    [United States Statutes at Large, Volume 128, 113th Congress, 2nd Session]
    [From the U.S. Government Publishing Office, www.gpo.gov]

    Public Law 113-240
    113th Congress

    An Act

    To amend the Public Health Service Act to reauthorize programs under
    part A of title XI of such Act. <>

    Be it enacted by the Senate and House of Representatives of the
    United States of America in Congress assembled, <>
    SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Newborn Screening
    Saves Lives Reauthorization Act of 2014''.
    (b) Table of Contents.--The table of contents of this Act is as
    follows:

    Sec. 1. Short title; table of contents.
    Sec. 2. Improved newborn and child screening and followup for heritable
    disorders.
    Sec. 3. Evaluating the effectiveness of newborn and child screening and
    followup programs.
    Sec. 4. Advisory Committee on Heritable Disorders in Newborns and
    Children.
    Sec. 5. Clearinghouse of Newborn Screening Information.
    Sec. 6. Laboratory quality and surveillance.
    Sec. 7. Interagency Coordinating Committee on Newborn and Child
    Screening.
    Sec. 8. National contingency plan for newborn screening.
    Sec. 9. Hunter Kelly Research Program.
    Sec. 10. Authorization of appropriations.
    Sec. 11. Reports to Congress.
    Sec. 12. Informed consent for newborn screening research.

    SEC. 2. IMPROVED NEWBORN AND CHILD SCREENING AND FOLLOWUP FOR
    HERITABLE DISORDERS.

    Section 1109 of the Public Health Service Act (42 U.S.C. 300b-8) is
    amended--
    (1) in subsection (a)--
    (A) in the matter preceding paragraph (1)--
    (i) by striking ``subsection (j)'' and
    inserting ``section 1117''; and
    (ii) by striking ``and in consultation with
    the Advisory Committee'' and inserting ``and
    taking into consideration the expertise of the
    Advisory Committee'';
    (B) by amending paragraph (2) to read as follows:
    ``(2) to assist in providing health care professionals and
    newborn screening laboratory personnel with education in newborn
    screening, counseling, and training in--
    ``(A) relevant and new technologies in newborn
    screening and congenital, genetic, and metabolic
    disorders;
    ``(B) the importance of the timeliness of
    collection, delivery, receipt, and screening of
    specimens; and
    ``(C) sharing of medical and diagnostic information
    with providers and families;'';
    (C) in paragraph (3), by striking ``and'' at the
    end;

    [[Page 2852]]

    (D) in paragraph (4)--
    (i) by striking ``treatment'' and inserting
    ``followup and treatment''; and
    (ii) by striking the period and inserting ``;
    and''; and
    (E) by adding at the end the following:
    ``(5) to improve the timeliness of--
    ``(A) the collection, delivery, receipt, and
    screening of specimens; and
    ``(B) the diagnosis of heritable disorders in
    newborns.'';
    (2) in subsection (c), by striking ``application submitted
    for a grant under subsection (a)(1)'' and inserting
    ``application for a grant under this section'';
    (3) in subsection (h), by striking ``application submitted
    under subsection (c)(2)'' each place it appears and inserting
    ``application for a grant under this section''; and
    (4) by striking subsection (j) (relating to authorization of
    appropriations).
    SEC. 3. EVALUATING THE EFFECTIVENESS OF NEWBORN AND CHILD
    SCREENING AND FOLLOWUP PROGRAMS.

    Section 1110 of the Public Health Service Act (42 U.S.C. 300b-9) is
    amended--
    (1) in the section heading, by inserting ``and followup''
    after ``child screening'';
    (2) in subsection (a), by striking ``of screening,'' and
    inserting ``, including with respect to timeliness, of
    screening, followup,'';
    (3) in subsection (b)--
    (A) in paragraph (1)--
    (i) by striking ``counseling, testing'' and
    inserting ``treatment, counseling, testing,
    followup,''; and
    (ii) by inserting before the semicolon the
    following: ``, including, as appropriate, through
    the assessment of health and development outcomes
    for such children through adolescence'';
    (B) in paragraph (2)--
    (i) by striking ``counseling, testing'' and
    inserting ``treatment, counseling, testing,
    followup,'';
    (ii) by inserting ``in a timely manner'' after
    ``in newborns and children''; and
    (iii) by striking ``or'' at the end;
    (C) in paragraph (3), by striking the period at the
    end and inserting a semicolon; and
    (D) by adding at the end the following:
    ``(4) methods that may be identified to improve quality in
    the diagnosis, treatment, and disease management of heritable
    disorders based on gaps in services or care; or
    ``(5) methods or best practices by which the eligible
    entities described in section 1109 can achieve in a timely
    manner--
    ``(A) collection, delivery, receipt, and screening
    of newborn screening specimens; and
    ``(B) diagnosis of heritable disorders in
    newborns.''; and
    (4) by striking subsection (d) (relating to authorization of
    appropriations).

