1.
(a)This Act may be cited as the Screening for Health of Infants and Newborns
Act
or the SHINE
Act
.
2.The purposes of this Act are the
following:
(1)To ensure the health and quality of life of
all newborns in the United States by enhancing the capacity to screen for
heritable diseases. This enhanced capacity will assist the States in making
progress toward the following goals:
(A)All babies born
in hospitals in the United States and the territories of the United States
should have access to, and be screened for, certain core conditions.
(B)Appropriate
newborn screening evaluations should be conducted for all newborns to allow
appropriate referrals and provisions for early medical intervention.
(C)Newborn screening
data collection should be standardized, and conditions detected by newborn
screening should be tracked and monitored.
(D)Information on
newborn screening and conditions for which a patient can be screened should be
readily accessible, current, and understandable to both health care providers
and parents. Information should include the following:
(i)A
component for rehabilitation, medical, and early intervention options that
ensure linkage to any new and existing national or State system of
intervention.
(ii)Rehabilitative
services for newborns with the conditions.
(E)Newborn screening
should be expanded to include more conditions, and additional newborn screening
tests should be developed to enhance the health of newborns.
(2)To expand newborn
screening, and improve systems to make newborn screening more efficient and
effective, by authorizing—
(A)statewide newborn
screening and medical evaluation systems and intervention programs;
(B)technical
assistance;
(C)national
demonstration grant programs; and
(D)interagency
collaborations between the appropriate Federal agencies, including the Agency
for Healthcare Research and Quality, Centers for Disease Control and
Prevention, Food and Drug Administration, Health Resources and Services
Administration, and National Institutes of Health.
3.Newborn
screening guidelines and grant programsPart 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:
1112.Recommended
guidelines for newborn screening and data collection; monitoring and
evaluation
(a)Recommended
guidelines for newborn screening and data collection
(1)The Director of the Centers for Disease Control and
Prevention (referred to in this section as the Director), in
collaboration with the Associate Administrator of the Maternal and Child Health
Bureau of the Health Resources and Services Administration and the Advisory
Committee on Heritable Disorders and Genetic Diseases in Newborns and Children
(referred to in this section as the Advisory Committee), shall
develop specific guidelines that the States may follow in reporting newborn
screening data, as requested by the Advisory Committee, from newborn screening
tests, including the screening tests for the core conditions designated by the
Newborn Screening Expert Group convened by the American College of Medical
Genetics, as commissioned by the Health Resources and Services
Administration.
(2)The
guidelines developed under paragraph (1) shall include—
(A)standardizing the
case definitions and names of the disorders for which newborn screening tests
are performed and the definitions of performance measures used to evaluate such
tests so that performance criteria and outcomes among all States may be
evaluated;
(B)establishing
procedures for standardized newborn screening data collection and reporting;
and
(C)ensuring that
tests and technologies used by each State meet established standards for
detecting and reporting positive screening results.
(3)The
Director shall submit the guidelines described in this subsection to the
Secretary. Not later than 90 days after receiving the guidelines, the
Secretary, in consultation with the Director, the Administrator of the Health
Resources and Services Administration (referred to in this section as the
Administrator), and the Assistant Administrator of the Maternal
and Child Health Bureau, shall implement such guidelines.
(4)Not later than 2 years after the date of enactment of the
Screening for Health of Infants and Newborns
Act, and each year thereafter, the Advisory Committee
shall—
(A)publish an annual
report on newborn screening guidelines in the United States;
(B)submit such
report to the appropriate committees of Congress, the Secretary, and the State
departments of health; and
(C)disseminate such
report on as wide a basis as practicable.
(b)Recommended
guidelines for monitoring, evaluation, and surveillance of newborn
screening
(1)
(A)The
Secretary, acting through the Administrator and in consultation with the
Director and the Advisory Committee, shall develop guidelines to—
(i)monitor and
evaluate newborn screening activities, including diagnosis, screening,
follow-up, and treatment activities, in the United States; and
(ii)coordinate the
results of surveillance activities in order to enhance monitoring of newborn
diseases.
(B)In
carrying out this paragraph, the Administrator, in consultation with the
Advisory Committee and the Director, shall collaborate with non-Governmental
organizations, such as the Joint Commission on Accreditation of Hospital
Organizations, laboratories certified by the Clinical Laboratory Improvement
Amendment (referred to in the part as CLIA
), and the Association
of Public Health Laboratories to ensure effective monitoring and evaluation of
newborn screening activities.
(2)Not
later than 90 days after the development of the guidelines under paragraph (1),
the Secretary, in consultation with the Director, the Administrator, and the
Assistant Administrator of the Maternal and Child Health Bureau, shall
implement such guidelines.
