Authorizing Legislation: PREEMIE Act

Calendar No. 541
109TH CONGRESS
"
2nd Session

!

SENATE

REPORT
109–298

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

JULY 31, 2006.—Ordered to be printed

Mr. ENZI, from the Committee on Health, Education, Labor, and
Pensions, submitted the following

R E P O R T
[To accompany S. 707]

The Committee on Health, Education, Labor, and Pensions, to
which was referred the bill (S. 707) 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, having considered the same, reports favorably thereon
with an amendment in the nature of a substitute and recommends
that the bill (as amended) do pass.
CONTENTS
Page

I.
II.
III.
IV.
V.
VI.
VII.
VIII.
IX.

Purpose and need for legislation ..................................................................
Summary ........................................................................................................
History of legislation and votes in committee .............................................
Explanation of bill and committee views .....................................................
Cost estimate and unfunded mandate statement .......................................
Application of law to the legislative branch ................................................
Regulatory impact statement ........................................................................
Section-by-section analysis ............................................................................
Changes in existing law ................................................................................

I. PURPOSE

AND

NEED

FOR

1
2
3
3
5
7
7
7
8

LEGISLATION

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The purpose of the ‘‘Prematurity Research Expansion and Education for Mothers who deliver Infants Early’’ or ‘‘PREEMIE Act,’’
is to reduce the rates of preterm labor and delivery; work toward
an evidence based standard of care for pregnant women at risk of
preterm labor, and for infants born preterm; and to reduce infant
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mortality and disabilities caused by prematurity. In nearly half of
cases, physicians and scientists cannot pinpoint a cause for preterm
labor and delivery.
The rate of preterm birth constitutes a serious public health
problem. In 2003, there were 499,008 preterm births in the United
States, representing 1 in 8 babies born. The rate of preterm birth
increased nearly 30 percent between 1983 and 2003 from 9.6 percent to 12.3 percent. Among racial/ethnic subgroups, preterm birth
rates were highest among infants born to non-Hispanic black mothers, 17.8 percent.
Premature birth is the leading cause of infant mortality in the
first year of life. For those who survive, approximately one quarter
will face significant health problems, including cerebral palsy, mental retardation, blindness, respiratory problems, and other chronic
conditions.
The human, societal and economic costs associated with prematurity are significant and increasing. According to the Institute
of Medicine, the annual societal economic burden associated with
preterm birth in the United States was at least $26.2 billion in
2005, or $51,600 per infant born preterm. Nearly two-thirds of the
societal cost was accounted for by medical care services ($16.9 billion), with more than 85 percent of those medical care services delivered in infancy. Maternal delivery costs contributed another $1.9
billion. Early intervention services cost an estimated $611 million,
whereas special education services associated with a higher prevalence of four disabling conditions, including cerebral palsy, mental
retardation, vision impairment, and hearing loss among premature
infants added $1.1 billion. Lost household and labor market productivity associated with those disabling conditions contributed
$5.7 billion. A separate analysis by the March of Dimes found the
direct health care costs to employers are $41,610 for a preterm
birth compared to $2,830 for full term.
In order to meet the Healthy People 2010 objective of reducing
the rate of preterm birth to 7.6 percent, an expanded and coordinated public-private research agenda is needed to best utilize the
resources available as developed by the ‘‘PREEMIE Act.’’

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II. SUMMARY
This legislation authorizes $91 million over 5 years to expand
and coordinate Federal research and educational activities related
to preterm birth. Of that amount, $1 million is designated for a
Surgeon General’s conference on preterm birth that will establish
a public-private agenda to speed the development of prevention
strategies for preterm labor and delivery.
First, the ‘‘PREEMIE Act’’ expands and coordinates prematurity
related research at the National Institutes of Health and Centers
for Disease Control and Prevention with the goal of best utilizing
existing Federal funding and additional funding as a result of this
bill; second, the bill authorizes demonstration projects to test promising prevention and treatment interventions; third, the legislation
codifies an existing Interagency Coordinating Council on Prematurity and Low Birthweight to stimulate research and enhance
coordination among all the agencies of the Department of Health
and Human Services; and finally, it calls for a Surgeon General’s
conference on preterm birth to establish a public-private agenda

