[Senate Report 110-280]
[From the U.S. Government Publishing Office]



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:
           Follow-up activities including those 
        necessary to achieve rapid diagnosis in the short-term 
        and those that ascertain long-term case management 
        outcomes;
           Implementation, monitoring, and evaluation 
        of newborn screening activities, including diagnosis, 
        screening, follow-up, and treatment activities;
           Quality assurance, oversight, and evaluation 
        of State newborn screening programs;
           The availability and reporting of testing 
        for conditions for which there is no existing 
        treatment;
           Standardized data collection and reporting 
        for assessment of newborn screening programs;
           The cost and effectiveness of newborn 
        screening and medical evaluation systems and 
        intervention programs conducted by State-based 
        programs; and
           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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