```

[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 707 Reported in Senate (RS)]

                                                       Calendar No. 541
109th CONGRESS
  2d Session
                                 S. 707

                          [Report No. 109-298]

To reduce preterm labor and delivery and the risk of pregnancy-related 
    deaths and complications due to pregnancy, and to reduce infant 
                    mortality caused by prematurity.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                             April 5, 2005

 Mr. Alexander (for himself, Mr. Dodd, Mr. Bennett, Mr. Bingaman, Mr. 
 Bond, Mrs. Clinton, Mr. Cochran, Mr. Graham, Mr. Hagel, Ms. Landrieu, 
   Mr. Obama, Mr. Inouye, Mr. Lieberman, Mr. Lugar, Ms. Collins, Mr. 
    Lautenberg, Mrs. Lincoln, Mr. Talent, Mr. Durbin, Mr. Bayh, Mr. 
  Johnson, Ms. Murkowski, Mr. Jeffords, Mr. Akaka, Ms. Mikulski, Mr. 
   Nelson of Florida, Mr. Isakson, Mrs. Hutchison, Mr. Sarbanes, Mr. 
  Coleman, Mr. Dorgan, Ms. Stabenow, Mr. Domenici, Mr. Menendez, Mr. 
DeWine, Mr. Schumer, Mr. Kennedy, Mr. Conrad, Mr. Pryor, Mr. Hatch, Mr. 
 Harkin, and Ms. Snowe) introduced the following bill; which was read 
 twice and referred to the Committee on Health, Education, Labor, and 
                                Pensions

                             July 31, 2006

                Reported by Mr. Enzi, with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 A BILL

 
To reduce preterm labor and delivery and the risk of pregnancy-related 
    deaths and complications due to pregnancy, and to reduce infant 
                    mortality caused by prematurity.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``Prematurity Research 
Expansion and Education for Mothers who deliver Infants Early Act'' or 
the ``PREEMIE Act''.</DELETED>

<DELETED>SEC. 2. FINDINGS AND PURPOSE.</DELETED>

<DELETED>    (a) Findings.--Congress makes the following 
findings:</DELETED>
        <DELETED>    (1) Premature birth is a serious and growing 
        problem. The rate of preterm birth increased 27 percent between 
        1982 and 2002 (from 9.4 percent to 11.9 percent). In 2001, more 
        than 480,000 babies were born prematurely in the United 
        States.</DELETED>
        <DELETED>    (2) Preterm birth accounts for 24 percent of 
        deaths in the first month of life.</DELETED>
        <DELETED>    (3) Premature infants are 14 times more likely to 
        die in the first year of life.</DELETED>
        <DELETED>    (4) Premature babies who survive may suffer 
        lifelong consequences, including cerebral palsy, mental 
        retardation, chronic lung disease, and vision and hearing 
        loss.</DELETED>
        <DELETED>    (5) Preterm and low birthweight birth is a 
        significant financial burden in health care. The estimated 
        charges for hospital stays for infants with any diagnosis of 
        prematurity/low birthweight were $15,500,000,000 in 2002. The 
        average lifetime medical costs of a premature baby are 
        conservatively estimated at $500,000.</DELETED>
        <DELETED>    (6) The proportion of preterm infants born to 
        African-American mothers (17.3 percent) was significantly 
        higher compared to the rate of infants born to white mothers 
        (10.6 percent). Prematurity or low birthweight is the leading 
        cause of death for African-American infants.</DELETED>
        <DELETED>    (7) The cause of approximately half of all 
        premature births is unknown.</DELETED>
        <DELETED>    (8) Women who smoke during pregnancy are twice as 
        likely as nonsmokers to give birth to a low birthweight baby. 
