[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 1068 Introduced in Senate (IS)]
108th CONGRESS
1st Session
S. 1068
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 SENATE OF THE UNITED STATES
May 15, 2003
Mr. Dodd (for himself and Mr. DeWine) introduced the following bill;
which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
A BILL
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.
Be it enacted by the Senate and House of Representatives 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
2003''.
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 screening throughout
the United States. While a newborn with a debilitating
condition may receive screening, early detection, and treatment
in one location, in another 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 newborn 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 professionals.--From
funds appropriated under subsection (h), the Secretary, acting
through the Associate 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 metabolic
disorders.
``(2) Grants to assist families.--From funds appropriated
under subsection (h), the Secretary, 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 followup.--From funds
appropriated under subsection (h), the Secretary, acting
through the Associate Administrator and in consultation with
the Advisory Committee, shall award grants to eligible entities
to enable such entities to establish, maintain, and operate a
system to assess and coordinate treatment relating to
congenital, genetic, and metabolic disorders.
``(b) Application.--An eligible entity that desires to receive a
grant under this section shall submit an application 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 application contains
assurances that the eligible entity--
``(i) will use grant funds only for the
purposes specified in the approved application
and in accordance with the requirements 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 Secretary shall--
``(i) conduct an assessment of existing
educational resources and training programs and
coordinated systems of followup care with
respect to newborn screening; and
``(ii) take all necessary steps to minimize
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 professionals.--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
organizations, and professional organizations and societies to
develop and deliver education and training programs that
include--
``(A) continuing medical education programs for
health care professionals and State health department
laboratory personnel in newborn screening;
``(B) education, technical assistance, and training
on new discoveries in newborn screening 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, newborn disorders,
including the prevalence and risk of certain newborn
disorders based on family history;
``(E) models to communicate effectively with
parents and families about--
``(i) the process and benefits of newborn
screening;
``(ii) how to use information gathered from
newborn screening;
``(iii) the meaning of screening results,
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 coordinated
systems of followup care after newborns are screened;
``(G) information on the disorders for which States
require and offer newborn screening 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
appropriate 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
screening 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 performed;
``(E) the disorders for which the State requires
newborns to be screened;
``(F) different options for newborn screening for
disorders other than those included by the State in the
mandated newborn screening program;
``(G) the meaning of various screening results
including the rate of false positives;
``(H) the prevalence and risk of newborn disorders,
including the increased risk of disorders 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
appropriate by the Secretary.
``(3) Grants for quality newborn screening 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 results to individuals,
families, primary care physicians, and subspecialists
in congenital, genetic, and metabolic disorders;
``(B) coordinate ongoing followup treatment with
individuals, families, primary care physicians, and
subspecialists in congenital, genetic, and metabolic
disorders after a newborn receives an indication of the
presence of a disorder on a screening test;
``(C) ensure the seamless integration of
confirmatory testing, tertiary care medical services,
comprehensive genetic services including genetic
counseling, and information about access 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 affecting newborns,
examine and respond to health concerns, recognize and
address relevant environmental, behavioral,
socioeconomic, demographic, 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 committees of Congress
reports--
``(A) evaluating the effectiveness and the impact
of the grants awarded under this section--
``(i) in promoting newborn screening--
``(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 metabolic
disorders; and
``(iii) on the continued development of
coordinated systems of followup care after
newborns are screened;
``(B) describing and evaluating the effectiveness
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 newborn
screening; and
``(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 section, the term
`eligible entity' means--
``(1) a State or a political subdivision of a State;
``(2) a consortium of 2 or more States or political
subdivisions of States;
``(3) a territory;
``(4) an Indian tribe or a hospital or outpatient health
care facility of the Indian Health Service; or
``(5) a nongovernmental organization with appropriate
expertise in newborn screening, as determined by the Secretary.
``(h) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section--
``(1) $15,000,000 for fiscal year 2004; and
``(2) such sums as may be necessary for each of fiscal
years 2005 through 2008.''.
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