I 
110TH CONGRESS 
1ST SESSION H. R. 2889 
To amend the Public Health Service Act to improve newborn screening 
activities, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 27, 2007 
Mr. REYNOLDS introduced the following bill; which was referred to the 
Committee on Energy and Commerce 
A BILL 
To amend the Public Health Service Act to improve newborn 
screening activities, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Screening for Health of Infants and Newborns Act’’ or 
the ‘‘SHINE Act’’. 
SEC. 2. PURPOSES. 
The purposes of this Act are the following: 
(1) To ensure the health and quality of life of 
all newborns in the United States by enhancing the 
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capacity to screen for heritable diseases. This en-
hanced capacity will assist the States in making 
progress toward the following goals: 
(A) All babies born in hospitals in the 
United States and the territories of the United 
States should have access to, and be screened 
for, certain core conditions. 
(B) Appropriate newborn screening evalua-
tions should be conducted for all newborns to 
allow appropriate referrals and provisions for 
early medical intervention. 
(C) Newborn screening data collection 
should be standardized, and conditions detected 
by newborn screening should be tracked and 
monitored. 
(D) Information on newborn screening and 
conditions for which a patient can be screened 
should be readily accessible, current, and under-
standable to both health care providers and par-
ents. Information should include the following: 
(i) A component for rehabilitation, 
medical, and early intervention options 
that ensure linkage to any new and exist-
ing national or State system of interven-
tion. 
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(ii) 
Rehabilitative 
services 
for 
newborns with the conditions. 
(E) Newborn screening should be expanded 
to include more conditions, and additional new-
born screening tests should be developed to en-
hance the health of newborns. 
(2) To expand newborn screening, and improve 
systems to make newborn screening more efficient 
and effective, by authorizing— 
(A) statewide newborn screening and med-
ical evaluation systems and intervention pro-
grams; 
(B) technical assistance; 
(C) national demonstration grant pro-
grams; and 
(D) interagency collaborations between the 
appropriate Federal agencies, including the 
Agency for Healthcare Research and Quality, 
Centers for Disease Control and Prevention, 
Food and Drug Administration, Health Re-
sources and Services Administration, and Na-
tional Institutes of Health. 
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SEC. 3. NEWBORN SCREENING GUIDELINES AND GRANT 
PROGRAMS. 
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: 
‘‘SEC. 1112. RECOMMENDED GUIDELINES FOR NEWBORN 
SCREENING AND DATA COLLECTION; MONI-
TORING AND EVALUATION. 
‘‘(a) RECOMMENDED GUIDELINES
FOR NEWBORN 
SCREENING AND DATA COLLECTION.— 
‘‘(1) IN GENERAL.—The Director of the Cen-
ters for Disease Control and Prevention (referred to 
in this section as the ‘Director’), in collaboration 
with the Associate Administrator of the Maternal 
and Child Health Bureau of the Health Resources 
and Services Administration and the Advisory Com-
mittee on Heritable Disorders and Genetic Diseases 
in Newborns and Children (referred to in this sec-
tion as the ‘Advisory Committee’), shall develop spe-
cific guidelines that the States may follow in report-
ing newborn screening data, as requested by the Ad-
visory Committee, from newborn screening tests, in-
cluding the screening tests for the core conditions 
designated by the Newborn Screening Expert Group 
convened by the American College of Medical Genet-
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ics, as commissioned by the Health Resources and 
Services Administration. 
‘‘(2) GUIDELINES.—The guidelines developed 
under paragraph (1) shall include— 
‘‘(A) standardizing the case definitions and 
names of the disorders for which newborn 
screening tests are performed and the defini-
tions of performance measures used to evaluate 
such tests so that performance criteria and out-
comes among all States may be evaluated; 
‘‘(B) establishing procedures for standard-
ized newborn screening data collection and re-
porting; and 
‘‘(C) ensuring that tests and technologies 
used by each State meet established standards 
for detecting and reporting positive screening 
results. 
‘‘(3) IMPLEMENTATION.—The Director shall 
submit the guidelines described in this subsection to 
the Secretary. Not later than 90 days after receiving 
the guidelines, the Secretary, in consultation with 
the Director, the Administrator of the Health Re-
sources and Services Administration (referred to in 
this section as the ‘Administrator’), and the Assist-
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ant Administrator of the Maternal and Child Health 
Bureau, shall implement such guidelines. 
‘‘(4) ANNUAL REPORT.—Not later than 2 years 
after the date of enactment of the Screening for 
Health of Infants and Newborns Act, and each year 
thereafter, the Advisory Committee shall— 
‘‘(A) publish an annual report on newborn 
screening guidelines in the United States; 
‘‘(B) submit such report to the appropriate 
committees of Congress, the Secretary, and the 
State departments of health; and 
‘‘(C) disseminate such report on as wide a 
basis as practicable. 
