[House Report 118-164]
[From the U.S. Government Publishing Office]


118th Congress }                                          { REPORT 
                        HOUSE OF REPRESENTATIVES
 1st Session   }                                          { 118-164

======================================================================
 
                 PREEMIE REAUTHORIZATION ACT OF 2023

                                _______
                                

August 25, 2023.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

Mrs. Rodgers of Washington, from the Committee on Energy and Commerce, 
                        submitted the following

                              R E P O R T

                        [To accompany H.R. 3226]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 3226) to reauthorize the Prematurity Research 
Expansion and Education for Mothers who deliver Infants Early 
Act, having considered the same, reports favorably thereon with 
an amendment and recommends that the bill as amended do pass.

                                CONTENTS

                                                                   Page
Purpose and Summary..............................................     2
Background and Need for Legislation..............................     3
Committee Action.................................................     3
Committee Votes..................................................     4
Oversight Findings and Recommendations...........................     6
New Budget Authority, Entitlement Authority, and Tax Expenditures     6
Congressional Budget Office Estimate.............................     6
Federal Mandates Statement.......................................     6
Statement of General Performance Goals and Objectives............     6
Duplication of Federal Programs..................................     6
Related Committee and Subcommittee Hearings......................     6
Committee Cost Estimate..........................................     7
Earmark, Limited Tax Benefits, and Limited Tariff Benefits.......     7
Advisory Committee Statement.....................................     7
Applicability to Legislative Branch..............................     7
Section-by-Section Analysis of the Legislation...................     7
Changes in Existing Law Made by the Bill, as Reported............     8

    The amendment is as follows:
    Strike all after the enacting clause and insert the 
following:

SECTION 1. SHORT TITLE.

  This Act may be cited as the ``PREEMIE Reauthorization Act of 2023''.

SEC. 2. RESEARCH RELATING TO PRETERM LABOR AND DELIVERY AND THE CARE, 
                    TREATMENT, AND OUTCOMES OF PRETERM AND LOW 
                    BIRTHWEIGHT INFANTS.

  (a) In General.--Section 3(e) of the Prematurity Research Expansion 
and Education for Mothers who deliver Infants Early Act (42 U.S.C. 
247b-4f(e)) is amended by striking ``fiscal years 2019 through 2023'' 
and inserting ``fiscal years 2024 through 2028''.
  (b) Technical Correction.--Effective as if included in the enactment 
of the PREEMIE Reauthorization Act of 2018 (Public Law 115-328), 
section 2 of such Act is amended, in the matter preceding paragraph 
(1), by striking ``Section 2'' and inserting ``Section 3''.

SEC. 3. INTERAGENCY WORKING GROUP.

  Section 5(a) of the PREEMIE Reauthorization Act of 2018 (Public Law 
115-328) is amended by striking ``The Secretary of Health and Human 
Services, in collaboration with other departments, as appropriate, may 
establish'' and inserting ``Not later than 18 months after the date of 
the enactment of the PREEMIE Reauthorization Act of 2023, the Secretary 
of Health and Human Services, in collaboration with other departments, 
as appropriate, shall establish''.

SEC. 4. STUDY ON PRETERM BIRTHS.

