Screening for Health of Infants and Newborns Act or the SHINE Act - Amends the Public Health Service Act to require the Director of the Centers for Disease Control and Prevention (CDC) to develop guidelines that states may follow in reporting data from newborn screening tests.
Requires the Secretary of Health and Human Services, acting through the Administrator of the Health Resources and Services Administration (HRSA), to develop guidelines to: (1) monitor and evaluate newborn screening activities; and (2) coordinate the results of surveillance activities.
Requires the Secretary, acting through the Director of CDC and the National Center on Birth Defects and Developmental Disabilities, to develop a surveillance system for newborn screening.
Directs the Advisory Committee on Heritable Disorders and Genetic Diseases in Newborns and Children to advise the Secretary on the guidelines and on monitoring and evaluating newborn screening and surveillance activities.
Requires the Secretary to: (1) direct the Maternal and Child Health Bureau of HRSA to establish a central clearinghouse of current education and family support and services information, materials, resources, research, and data on newborn screening; (2) award grants for demonstration projects that increase state capacity to screen for all of the core conditions; (3) award Hunter Kelly Newborn Screening grants for demonstration projects that develop screening tests for additional newborn conditions or develop multiple markers to increase the specificity of such tests; and (4) appoint an Interagency Grant Review Panel to select grant applications and provide oversight on the grant program.
[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2889 Introduced in House (IH)]
110th CONGRESS
1st Session
H. R. 2889
To amend the Public Health Service Act to improve newborn screening
activities, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
June 27, 2007
Mr. Reynolds introduced the following bill; which was referred to the
Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to improve newborn screening
activities, 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.
(a) Short Title.--This Act may be cited as the ``Screening for
Health of Infants and Newborns Act'' or the ``SHINE Act''.
SEC. 2. PURPOSES.
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.
SEC. 3. NEWBORN SCREENING GUIDELINES AND GRANT PROGRAMS.
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. RECOMMENDED GUIDELINES FOR NEWBORN SCREENING AND DATA
COLLECTION; MONITORING AND EVALUATION.
``(a) Recommended Guidelines for Newborn Screening and Data
Collection.--
``(1) In general.--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) Guidelines.--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) Implementation.--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) Annual report.--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) In general.--
``(A) Development.--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) Duties.--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) Implementation.--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 Research.--The 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 Meetings.--The 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 Appropriations.--There 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.
``SEC. 1113. CLEARINGHOUSE OF NEWBORN SCREENING INFORMATION.
``(a) Clearinghouse.--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) Internet Availability.--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 Appropriations.--There 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.
``SEC. 1114. INTERAGENCY GRANT REVIEW PANEL.
``(a) Definition of SHINE Grant Program.--In 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) Review Panel.--The Secretary shall appoint an Interagency
Grant Review Panel to review grant applications and provide oversight
of the SHINE grant program.
``(c) Membership.--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) Duties.--
``(1) Duties of the secretary.--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 recipients.--Upon 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 recipients.--The
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) Oversight of grants.--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.
``SEC. 1115. CAPACITY GRANT PROGRAM.
``(a) In General.--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) Eligibility.--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 Panel.--An 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) Evaluation and Results.--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 Appropriations.--There 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.
``SEC. 1116. HUNTER KELLY GRANT PROGRAM.
``(a) Additional Newborn Screening Tests Grants.--
``(1) In general.--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 condition.--For 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) Eligibility.--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 Panel.--An 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) Evaluation and Results.--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 Appropriations.--There 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.
``SEC. 1117. PRIVACY PROTECTIONS.
``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.''.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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