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

                                                       Calendar No. 282
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, Mr. Hatch, Mr. Enzi, Mr. Casey, Ms. Collins, 
 Mr. Schumer, Mr. Cochran, Mr. Bennet, Ms. Cantwell, Mr. Donnelly, Mr. 
Murphy, Mr. Schatz, Mr. Franken, Mr. Harkin, and Mr. Wicker) introduced 
the following bill; which was read twice and referred to the Committee 
               on Health, Education, Labor, and Pensions

                           December 19, 2013

               Reported by Mr. Harkin, with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 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,

<DELETED>SECTION 1. SHORT TITLE; TABLE OF CONTENTS.</DELETED>

<DELETED>    (a) Short Title.--This Act may be cited as the ``Newborn 
Screening Saves Lives Reauthorization Act of 2013''.</DELETED>
<DELETED>    (b) Table of Contents.--The table of contents of this Act 
is as follows:</DELETED>

<DELETED>Sec. 1. Short title; table of contents.
<DELETED>Sec. 2. Improved newborn and child screening and follow-up for 
                            heritable disorders.
<DELETED>Sec. 3. Evaluating the effectiveness of newborn and child 
                            screening and follow-up programs.
<DELETED>Sec. 4. Advisory committee on heritable disorders in newborns 
                            and children.
<DELETED>Sec. 5. Clearinghouse of Newborn Screening Information.
<DELETED>Sec. 6. Laboratory quality.
<DELETED>Sec. 7. Interagency Coordinating Committee on Newborn and 
                            Child Screening.
<DELETED>Sec. 8. National contingency plan for newborn screening.
<DELETED>Sec. 9. Hunter Kelly Research Program.
<DELETED>Sec. 10. Authorization of appropriations.

<DELETED>SEC. 2. IMPROVED NEWBORN AND CHILD SCREENING AND FOLLOW-UP FOR 
              HERITABLE DISORDERS.</DELETED>

<DELETED>    Section 1109 of the Public Health Service Act (42 U.S.C. 
300b-8) is amended--</DELETED>
        <DELETED>    (1) in subsection (a)--</DELETED>
                <DELETED>    (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'';</DELETED>
                <DELETED>    (B) in paragraph (2), by striking 
                ``screening and training'' and inserting ``screening, 
                counseling, and training''; and</DELETED>
                <DELETED>    (C) in paragraph (4), by striking 
                ``treatment'' and inserting ``follow-up and 
                treatment'';</DELETED>
        <DELETED>    (2) in subsection (h), by striking ``subsection 
        (c)(2)'' each place that such appears and inserting 
        ``subsection (c)''; and</DELETED>
        <DELETED>    (3) by striking subsection (j) (relating to 
        authorization of appropriations).</DELETED>

<DELETED>SEC. 3. EVALUATING THE EFFECTIVENESS OF NEWBORN AND CHILD 
              SCREENING AND FOLLOW-UP PROGRAMS.</DELETED>

<DELETED>    Section 1110 of the Public Health Service Act (42 U.S.C. 
300b-9) is amended--</DELETED>
        <DELETED>    (1) in the section heading, by inserting ``and 
        follow-up'' after ``child screening'';</DELETED>
        <DELETED>    (2) in subsection (a), by inserting ``follow-up,'' 
        after ``the effectiveness of screening,'';</DELETED>
        <DELETED>    (3) in subsection (b)--</DELETED>
                <DELETED>    (A) in paragraph (1), by inserting 
                ``ascertainment, treatment,'' after ``the effectiveness 
                of screening, counseling,'';</DELETED>
                <DELETED>    (B) in paragraph (2)--</DELETED>
                        <DELETED>    (i) by inserting ``ascertainment, 
                        treatment,'' after ``the effectiveness of 
                        screening, counseling,''; and</DELETED>
                        <DELETED>    (ii) by striking ``or'' at the 
                        end;</DELETED>
                <DELETED>    (C) in paragraph (3), by striking the 
                period at the end and inserting a semicolon; 
                and</DELETED>
                <DELETED>    (D) by adding at the end the 
                following:</DELETED>
        <DELETED>    ``(4) the availability and effectiveness of 
        follow-up care for newborns and their families after screening 
        and diagnosis;</DELETED>
        <DELETED>    ``(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;</DELETED>
        <DELETED>    ``(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;</DELETED>
        <DELETED>    ``(7) the level of data sharing regarding newborn 
        screening with State-based birth defects and developmental 
        disabilities monitoring programs;</DELETED>
        <DELETED>    ``(8) the coordination of surveillance activities, 
        including--</DELETED>
                <DELETED>    ``(A) standardized data collection and 
                reporting; and</DELETED>
                <DELETED>    ``(B) use of electronic health 
                records;</DELETED>
        <DELETED>    ``(9) the facilitation of quality improvement in 
        treatment and disease management based on gaps in services or 
        care identified by longitudinal tracking systems; and</DELETED>
        <DELETED>    ``(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</DELETED>
        <DELETED>    (4) by striking subsection (d) (relating to 
        authorization of appropriations).</DELETED>

