I 
110TH CONGRESS 
1ST SESSION H. R. 1634 
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 
MARCH 21, 2007 
Ms. ROYBAL-ALLARD (for herself and Mr. SIMPSON) introduced the following 
bill; which was referred to the Committee on Energy and Commerce 
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 2007’’. 
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SEC. 2. FINDINGS. 
Congress finds the following: 
(1) Each year, approximately 4,000,000 babies 
are born in the United States, and all are offered 
some type of newborn screening by State and private 
laboratories to detect certain conditions that may 
threaten their long-term health. 
(2) However, there is a lack of uniformity in 
the number of conditions for which newborns are 
screened through State-based programs. Although a 
newborn may be screened and treated for a debili-
tating condition in one State, in another State the 
condition may go undetected and result in perma-
nent disability or even death. 
(3) In 2004, the American College of Medical 
Genetics (ACMG) completed a report commissioned 
by the Department of Health and Human Services 
which recommended that every baby born in the 
United States be screened for 29 specific disorders, 
which, if diagnosed early, can be successfully man-
aged or treated to prevent severe and often lifelong 
health consequences. 
(4) Currently only 11 States and the District of 
Columbia require infants to be screened for all 29 of 
these recommended disorders. 
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(5) The March of Dimes estimates that 1,000 
of the 5,000 babies born every year in the United 
States with one of the 29 core conditions do not re-
ceive comprehensive newborn screening that includes 
their particular disorder. This results in catastrophic 
consequences for the child and the family and enor-
mous costs for society. 
(6) Continuity plays a critical role in the 
screening, diagnosis, referral, and treatment of these 
disorders. Currently there is no national contingency 
plan for maintaining continuity of newborn screen-
ing systems during a public health emergency, such 
as a catastrophic natural disaster or a widespread 
terrorist event, that results in State or regional dis-
ruption of newborn screening services. 
SEC. 3. AMENDMENT TO TITLE III OF THE PUBLIC HEALTH 
SERVICE ACT. 
Part Q of title III of the Public Health Service Act 
(42 U.S.C. 280h et seq.) is amended by adding at the end 
the following: 
‘‘SEC. 399Z–1. NEWBORN SCREENING. 
‘‘(a) AUTHORIZATION OF GRANT PROGRAMS.— 
‘‘(1) GRANTS TO ASSIST HEALTH CARE PROFES-
SIONALS.—From funds appropriated under sub-
section (h), the Secretary, acting through the Asso-
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ciate Administrator of the Maternal and Child 
Health Bureau of the Health Resources and Services 
Administration (referred to in this section as the 
‘Associate 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 to assist in 
providing health care professionals and newborn 
screening laboratory personnel with— 
‘‘(A) education in newborn screening; and 
‘‘(B) training in— 
‘‘(i) relevant and new technologies in 
newborn screening; and 
‘‘(ii) congenital, genetic, and meta-
bolic disorders. 
‘‘(2) GRANTS TO ASSIST FAMILIES.— 
‘‘(A) IN
GENERAL.—From funds appro-
priated under subsection (h), the Secretary, act-
ing through the Associate Administrator and in 
consultation with the Advisory Committee, shall 
award grants to eligible entities to enable such 
entities to develop and deliver educational pro-
grams about newborn screening to parents, 
families, and patient advocacy and support 
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groups. The educational materials accom-
panying such educational programs shall be 
provided at appropriate literacy levels. 
‘‘(B) AWARENESS OF THE AVAILABILITY 
OF PROGRAMS.—To the extent practicable, the 
Secretary shall make relevant health care pro-
viders aware of the availability of the edu-
cational programs supported pursuant to sub-
paragraph (A). 
‘‘(3) GRANTS FOR QUALITY NEWBORN SCREEN-
ING
FOLLOWUP.—From funds appropriated under 
subsection (h), the Secretary, acting through the As-
sociate Administrator and in consultation with the 
Advisory Committee, shall award grants to eligible 
entities to enable such entities to establish, main-
tain, and operate a system to assess and coordinate 
treatment relating to congenital, genetic, and meta-
bolic disorders. 
