[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1281 Enrolled Bill (ENR)]
H.R.1281
One Hundred Thirteenth Congress
of the
United States of America
AT THE SECOND SESSION
Begun and held at the City of Washington on Friday,
the third day of January, two thousand and fourteen
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. 12. Informed consent for newborn screening research.
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.
SEC. 12. INFORMED CONSENT FOR NEWBORN SCREENING RESEARCH.
(a) In General.--Research on newborn dried blood spots shall be
considered research carried out on human subjects meeting the
definition of section 46.102(f)(2) of title 45, Code of Federal
Regulations, for purposes of Federally funded research conducted
pursuant to the Public Health Service Act until such time as updates to
the Federal Policy for the Protection of Human Subjects (the Common
Rule) are promulgated pursuant to subsection (c). For purposes of this
subsection, sections 46.116(c) and 46.116(d) of title 45, Code of
Federal Regulations, shall not apply.
(b) Effective Date.--Subsection (a) shall apply only to newborn
dried blood spots used for purposes of Federally funded research that
were collected not earlier than 90 days after the date of enactment of
this Act.
(c) Regulations.--Not later than 6 months after the date of
enactment of this Act, the Secretary of Health and Human Services shall
promulgate proposed regulations related to the updating of the Federal
Policy for the Protection of Human Subjects (the Common Rule),
particularly with respect to informed consent. Not later than 2 years
after such date of enactment, the Secretary shall promulgate final
regulations based on such proposed regulations.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.