of the National 
Heart, Lung, and Blood Institute, shall establish a program 
under which the Director of the National Institutes of Health 
shall support or conduct research on valvular heart disease, 
and for other purposes, having considered the same, reports 
favorably thereon with amendments and recommends that the bill 
as amended do pass.

                                CONTENTS

                                                                     Page
  I. Purpose and Summary..............................................  3
 II. Background and Need for the Legislation..........................  3
III. Committee Hearings...............................................  4
 IV. Committee Consideration..........................................  4
  V. Committee Votes..................................................  4
 VI. Oversight Findings...............................................  5
VII. New Budget Authority, Entitlement Authority, and Tax Expenditures  5
VIII.Federal Mandates Statement.......................................  5
 IX. Statement of General Performance Goals and Objectives............  5
  X. Duplication of Federal Programs..................................  5
 XI. Committee Cost Estimate..........................................  5
XII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits......  6
XIII.Advisory Committee Statement.....................................  6
XIV. Applicability to Legislative Branch..............................  6
 XV. Section-by-Section Analysis of the Legislation...................  6
XVI. Changes in Existing Law Made by the Bill, as Reported............  7

    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 ``Cardiovascular Advances in Research 
and Opportunities Legacy Act''.

SEC. 2. GRANTS FOR VALVULAR HEART DISEASE RESEARCH.

  Subpart 2 of part C of title IV of the Public Health Service Act (42 
U.S.C. 285b et seq.) is amended by inserting after section 424C (42 
U.S.C. 285b-7c) the following:

``SEC. 424D. GRANTS FOR VALVULAR HEART DISEASE RESEARCH.

  ``(a) In General.--The Director of the National Institutes of Health, 
in consultation with the Director of the Institute, shall support or 
conduct research regarding valvular heart disease.
  ``(b) Support Guidelines.--The distribution of funding authorized 
under subsection (a) may be used to pursue the following outcomes:
          ``(1) Using precision medicine and advanced technological 
        imaging to generate data on individuals with valvular heart 
        disease.
          ``(2) Identifying and developing a cohort of individuals with 
        valvular heart disease and available data.
          ``(3) Corroborating data generated through clinical trials to 
        develop a prediction model to distinguish individuals at high 
        risk for sudden cardiac arrest or sudden cardiac death from 
        valvular heart disease.
          ``(4) For other outcomes needed to acquire necessary data on 
        valvular heart disease.
  ``(c) Mitral Valve Prolapse Workshop.--Not later than one year after 
the date of the enactment of this section, the Director of the 
Institute shall convene a workshop composed of subject matter experts 
and stakeholders to identify research needs and opportunities to 
develop prescriptive guidelines for treatment of individuals with 
mitral valve prolapse.
  ``(d) Authorization of Appropriations.--For the purpose of carrying 
out this section, there is authorized to be appropriated $20,000,000 
for each of fiscal years 2022 through 2026.''.

SEC. 3. PROGRAMS OF CENTERS FOR DISEASE CONTROL AND PREVENTION.

  Part B of title III of the Public Health Service Act (42 U.S.C. 243 
et seq.) is amended by inserting after section 312 the following 
section:

``SEC. 312A. PREVENTION OF SUDDEN CARDIAC DEATH AS A RESULT OF VALVULAR 
                    HEART DISEASE.

