[DOCID: f:sr280.110]
From the Senate Reports Online via GPO Access
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110th Congress Report
SENATE
2nd Session 110-280
======================================================================
NEWBORN SCREENING SAVES LIVES ACT OF 2007
_______
April 8, 2008.--Ordered to be printed
_______
Mr. Kennedy, from the Committee on Health, Education, Labor and
Pensions, submitted the following
R E P O R T
[To accompany S. 1858]
The Committee on Health, Education, Labor, and Pensions, to
which was referred the bill (S. 1858) to amend the Public
Health Service Act to establish grant programs to provide for
education and outreach on newborn screening and coordinated
followup care once newborn screening has been conducted, to
reauthorize programs under part A of title XI of such Act, and
for other purposes, 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....................................................8
VI. Application of Law to the Legislative Branch.....................9
VII. Regulatory Impact Statement......................................9
VIII.Section-by-Section Analysis.....................................10
IX. Changes in Existing Law.........................................13
I. Purpose and Need for Legislation
The purpose of the ``Newborn Screening Saves Lives Act of
2007'' is to facilitate the creation of Federal guidelines on
newborn screening, to assist State newborn screening programs
in meeting Federal guidelines, to improve education, outreach,
and coordinated follow-up care, and to improve the laboratory
quality and surveillance for newborn screening.
Newborn screening is a public health activity, which
provides early identification and follow-up for treatment of
infants affected by certain genetic, metabolic, hormonal and/or
functional conditions. Since the early 1960s, when Robert
Guthrie devised a screening test for phenylketonuria (PKU)
using a newborn blood spot dried onto a filter paper card, more
than 150 million infants have been screened for a number of
genetic and congenital disorders. Screening detects disorders
in newborns that, if left untreated, can cause disability,
intellectual disabilities, serious illness and even death.
Except for hearing, screening tests are done using a few drops
of blood from the newborn's heel, usually taken in the hospital
24 to 48 hours after birth. With the advent of the tandem mass
spectrometer, it is now possible to detect more than 40
conditions and for some conditions such as PKU, tandem mass
spectrometry has been shown to reduce the false positive rate
for this disorder.
Parents are often unaware that the number and quality of
newborn screens varies from State to State and while newborns
are regularly screened and treated for debilitating conditions
in some States, in others, screening may not be required and
conditions may go undiagnosed and untreated. In 2004, the
American College of Medical Genetics completed a report
commissioned by the United States Department of Health and
Human Services which recommended that, at a minimum, every baby
born in the U.S. be screened for a core set of 29 treatable
disorders regardless of the State in which he or she is born.
At present, only 15 States and the District of Columbia require
infants to be screened for all 29 of the recommended disorders.
In fact, States currently mandate screening newborns for as few
as 9 conditions while others mandate more than 40 conditions.
An estimated 1,000 of the 5,000 babies born every year in the
United States with one of the 29 core conditions potentially go
unscreened through newborn screening. If diagnosed early these
conditions can be successfully managed.
The ``Newborn Screening Saves Lives Act of 2007'' will
assist States in improving and expanding their newborn
screening programs as well as provide for Federal guidelines on
the conditions for which newborns in all States should be
screened. The public health crisis that ensued after hurricanes
such as Katrina and Rita demonstrated, among other things, that
contingency planning for newborn screening is essential. Under
this legislation the Secretary is required to develop a
national contingency plan for newborn screening for use by
States in the event of a public health emergency.
II. Summary
This legislation authorizes $58,500,000 in fiscal year 2008
to expand, improve, coordinate, and evaluate Federal research,
educational, and programmatic activities related to newborn
screening. Within this authorization is funding to enhance and
expand the ability of State and local health agencies to
provide screening, counseling, or health care services to
newborns and children at risk for or diagnosed with heritable
disorders as well as to educate and train health care
professionals, State laboratory personnel, parents, families,
and patient advocates about newborn screening, including new
technologies, follow-up, and treatment.
The ``Newborn Screening Saves Lives Act'' would also
allocate funding to analyze the effectiveness of these newborn
screening programs. It reauthorizes and expands the role of the
Advisory Committee on Heritable Disorders in Newborns and
Children, establishes an Interagency Coordinating Committee on
Newborn and Child Screening, and creates an Internet-based
information clearinghouse to provide information about newborn
and child screening for heritable disorders. The bill requires
the Secretary to ensure the quality of laboratories involved in
newborn screening activities, and to develop a national
contingency plan for newborn screening. Finally, it gives the
National Institutes of Health the authority to carry out
research in newborn screening, including identifying new
screening technologies and researching disease management
strategies for conditions that can be detected through
screening, but for which no treatment is yet available.
III. History of Legislation and Votes in Committee
The ``Newborn Screening Saves Lives Act,'' was first
introduced in the second session of the 107th Congress, S.
2890, and was referred to the Senate Committee on Health,
Education, Labor, and Pensions. A hearing on the bill took
place on June 14, 2002 before the Committee on Health,
Education, Labor, and Pensions Subcommittee on Children and
Families. No further action on S. 2890 was taken during the
107th Congress. A companion bill was introduced in the House of
Representatives during the second session of the 107th
Congress, H.R. 5703. The bill was referred to the House
Committee on Energy and Commerce Subcommittee on Health with no
further action taken on it during the 107th Congress.
The ``Newborn Screening Saves Lives Act'' was reintroduced
in the first session of the 108th Congress, S. 1068, the second
session of the 109th Congress, S. 2663, and again in the first
session of the 110th Congress, S. 634. The bills were referred
to the Committee on Health, Education, Labor, and Pensions.
Companion bills were reintroduced in the second session of the
108th Congress, H.R. 4493, the second session of the 109th
Congress, H.R. 5397, and again in the first session of the
110th Congress, H.R. 1634. They were referred to the House
Committee on Energy and Commerce Subcommittee on Health.
In the first session of the 110th Congress, the ``Newborn
Screening Saves Lives Act'' was reintroduced as S. 1858 with
additions from the Screening for Health of Infants and Newborns
Act, S. 1712. On November 14, 2007, the Committee on Health,
Education, Labor and Pensions ordered the bill to be reported
favorably with an amendment in the nature of a substitute by
voice vote. The amendment was co-sponsored by Senators Dodd,
Hatch, Clinton, and Kennedy. A companion bill was introduced in
the House, H.R. 3825, on October 15, 2007 and referred to the
House Committee on Energy and Commerce Subcommittee on Health.
