1.This Act may be cited as the
Newborn Screening Saves Lives Act of
2007
.
2.Congress finds the following:
(1)Each year more
than 4,000,000 babies born in the United States are screened by State and
private laboratories to detect some conditions that may threaten their
long-term health.
(2)However, there is
a lack of uniformity in the number of conditions for which newborns are
screened throughout the United States. While a newborn may be screened and
treated for a debilitating condition in one State, in another State, the
condition may go undetected and result in permanent disability or even
death.
(3)Approximately
4,000 infants born each year are diagnosed with these detectable and treatable
disorders. If diagnosed early, these conditions can be successfully managed or
treated to prevent severe and often lifelong health consequences.
(4)In 2004, the
American College of Medical Genetics (ACMG) completed a report commissioned by
the Department of Health and Human Services which recommended that every baby
born in the United States be screened for 29 specific disorders, including
certain metabolic conditions and hearing deficiencies.
(5)Currently only 11
States and the District of Columbia require infants to be screened for all 29
of these recommended disorders.
(6)Continuity,
especially during a public health emergency, plays a critical role in the
screening, diagnosis, referral, and treatment of these disorders. Currently
there is no national contingency plan for maintaining continuity of newborn
screening systems following a public health emergency.
3.Amendment to
title III of the Public Health Service
ActPart 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:
399Z–1.
(a)Authorization of
grant programsFrom funds appropriated under subsection (h), the
Secretary, acting through the Administrator of the Health Resources and
Services Administration (referred to in this section as the
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—
(1)education in
newborn screening; and
(2)training
in—
(A)relevant and new
technologies in newborn screening; and
(B)congenital,
genetic, and metabolic disorders.
(b)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)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)
(A)Requirements for
approvalAn 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)Prior to awarding a grant under this section, the
Secretary shall—
(i)conduct an
assessment of existing educational resources and training programs with respect
to newborn screening; and
(ii)take all
necessary steps to minimize the duplication of the resources and programs
described in clause (i) and ensure that funding under this section will
supplement, not supplant, existing funding for such activities.
(d)The
Secretary shall take all necessary steps to coordinate programs funded with
grants received under this section and to coordinate with existing newborn
screening activities.
(e)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 professional organizations and societies to develop and deliver education
and training programs that include—
(1)continuing medical
education programs for health care professionals and newborn screening
laboratory personnel in newborn screening;
(2)education,
technical assistance, and training on new discoveries in newborn screening and
the use of any related technology;
(3)models to evaluate
the prevalence of, and assess and communicate the risks of, congenital
conditions, including the prevalence and risk of some of these conditions based
on family history;
(4)models to
communicate effectively with parents and families about—
(A)the process and
benefits of newborn screening and the meaning of screening results, including
the possibility of false positive findings;
(B)how to use
information gathered from newborn screening;
(C)the right of
refusal of newborn screening, if applicable; and
(D)the potential need
for followup care after newborns are screened;
(5)information and
resources on coordinated systems of followup care after newborns are
screened;
(6)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;
(7)information on
additional newborn screening that may not be required by the State, but that
may be available from other sources; and
(8)other items to
carry out the purpose described in subsection (a)(1) as determined appropriate
by the Secretary.
(f)
(1)Subject to paragraph (2), the Secretary shall submit to
the relevant committees of Congress reports—
(A)evaluating the
effectiveness and the impact of the grants awarded under this section—
(i)in promoting
newborn screening 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, State, and local actions to support—
(i)education and
training in newborn screening; and
(ii)followup care
after newborns are screened.
(2)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 entityIn 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)other entities
with appropriate expertise in newborn screening, as determined by the
Secretary.
(h)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 may
be necessary for each of fiscal years 2009 through
2012.
.
4.Improved newborn
and child screening for heritable disordersSection 1109 of the Public Health Service
Act (42 U.S.C. 300b–8) is amended—
(1)in subsection
(c)(2)—
(A)in subparagraph
(E), by striking and
after the semicolon;
(B)by redesignating
subparagraph (F) as subparagraph (G); and
(C)by inserting after
subparagraph (E) the following:
(F)an assurance that
the entity has adopted and implemented, is in the process of adopting and
implementing, or will use grant amounts received under this section to adopt
and implement the guidelines and recommendations of the Advisory Committee on
Heritable Disorders in Newborns and Children established under section 1111
(referred to in this section as the Advisory Committee
) that are
adopted by the Secretary and in effect at the time the grant is awarded or
renewed under this section, which shall include the screening of each newborn
for the heritable disorders recommended by the Advisory Committee and adopted
by the Secretary and the reporting of results;
and
;
and
(2)in subsection (i),
by striking such sums
and all that follows through the period at
the end and inserting $15,000,000 for fiscal year 2008 and such sums as
may be necessary for each of the fiscal years 2009 through
2012.
.