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3
that will speed the development of prevention strategies for
preterm labor and delivery.
III. HISTORY

OF

LEGISLATION

AND

VOTES

IN

COMMITTEE

The Prematurity Research Expansion and Education for Mothers
who deliver Infants Early Act, referred to as the PREEMIE Act,
was first introduced in the first session of the 108th Congress, S.
1726, and was referred to the Senate Committee on Health, Education, Labor, and Pensions. A hearing on the bill took place on
May 13, 2004 before the Committee on Health, Education, Labor,
and Pensions Subcommittee on Children and Families (now called
the Subcommittee on Education and Early Childhood Development). No further action on S. 1726 was taken during the 108th
Congress. A companion bill was introduced in the House during the
first session of the 108th Congress, H.R. 3350. The bill was referred to the House Committee on Energy and Commerce, Subcommittee on Health with no further action taken on it during the
108th Congress. In the second session of the 108th Congress, the
Senate unanimously passed a resolution, S. Res. 476, supporting
the goals, activities, and ideals of National Prematurity Awareness
Month during November 2004.
In the first session of the 109th Congress, the PREEMIE Act was
introduced in the Senate on April 5, 2005 and referred to the Committee on Health, Education, Labor, and Pensions. On June 28,
2006, the Committee on Health, Education, Labor, and Pensions
ordered the bill to be reported favorably with an amendment in the
nature of a substitute co-sponsored by Senators Alexander, Dodd,
Isakson, Kennedy, DeWine, Mikulski, Hatch, Bingaman, Murray,
Reed, Clinton, Jeffords, Harkin and Enzi by unanimous consent. A
companion bill was introduced in the House, H.R. 2861, on June
9, 2005 and referred to the House Committee on Energy and Commerce.

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IV. EXPLANATION

OF

BILL

AND

COMMITTEE VIEWS

The bill has a variety of provisions, the explanation of and committee views on which follow below:
To reduce the rates of preterm birth, more research is needed on
the underlying causes of preterm delivery, the development of
treatments for the prevention of preterm birth, and treatments improving outcomes for infants born preterm. The committee believes
that the expansion and coordination of preterm birth research
within the National Institutes of Health and the Centers for Disease Control and Prevention is vital to achieving these outcomes.
The committee strongly supports the work being done at the research networks at the National Institutes of Health. The bill establishes a multi-center clinical program that will authorize three
networks that are currently in existence at the National Institutes
of Health. This committee expects that initially the three existing
networks will be the ones authorized, but the bill language provides the flexibility to adapt these Networks in the future as needed.
As part of the research expansion at the National Institutes of
Health and the Centers for Disease Control and Prevention, the
committee urges the Department of Health and Human Services to

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4
consider the recommendations made by the 2006 Institute of Medicine Report ‘‘Preterm Birth: Causes, Consequences, and Prevention.’’
The bill requests epidemiological studies by the Centers for Disease Control and Prevention on the relationship between prematurity, birth defects, and developmental disabilities. The committee expects that these studies will be important in properly
identifying the contribution of birth defects to the problem of
preterm birth. In addition, these studies will help better understand the association between developmental disabilities and
preterm birth.
This bill establishes systems for the collection of medical information, including electronic health records, to link with the Pregnancy Risk Assessment Monitoring System (PRAMS) in order to
track pregnancy outcomes. This committee expects that any systems created or electronic health records accessed through these
systems will utilize applicable interoperability standards as determined by the Secretary through a joint public and private sector
process, including standards adopted by the Office of the National
Coordinator for Health Information Technology.
The bill establishes a grant program to conduct demonstration
projects 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. Activities under this grant program 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. The committee expects these activities to be culturally competent.
In addition to prematurity research activities sponsored by academia and government sources, the committee recognizes that clinical, evidence-based research by specialists in the private sector has
also contributed significantly to improved outcomes for mothers at
risk of preterm delivery, and for premature babies. The result of
these efforts is the ability to care for babies born as early as 24
weeks gestational age, and those weighing as little as 1 lb. The Department is encouraged to utilize the participation of private sector
organizations, including physician groups, with demonstrated expertise in conducting research into the care of premature infants
in Federal research activities designed to improve treatment for
prematurity and outcomes for babies born prematurely, and to include such private sector expertise in the Surgeon General’s Conference on Preterm Birth.
The grant programs established by this act will only be used to
fund public or private non-profit entities.
The bill authorizes an already existing Interagency Coordinating
Council on Prematurity and Low Birthweight. The committee believes the continuation of this Council will foster greater collaboration across the Department of Health and Human Services. The
Council will also be required to annually report to Congress on Departmental activities related to preterm birth.
The bill requires the Surgeon General to convene a conference on
preterm birth within 1 year of enactment. The conference will examine the current findings and reports issued by the Interagency