‘‘(b) RECOMMENDED GUIDELINES FOR MONITORING, 
EVALUATION, 
AND
SURVEILLANCE
OF
NEWBORN 
SCREENING.— 
‘‘(1) IN GENERAL.— 
‘‘(A) DEVELOPMENT.—The Secretary, act-
ing through the Administrator and in consulta-
tion with the Director and the Advisory Com-
mittee, shall develop guidelines to— 
‘‘(i) monitor and evaluate newborn 
screening activities, including diagnosis, 
screening, follow-up, and treatment activi-
ties, in the United States; and 
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‘‘(ii) coordinate the results of surveil-
lance activities in order to enhance moni-
toring of newborn diseases. 
‘‘(B) DUTIES.—In carrying out this para-
graph, the Administrator, in consultation with 
the Advisory Committee and the Director, shall 
collaborate with non-Governmental organiza-
tions, such as the Joint Commission on Accredi-
tation of Hospital Organizations, laboratories 
certified by the Clinical Laboratory Improve-
ment Amendment (referred to in the part as 
‘CLIA’), and the Association of Public Health 
Laboratories to ensure effective monitoring and 
evaluation of newborn screening activities. 
‘‘(2) IMPLEMENTATION.—Not later than 90 
days after the development of the guidelines under 
paragraph (1), the Secretary, in consultation with 
the Director, the Administrator, and the Assistant 
Administrator of the Maternal and Child Health Bu-
reau, shall implement such guidelines. 
‘‘(c) SURVEILLANCE
AND
IDENTIFICATION
RE-
SEARCH.—The Secretary, acting through the Director and 
the National Center on Birth Defects and Developmental 
Disabilities, and in consultation with the Administrator 
and Advisory Committee, shall develop a surveillance sys-
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tem for newborn screening. The system shall use the 
standardized procedures and guidelines developed under 
subsection (b) for data management and tracking program 
effectiveness and costs, in order to— 
‘‘(1) ensure quality monitoring of newborn 
screening and medical evaluation systems and inter-
vention programs; 
‘‘(2) provide technical assistance on data collec-
tion and management; 
‘‘(3) study the cost and effectiveness of new-
born screening and medical evaluation systems and 
intervention programs conducted by State-based pro-
grams in order to answer issues of importance to na-
tional and State policymakers; and 
‘‘(4) identify the causes of, and risk factors for, 
heritable disorders. 
‘‘(d) ADVISORY COMMITTEE MEETINGS.—The Advi-
sory Committee shall meet not less than annually to— 
‘‘(1) assess the implementation of the guidelines 
and surveillance activities developed under this sec-
tion; 
‘‘(2) advise the Secretary with respect to— 
‘‘(A) such guidelines; and 
‘‘(B) monitoring and evaluating newborn 
screening and surveillance activities; 
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‘‘(3) consider ways to ensure that States attain 
the capacity to screen for the core conditions de-
scribed in subsection (a)(1), and include in such con-
sideration the results of the demonstration projects 
funded under section 1115; and 
‘‘(4) consider any addition to the list of the core 
conditions described in subsection (a)(1), and in-
clude in such consideration the results of the dem-
onstration projects funded under section 1116. 
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 
are authorized to be appropriated to carry out this sec-
tion— 
‘‘(1) $10,000,000 for fiscal year 2008; and 
‘‘(2) such sums as necessary for fiscal year 
2009 through 2012. 
‘‘SEC. 1113. CLEARINGHOUSE OF NEWBORN SCREENING IN-
FORMATION. 
‘‘(a) CLEARINGHOUSE.—The Secretary shall direct 
the Maternal and Child Health Bureau of the Health Re-
sources and Services Administration, working through the 
Regional Genetic and Newborn Screening Collaborative 
Groups of such Bureau, the National Coordinating Center, 
and the National Newborn Screening and Genetic Re-
source Center, to collaborate with the Director of the Cen-
ters for Disease Control and Prevention and the National 
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Library of Medicine of the National Institutes of Health 
to establish and maintain a central clearinghouse of cur-
rent educational and family support and services informa-
tion, materials, resources, research, and data on newborn 
screening to— 
‘‘(1) enable parents and family members of 
newborns, health professionals, industry representa-
tives, and other members of the public to increase 
their awareness, knowledge, and understanding of 
newborn screening; 
‘‘(2) increase awareness, knowledge, and under-
standing of newborn diseases and screening services 
for individuals wishing to have children and expect-
ant families; and 
‘‘(3) develop and maintain current data on 
quality indicators to measure performance of new-
born screening entities, such as false-positive rates 
and other quality indicators as determined by the 
Advisory Committee described under section 1112. 
