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[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 1858 Enrolled Bill (ENR)]

        S.1858

                       One Hundred Tenth Congress

                                 of the

                        United States of America

                          AT THE SECOND SESSION

          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;
        ``(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);
            (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) 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:
``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.''.
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
        ``(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 CONTINGENCY PLAN FOR NEWBORN SCREENING.
    ``(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.
        ``(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.
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