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Coordinating Council and other key stakeholders and develop a
public-private agenda to speed the reduction in preterm birth rates.
The committee strongly believes that the public awareness and coordinated public private agenda resulting from a Surgeon General’s
conference will be key to achieving the purposes of this bill.
V. COST ESTIMATE

AND

UNFUNDED MANDATE STATEMENT
U.S. CONGRESS,
CONGRESSIONAL BUDGET OFFICE,
Washington, DC, July 13, 2006.

Hon. MIKE ENZI,
Chairman, Committee on Health, Education, Labor, and Pensions,
U.S. Senate, Washington, DC.
DEAR MR. CHAIRMAN: The Congressional Budget Office has prepared the enclosed cost estimate for S. 707, the Prematurity Research Expansion and Education for Mothers who deliver Infants
Early Act.
If you wish further details on this estimate, we will be pleased
to provide them. The CBO staff contact is Sarah Evans.
Sincerely,
DONALD B. MARRON,
Acting Director.
Enclosure.

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S. 707—Prematurity Research Expansion and Education for Mothers who deliver Infants Early Act
Summary: S. 707 would amend the Public Health Service Act to
direct the Secretary of Health and Human Services (HHS) to intensify and coordinate research and surveillance activities relating to
preterm labor and delivery and infant mortality, to conduct demonstration projects designed to improve the outcomes for premature
babies, and to host a conference on preterm birth. Several of those
activities would be implemented through the Director of the National Institutes of Health (NIH), the Director of the Centers for
Disease Control and Prevention (CDC), and the Surgeon General.
The bill also would require the Secretary of HHS to establish an
Interagency Coordinating Council on Prematurity and Low Birthweight to oversee and coordinate those activities.
For the activities described above, S. 707 would authorize the appropriation of $19 million for fiscal year 2007 and $18 million a
year for 2008 through 2011. CBO estimates that implementing the
bill would cost $8 million in 2007 and $76 million over the 2007–
2011 period, assuming the appropriation of the authorized
amounts. Enacting S. 707 would have no effect on direct spending
or revenues.
The bill contains no intergovernmental or private-sector mandates as defined in the Unfunded Mandates Reform Act (UMRA)
and would impose no costs on state, local, or tribal governments.
Estimated Cost to the Federal Government: The estimated budgetary impact of S. 707 is shown in the following table. The costs
of this legislation fall within budget function 550 (health).

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By fiscal year, in millions of dollars—
2007

2008

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CHANGES IN SPENDING SUBJECT TO APPROPRIATION
Estimated authorization level .............................................................
19
18
Estimated outlays ...............................................................................
8
15