‘‘(b) APPLICATION.—An eligible entity that desires to 
receive a grant under this section shall submit an applica-
tion to the Secretary at such time, in such manner, and 
accompanied by such information as the Secretary may 
require. 
‘‘(c) SELECTION OF GRANT RECIPIENTS.— 
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‘‘(1) IN GENERAL.—Not later than 120 days 
after receiving an application under subsection (b), 
the Secretary, after considering the approval factors 
under paragraph (2), shall determine whether to 
award the eligible entity a grant under this section. 
‘‘(2) APPROVAL FACTORS.— 
‘‘(A) REQUIREMENTS FOR APPROVAL.—An 
application submitted under subsection (b) may 
not be approved by the Secretary unless the ap-
plication contains assurances that the eligible 
entity— 
‘‘(i) will use grant funds only for the 
purposes specified in the approved applica-
tion and in accordance with the require-
ments of this section; and 
‘‘(ii) will establish such fiscal control 
and fund accounting procedures as may be 
necessary to assure proper disbursement 
and accounting of Federal funds paid to 
the eligible entity under the grant. 
‘‘(B) 
EXISTING
PROGRAMS.—Prior 
to 
awarding a grant under this section, the Sec-
retary shall— 
‘‘(i) conduct an assessment of existing 
educational resources and training pro-
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grams and coordinated systems of followup 
care with respect to newborn screening; 
and 
‘‘(ii) take all necessary steps to mini-
mize the duplication of the resources and 
programs described in clause (i). 
‘‘(d) COORDINATION.—The Secretary shall take all 
necessary steps to coordinate programs funded with 
grants received under this section. 
‘‘(e) USE OF GRANT FUNDS.— 
‘‘(1) GRANTS TO ASSIST HEALTH CARE PROFES-
SIONALS.—An eligible entity that receives a grant 
under subsection (a)(1) may use the grant funds to 
work with appropriate medical schools, nursing 
schools, schools of public health, schools of genetic 
counseling, internal education programs in State 
agencies, nongovernmental organizations, and pro-
fessional organizations and societies to develop and 
deliver education and training programs that in-
clude— 
‘‘(A) continuing medical education pro-
grams for health care professionals and new-
born screening laboratory personnel in newborn 
screening; 
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‘‘(B) education, technical assistance, and 
training on new discoveries in newborn screen-
ing and the use of any related technology; 
‘‘(C) models to evaluate the prevalence of, 
and assess and communicate the risks of, con-
genital conditions, including the prevalence and 
risk of some of these conditions based on family 
history; 
‘‘(D) models to communicate effectively 
with parents and families about— 
‘‘(i) the process and benefits of new-
born screening; 
‘‘(ii) how to use information gathered 
from newborn screening; 
‘‘(iii) the meaning of screening re-
sults, including the possibility of false posi-
tive findings; 
‘‘(iv) the right of refusal of newborn 
screening, if applicable; and 
‘‘(v) the potential need for followup 
care after newborns are screened; 
‘‘(E) information and resources on coordi-
nated systems of followup care after newborns 
are screened; 
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‘‘(F) information on the disorders for 
which States require and offer newborn screen-
ing and options for newborn screening relating 
to conditions in addition to such disorders; 
‘‘(G) information on additional newborn 
screening that may not be required by the 
State, but that may be available from other 
sources; and 
‘‘(H) other items to carry out the purpose 
described in subsection (a)(1) as determined ap-
propriate by the Secretary. 
‘‘(2) GRANTS TO ASSIST FAMILIES.—An eligible 
entity that receives a grant under subsection (a)(2) 
may use the grant funds to develop and deliver to 
parents, families, and patient advocacy and support 
groups, educational programs about newborn screen-
ing that include information on— 
‘‘(A) what newborn screening is; 
‘‘(B) how newborn screening is performed; 
‘‘(C) who performs newborn screening; 
‘‘(D) where newborn screening is per-
formed; 
‘‘(E) the disorders for which the State re-
quires newborns to be screened; 
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‘‘(F) different options for newborn screen-
ing for disorders other than those included by 
the State in the mandated newborn screening 
program; 
‘‘(G) the meaning of various screening re-
sults, including the possibility of false positive 
and false negative findings; 
‘‘(H) the prevalence and risk of newborn 
disorders, including the increased risk of dis-
orders that may stem from family history; 
‘‘(I) coordinated systems of followup care 
after newborns are screened; and 
‘‘(J) other items to carry out the purpose 
described in subsection (a)(2) as determined ap-
propriate by the Secretary. 