5.Evaluating the
effectiveness of newborn- and child-screening programsSection 1110 of the Public Health Service
Act (42 U.S.C. 300b–9) is amended by adding at the end the following:
(d)Authorization of
appropriationsThere are authorized to be appropriated to carry
out this section $5,000,000 for fiscal year 2008 and such sums as may be
necessary for each of the fiscal years 2009 through
2012.
.
6.Advisory
committee on heritable disorders in newborns and childrenSection 1111 of the Public Health Service
Act (42 U.S.C. 300b–10) is amended—
(1)in subsection
(b)—
(A)in paragraph (1),
by inserting and grants awarded under section 399Z–1
before the
semicolon;
(B)by redesignating
paragraph (3) as paragraph (6);
(C)in paragraph (2),
by striking and
after the semicolon;
(D)by inserting after
paragraph (2) the following:
(3)make systematic
evidence-based and peer-reviewed recommendations that include the heritable
disorders for which all newborns should be screened, including secondary
conditions that may be identified as a result of the laboratory methods used
for screening;
(4)develop a model
decision-matrix for newborn screening program expansion, and periodically
update the recommended uniform screening panel, as appropriate, based on such
decision-matrix;
(5)consider ways to
ensure that States attain the capacity to screen for the conditions described
in paragraph (3), and include in such consideration the results of grant
funding under section 1109;
and
;
(E)in paragraph (6)
(as so redesignated by subparagraph (A)), by striking the period at the end and
inserting “, which may include recommendations, advice, or information dealing
with—
(A)followup
activities, including those necessary to achieve rapid diagnosis in the short
term, and those that ascertain long-term case management outcomes and
appropriate access to related services;
(B)implementation,
monitoring, and evaluation of newborn screening activities, including
diagnosis, screening, follow-up, and treatment activities;
(C)diagnostic and
other technology used in screening;
(D)the availability
and reporting of testing for conditions for which there is no existing
treatment;
(E)conditions not
included in the recommended uniform screening panel that are treatable with
Food and Drug Administration-approved products;
(F)minimum standards
and related policies and procedures used by State newborn screening programs,
such as language and terminology used by State newborn screening programs to
include standardization of case definitions and names of disorders for which
newborn screening tests are performed;
(G)quality assurance,
oversight, and evaluation of State newborn screening programs, including
ensuring that tests and technologies used by each State meet established
standards for detecting and reporting positive screening results;
(H)public and
provider awareness and education;
(I)the cost and
effectiveness of newborn screening and medical evaluation systems and
intervention programs conducted by State-based programs;
(J)identification of
the causes of, and risk factors for heritable disorders; and
(K)coordination of
surveillance activities, including standardized data collection and reporting,
harmonization of laboratory definitions for heritable disorders and testing
results, and confirmatory testing and verification of positive results, in
order to assess and enhance monitoring of newborn
diseases.
;
and
(2)in subsection
(c)(2)—
(A)by redesignating
subparagraphs (E), (F) and (G) as subparagraphs (F), (H), and (I);
(B)by inserting after
subparagraph (D) the following:
(E)the Commissioner
of the Food and Drug Administration;
;
and
(C)by inserting after
subparagraph (F), as so redesignated, the following:
(G)individuals with
expertise in ethics who have worked and published material in the area of
newborn screening;
;
and
(3)by adding at the
end the following:
(d)Decision on
recommendations
(1)Not later than 180 days after the Advisory Committee
issues a recommendation pursuant to this section, the Secretary shall adopt or
reject such recommendation.
(2)The Secretary shall adopt or reject any
recommendation issued by the Advisory Committee that is pending on the date of
enactment of the Newborn Screening Saves
Lives Act of 2007 by not later than 180 days after the date of
enactment of such Act.
(3)Determinations
to be made publicThe Secretary shall publicize any determination
on adopting or rejecting a recommendation of the Advisory Committee pursuant to
this subsection, including the justification for the determination.
(e)Not later than 2 years after the date of enactment of the
Newborn Screening Saves Lives Act of
2007, and each fiscal year thereafter, the Advisory Committee
shall—
(1)publish a report
on peer-reviewed newborn screening guidelines in the United States;
(2)submit such report
to the appropriate committees of Congress, the Secretary, and the State
departments of health; and
(3)disseminate such
report on as wide a basis as practicable, including through posting on the
internet clearinghouse established under section 1112.
(f)Continuation of
operation of committeeNotwithstanding section 14 of the Federal
Advisory Committee Act (5 U.S.C. App.), the Advisory Committee shall continue
to operate during the 5-year period beginning on the date of enactment of the
Newborn Screening Saves Lives Act of
2007.
(g)Authorization of
appropriationsThere are authorized to be appropriated to carry
out this section—
(1)$1,000,000 for
fiscal year 2008; and
(2)such sums as may
be necessary for each of the fiscal years 2009 through
2012.
.
