Newborn Screening Saves Lives Act of 2007
PL 110-204 (S.1858), enacted 04/24/2008

122 STAT. 705 
PUBLIC LAW 110–204—APR. 24, 2008 
Public Law 110–204 
110th Congress 
An Act 
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. 
Be it enacted by the Senate and House of Representatives of 
the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Newborn Screening Saves Lives 
Act of 2007’’. 
SEC. 2. IMPROVED NEWBORN AND CHILD SCREENING FOR HERITABLE 
DISORDER. 
Section 1109 of the Public Health Service Act (42 U.S.C. 300b– 
8) is amended— 
(1) by striking subsections (a), (b), and (c) and inserting 
the following: 
‘‘(a) AUTHORIZATION
OF
GRANT
PROGRAM.—From amounts 
appropriated under subsection (j), the Secretary, acting through 
the Administrator of the Health Resources and Services Administra-
tion (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, coun-
seling, 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 new-
born 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 appro-
priate 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; 
Newborn 
Screening Saves 
Lives Act of 2007. 
42 USC 201 note. 
Apr. 24, 2008 
[S. 1858] 
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122 STAT. 706 
PUBLIC LAW 110–204—APR. 24, 2008 
‘‘(2) a consortium of 2 or more States or political subdivi-
sions 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.’’; 
(2) by redesignating subsections (d) through (i) as sub-
sections (e) through (j), respectively; 
(3) by inserting after subsection (c), the following: 
‘‘(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.’’; and 
(4) by striking subsection (j) (as so redesignated) and 
inserting the following: 
‘‘(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 activi-
ties 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. 3. EVALUATING THE EFFECTIVENESS OF NEWBORN AND CHILD 
SCREENING PROGRAMS. 
Section 1110 of the Public Health Service Act (42 U.S.C. 300b– 
9) is amended by adding at the end the following: 
‘‘(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. 4. ADVISORY COMMITTEE ON HERITABLE DISORDERS IN 
NEWBORNS AND CHILDREN. 
Section 1111 of the Public Health Service Act (42 U.S.C. 300b– 
10) is amended— 
(1) in subsection (b)— 
(A) by redesignating paragraph (3) as paragraph (6); 
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122 STAT. 707 
PUBLIC LAW 110–204—APR. 24, 2008 
(B) in paragraph (2), by striking ‘‘and’’ after the semi-
colon; 
(C) by inserting after paragraph (2) the following: 
‘‘(3) make systematic evidence-based and peer-reviewed rec-
ommendations 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 rec-
ommended uniform screening panel, as appropriate, based on 
such decision-matrix; 
‘‘(5) consider ways 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’’; 
(D) in paragraph (6) (as so redesignated by subpara-
graph (A)), by striking the period at the end and inserting 
‘‘, which may include recommendations, advice, or informa-
tion 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 appro-
priate 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 condi-
tions for which there is no existing treatment; 
‘‘(E) conditions not included in the recommended uni-
form 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 proce-
dures 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 
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122 STAT. 708 
PUBLIC LAW 110–204—APR. 24, 2008 
results, and confirmatory testing and verification of positive 
results, in order to assess and enhance monitoring of new-
born diseases.’’; and 
(2) in subsection (c)(2)— 
(A) by redesignating subparagraphs (E), (F) and (G) 
as subparagraphs (F), (H), and (I); 
(B) by inserting after subparagraph (D) the following: 
‘‘(E) the Commissioner of the Food and Drug Adminis-
tration;’’; and 
(C) by inserting after subparagraph (F), as so redesig-
nated, the following: 
‘‘(G) individuals with expertise in ethics and infectious 
diseases who have worked and published material in the 
area of newborn screening;’’; and 
(3) by adding at the end the following: 
‘‘(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 recommenda-
tion. 
‘‘(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, the Interagency Coordinating Com-
mittee established under Section 1114, and the State depart-
ments of health; and 
‘‘(3) disseminate such report on as wide a basis as prac-
ticable, including through posting on the internet clearinghouse 
established under section 1112. 
‘‘(f) CONTINUATION
OF OPERATION
OF COMMITTEE.—Notwith-
standing 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. 5. INFORMATION CLEARINGHOUSE. 
Part A of title XI of the Public Health Service Act (42 U.S.C. 
300b–1 et seq.) is amended by adding at the end the following: 
Web site. 
Deadlines. 
