[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\
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\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).
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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.
* * * * * * *
[all]