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                                                       Calendar No. 541
109th Congress                                                   Report
                                 SENATE
 2nd Session                                                    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. Purpose and need for legislation.................................1
 II. Summary..........................................................2
III. History of legislation and votes in committee....................3
 IV. Explanation of bill and committee views..........................3
  V. Cost estimate and unfunded mandate statement.....................5
 VI. Application of law to the legislative branch.....................7
VII. Regulatory impact statement......................................7
VIII.Section-by-section analysis......................................7

 IX. Changes in existing law..........................................8

                  I. Purpose and Need for Legislation

    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 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.''

                              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 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.

              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 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 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.

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).

----------------------------------------------------------------------------------------------------------------
                                                                    By fiscal year, in millions of dollars--
                                                               -------------------------------------------------
                                                                  2007      2008      2009      2010      2011
----------------------------------------------------------------------------------------------------------------
                                  CHANGES IN SPENDING SUBJECT TO APPROPRIATION

Estimated authorization level.................................        19        18        18        18        18
Estimated outlays.............................................         8        15        17        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 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''.

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.
    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.

                      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 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

           *       *       *       *       *       *       *


     TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE


                   Part A--Research and Investigation


                               IN GENERAL

    Sec. 301. (a) * * *

           *       *       *       *       *       *       *

    (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.

           *       *       *       *       *       *       *


SEC. [399O] 399P GRANTS TO FOSTER PUBLIC HEALTH RESPONSES TO DOMESTIC 
                    VIOLENCE, DATING VIOLENCE, SEXUAL ASSAULT, AND 
                    STALKING.

    (A) Authority to Award Grants.--* * *

           *       *       *       *       *       *       *


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.

           *       *       *       *       *       *       *


                 TITLE IV--NATIONAL RESEARCH INSTITUTES


                 Part A--National Institutes of Health


           ORGANIZATION OF THE NATIONAL INSTITUTES OF HEALTH

    Sec. 401. * * *

           *       *       *       *       *       *       *


   Part B--General Provisions Respecting National Research Institutes


  APPOINTMENT AND AUTHORITY OF THE DIRECTORS OF THE NATIONAL RESEARCH 
                               INSTITUTES

    Sec. 405. * * *

           *       *       *       *       *       *       *


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.

           *       *       *       *       *       *       *