7.Information
clearinghousePart 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.Clearinghouse
of newborn screening information
(a)The Secretary, acting through the Administrator of the
Health Resources and Services Administration (referred to in this part as the
Administrator
), in consultation with the Director of the Centers
for Disease Control and Prevention and the Director of the National Institutes
of Health, shall 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 wanting to have children and expectant families;
and
(3)develop and
maintain current data on quality indicators to measure performance of newborn
screening, such as false-positive rates and other quality indicators as
determined by the Advisory Committee under section 1111.
(b)The Secretary, acting through the Administrator,
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, non-profit, and other Internet websites of laboratories
as determined appropriate by the Secretary 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 from
laboratories certified under subpart 2 of part F of title III, including
information about supplemental screening that is available but not required, in
the State where the infant is born;
(C)current research
on both treatable and not-yet treatable conditions for which newborn screening
tests are available;
(D)the availability
of Federal funding for newborn and child screening for heritable disorders
including grants authorized under the Newborn
Screening Saves Lives Act of 2007; and
(E)other relevant
information as determined appropriate by the Secretary.
(c)In
developing the clearinghouse under this section, the Secretary shall ensure
that such clearinghouse minimizes duplication and supplements, not supplants,
existing information sharing efforts.
(d)Authorization of
appropriationsThere are authorized to be appropriated to carry
out this section—
(1)$2,500,000 for
fiscal year 2008; and
(2)such sums as may
be necessary for each of the fiscal years 2009 through
2012.
.
8.Laboratory
quality and surveillancePart
A of title XI of the Public Health Service Act (42 U.S.C. 300b–1 et seq.), as
amended by section 7, is further amended by adding at the end the
following:
1113.
(a)The Secretary, acting
through the Director of the Centers for Disease Control and Prevention and in
consultation with the Advisory Committee on Heritable Disorders in Newborns and
Children established under section 1111, shall provide for—
(1)quality assurance
for laboratories involved in screening newborns and children for heritable
disorders, including quality assurance for newborn-screening tests, performance
evaluation services, and technical assistance and technology transfer to
newborn screening laboratories to ensure analytic validity and utility of
screening tests; and
(2)population-based
pilot testing for new screening tools for evaluating use on a mass
scale.
(b)Authorization of
appropriationsFor the purpose of carrying out this section,
there are authorized to be appropriated $5,000,000 for fiscal year 2008 and
such sums as may be necessary for each of the fiscal years 2009 through
2012.
1114.Surveillance
programs for heritable disorders screening
(a)The Secretary, acting through an Interagency Group
consisting of the Director of the Agency for Healthcare Research and Quality,
the Director of the Centers for Disease Control and Prevention, the
Administrator, and the Director of the National Institutes of Health, shall
build upon existing activities and infrastructure to carry out programs—
(1)to collect,
analyze, and make available data on the heritable disorders recommended by the
Advisory Committee on Heritable Disorders in Newborns and Children established
under section 1111, including data on the incidence and prevalence of, as well
as poor health outcomes resulting from, such disorders;
(2)to operate
regional centers for the conduct of applied epidemiological research on
effective interventions for such disorders for the prevention of poor health
outcomes;
(3)to provide
information and education to the public on effective interventions for the
prevention of poor health outcomes resulting from such disorders; and
(4)to conduct
research on and to promote the prevention of poor health outcomes resulting
from such disorders, and secondary health conditions among individuals with
such disorders.
(b)
(1)In carrying out subsection (a), the Secretary may make
grants to and enter into contracts with public and nonprofit private
entities.
(2)Supplies and
services in lieu of award funds
(A)Upon the request of a recipient of an award of a grant or
contract under paragraph (1), the Secretary may, subject to subparagraph (B),
provide supplies, equipment, and services for the purpose of aiding the
recipient in carrying out the purposes for which the award is made and, for
such purposes, may detail to the recipient any officer or employee of the
Department of Health and Human Services.
(B)With
respect to a request described in subparagraph (A), the Secretary shall reduce
the amount of payments under the award involved by an amount equal to the costs
of detailing personnel and the fair market value of any supplies, equipment, or
services provided by the Secretary. The Secretary shall, for the payment of
expenses incurred in complying with such request, expend the amounts
withheld.
(3)The Secretary may make an award of a grant or contract
under paragraph (1) only if an application for the award is submitted to the
Secretary and the application is in such form, is made in such manner, and
contains such agreements, assurances, and information as the Secretary
determines to be necessary to carry out the purposes for which the award is to
be made.
(c)
(1)Subject to paragraph (2), the Secretary shall submit to
the relevant committees of Congress reports—
(A)containing
information under paragraph (1) that is specific to various racial, ethnic, and
socioeconomic groups;
(B)containing an
assessment of the extent to which various approaches of preventing heritable
disorders and secondary health conditions among individuals with such disorders
have been effective;
(C)describing the
activities carried out under this section;
(D)containing
information on the incidence and prevalence of individuals living with
heritable disorders, information on the health status of individuals with such
disorders including the extent to which such disorders have contributed to the
incidence and prevalence of infant mortality, information on any health
disparities experienced by such individuals, and recommendations for improving
the health and wellness and quality of life of such individuals;
(E)containing a
summary of recommendations from all heritable disorders research conferences
sponsored by the Centers for Disease Control and Prevention; and
(F)containing any
recommendations of the Secretary regarding this section.
