[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[S. 1417 Referred in House (RFH)]
113th CONGRESS
2d Session
S. 1417
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
January 31, 2014
Referred to the Committee on Energy and Commerce
_______________________________________________________________________
AN ACT
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 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.
Passed the Senate January 29, 2014.
Attest:
NANCY ERICKSON,
Secretary.