        Babies born to smokers weigh, on average, 200 grams less than 
        nonsmokers' babies.</DELETED>
        <DELETED>    (9) To reduce the rates of preterm labor and 
        delivery more research is needed on the underlying causes of 
        preterm delivery, the development of treatments for prevention 
        of preterm birth, and treatments improving outcomes for infants 
        born preterm.</DELETED>
<DELETED>    (b) Purposes.--It the purpose of this Act to--</DELETED>
        <DELETED>    (1) reduce rates of preterm labor and 
        delivery;</DELETED>
        <DELETED>    (2) work toward an evidence-based standard of care 
        for pregnant women at risk of preterm labor or other serious 
        complications, and for infants born preterm and at a low 
        birthweight; and</DELETED>
        <DELETED>    (3) reduce infant mortality and disabilities 
        caused by prematurity.</DELETED>

<DELETED>SEC. 3. RESEARCH RELATING TO PRETERM LABOR AND DELIVERY AND 
              THE CARE, TREATMENT, AND OUTCOMES OF PRETERM AND LOW 
              BIRTHWEIGHT INFANTS.</DELETED>

<DELETED>    (a) General Expansion of NIH Research.--Part B of title IV 
of the Public Health Service Act (42 U.S.C. 284 et seq.) is amended by 
adding at the end the following:</DELETED>

<DELETED>``SEC. 409J. EXPANSION AND COORDINATION OF RESEARCH RELATING 
              TO PRETERM LABOR AND DELIVERY AND INFANT 
              MORTALITY.</DELETED>

<DELETED>    ``(a) In General.--The Director of NIH shall expand, 
intensify, and coordinate the activities of the National Institutes of 
Health with respect to research on the causes of preterm labor and 
delivery, infant mortality, and improving the care and treatment of 
preterm and low birthweight infants.</DELETED>
<DELETED>    ``(b) Authorization of Research Networks.--There shall be 
established within the National Institutes of Health a Maternal-Fetal 
Medicine Units Network and a Neonatal Research Units Network. In 
complying with this subsection, the Director of NIH shall utilize 
existing networks.</DELETED>
<DELETED>    ``(c) Authorization of Appropriations.--There are 
authorized to be appropriated to carry out this section, such sums as 
may be necessary for each of fiscal years 2005 through 
2009.''.</DELETED>
<DELETED>    (b) 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:</DELETED>
<DELETED>    ``(e) 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.''.</DELETED>
<DELETED>    (c) Study on Assisted Reproduction Technologies.--Section 
1004(c) of the Children's Health Act of 2000 (Public Law 106-310) is 
amended--</DELETED>
        <DELETED>    (1) in paragraph (2), by striking ``and'' at the 
        end;</DELETED>
        <DELETED>    (2) in paragraph (3), by striking the period and 
        inserting ``; and''; and</DELETED>
        <DELETED>    (3) by adding at the end the following:</DELETED>
        <DELETED>    ``(4) consider the impact of assisted reproduction 
        technologies on the mother's and children's health and 
        development.''.</DELETED>
<DELETED>    (d) Study on Relationship Between Prematurity and Birth 
Defects.--</DELETED>
        <DELETED>    (1) In general.--The Director of the Centers for 
        Disease Control and Prevention shall conduct a study on the 
        relationship between prematurity, birth defects, and 
        developmental disabilities.</DELETED>
        <DELETED>    (2) Report.--Not later than 2 years after the date 
        of enactment of this Act, the Director of the Centers for 
        Disease Control and Prevention shall submit to the appropriate 
        committees of Congress a report concerning the results of the 
        study conducted under paragraph (1).</DELETED>
<DELETED>    (e) Review of Pregnancy Risk Assessment Monitoring 
Survey.--The Director of the Centers for Disease Control and Prevention 
shall conduct a review of the Pregnancy Risk Assessment Monitoring 
Survey to ensure that the Survey includes information relative to 
medical care and intervention received, in order to track pregnancy 
outcomes and reduce instances of preterm birth.</DELETED>
<DELETED>    (f) Study on the Health and Economic Consequences of 
Preterm Birth.--</DELETED>
        <DELETED>    (1) In general.--The Director of the National 
        Institutes of Health in conjunction with the Director of the 
        Centers for Disease Control and Prevention shall enter into a 
        contract with the Institute of Medicine of the National Academy 
        of Sciences for the conduct of a study to define and address 
        the health and economic consequences of preterm birth. In 
        conducting the study, the Institute of Medicine shall--
        </DELETED>
                <DELETED>    (A) review and assess the epidemiology of 
                premature birth and low birthweight, and the associated 
                maternal and child health effects in the United States, 
                with attention paid to categories of gestational age, 
                plurality, maternal age, and racial or ethnic 
                disparities;</DELETED>
                <DELETED>    (B) review and describe the spectrum of 
                short and long-term disability and health-related 
                quality of life associated with premature births and 
                the impact on maternal health, health care and quality 
                of life, family employment, caregiver issues, and other 
                social and financial burdens;</DELETED>
                <DELETED>    (C) assess the direct and indirect costs 
                associated with premature birth, including morbidity, 
                disability, and mortality;</DELETED>