IV. Explanation of Bill and Committee Views
The bill has a variety of provisions, the explanation of
and committee views on which follow below:
Newborn screening is an essential public health function
provided to all newborns in the United States. Unfortunately,
the number and quality of conditions screened for at birth
varies from State to State. In addition, newborn screening
programs should be comprehensive, including not only screening
and diagnosis, but also long-term follow-up care and treatment.
The committee believes newborn screening programs should
include high quality screening with state-of-the-art
technology, proper educational materials for parents, trained
personnel, and a system to assess and coordinate timely follow-
up care and treatment of newborns screened and program
evaluation.
The committee believes that reauthorization and expansion
of section 1109 of the Public Health Service Act will help to
address these issues. The bill amends the Public Health Service
Act to require the Secretary of Health and Human Services,
acting through the Administrator of the Health Resources and
Services Administration (HRSA), and in consultation with the
Advisory Committee on Heritable Disorders in Newborns and
Children, to award grants to eligible entities for the
enhancement, expansion or improvement of State newborn
screening programs. The committee recognizes that there is a
lack of uniformity in what conditions States screen for with
some States screening as few as 9 conditions while others
screen for more than 40 conditions. This puts the health of
newborns in one State at greater risk for the conditions to go
undetected and untreated than newborns in another State. The
committee intends that the grants under section 1109 will be an
incentive for States, at a minimum, to screen for all of the
core conditions recommended by the Advisory Committee on
Heritable Disorders in Newborns and Children.
The bill expands section 1109 grants to eligible entities
to assist in providing health care professionals and newborn
screening laboratory personnel with education and training in
newborn screening to include training in relevant and new
technologies as well as congenital, genetic, and metabolic
disorders. The committee believes that the education and
training programs for health care professionals and laboratory
personnel developed and delivered under these grants should
include continuing medical education programs for health care
professionals and newborn screening laboratory personnel;
models to evaluate the prevalence of, and assess and
communicate the risks of, congenital, genetic, and metabolic
conditions based on family history; models to communicate
effectively with parents and families about the process and
benefits of newborn screening and the meaning of screening
results, how to use information gathered from newborn
screening, the right to refusal of newborn screening, if
applicable; information and resources on systems of follow-up
care and treatment after newborns are screened; and information
on the disorders for which States require and offer newborn
screening as well as information on additional newborn
screening that may not be required by the State, but that may
be available from other sources.
The bill expands section 1109 grants to eligible entities
to develop and deliver educational programs about newborn
screening to parents, families, and patient advocacy and
support groups. The committee expects these programs to be
provided at appropriate literacy levels and to be culturally
competent. The committee believes that educational programs
should include information on what newborn screening is and how
it is performed; who performs newborn screening; where newborn
screening is performed; the disorders for which the State
requires newborns to be screened; options available to screen
for additional disorders other than those mandated by the
State; the meaning of various screening results, including the
possibility of false positives and false negative findings; the
prevalence and risk of newborn disorders, including the
increased risk of disorders that may stem from family history;
and systems of follow-up care and treatment after newborns are
screened.
The bill further expands section 1109 grants to eligible
entities to establish, maintain, and operate a system to assess
and coordinate treatment relating to congenital, genetic, and
metabolic disorders. The committee expects these grants to
expand on existing procedures and systems, where appropriate
and available, for the timely reporting of newborn screening
results to individuals, families, primary care physicians, and
appropriate subspecialists; coordinate ongoing follow-up care
and treatment with individuals, families, primary care
physicians, and appropriate subspecialists after a newborn
receives an indication of the presence or increased risk of a
disorder on a screening test; ensure the seamless integration
of confirmatory testing, tertiary care medical services,
comprehensive genetic services including genetic counseling,
and information about Food and Drug Administration (FDA)-
approved treatments or other safe and effective treatments as
well as access to developing therapies by participating in
approved clinical trials involving the primary health care of
the infant; and analyze data, if appropriate and available,
collected from newborn screening to identify populations at
risk for disorders affecting newborns, examine and respond to
health concerns, and recognize and address relevant
environmental, behavioral, socioeconomic, demographic, and
other relevant risk factors.
Eligible entities for section 1109 grants are a State or a
political subdivision of a State, a consortium of 2 or more
States or political subdivisions of States, a territory, a
health facility or program operated by or pursuant to a
contract with or a grant from the Indian Health Service, or any
other entity with appropriate expertise in newborn screening,
as determined by the Secretary. The committee intends that
other entities with appropriate expertise include those that
have the capacity to perform the core newborn screening tests
recommended by the Advisory Committee, those with a
demonstrated history of expertise with newborn screening
activities, or those determined appropriate by the Secretary.
The bill reauthorizes Section 1110 of the Public Health
Service Act to continue grants that evaluate the effectiveness
of newborn and child screening programs. The committee believes
HRSA's current activities aimed at assuring the best outcome
for newborns should be continued. These activities include
examining the impact of false positive screens, and the
public's awareness, or lack thereof, and understanding about,
newborn tests, tools, and technologies.
The bill reauthorizes and expands the role of the
Secretary's Advisory Committee on Heritable Disorders in
Newborns and Children. The committee strongly believes that
Federal guidelines and recommendations on issues related to
newborn screening are needed in order to address the
disparities among State newborn screening programs. Therefore,
the bill requires the Advisory Committee to make
recommendations that include the heritable disorders for which
all newborns should be screened, to develop a model decision-
matrix for newborn screening program expansion, and to consider
ways to ensure that all States attain the capacity to screen
for conditions recommended by the Advisory Committee, and
include in such consideration the results of grant funding
under section 1109. The bill includes several areas of
particular concern where additional expertise from the Advisory
Committee would be useful. The bill allows the Advisory
Committee to make recommendations, advice or information
dealing with follow-up care and treatment of newborns,
implementation, monitoring, and evaluation of newborn screening
activities, the availability and reporting of testing for
conditions for which there is no existing treatment, the cost
and effectiveness of newborn screening, coordination of
surveillance activities, among other areas.
The committee is particularly concerned by the lack of
response from the Secretary of Health and Human Services to
previous recommendations made by the Advisory Committee.
Although the bill requires the Secretary to accept or reject
any recommendation issued by the Advisory Committee that is
pending on the date of enactment of the bill by not later than
180 days after the date of enactment, nothing in the bill
prevents the Secretary from acting more expeditiously.
The bill authorizes the creation and maintenance of a
central Internet clearinghouse of current educational and
family support and services information, materials, resources,
research and data on newborn screening. Such clearinghouse will
also be used to maintain data on quality indicators to measure
performance of newborn screening, as developed by the Advisory
Committee. The committee believes this Internet clearinghouse
will help parents and health care providers to be better
informed about all aspects of newborn screening, which will
lead to better outcomes for children.