  ``(a) In General.--The Secretary, acting through the Director of the 
Centers for Disease Control and Prevention, may carry out projects to 
increase education, awareness, or diagnosis of valvular heart disease 
and to reduce the incidence of sudden cardiac death caused by valvular 
heart disease. Such projects may be carried out by the Secretary 
directly or through awards of grants or contracts to public or 
nonprofit private entities. The Secretary may directly (or through such 
awards) provide technical assistance with respect to the planning, 
development, and operation of such projects.
  ``(b) Certain Activities.--Upon availability of applicable data, 
projects carried out under subsection (a) may include--
          ``(1) continuing the activities at the Division for Heart 
        Disease and Stroke Prevention, including those related to 
        valvular heart disease;
          ``(2) broadening the awareness of the public concerning the 
        risk factors for, the symptoms of, and the public health 
        consequences of valvular heart disease; and
          ``(3) enhancing surveillance of out-of-hospital cardiac 
        arrests to improve patient outcomes.
  ``(c) Grant Prioritization.--The Secretary may, in awarding grants or 
entering into contracts pursuant to subsection (a), give priority to 
entities seeking to carry out projects that target populations most 
impacted by valvular heart disease.
  ``(d) Coordination of Activities.--The Secretary shall ensure that 
activities under this section are coordinated, as appropriate, with 
other agencies of the Public Health Service that carry out activities 
regarding valvular heart disease.
  ``(e) Best Practices.--The Secretary, acting through the Director of 
the Centers for Disease Control and Prevention, shall--
          ``(1) collect and analyze the findings of research conducted 
        with respect to valvular heart disease; and
          ``(2) taking into account such findings, publish on the 
        website of the Centers for Disease Control and Prevention best 
        practices for physicians and other health care providers who 
        provide care to individuals with valvular heart disease.''.

    Amend the title so as to read:
    A bill to amend title IV of the Public Health Service Act 
to direct the Director of the National Institutes of Health, in 
consultation with the Director of the National Heart, Lung, and 
Blood Institute, to establish a program under which the 
Director of the National Institutes of Health shall support or 
conduct research on valvular heart disease, and for other 
purposes.

                         I. Purpose and Summary

    H.R. 1193, the ``Cardiovascular Advances in Research and 
Opportunities Legacy Act'' or the ``CAROL Act,'' authorizes the 
National Institutes of Health (NIH) in collaboration with the 
National Heart, Lung, and Blood Institute (NHLBI) to support 
research on valvular heart disease and to convene a workshop of 
subject matter experts and stakeholders to identify research 
needs and treatment guidelines for individuals diagnosed with 
mitral valve prolapse, a type of valvular heart disease (VHD). 
The bill also requires the Centers for Disease Control and 
Prevention (CDC) to carry out projects to increase education, 
awareness, or diagnosis of valvular heart disease, and to carry 
out initiatives to help reduce cardiac deaths caused by 
valvular heart disease.

                II. Background and Need for Legislation

    VHD is caused by damage or disease affecting the valves of 
the heart that regulate blood flow into the heart.\1\ VHD 
affects 2.5 percent of the general United States population and 
13 percent of the elderly population.\2\ It is the cause of 
approximately 27,000 deaths in the United States each year, 
predominantly in women, and it is on the rise, accounting for 
more than five million diagnoses each 
year.34 Despite the rising incidence of 
VHD, low awareness and the often-asymptomatic nature of the 
disease contribute to the underdiagnosis and undertreatment of 
these potentially fatal conditions.\5\
---------------------------------------------------------------------------
    \1\Centers for Disease Control and Prevention, Valvular Heart 
Disease (www.cdc.gov/heartdisease/valvular_disease.htm) (accessed Nov. 
29, 2021).
    \2\Id.
    \3\Id.
    \4\American College of Cardiology, Succeed in Managing Heart Valve 
Disease Initiative (www.acc.org/tools-and-practice-support/quality-
programs/valvular-heart-disease-initiatives) (accessed Nov. 29, 2021).
    \5\Patient-Centered Outcomes Research Institute, Building and 
Educating a Heart Valve Disease Network Prepared to Engage in Research 
(www.pcori.org/research-results/2019/building-and-educating-heart-
valve-disease-network-prepared-engage-research) (accessed Nov. 29, 
2021).
---------------------------------------------------------------------------
    Some known causes of VHD include congenital conditions, 
infections, generative conditions, and conditions linked to 
other types of heart disease.\6\ VHD can develop quickly or 
over a long period of time. When the disease develops more 
slowly, there may be no symptoms until the condition is quite 
advanced.\7\ However, there is a gap in understanding about 
what makes valvular heart disease life-threatening since there 
has been little research on the condition and its treatment.\8\
---------------------------------------------------------------------------
    \6\Centers for Disease Control and Prevention, Valvular Heart 
Disease (www.cdc.gov/heartdisease/valvular_disease.htm) (accessed Nov. 
29, 2021).
    \7\Id.
    \8\Stecker, E. & Nazer, B., The Shadows of Sudden Cardiac Death, 
Journal of the American College of Cardiology (www.jacc.org/doi/
10.1016/j.jacc.2021.03.321) (accessed Nov. 29, 2021).
---------------------------------------------------------------------------
    H.R. 1193 aims to expand research on VHD and its treatment 
by authorizing a grant program at NIH to support research on 
the condition and to convene a workshop of subject matter 
experts to identify research needs and treatment guidelines for 
mitral valve prolapse. In order to create awareness about VHD, 
the bill would support increasing public awareness on the risk 
factors and symptoms of VHD and enhancing surveillance around 
cardiac deaths. These initiatives will help address the gaps in 
our understanding of what causes sudden cardiac death, 
particularly in young women.

