Newborn Screening Saves Lives Reauthorization Act of 2014
PL 113-240 (H.R.1281), enacted 12/18/2014

[113th Congress Public Law 240]
[From the U.S. Government Publishing Office]



[[Page 128 STAT. 2851]]

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. <<NOTE: Dec. 18, 2014 -  [H.R. 1281]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, <<NOTE: Newborn 
Screening Saves Lives Reauthorization Act of 2014. 42 USC 201 note.>> 
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 128 STAT. 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 128 STAT. 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) <<NOTE: Determination. Time 
                      period. Notification.>>  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 128 STAT. 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 128 STAT. 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) <<NOTE: Deadline.>>  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 128 STAT. 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. <<NOTE: 42 USC 300b-16.>>  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) <<NOTE: 42 USC 300b-17.>>  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 128 STAT. 2857]]

SEC. 12. <<NOTE: 42 USC 289 note.>>  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) <<NOTE: Applicability.>>  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) <<NOTE: Deadlines.>>  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.

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