Newborn screening has long been recognized as an essential,
life-saving, and effective preventive public health service
that has identified thousands of babies each year in the United
States who are born with congenital, genetic and metabolic
conditions that are not apparent at birth. The Center for
Disease Control and Prevention (CDC)'s Environmental Health
Laboratory houses the only comprehensive program in the world
devoted to ensuring the accuracy of newborn screening tests.
The Newborn Screening Quality Assurance Program (NSQAP)
provides training, consultation, proficiency testing,
guidelines, and reference materials to State public health
laboratories and other laboratories responsible for newborn
screening in the United States. Because of NSQAP, parents and
doctors in the United States can trust the results of their
newborn screening tests regardless of where their babies were
born. To further facilitate this effort, the committee
encourages CDC's Environmental Health Laboratory to continue
its efforts in quality assurance and to harness the latest
advances in science and technology so that additional disorders
can be detected. Specifically, the committee intends for CDC's
Environmental Health Laboratory to develop new screening
methods for specific disorders; adapt innovative technologies,
such as DNA testing and nanotechnology; transfer new screening
technologies to State public health laboratories; and provide
technical assistance to States in conducting pilot studies
related to new screening tests for congenital, genetic and
metabolic conditions not currently in the recommended core
panel. Such conditions may include, but are not limited to,
severe combined immune deficiency (SCID), metabolic storage
disorders such as Pompe Disease and X-linked
Adrenoleukodystrophy (XALD), and maternal or fetal infections
such as lymphocytic choriomeningitis (LCM) virus.
The bill authorizes programs that build upon existing
activities and infrastructures to collect, analyze and make
available data on the heritable disorders recommended by the
Advisory Committee; to identify regional centers to conduct
epidemiological research; to provide information and education
to the public on effective interventions for the prevention of
poor health outcomes resulting from the disorders; and to
conduct research on the health outcomes associated with these
disorders. The committee believes these programs should build
upon existing infrastructure and should be a collaborative
effort administrated by an Interagency Group comprised of the
Agency for Healthcare Research and Quality, CDC, HRSA and the
National Institutes of Health. Surveillance forms the backbone
of a vital, functional and responsive public health network and
establishing a national program to track the incidence of
heritable disorders will assist in efforts around the country
to study these disorders. Also, additional research on these
genetic, metabolic, hormonal and or functional conditions
detected through newborn screening is sorely needed. Since many
of these conditions are extremely rare it is necessary to
conduct additional epidemiological studies to unveil the causes
and potential treatments for these conditions. Epidemiological
research into the causes of heritable disorders is a critical
step in the development of cost-effective strategies to detect
and treat these conditions.
Contingency planning for newborn screening is essential
because of the short timeframe for detecting and treating
congenital disorders. More than 11,000 babies are born each day
in the United States, so it is important that every State have
a contingency plan for newborn screening in place in the event
of a public health emergency. A national plan is essential for
integrating the components of the various State plans and
assuring nationwide preparedness. The committee believes that a
national contingency plan for newborn screening should address
contingency measures for sample delivery, backup laboratory
operations, and effective follow-up including care and
treatment, medications and other safe and effective treatments,
such as dietary interventions. Because of its primary role in
national public health emergency planning and response, the
committee believes that CDC is the appropriate Federal agency
to oversee the development of a national contingency plan for
newborn screening and to conduct practice drills that ensure
its operational integrity.
The bill allows the Secretary, in conjunction with the
Director of NIH and taking into consideration the
recommendations of the Advisory Committee, to continue carrying
out, coordinating, and expanding research on additional newborn
conditions beyond those recommended by the Advisory Committee
and adopted by the Secretary. Those conditions include, but are
not limited to, Krabbe disease, Diabetes mellitus, insulin
dependent, and Turner syndrome. The committee believes that
engaging in such research is not only essential to improving
currently existing screening technology, but also to developing
new treatments, interventions and possible cures for conditions
that currently can be detected through newborn screening, but
which have no existing treatment.
V. Cost Estimate
U.S. Congress,
Congressional Budget Office,
Washington, DC, April 1, 2008.
Hon. Edward M. Kennedy,
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. 1858, the Newborn
Screening Saves Lives Act of 2007.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contacts are Sarah
Evans, Tim Gronniger, Andrea Noda, and Lara Robillard.
Sincerely,
Robert A. Sunshine
(For Peter R. Orszag, Director).
Enclosure.
S. 1858--Newborn Screening Saves Lives Act of 2007
Summary: S. 1858 would amend the Public Health Service Act
to authorize grant programs and other initiatives to promote
expanded screening of newborns and children for heritable
diseases.
CBO estimates that the act would authorize the
appropriation of $45 million for 2008 and $229 million over the
2008-12 period. Assuming the appropriation of those amounts,
CBO estimates that implementing the act would cost $11 million
in 2008 and $218 million over the 2008-13 period. S. 1858 would
not affect direct spending or revenues.
S. 1858 contains no intergovernmental or private-sector
mandates as defined in the Unfunded Mandates Reform Act (UMRA).
Estimated cost to the Federal Government: The estimated
budgetary impact of S. 1858 is shown in the following table.
The costs of this legislation fall within budget function 550
(health).
----------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
-----------------------------------------------------
2008 2009 2010 2011 2012 2013
----------------------------------------------------------------------------------------------------------------
CHANGES IN SPENDING SUBJECT TO APPROPRIATION
HRSA Activities:
Authorization Level................................... 39 39 39 40 40 0
Estimated Outlays..................................... 10 37 39 42 40 19
CDC Activities:
Authorization Level................................... 6 6 6 6 6 0
Estimated Outlays..................................... 1 5 6 6 6 5
Contingency Planning (CDC and HRSA):
Estimated Authorization Level......................... 0 2 0 0 0 0
Estimated Outlays..................................... 0 2 0 0 0 0
Total Changes:
Estimated Authorization Level......................... 45 47 45 46 46 0
Estimated Outlays..................................... 11 44 45 48 46 24
----------------------------------------------------------------------------------------------------------------
Note: HRSA = Health Resources and Services Administration; CDC = Centers for Disease Control and Prevention.
Basis of estimate: The activities authorized under S. 1858
would be carried out by the Health Resources and Services
Administration (HRSA) and the Centers for Disease Control and
Prevention (CDC). The estimate is based on historical spending
patterns for similar activities, and assumes that the
authorized amounts would be appropriated in the spring of 2008
and near the beginning of the fiscal year in subsequent years.
The act would direct HRSA to establish grant programs to
promote expanded screening of newborns and children for
heritable diseases, and to establish a clearinghouse on
heritable diseases. The act would authorize the appropriation
of $39 million for 2008 and $197 million over the 2008-12
period for those activities. CBO estimates that implementing
those provisions would cost $10 million in 2008 and $187
million over the 2008-13 period.