(c)Surveillance
and identification researchThe Secretary, acting through the
Director and the National Center on Birth Defects and Developmental
Disabilities, and in consultation with the Administrator and Advisory
Committee, shall develop a surveillance system for newborn screening. The
system shall use the standardized procedures and guidelines developed under
subsection (b) for data management and tracking program effectiveness and
costs, in order to—
(1)ensure quality
monitoring of newborn screening and medical evaluation systems and intervention
programs;
(2)provide technical
assistance on data collection and management;
(3)study the cost
and effectiveness of newborn screening and medical evaluation systems and
intervention programs conducted by State-based programs in order to answer
issues of importance to national and State policymakers; and
(4)identify the
causes of, and risk factors for, heritable disorders.
(d)Advisory
committee meetingsThe Advisory Committee shall meet not less
than annually to—
(1)assess the
implementation of the guidelines and surveillance activities developed under
this section;
(2)advise the
Secretary with respect to—
(A)such guidelines;
and
(B)monitoring and
evaluating newborn screening and surveillance activities;
(3)consider ways to
ensure that States attain the capacity to screen for the core conditions
described in subsection (a)(1), and include in such consideration the results
of the demonstration projects funded under section 1115; and
(4)consider any
addition to the list of the core conditions described in subsection (a)(1), and
include in such consideration the results of the demonstration projects funded
under section 1116.
(e)Authorization
of appropriationsThere are authorized to be appropriated to
carry out this section—
(1)$10,000,000 for
fiscal year 2008; and
(2)such sums as
necessary for fiscal year 2009 through 2012.
1113.Clearinghouse
of newborn screening information
(a)The
Secretary shall direct the Maternal and Child Health Bureau of the Health
Resources and Services Administration, working through the Regional Genetic and
Newborn Screening Collaborative Groups of such Bureau, the National
Coordinating Center, and the National Newborn Screening and Genetic Resource
Center, to collaborate with the Director of the Centers for Disease Control and
Prevention and the National Library of Medicine of the National Institutes of
Health to 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 representatives,
and other members of the public to increase their awareness, knowledge, and
understanding of newborn screening;
(2)increase
awareness, knowledge, and understanding of newborn diseases and screening
services for individuals wishing to have children and expectant families;
and
(3)develop and
maintain current data on quality indicators to measure performance of newborn
screening entities, such as false-positive rates and other quality indicators
as determined by the Advisory Committee described under section 1112.
(b)The Health Resources and Services Administration
shall ensure that the clearinghouse 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, nonprofit, and other 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, including
the ability of infants to obtain additional comprehensive screening services
that may not be required in the State where the infant is born, from
CLIA-certified laboratories for disorders;
(C)current research
on both treatable and not-yet treatable conditions for which newborn screening
tests are available;
(D)information about
newborn diseases and screening services available in each State; and
(E)other relevant
information as determined appropriate by the Secretary.
(c)Authorization
of appropriationsThere are authorized to be appropriated to
carry out this section—
(1)$5,000,000 for
fiscal year 2008; and
(2)such sums as
necessary for fiscal years 2009 through 2012.
1114.Interagency Grant
Review Panel
(a)Definition of
SHINE grant programIn this section, the term Screening for
Health of Infants and Newborns grant program or SHINE grant
program means any grant program under section 1115 or 1116.
(b)The Secretary shall
appoint an Interagency Grant Review Panel to review grant applications and
provide oversight of the SHINE grant program.
(c)The Secretary shall ensure that the
Interagency Grant Review Panel includes representation from all appropriate
Federal agencies, including the Agency for Healthcare Research and Quality, the
Centers for Disease Control and Prevention, the Food and Drug Administration,
the Health Resources and Services Administration, and the National Institutes
of Health.
(d)
(1)After the last day of the application period for a
SHINE grant program, the Secretary shall forward the grant applications
received for the program to the Interagency Grant Review Panel.
(2)Duties of the
interagency grant review panel
(A)Selection of
grant recipientsUpon receipt of the grant applications for a
SHINE grant program from the Secretary, the Interagency Grant Review Panel
shall review the applications for grants under the program and shall select, on
a competitive basis, all of the grant recipients for the program and the amount
of each grant award.
(B)Submission of
grant recipientsThe Interagency Grant Review Panel shall submit
the list of award recipients for grants under a SHINE grant program to the
Secretary at a time determined by the Secretary, but not later than 90 days
after the last day of the application period for a grant under such
program.
(C)The Interagency Grant Review Panel shall provide oversight
of the programs and activities funded by grants under a SHINE grant program,
and shall report to the Secretary on the program and activities as the
Secretary or the Panel determines necessary.
1115.