(2)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.
(d)Applicability of
Privacy LawsThe provisions of this section shall be subject to
the requirements of section 552a of title 5, United States Code. All Federal
laws relating to the privacy of information shall apply to the data and
information that is collected under this section.
(e)
(1)In carrying out this section, the Secretary shall
coordinate, to the extent practicable, programs under this section with
programs on birth defects and developmental disabilities authorized under
section 317C.
(2)Priority in
grants and contractsIn making grants and contracts under this
section, the Secretary shall give priority to entities that demonstrate the
ability to coordinate activities under a grant or contract made under this
section with existing birth defects surveillance activities.
(f)Authorization of
AppropriationsFor the purpose of carrying out this section,
there are authorized to be appropriated $15,000,000 for fiscal year 2008 and
such sums as may be necessary for each of the fiscal years 2009 through
2012.
.
9.Part A of title XI of the Public Health
Service Act (42 U.S.C. 300b–1 et seq.), as amended by section 8, is further
amended by adding at the end the following:
1115.
(a)Authorization of
grant program
(1)From funds appropriated under subsection (h), the
Secretary, acting through the Administrator and in consultation with the
Advisory Committee, shall award grants to eligible entities to—
(A)enable such
entities to develop and deliver educational programs about newborn screening to
parents, families, and patient advocacy and support groups, such educational
materials accompanying such educational programs to be provided at appropriate
literacy levels; and
(B)enable such
entities to establish, maintain, and operate a system to assess and coordinate
treatment relating to congenital, genetic, and metabolic disorders.
(2)Awareness of the
availability of programsTo the extent practicable, the Secretary
shall make relevant health care providers aware of the availability of the
educational programs supported pursuant to paragraph (1).
(b)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)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)
(A)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)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) and ensure that funding under this section will
supplement, not supplant, existing funding for such activities.
(d)The
Secretary shall take all necessary steps to coordinate programs funded with
grants received under this section and to coordinate with existing newborn
screening activities.
(e)
(1)An eligible entity that receives a grant under this
section may use the grant funds—
(A)for purposes of
grants under subsection (a)(1)(A), to develop and deliver to parents, families,
and patient advocacy and support groups, educational programs about newborn
screening that include information on—
(i)what newborn
screening is and how it is performed;
(ii)who performs
newborn screening;
(iii)where newborn
screening is performed;
(iv)the disorders for
which the State requires newborns to be screened;
(v)different options
for newborn screening for disorders other than those included by the State in
the mandated newborn screening program;
(vi)the meaning of
various screening results, including the possibility of false positive and
false negative findings;
(vii)the prevalence
and risk of newborn disorders, including the increased risk of disorders that
may stem from family history;
(viii)coordinated
systems of followup care after newborns are screened; and
(ix)other items to
carry out the purpose described in subsection (a)(1) as determined appropriate
by the Secretary; and
(B)for purposes of
grants under subsection (a)(1)(B), to—
(i)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 appropriate subspecialists such as in congenital, genetic, and
metabolic disorders;
(ii)coordinate
ongoing followup treatment with individuals, families, primary care physicians,
and appropriate subspecialists such as in congenital, genetic, and metabolic
disorders after a newborn receives an indication of the presence or increased
risk of a disorder on a screening test;
(iii)ensure the
seamless integration of confirmatory testing, tertiary care medical services,
comprehensive genetic services including genetic counseling, and information
about Food and Drug Administration-approved treatments as well as access to
developing therapies by participation in approved clinical trials involving the
primary health care of the infant;
(iv)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;
(v)collect, analyze
and report data on the costs, benefits and effectiveness of such tests;
and
(vi)carry out such
other activities as the Secretary may determine necessary.
(f)
(1)Subject to paragraph (2), the Secretary shall submit to
the relevant 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, State, and local actions to support—
(i)education and
training in newborn screening; and
(ii)followup care
after newborns are screened.
(2)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
(i)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)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)other entities
with appropriate expertise in newborn screening, as determined by the
Secretary.
(h)Authorization of
appropriationsThere is authorized to be appropriated to carry
out this section—
(1)$10,000,000 for
fiscal year 2008; and
(2)such sums as may
be necessary for each of fiscal years 2009 through
2012.
.
10.Part A of title XI of
the Public Health Service Act (42 U.S.C. 300b–1 et seq.), as amended by section
9, is further amended by adding at the end the following:
1116.National
contingency plan for newborn screening
(a)Not later than 180 days after the date of enactment of
this section, the Secretary, acting through the Director of the Centers for
Disease Control and Prevention and in consultation with the Administrator and
State departments of health (or related agencies), shall develop a national
contingency plan for newborn screening for use by a State, region, or consortia
of States in the event of a public health emergency.
