Att C - Newborn Screening Act

S. 1858

One Hundred Tenth Congress
of the
United States of America
AT T H E S E C O N D S E S S I O N
Begun and held at the City of Washington on Thursday,
the third day of January, two thousand and eight

An Act
To amend the Public Health Service Act to establish grant programs to provide
for education and outreach on newborn screening and coordinated followup care
once newborn screening has been conducted, to reauthorize programs under part
A of title XI of such Act, and for other purposes.

Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.

This Act may be cited as the ‘‘Newborn Screening Saves Lives
Act of 2007’’.
SEC. 2. IMPROVED NEWBORN AND CHILD SCREENING FOR HERITABLE
DISORDER.

Section 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 PROGRAM.—From 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) ELIGIBLE ENTITY.—In this section, the term ‘eligible entity’
means—
‘‘(1) a State or a political subdivision of a State;

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‘‘(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) APPROVAL FACTORS.—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) COORDINATION.—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 APPROPRIATIONS.—There 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.’’.
SEC. 3. EVALUATING THE EFFECTIVENESS OF NEWBORN AND CHILD
SCREENING PROGRAMS.

Section 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 APPROPRIATIONS.—There 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.’’.
SEC.

4.

ADVISORY COMMITTEE ON
NEWBORNS AND CHILDREN.

HERITABLE

DISORDERS

IN

Section 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);

S. 1858—3
(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

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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) IN GENERAL.—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) PENDING RECOMMENDATIONS.—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 PUBLIC.—The 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) ANNUAL REPORT.—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 COMMITTEE.—Notwithstanding 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 APPROPRIATIONS.—There 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.’’.
SEC. 5. INFORMATION CLEARINGHOUSE.

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:

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‘‘SEC. 1112. CLEARINGHOUSE OF NEWBORN SCREENING INFORMATION.

‘‘(a) IN GENERAL.—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) INTERNET AVAILABILITY.—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) NONDUPLICATION.—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 APPROPRIATIONS.—There 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.’’.

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SEC. 6. LABORATORY QUALITY AND SURVEILLANCE.

Part 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:
‘‘SEC. 1113. LABORATORY QUALITY.

‘‘(a) IN GENERAL.—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 APPROPRIATIONS.—For 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.
‘‘SEC. 1114. INTERAGENCY COORDINATING COMMITTEE ON NEWBORN
AND CHILD SCREENING.

‘‘(a) PURPOSE.—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) ESTABLISHMENT.—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) COMPOSITION.—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) ACTIVITIES.—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

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‘‘(2) carry out other activities determined appropriate by
the Secretary.
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—For 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.’’.
SEC. 7. CONTINGENCY PLANNING.

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:
‘‘SEC.

1115.

NATIONAL
SCREENING.

CONTINGENCY

PLAN

FOR

NEWBORN

‘‘(a) IN GENERAL.—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) CONTENTS.—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.
‘‘SEC. 1116. HUNTER KELLY RESEARCH PROGRAM.

‘‘(a) NEWBORN SCREENING ACTIVITIES.—
‘‘(1) IN GENERAL.—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.

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‘‘(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 recommended by the Advisory Committee and adopted by the
Secretary.
‘‘(b) FUNDING.—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) REPORTS.—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) NONDUPLICATION.—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) PEER REVIEW.—Nothing in this section shall be construed
to interfere with the scientific peer-review process at the National
Institutes of Health.’’.

Speaker of the House of Representatives.

Vice President of the United States and
President of the Senate.