[Congressional Record Volume 160, Number 17 (Wednesday, January 29, 2014)]
[Senate]
[Pages S605-S607]
From the Congressional Record Online through the 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.
[[Page S606]]
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
[[Page S607]]
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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