(b)The
contingency plan developed under subsection (a) shall include a plan
for—
(1)the collection and
transport of specimens;
(2)the shipment of
specimens to State newborn screening laboratories;
(3)the processing of
specimens;
(4)the reporting of
screening results to physicians and families;
(5)the diagnostic
confirmation of positive screening results;
(6)ensuring the
availability of treatment and management resources;
(7)educating families
about newborn screening; and
(8)carrying out other
activities determined appropriate by the Secretary.
1117.Hunter Kelly
research program
(a)Additional
newborn screening tests grants
(1)The Secretary, in conjunction with the Director of the
National Institutes of Health and taking into consideration the recommendations
of the Advisory Committee, shall establish a research program (to be known as
Hunter Kelly Newborn Screening Research Program
) by expanding,
carrying out, and coordinating research in—
(A)identifying,
developing, and testing the most promising new screening technologies, in order
to improve already existing screening tests, which may include tests for Krabbe
Disease and Insulin Dependent Diabetes Mellitus, and Turner Syndrome, increase
the specificity of newborn screening, and expand the number of conditions for
which screening tests are available;
(B)experimental
treatments and disease management strategies for additional newborn conditions,
and other genetic, metabolic, hormonal and/or functional conditions that can be
detected through newborn screening for which treatment is not yet available;
and
(C)other activities
that would improve newborn screening, as identified by the Director.
(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.
(b)In
carrying out the research program under this section, the Secretary and the
Director shall ensure that entities receiving funding through the program will
provide assurances, as practicable, that such entities will work in
consultation with the appropriate State departments of health, and, as
practicable, focus their research on screening technology not currently
performed in the States in which the entities are located, and the conditions
on the uniform screening panel (or the standard test existing on the uniform
screening panel).
(c)The Director shall—
(1)monitor and report
on the activities resulting from any funding distributed under this section;
and
(2)on an annual
basis—
(A)publish and
disseminate the results of such monitoring on as wide a basis as is
practicable, which may include incorporation of these results in other newborn
screening reports and posting on the Internet Clearinghouse established under
section 1112;
(B)submit to the
relevant committees of Congress the results of such evaluation, which may
include incorporation of such results in other newborn screening reports being
submitted to Congress.
(d)In
carrying out programs under this section, the Secretary shall minimize
duplication and supplement, not supplant, existing efforts of the type carried
out under this section.
(e)Nothing in this section shall be construed to interfere
with the scientific peer-review process at the National Institutes of
Health.
(f)Authorization of
appropriationsThere are authorized to be appropriated to carry
out this section—
(1)$7,000,000 for
fiscal year 2008; and
(2)such sums as may
be necessary for fiscal years 2009 through
2012.
.
1.This Act may be cited as the
Newborn Screening Saves Lives Act of
2007
.
2.Improved newborn and
child screening for heritable disorderSection 1109 of the Public Health Service
Act (42 U.S.C. 300b–8) is amended—
(1)by striking subsections
(a), (b), and (c) and inserting the following:
(a)Authorization of grant
programFrom amounts appropriated under subsection (j), the
Secretary, acting through the Administrator of the Health Resources and
Services Administration (referred to in this section as the
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—
(1)to enhance, improve or
expand the ability of State and local public health agencies to provide
screening, counseling, or health care services to newborns and children having
or at risk for heritable disorders;
(2)to assist in providing
health care professionals and newborn screening laboratory personnel with
education in newborn screening and training in relevant and new technologies in
newborn screening and congenital, genetic, and metabolic disorders;
(3)to develop and deliver
educational programs (at appropriate literacy levels) about newborn screening
counseling, testing, follow-up, treatment, and specialty services to parents,
families, and patient advocacy and support groups; and
(4)to establish, maintain,
and operate a system to assess and coordinate treatment relating to congenital,
genetic, and metabolic disorders
(b)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)a health facility or
program operated by or pursuant to a contract with or grant from the Indian
Health Service; or
(5)any other entity with
appropriate expertise in newborn screening, as determined by the
Secretary.
(c)An application submitted for a grant under subsection
(a)(1) shall not be approved by the Secretary unless the application contains
assurances that the eligible entity has adopted and implemented, is in the
process of adopting and implementing, or will use amounts received under such
grant to adopt and implement the guidelines and recommendations of the Advisory
Committee that are adopted by the Secretary and in effect at the time the grant
is awarded or renewed under this section, which shall include the screening of
each newborn for the heritable disorders recommended by the Advisory Committee
and adopted by the
Secretary.
;
(2)by redesignating
subsections (d) through (i) as subsections (e) through (j),
respectively;
(3)by inserting after
subsection (c), the following:
(d)The
Secretary shall take all necessary steps to coordinate programs funded with
grants received under this section and to coordinate with existing newborn
screening activities.
