IB 
Union Calendar No. 352 
110TH CONGRESS 
2D SESSION 
H. R. 3825 
[Report No. 110–570] 
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. 
IN THE HOUSE OF REPRESENTATIVES 
OCTOBER 15, 2007 
Ms. ROYBAL-ALLARD (for herself, Mr. SIMPSON, Mr. REYNOLDS, and Mr. 
WAXMAN) introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce 
APRIL 8, 2008 
Additional sponsors: Mrs. MCCARTHY of New York, Ms. BALDWIN, Mr. RUSH, 
Ms. MATSUI, Mr. ROTHMAN, Ms. ESHOO, Mr. PEARCE, Mr. TOWNS, Mr. 
RAMSTAD, Mr. SCHIFF, Ms. SCHAKOWSKY, Mr. SPRATT, Mr. FATTAH, 
Mr. GORDON of Tennessee, Mr. MCNULTY, Mr. PASTOR, Mr. LARSON of 
Connecticut, Mr. ARCURI, Mr. HINOJOSA, Mr. COHEN, Mr. LANGEVIN, 
Mr. ABERCROMBIE, Ms. DEGETTE, Mr. HIGGINS, Mr. SHAYS, Mr. 
ENGEL, Mr. GENE GREEN of Texas, Mrs. TAUSCHER, Mr. ALLEN, Mr. 
GRIJALVA, Mr. GONZALEZ, Ms. HERSETH SANDLIN, Mr. SIRES, Mr. 
BOUCHER, Mrs. CAPPS, Mr. BACA, Mrs. NAPOLITANO, Mr. ORTIZ, Mr. 
SALAZAR, Mr. LAMPSON, Ms. SOLIS, Ms. VELA´ZQUEZ, Mr. RODRIGUEZ, 
Mr. CARDOZA, Mr. BECERRA, Mr. STARK, Ms. LORETTA SANCHEZ of 
California, Mr. CUELLAR, Mr. GUTIERREZ, Mr. SERRANO, Ms. LINDA T. 
SA´NCHEZ of California, Ms. DELAURO, Mrs. LOWEY, Ms. LEE, Mr. 
JACKSON of Illinois, Mr. KENNEDY, Mr. HONDA, Mr. RYAN of Ohio, Ms. 
WASSERMAN SCHULTZ, Ms. BERKLEY, Ms. RICHARDSON, Mr. HASTINGS 
of Florida, Mr. HINCHEY, Mr. BERRY, Mr. DUNCAN, Mr. BURGESS, Mr. 
FOSSELLA, Ms. PRYCE of Ohio, Mrs. CAPITO, Mr. MCHUGH, Mr. JOHN-
SON of Georgia, Mr. FILNER, Mr. DAVIS of Illinois, Ms. GRANGER, Mr. 
TIM MURPHY of Pennsylvania, Ms. HIRONO, Mr. MOORE of Kansas, and 
Mr. LEWIS of Georgia 
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APRIL 8, 2008 
Reported with an amendment, committed to the Committee of the Whole 
House on the State of the Union, and ordered to be printed 
[Strike out all after the enacting clause and insert the part printed in italic] 
[For text of introduced bill, see copy of bill as introduced on October 15, 2007] 
A BILL 
To amend the Public Health Service Act to establish grant 
programs to provide for education and outreach on new-
born screening and coordinated followup care once new-
born screening has been conducted, to reauthorize pro-
grams under part A of title XI of such Act, 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. 
This Act may be cited as the ‘‘Newborn Screening 
Saves Lives Act of 2008’’. 
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 
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and Services Administration (referred to in this section as 
the ‘Administrator’) and in consultation with the Advisory 
Committee on Heritable Disorders in Newborns and Chil-
dren (referred to in this section as the ‘Advisory Com-
mittee’), 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 profes-
sionals 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 screen-
ing counseling, testing, follow-up, treatment, and spe-
cialty services to parents, families, and patient advo-
cacy and support groups; and 
‘‘(4) to establish, maintain, and operate a system 
to assess and coordinate treatment relating to con-
genital, genetic, and metabolic disorders. 