2009

18
17

2010

18
18

2011

18
18

Basis of estimate: S. 707 would authorize the appropriation of
$19 million in 2007 and $18 million a year for 2008 through 2011
to fund research and activities designed to reduce the rates of
preterm labor and delivery and to reduce infant mortality and disabilities associated with prematurity.
For this estimate, CBO assumes that S. 707 will be enacted near
the start of fiscal year 2007 and that the authorized amounts will
be appropriated for each year. Using historical patterns of spending
for similar programs, CBO estimates that the costs of the bill
would be $8 million in 2007 and $76 million over the 2007–2011
period.
The National Institute for Child Health and Human Development (NICHD) currently administers several maternal and child
health research programs through its Pregnancy and Perinatology
Branch. Among these are the Maternal-Fetal Medicine Unit, the
Neonatal Research Network, and the Genomic and Proteomic Network for Premature Birth Research. According to officials at
NICHD, approximately $22 million was spent on these programs in
fiscal year 2005 through NICHD’s broad authorization to conduct
and support research with respect to gynecologic health, maternal
health, and child health. S. 707 would specifically authorize funding through 2011 for the above research programs as well as other
research programs at NIH that focus on preterm labor and delivery.
The CDC’s National Center on Birth Defects and Developmental
Disabilities currently administers many public health research and
education programs targeted at the health of newborns. These activities include tracking the prevalence of birth defects, researching
their causes, and educating providers and patients about the best
techniques for avoiding birth defects. S. 707 would authorize funding for expanding research in such areas as it relates to preterm
delivery and infant mortality. The bill would also require the Director of CDC to establish additional surveillance systems for monitoring maternal-infant clinical and biomedical information that
could be linked with the Pregnancy Monitoring Risk Assessment
System.
The bill would authorize the appropriation of $3 million for the
additional maternal-infant surveillance systems for each of fiscal
years 2007 through 2011. For the other research and activities at
the NIH and the CDC, the bill would authorize the appropriation
of $10 million for each of those fiscal years.
S. 707 also would authorize the appropriation of $5 million for
each of fiscal years 2007 through 2011 for the Secretary of HHS
to provide grants to public and nonprofit organizations for demonstration projects designed to improve the treatment and outcomes for premature babies.
The bill also would require the Secretary to establish an Interagency Coordinating Council on Prematurity and Low Birthweight.
The Council would be composed of representatives of the agencies

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of HHS and would oversee the coordination of activities authorized
under this act. CBO expects that supporting the council would cost
less than $200,000 a year, subject to the availability of appropriated funds.
S. 707 also would require the Surgeon General to convene a conference on preterm birth within one year of the enactment of the
bill. The bill would authorize the appropriation of $1 million for
this conference.
Intergovernmental and private-sector impact: S. 707 contains no
intergovernmental or private-sector mandates as defined in UMRA
and would impose no costs on state, local, or tribal governments.
Estimate prepared by: Federal costs: Sarah Evans and Tim
Gronniger; impact on state, local, and tribal governments: Leo Lex;
impact on the private sector: Jennifer Doleac.
Estimate approved by: Peter H. Fontaine, Deputy Assistant Director for Budget Analysis.
VI. APPLICATION

OF

LAW

TO THE

LEGISLATIVE BRANCH

The committee has determined that there is no impact of this
law on the Legislative Branch.
VII. REGULATORY IMPACT STATEMENT
In accordance with paragraph 11(b) of rule XXVI of the Standing
Rules of the Senate, the committee has determined that there will
be minimal increases in the regulatory burden imposed by this bill.
VIII. SECTION-BY-SECTION ANALYSIS
Section 1. Short title
‘‘Prematurity Research Expansion and Education for Mothers
who deliver Infants Early Act of 2005’’.

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Section 2. Purpose
The purpose of the bill is to reduce rates of preterm labor and
delivery, to promote the use of evidence-based care for pregnant
women at risk of preterm labor and for infants born preterm, and
to reduce infant mortality and disabilities caused by prematurity.
Section 3. Expansion of Federal research related to preterm labor
and delivery and the care, treatment, and outcomes of preterm
and low birthweight infants
This section authorizes the National Institutes of Health (NIH)
and the Centers for Disease Control and Prevention (CDC) to expand, intensify and coordinate research related to prematurity.
This section authorizes three existing networks at the NIH: the
Maternal-Fetal Medicine Units Network, the Neonatal Research
Units Network, and the Genomics and Proteomics Network for Premature Birth Research.
This section asks the CDC to conduct studies on the relationship
between prematurity and birth defects and developmental disabilities. It asks the CDC to collect additional information such as maternal and infant clinical/medical information to link with their existing Pregnancy Risk Assessment Monitoring System (PRAMS) to
track pregnancy outcomes and prevent preterm birth.

