Newborn Screening Saves Lives Reauthorization Act of 2014

Summary: (This measure has not been amended since it was passed by the Senate on December 8, 2014.  Newborn Screening Saves Lives Reauthorization Act of 2014 - (Sec. 2) Amends the Public Health Service Act to revise and extend through FY2019 a grant program for screening, counseling, and other services related to heritable disorders that can be detected in newborns. Allows grants to be used to improve timeliness of newborn screening and provide training to health care professionals on the importance of timely screening and on the sharing of medical and diagnostic information with providers and families.  (Sec. 3) Extends through FY2019 a grant program to evaluate the effectiveness of screening, counseling, or health care services in reducing the morbidity and mortality caused by heritable disorders in newborns and children. Expands the program to include evaluation of health outcomes through adolescence and best practices for timely screening of newborns. (Sec. 4) Extends for five years the operation of the Advisory Committee on Heritable Disorders in Newborns and Children. Authorizes the Secretary of Health and Human Services (HHS) to continue the Advisory Committee after such time.  (Sec. 5) Extends through FY2019 the clearinghouse for newborn screening information. Expands the duties of the clearinghouse to include: (1) maintaining current information on the number of conditions for which screening is conducted in each state; and (2) disseminating guidelines for diagnosis, counseling, and treatment of conditions detected by newborn screening. (Sec. 6) Extends through FY2019 requirements for the Director of the Centers for Disease Control and Prevention (CDC) to provide for quality assurance of laboratories involved in screening newborns and children for heritable disorders. Authorizes the Director to coordinate surveillance activities, including through standardized data collection and reporting and electronic health records. (Sec. 7) Makes permanent the Interagency Coordinating Committee on Newborn and Child Screening. Adds the Administrator of the Health Resources and Services Administration and the Commissioner of Food and Drugs (FDA) to this committee.  (Sec. 8) Requires the Director to update the national contingency plan for newborn screening at least every five years. (Sec. 9) Authorizes the Secretary to expand the Hunter Kelly Newborn Screening Research Program to: (1) provide research and data for newborn conditions under review by the Advisory Committee to be added to the Recommended Uniform Screening Panel, and (2) conduct pilot studies on conditions recommended by the Advisory Committee to ensure that screenings are ready for nationwide implementation. (Sec. 11) Requires the Comptroller General (GAO) to report on the timeliness of newborn screening. Requires the Secretary to report on newborn screening activities and expenditures. (Sec. 12) Directs HHS to update the Federal Policy for the Protection of Human Subjects, also known as the Common Rule, not later than two years after enactment of this Act. Applies the following provisions until HHS updates the Common Rule:  requires federally funded research on newborn dried blood spots to be considered research on human subjects (which requires the informed consent of the subject), and eliminates the ability of an institutional review board to waive informed consent requirements for research on newborn dried blood spots.  

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;
            (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).
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 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;
        (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
        (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.
  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.

                               Speaker of the House of Representatives.

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