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‘‘(b) ELIGIBLE ENTITY.—In this section, the term ‘eli-
gible entity’ means— 
‘‘(1) a State or a political subdivision of a State; 
‘‘(2) a consortium of 2 or more States or polit-
ical 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 Com-
mittee 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 Com-
mittee and adopted by the Secretary.’’; 
(2) by redesignating subsections (d) through (i) 
as subsections (e) through (j), respectively; 
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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 fol-
lowing: 
‘‘(d) AUTHORIZATION
OF APPROPRIATIONS.—There 
are authorized to be appropriated to carry out this section 
$5,000,000 for fiscal year 2009, $5,062,500 for fiscal year 
2010, $5,125,000 for fiscal year 2011, $5,187,500 for fiscal 
year 2012, and $5,250,000 for fiscal year 2013.’’. 
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); 
(B) in paragraph (2), by striking ‘‘and’’ 
after the semicolon; 
(C) by inserting after paragraph (2) the fol-
lowing: 
‘‘(3) make systematic evidence-based and peer-re-
viewed recommendations that include the heritable 
disorders that have the potential to significantly im-
pact public health for which all newborns should be 
screened, including secondary conditions that may be 
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identified as a result of the laboratory methods used 
for screening; 
‘‘(4) develop a model decision-matrix for new-
born 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 deci-
sion-matrix; 
‘‘(5) consider ways to ensure that all States at-
tain the capacity to screen for the conditions de-
scribed in paragraph (3), and include in such consid-
eration 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 rec-
ommendations, 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 eval-
uation of newborn screening activities, including 
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diagnosis, screening, follow-up, and treatment 
activities; 
‘‘(C) diagnostic and other technology used 
in screening; 
‘‘(D) the availability and reporting of test-
ing for conditions for which there is no existing 
treatment; 
‘‘(E) conditions not included in the rec-
ommended 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 poli-
cies and procedures used by State newborn 
screening programs, such as language and termi-
nology used by State newborn screening pro-
grams to include standardization of case defini-
tions and names of disorders for which newborn 
screening tests are performed; 
‘‘(G) quality assurance, oversight, and eval-
uation of State newborn screening programs, in-
cluding ensuring that tests and technologies used 
by each State meet established standards for de-
tecting and reporting positive screening results; 
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‘‘(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 re-
porting, harmonization of laboratory definitions 
for heritable disorders and testing results, and 
confirmatory testing and verification of positive 
results, in order to assess and enhance moni-
toring of newborn diseases.’’; and 
(2) in subsection (c)(2)— 
(A) by redesignating subparagraphs (E), 
(F), and (G) as subparagraphs (F), (H), and (I), 
respectively; 
(B) by inserting after subparagraph (D) the 
following: 
‘‘(E) the Commissioner of the Food and 
Drug Administration;’’; and 
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(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 recommenda-
tion pursuant to this section, the Secretary shall 
adopt or reject such recommendation. 
‘‘(2) PENDING
RECOMMENDATIONS.—The Sec-
retary 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 2008 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 Advi-
sory 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 
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Act of 2008, and each fiscal year thereafter, the Advisory 
Committee shall— 
‘‘(1) publish a report on peer-reviewed newborn 
screening guidelines, including follow-up and treat-
ment, in the United States; 
‘‘(2) submit such report to the appropriate com-
mittees 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 inter-
net clearinghouse established under section 1112. 
‘‘(f) CONTINUATION OF OPERATION OF COMMITTEE.— 
Notwithstanding section 14 of the Federal Advisory Com-
mittee 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 2008. 
‘‘(g) AUTHORIZATION
OF APPROPRIATIONS.—There 
are authorized to be appropriated to carry out this section, 
$1,000,000 for fiscal year 2009, $1,012,500 for fiscal year 
2010, $1,025,000 for fiscal year 2011, $1,037,500 for fiscal 
year 2012, and $1,050,000 for fiscal year 2013.’’. 
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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: 
‘‘SEC. 1112. CLEARINGHOUSE OF NEWBORN SCREENING IN-
FORMATION. 
‘‘(a) IN GENERAL.—The Secretary, acting through the 
Administrator of the Health Resources and Services Admin-
istration (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 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 expectant individuals and families; and 
‘‘(3) maintain current data on quality indica-
tors to measure performance of newborn screening, 
such as false-positive rates and other quality indica-
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tors as determined by the Advisory Committee under 
section 1111. 
‘‘(b) INTERNET AVAILABILITY.—The Secretary, acting 
through the Administrator, shall ensure that the clearing-
house 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; 
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‘‘(D) the availability of Federal funding for 
newborn and child screening for heritable dis-
orders including grants authorized under the 
Newborn Screening Saves Lives Act of 2008; and 
‘‘(E) other relevant information as deter-
mined appropriate by the Secretary. 