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This section asks the Secretary of Health and Human Services
to assess other relevant tools, systems, surveys, etc. to ensure that
they include information related to some of the known risk factors
of low birth weight and preterm birth.
This section authorizes a total of $13 million for each of fiscal
years 2007 through 2011, of which $3 million each year is authorized to carry out the requirements under the Pregnancy Risk Assessment Monitoring Survey (PRAMS).
Section 4. Public and health care provider education and support
service grants
This section authorizes the awarding of grants to public or private non-profit entities for demonstration projects to improve the
provision of information on prematurity to health care providers
and the public to improve the treatment and outcomes for babies
born prematurely. It is one grant program that can be used to fund
programs to test and evaluate strategies to provide information and
education to health care providers and the public related to prematurity; to improve treatments and outcomes for babies born prematurely; and to respond to the informational needs of families
during the stay of a preterm infant in a neonatal intensive care
unit, during the transition of the infant home, and in the event of
a newborn death.
This section authorizes $5 million for each of fiscal years 2007
through 2011.
Section 5. Interagency Coordinating Council on Prematurity and
Low Birthweight
This section authorizes the existing Interagency Coordinating
Council on Prematurity and Low Birthweight at the Department of
Health and Human Services. The Council is to include (and does
include now) representatives of the Department of Health and
Human Services agencies that conduct prematurity-related activities. The Council is to report annually to the Secretary of Health
and Human Services and Congress on current activities related to
prematurity. The Council is to oversee the coordination of the implementation of this act.
Section 6. Surgeon General’s Conference on Preterm Birth
This section requires the Secretary of Health and Human Services, acting through the Surgeon General, to hold a conference on
preterm birth within 1 year of enactment of this act. With the goal
of increasing awareness of preterm birth, the conference will review findings and reports issued by the Interagency Coordinating
Council, key stakeholders, and any other relevant entity. The conference will establish an agenda for activities in both public and
private sectors that will speed the identification of, and treatments
for, the causes of preterm labor and delivery. The agenda will be
reported to Congress.
This section authorizes $1 million.

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IX. CHANGES

IN

EXISTING LAW

In compliance with rule XXVI paragraph 12 of the Standing
Rules of the Senate, the following provides a print of the statute
or the part or section thereof to be amended or replaced (existing

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law proposed to be omitted is enclosed in black brackets, new matter is printed in italic, existing law in which no change is proposed
is shown in roman):

PUBLIC HEALTH SERVICE ACT
*

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TITLE III—GENERAL POWERS AND DUTIES OF PUBLIC
HEALTH SERVICE
PART A—RESEARCH

AND INVESTIGATION

IN GENERAL

SEC. 301. (a) * * *
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*
*
*
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(d) * * *
(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.
*

*

*

*

*

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SEC. ø399O¿ 399P GRANTS TO FOSTER PUBLIC HEALTH RESPONSES TO
DOMESTIC VIOLENCE, DATING VIOLENCE, SEXUAL ASSAULT, AND STALKING.
(A) AUTHORITY TO AWARD GRANTS.—* * *

*

*

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*

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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

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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.
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TITLE IV—NATIONAL RESEARCH INSTITUTES
PART A—NATIONAL INSTITUTES

OF

HEALTH

ORGANIZATION OF THE NATIONAL INSTITUTES OF HEALTH

SEC. 401. * * *
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*

PART B—GENERAL PROVISIONS RESPECTING NATIONAL RESEARCH
INSTITUTES
APPOINTMENT AND AUTHORITY OF THE DIRECTORS OF THE NATIONAL
RESEARCH INSTITUTES

SEC. 405. * * *
*

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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.

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Æ

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