[110th Congress Public Law 204]
[From the U.S. Government Printing Office]


[DOCID: f:publ204.110]

[[Page 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 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 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 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: Website.>>  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 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 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 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 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: Website.>>  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.

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