  (a) In General.--The Secretary of Health and Human Services shall 
enter into appropriate arrangements with the National Academies of 
Sciences, Engineering, and Medicine under which the National Academies 
shall--
          (1) not later than 30 days after the date of enactment of 
        this Act, convene a committee of experts in maternal health to 
        study premature births in the United States; and
          (2) upon completion of the study under paragraph (1)--
                  (A) approve by consensus a report on the results of 
                such study;
                  (B) include in such report--
                          (i) an assessment of each of the topics 
                        listed in subsection (b);
                          (ii) the analysis required by subsection (c); 
                        and
                          (iii) the raw data used to develop such 
                        report; and
                  (C) not later than 24 months after the date of 
                enactment of this Act, transmit such report to--
                          (i) the Secretary of Health and Human 
                        Services;
                          (ii) the Committee on Energy and Commerce of 
                        the House of Representatives; and
                          (iii) the Committee on Finance and the 
                        Committee on Health, Education, Labor, and 
                        Pensions of the Senate.
  (b) Assessment Topics.--The topics listed in this subsection are of 
each of the following:
          (1) The financial costs of premature birth to society, 
        including--
                  (A) an analysis of stays in neonatal intensive care 
                units and the cost of such stays;
                  (B) long-term costs of stays in such units to society 
                and the family involved post-discharge; and
                  (C) health care costs for families post-discharge 
                from such units (such as medications, therapeutic 
                services, co-pays visits and specialty equipment).
          (2) The factors that impact pre-term birth rates.
          (3) Opportunities for earlier detection of premature birth 
        risk factors, including--
                  (A) opportunities to improve maternal and infant 
                health; and
                  (B) opportunities for public health programs to 
                provide support and resources for parents in-hospital, 
                in non-hospital settings, and post-discharge.
  (c) Analysis.--The analysis required by this subsection is an 
analysis of--
          (1) targeted research strategies to develop effective drugs, 
        treatments, or interventions to bring at-risk pregnancies to 
        term;
          (2) State and other programs' best practices with respect to 
        reducing premature birth rates; and
          (3) precision medicine and preventative care approaches 
        starting early in the life course (including during pregnancy) 
        with a focus on behavioral and biological influences on 
        premature birth, child health, and the trajectory of such 
        approaches into adulthood.

                          Purpose and Summary

    H.R. 3226 would reauthorize the Prematurity Research 
Expansion and Education for Mothers who deliver Infants Early 
Act for fiscal years 2024-2028. This reauthorization would 
include the renewal of research, education, and intervention 
activities and programs at the Centers for Disease Control and 
Prevention (CDC) and the Health Resources and Services 
Administration (HRSA) that focus on preventing preterm births 
and reducing infant mortality. The bill would also authorize a 
new study on the financial costs of premature births to 
society, among other things.

                  Background and Need for Legislation

    The programs reauthorized under the Prematurity Research 
Expansion and Education for Mothers who deliver Infants Early 
(PREEMIE) Reauthorization Act of 2023 facilitate federal 
research, education, and intervention activities to reduce 
preterm birth and infant mortality. The U.S. preterm birth rate 
increased to 10.5 percent in 2021, an increase of four percent 
since 2020 and the highest recorded rate since 2007.\1\ Across 
the country, 45 states, Washington, D.C., and Puerto Rico 
experienced an increase in preterm birth rates, while four 
states saw a decrease.\2\ This means about 1 in 10 infants in 
the United States are born prematurely each year, or more than 
383,000 babies. \3\ While there are certain risk factors, 
preterm birth can happen to any pregnant woman.\4\ Premature 
babies may face serious\5\ and increased health problems, such 
as problems with their brain, lungs, heart, eyes and other 
organs, as well as long-term challenges, intellectual and 
developmental disabilities.\6\ Though babies born prematurely 
are more likely to survive than ever before,\7\ preterm birth 
and its complications remain the second leading cause of infant 
deaths. In 2016, the estimated annual societal economic cost 
(medical, educational, and lost productivity) associated with 
preterm birth in United States was $25.2 billion.\8\ 
Individually, the average first year medical costs are about 4 
times greater ($49,140) than for term infants ($13,024).\9\
---------------------------------------------------------------------------
    \1\2022 March of Dimes Report Card, https://www.marchofdimes.org/
report-card.
    \2\2022 March of Dimes Report Card, https://www.marchofdimes.org/
report-card.
    \3\A Profile of Prematurity in the United States, March of Dimes. 
https://www.marchofdimes.org/peristats/reports/united-states/
prematurity-profile.
    \4\Preterm labor and premature birth: Are you at risk? March of 
Dimes, https://www.marchofdimes.org/find-support/topics/birth/preterm-
labor-and-premature-birth-are-you-risk.
    \5\Waitzman NJ, Jalali A, Grosse SD. Preterm birth lifetime costs 
in the United States in 2016: An update. Semin Perinatol. 2021 
Apr;45(3):151390.
    \6\Long-term health effects of premature birth, March of Dimes, 
https://www.marchofdimes.org/find-support/topics/birth/long-term-
health-effects-premature-birth.
    \7\Waitzman NJ, Jalali A, Grosse SD. Preterm birth lifetime costs 
in the United States in 2016: An update. Semin Perinatol. 2021 
Apr;45(3):151390.
    \8\Medical Costs of Preterm Birth, March of Dimes, https://
www.marchofdimes.org/peristats/
data?dv=ls®=99⊤=3&stop=362&lev=1&slev=1&obj=1.
    \9\Maternal death and pregnancy-related death, March of Dimes, 
https://www.marchofdimes.org/find-support/topics/miscarriage-loss-
grief/maternal-death-and-pregnancy-related-death.
---------------------------------------------------------------------------

