```

[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1281 Referred in Senate (RFS)]

113th CONGRESS
  2d Session
                                H. R. 1281

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                             June 25, 2014

                                Received

_______________________________________________________________________

                                 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. 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.

            Passed the House of Representatives June 24, 2014.

            Attest:

                                                 KAREN L. HAAS,

                                                                 Clerk.
```