‘‘(b) INTERNET AVAILABILITY.—The Health Re-
sources and Services Administration shall ensure that the 
clearinghouse described under subsection (a)— 
‘‘(1) is available on the Internet; 
‘‘(2) includes an interactive forum; 
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‘‘(3) is updated on a regular basis, but not less 
than quarterly; and 
‘‘(4) provides— 
‘‘(A) links to Government-sponsored, non-
profit, and other websites of laboratories that 
have demonstrated expertise in newborn screen-
ing 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, 
including the ability of infants to obtain addi-
tional comprehensive screening services that 
may not be required in the State where the in-
fant is born, from CLIA-certified laboratories 
for disorders; 
‘‘(C) current research on both treatable 
and not-yet treatable conditions for which new-
born screening tests are available; 
‘‘(D) information about newborn diseases 
and screening services available in each State; 
and 
‘‘(E) other relevant information as deter-
mined appropriate by the Secretary. 
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‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—There 
are authorized to be appropriated to carry out this sec-
tion— 
‘‘(1) $5,000,000 for fiscal year 2008; and 
‘‘(2) such sums as necessary for fiscal years 
2009 through 2012. 
‘‘SEC. 1114. INTERAGENCY GRANT REVIEW PANEL. 
‘‘(a) DEFINITION OF SHINE GRANT PROGRAM.—In 
this section, the term ‘Screening for Health of Infants and 
Newborns grant program’ or ‘SHINE grant program’ 
means any grant program under section 1115 or 1116. 
‘‘(b) REVIEW PANEL.—The Secretary shall appoint 
an Interagency Grant Review Panel to review grant appli-
cations and provide oversight of the SHINE grant pro-
gram. 
‘‘(c) MEMBERSHIP.—The Secretary shall ensure that 
the Interagency Grant Review Panel includes representa-
tion from all appropriate Federal agencies, including the 
Agency for Healthcare Research and Quality, the Centers 
for Disease Control and Prevention, the Food and Drug 
Administration, the Health Resources and Services Ad-
ministration, and the National Institutes of Health. 
‘‘(d) DUTIES.— 
‘‘(1) DUTIES OF THE SECRETARY.—After the 
last day of the application period for a SHINE 
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grant program, the Secretary shall forward the 
grant applications received for the program to the 
Interagency Grant Review Panel. 
‘‘(2) DUTIES OF THE INTERAGENCY GRANT RE-
VIEW PANEL.— 
‘‘(A) SELECTION OF GRANT RECIPIENTS.— 
Upon receipt of the grant applications for a 
SHINE grant program from the Secretary, the 
Interagency Grant Review Panel shall review 
the applications for grants under the program 
and shall select, on a competitive basis, all of 
the grant recipients for the program and the 
amount of each grant award. 
‘‘(B) SUBMISSION
OF
GRANT
RECIPI-
ENTS.—The Interagency Grant Review Panel 
shall submit the list of award recipients for 
grants under a SHINE grant program to the 
Secretary at a time determined by the Sec-
retary, but not later than 90 days after the last 
day of the application period for a grant under 
such program. 
‘‘(C) OVERSIGHT OF GRANTS.—The Inter-
agency Grant Review Panel shall provide over-
sight of the programs and activities funded by 
grants under a SHINE grant program, and 
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shall report to the Secretary on the program 
and activities as the Secretary or the Panel de-
termines necessary. 
‘‘SEC. 1115. CAPACITY GRANT PROGRAM. 
‘‘(a) IN
GENERAL.—The Secretary shall award 
grants, in conjunction with the Interagency Grant Review 
Panel established under section 1114, to eligible entities 
for demonstration projects that increase the capacity of 
a State to screen for all of the core conditions designated 
by the Advisory Committee described under section 1112. 
Such grants shall be made on a competitive basis. 
‘‘(b) ELIGIBILITY.—To be eligible to receive a grant 
under this section, an entity shall— 
‘‘(1) submit to the Secretary an application at 
such time, in such manner, and containing such in-
formation as the Secretary may require; 
‘‘(2) be a public or private organization, includ-
ing an academic research center, medical center, 
physician group, newborn screening program, or 
CLIA-certified laboratory with expertise in newborn 
metabolic screening; 
‘‘(3) provide assurance that such organization 
will work in consultation with the appropriate State 
department of health; 
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‘‘(4) have the capacity to perform the core new-
born screening tests described in subsection (a) and 
to collect and report data on the costs, benefits, and 
effectiveness of such tests, in consultation with the 
appropriate State department of health and in ac-
cordance with the guidelines implemented under sec-
tion 1112; 
‘‘(5) demonstrate sustainability of such activi-
ties based on the outcomes of the demonstration 
project; and 
‘‘(6) if applicable, submit to the Secretary a 
plan for follow-up, diagnosis, and treatment of those 
infants who test positive on newborn screening tests 
developed under this section. 