    [[Page 2853]]

    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 paragraphs (4) through (6) as
    paragraphs (6) through (8), respectively;
    (B) by inserting after paragraph (3), the following:
    ``(4) provide technical assistance, as appropriate, to
    individuals and organizations regarding the submission of
    nominations to the uniform screening panel, including prior to
    the submission of such nominations;
    ``(5) take appropriate steps, at its discretion, to prepare
    for the review of nominations prior to their submission,
    including for conditions for which a screening method has been
    validated but other nomination criteria are not yet met, in
    order to facilitate timely action by the Advisory Committee once
    such submission has been received by the Committee;'';
    (C) in paragraph (6) (as so redesignated), by
    inserting ``, including the cost'' after ``public health
    impact''; and
    (D) in paragraph (8) (as so redesignated)--
    (i) in subparagraph (A), by striking ``achieve
    rapid diagnosis'' and inserting ``achieve best
    practices in rapid diagnosis and appropriate
    treatment'';
    (ii) in subparagraph (D), by inserting before
    the semicolon ``, including information on cost
    and incidence'';
    (iii) in subparagraph (J), by striking ``and''
    at the end;
    (iv) in subparagraph (K), by striking the
    period and inserting ``; and''; and
    (v) by adding at the end the following:
    ``(L) the timeliness of collection, delivery,
    receipt, and screening of specimens to be tested for
    heritable disorders in newborns in order to ensure rapid
    diagnosis and followup.'';
    (2) in subsection (d)--
    (A) in paragraph (1)--
    (i) by striking ``180'' and inserting ``120'';
    and
    (ii) <>  by adding at the end the
    following: ``If the Secretary is unable to make a
    determination to adopt or reject such
    recommendation within such 120-day period, the
    Secretary shall notify the Advisory Committee and
    the appropriate committees of Congress of such
    determination together with an explanation for why
    the Secretary was unable to comply within such
    120-day period, as well as a plan of action for
    consideration of such pending recommendation.'';
    (B) by striking paragraph (2);
    (C) by redesignating paragraph (3) as paragraph (2);
    and
    (D) by adding at the end the following:
    ``(3) Deadline for review.--For each condition nominated to
    be added to the recommended uniform screening panel in
    accordance with the requirements of this section, the Advisory
    Committee shall review and vote on the nominated condition
    within 9 months of the date on which the Advisory Committee

    [[Page 2854]]

    referred the nominated condition to the condition review
    workgroup.'';
    (3) by redesignating subsections (f) and (g) as subsections
    (g) and (h), respectively;
    (4) by inserting after subsection (e) the following new
    subsection:

    ``(f) Meetings.--The Advisory Committee shall meet at least 4 times
    each calendar year, or at the discretion of the Designated Federal
    Officer in consultation with the Chair.'';
    (5) by amending subsection (g) (as so redesignated) to read
    as follows:

    ``(g) Continuation of Operation of Committee.--
    ``(1) In general.--Notwithstanding section 14 of the Federal
    Advisory Committee Act, the Advisory Committee shall continue to
    operate through the end of fiscal year 2019.
    ``(2) Continuation if not reauthorized.--If at the end of
    fiscal year 2019 the duration of the Advisory Committee has not
    been extended by statute, the Advisory Committee may be deemed,
    for purposes of the Federal Advisory Committee Act, an advisory
    committee established by the President or an officer of the
    Federal Government under section 9(a) of such Act.''; and
    (6) by striking subsection (h) (relating to authorization of
    appropriations), as redesignated by paragraph (3).
    SEC. 5. CLEARINGHOUSE OF NEWBORN SCREENING INFORMATION.

