[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1281 Referred in Senate (RFS)]
113th CONGRESS
2d Session
H. R. 1281
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
June 25, 2014
Received
_______________________________________________________________________
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 2014''.
(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 followup for heritable
disorders.
Sec. 3. Evaluating the effectiveness of newborn and child screening and
followup 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 FOLLOWUP 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) by amending paragraph (2) to read as follows:
``(2) to assist in providing health care professionals and
newborn screening laboratory personnel with education in
newborn screening, counseling, and training in--
``(A) relevant and new technologies in newborn
screening and congenital, genetic, and metabolic
disorders;
``(B) the importance of the timeliness of
collection, delivery, receipt, and screening of
specimens; and
``(C) sharing of medical and diagnostic information
with providers and families;'';
(C) in paragraph (3), by striking ``and'' at the
end;
(D) in paragraph (4)--
(i) by striking ``treatment'' and inserting
``followup and treatment''; and
(ii) by striking the period and inserting
``; and''; and
(E) by adding at the end the following:
``(5) to improve the timeliness of--
``(A) the collection, delivery, receipt, and
screening of specimens; and
``(B) the diagnosis of heritable disorders in
newborns.'';
(2) in subsection (c), by striking ``application submitted
for a grant under subsection (a)(1)'' and inserting
``application for a grant under this section'';
(3) in subsection (h), by striking ``application submitted
under subsection (c)(2)'' each place it appears and inserting
``application for a grant under this section''; and
(4) by striking subsection (j) (relating to authorization
of appropriations).
SEC. 3. EVALUATING THE EFFECTIVENESS OF NEWBORN AND CHILD SCREENING AND
FOLLOWUP 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 followup''
after ``child screening'';
(2) in subsection (a), by striking ``of screening,'' and
inserting ``, including with respect to timeliness, of
screening, followup,'';
(3) in subsection (b)--
(A) in paragraph (1)--
(i) by striking ``counseling, testing'' and
inserting ``treatment, counseling, testing,
followup,''; 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,
followup,'';
(ii) by inserting ``in a timely manner''
after ``in newborns and children''; and
(iii) 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 in a timely
manner--
``(A) collection, delivery, receipt, and screening
of newborn screening specimens; and
``(B) 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 (6) through (8), 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;
``(5) take appropriate steps, at its discretion, to prepare
for the review of nominations prior to their submission,
including for conditions for which a screening method has been
validated but other nomination criteria are not yet met, in
order to facilitate timely action by the Advisory Committee
once such submission has been received by the Committee;'';
(C) in paragraph (6) (as so redesignated), by
inserting ``, including the cost'' after ``public
health impact''; and
(D) in paragraph (8) (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 timeliness of collection, delivery,
receipt, and screening of specimens to be tested for
heritable disorders in newborns in order to ensure
rapid diagnosis and followup.'';
(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
recommendation.'';
(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 condition nominated to
be added to the recommended uniform screening panel in
accordance with the requirements of this section, the Advisory
Committee shall review and vote on the nominated condition
within 9 months of the date on which the Advisory Committee
referred the nominated condition 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 at the discretion of the Designated Federal
Officer in consultation with the Chair.'';
(5) by amending subsection (g) (as so redesignated) to read
as follows:
``(g) Continuation of Operation of Committee.--
``(1) In general.--Notwithstanding section 14 of the
Federal Advisory Committee Act, the Advisory Committee shall
continue to operate through the end of fiscal year 2019.
``(2) Continuation if not reauthorized.--If at the end of
fiscal year 2019 the duration of the Advisory Committee has not
been extended by statute, the Advisory Committee may be deemed,
for purposes of the Federal Advisory Committee Act, an advisory
committee established by the President or an officer of the
Federal Government under section 9(a) of such Act.''; 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'' at the
end;
(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 2014'';
(3) in subsection (c)--
(A) by striking ``developing the clearinghouse''
and inserting ``carrying out activities''; and
(B) by striking ``clearinghouse minimizes
duplication and supplements, not supplants'' and
inserting ``activities minimize duplication and
supplement, not supplant''; 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) 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''; and
(B) in paragraph (1), by inserting ``timeliness for
processing such tests,'' after ``newborn-screening
tests,''; 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--
(1) by striking ``consortia'' and inserting ``consortium'';
and
(2) 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 of the Public Health Service Act (42 U.S.C. 300b-15)
is amended--
(1) in subsection (a)(1)--
(A) in subparagraph (B), by striking ``; and'' and
inserting a semicolon;
(B) by redesignating subparagraph (C) as
subparagraph (E); and
(C) by inserting after subparagraph (B) the
following:
``(C) 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''; and
(2) in subsection (c), by striking ``of the National
Institutes of Health Reform Act of 2006''.
SEC. 10. AUTHORIZATION OF APPROPRIATIONS.
Part A of title XI of the Public Health Service Act (42 U.S.C.
300b-1 et seq.) 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,
$11,900,000 for each of fiscal years 2015 through 2019; and
``(2) to carry out section 1113, $8,000,000 for each of
fiscal years 2015 through 2019.''.
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 followup testing,
and followup 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 this Act, 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, 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 House of Representatives June 24, 2014.
Attest:
KAREN L. HAAS,
Clerk.