‘‘(c) REPORT
TO SECRETARY
AND INTERAGENCY 
PANEL.—An organization that receives a grant under this 
section shall, on an annual basis, submit to the Secretary 
and the Interagency Grant Review Panel established 
under section 1114 a report that describes the activities 
conducted pursuant to such grant and the outcomes of 
such activities. 
‘‘(d) EVALUATION
AND RESULTS.—The Secretary 
shall— 
‘‘(1) evaluate the demonstration projects funded 
under this section; and 
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‘‘(2) on an annual basis— 
‘‘(A) publish and disseminate the results of 
such evaluation on as wide a basis as is prac-
ticable; and 
‘‘(B) submit to the appropriate committees 
of Congress the results of such evaluation. 
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 
are authorized to be appropriated to carry out this sec-
tion— 
‘‘(1) $10,000,000 for fiscal year 2008; and 
‘‘(2) such sums as necessary for fiscal years 
2009 through 2012. 
‘‘SEC. 1116. HUNTER KELLY GRANT PROGRAM. 
‘‘(a) ADDITIONAL
NEWBORN
SCREENING
TESTS 
GRANTS.— 
‘‘(1) IN GENERAL.—The Secretary shall award 
grants (to be known as Hunter Kelly Newborn 
Screening grants), in conjunction with the Inter-
agency Grant Review Panel established under sec-
tion 1114, to eligible entities to carry out dem-
onstration projects that develop screening tests for 
additional newborn conditions, such as tests for 
Krabbe disease and Insulin Dependent Diabetes 
Mellitus, or develop multiple markers to increase the 
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specificity of newborn screening tests. Such grants 
shall be made on a competitive basis. 
‘‘(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 designated by the Advi-
sory Committee described under section 1112. 
‘‘(b) ELIGIBILITY.—To be eligible to receive a grant 
under this section, an entity shall— 
‘‘(1) submit to the Secretary an application at 
such time, in such manner, and containing such in-
formation as the Secretary may require; 
‘‘(2) be a public or private organization includ-
ing, an academic research center, medical center, 
physician group, newborn screening program, or 
CLIA-certified laboratory with expertise in newborn 
metabolic screening; 
‘‘(3) provide assurance that such entity will 
work in consultation with the appropriate State de-
partment of health; 
‘‘(4) submit to the Secretary a strategic plan 
for performing additional newborn screening tests 
and for collecting and reporting data on the costs, 
benefits, and effectiveness of such tests, in consulta-
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tion with the appropriate State department of 
health; 
‘‘(5) demonstrate sustainability of such activi-
ties based on the outcomes of the demonstration 
project; 
‘‘(6) provide assurance that the entity will de-
velop newborn screening tests that are not currently 
performed in the State in which the entity is located; 
and 
‘‘(7) if applicable, submit to the Secretary a 
plan for short- and long-term follow-up, diagnosis, 
and treatment of those infants who test positive on 
newborn screening tests developed under this sec-
tion. 
‘‘(c) REPORT
TO SECRETARY
AND INTERAGENCY 
PANEL.—An organization that receives a grant under this 
section shall, on an annual basis, submit to the Secretary 
and the Interagency Grant Review Panel established 
under section 1114 a report that describes the activities 
conducted pursuant to such grant and the outcomes of 
such activities. 
‘‘(d) EVALUATION
AND RESULTS.—The Secretary 
shall— 
‘‘(1) evaluate the demonstration projects funded 
under this section; and 
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‘‘(2) on an annual basis— 
‘‘(A) publish and disseminate the results of 
such evaluation on as wide a basis as is prac-
ticable; and 
‘‘(B) submit to the appropriate committees 
of Congress the results of such evaluation. 
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 
are authorized to be appropriated to carry out this sec-
tion— 
‘‘(1) $30,000,000 for fiscal year 2008; and 
‘‘(2) such sums as necessary for fiscal years 
2009 through 2012. 
‘‘SEC. 1117. PRIVACY PROTECTIONS. 
‘‘Except to the extent inconsistent with this part, the 
provision of information pursuant to sections 1112 
through 1116, and any subsequent transfer of such infor-
mation in accordance with those sections, are subject to 
any requirement that would otherwise apply under the reg-
ulations promulgated pursuant to section 264(c) of the 
Health Insurance Portability and Accountability Act of 
1996.’’. 
Æ 
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