‘‘(c) NONDUPLICATION.—In developing the clearing-
house 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 2009, $2,531,250 for fiscal year 
2010, $2,562,500 for fiscal year 2011, $2,593,750 for fiscal 
year 2012, and $2,625,000 for fiscal year 2013.’’. 
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 fur-
ther 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 Heri-
table Disorders in Newborns and Children established under 
section 1111, shall provide for— 
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‘‘(1) quality assurance for laboratories involved 
in screening newborns and children for heritable dis-
orders, including quality assurance for newborn- 
screening tests, performance evaluation services, and 
technical assistance and technology transfer to new-
born screening laboratories to ensure analytic validity 
and utility of screening tests; and 
‘‘(2) appropriate quality control and other per-
formance 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 2009, 
$5,062,500 for fiscal year 2010, $5,125,000 for fiscal year 
2011, $5,187,500 for fiscal year 2012, and $5,250,000 for 
fiscal year 2013. 
‘‘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 develop-
mental disabilities authorized under section 317C, in 
order to make recommendations for programs to col-
lect, analyze, and make available data on the heri-
table disorders recommended by the Advisory Com-
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mittee on Heritable Disorders in Newborns and Chil-
dren under section 1111, including data on the inci-
dence and prevalence of, as well as poor health out-
comes resulting from, such disorders; and 
‘‘(2) make recommendations for the establishment 
of regional centers for the conduct of applied epide-
miological research on effective interventions to pro-
mote the prevention of poor health outcomes resulting 
from such disorders as well as providing information 
and education to the public on such effective interven-
tions. 
‘‘(b) ESTABLISHMENT.—The Secretary shall establish 
an Interagency Coordinating Committee on Newborn and 
Child Screening (referred to in this section as the ‘Inter-
agency 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 Qual-
ity, and the Director of the National Institutes of Health, 
or their designees. 
‘‘(d) ACTIVITIES.—The Interagency Coordinating 
Committee shall— 
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‘‘(1) report to the Secretary and the appropriate 
committees of Congress on its recommendations re-
lated to the purpose described in subsection (a); and 
‘‘(2) carry out other activities determined appro-
priate 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 2009, 
$1,012,500 for fiscal year 2010, $1,025,000 for fiscal year 
2011, $1,037,500 for fiscal year 2012, and $1,050,000 for 
fiscal year 2013.’’. 
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 fur-
ther 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 de-
velop 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. 
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‘‘(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 physi-
cians 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 ap-
propriate by the Secretary. 
‘‘SEC. 1116. HUNTER KELLY RESEARCH PROGRAM. 
‘‘(a) NEWBORN SCREENING ACTIVITIES.— 
‘‘(1) IN GENERAL.—The Secretary, in conjunc-
tion with the Director of the National Institutes of 
Health and taking into consideration the rec-
ommendations of the Advisory Committee, may con-
tinue carrying out, coordinating, and expanding re-
search in newborn screening (to be known as ‘Hunter 
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Kelly Newborn Screening Research Program’) includ-
ing— 
‘‘(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, hor-
monal, or functional conditions that can be de-
tected 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 new-
born 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 en-
sure that entities receiving funding through the program 
will provide assurances, as practicable, that such entities 
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will work in consultation with the appropriate State de-
partments 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 exist-
ing on the uniform screening panel). 
‘‘(c) REPORTS.—The Director is encouraged to include 
information about the activities carried out under this sec-
tion 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 Clear-
inghouse established under section 1112. 
‘‘(d) NONDUPLICATION.—In carrying out programs 
under this section, the Secretary shall minimize duplication 
and supplement, not supplant, existing efforts of the type 
carried out under this section. 
‘‘(e) PEER REVIEW.—Nothing in this section shall be 
construed to interfere with the scientific peer-review process 
at the National Institutes of Health.’’. 
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Union Calendar No. 352 
110TH CONGRESS 
2D SESSION 
H. R. 3825 
[Report No. 110–570] 
A BILL 
To amend the Public Health Service Act to estab-
lish 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. 
APRIL 8, 2008 
Reported with an amendment, committed to the Com-
mittee of the Whole House on the State of the Union, 
and ordered to be printed 
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