[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1281 Introduced in House (IH)]

113th CONGRESS
  1st Session
                                H. R. 1281

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 20, 2013

    Ms. Roybal-Allard (for herself and Mr. Simpson) introduced the 
   following bill; which was referred to the Committee on Energy and 
                                Commerce

_______________________________________________________________________

                                 A BILL


 
 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 2013''.
    (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 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.
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. Newborn screening surveillance, followup, and applied 
                            research.
Sec. 11. Authorization of appropriations.

SEC. 2. IMPROVED NEWBORN AND CHILD SCREENING 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), by 
                striking ``and in consultation with the Advisory 
                Committee'' and inserting ``and taking into 
                consideration the recommendations of the Advisory 
                Committee'';
                    (B) in paragraph (2), by striking ``screening and 
                training'' and inserting ``screening, counseling, and 
                training''; and
                    (C) in paragraph (4), by striking ``treatment'' and 
                inserting ``followup and treatment'';
            (2) in subsection (b)--
                    (A) in paragraph (4), by striking ``or'' at the 
                end;
                    (B) by redesignating paragraph (5) as paragraph 
                (7); and
                    (C) by inserting after paragraph (4) the following:
            ``(5) a health professional organization;
            ``(6) an early childhood health system; or''; and
            (3) 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 inserting ``followup,'' after 
        ``the effectiveness of screening,'';
            (3) in subsection (b)--
                    (A) in paragraph (1), by inserting ``ascertainment, 
                treatment,'' after ``the effectiveness of screening, 
                counseling,'';
                    (B) in paragraph (2)--
                            (i) by inserting ``ascertainment, 
                        treatment,'' after ``the effectiveness of 
                        screening, counseling,''; and
                            (ii) by striking ``or'' at the end;
                    (C) in paragraph (3), by striking the period at the 
                end and inserting ``; or''; and
                    (D) by adding at the end the following:
            ``(4) the availability and effectiveness of treatment and 
        followup care for newborns and their families after screening 
        and diagnosis.''; 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) in paragraph (4), by striking ``public health 
                impact'' and inserting ``public health impact and 
                cost''; and
                    (B) in paragraph (6)--
                            (i) in subparagraph (A), by striking 
                        ``achieve rapid diagnosis'' and inserting 
                        ``achieve best practices in rapid diagnosis and 
                        appropriate treatment''; and
                            (ii) in subparagraph (D), by inserting 
                        before the semicolon ``, including information 
                        on cost and incidence'';
            (2) by redesignating subsections (f) and (g) as subsections 
        (g) and (h), respectively;
            (3) by inserting after subsection (e) the following new 
        subsection:
    ``(f) Meetings.--The Advisory Committee shall meet in person at 
least twice each year.'';
            (4) by amending subsection (g), as redesignated by 
        paragraph (2), to read as follows:
    ``(g) Continuation of Operation of Committee.--
            ``(1) In general.--Notwithstanding section 14 of the 
        Federal Advisory Committee Act (5 U.S.C. App.), the Advisory 
        Committee shall continue to operate for the period beginning on 
        the date of enactment of the Newborn Screening Saves Lives 
        Reauthorization Act of 2013 and concluding at the end of the 
        fifth fiscal year which begins after such date.
            ``(2) Continuation if not reauthorized.--If at the end of 
        the fifth fiscal year described in paragraph (1) the duration 
        of the Advisory Committee has not been extended by statute--
                    ``(A) the Advisory Committee may be considered, for 
                the purposes of the Federal Advisory Committee Act, to 
                be an advisory committee established by the President 
                or an officer of the Federal Government under section 
                9(a) of such Act; and
                    ``(B) the Secretary may renew the Advisory 
                Committee under section 14(a)(1)(A) of such Act.''; and
            (5) by striking subsection (h) (relating to authorization 
        of appropriations), as redesignated by paragraph (2).

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'' and 
                inserting a semicolon;
                    (B) in paragraph (3), 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 data on the number of conditions for 
        which screening is conducted in each State; and
            ``(5) establish or disseminate guidelines for services and 
        personnel necessary for followup, 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 2013''; and
            (3) by striking subsection (d) (relating to authorization 
        of appropriations).

SEC. 6. LABORATORY QUALITY.