;
and
(4)by striking subsection
(j) (as so redesignated) and inserting the following:
(j)Authorization of
appropriationsThere is authorized to be appropriated—
(1)to provide grants for the
purpose of carrying activities under section (a)(1), $15,000,000 for fiscal
year 2008; $15,187,500 for fiscal year 2009, $15,375,000 for fiscal year 2010,
$15,562,500 for fiscal year 2011, and $15,750,000 for fiscal year 2012;
and
(2)to provide grant for the
purpose of carrying out activities under paragraphs (2), (3), and (4) of
subsection (a), $15,000,000 for fiscal year 2008, $15,187,500 for fiscal year
2009, $15,375,000 for fiscal year 2010, $15,562,500 for fiscal year 2011, and
$15,750,000 for fiscal year
2012.
.
3.Evaluating the
effectiveness of newborn and child screening programsSection 1110 of the Public Health Service
Act (42 U.S.C. 300b–9) is amended by adding at the end the following:
(d)Authorization of
appropriationsThere are authorized to be appropriated to carry
out this section $5,000,000 for fiscal year 2008, $5,062,500 for fiscal year
2009, $5,125,000 for fiscal year 2010, $5,187,500 for fiscal year 2011, and
$5,250,000 for fiscal year
2012.
.
4.Advisory committee on
heritable disorders in newborns and childrenSection 1111 of the Public Health Service
Act (42 U.S.C. 300b–10) is amended—
(1)in subsection (b)—
(A)by redesignating
paragraph (3) as paragraph (6);
(B)in paragraph (2), by
striking and
after the semicolon;
(C)by inserting after
paragraph (2) the following:
(3)make systematic
evidence-based and peer-reviewed recommendations that include the heritable
disorders that have the potential to significantly impact public health for
which all newborns should be screened, including secondary conditions that may
be identified as a result of the laboratory methods used for screening;
(4)develop a model
decision-matrix for newborn screening expansion, including an evaluation of the
potential public health impact of such expansion, and periodically update the
recommended uniform screening panel, as appropriate, based on such
decision-matrix;
(5)consider ways to ensure
that all States attain the capacity to screen for the conditions described in
paragraph (3), and include in such consideration the results of grant funding
under section 1109;
and
;
(E)in paragraph (6) (as so
redesignated by subparagraph (A)), by striking the period at the end and
inserting “, which may include recommendations, advice, or information dealing
with—
(A)follow-up activities,
including those necessary to achieve rapid diagnosis in the short-term, and
those that ascertain long-term case management outcomes and appropriate access
to related services;
(B)implementation,
monitoring, and evaluation of newborn screening activities, including
diagnosis, screening, follow-up, and treatment activities;
(C)diagnostic and other
technology used in screening;
(D)the availability and
reporting of testing for conditions for which there is no existing
treatment;
(E)conditions not included
in the recommended uniform screening panel that are treatable with Food and
Drug Administration-approved products or other safe and effective treatments,
as determined by scientific evidence and peer review;
(F)minimum standards and
related policies and procedures used by State newborn screening programs, such
as language and terminology used by State newborn screening programs to include
standardization of case definitions and names of disorders for which newborn
screening tests are performed;
(G)quality assurance,
oversight, and evaluation of State newborn screening programs, including
ensuring that tests and technologies used by each State meet established
standards for detecting and reporting positive screening results;
(H)public and provider
awareness and education;
(I)the cost and
effectiveness of newborn screening and medical evaluation systems and
intervention programs conducted by State-based programs;
(J)identification of the
causes of, public health impacts of, and risk factors for heritable disorders;
and
(K)coordination of
surveillance activities, including standardized data collection and reporting,
harmonization of laboratory definitions for heritable disorders and testing
results, and confirmatory testing and verification of positive results, in
order to assess and enhance monitoring of newborn
diseases.
;
and
(2)in subsection
(c)(2)—
(A)by redesignating
subparagraphs (E), (F) and (G) as subparagraphs (F), (H), and (I);
(B)by inserting after
subparagraph (D) the following:
(E)the Commissioner of the
Food and Drug Administration;
;
and
(C)by inserting after
subparagraph (F), as so redesignated, the following:
(G)individuals with
expertise in ethics and infectious diseases who have worked and published
material in the area of newborn
screening;
;
and
(3)by adding at the end the
following:
(d)Decision on
recommendations
(1)Not later than 180 days after the Advisory Committee
issues a recommendation pursuant to this section, the Secretary shall adopt or
reject such recommendation.
(2)The Secretary shall adopt or reject any
recommendation issued by the Advisory Committee that is pending on the date of
enactment of the Newborn Screening Saves
Lives Act of 2007 by not later than 180 days after the date of
enactment of such Act.
(3)Determinations to be
made publicThe Secretary shall publicize any determination on
adopting or rejecting a recommendation of the Advisory Committee pursuant to
this subsection, including the justification for the determination.
(e)Not later than 3 years after the date of enactment of the
Newborn Screening Saves Lives Act of
2007, and each fiscal year thereafter, the Advisory Committee
shall—
(1)publish a report on
peer-reviewed newborn screening guidelines, including follow-up and treatment,
in the United States;
(2)submit such report to the
appropriate committees of Congress, the Secretary, and the State departments of
health; and
(3)disseminate such report
on as wide a basis as practicable, including through posting on the internet
clearinghouse established under section 1112.