S. 1858 also would authorize CDC to implement programs to
promote quality in clinical laboratories that test for
heritable diseases and to create a surveillance program for
heritable disorders. The act would authorize the appropriation
of $6 million for 2008 and $30 million over the 2008-12 period.
CBO estimates that implementing those provisions would cost $1
million in 2008 and $29 million over the 2008-13 period.
In addition, the act would direct CDC and HRSA to
collaborate to create a national contingency plan for newborn
screening in the event of a public health disaster. CBO
estimates that it would cost $2 million in 2009 to develop that
plan, assuming the availability of appropriated funds.
Intergovernmental and private-sector impact: S. 1858
contains no intergovernmental or private-sector mandates as
defined in UMRA. State and local governments that participate
in newborn and child screening programs would benefit from
funds authorized by the bill.
Previous CBO estimate: On April 1, 2008, CBO transmitted a
cost estimate for H.R. 3825, the Newborn Screening Saves Lives
Act of 2008, as ordered reported by the House Committee on
Energy and Commerce on March 13, 2008. The two bills are very
similar, except that S. 1858 would authorize appropriations for
the 2008-12 period (rather than the 2009-13 period specified in
H.R. 3825). CBO's estimate for S. 1858 differs from that for
H.R. 3825 because of the differences in the timing of the
authorized appropriations.
Estimate prepared by: Federal costs: Sarah Evans, Tim
Gronniger, Andrea Noda, and Lara Robillard; Impact on State,
local, and tribal governments: Lisa Ramirez-Branum; Impact on
the private sector: Patrick Bernhardt.
Estimate approved by: Keith J. Fontenot, Deputy Assistant
Director for Health and Human Resources, Budget Analysis
Division.
VI. Application of Law to the Legislative Branch
The committee has determined that there will be minimal
increases in the regulatory burden imposed by this bill.
VII. Regulatory Impact Statement
The committee has determined that there is no legislative
impact.
VIII. Section-by-Section Analysis
Section 1. Short title
``Newborn Screening Saves Lives Act of 2007.''
Section 2. Improved newborn and child screening for heritable disorders
This section amends Section 1109 of the Public Health
Service Act to authorize grants for enhancing, improving, or
expanding the ability of States and local public health
agencies to provide screening, counseling or health care
services to newborns and children having or at risk for
heritable disorders. In order to receive a grant, an eligible
entity must commit to adopting and implementing or be in the
process of adopting and implementing the guidelines and
recommendations of the Advisory Committee on Heritable
Disorders in Newborns and Children (Advisory Committee) that
are adopted by the Secretary. The authorization of
appropriations for this grant is $15,000,000 for fiscal year
2008, $15,187,500 for fiscal year 2009, $15,375,000 for fiscal
year 2010, $15,562,500 for fiscal year 2011, and $15,750,000
for fiscal year 2012. Eligible entities for this grant are a
State, a consortium of 2 or more States, a territory, a health
facility or program operated by or pursuant to a contract with
or grant from the Indian Health Services, or any other entity
with appropriate expertise in newborn screening, as determined
by the Secretary.
This section authorizes grants for educating and training
health care professionals and State laboratory personnel in
newborn screening and relevant new technologies; developing and
delivering educational programs to inform parents, families,
and patient advocacy and support groups about newborn
screening, testing, follow-up and treatment; and establishing,
operating, and maintaining a system to assess and coordinate
treatment relating to congenital, genetic, and metabolic
disorders. The authorization of appropriations for these grants
is $15,000,000 for fiscal year 2008, $15,187,500 for fiscal
year 2009, $15,375,000 for fiscal year 2010, $15,562,500 for
fiscal year 2011, and $15,750,000 for fiscal year 2012.
Eligible entities for these grants are a State, a consortium of
2 or more States, a territory, a health facility or program
operated by or pursuant to a contract with or grant from the
Indian Health Services, or any other entity with appropriate
expertise in newborn screening, as determined by the Secretary.
Section 3. Evaluating the effectiveness of newborn and child screening
programs
This section amends Section 1110 of the Public Health
Service Act to authorize $5,000,000 for fiscal year 2008,
$5,062,500 for fiscal year 2009, $5,125,000 for fiscal year
2010, $5,187,500 for fiscal year 2011, and $5,250,000 for
fiscal year 2012 to evaluate the effectiveness of Newborn and
Child Screening Programs.
Section 4. Advisory Committee on Heritable Disorders in Newborns and
Children
This section amends Section 1111 of the Public Health
Service Act to reauthorize the Advisory Committee for the 5-
year period beginning on the date of enactment of the bill. It
expands the role of the Advisory Committee to require that the
Advisory Committee make systematic evidence-based and peer-
reviewed recommendations that include heritable disorders,
including secondary conditions that may be identified. It
requires the Advisory Committee to develop a model decision-
matrix for newborn screening expansion and periodic updating of
the recommended uniform screening panel as well as to consider
ways to ensure that all States attain the capacity to screen
for the recommended panel of disorders. The Advisory Committee
is also required to provide recommendations, advice, or
information to the Secretary of HHS to reduce the mortality or
morbidity from heritable disorders which may include:
<bullet> Follow-up activities including those
necessary to achieve rapid diagnosis in the short-term
and those that ascertain long-term case management
outcomes;
<bullet> Implementation, monitoring, and evaluation
of newborn screening activities, including diagnosis,
screening, follow-up, and treatment activities;
<bullet> Quality assurance, oversight, and evaluation
of State newborn screening programs;
<bullet> The availability and reporting of testing
for conditions for which there is no existing
treatment;
<bullet> Standardized data collection and reporting
for assessment of newborn screening programs;
<bullet> The cost and effectiveness of newborn
screening and medical evaluation systems and
intervention programs conducted by State-based
programs; and
<bullet> Coordination of surveillance activities in
order to enhance monitoring of newborn diseases.
This section adds individuals with expertise in ethics and
infectious diseases who have worked and published material in
newborn screening and the Commissioner of the Food and Drug
Administration to the Advisory Committee. It requires the
Secretary to adopt or reject any recommendation issued by the
Advisory Committee that is pending on the date of enactment and
requires the Secretary to adopt or reject future
recommendations of the Advisory Committee after not more than
180 days and make public such determination. It also requires
the Advisory Committee to report to Congress and the public not
later than 3 years after the date of enactment, and each year
thereafter, on newborn screening guidelines, including follow-
up and treatment, in the United States.