                            Committee Action

    On June 14, 2023, the Subcommittee on Health held a hearing 
on H.R. 3226. The Subcommittee received testimony from:
           Dr. Elizabeth Cherot, MD, MBA, Senior Vice 
        President and Chief Medical Health Officer, March of 
        Dimes;
           Dr. Alexis A. Thompson, MD, MPH, Chief of 
        Division of Hematology, Elias Schwartz MD Endowed Chair 
        in Hematology, Children's Hospital of Philadelphia, 
        Professor of Pediatrics, University of Pennsylvania 
        Perelman School of Medicine;
           Dr. Meredithe McNamara, MD, MS, FAAP, 
        Assistant Professor, Yale School of Medicine;
           Dr. Miriam Grossman, MD, Child, Adolescent, 
        and Adult Psychiatrist;
           Mr. George Manahan, Parkinson's Advocate and 
        Patient; and
           Mr. Kevin O'Connor, Assistant to the General 
        President for Government Affairs and Political Action, 
        International Association of Fire Fighters.
    On July 13, 2023, the Subcommittee on Health met in open 
markup session and forwarded H.R. 3226, as amended, to the full 
Committee by a record vote of 26 yeas and 0 nays. On July 19, 
2023, the full Committee on Energy and Commerce met in open 
markup session and ordered H.R. 3226, as amended, favorably 
reported to the House by a record vote of 48 yeas and 0 nays.

                            Committee Votes

    Clause 3(b) of rule XIII requires the Committee to list the 
record votes on the motion to report legislation and amendments 
thereto. The following reflects the record votes taken during 
the Committee consideration:


                 Oversight Findings and Recommendations

    Pursuant to clause 2(b)(1) of rule X and clause 3(c)(1) of 
rule XIII, the Committee held a hearing and made findings that 
are reflected in this report.

           New Budget Authority, Entitlement Authority, and 
                            Tax Expenditures

    Pursuant to clause 3(c)(2) of rule XIII, the Committee 
finds that H.R. 3226 would result in no new or increased budget 
authority, entitlement authority, or tax expenditures or 
revenues.

                  Congressional Budget Office Estimate

    Pursuant to clause 3(c)(3) of rule XIII, at the time this 
report was filed, the cost estimate prepared by the Director of 
the Congressional Budget Office pursuant to section 402 of the 
Congressional Budget Act of 1974 was not available.

                       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.

         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 
facilitate federal research, education, and intervention 
activities to reduce preterm birth and infant mortality by 
reauthorizing the PREEMIE Act.

                    Duplication of Federal Programs

    Pursuant to clause 3(c)(5) of rule XIII, no provision of 
H.R. 3226 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.

              Related Committee and Subcommittee Hearings

    Pursuant to clause 3(c)(6) of rule XIII, the following 
related hearing was used to develop or consider H.R. 3326:
           On June 14, 2023, the Subcommittee on Health 
        held a hearing on H.R. 3226. The Subcommittee received 
        testimony from:
                   Dr. Elizabeth Cherot, MD, MBA, 
                Senior Vice President and Chief Medical Health 
                Officer, March of Dimes;
                   Dr. Alexis A. Thompson, MD, MPH, 
                Chief of Division of Hematology, Elias Schwartz 
                MD Endowed Chair in Hematology, Children's 
                Hospital of Philadelphia, Professor of 
                Pediatrics, University of Pennsylvania Perelman 
                School of Medicine;
                   Dr. Meredithe McNamara, MD, MS, 
                FAAP, Assistant Professor, Yale School of 
                Medicine;
                   Dr. Miriam Grossman, MD, Child, 
                Adolescent, and Adult Psychiatrist;
                   Mr. George Manahan, Parkinson's 
                Advocate and Patient; and
                   Mr. Kevin O'Connor, Assistant to 
                the General President for Government Affairs 
                and Political Action, International Association 
                of Fire Fighters.

                        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. At the time this report was 
filed, the estimate was not available.

