I 
109TH CONGRESS 
2D SESSION 
H. R. 5397 
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 
MAY 16, 2006 
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 2006’’. 
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SEC. 2. FINDINGS. 
Congress finds the following: 
(1) Currently, it is possible to test for more 
than 30 disorders through newborn screening. 
(2) There is a lack of uniform newborn screen-
ing throughout the United States. While a newborn 
with a debilitating condition may receive screening, 
early detection, and treatment in 1 location, in an-
other location the condition may go undetected and 
result in catastrophic consequences. 
(3) Each year more than 4,000,000 babies are 
screened by State and private laboratories to detect 
conditions that may threaten their long-term health. 
(4) There are more than 2,000 babies born 
every year in the United States with detectable and 
treatable disorders that go unscreened through new-
born screening. 
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. 399AA. NEWBORN SCREENING. 
‘‘(a) AUTHORIZATION OF GRANT PROGRAMS.— 
‘‘(1) GRANTS TO ASSIST HEALTH CARE PROFES-
SIONALS.—From funds appropriated under sub-
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section (h), the Secretary, acting through the Asso-
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, 
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families, and patient advocacy and support 
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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