    Section 1112 of the Public Health Service Act (42 U.S.C. 300b-11) is
    amended--
    (1) in subsection (a)--
    (A) in paragraph (2), by striking ``and'' at the
    end;
    (B) in paragraph (3)--
    (i) by striking ``data'' and inserting
    ``information''; and
    (ii) by striking the period at the end and
    inserting a semicolon; and
    (C) by adding at the end the following new
    paragraphs:
    ``(4) maintain current information on the number of
    conditions for which screening is conducted in each State; and
    ``(5) disseminate available evidence-based guidelines
    related to diagnosis, counseling, and treatment with respect to
    conditions detected by newborn screening.'';
    (2) in subsection (b)(4)(D), by striking ``Newborn Screening
    Saves Lives Act of 2008'' and inserting ``Newborn Screening
    Saves Lives Reauthorization Act of 2014'';
    (3) in subsection (c)--
    (A) by striking ``developing the clearinghouse'' and
    inserting ``carrying out activities''; and
    (B) by striking ``clearinghouse minimizes
    duplication and supplements, not supplants'' and
    inserting ``activities minimize duplication and
    supplement, not supplant''; and
    (4) by striking subsection (d) (relating to authorization of
    appropriations).
    SEC. 6. LABORATORY QUALITY AND SURVEILLANCE.

    Section 1113 of the Public Health Service Act (42 U.S.C. 300b-12) is
    amended--
    (1) in the section heading, by inserting ``and
    surveillance'' before the period;

    [[Page 2855]]

    (2) in subsection (a)--
    (A) in the matter preceding paragraph (1), by
    striking ``and in consultation with the Advisory
    Committee'' and inserting ``and taking into
    consideration the expertise of the Advisory Committee'';
    and
    (B) in paragraph (1), by inserting ``timeliness for
    processing such tests,'' after ``newborn-screening
    tests,''; and
    (3) by striking subsection (b) (relating to authorization of
    appropriations) and inserting the following:

    ``(b) Surveillance Activities.--The Secretary, acting through the
    Director of the Centers for Disease Control and Prevention, and taking
    into consideration the expertise of the Advisory Committee on Heritable
    Disorders in Newborns and Children established under section 1111, may
    provide, as appropriate, for the coordination of surveillance
    activities, including--
    ``(1) through standardized data collection and reporting, as
    well as the use of electronic health records; and
    ``(2) by promoting data sharing regarding newborn screening
    with State-based birth defects and developmental disabilities
    monitoring programs.''.
    SEC. 7. INTERAGENCY COORDINATING COMMITTEE ON NEWBORN AND CHILD
    SCREENING.

    Section 1114 of the Public Health Service Act (42 U.S.C. 300b-13) is
    amended--
    (1) in subsection (c), by striking ``the Administrator, the
    Director of the Agency for Healthcare Research and Quality,''
    and inserting ``the Administrator of the Health Resources and
    Services Administration, the Director of the Agency for
    Healthcare Research and Quality, the Commissioner of Food and
    Drugs,''; and
    (2) by striking subsection (e) (relating to authorization of
    appropriations).
    SEC. 8. NATIONAL CONTINGENCY PLAN FOR NEWBORN SCREENING.

    Section 1115(a) of the Public Health Service Act (42 U.S.C. 300b-
    14(a)) is amended--
    (1) by striking ``consortia'' and inserting ``consortium'';
    and
    (2) <>  by adding at the end the following:
    ``The plan shall be updated as needed and at least every five
    years.''.
    SEC. 9. HUNTER KELLY RESEARCH PROGRAM.

    Section 1116 of the Public Health Service Act (42 U.S.C. 300b-15) is
    amended--
    (1) in subsection (a)(1)--
    (A) in subparagraph (B), by striking ``; and'' and
    inserting a semicolon;
    (B) by redesignating subparagraph (C) as
    subparagraph (E); and
    (C) by inserting after subparagraph (B) the
    following:
    ``(C) providing research findings and data for
    newborn conditions under review by the Advisory
    Committee on Heritable Disorders in Newborns and
    Children to be added to the recommended uniform
    screening panel;
    ``(D) conducting pilot studies on conditions
    recommended by the Advisory Committee on Heritable
    Disorders in Newborns and Children to ensure that
    screenings are ready for nationwide implementation;
    and''; and

    [[Page 2856]]

    (2) in subsection (c), by striking ``of the National
    Institutes of Health Reform Act of 2006''.
    SEC. 10. AUTHORIZATION OF APPROPRIATIONS.