This section authorizes $1,000,000 for fiscal year 2008,
$1,012,500 for fiscal year 2009, $1,025,000 for fiscal year
2010, $1,037,500 for fiscal year 2011, and $1,050,000 for
fiscal year 2012.
Section 5. Information clearinghouse
This section requires the Secretary of Health and Human
Services to establish a central clearinghouse within the Health
Resources and Services Administration, in consultation with the
Centers for Disease Control and Prevention and the National
Institutes of Health. This clearinghouse is to be made
available via the Internet to provide current educational and
family support information, resources, and data on newborn
screening for parents and family members of newborns as well as
information about newborn screening services available in each
State, current research on both treatable and not-yet treatable
conditions for which newborn screening tests are available, and
the availability of Federal funding for newborn and child
screening for heritable disorders including grants authorized
by the bill.
This section authorizes $2,500,000 for fiscal year 2008,
$2,531,250 for fiscal year 2009, $2,562,500 for fiscal year
2010, $2,593,750 for fiscal year 2011, and $2,625,000 for
fiscal year 2012.
Section 6. Laboratory quality and surveillance
This section requires the Secretary, acting through the
Director of the Centers for Disease Control and Prevention and
in consultation with the Advisory Committee, to ensure the
quality of laboratories involved in newborn screening including
quality assurance for newborn screening tests, performance
evaluation services, and technical assistance and technology
transfer to newborn screening laboratories to ensure analytic
validity and utility of screening tests as well as to provide
for appropriate quality control and other performance test
materials to evaluate the performance of new screening tools.
This section authorizes $5,000,000 for fiscal year 2008,
$5,062,500 for fiscal year 2009, $5,125,000 for fiscal year
2010, $5,187,500 for fiscal year 2011, and $5,250,000 for
fiscal year 2012.
This section also requires the Secretary, acting through an
Interagency Group consisting of the Director 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, and the Director
of the National Institutes of Health, to build upon existing
programs to award grants to and enter into contracts with
public and nonprofit private entities to collect, analyze, and
make available data on the heritable disorders recommended by
the Advisory Committee, including data on the incidence and
prevalence of, as well as poor health outcomes resulting from,
such disorders. The Interagency Group is required to award
grants to and enter into contracts with public and nonprofit
private entities to carry out programs to identify regional
centers for the conduct of applied epidemiological research on
effective interventions for such disorders for the prevention
of poor health outcomes and to provide information and
education to the public on effective interventions for the
prevention of poor health outcomes resulting from such
disorders. The Interagency Group is also required to award
grants to and enter into contracts with public and nonprofit
private entities to carry out programs to conduct research on
and to promote the prevention of poor health outcomes resulting
from such disorders and secondary health conditions among
individuals with such disorders. This section requires the
Secretary to submit to Congress a report not later than 30
months after the date on which the first grant funds are
awarded and again not later than 60 months after date on which
the first grant funds are awarded containing information that
is specific to various racial, ethnic, and socioeconomic
groups, containing an assessment of the extent to which various
approaches of preventing heritable disorders and secondary
health conditions among individuals with such disorders have
been effective, and containing information on the incidence and
prevalence of individuals living with heritable disorders,
information on their health status, information on any health
disparities experienced by such individuals, and
recommendations for improving the health and wellness and
quality of life of such individuals. The report must also
contain a summary of recommendations from all heritable
disorders research conferences sponsored by the Centers for
Disease Control and Prevention or the National Institutes of
Health. In carrying out this section, the Secretary shall
coordinate, to the extent practicable, programs under this
section with programs on birth defects and developmental
disabilities under section 317C of the Public Health Service
Act and give priority for grant funds to entities that
demonstrate the ability to coordinate with existing birth
defects surveillance activities. This section authorizes
$15,000,000 for fiscal year 2008, $15,187,500 for fiscal year
2009, $15,375,000 for fiscal year 2010, $15,562,500 for fiscal
year 2011, and $15,750,000 for fiscal year 2012.
Section 7. Contingency planning
This section requires the Secretary, acting through the
Director of the Centers for Disease Control and Prevention, to
develop a national contingency plan for newborn screening for
use by a State, region, or consortia of States in the event of
a public health emergency. The national contingency plan shall
be developed not later than 180 days after enactment of the
bill and shall include a plan for the collection and transport
of specimens, the shipment and processing of specimens, the
reporting of screening results to physicians and families, the
diagnostic confirmation of positive screening results, the
availability of treatment and management resources, and the
education of families about newborn screening.
This section allows the Secretary, in conjunction with the
Director of the National Institutes of Health and taking into
consideration the recommendations of the Advisory Committee, to
continue carrying out, coordinating, and expanding research in
newborn screening (to be known as the Hunter Kelly Newborn
Screening Research Program) including identifying, developing,
and testing the most promising new screening technologies in
order to improve already existing screening tests and expand
the number of conditions for which screening tests are
available and experimental treatments and disease management
strategies for additional newborn conditions beyond those
recommended by the Advisory Committee and adopted by the
Secretary that can be detected through newborn screening for
which treatment is not yet available. In carrying out the
research under this section, the Secretary and the Director
shall ensure that entities receiving funding will focus their
research on screening technology not currently performed in the
State in which the entities are located and the conditions not
on the uniform screening panel. The Director is encouraged to
include information about the activities carried out under this
section in the biennial report required under section 403 of
the National Institutes of Health Reform Act of 2006 and, where
applicable, the Internet clearinghouse established under
section 5 of this bill.
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 XI--GENETIC DISEASES, HEMOPHILIA PROGRAMS, AND SUDDEN INFANT
DEATH SYNDROME
Part A--Genetic Diseases
RESEARCH PROJECT GRANTS AND CONTRACTS
Sec. 1102. * * *
* * * * * * *
SEC. 1109. [300B-8] IMPROVED NEWBORN AND CHILD SCREENING FOR HERITABLE
DISORDERS.
[(a) In General.--The Secretary shall award grants to
eligible entities to enhance, improve or expand the ability of
State and local public health agencies to provide screening,
counseling or health care services to newborns and children
having or at risk for heritable disorders.
[(b) Use of Funds.--Amounts provided under a grant awarded
under subsection (a.) shall be used to--
[(1) establish, expand, or improve systems or
programs to provide screening, counseling, testing or
specialty services for newborns and children at risk
for heritable disorders;
[(2) establish, expand, or improve programs or
services to reduce mortality or morbidity from
heritable disorders;
[(3) establish, expand, or improve systems or
programs to provide information and counseling on
available therapies for newborns and children with
heritable disorders;
[(4) improve the access of medically undeserved
populations to screening, counseling, testing and
specialty services for newborns and children having or
at risk for heritable disorders; or
[(5) conduct such other activities as may be
necessary to enable newborns and children having or at
risk for heritable disorders to receive screening,
counseling, testing or specialty services, regardless
of income, race, color, religion, sex, national origin,
age, or disability.
