[Congressional Record (Bound Edition), Volume 160 (2014), Part 2]
[Senate]
[Pages 2242-2243]
[From the U.S. Government Publishing Office, www.gpo.gov]




                       PUBLIC HEALTH SERVICE ACT

  Mr. WHITEHOUSE. Mr. President, I ask unanimous consent that the 
Senate proceed to the immediate consideration of Calendar No. 282, S. 
1417.
  The PRESIDING OFFICER. The clerk will report the bill by title.
  The assistant legislative clerk read as follows:

       A bill (S. 1417) to amend the Public Health Service Act to 
     reauthorize programs under part A of title XI of such Act.

  There being no objection, the Senate proceeded to consider the bill.
  Mr. WHITEHOUSE. I further ask that the committee-reported substitute 
be agreed to; the bill, as amended, be read a third time and passed, 
and the motion to reconsider be considered made and laid upon the 
table, with no intervening action or debate.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The committee amendment in the nature of a substitute was agreed to.
  The bill (S. 1417) was ordered to be engrossed for a third reading, 
was read the third time, and passed as follows:

     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).

[[Page 2243]]



     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.

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