    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. 1117. <>  AUTHORIZATION OF
    APPROPRIATIONS FOR NEWBORN SCREENING
    PROGRAMS AND ACTIVITIES.

    ``There are authorized to be appropriated--
    ``(1) to carry out sections 1109, 1110, 1111, and 1112,
    $11,900,000 for each of fiscal years 2015 through 2019; and
    ``(2) to carry out section 1113, $8,000,000 for each of
    fiscal years 2015 through 2019.''.
    SEC. 11. REPORTS TO CONGRESS.

    (a) GAO Report on Timeliness of Newborn Screening.--
    (1) In general.--Not later than 2 years after the date of
    enactment of this Act, the Comptroller General of the United
    States shall submit a report to the Committee on Health,
    Education, Labor, and Pensions of the Senate and the Committee
    on Energy and Commerce of the House of Representatives
    concerning the timeliness of screening for heritable disorders
    in newborns.
    (2) <>  Contents.--The report submitted
    under paragraph (1) shall include the following:
    (A) An analysis of information regarding the
    timeliness of newborn screening, which may include the
    time elapsed from birth to specimen collection, specimen
    collection to receipt by laboratory, specimen receipt to
    reporting, reporting to followup testing, and followup
    testing to confirmed diagnosis.
    (B) <>  A summary of any guidelines,
    recommendations, or best practices available to States
    and health care providers intended to support a timely
    newborn screening system.
    (C) An analysis of any barriers to maintaining a
    timely newborn screening system which may exist and
    recommendations for addressing such barriers.

    (b) <>  Report by Secretary.--
    (1) In general.--The Secretary of Health and Human Services
    shall--
    (A) not later than 1 year after the date of
    enactment of this Act, submit to the Committee on
    Health, Education, Labor, and Pensions of the Senate and
    the Committee on Energy and Commerce of the House of
    Representatives a report on activities related to--
    (i) newborn screening; and
    (ii) screening children who have or are at
    risk for heritable disorders; and
    (B) not less than every 2 years, submit to such
    committees an updated version of such report.
    (2) Contents.--The report submitted under this subsection
    shall contain a description of--
    (A) the ongoing activities under sections 1109,
    1110, and 1112 through 1115 of the Public Health Service
    Act; and
    (B) the amounts expended on such activities.

    [[Page 2857]]

    SEC. 12. <>  INFORMED CONSENT FOR NEWBORN
    SCREENING RESEARCH.

    (a) In General.--Research on newborn dried blood spots shall be
    considered research carried out on human subjects meeting the definition
    of section 46.102(f)(2) of title 45, Code of Federal Regulations, for
    purposes of Federally funded research conducted pursuant to the Public
    Health Service Act until such time as updates to the Federal Policy for
    the Protection of Human Subjects (the Common Rule) are promulgated
    pursuant to subsection (c). For purposes of this subsection, sections
    46.116(c) and 46.116(d) of title 45, Code of Federal Regulations, shall
    not apply.
    (b) <>  Effective Date.--Subsection (a) shall
    apply only to newborn dried blood spots used for purposes of Federally
    funded research that were collected not earlier than 90 days after the
    date of enactment of this Act.

    (c) <>  Regulations.--Not later than 6 months
    after the date of enactment of this Act, the Secretary of Health and
    Human Services shall promulgate proposed regulations related to the
    updating of the Federal Policy for the Protection of Human Subjects (the
    Common Rule), particularly with respect to informed consent. Not later
    than 2 years after such date of enactment, the Secretary shall
    promulgate final regulations based on such proposed regulations.

    Approved December 18, 2014.

    LEGISLATIVE HISTORY--H.R. 1281:
    ---------------------------------------------------------------------------

    HOUSE REPORTS: No. 113-478 (Comm. on Energy and Commerce).
    CONGRESSIONAL RECORD, Vol. 160 (2014):
    June 24, considered and passed House.
    Dec. 8, considered and passed Senate, amended.
    Dec. 10, House concurred in Senate amendment.