[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