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
;
(D)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, the
Interagency Coordinating Committee established under Section 1114, 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.Interagency
coordinating committee on newborn and child screening
(a)It
is the purpose of this section to—
(1)assess existing
activities and infrastructure, including activities on birth defects and
developmental disabilities authorized under section 317C, in order to make
recommendations for programs to collect, analyze, and make available data on
the heritable disorders recommended by the Advisory Committee on Heritable
Disorders in Newborns and Children under section 1111, including data on the
incidence and prevalence of, as well as poor health outcomes resulting from,
such disorders; and
(2)make
recommendations for the establishment of regional centers for the conduct of
applied epidemiological research on effective interventions to promote the
prevention of poor health outcomes resulting from such disorders as well as
providing information and education to the public on such effective
interventions.
(b)The
Secretary shall establish an Interagency Coordinating Committee on Newborn and
Child Screening (referred to in this section as the Interagency
Coordinating Committee
) to carry out the purpose of this
section.
(c)The
Interagency Coordinating Committee shall be composed of the Director of the
Centers for Disease Control and Prevention, the Administrator, the Director of
the Agency for Healthcare Research and Quality, and the Director of the
National Institutes of Health, or their designees.
(d)The
Interagency Coordinating Committee shall—
(1)report to the
Secretary and the appropriate committees of Congress on its recommendations
related to the purpose described in subsection (a); and
(2)carry out other
activities determined appropriate by the Secretary.
(e)Authorization
of appropriationsFor the purpose of carrying out this section,
there are authorized to be appropriated $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.
.
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.
.
Passed the Senate
December 13, 2007.
Nancy Erickson,
Secretary