‘‘(3) GRANTS FOR QUALITY NEWBORN SCREEN-
ING FOLLOWUP.—An eligible entity that receives a 
grant under subsection (a)(3) shall use the grant 
funds to— 
‘‘(A) expand on existing procedures and 
systems, where appropriate and available, for 
the timely reporting of newborn screening re-
sults to individuals, families, primary care phy-
sicians, and subspecialists in congenital, ge-
netic, and metabolic disorders; 
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‘‘(B) coordinate ongoing followup treat-
ment with individuals, families, primary care 
physicians, and subspecialists in congenital, ge-
netic, and metabolic disorders after a newborn 
receives an indication of the presence or in-
creased risk of a disorder on a screening test; 
‘‘(C) ensure the seamless integration of 
confirmatory testing, tertiary care medical serv-
ices, comprehensive genetic services including 
genetic counseling, and information about ac-
cess to developing therapies by participation in 
approved clinical trials involving the primary 
health care of the infant; 
‘‘(D) analyze data, if appropriate and 
available, collected from newborn screenings to 
identify populations at risk for disorders affect-
ing newborns, examine and respond to health 
concerns, recognize and address relevant envi-
ronmental, behavioral, socioeconomic, demo-
graphic, and other relevant risk factors; and 
‘‘(E) carry out such other activities as the 
Secretary may determine necessary. 
‘‘(f) REPORTS TO CONGRESS.— 
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‘‘(1) IN GENERAL.—Subject to paragraph (2), 
the Secretary shall submit to the appropriate com-
mittees of Congress reports— 
‘‘(A) evaluating the effectiveness and the 
impact of the grants awarded under this sec-
tion— 
‘‘(i) in promoting newborn screen-
ing— 
‘‘(I) education and resources for 
families; and 
‘‘(II) education, resources, and 
training for health care professionals; 
‘‘(ii) on the successful diagnosis and 
treatment of congenital, genetic, and meta-
bolic disorders; and 
‘‘(iii) on the continued development of 
coordinated systems of followup care after 
newborns are screened; 
‘‘(B) describing and evaluating the effec-
tiveness of the activities carried out with grant 
funds received under this section; and 
‘‘(C) that include recommendations for 
Federal actions to support— 
‘‘(i) education and training in new-
born screening; and 
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‘‘(ii) followup care after newborns are 
screened. 
‘‘(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. 
‘‘(g) DEFINITION OF ELIGIBLE ENTITY.—In this sec-
tion, the term ‘eligible 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) an Indian tribe or a hospital or outpatient 
health care facility of the Indian Health Service; or 
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‘‘(5) a nongovernmental organization with ap-
propriate expertise in newborn screening, as deter-
mined by the Secretary. 
‘‘(h) NATIONAL CONTINGENCY PLAN FOR NEWBORN 
SCREENING.— 
‘‘(1) IN GENERAL.—Not later than 180 days 
after the date of enactment of this section, the Sec-
retary, acting through the Director of the Centers 
for Disease Control and Prevention and in consulta-
tion with the Associate Administrator, shall develop 
a national contingency plan for newborn screening 
for use in the event of a public health emergency 
that results in State or regional disruption of new-
born screening services. 
‘‘(2) REQUIREMENTS.—The contingency plan 
developed under paragraph (1) shall include a plan 
for— 
‘‘(A) the collection and transport of speci-
mens; 
‘‘(B) the shipment of specimens to State 
newborn screening laboratories; 
‘‘(C) the processing of specimens; 
‘‘(D) the reporting of screening results to 
physicians and families; 
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‘‘(E) the diagnostic confirmation of posi-
tive screening results; 
‘‘(F) ensuring the availability of treatment 
and management resources; 
‘‘(G) educating families about newborn 
screening; and 
‘‘(H) carrying out other activities deter-
mined appropriate by the Secretary. 