    Section 1113 of the Public Health Service Act (42 U.S.C. 300b-12) 
is amended--
            (1) in subsection (a)--
                    (A) by striking the subsection enumerator and 
                heading; and
                    (B) by striking ``and in consultation with the 
                Advisory Committee'' and inserting ``and taking into 
                consideration the recommendations of the Advisory 
                Committee''; and
            (2) by striking subsection (b) (relating to authorization 
        of appropriations).

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) and inserting the following:
    ``(e) Report to Congress.--
            ``(1) In general.--The Secretary shall--
                    ``(A) not later than 1 year after the date of 
                enactment of the Newborn Screening Saves Lives 
                Reauthorization Act of 2013, submit to the Health, 
                Education, Labor, and Pensions Committee of the Senate 
                and the Energy and Commerce Committee 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, shall submit to 
                such committees an updated version of such report.
            ``(2) Contents.--The report submitted under subsection (a) 
        shall contain a description of--
                    ``(A) the implementation of sections 1111 through 
                1116B, including this section; and
                    ``(B) the amounts expended on such 
                implementation.''.

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 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(a)(1) of the Public Health Service Act (42 U.S.C. 
300b-15(a)(1)) is amended--
            (1) in subparagraph (B), by striking ``; and'' and 
        inserting a semicolon;
            (2) by redesignating subparagraph (C) as subparagraph (E); 
        and
            (3) by inserting after subparagraph (B) the following:
                    ``(C) providing research 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''.

SEC. 10. NEWBORN SCREENING SURVEILLANCE, FOLLOWUP, AND APPLIED 
              RESEARCH.

    The Public Health Service Act is amended by inserting after section 
1116 of such Act (42 U.S.C. 300b-15) the following:

``SEC. 1116A. NEWBORN SCREENING SURVEILLANCE, FOLLOWUP, AND APPLIED 
              RESEARCH.

    ``(a) In General.--The Secretary, acting through the Director of 
the Centers for Disease Control and Prevention, shall award grants to, 
or enter into cooperative agreements with, eligible entities to develop 
longitudinal followup and tracking programs for newborn screening.
    ``(b) Program.--Longitudinal followup and tracking programs 
developed through a grant under subsection (a) shall incorporate 
standardized procedures for data management and program effectiveness 
and costs, such as--
            ``(1) studying the costs and effectiveness of newborn 
        screening, evaluation and intervention programs, and 
        surveillance systems conducted by State-based programs in order 
        to answer issues of importance to State and national 
        policymakers;
            ``(2) studying the effectiveness of newborn screening 
        followup and intervention programs by assessing the health and 
        development of children at school age and as young adults;
            ``(3) promoting the sharing of data regarding newborn 
        screening with State-based birth defects and developmental 
        disabilities monitoring programs;
            ``(4) ensuring coordination of surveillance activities, 
        including--
                    ``(A) standardized data collection and reporting; 
                and
                    ``(B) use of electronic health records;
            ``(5) facilitating quality improvement in treatment and 
        disease management based on gaps in services or care identified 
        by longitudinal tracking systems; and
            ``(6) utilizing data from longitudinal tracking systems to 
        support the development and evaluation of evidence-based 
        guidelines for diagnosis, treatment, and disease management.
    ``(c) Eligible Entity.--In this section, the term `eligible entity' 
means--
            ``(1) a State or a political subdivision of a State;
            ``(2) a consortium of 2 or more States or subdivisions 
        described in paragraph (1);
            ``(3) a health facility or program operated by or pursuant 
        to a contract with, or a grant from, the Indian Health Service; 
        or
            ``(4) any other entity with appropriate expertise in 
        newborn screening, as determined by the Secretary.''.

SEC. 11. AUTHORIZATION OF APPROPRIATIONS.

    The Public Health Service Act is amended by inserting after section 
1116A of such Act, as added by section 10 of this Act, the following:

``SEC. 1116B. 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, 
        $13,334,000 for each of fiscal years 2014 through 2018;
            ``(2) to carry out section 1113, $7,500,000 for each of 
        fiscal years 2014 through 2018; and
            ``(3) to carry out section 1116A, $5,000,000 for each of 
        fiscal years 2014 through 2018.''.
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