(a)The Secretary shall award grants, in conjunction with the
Interagency Grant Review Panel established under section 1114, to eligible
entities for demonstration projects that increase the capacity of a State to
screen for all of the core conditions designated by the Advisory Committee
described under section 1112. Such grants shall be made on a competitive
basis.
(b)To
be eligible to receive a grant under this section, an entity shall—
(1)submit to the
Secretary an application at such time, in such manner, and containing such
information as the Secretary may require;
(2)be a public or
private organization, including an academic research center, medical center,
physician group, newborn screening program, or CLIA-certified laboratory with
expertise in newborn metabolic screening;
(3)provide assurance
that such organization will work in consultation with the appropriate State
department of health;
(4)have the capacity
to perform the core newborn screening tests described in subsection (a) and to
collect and report data on the costs, benefits, and effectiveness of such
tests, in consultation with the appropriate State department of health and in
accordance with the guidelines implemented under section 1112;
(5)demonstrate
sustainability of such activities based on the outcomes of the demonstration
project; and
(6)if applicable,
submit to the Secretary a plan for follow-up, diagnosis, and treatment of those
infants who test positive on newborn screening tests developed under this
section.
(c)Report to
Secretary and Interagency PanelAn organization that receives a
grant under this section shall, on an annual basis, submit to the Secretary and
the Interagency Grant Review Panel established under section 1114 a report that
describes the activities conducted pursuant to such grant and the outcomes of
such activities.
(d)The Secretary shall—
(1)evaluate the
demonstration projects funded under this section; and
(2)on an annual
basis—
(A)publish and
disseminate the results of such evaluation on as wide a basis as is
practicable; and
(B)submit to the
appropriate committees of Congress the results of such evaluation.
(e)Authorization
of appropriationsThere are authorized to be appropriated to
carry out this section—
(1)$10,000,000 for
fiscal year 2008; and
(2)such sums as
necessary for fiscal years 2009 through 2012.
1116.Hunter Kelly
grant program
(a)Additional
newborn screening tests grants
(1)The Secretary shall award grants (to be known as Hunter
Kelly Newborn Screening grants), in conjunction with the Interagency Grant
Review Panel established under section 1114, to eligible entities to carry out
demonstration projects that develop screening tests for additional newborn
conditions, such as tests for Krabbe disease and Insulin Dependent Diabetes
Mellitus, or develop multiple markers to increase the specificity of newborn
screening tests. Such grants shall be made on a competitive basis.
(2)Additional
newborn conditionFor purposes of this subsection, the term
additional newborn condition means any condition that is not one
of the core conditions designated by the Advisory Committee described under
section 1112.
(b)To
be eligible to receive a grant under this section, an entity shall—
(1)submit to the
Secretary an application at such time, in such manner, and containing such
information as the Secretary may require;
(2)be a public or
private organization including, an academic research center, medical center,
physician group, newborn screening program, or CLIA-certified laboratory with
expertise in newborn metabolic screening;
(3)provide assurance
that such entity will work in consultation with the appropriate State
department of health;
(4)submit to the
Secretary a strategic plan for performing additional newborn screening tests
and for collecting and reporting data on the costs, benefits, and effectiveness
of such tests, in consultation with the appropriate State department of
health;
(5)demonstrate
sustainability of such activities based on the outcomes of the demonstration
project;
(6)provide assurance
that the entity will develop newborn screening tests that are not currently
performed in the State in which the entity is located; and
(7)if applicable,
submit to the Secretary a plan for short- and long-term follow-up, diagnosis,
and treatment of those infants who test positive on newborn screening tests
developed under this section.
(c)Report to
Secretary and Interagency PanelAn organization that receives a
grant under this section shall, on an annual basis, submit to the Secretary and
the Interagency Grant Review Panel established under section 1114 a report that
describes the activities conducted pursuant to such grant and the outcomes of
such activities.
(d)The Secretary shall—
(1)evaluate the
demonstration projects funded under this section; and
(2)on an annual
basis—
(A)publish and
disseminate the results of such evaluation on as wide a basis as is
practicable; and
(B)submit to the
appropriate committees of Congress the results of such evaluation.
(e)Authorization
of appropriationsThere are authorized to be appropriated to
carry out this section—
(1)$30,000,000 for
fiscal year 2008; and
(2)such sums as
necessary for fiscal years 2009 through 2012.
1117.Except to the
extent inconsistent with this part, the provision of information pursuant to
sections 1112 through 1116, and any subsequent transfer of such information in
accordance with those sections, are subject to any requirement that would
otherwise apply under the regulations promulgated pursuant to section 264(c) of
the Health Insurance Portability and Accountability Act of
1996.
.