[(c) Eligible Entities.--To be eligible to receive a grant
under subsection (a) an entity shall--
[(1) be a State or political subdivision of a State,
or a consortium of two or more States or political
subdivisions of States; and
[(2) prepare and submit to the Secretary an
application that includes--
[(A) a plan to use amounts awarded under the
grant to meet specific health status goals and
objectives relative to heritable disorders,
including attention to needs of medically
under-served populations;
[(B) a plan for the collection of outcome
data or other methods of evaluating the degree
to which amounts awarded under this grant will
be used to achieve the goals and objectives
identified under subparagraph (A);
[(C) a plan for monitoring and ensuring the
quality of services provided under the grant;
[(D) an assurance that amounts awarded under
the grant will be used only to implement the
approved plan for the State;
[(E) an assurance that the provision of
services under the plan is coordinated with
services provided under programs implemented in
the State under title V, XVIII, XIX, XX, or XXI
of the Social Security Act (subject to Federal
regulations applicable to such programs) so
that the coverage of services under such titles
is not substantially diminished by the use of
granted funds; and
[(F) such other information determined by the
Secretary to be necessary.]
(a) Authorization of Grant Program.--From amounts
appropriated under subsection (j), the Secretary, acting
through the Administrator of the Health Resources and Services
Administration (referred to in this section as the
``Administrator'') and in consultation with the Advisory
Committee on Heritable Disorders in Newborns and Children
(referred to in this section as the ``Advisory Committee''),
shall award grants to eligible entities to enable such
entities--
(1) to enhance, improve, or expand the ability of
State and local public health agencies to provide
screening, counseling, or health care services to
newborns and children having or at risk for heritable
disorders;
(2) to assist in providing health care professionals
and newborn screening laboratory personnel with
education in newborn screening and training in relevant
and new technologies in newborn screening and
congenital, genetic, and metabolic disorders;
(3) to develop and deliver educational programs (at
appropriate literacy levels) about newborn screening
counseling, testing, follow-up, treatment, and
specialty services to parents, families, and patient
advocacy and support groups; and
(4) to establish, maintain, and operate a system to
assess and coordinate treatment relating to congenital,
genetic, and metabolic disorders.
(b) Eligible Entity.--In this section, the term ``eligible
entity'' means--
(1) a State or a political subdivision of a State;
(2) a consortium of 2 or more States or political
subdivisions of States;
(3) a territory;
(4) a health facility or program operated by or
pursuant to a contract with or grant from the Indian
Health Service; or
(5) any other entity with appropriate expertise in
newborn screening, as determined by the Secretary.
(c) Approval Factors.--An application submitted for a grant
under subsection (a)(1) shall not be approved by the Secretary
unless the application contains assurances that the eligible
entity has adopted and implemented, is in the process of
adopting and implementing, or will use amounts received under
such grant to adopt and implement the guidelines and
recommendations of the Advisory Committee that are adopted by
the Secretary and in effect at the time the grant is awarded or
renewed under this section, which shall include the screening
of each newborn for the heritable disorders recommended by the
Advisory Committee and adopted by the Secretary.
(d) Coordination.--The Secretary shall take all necessary
steps to coordinate programs funded with grants received under
this section and to coordinate with existing newborn screening
activities.
[(d)] (e) Limitation.--* * *
* * * * * * *
[(e)] (f) Voluntary Participation.--* * *
[(f)] (g) Supplement Not Supplant.--* * *
[(g)] (h) Publication.--
(1) In general.--* * *
* * * * * * *
[(h)] (i) Technical Assistance.--* * *
[(i) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section such sums as may
be necessary for each of the fiscal years 2001 through 2005.]
(j) Authorization of Appropriations.--There is authorized
to be appropriated--
(1) to provide grants for the purpose of carrying
activities under section (a)(1), $15,000,000 for fiscal
year 2008; $15,187,500 for fiscal year 2009,
$15,375,000 for fiscal year 2010, $15,562,500 for
fiscal year 2011, and $15,750,000 for fiscal year 2012;
and
(2) to provide grant for the purpose of carrying out
activities under paragraphs (2), (3), and (4) of
subsection (a), $15,000,000 for fiscal year 2008,
$15,187,500 for fiscal year 2009, $15,375,000 for
fiscal year 2010, $15,562,500 for fiscal year 2011, and
$15,750,000 for fiscal year 2012.
* * * * * * *
SEC. 1110. [300B-9] EVALUATING THE EFFECTIVENESS OF NEWBORN AND CHILD
SCREENING PROGRAMS.
(a) In General.--* * *
* * * * * * *
(c) * * *
(d) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section $5,000,000 for
fiscal year 2008, $5,062,500 for fiscal year 2009, $5,125,000
for fiscal year 2010, $5,187,500 for fiscal year 2011, and
$5,250,000 for fiscal year 2012.
* * * * * * *
SEC. 1111. [300B-10] ADVISORY COMMITTEE ON HERITABLE DISORDERS IN
NEWBORNS AND CHILDREN.
(a) Establish.--* * *
(b) Duties.--The Advisory Committee shall--
(1) * * *
(2) provide technical information to the Secretary
for the development of policies and priorities for the
administration of grants under section 1109; [and]
(3) make systematic evidence-based and peer-reviewed
recommendations that include the heritable disorders
that have the potential to significantly impact public
health for which all newborns should be screened,
including secondary conditions that may be identified
as a result of the laboratory methods used for
screening;
(4) develop a model decision-matrix for newborn
screening expansion, including an evaluation of the
potential public health impact of such expansion, and
periodically update the recommended uniform screening
panel, as appropriate, based on such decision-matrix;
(5) consider was to ensure that all States attain the
capacity to screen for the conditions described in
paragraph (3), and include in such consideration the
results of grant funding under section 1109; and
[(3)] (6) provide such recommendations, advice or
information as may be necessary to enhance, expand or
improve the ability of the Secretary to reduce the
mortality or morbidity from heritable disorders[.],
which may include recommendations, advice, or
information dealing with--
(A) follow-up activities, including those
necessary to achieve rapid diagnosis in the
short-term, and those that ascertain long-term
case management outcomes and appropriate access
to related services;
(B) implementation, monitoring, and
evaluation of newborn screening activities,
including diagnosis, screening, follow-up, and
treatment activities;
(C) diagnostic and other technology used in
screening;
(D) the availability and reporting of testing
for conditions for which there is no existing
treatment;
(E) conditions not included in the
recommended uniform screening panel that are
treatable with Food and Drug Administration-
approved products or other safe and effective
treatments, as determined by scientific
evidence and peer review;
(F) minimum standards and related policies
and procedures used by State newborn screening
programs, such as language and terminology used
by State newborn screening programs to include
standardization of case definitions and names
of disorders for which newborn screening tests
are performed;
(G) quality assurance, oversight, and
evaluation of State newborn screening programs,
including ensuring that tests and technologies
used by each State meet established standards
for detecting and reporting positive screening
results;
(H) public and provider awareness and
education;
(I) the cost and effectiveness of newborn
screening and medical evaluation systems and
intervention programs conducted by State-based
programs;
(J) identification of the causes of, public
health impacts of, and risk factors for
heritable disorders; and
(K) coordination of surveillance activities,
including standardized data collection and
reporting, harmonization of laboratory
definitions for heritable disorders and testing
results, and confirmatory testing and
verification of positive results, in order to
assess and enhance monitoring of newborn
diseases.