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122 STAT. 709 
PUBLIC LAW 110–204—APR. 24, 2008 
‘‘SEC. 1112. CLEARINGHOUSE OF NEWBORN SCREENING INFORMATION. 
‘‘(a) IN GENERAL.—The Secretary, acting through the Adminis-
trator 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 mem-
bers 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 individ-
uals 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 quar-
terly; and 
‘‘(4) provides— 
‘‘(A) links to Government-sponsored, non-profit, and 
other Internet websites of laboratories that have dem-
onstrated expertise in newborn screening that supply 
research-based information on newborn screening tests cur-
rently 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 not-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 appro-
priate 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.’’. 
Establishment. 
42 USC 300b–11. 
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122 STAT. 710 
PUBLIC LAW 110–204—APR. 24, 2008 
SEC. 6. LABORATORY QUALITY AND SURVEILLANCE. 
Part A of title XI of the Public Health Service Act (42 U.S.C. 
300b–1 et seq.), as amended by section 5, is further amended 
by adding at the end the following: 
‘‘SEC. 1113. LABORATORY QUALITY. 
‘‘(a) IN GENERAL.—The Secretary, acting through the Director 
of the Centers for Disease Control and Prevention and in consulta-
tion with the Advisory Committee on Heritable Disorders in 
Newborns and Children established under section 1111, shall pro-
vide 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. INTERAGENCY COORDINATING COMMITTEE ON NEWBORN 
AND CHILD SCREENING. 
‘‘(a) PURPOSE.—It is the purpose of this section to— 
‘‘(1) assess existing activities and infrastructure, including 
activities on birth defects and developmental disabilities author-
ized under section 317C, in order to make recommendations 
for programs to collect, analyze, and make available data on 
the heritable disorders recommended by the Advisory Com-
mittee on Heritable Disorders in Newborns and Children under 
section 1111, including data on the incidence and prevalence 
of, as well as poor health outcomes resulting from, such dis-
orders; and 
‘‘(2) make recommendations for the establishment of 
regional centers for the conduct of applied epidemiological 
research on effective interventions to promote the prevention 
of poor health outcomes resulting from such disorders as well 
as providing information and education to the public on such 
effective interventions. 
‘‘(b) ESTABLISHMENT.—The Secretary shall establish an Inter-
agency Coordinating Committee on Newborn and Child Screening 
(referred to in this section as the ‘Interagency Coordinating Com-
mittee’) to carry out the purpose of this section. 
‘‘(c) COMPOSITION.—The Interagency Coordinating Committee 
shall be composed of the Director of the Centers for Disease Control 
and Prevention, the Administrator, the Director of the Agency for 
Healthcare Research and Quality, and the Director of the National 
Institutes of Health, or their designees. 
‘‘(d) ACTIVITIES.—The Interagency Coordinating Committee 
shall— 
‘‘(1) report to the Secretary and the appropriate committees 
of Congress on its recommendations related to the purpose 
described in subsection (a); and 
Reports. 
42 USC 300b–13. 
42 USC 300b–12. 
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122 STAT. 711 
PUBLIC LAW 110–204—APR. 24, 2008 
‘‘(2) carry out other activities determined appropriate by 
the Secretary. 
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of 
carrying out this section, there are authorized to be appropriated 
$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. 7. CONTINGENCY PLANNING. 
Part A of title XI of the Public Health Service Act (42 U.S.C. 
300b–1 et seq.), as amended by section 6, is further amended 
by adding at the end the following: 
‘‘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 consulta-
tion 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 sub-
section (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 prom-
ising 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. 
42 USC 300b–15. 
Deadline. 
42 USC 300b–14. 
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122 STAT. 712 
PUBLIC LAW 110–204—APR. 24, 2008 
LEGISLATIVE HISTORY—S. 1858 (H.R. 3825): 
HOUSE REPORTS: No. 110–570 accompanying H.R. 3825 (Comm. on Energy and 
Commerce). 
SENATE REPORTS: No. 110–280 (Comm. on Health, Education, Labor, and Pen-
sions). 
CONGRESSIONAL RECORD: 
Vol. 153 (2007): Dec. 13, considered and passed Senate. 
Vol. 154 (2008): Apr. 8, considered and passed House. 
‘‘(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 rec-
ommended 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 enti-
ties 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 panel (or the standard test existing on 
the uniform screening panel). 
‘‘(c) REPORTS.—The Director is encouraged to include informa-
tion 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.’’. 
Approved April 24, 2008. 
Web site. 
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