69–010 

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 


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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 


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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 


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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; opVerDate Aug 31 2005 01:20 Apr 10, 2008 Jkt 069010 PO 00000 Frm 00004 Fmt 6659 Sfmt 6602 E:\HR\OC\SR280.XXX SR280

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tions 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 


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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, lifesaving, 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 reVerDate Aug 31 2005 01:20 Apr 10, 2008 Jkt 069010 PO 00000 Frm 00006 Fmt 6659 Sfmt 6602 E:\HR\OC\SR280.XXX SR280

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lated 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 


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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. 


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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. 


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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, followup 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 


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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 


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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 


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13 

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 matVerDate Aug 31 2005 01:20 Apr 10, 2008 Jkt 069010 PO 00000 Frm 00013 Fmt 6659 Sfmt 6602 E:\HR\OC\SR280.XXX SR280

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ter 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. 

ø(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. 

ø(b) USE OF FUNDS.—Amounts provided under a grant awarded 

under subsection (a.) shall be used to—

ø(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; 

ø(2) establish, expand, or improve programs or services to reduce mortality or morbidity from heritable disorders; 

ø(3) establish, expand, or improve systems or programs to 

provide information and counseling on available therapies for 

newborns and children with heritable disorders; 

ø(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 

ø(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. 

ø(c) ELIGIBLE ENTITIES.—To be eligible to receive a grant under 

subsection (a) an entity shall—

ø(1) be a State or political subdivision of a State, or a consortium of two or more States or political subdivisions of States; 

and 

ø(2) prepare and submit to the Secretary an application that 

includes—

ø(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; 

ø(B) a plan for the collection of outcome data or other 

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smartinez on PRODPC60 with REPORTS
15 

ed under this grant will be used to achieve the goals and 

objectives identified under subparagraph (A); 

ø(C) a plan for monitoring and ensuring the quality of 

services provided under the grant; 

ø(D) an assurance that amounts awarded under the 

grant will be used only to implement the approved plan for 

the State; 

ø(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 

ø(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 


smartinez on PRODPC60 with REPORTS
16 

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. 

ø(d)¿ (e) LIMITATION.—* * * 

* * * * * * * 

ø(e)¿ (f) VOLUNTARY PARTICIPATION.—* * * 

ø(f)¿ (g) SUPPLEMENT NOT SUPPLANT.—* * * 

ø(g)¿ (h) PUBLICATION.—

(1) IN GENERAL.—* * * 

* * * * * * * 

ø(h)¿ (i) TECHNICAL ASSISTANCE.—* * * 

ø(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; øand¿ 


smartinez on PRODPC60 with REPORTS
17 

(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 

ø(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 disordersø.¿, 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 


smartinez on PRODPC60 with REPORTS
18 

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; 

ø(E)¿ (F) * * * 

(G) individuals with expertise in ethics and infectious 

diseases who have worked and published material in the 

area of newborn screening; 

ø(F)¿ (H) * * * 

ø(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. 

* * * * * * * 


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19 

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 


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20 

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 recipiVerDate Aug 31 2005 01:20 Apr 10, 2008 Jkt 069010 PO 00000 Frm 00020 Fmt 6659 Sfmt 6603 E:\HR\OC\SR280.XXX SR280

smartinez on PRODPC60 with REPORTS
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ent 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.—


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(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 


smartinez on PRODPC60 with REPORTS
23 

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. 

* * * * * * * 

Æ 


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