(c) Membership.--
(1) In general.--* * *
(2) Required members.--* * *
(A) * * *
* * * * * * *
(D) * * *
(E) the Commissioner of the Food and Drug
Administration;
[(E)] (F) * * *
(G) individuals with expertise in ethics and
infectious diseases who have worked and
published material in the area of newborn
screening;
[(F)] (H) * * *
[(G)] (I) * * *
(d) Decision on Recommendations.--
(1) In general.--Not later than 180 days after the
Advisory Committee issues a recommendation pursuant to
this section, the Secretary shall adopt or reject such
recommendation.
(2) Pending recommendations.--The Secretary shall
adopt or reject any recommendation issued by the
Advisory Committee that is pending on the date of
enactment of the Newborn Screening Saves Lives Act of
2007 by not later than 180 days after the date of
enactment of such Act.
(3) Determinations to be made public.--The Secretary
shall publicize any determination on adopting or
rejecting a recommendation of the Advisory Committee
pursuant to this subsection, including the
justification for the determination.
(e) Annual Report.--Not later than 3 years after the date
of enactment of the Newborn Screening Saves Lives Act of 2007,
and each fiscal year thereafter, the Advisory Committee shall--
(1) publish a report on peer-reviewed newborn
screening guidelines, including follow-up and
treatment, in the United States;
(2) submit such report to the appropriate committees
of Congress, the Secretary, and the State departments
of health; and
(3) disseminate such report on as wide a basis as
practicable, including through posting on the internet
clearinghouse established under section 1112.
(f) Continuation of Operation of Committee.--
Notwithstanding section 14 of the Federal Advisory Committee
Act (5 U.S.C. App.), the Advisory Committee shall continue to
operate during the 5-year period beginning on the date of
enactment of the Newborn Screening Saves Lives Act of 2007.
(g) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section, $1,000,000 for
fiscal year 2008, $1,012,500 for fiscal year 2009, $1,025,000
for fiscal year 2010, $1,037,500 for fiscal year 2011, and
$1,050,000 for fiscal year 2012.
* * * * * * *
SEC. 1112. CLEARINGHOUSE OF NEWBORN SCREENING INFORMATION.
(a) In General.--The Secretary, acting through the
Administrator of the Health Resources and Services
Administration (referred to in this part as the
``Administrator''), in consultation with the Director of the
Centers for Disease Control and Prevention and the Director of
the National Institutes of Health, shall establish and maintain
a central clearinghouse of current educational and family
support and services information, materials, resources,
research, and data on newborn screening to--
(1) enable parents and family members of newborns,
health professionals, industry representatives, and
other members of the public to increase their
awareness, knowledge, and understanding of newborn
screening;
(2) increase awareness, knowledge, and understanding
of newborn diseases and screening services for
expectant individuals and families; and
(3) maintain current data on quality indicators to
measure performance of newborn screening, such as
false-positive rates and other quality indicators as
determined by the Advisory Committee under section
1111.
(b) Internet Availability.--The Secretary, acting through
the Administrator, shall ensure that the clearinghouse
described under subsection (a)--
(1) is available on the Internet;
(2) includes an interactive forum;
(3) is updated on a regular basis, but not less than
quarterly; and
(4) provides--
(A) links to Government-sponsored, non-
profit, and other Internet websites of
laboratories that have demonstrated expertise
in newborn screening that supply research-based
information on newborn screening tests
currently available throughout the United
States;
(B) information about newborn conditions and
screening services available in each State from
laboratories certified under subpart 2 of part
F of title III, including information about
supplemental screening that is available but
not required, in the State where the infant is
born;
(C) current research on both treatable and
non-yet treatable conditions for which newborn
screening tests are available;
(D) the availability of Federal funding for
newborn and child screening for heritable
disorders including grants authorized under the
Newborn Screening Saves Lives Act of 2007; and
(E) other relevant information as determined
appropriate by the Secretary.
(c) Nonduplication.--In developing the clearinghouse under
this section, the Secretary shall ensure that such
clearinghouse minimizes duplication and supplements, not
supplants, existing information sharing efforts.
(d) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section, $2,500,000 for
fiscal year 2008, $2,531,250 for fiscal year 2009, $2,562,500
for fiscal year 2010, $2,593,750 for fiscal year 2011, and
$2,625,000 for fiscal year 2012.
* * * * * * *
SEC. 1113. LABORATORY QUALITY.
(a) In General.--The Secretary, acting through the Director
of the Centers for Disease Control and Prevention and in
consultation with, the Advisory Committee on Heritable
Disorders in Newborns and Children established under section
1111, shall provide for--
(1) quality assurance for laboratories involved in
screening newborns and children for heritable
disorders, including quality assurance for newborn-
screening tests, performance evaluation services, and
technical assistance and technology transfer to newborn
screening laboratories to ensure analytic validity and
utility of screening tests; and
(2) appropriate quality control and other performance
test materials to evaluate the performance of new
screening tools.
(b) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated $5,000,000 for fiscal year 2008, $5,062,500 for
fiscal year 2009, $5,125,000 for fiscal year 2010, $5,187,500
for fiscal year 2011, and $5,250,000 for fiscal year 2012.
SEC. 1114. SURVEILLANCE PROGRAMS FOR HERITABLE DISORDERS SCREENING.