                        III. Committee Hearings

    For the purposes of section 3(c) of rule XIII of the Rules 
of the House of Representatives, the following hearing was used 
to develop or consider H.R. 1193:
    The Subcommittee on Health held a legislative hearing on 
October 20, 2021, entitled ``Enhancing Public Health: 
Legislation to Protect Children and Families.'' The 
Subcommittee received testimony from the following witnesses:
           Bruce L. Cassis, D.D.S., President, Academy 
        of General Dentistry;
           Raymond DuBois, M.D., Ph.D., Former 
        President, American Association for Cancer Research;
           Donald M. Lloyd-Jones, M.D., Sc.M., 
        President, American Heart Association;
           Ellyn Miller, President and Founder, 
        Smashing Walnuts Foundation;
           Rick Nolan, Former U.S. Representative (MN);
           Jenny Radesky, M.D., Assistant Professor of 
        Pediatrics, University of Michigan Medical School; and
           Stacey Stewart, President and CEO, March of 
        Dimes.

                      IV. Committee Consideration

    H.R. 1193, the ``Cardiovascular Advances in Research and 
Opportunities Legacy Act'' or the ``CAROL Act,'' was introduced 
on February 22, 2021, by Representative Andy Barr (R-KY) and 
referred the Committee on Energy and Commerce. Subsequently, on 
February 23, 2021, the bill was referred to the Subcommittee on 
Health.
    On November 4, 2021, the Subcommittee on Health met in open 
markup session, pursuant to notice, to consider H.R. 1193 and 
eight other bills. During consideration of the bill, an 
amendment in the nature of a substitute (AINS) offered by 
Representative Guthrie (R-KY) was agreed to by a voice vote. 
Upon conclusion of consideration of the bill, the Subcommittee 
on Health agreed to report the bill favorably to the full 
Committee, amended, by a voice vote.
    On November 17, 2021, the full Committee met in open markup 
session, pursuant to notice, to consider H.R. 1193 and 11 other 
bills. No amendments were offered during consideration of the 
bill. Upon conclusion of consideration of the bill, the full 
Committee agreed to a motion on final passage offered by 
Representative Pallone (D-NJ), Chairman of the Committee, to 
order H.R. 1193 reported favorably to the House, as amended, by 
a voice vote.

                           V. 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. The 
Committee advises that there were no record votes taken on H.R. 
1193, including a motion by Mr. Pallone ordering H.R. 1193 
favorably reported to the House, as amended.

                         VI. Oversight Findings

    Pursuant to 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 portion of the report.