                <DELETED>    (D) identify gaps and provide 
                recommendations for feasible systems of monitoring and 
                assessing associated economic and quality of life 
                burdens associated with prematurity;</DELETED>
                <DELETED>    (E) explore the implications of the burden 
                of premature births for national health 
                policy;</DELETED>
                <DELETED>    (F) identify community outreach models 
                that are effective in decreasing prematurity rates in 
                communities;</DELETED>
                <DELETED>    (G) consider options for addressing, as 
                appropriate, the allocation of public funds to 
                biomedical and behavioral research, the costs and 
                benefits of preventive interventions, public health, 
                and access to health care; and</DELETED>
                <DELETED>    (H) provide recommendations on best 
                practices and interventions to prevent premature birth, 
                as well as the most promising areas of research to 
                further prevention efforts.</DELETED>
        <DELETED>    (2) Report.--Not later than 1 year after the date 
        on which the contract is entered into under paragraph (1), the 
        Institute of Medicine shall submit to the Director of the 
        National Institutes of Health, the Director of the Centers for 
        Disease Control and Prevention, and the appropriate committees 
        of Congress a report concerning the results of the study 
        conducted under such paragraph.</DELETED>
<DELETED>    (g) Evaluation of National Core Performance Measures.--
</DELETED>
        <DELETED>    (1) In general.--The Administrator of the Health 
        Resources and Services Administration shall conduct an 
        assessment of the current national core performance measures 
        and national core outcome measures utilized under the Maternal 
        and Child Health Block Grant under title V of the Social 
        Security Act (42 U.S.C. 701 et seq.) for purposes of expanding 
        such measures to include some of the known risk factors of low 
        birthweight and prematurity, including the percentage of 
        infants born to pregnant women who smoked during 
        pregnancy.</DELETED>
        <DELETED>    (2) Report.--Not later than 1 year after the date 
        of enactment of this Act, the Administrator of the Health 
        Resources and Services Administration shall submit to the 
        appropriate committees of Congress a report concerning the 
        results of the evaluation conducted under paragraph 
        (1).</DELETED>

<DELETED>SEC. 4. PUBLIC AND HEALTH CARE PROVIDER EDUCATION AND SUPPORT 
              SERVICES.</DELETED>

<DELETED>    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:</DELETED>

<DELETED>``SEC. 399O. PUBLIC AND HEALTH CARE PROVIDER EDUCATION AND 
              SUPPORT SERVICES.</DELETED>

<DELETED>    ``(a) In General.--The Secretary, directly or through the 
awarding of grants to public or private nonprofit entities, shall 
conduct a demonstration project to improve the provision of information 
on prematurity to health professionals and other health care providers 
and the public.</DELETED>
<DELETED>    ``(b) Activities.--Activities to be carried out under the 
demonstration project under subsection (a) shall include the 
establishment of programs--</DELETED>
        <DELETED>    ``(1) to provide information and education to 
        health professionals, other health care providers, and the 
        public concerning--</DELETED>
                <DELETED>    ``(A) the signs of preterm labor, updated 
                as new research results become available;</DELETED>
                <DELETED>    ``(B) the screening for and the treating 
                of infections;</DELETED>
                <DELETED>    ``(C) counseling on optimal weight and 
                good nutrition, including folic acid;</DELETED>
                <DELETED>    ``(D) smoking cessation education and 
                counseling; and</DELETED>
                <DELETED>    ``(E) stress management; and</DELETED>
        <DELETED>    ``(2) to improve the treatment and outcomes for 
        babies born premature, including the use of evidence-based 
        standards of care by health care professionals for pregnant 
        women at risk of preterm labor or other serious complications 
        and for infants born preterm and at a low 
        birthweight.</DELETED>
<DELETED>    ``(c) Requirement.--Any program or activity funded under 
this section shall be evidence-based.</DELETED>
<DELETED>    ``(d) NICU Family Support Programs.--The Secretary shall 
conduct, through the awarding of grants to public and nonprofit private 
entities, projects to respond to the emotional and informational needs 
of families during the stay of an infant in a neonatal intensive care 
unit, during the transition of the infant to the home, and in the event 
of a newborn death. Activities under such projects may include 
providing books and videos to families that provide information about 
the neonatal intensive care unit experience, and providing direct 
services that provide emotional support within the neonatal intensive 
care unit setting.</DELETED>
<DELETED>    ``(e) Authorization of Appropriations.--There are 
authorized to be appropriated to carry out this section, such sums as 
may be necessary for each of fiscal years 2005 through 
2009.''.</DELETED>

<DELETED>SEC. 5. INTERAGENCY COORDINATING COUNCIL ON PREMATURITY AND 
              LOW BIRTHWEIGHT.</DELETED>

<DELETED>    (a) Purpose.--It is the purpose of this section to 
