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[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[S. 1417 Introduced in Senate (IS)]

113th CONGRESS
  1st Session
                                S. 1417

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

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                             August 1, 2013

 Mrs. Hagan (for herself and Mr. Hatch) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 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 and follow-up for 
                            heritable disorders.
Sec. 3. Evaluating the effectiveness of newborn and child screening and 
                            follow-up 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. Authorization of appropriations.

SEC. 2. IMPROVED NEWBORN AND CHILD SCREENING AND FOLLOW-UP 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 ``follow-up and treatment'';
            (2) in subsection (h), by striking ``subsection (c)(2)'' 
        each place that such appears and inserting ``subsection (c)''; 
        and
            (3) by striking subsection (j) (relating to authorization 
        of appropriations).

SEC. 3. EVALUATING THE EFFECTIVENESS OF NEWBORN AND CHILD SCREENING AND 
              FOLLOW-UP 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 follow-up'' 
        after ``child screening'';
            (2) in subsection (a), by inserting ``follow-up,'' 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 a semicolon; and
                    (D) by adding at the end the following:
            ``(4) the availability and effectiveness of follow-up care 
        for newborns and their families after screening and diagnosis;
            ``(5) 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;
            ``(6) the effectiveness of newborn screening follow-up and 
        intervention programs through the assessment of the health and 
        development of children at school age and as young adults;
            ``(7) the level of data sharing regarding newborn screening 
        with State-based birth defects and developmental disabilities 
        monitoring programs;
            ``(8) the coordination of surveillance activities, 
        including--
                    ``(A) standardized data collection and reporting; 
                and
                    ``(B) use of electronic health records;
            ``(9) the facilitation of quality improvement in treatment 
        and disease management based on gaps in services or care 
        identified by longitudinal tracking systems; and
            ``(10) the utilization of data from longitudinal tracking 
        systems to support the development and evaluation of evidence-
        based guidelines for diagnosis, treatment, and disease 
        management.''; 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, 
                including the 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'';
                            (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; and
                            (iv) in subparagraph (K), by striking the 
                        period and inserting ``; and'';
            (2) in subsection (d)--
                    (A) in paragraph (1), by striking ``180'' and 
                inserting ``60'';
                    (B) in paragraph (2), by striking ``Newborn 
                Screening Saves Lives Act of 2008'' and insert 
                ``Newborn Screening Saves Lives Reauthorization Act of 
                2013''; and
                    (C) by adding at the end the following:
            ``(4) Priority review.--
                    ``(A) In general.--For each nomination to the 
                recommended uniform screening panel that meets the 
                criteria of subparagraph (B), the Advisory Committee on 
                Heritable Disorders in Newborns and Children shall 
                provide a priority review as described in this 
                paragraph and subject to the deadlines in subparagraph 
                (C).
                    ``(B) Criteria for priority review.--The Advisory 
                Committee on Heritable Disorders in Newborns and 
                Children shall provide a priority review with respect 
                to a nomination to the recommended uniform screening 
                panel that meets each of the following criteria:
                            ``(i) A human drug application, as defined 
                        in section 735(1) of the Federal Food, Drug, 
                        and Cosmetic Act (21 U.S.C. 379g(1)), has been 
                        submitted to the Secretary for treatment of 
                        such disease or condition.
                            ``(ii) The application described in clause 
                        (i) has been granted priority review or has 
                        received fast track or breakthrough therapy 
                        designations by the Secretary as described in 
                        section 529(a)(1) of the Federal Food, Drug, 
                        and Cosmetic Act (21 U.S.C. 360ff(a)(1)).
                    ``(C) Deadlines for priority review.--The Advisory 
                Committee on Heritable Disorders in Newborns and 
                Children shall vote on the nominated condition that is 
                under priority review within 8 months of the later of--
                            ``(i) the date on which the Advisory 
                        Committee refers the nomination to the 
                        condition review workgroup; or
                            ``(ii) the date of the approval, by the 
                        Food and Drug Administration, of the treatment 
                        associated with the nomination to the 
                        recommended uniform screening panel.
                    ``(D) Failure to act.--If the Secretary fails to 
                act on a recommendation within the time period provided 
                for in paragraph (1), the Secretary shall adopt the 
                recommendation and include the screening recommended by 
                the Advisory Committee on Heritable Disorders in 
                Newborns and Children in the recommended uniform 
                screening panel.
                    ``(E) Other reviews.--For each nomination to the 
                recommended uniform screening panel that does not meet 
                the criteria of subparagraph (B), the Advisory 
                Committee on Heritable Disorders in Newborns and 
                Children shall provide for a review and vote on the 
                nominated condition that is under review within 10 
                months of the date on which the Advisory Committee 
                referred the nomination 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 with at least 2 meetings in person.''; 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) disseminate available evidence-informed 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 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. AUTHORIZATION OF APPROPRIATIONS.

    Part A of title XI of the Public Health Service Act 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, 
        $18,334,000 for each of fiscal years 2014 through 2018; and
            ``(2) to carry out section 1113, $7,500,000 for each of 
        fiscal years 2014 through 2018.''.
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