<DELETED>SEC. 4. ADVISORY COMMITTEE ON HERITABLE DISORDERS IN NEWBORNS 
              AND CHILDREN.</DELETED>

<DELETED>    Section 1111 of the Public Health Service Act (42 U.S.C. 
300b-10) is amended--</DELETED>
        <DELETED>    (1) in subsection (b)--</DELETED>
                <DELETED>    (A) in paragraph (4), by striking ``public 
                health impact'' and inserting ``public health impact, 
                including the cost''; and</DELETED>
                <DELETED>    (B) in paragraph (6)--</DELETED>
                        <DELETED>    (i) in subparagraph (A), by 
                        striking ``achieve rapid diagnosis'' and 
                        inserting ``achieve best practices in rapid 
                        diagnosis and appropriate 
                        treatment'';</DELETED>
                        <DELETED>    (ii) in subparagraph (D), by 
                        inserting before the semicolon ``, including 
                        information on cost and incidence'';</DELETED>
                        <DELETED>    (iii) in subparagraph (J), by 
                        striking ``and'' at the end; and</DELETED>
                        <DELETED>    (iv) in subparagraph (K), by 
                        striking the period and inserting ``; 
                        and'';</DELETED>
        <DELETED>    (2) in subsection (d)--</DELETED>
                <DELETED>    (A) in paragraph (1), by striking ``180'' 
                and inserting ``60'';</DELETED>
                <DELETED>    (B) in paragraph (2), by striking 
                ``Newborn Screening Saves Lives Act of 2008'' and 
                insert ``Newborn Screening Saves Lives Reauthorization 
                Act of 2013''; and</DELETED>
                <DELETED>    (C) by adding at the end the 
                following:</DELETED>
        <DELETED>    ``(4) Priority review.--</DELETED>
                <DELETED>    ``(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).</DELETED>
                <DELETED>    ``(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:</DELETED>
                        <DELETED>    ``(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.</DELETED>
                        <DELETED>    ``(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)).</DELETED>
                <DELETED>    ``(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--</DELETED>
                        <DELETED>    ``(i) the date on which the 
                        Advisory Committee refers the nomination to the 
                        condition review workgroup; or</DELETED>
                        <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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.'';</DELETED>
        <DELETED>    (3) by redesignating subsections (f) and (g) as 
        subsections (g) and (h), respectively;</DELETED>
        <DELETED>    (4) by inserting after subsection (e) the 
        following new subsection:</DELETED>
<DELETED>    ``(f) Meetings.--The Advisory Committee shall meet at 
least 4 times each calendar year with at least 2 meetings in person.''; 
and</DELETED>
        <DELETED>    (5) by striking subsection (h) (relating to 
        authorization of appropriations), as redesignated by paragraph 
        (2).</DELETED>

<DELETED>SEC. 5. CLEARINGHOUSE OF NEWBORN SCREENING 
              INFORMATION.</DELETED>

<DELETED>    Section 1112 of the Public Health Service Act (42 U.S.C. 
300b-11) is amended--</DELETED>
        <DELETED>    (1) in subsection (a)--</DELETED>
                <DELETED>    (A) in paragraph (2), by striking ``; 
                and'' and inserting a semicolon;</DELETED>
                <DELETED>    (B) in paragraph (3), by striking the 
                period at the end and inserting a semicolon; 
                and</DELETED>
                <DELETED>    (C) by adding at the end the following new 
                paragraphs:</DELETED>
        <DELETED>    ``(4) maintain current data on the number of 
        conditions for which screening is conducted in each State; 
        and</DELETED>
        <DELETED>    ``(5) disseminate available evidence-informed 
        guidelines related to diagnosis, counseling, and treatment with 
        respect to conditions detected by newborn 
        screening.'';</DELETED>
        <DELETED>    (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</DELETED>
        <DELETED>    (3) by striking subsection (d) (relating to 
        authorization of appropriations).</DELETED>

<DELETED>SEC. 6. LABORATORY QUALITY.</DELETED>

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

<DELETED>SEC. 7. INTERAGENCY COORDINATING COMMITTEE ON NEWBORN AND 
              CHILD SCREENING.</DELETED>

<DELETED>    Section 1114 of the Public Health Service Act (42 U.S.C. 
300b-13) is amended--</DELETED>
        <DELETED>    (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</DELETED>
        <DELETED>    (2) by striking subsection (e) (relating to 
        authorization of appropriations) and inserting the 
        following:</DELETED>
<DELETED>    ``(e) Report to Congress.--</DELETED>
        <DELETED>    ``(1) In general.--The Secretary shall--</DELETED>
                <DELETED>    ``(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--
                </DELETED>
                        <DELETED>    ``(i) newborn screening; 
                        and</DELETED>
                        <DELETED>    ``(ii) screening children who have 
                        or are at risk for heritable disorders; 
                        and</DELETED>
                <DELETED>    ``(B) not less than every 2 years, shall 
                submit to such committees an updated version of such 
                report.</DELETED>
        <DELETED>    ``(2) Contents.--The report submitted under 
        subsection (a) shall contain a description of--</DELETED>
                <DELETED>    ``(A) the implementation of sections 1111 
                through 1116B, including this section; and</DELETED>
                <DELETED>    ``(B) the amounts expended on such 
                implementation.''.</DELETED>

