1.This Act may be cited as
the Prematurity Research Expansion and
Education for Mothers who deliver Infants Early Act
or
the PREEMIE
Act
.
2.It is the purpose of this Act to—
(1)reduce preterm
birth, its associated disabilities, and deaths of babies born preterm;
(2)expand research
into the causes of preterm birth; and
(3)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.
3.Research and
activities at the National Institutes of HealthPart 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:
409K.Expansion and
coordination of research relating to preterm labor and delivery and infant
mortality
(a)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.
(b)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.
(c)Trans-Disciplinary
centers for preterm birth research
(1)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.
(2)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.
(3)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.
(d)Authorization of
appropriationsThere 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—
(1)for fiscal year 2011, such sums as may be
necessary shall be made available for planning grants under subsection (c);
and
(2)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.
(e)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).
.
4.Research and
activities at the Centers for Disease Control and Prevention
(a)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:
(b)Studies and
activities on the relationship between prematurity and birth defects
(1)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—
(A)conduct ongoing
epidemiological studies on the clinical, biological, social, environmental,
genetic and behavioral factors relating to prematurity;
(B)conduct
activities to improve national data to facilitate tracking the burden of
preterm birth;
(C)develop,
implement, and evaluate novel methods for prevention to better understand the
growing problem of late preterm birth;
(D)conduct etiologic
and epidemiologic studies of preterm birth;
(E)expand research
on obesity, racial, and ethnic disparities as they relate to preterm birth;
and
(F)conduct ongoing
epidemiological studies on the effectiveness of community based
interventions.
(2)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).
.
(b)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
.
5.Research and
activities at the Health Resources and Services Administration
(a)Telemedicine
demonstration project on high risk pregnanciesSection 330I of
the Public Health Service Act (42 U.S.C. 254c–14) is amended—
(1)by redesignating
subsections (q) through (s) as subsections (r) through (t),
respectively;
(2)by inserting
after subsection (p), the following:
(q)Telemedicine
demonstration project on high risk pregnancies
(1)The Director shall award grants under this section to
eligible entities to establish demonstration projects for—
(A)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
(B)for the conduct
of educational activities regarding risk factors for preterm birth.
(2)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
(3)in subsection (t)
(as so redesignated)—
(A)in paragraph (1),
by striking and
at the end;
(B)in paragraph (2),
by striking the period and inserting ; and
; and
(C)by adding at the
end the following:
(3)for grants under
subsection (q), such sums as may be necessary for each of fiscal years 2011
through
2015.
.
(b)Public and
health care provider educationSection 399Q of the Public Health
Service Act (42 U.S.C. 280g–5) is amended—
(1)in subsection
(b), by striking subparagraphs (A) through (F) and inserting the
following:
(A)the core risk
factors for preterm labor;
(B)medically
indicated deliveries before 39 weeks;
(C)outcomes for
infants born before 39 weeks;
(D)risk factors for
preterm delivery;
(E)the importance of
preconception- and prenatal care;
(F)smoking cessation
and weight maintenance;
(G)treatments and
outcomes for babies born premature;
(H)the informational
needs of families during the stay of an infant in a neonatal intensive care
unit;
(I)preventable birth
injuries;
(J)oral health;
and
(K)the use of
progesterone;
;
and
(2)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
.
6.
(a)National
educational campaign
(1)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.
(2)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.
(3)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.
(b)Advisory
Committee on Infant Mortality
(1)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.
(2)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.
(3)The
Secretary shall ensure that the membership of the Advisory Committee on Infant
Mortality includes the following:
(A)Representatives
provided for in the original charter of the Advisory Committee.
(B)A representative
of the National Center for Health Statistics.
(c)
(1)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.
(2)The
Secretary may carry out this subsection through the awarding of grants to
eligible entities.
(3)To
be eligible to receive a grant under this section an entity shall—
(A)be—
(i)a
hospital or hospital systems that utilizes evidence-based best practices;
or
(ii)a
prematurity prevention network or other types of collaborative; and
(B)submit to the
Secretary an application at such time, in such manner, and containing such
information as the Secretary may require.
(4)In
awarding grants under this subsection, the Secretary shall target those areas
with a demonstrated persistent high rate of preterm birth.
(d)Authorization
of appropriationsThere is authorized to be appropriated to carry
out this section, such sums as may be necessary for each of fiscal years 2011
through 2016.