[United States Statutes at Large, Volume 128, 113th Congress, 2nd Session]
[From the U.S. Government Publishing Office, www.gpo.gov]


Public Law 113-240
113th Congress

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;

[[Page 2852]]

(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).

[[Page 2853]]

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

[[Page 2854]]

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;

[[Page 2855]]

(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

[[Page 2856]]

(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.

[[Page 2857]]

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.

Approved December 18, 2014.

LEGISLATIVE HISTORY--H.R. 1281:
---------------------------------------------------------------------------

HOUSE REPORTS: No. 113-478 (Comm. on Energy and Commerce).
CONGRESSIONAL RECORD, Vol. 160 (2014):
June 24, considered and passed House.
Dec. 8, considered and passed Senate, amended.
Dec. 10, House concurred in Senate amendment.