(f)Continuation of
operation of committeeNotwithstanding section 14 of the Federal
Advisory Committee Act (5 U.S.C. App.), the Advisory Committee shall continue
to operate during the 5-year period beginning on the date of enactment of the
Newborn Screening Saves Lives Act of
2007.
(g)Authorization of
appropriationsThere are authorized to be appropriated to carry
out this section, $1,000,000 for fiscal year 2008, $1,012,500 for fiscal year
2009, $1,025,000 for fiscal year 2010, $1,037,500 for fiscal year 2011, and
$1,050,000 for fiscal year
2012.
.
5.Information
clearinghousePart 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.Clearinghouse of
newborn screening information
(a)The Secretary, acting through the Administrator of the
Health Resources and Services Administration (referred to in this part as the
Administrator), in consultation with the Director of the Centers
for Disease Control and Prevention and the Director of the National Institutes
of Health, shall 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
expectant individuals and families; and
(3)maintain current data on
quality indicators to measure performance of newborn screening, such as
false-positive rates and other quality indicators as determined by the Advisory
Committee under section 1111.
(b)The Secretary, acting through the Administrator,
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, non-profit, and other Internet 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 from laboratories
certified under subpart 2 of part F of title III, including information about
supplemental screening that is available but not required, in the State where
the infant is born;
(C)current research on both
treatable and not-yet treatable conditions for which newborn screening tests
are available;
(D)the availability of
Federal funding for newborn and child screening for heritable disorders
including grants authorized under the Newborn
Screening Saves Lives Act of 2007; and
(E)other relevant
information as determined appropriate by the Secretary.
(c)In
developing the clearinghouse under this section, the Secretary shall ensure
that such clearinghouse minimizes duplication and supplements, not supplants,
existing information sharing efforts.
(d)Authorization of
appropriationsThere are authorized to be appropriated to carry
out this section, $2,500,000 for fiscal year 2008, $2,531,250 for fiscal year
2009, $2,562,500 for fiscal year 2010, $2,593,750 for fiscal year 2011, and
$2,625,000 for fiscal year
2012.
.
6.Laboratory quality and
surveillancePart A of title
XI of the Public Health Service Act (42 U.S.C. 300b–1 et seq.), as amended by
section 5, is further amended by adding at the end the following:
1113.
(a)The Secretary, acting
through the Director of the Centers for Disease Control and Prevention and in
consultation with the Advisory Committee on Heritable Disorders in Newborns and
Children established under section 1111, shall provide for—
(1)quality assurance for
laboratories involved in screening newborns and children for heritable
disorders, including quality assurance for newborn-screening tests, performance
evaluation services, and technical assistance and technology transfer to
newborn screening laboratories to ensure analytic validity and utility of
screening tests; and
(2)appropriate quality
control and other performance test materials to evaluate the performance of new
screening tools.
(b)Authorization of
appropriationsFor the purpose of carrying out this section,
there are authorized to be appropriated $5,000,000 for fiscal year 2008,
$5,062,500 for fiscal year 2009, $5,125,000 for fiscal year 2010, $5,187,500
for fiscal year 2011, and $5,250,000 for fiscal year 2012.
1114.Surveillance programs
for heritable disorders screening
(a)The Secretary, acting through an Interagency Group
consisting of the Director of the Agency for Healthcare Research and Quality,
the Director of the Centers for Disease Control and Prevention, the
Administrator, and the Director of the National Institutes of Health, shall
build upon existing activities and infrastructure to carry out programs—
(1)to collect, analyze, and
make available data on the heritable disorders recommended by the Advisory
Committee on Heritable Disorders in Newborns and Children established under
section 1111, including data on the incidence and prevalence of, as well as
poor health outcomes resulting from, such disorders;
(2)to identify regional
centers for the conduct of applied epidemiological research on effective
interventions for such disorders for the prevention of poor health
outcomes;
(3)to provide information
and education to the public on effective interventions for the prevention of
poor health outcomes resulting from such disorders; and
(4)to conduct research on
and to promote the prevention of poor health outcomes resulting from such
disorders, and secondary health conditions among individuals with such
disorders.
(b)
(1)In carrying out subsection (a), the Secretary may make
grants to and enter into contracts with public and nonprofit private
entities.
(2)Supplies and services
in lieu of award funds
(A)Upon the request of a recipient of an award of a grant or
contract under paragraph (1), the Secretary may, subject to subparagraph (B),
provide supplies, equipment, and services for the purpose of aiding the
recipient in carrying out the purposes for which the award is made and, for
such purposes, may detail to the recipient any officer or employee of the
Department of Health and Human Services.
