I 
108TH CONGRESS 
2D SESSION 
H. R. 4493 
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, and for other 
purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 2, 2004 
Ms. ROYBAL-ALLARD (for herself, Mr. SIMPSON, Mr. SERRANO, Mr. KILDEE, 
Mr. GORDON, Mr. ANDREWS, Mr. GREEN of Texas, Mr. WALSH, Mr. 
WEXLER, Mr. MEEHAN, Mr. CUNNINGHAM, and Mr. SCHIFF) 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, and for other pur-
poses. 
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 2004’’.
SEC. 2. FINDINGS. 
Congress finds the following: 
(1) Currently, it is possible to test for at least 
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 one 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 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 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-
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 State health 
department 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.—From 
funds appropriated under subsection (h), the Sec-
retary, acting 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 programs 
about newborn screening to parents, families, and 
patient advocacy and support groups.
‘‘(3) GRANTS FOR NEWBORN SCREENING FOL-
LOWUP.—From funds appropriated under subsection 
(h), the Secretary, acting through the Associate Ad-
ministrator and in consultation with the Advisory 
Committee, shall award grants to eligible entities to 
enable such entities to establish, maintain, and oper-
ate a system to assess and coordinate treatment re-
lating to congenital, genetic, and metabolic dis-
orders. 
‘‘(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.— 
‘‘(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-
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, internal education 
programs in State agencies, nongovernmental orga-
nizations, and professional organizations and soci-
eties to develop and deliver education and training 
programs that include— 
‘‘(A) continuing medical education pro-
grams for health care professionals and State 
health department laboratory personnel in new-
born screening; 
‘‘(B) education, technical assistance, and 
training on new discoveries in newborn screen-
ing and the use of any related technology; 
‘‘(C) models to evaluate what a newborn 
should be screened for and when and where 
that screening should take place; 
‘‘(D) models to evaluate the prevalence of, 
and assess and communicate the risks of, new-
born disorders, including the prevalence and 
risk of certain newborn disorders based on fam-
ily history;
‘‘(E) 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 rate of false positives; 
‘‘(iv) the right of refusal of newborn 
screening; and 
‘‘(v) the potential need for followup 
care after newborns are screened; 
‘‘(F) information and resources on coordi-
nated systems of followup care after newborns 
are screened; 
‘‘(G) 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; 
‘‘(H) information on supplemental newborn 
screening that the States do not require and 
offer but that parents may want; and 
‘‘(I) 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 is newborn screening; 
‘‘(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; 
‘‘(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 rate of false positives; 
‘‘(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; 
‘‘(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 of a dis-
order 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.— 
‘‘(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;