II
111th CONGRESS
2d Session
S. 3906
IN THE SENATE OF THE UNITED STATES
September 29, 2010
Mr. Alexander (for himself and Mr. Dodd) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions
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.
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
.
Purposes
It is the purpose of this Act to—
reduce preterm birth, its associated disabilities, and deaths of babies born preterm;
expand research into the causes of preterm birth; and
promote the development, availability, and use of evidence-based standards of care for pregnant women at risk of preterm labor or other serious pregnancy-related complications and for infants born preterm.
Research and activities at the National Institutes of Health
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:
Expansion and coordination of research relating to preterm labor and delivery and infant mortality
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, tools to detect, prevent, or reduce prevalence of preterm labor and delivery, and the care and treatment of preterm infants. Research supported under this section shall integrate clinical, public health, basic, and behavioral and social science disciplines together with bioinformatics, engineering, mathematical, and computer sciences to address the causes of preterm labor and delivery collaboratively.
Clinical program
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—
investigate problems in clinical obstetrics, particularly those related to prevention of low birth weight, prematurity, and medical problems of pregnancy;
improve the care and outcomes of neonates, especially very-low-birth weight infants; and
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.
Trans-Disciplinary centers for preterm birth research
In general
The Director of NIH shall award grants and contracts to public and nonprofit private entities to pay all or part of the cost of planning, establishing, improving and providing basic operating support for trans-disciplinary research centers for prematurity.
Eligibility
To be eligible to receive a grant or contract under paragraph (1), an entity shall submit to the Director an application at such time, in such manner, and containing such information as the Director may require, including, if appropriate, an assurance that the entity will carry out programs related to prematurity research that include neonatal and maternal-fetal medicine multi-center research networks with a focus on clinical trials.
Focus
Activities carried out under this subsection shall focus primarily on basic research and progress logically over time to include the need for translational, interventional, and clinical research.
Authorization of appropriations
There is authorized to be appropriated to carry out this section, such sums as may be necessary for each of fiscal years 2011 through 2016, of which—
for fiscal year 2011, such sums as may be necessary shall be made available for planning grants under subsection (c); and
for each of fiscal years 2012 through 2016, such sums as may be necessary for each such fiscal year for establishing centers under such subsection.
Report
The Director of NIH shall include in the report under section 402A(c) information on the activities of the trans-disciplinary research centers for prematurity under subsection (c).
.
Research and activities at the Centers for Disease Control and Prevention
Epidemiological studies
Section 3 of the Prematurity Research Expansion and Education for Mothers who deliver Infants Early Act (42 U.S.C. 247b–4f) is amended by striking subsection (b) and inserting the following:
Studies and activities on the relationship between prematurity and birth defects
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 clinical, biological, social, environmental, genetic and behavioral factors relating to prematurity;
conduct activities to improve national data to facilitate tracking the burden of preterm birth;
develop, implement, and evaluate novel methods for prevention to better understand the growing problem of late preterm birth;
conduct etiologic and epidemiologic studies of preterm birth;
expand research on obesity, racial, and ethnic disparities as they relate to preterm birth; and
conduct ongoing epidemiological studies on the effectiveness of community based interventions.
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).
.
Reauthorization
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
$5,000,000
and all that follows through 2011
and
inserting the following: such sums as may be necessary for each of
fiscal years 2012 through 2016
.
Research and activities at the Health Resources and Services Administration
Telemedicine demonstration project on high risk pregnancies
Section 330I of the Public Health Service Act (42 U.S.C. 254c–14) is amended—
by redesignating subsections (q) through (s) as subsections (r) through (t), respectively;
by inserting after subsection (p), the following:
Telemedicine demonstration project on high risk pregnancies
In general
The Director shall award grants under this section to eligible entities to establish demonstration projects for—
the provision of preconception, antepartum, intrapartum, and obstetric services to high risk women of child bearing age remotely by Ob/Gyn’s, nurse practitioners, certified nurse-midwives, certified midwives, or other health care providers using telehealth; and
for the conduct of educational activities regarding risk factors for preterm birth.
Eligibility
To be eligible to receive a grant under paragraph (1), an entity shall submit an application to the Director at such time, in such manner, and containing such information as the Director my require.
; and
in subsection (t) (as so redesignated)—
in paragraph (1),
by striking and
at the end;
in paragraph (2),
by striking the period and inserting ; and
; and
by adding at the end the following:
for grants under subsection (q), such sums as may be necessary for each of fiscal years 2011 through 2015.
.
Public and health care provider education
Section 399Q of the Public Health Service Act (42 U.S.C. 280g–5) is amended—
in subsection (b), by striking subparagraphs (A) through (F) and inserting the following:
the core risk factors for preterm labor;
medically indicated deliveries before 39 weeks;
outcomes for infants born before 39 weeks;
risk factors for preterm delivery;
the importance of preconception- and prenatal care;
smoking cessation and weight maintenance;
treatments and outcomes for babies born premature;
the informational needs of families during the stay of an infant in a neonatal intensive care unit;
preventable birth injuries;
oral health; and
the use of progesterone;
; and
in subsection
(c), by striking $5,000,000
and all that follows through
2011
and insert the following: such sums as may be
necessary for each of fiscal years 2011 through 2016
.
Other activities
National educational campaign
Establishment
The Secretary of Health and Human Services, (referred to in this section as the Secretary) acting through the Surgeon General and in consultation with Director of the National Institute on Child Health and Human Development, shall establish and implement a national science-based consumer education campaign on the prevention of preterm birth.
Targeting
The campaign established under paragraph (1) shall target women of childbearing age, high risk populations, ethnic and minority groups, and individuals with a low socioeconomic status.
Contracts
The Secretary shall implement the campaign under paragraph (1) through the awarding of competitive contracts to entities submitting applications to the Secretary (at such time and in such form and manner as the Secretary may require), and may include the use of television, radio, the Internet, and other commercial marketing venues.
Advisory Committee on Infant Mortality
Strategic plan
The Advisory Committee on Infant Mortality of the Department of Health and Human Services shall annually develop and annually update and submit to the Secretary a strategic plan for the conduct of preterm birth related research.
Annual report
Not later than January 1, 2011, and each January 1 thereafter, the Advisory Committee on Infant Mortality shall submit to the Secretary, and make available to the general public, a report concerning the activities of the Advisory Committee related to infant mortality, prematurity, and low birthweight.
Membership
The Secretary shall ensure that the membership of the Advisory Committee on Infant Mortality includes the following:
Representatives provided for in the original charter of the Advisory Committee.
A representative of the National Center for Health Statistics.
Pilot programs
In general
The Secretary, acting through the Administration of the Agency for Healthcare Research and Quality, the Director of the Centers for Disease Control and Prevention, the Administrator of the Health Resources and Services Administration, the Director of the Centers for Medicare & Medicaid Services, the Assistant Secretary for Planning and Evaluation of the Department of Health and Human Services, and the heads of other appropriate agencies, shall conduct and report on research studies and demonstration projects that test maternity care models that are designed to reduce the rate of preterm birth.
Grants
The Secretary may carry out this subsection through the awarding of grants to eligible entities.
Eligibility
To be eligible to receive a grant under this section an entity shall—
be—
a hospital or hospital systems that utilizes evidence-based best practices; or
a prematurity prevention network or other types of collaborative; and
submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require.
Targeting
In awarding grants under this subsection, the Secretary shall target those areas with a demonstrated persistent high rate of preterm birth.
Authorization of appropriations
There is authorized to be appropriated to carry out this section, such sums as may be necessary for each of fiscal years 2011 through 2016.