‘‘(i) AUTHORIZATION OF APPROPRIATIONS.—There 
are authorized to be appropriated to carry out this sec-
tion— 
‘‘(1) $15,000,000 for fiscal year 2008; and 
‘‘(2) such sums as may be necessary for each 
of fiscal years 2009 through 2012.’’. 
SEC. 4. IMPROVED NEWBORN AND CHILD SCREENING FOR 
HERITABLE DISORDERS. 
Section 1109 of the Public Health Service Act (42 
U.S.C. 300b–8) is amended— 
(1) in subsection (c)(2)— 
(A) in subparagraph (E), by striking 
‘‘and’’ after the semicolon; 
(B) by redesignating subparagraph (F) as 
subparagraph (G); and 
(C) by inserting after subparagraph (E) 
the following: 
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‘‘(F) an assurance that the entity has 
adopted and implemented, is in the process of 
adopting and implementing, or will use grant 
amounts received under this section to adopt 
and implement the guidelines and recommenda-
tions of the Advisory Committee on Heritable 
Disorders in Newborns and Children established 
under section 1111 (referred to in this section 
as 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 new-
born for the heritable disorders recommended 
by the Advisory Committee and adopted by the 
Secretary and the reporting of results; and’’; 
and 
(2) in subsection (i), by striking ‘‘such sums’’ 
and all that follows through the period at the end 
and inserting ‘‘$25,000,000 for fiscal year 2008 and 
such sums as may be necessary for each of the fiscal 
years 2009 through 2012.’’. 
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SEC. 5. 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 2008 and such sums as may 
be necessary for each of the fiscal years 2009 through 
2012.’’. 
SEC. 6. 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 (5); 
(B) in paragraph (2), by striking ‘‘and’’ 
after the semicolon; 
(C) by inserting after paragraph (2) the 
following: 
‘‘(3) recommend a uniform screening panel for 
newborn screening programs that includes the heri-
table disorders 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 program expansion, and periodically 
update the recommended uniform screening panel 
described in paragraph (3) based on such decision- 
matrix; and’’; and 
(D) in paragraph (5) (as redesignated by 
subparagraph (A)), by striking the period at the 
end and inserting ‘‘, including recommenda-
tions, advice, or information dealing with— 
‘‘(A) followup activities, including those 
necessary to achieve rapid diagnosis in the 
short term, and those that ascertain long-term 
case management outcomes and appropriate ac-
cess to related services; 
‘‘(B) diagnostic and other technology used 
in screening; 
‘‘(C) the availability and reporting of test-
ing for conditions for which there is no existing 
treatment; 
‘‘(D) minimum standards and related poli-
cies and procedures for State newborn screen-
ing programs; 
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‘‘(E) quality assurance, oversight, and 
evaluation of State newborn screening pro-
grams; 
‘‘(F) data collection for assessment of new-
born screening programs; 
‘‘(G) public and provider awareness and 
education; 
‘‘(H) language and terminology used by 
State newborn screening programs; 
‘‘(I) confirmatory testing and verification 
of positive results; and 
‘‘(J) harmonization of laboratory defini-
tions for results that are within the expected 
range and results that are outside of the ex-
pected range.’’; and 
(2) 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 
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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 Advi-
sory Committee pursuant to this subsection, includ-
ing the justification for the determination. 
‘‘(e) CONTINUATION
OF
OPERATION
OF
COM-
MITTEE.—Notwithstanding section 14 of the Federal Ad-
visory Committee Act (5 U.S.C. App.), the Advisory Com-
mittee shall continue to operate during the 5-year period 
beginning on the date of enactment of the Newborn 
Screening Saves Lives Act of 2007.’’. 
SEC. 7. LABORATORY QUALITY AND SURVEILLANCE. 
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. LABORATORY QUALITY. 
‘‘(a) IN GENERAL.—The Secretary, acting through 
the Director of the Centers for Disease Control and Pre-
vention and in consultation with the Advisory Committee 
on Heritable Disorders in Newborns and Children estab-
lished under section 1111, shall provide for— 
‘‘(1) quality assurance for laboratories involved 
in screening newborns and children for heritable dis-
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