(B)With
respect to a request described in subparagraph (A), the Secretary shall reduce
the amount of payments under the award involved by an amount equal to the costs
of detailing personnel and the fair market value of any supplies, equipment, or
services provided by the Secretary. The Secretary shall, for the payment of
expenses incurred in complying with such request, expend the amounts
withheld.
(3)The Secretary may make an award of a grant or contract
under paragraph (1) only if an application for the award is submitted to the
Secretary and the application is in such form, is made in such manner, and
contains such agreements, assurances, and information as the Secretary
determines to be necessary to carry out the purposes for which the award is to
be made.
(c)
(1)Subject to paragraph (2), the Secretary shall submit to
the relevant committees of Congress reports—
(A)containing information
under paragraph (1) that is specific to various racial, ethnic, and
socioeconomic groups;
(B)containing an assessment
of the extent to which various approaches of preventing heritable disorders and
secondary health conditions among individuals with such disorders have been
effective;
(C)describing the activities
carried out under this section;
(D)containing information on
the incidence and prevalence of individuals living with heritable disorders,
information on the health status of individuals with such disorders including
the extent to which such disorders have contributed to the incidence and
prevalence of infant mortality, information on any health disparities
experienced by such individuals, and recommendations for improving the health
and wellness and quality of life of such individuals;
(E)containing a summary of
recommendations from all heritable disorders research conferences sponsored by
the Centers for Disease Control and Prevention or the National Institutes of
Health; and
(F)containing any
recommendations of the Secretary regarding this section.
(2)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.
(d)
(1)In carrying out this section, the Secretary shall
coordinate, to the extent practicable, programs under this section with
programs on birth defects and developmental disabilities authorized under
section 317C.
(2)Priority in grants and
contractsIn making grants and contracts under this section, the
Secretary shall give priority to entities that demonstrate the ability to
coordinate activities under a grant or contract made under this section with
existing birth defects surveillance activities.
(e)Authorization of
AppropriationsFor the purpose of carrying out this section,
there are authorized to be appropriated $15,000,000 for fiscal year 2008,
$15,187,500 for fiscal year 2009, $15,375,000 for fiscal year 2010, $15,562,500
for fiscal year 2011, and $15,750,000 for fiscal year
2012.
.
7.Part A of title XI of
the Public Health Service Act (42 U.S.C. 300b–1 et seq.), as amended by section
6, is further amended by adding at the end the following:
1115.National contingency
plan for newborn screening
(a)Not later than 180 days after the date of enactment of
this section, the Secretary, acting through the Director of the Centers for
Disease Control and Prevention and in consultation with the Administrator and
State departments of health (or related agencies), shall develop a national
contingency plan for newborn screening for use by a State, region, or consortia
of States in the event of a public health emergency.
(b)The
contingency plan developed under subsection (a) shall include a plan
for—
(1)the collection and
transport of specimens;
(2)the shipment of specimens
to State newborn screening laboratories;
(3)the processing of
specimens;
(4)the reporting of
screening results to physicians and families;
(5)the diagnostic
confirmation of positive screening results;
(6)ensuring the availability
of treatment and management resources;
(7)educating families about
newborn screening; and
(8)carrying out other
activities determined appropriate by the Secretary.
1116.Hunter Kelly research
program
(a)Newborn screening
activities
(1)The Secretary, in conjunction with the Director of the
National Institutes of Health and taking into consideration the recommendations
of the Advisory Committee, may continue carrying out, coordinating, and
expanding research in newborn screening (to be known as Hunter Kelly
Newborn Screening Research Program) including—
(A)identifying, developing,
and testing the most promising new screening technologies, in order to improve
already existing screening tests, increase the specificity of newborn
screening, and expand the number of conditions for which screening tests are
available;
(B)experimental treatments
and disease management strategies for additional newborn conditions, and other
genetic, metabolic, hormonal and or functional conditions that can be detected
through newborn screening for which treatment is not yet available; and
(C)other activities that
would improve newborn screening, as identified by the Director.
(2)Additional newborn
conditionFor purposes of this subsection, the term
additional newborn condition means any condition that is not one
of the core conditions recommended by the Advisory Committee and adopted by the
Secretary.
(b)In
carrying out the research program under this section, the Secretary and the
Director shall ensure that entities receiving funding through the program will
provide assurances, as practicable, that such entities will work in
consultation with the appropriate State departments of health, and, as
practicable, focus their research on screening technology not currently
performed in the States in which the entities are located, and the conditions
on the uniform screening panel (or the standard test existing on the uniform
screening panel).
(c)The
Director is encouraged to include information about the activities carried out
under this section in the biennial report required under section 403 of the
National Institutes of Health Reform Act of 2006. If such information is
included, the Director shall make such information available to be included on
the Internet Clearinghouse established under section 1112.
(d)In
carrying out programs under this section, the Secretary shall minimize
duplication and supplement, not supplant, existing efforts of the type carried
out under this section.
(e)Nothing in this section shall be construed to interfere
with the scientific peer-review process at the National Institutes of
Health.
.
December 5, 2007
Reported with an amendment