 VII. New Budget Authority, Entitlement Authority, and Tax Expenditures

    Pursuant to 3(c)(2) of rule XIII of the Rules of the House 
of Representatives, the Committee adopts as its own the 
estimate of new budget authority, entitlement authority, or tax 
expenditures or revenues contained in the cost estimate 
prepared by the Director of the Congressional Budget Office 
pursuant to section 402 of the Congressional Budget Act of 
1974.
    The Committee has requested but not received from the 
Director of the Congressional Budget Office a statement as to 
whether this bill contains any new budget authority, spending 
authority, credit authority, or an increase or decrease in 
revenues or tax expenditures.

                    VIII. Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

       IX. Statement of General Performance Goals and Objectives

    Pursuant to clause 3(c)(4) of rule XIII, the general 
performance goal or objective of this legislation is to expand 
research on VHD and its treatment, and increase awareness and 
education around cardiac deaths caused by VHD.

                   X. Duplication of Federal Programs

    Pursuant to clause 3(c)(5) of rule XIII, no provision of 
H.R. 1193 is known to be duplicative of another Federal 
program, including any program that was included in a report to 
Congress pursuant to section 21 of Public Law 111-139 or the 
most recent Catalog of Federal Domestic Assistance.

                      XI. Committee Cost Estimate

    Pursuant to clause 3(d)(1) of rule XIII, the Committee 
adopts as its own the cost estimate prepared by the Director of 
the Congressional Budget Office pursuant to section 402 of the 
Congressional Budget Act of 1974.

    XII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits

    Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the 
Committee finds that H.R. 1193 contains no earmarks, limited 
tax benefits, or limited tariff benefits.

                   XIII. Advisory Committee Statement

    No advisory committee within the meaning of section 5(b) of 
the Federal Advisory Committee Act was created by this 
legislation.

                XIV. Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

           XV. Section-by-Section Analysis of the Legislation


Section 1. Short title

    Section 1 designates that the Act may be cited as the 
``Cardiovascular Advances in Research and Opportunities Legacy 
Act.''

Sec. 2. Grants for valvular heart disease research

    Section 2 amends the Public Health Service Act (PHSA) to 
direct the Director of NIH, in consultation with the Director 
of NHLBI to support or conduct valvular heart disease research. 
The funding authorized under this section may be used to pursue 
the use of precision medicine and advanced technological 
imaging to generate data on individuals with VHD; the 
identification and development of a cohort of individuals with 
VHD and available data; and the generation of data through 
clinical trials to develop a prediction model to identify 
patients at high risk for sudden cardiac arrest or sudden 
cardiac death from valvular disease.
    Section 2 further instructs the Director of NHLBI to 
convene a workshop of subject matter experts and stakeholders 
within one year of enactment to identify research needs and 
opportunities to develop prescriptive guidelines for treatment 
of individuals with mitral valve prolapse.
    This section authorizes $20 million for each of fiscal 
years 2022 through 2026 for these activities.

Sec. 3. Programs of Centers for Disease Control and Prevention

    Section 3 amends the PHSA to direct the Secretary, acting 
through the Director of the Centers for Disease Control and 
Prevention (CDC), to carry out projects to increase education, 
awareness, or diagnosis of VHD in order to reduce the incidence 
of sudden cardiac death caused by VHD. Such projects may be 
carried out by CDC or through grants or contracts to public or 
nonprofit organizations.
    Upon availability of applicable data, Section 3 also 
authorizes the continuations of projects and activities at the 
Division of Heart and Stroke at CDC, including broadening 
public awareness activities concerning risk factors for, 
symptoms of, and the public health consequences of VHD; and 
enhancing hospital surveillance data related to cardiac 
arrests.
    Section 3 provides discretion to the Secretary of Health 
and Human Services (HHS), acting through the Director of CDC, 
to give priority for grants or contracts to entities seeking to 
carry out projects that target populations most impacted by 
VHD.
    Section 3 requires the HHS Secretary to ensure that 
activities under this section are coordinated, as appropriate, 
with other agencies of the Public Health Service that carry out 
activities regarding VHD, and instructs the Secretary, acting 
through the Director of CDC, to collect and analyze the 
findings of valvular heart disease research and publish best 
practices on the CDC website for physicians and other health 
care providers who provide care to individuals with valvular 
heart disease.

