[United States Statutes at Large, Volume 122, 110th Congress, 2nd Session]
[From the U.S. Government Printing Office, www.gpo.gov]

122 STAT. 705

Public Law 110-204
110th Congress

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. [NOTE: Apr. 24, 2008 -  [S. 1858]]

Be it enacted by the Senate and House of Representatives of the
United States of America in Congress [NOTE: Newborn Screening Saves
Lives Act of 2007. 42 USC 201 note.] 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;

[[Page 706]]
122 STAT. 706

``(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 HERITABLE DISORDERS IN NEWBORNS AND
CHILDREN.

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);

[[Page 707]]
122 STAT. 707

(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

[[Page 708]]
122 STAT. 708

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) [NOTE: Deadlines.]  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) [NOTE: Web site.]  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:

[[Page 709]]
122 STAT. 709

``SEC. 1112. [NOTE: Establishment. 42 USC 300b-11.]
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.''.

[[Page 710]]
122 STAT. 710

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. [NOTE: 42 USC 300b-12.]  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. [NOTE: 42 USC 300b-13.]  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) [NOTE: Reports.]  report to the Secretary and the
appropriate committees of Congress on its recommendations
related to the purpose described in subsection (a); and

[[Page 711]]
122 STAT. 711

``(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. [NOTE: 42 USC 300b-14.]  NATIONAL CONTINGENCY PLAN
FOR NEWBORN SCREENING.

``(a) [NOTE: Deadline.]  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. [NOTE: 42 USC 300b-15.]  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.

[[Page 712]]
122 STAT. 712

``(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. [NOTE: Web site.]  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.''.

Approved April 24, 2008.

LEGISLATIVE HISTORY--S. 1858 (H.R. 3825):
---------------------------------------------------------------------------

HOUSE REPORTS: No. 110-570 accompanying H.R. 3825 (Comm. on Energy and
Commerce).
SENATE REPORTS: No. 110-280 (Comm. on Health, Education, Labor, and
Pensions).
CONGRESSIONAL RECORD:
Vol. 153 (2007):
Dec. 13, considered and passed
Senate.
Vol. 154 (2008):
Apr. 8, considered and passed House.