       Earmark, 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. 3226 contains no earmarks, limited 
tax benefits, or limited tariff benefits.

                      Advisory Committee Statement

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

                  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.

             Section-by-Section Analysis of the Legislation


Section 1. Short title

    Section 1 provides a short title of ``PREEMIE 
Reauthorization Act of 2023''.

Section 2. Research relating to preterm labor and delivery and the 
        care, treatment, and outcomes of preterm and low birth-weight 
        infants

    Section 2 reauthorizes the Prematurity Research Expansion 
and Education for Mothers who delivery Infants Early Act 
through fiscal years 2024 through 2028 and includes a technical 
correction to the bill.

Section 3. Interagency working group

    Section 3 establishes an interagency working group between 
the U.S. Department of Health and Human Services and other 
departments.

Section 4. Study on preterm births

    Section 4 authorizes a new study on the financial costs of 
premature births to society.

         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 italics, and existing law in which no 
change is proposed is shown in roman):

 PREMATURITY RESEARCH EXPANSION AND EDUCATION FOR MOTHERS WHO DELIVER 
                           INFANTS EARLY ACT

[Section 2(b) of H.R. 3226 (as reported) provides for a 
technical correction to section 2 of the PREEMIE 
Reauthorization Act of 2018 (Public Law 115-328) shown in the 
second Act below. Such amendment will result in the amendments 
made by such Act to be carried out to section 3 of the 
Prematurity Research Expansion and Education for Mothers who 
deliver Infants Early Act which are reflected here in order to 
represent the amendment by section 2(a) of H.R. 3226 (as 
reported).]



           *       *       *       *       *       *       *
SEC. 3. RESEARCH RELATING TO PRETERM LABOR AND DELIVERY AND THE CARE, 
                    TREATMENT, AND OUTCOMES OF PRETERM AND LOW 
                    BIRTHWEIGHT INFANTS.

  (a) General Expansion of CDC Research.--Section 301 of the 
Public Health Service Act (42 U.S.C. 241 et seq.) is amended by 
adding at the end the following:
  ``(e) The Secretary, acting through the Director of the 
Centers for Disease Control and Prevention, shall expand, 
intensify, and coordinate the activities of the Centers for 
Disease Control and Prevention with respect to preterm labor 
and delivery and infant mortality.''.
  (b) Studies and Activities on Preterm Birth.
          (1) In general.--The Secretary of Health and Human 
        Services, acting through the Director of the Centers 
        for Disease Control and Prevention, may, subject to the 
        availability of appropriations--
                  (A) conduct epidemiological studies on the 
                factors relating to prematurity, such as 
                clinical, biological, social, environmental, 
                genetic, and behavioral factors, and other 
                determinants that contribute to health 
                disparities and are related to prematurity, as 
                appropriate;
                  (B) conduct activities to improve national 
                data to facilitate tracking the burden of 
                preterm birth; and
                  (C) continue efforts to prevent preterm 
                birth, including late preterm birth, through 
                the identification of opportunities for 
                prevention and the assessment of the impact of 
                such efforts.
          (2) Report.--Not later than 2 years after the date of 
        enactment of the PREEMIE Reauthorization Act, and every 
        2 years thereafter, the Secretary of Health and Human 
        Services, acting through the Director of the Centers 
        for Disease Control and Prevention, shall submit to the 
        appropriate committees of Congress reports regarding 
        activities and studies conducted under paragraph (1), 
        including any applicable analyses of preterm birth. 
        Such report shall be posted on the Internet website of 
        the Department of Health and Human Services..
  (c) Pregnancy Risk Assessment Monitoring Survey.--The 
Secretary of Health and Human Services, acting through the 
Director of the Centers for Disease Control and Prevention, 
shall--
          (1) continue systems for the collection of maternal-
        infant clinical and biomedical information, including 
        electronic health records, electronic databases, and 
        biobanks, to link with the Pregnancy Risk Assessment 
        Monitoring System (PRAMS) and other epidemiological 
        studies of prematurity in order to track, to the extent 
        practicable, all pregnancy outcomes and prevent preterm 
        birth; and
          (2) provide technical assistance, as appropriate, to 
        support States in improving the collection of 
        information pursuant to this subsection.
  (d) Evaluation of Existing Tools and Measures.--The Secretary 
of Health and Human Services shall review existing tools and 
measures to ensure that such tools and measures include 
information related to the known risk factors of low birth 
weight and preterm birth.
  (e) Authorization of Appropriations.--There is authorized to 
be appropriated to carry out this section, $2,000,000 for each 
of [fiscal years 2019 through 2023] fiscal years 2024 through 
2028.