       XVI. 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 (new matter is 
printed in italics and 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 B--Federal-State Cooperation

           *       *       *       *       *       *       *



SEC. 312A. PREVENTION OF SUDDEN CARDIAC DEATH AS A RESULT OF VALVULAR 
                    HEART DISEASE.

  (a) In General.--The Secretary, acting through the Director 
of the Centers for Disease Control and Prevention, may carry 
out projects to increase education, awareness, or diagnosis of 
valvular heart disease and to reduce the incidence of sudden 
cardiac death caused by valvular heart disease. Such projects 
may be carried out by the Secretary directly or through awards 
of grants or contracts to public or nonprofit private entities. 
The Secretary may directly (or through such awards) provide 
technical assistance with respect to the planning, development, 
and operation of such projects.
  (b) Certain Activities.--Upon availability of applicable 
data, projects carried out under subsection (a) may include--
          (1) continuing the activities at the Division for 
        Heart Disease and Stroke Prevention, including those 
        related to valvular heart disease;
          (2) broadening the awareness of the public concerning 
        the risk factors for, the symptoms of, and the public 
        health consequences of valvular heart disease; and
          (3) enhancing surveillance of out-of-hospital cardiac 
        arrests to improve patient outcomes.
  (c) Grant Prioritization.--The Secretary may, in awarding 
grants or entering into contracts pursuant to subsection (a), 
give priority to entities seeking to carry out projects that 
target populations most impacted by valvular heart disease.
  (d) Coordination of Activities.--The Secretary shall ensure 
that activities under this section are coordinated, as 
appropriate, with other agencies of the Public Health Service 
that carry out activities regarding valvular heart disease.
  (e) Best Practices.--The Secretary, acting through the 
Director of the Centers for Disease Control and Prevention, 
shall--
          (1) collect and analyze the findings of research 
        conducted with respect to valvular heart disease; and
          (2) taking into account such findings, publish on the 
        website of the Centers for Disease Control and 
        Prevention best practices for physicians and other 
        health care providers who provide care to individuals 
        with valvular heart disease.

           *       *       *       *       *       *       *


TITLE IV--NATIONAL RESEARCH INSTITUTES

           *       *       *       *       *       *       *



Part C--Specific Provisions Respecting National Research Institutes

           *       *       *       *       *       *       *



Subpart 2--National Heart, Lung, and Blood Institute

           *       *       *       *       *       *       *



SEC. 424D. GRANTS FOR VALVULAR HEART DISEASE RESEARCH.

  (a) In General.--The Director of the National Institutes of 
Health, in consultation with the Director of the Institute, 
shall support or conduct research regarding valvular heart 
disease.
  (b) Support Guidelines.--The distribution of funding 
authorized under subsection (a) may be used to pursue the 
following outcomes:
          (1) Using precision medicine and advanced 
        technological imaging to generate data on individuals 
        with valvular heart disease.
          (2) Identifying and developing a cohort of 
        individuals with valvular heart disease and available 
        data.
          (3) Corroborating data generated through clinical 
        trials to develop a prediction model to distinguish 
        individuals at high risk for sudden cardiac arrest or 
        sudden cardiac death from valvular heart disease.
          (4) For other outcomes needed to acquire necessary 
        data on valvular heart disease.
  (c) Mitral Valve Prolapse Workshop.--Not later than one year 
after the date of the enactment of this section, the Director 
of the Institute shall convene a workshop composed of subject 
matter experts and stakeholders to identify research needs and 
opportunities to develop prescriptive guidelines for treatment 
of individuals with mitral valve prolapse.
  (d) Authorization of Appropriations.--For the purpose of 
carrying out this section, there is authorized to be 
appropriated $20,000,000 for each of fiscal years 2022 through 
2026.

           *       *       *       *       *       *       *


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