PUBLIC LAW 110–204—APR. 24, 2008 122 STAT. 705 

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 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; 

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 subdivisions of States; 

‘‘(3) a territory; 

‘‘(4) a health facility or program operated by or pursuant 

to a contract with or grant from the Indian Health Service; 

or 

‘‘(5) any other entity with appropriate expertise in newborn 

screening, as determined by the Secretary. 

‘‘(c) APPROVAL FACTORS.—An application submitted for a grant 

under subsection (a)(1) shall not be approved by the Secretary 

unless the application contains assurances that the eligible entity 

has adopted and implemented, is in the process of adopting and 

implementing, or will use amounts received under such grant to 

adopt and implement the guidelines and recommendations of the 

Advisory Committee that are adopted by the Secretary and in 

effect at the time the grant is awarded or renewed under this 

section, which shall include the screening of each newborn for 

the heritable disorders recommended by the Advisory Committee 

and adopted by the Secretary.’’; 

(2) by redesignating subsections (d) through (i) as subsections (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 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. 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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PUBLIC LAW 110–204—APR. 24, 2008 122 STAT. 707 

(B) in paragraph (2), by striking ‘‘and’’ after the semicolon; 

(C) by inserting after paragraph (2) the following: 

‘‘(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 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 subparagraph (A)), by striking the period at the end and inserting 

‘‘, 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 


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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 newborn 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 Administration;’’; and 

(C) by inserting after subparagraph (F), as so redesignated, 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 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, the Interagency Coordinating Committee established under Section 1114, and the State departments of health; and 

‘‘(3) disseminate such report on as wide a basis as practicable, including through posting on the internet clearinghouse 

established under section 1112. 

‘‘(f) CONTINUATION OF OPERATION OF COMMITTEE.—Notwithstanding section 14 of the Federal Advisory Committee Act (5 

U.S.C. App.), the Advisory Committee shall continue to operate 

during the 5-year period beginning on the date of enactment of 

the Newborn Screening Saves Lives Act of 2007. 

‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—There are authorized 

to be appropriated to carry out this section, $1,000,000 for fiscal 

year 2008, $1,012,500 for fiscal year 2009, $1,025,000 for fiscal 

year 2010, $1,037,500 for fiscal year 2011, and $1,050,000 for fiscal 

year 2012.’’. 

SEC. 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: 

Website. 

Deadlines. 


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PUBLIC LAW 110–204—APR. 24, 2008 122 STAT. 709 

‘‘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 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 appropriate by the Secretary. 

‘‘(c) NONDUPLICATION.—In developing the clearinghouse under 

this section, the Secretary shall ensure that such clearinghouse 

minimizes duplication and supplements, not supplants, existing 

information sharing efforts. 

‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There are authorized 

to be appropriated to carry out this section, $2,500,000 for fiscal 

year 2008, $2,531,250 for fiscal year 2009, $2,562,500 for fiscal 

year 2010, $2,593,750 for fiscal year 2011, and $2,625,000 for fiscal 

year 2012.’’. 

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 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. 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 authorized 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 Committee 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 disorders; 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 Interagency Coordinating Committee on Newborn and Child Screening 

(referred to in this section as the ‘Interagency Coordinating Committee’) 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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‘‘(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 consultation with the Administrator and State departments of health (or 

related agencies), shall develop a national contingency plan for 

newborn screening for use by a State, region, or consortia of States 

in the event of a public health emergency. 

‘‘(b) CONTENTS.—The contingency plan developed under subsection (a) shall include a plan for— 

‘‘(1) the collection and transport of specimens; 

‘‘(2) the shipment of specimens to State newborn screening 

laboratories; 

‘‘(3) the processing of specimens; 

‘‘(4) the reporting of screening results to physicians and 

families; 

‘‘(5) the diagnostic confirmation of positive screening 

results; 

‘‘(6) ensuring the availability of treatment and management 

resources; 

‘‘(7) educating families about newborn screening; and 

‘‘(8) carrying out other activities determined appropriate 

by the Secretary. 

‘‘SEC. 1116. HUNTER KELLY RESEARCH PROGRAM. 

‘‘(a) NEWBORN SCREENING ACTIVITIES.— 

‘‘(1) IN GENERAL.—The Secretary, in conjunction with the 

Director of the National Institutes of Health and taking into 

consideration the recommendations of the Advisory Committee, 

may continue carrying out, coordinating, and expanding 

research in newborn screening (to be known as ‘Hunter Kelly 

Newborn Screening Research Program’) including— 

‘‘(A) identifying, developing, and testing the most promising new screening technologies, in order to improve 

already existing screening tests, increase the specificity 

of newborn screening, and expand the number of conditions 

for which screening tests are available; 

‘‘(B) experimental treatments and disease management 

strategies for additional newborn conditions, and other 

genetic, metabolic, hormonal and or functional conditions 

that can be detected through newborn screening for which 

treatment is not yet available; and 

‘‘(C) other activities that would improve newborn 

screening, as identified by the Director. 

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 Pensions). 

CONGRESSIONAL RECORD: 

Vol. 153 (2007): Dec. 13, considered and passed Senate. 

Vol. 154 (2008): Apr. 8, considered and passed House. 

Æ 

‘‘(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 panel (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.’’. 

Approved April 24, 2008. 

Website. 


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