           *       *       *       *       *       *       *

                              ----------                              


                  PREEMIE REAUTHORIZATION ACT OF 2018



           *       *       *       *       *       *       *
SEC. 2. RESEARCH RELATING TO PRETERM LABOR AND DELIVERY AND THE CARE, 
                    TREATMENT, AND OUTCOMES OF PRETERM AND LOW 
                    BIRTHWEIGHT INFANTS.

   [Section 2] Section 3 of the Prematurity Research Expansion 
and Education for Mothers who deliver Infants Early Act (42 
U.S.C. 247b-4f) is amended--
          (1) in subsection (b)--
                  (A) in paragraph (1)(A), by striking 
                ``clinical, biological, social, environmental, 
                genetic, and behavioral factors relating'' and 
                inserting ``factors relating to prematurity, 
                such as clinical, biological, social, 
                environmental, genetic, and behavioral factors, 
                and other determinants that contribute to 
                health disparities and are related''; and
                  (B) in paragraph (2), by striking `` 
                concerning the progress and any results of 
                studies conducted under paragraph (1)'' and 
                inserting ``regarding activities and studies 
                conducted under paragraph (1), including any 
                applicable analyses of preterm birth. Such 
                report shall be posted on the Internet website 
                of the Department of Health and Human 
                Services.'';
          (2) by striking subsection (c) and inserting the 
        following:
  ``(c) Pregnancy Risk Assessment Monitoring Survey.--The 
Secretary of Health and Human Services, acting through the 
Director of the Centers for Disease Control and Prevention, 
shall--
          ``(1) continue systems for the collection of 
        maternal-infant clinical and biomedical information, 
        including electronic health records, electronic 
        databases, and biobanks, to link with the Pregnancy 
        Risk Assessment Monitoring System (PRAMS) and other 
        epidemiological studies of prematurity in order to 
        track, to the extent practicable, all pregnancy 
        outcomes and prevent preterm birth; and
          ``(2) provide technical assistance, as appropriate, 
        to support States in improving the collection of 
        information pursuant to this subsection.''; and
          (3) in subsection (e), by striking ``except for 
        subsection (c), $1,880,000 for each of fiscal years 
        2014 through 2018'' and inserting ``$2,000,000 for each 
        of fiscal years 2019 through 2023''.

           *       *       *       *       *       *       *


SEC. 5. INTERAGENCY WORKING GROUP.

  (a) In General.--[The Secretary of Health and Human Services, 
in collaboration with other departments, as appropriate, may 
establish] Not later than 18 months after the date of the 
enactment of the PREEMIE Reauthorization Act of 2023, the 
Secretary of Health and Human Services, in collaboration with 
other departments, as appropriate, shall establish an 
interagency working group in order to improve coordination of 
programs and activities to prevent preterm birth, infant 
mortality, and related adverse birth outcomes.
  (b) Duties.--The working group established under subsection 
(a) shall--
          (1) identify gaps, unnecessary duplication, and 
        opportunities for improved coordination in Federal 
        programs and activities related to preterm birth and 
        infant mortality;
          (2) assess the extent to which the goals and metrics 
        of relevant programs and activities within the 
        Department of Health and Human Services, and, as 
        applicable, those in other departments, are aligned; 
        and
          (3) assess the extent to which such programs are 
        coordinated across agencies within such Department; and
          (4) make specific recommendations, as applicable, to 
        reduce or minimize gaps and unnecessary duplication, 
        and improve coordination of goals, programs, and 
        activities across agencies within such Department.
  (c) Report.--Not later than 1 year after the date on which 
the working group is established under subsection (a), the 
Secretary of Health and Human Services shall submit to the 
Committee on Health, Education, Labor, and Pensions of the 
Senate and the Committee on Energy and Commerce of the House of 
Representatives a report summarizing the findings of the 
working group under subsection (b) and the specific 
recommendations to improve Federal programs at the Department 
of Health and Human Services under subsection (b)(4).

           *       *       *       *       *       *       *


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