(a) In General.--The Secretary, acting through an
Interagency Group consisting of the Director of the Agency for
Healthcare Research and Quality, the Director of the Centers
for Disease Control and Prevention, the Administrator, and the
Director of the National Institutes of Health, shall build upon
existing activities and infrastructure to carry out programs--
(1) to collect, analyze, and make available data on
the heritable disorders recommended by the Advisory
Committee on Heritable Disorders in Newborns and
Children established under section 1111, including data
on the incidence and prevalence of, as well as poor
health outcomes resulting from, such disorders;
(2) to identify regional centers for the conduct of
applied epidemiological research on effective
interventions for such disorders for the prevention of
poor health outcomes;
(3) to provide information and education to the
public on effective interventions for the prevention of
poor health outcomes resulting from such disorders; and
(4) to conduct research on and to promote the
prevention of poor health outcomes resulting from such
disorders, and secondary health conditions among
individuals with such disorders.
(b) Grants and Contracts.--
(1) In general.--In carrying out subsection (a), the
Secretary may make grants to and enter into contracts
with public and nonprofit private entities.
(2) Supplies and services in lieu of award funds.--
(A) In general.--Upon the request of a
recipient of an award of a grant or contract
under paragraph (1), the Secretary may, subject
to subparagraph (B), provide supplies,
equipment, and services for the purpose of
aiding the recipient in carrying out the
purposes for which the award is made and, for
such purposes, may detail to the recipient any
officer or employee of the Department of Health
and Human Services.
(B) Reduction.--With respect to a request
described in subparagraph (A), the Secretary
shall reduce the amount of payments under the
award involved by an amount equal to the costs
of detailing personnel and the fair market
value of any supplies, equipment, or services
provided by the Secretary. The Secretary shall,
for the payment of expenses incurred in
complying with such request, expend the amounts
withheld.
(3) Application for award.--The Secretary may make an
award of a grant or contract under paragraph (1) only
if an application for the award is submitted to the
Secretary and the application is in such form, is made
in such manner, and contains such agreements,
assurances, and information as the Secretary determines
to be necessary to carry out the purposes for which the
award is to be made.
(c) Reports to Congress.--
(1) In general.--Subject to paragraph (2), the
Secretary shall submit to the relevant committees of
Congress reports--
(A) containing information under paragraph
(1) that is specific to various racial, ethnic,
and socioeconomic groups;
(B) containing an assessment of the extent to
which various approaches of preventing
heritable disorders and secondary health
conditions among individuals with such
disorders have been effective;
(C) describing the activities carried out
under this section;
(D) containing information on the incidence
and prevalence of individuals living with
heritable disorders, information on the health
status of individuals with such disorders
including the extent to which such disorders
have contributed to the incidence and
prevalence of infant mortality, information on
any health disparities experienced by such
individuals, and recommendations for improving
the health and wellness and quality of life of
such individuals;
(E) containing a summary of recommendations
from all heritable disorders research
conferences sponsored by the Centers for
Disease Control and Prevention or the National
Institutes of Health; and
(F) containing any recommendations of the
Secretary regarding this section.
(2) Timing of reports.--The Secretary shall submit--
(A) an interim report that includes the
information described in paragraph (1), not
later than 30 months after the date on which
the first grant funds are awarded under this
section; and
(B) a subsequent report that includes the
information described in paragraph (1), not
later than 60 months after the date on which
the first grant funds are awarded under this
section.
(d) Coordination.--
(1) In general.--In carrying out this section, the
Secretary shall coordinate, to the extent practicable,
programs under this section with programs on birth
defects and developmental disabilities authorized under
section 317C.
(2) Priority in grants and contracts.--In making
grants and contracts under this section, the Secretary
shall give priority to entities that demonstrate the
ability to coordinate activities under a grant or
contract made under this section with existing birth
defects surveillance activities.
(e) Authorization of appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated $15,000,000 for fiscal year 2008, $15,187,500 for
fiscal year 2009, $15,375,000 for fiscal year 2010, $15,562,500
for fiscal year 2011, and $15,750,000 for fiscal year 2012.
* * * * * * *
SEC. 1115. NATIONAL CONTINGENCY PLAN FOR NEWBORN SCREENING.
(a) In general.--Not later than 180 days after the date of
enactment of this section, the Secretary, acting through the
Director of the Centers for Disease Control and Prevention and
in consultation with the Administrator and State departments of
health (or related agencies), shall develop a national
contingency plan for newborn screening for use by a State,
region, or consortia of States in the event of a public health
emergency.
(b) Contents.--The contingency plan developed under
subsection (a) shall include a plan for--
(1) the collection and transport of specimens;
(2) the shipment of specimens to State newborn
screening laboratories;
(3) the processing of specimens;
(4) the reporting of screening results to physicians
and families;
(5) the diagnostic confirmation of positive screening
results;
(6) ensuring the availability of treatment and
management resources;
(7) educating families about newborn screening; and
(8) carrying out other activities determined
appropriate by the Secretary.
SEC. 1116. HUNTER KELLY RESEARCH PROGRAM.
(a) Newborn Screening Activities.--
(1) In general.--The Secretary, in conjunction with
the Director of the National Institutes of Health and
taking into consideration the recommendations of the
Advisory Committee, may continue carrying out,
coordinating, and expanding research in newborn
screening (to be known as ``Hunter Kelly Newborn
Screening Research Program'') including--
(A) identifying, developing, and testing the
most promising new screening technologies, in
order to improve already existing screening
tests, increase the specificity of newborn
screening, and expand the number of conditions
for which screening tests are available;
(B) experimental treatments and disease
management strategies for additional newborn
conditions, and other genetic, metabolic,
hormonal and or functional conditions that can
be detected through newborn screening for which
treatment is not yet available; and
(C) other activities that would improve
newborn screening, as identified by the
Director.
(2) Additional newborn condition.--For purposes of
this subsection, the term ``additional newborn
condition'' means any condition that is not one of the
core conditions recommended by the Advisory Committee
and adopted by the Secretary.
(b) Funding.--In carrying out the research program under
this section, the Secretary and the Director shall ensure that
entities receiving funding through the program will provide
assurances, as practicable, that such entities will work in
consultation with the appropriate State departments of health,
and, as practicable, focus their research. on screening
technology not currently performed in the States in which the
entities are located, and the conditions on the uniform
screening parcel (or the standard test existing on the uniform
screening panel).
(c) Reports.--The Director is encouraged to include
information about the activities carried out under this section
in the biennial report required under section 403 of the
National Institutes of Health Reform Act of 2006. If such
information is included, the Director shall make such
information available to be included on the Internet
Clearinghouse established under section 1112.
(d) Nonduplication.--In carrying out programs under this
section, the Secretary shall minimize duplication and
supplement, not supplant, existing efforts of the type carried
out under this section.
(e) Peer Review.--Nothing in this section shall be
construed to interfere with the scientific peer-review process
at the National Institutes of Health.
* * * * * * *
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