stimulate multidisciplinary research, scientific exchange, and 
collaboration among the agencies of the Department of Health and Human 
Services and to assist the Department in targeting efforts to achieve 
the greatest advances toward the goal of reducing prematurity and low 
birthweight.</DELETED>
<DELETED>    (b) Establishment.--The Secretary of Health and Human 
Services shall establish an Interagency Coordinating Council on 
Prematurity and Low Birthweight (referred to in this section as the 
Council) to carry out the purpose of this section.</DELETED>
<DELETED>    (c) Composition.--The Council shall be composed of members 
to be appointed by the Secretary, including representatives of--
</DELETED>
        <DELETED>    (1) the agencies of the Department of Health and 
        Human Services; and</DELETED>
        <DELETED>    (2) voluntary health care organizations, including 
        grassroots advocacy organizations, providers of specialty 
        obstetrical and pediatric care, and researcher 
        organizations.</DELETED>
<DELETED>    (d) Activities.--The Council shall--</DELETED>
        <DELETED>    (1) annually report to the Secretary of Health and 
        Human Services on current Departmental activities relating to 
        prematurity and low birthweight;</DELETED>
        <DELETED>    (2) plan and hold a conference on prematurity and 
        low birthweight under the sponsorship of the Surgeon 
        General;</DELETED>
        <DELETED>    (3) establish a consensus research plan for the 
        Department of Health and Human Services on prematurity and low 
        birthweight;</DELETED>
        <DELETED>    (4) report to the Secretary of Health and Human 
        Services and the appropriate committees of Congress on 
        recommendations derived from the conference held under 
        paragraph (2) and on the status of Departmental research 
        activities concerning prematurity and low 
        birthweight;</DELETED>
        <DELETED>    (5) carry out other activities determined 
        appropriate by the Secretary of Health and Human Services; 
        and</DELETED>
        <DELETED>    (6) oversee the coordination of the implementation 
        of this Act.</DELETED>

<DELETED>SEC. 6. AUTHORIZATION OF APPROPRIATIONS.</DELETED>

<DELETED>    There are authorized to be appropriated to carry out this 
Act, such sums as may be necessary for each of fiscal years 2005 
through 2009.</DELETED>

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Prematurity Research Expansion and 
Education for Mothers who deliver Infants Early Act'' or the ``PREEMIE 
Act''.

SEC. 2. PURPOSE.

    It the purpose of this Act to--
            (1) reduce rates of preterm labor and delivery;
            (2) work toward an evidence-based standard of care for 
        pregnant women at risk of preterm labor or other serious 
        complications, and for infants born preterm and at a low 
        birthweight; and
            (3) reduce infant mortality and disabilities caused by 
        prematurity.

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 NIH Research.--Part B of title IV of the 
Public Health Service Act (42 U.S.C. 284 et seq.) is amended by adding 
at the end the following:

``SEC. 409J. EXPANSION AND COORDINATION OF RESEARCH RELATING TO PRETERM 
              LABOR AND DELIVERY AND INFANT MORTALITY.

    ``(a) In General.--The Secretary, acting through the Director of 
NIH, shall expand, intensify, and coordinate the activities of the 
National Institutes of Health with respect to research on the causes of 
preterm labor and delivery, infant mortality, and improving the care 
and treatment of preterm and low birthweight infants.
    ``(b) Authorization of Research Networks.--There shall be 
established within the National Institutes of Health a multi-center 
clinical program (that shall be initially established utilizing 
existing networks) designed to--
            ``(1) investigate problems in clinical obstetrics, 
        particularly those related to prevention of low birth weight, 
        prematurity, and medical problems of pregnancy;
            ``(2) improve the care and outcomes of neonates, especially 
        very-low-birth weight infants; and
            ``(3) enhance the understanding of DNA and proteins as they 
        relate to the underlying processes that lead to preterm birth 
        to aid in formulating more effective interventions to prevent 
        preterm birth.''.
    (b) 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.''.
    (c) Studies on Relationship Between Prematurity and Birth 
Defects.--
            (1) In general.--The Secretary of Health and Human 
        Services, acting through the Director of the Centers for 
        Disease Control and Prevention, shall, subject to the 
        availability of appropriations, conduct ongoing epidemiological 
        studies on the relationship between prematurity, birth defects, 
        and developmental disabilities.
            (2) Report.--Not later than 2 years after the date of 
        enactment of this 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 
        concerning the progress and any results of studies conducted 
        under paragraph (1).
    (d) Pregnancy Risk Assessment Monitoring Survey.--
            (1) In general.--The Secretary of Health and Human 
        Services, acting through the Director of the Centers for 
        Disease Control and Prevention, shall establish 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 pregnancy outcomes and 
        prevent preterm birth.
            (2) Authorization of appropriations.--There is authorized 
        to be appropriated to carry out paragraph (1), $3,000,000 for 
        each of fiscal years 2007 through 2011.