<DELETED>SEC. 8. NATIONAL CONTINGENCY PLAN FOR NEWBORN 
              SCREENING.</DELETED>

<DELETED>    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.''.</DELETED>

<DELETED>SEC. 9. HUNTER KELLY RESEARCH PROGRAM.</DELETED>

<DELETED>    Section 1116(a)(1) of the Public Health Service Act (42 
U.S.C. 300b-15(a)(1)) is amended--</DELETED>
        <DELETED>    (1) in subparagraph (B), by striking ``; and'' and 
        inserting a semicolon;</DELETED>
        <DELETED>    (2) by redesignating subparagraph (C) as 
        subparagraph (E); and</DELETED>
        <DELETED>    (3) by inserting after subparagraph (B) the 
        following:</DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(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''.</DELETED>

<DELETED>SEC. 10. AUTHORIZATION OF APPROPRIATIONS.</DELETED>

<DELETED>    Part A of title XI of the Public Health Service Act is 
amended by adding at the end, the following:</DELETED>

<DELETED>``SEC. 1117. AUTHORIZATION OF APPROPRIATIONS FOR NEWBORN 
              SCREENING PROGRAMS AND ACTIVITIES.</DELETED>

<DELETED>    ``There are authorized to be appropriated--</DELETED>
        <DELETED>    ``(1) to carry out sections 1109, 1110, 1111, and 
        1112, $18,334,000 for each of fiscal years 2014 through 2018; 
        and</DELETED>
        <DELETED>    ``(2) to carry out section 1113, $7,500,000 for 
        each of fiscal years 2014 through 2018.''.</DELETED>

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 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 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)--
                            (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) in paragraph (2), by striking ``screening and 
                training'' and inserting ``screening, counseling, and 
                training'';
                    (C) in paragraph (3), by striking ``and'' at the 
                end;
                    (D) in paragraph (4)--
                            (i) by striking ``treatment'' and inserting 
                        ``follow-up and treatment''; and
                            (ii) by striking the period and inserting 
                        ``; and''; and
                    (E) by adding at the end the following:
            ``(5) to improve the timely collection, delivery, receipt, 
        and screening of specimens, and the timely diagnosis of 
        heritable disorders in newborns.'';
            (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 striking ``of screening,'' and 
        inserting ``, including with respect to timeliness, of 
        screening, follow-up,'';
            (3) in subsection (b)--
                    (A) in paragraph (1)--
                            (i) by striking ``counseling, testing'' and 
                        inserting ``treatment, counseling, testing, 
                        follow-up,''; 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, 
                        follow-up,''; 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) 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 the timely 
        collection, delivery, receipt, and screening of newborn 
        screening specimens, and the timely 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 (5) through (7), 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;'';
                    (C) in paragraph (5) (as so redesignated), by 
                inserting ``, including the cost'' after ``public 
                health impact''; and
                    (D) in paragraph (7) (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 timely collection, delivery, receipt, and 
                screening of specimens to be tested for heritable 
                disorders in newborns in order to ensure rapid 
                diagnosis and follow-up.'';
            (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 
                        recommendations.'';
                    (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 nomination to the 
        recommended uniform screening panel, the Advisory Committee on 
        Heritable Disorders in Newborns and Children shall review and 
        vote on the nominated condition within 9 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, or as subject to the discretion of the Designated 
Federal Officer in consultation with the Chair.'';
            (5) in subsection (g) (as so redesignated), by striking 
        ``Newborn Screening Saves Lives Act of 2008'' and inserting 
        ``Newborn Screening Saves Lives Reauthorization Act of 2013''; 
        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'' and 
                inserting a semicolon;
                    (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 2013'';
            (3) in subsection (c)--
                    (A) by striking ``developing the clearinghouse'' 
                and inserting ``carrying out activities''; and
                    (B) by striking ``clearinghouse minimizes'' and 
                inserting ``activities minimize''; 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) by striking the subsection enumerator and 
                heading;
                    (B) 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'';
                    (C) in paragraph (1)--
                            (i) by inserting ``timeliness for 
                        processing such tests,'' after ``newborn 
                        screening tests''; and
                            (ii) by striking ``and'' at the end; and
                    (D) in paragraph (2), by striking the period and 
                inserting ``; and''; 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 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) by 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''.

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.''.

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 follow-up testing, 
                and follow-up 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 the Newborn Screening Saves Lives 
                Reauthorization Act of 2013, 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, shall 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.
                                                       Calendar No. 282

113th CONGRESS

  1st Session

                                S. 1417

_______________________________________________________________________

                                 A BILL

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

_______________________________________________________________________

                           December 19, 2013

                       Reported with an amendment
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