    (e) 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 some 
of the known risk factors of low birth weight and preterm birth.
    (f) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, except for subsection (d), 
$10,000,000 for each of fiscal years 2007 through 2011.

SEC. 4. PUBLIC AND HEALTH CARE PROVIDER EDUCATION AND SUPPORT SERVICES.

    Part P of title III of the Public Health Service Act (42 U.S.C. 
280g et seq.) is amended--
            (1) by redesignating the second section 399O (relating to 
        grants to foster public health responses to domestic violence, 
        dating violence, sexual assault, and stalking) as section 399P; 
        and
            (2) by adding at the end the following:

``SEC. 399Q. PUBLIC AND HEALTH CARE PROVIDER EDUCATION AND SUPPORT 
              SERVICES.

    ``(a) In General.--The Secretary, directly or through the awarding 
of grants to public or private nonprofit entities, may conduct 
demonstration projects to improve the provision of information on 
prematurity to health professionals and other health care providers and 
the public and to improve the treatment and outcomes for babies born 
preterm.
    ``(b) Activities.--Activities to be carried out under the 
demonstration project under subsection (a) may include the 
establishment of programs--
            ``(1) to test and evaluate various strategies to provide 
        information and education to health professionals, other health 
        care providers, and the public concerning--
                    ``(A) the signs of preterm labor, updated as new 
                research results become available;
                    ``(B) the screening for and the treating of 
                infections;
                    ``(C) counseling on optimal weight and good 
                nutrition, including folic acid;
                    ``(D) smoking cessation education and counseling;
                    ``(E) stress management; and
                    ``(F) appropriate prenatal care;
            ``(2) to improve the treatment and outcomes for babies born 
        premature, including the use of evidence-based standards of 
        care by health care professionals for pregnant women at risk of 
        preterm labor or other serious complications and for infants 
        born preterm and at a low birthweight; and
            ``(3) to respond to the informational needs of families 
        during the stay of an infant in a neonatal intensive care unit, 
        during the transition of the infant to the home, and in the 
        event of a newborn death.
    ``(c) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, $5,000,000 for each of fiscal 
years 2007 through 2011.''.

SEC. 5. INTERAGENCY COORDINATING COUNCIL ON PREMATURITY AND LOW 
              BIRTHWEIGHT.

    (a) Purpose.--It is the purpose of this section to stimulate 
multidisciplinary research, scientific exchange, and collaboration 
among the agencies of the Department of Health and Human Services and 
to assist the Department in targeting efforts to achieve the greatest 
advances toward the goal of reducing prematurity and low birthweight.
    (b) Establishment.--The Secretary of Health and Human Services 
shall establish an Interagency Coordinating Council on Prematurity and 
Low Birthweight (referred to in this section as the Council) to carry 
out the purpose of this section.
    (c) Composition.--The Council shall be composed of members to be 
appointed by the Secretary, including representatives of the agencies 
of the Department of Health and Human Services.
    (d) Activities.--The Council shall--
            (1) annually report to the Secretary of Health and Human 
        Services and Congress on current Departmental activities 
        relating to prematurity and low birthweight;
            (2) carry out other activities determined appropriate by 
        the Secretary of Health and Human Services; and
            (3) oversee the coordination of the implementation of this 
        Act.

SEC. 6. SURGEON GENERAL'S CONFERENCE ON PRETERM BIRTH.

    (a) Convening of Conference.--Not later than 1 year after the date 
of enactment of this Act, the Secretary of Health and Human Services, 
acting through the Surgeon General, shall convene a conference on 
preterm birth.
    (b) Purposes of Conference.--The purpose of the conference convened 
under subsection (a) shall be to--
            (1) increase awareness of preterm birth as a serious, 
        common, and costly public health problem in the United States;
            (2) review the findings and reports issued by the 
        Interagency Coordinating Council, key stakeholders, and any 
        other relevant entity; and
            (3) establish an agenda, and report such agenda to 
        Congress, for activities in both the public and private sectors 
        that will speed the identification of, and treatments for, the 
        causes of preterm labor and delivery.
    (c) Authorization of appropriations.--There is authorized to be 
appropriated to carry out this section, $1,000,000.
                                                       Calendar No. 541

109th CONGRESS

  2d Session

                                 S. 707

                          [Report No. 109-298]

_______________________________________________________________________

                                 A BILL

To reduce preterm labor and delivery and the risk of pregnancy-related 
    deaths and complications due to pregnancy, and to reduce infant 
                    mortality caused by prematurity.

_______________________________________________________________________

                             July 31, 2006

                       Reported with an amendment
```