[House Report 113-478]
[From the U.S. Government Publishing Office]
113th Congress } { Report
2d Session } HOUSE OF REPRESENTATIVES { 113-478
=======================================================================
NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2014
_______
June 19, 2014.--Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
_______
Mr. Upton, from the Committee on Energy and Commerce, submitted the
following
R E P O R T
[To accompany H.R. 1281]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 1281) to amend the Public Health Service Act to
reauthorize programs under part A of title XI of such Act,
having considered the same, report favorably thereon with an
amendment and recommend that the bill as amended do pass.
CONTENTS
Page
Amendment........................................................ 2
Purpose and Summary.............................................. 6
Background and Need for Legislation.............................. 6
Hearings......................................................... 6
Committee Consideration.......................................... 7
Committee Votes.................................................. 7
Committee Oversight Findings..................................... 7
Statement of General Performance Goals and Objectives............ 7
New Budget Authority, Entitlement Authority, and Tax Expenditures 7
Earmark, Limited Tax Benefits, and Limited Tariff Benefits....... 7
Committee Cost Estimate.......................................... 8
Congressional Budget Office Estimate............................. 8
Federal Mandates Statement....................................... 10
Duplication of Federal Programs.................................. 10
Disclosure of Directed Rule Makings.............................. 10
Advisory Committee Statement..................................... 10
Applicability to Legislative Branch.............................. 10
Section-by-Section Analysis of the Legislation................... 10
Changes in Existing Law Made by the Bill, as Reported............ 13
Amendment
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
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.
Purpose and Summary
H.R. 1281, the ``Newborn Screening Saves Lives
Reauthorization Act of 2014,'' was introduced on March 20,
2013, by Rep. Lucille Roybal-Allard (D-CA) and Rep. Mike
Simpson (R-ID) and referred to the Committee on Energy and
Commerce.
The bill would reauthorize the Newborn Screening Saves
Lives Act of 2008 to continue Federal support for newborn
screening activities.
Background and Need for Legislation
Newborn screening is the practice of testing newborns for
certain disorders that are treatable, but not clinically
evident at birth. The baby may look healthy, but have certain
genetic and metabolic conditions that can affect the child's
long-term health or survival. Newborn screening was introduced
as a public health program in the early 1960s. Every State now
requires newborn screening, but each State determines that
tests are required.\1\
---------------------------------------------------------------------------
\1\http://www.hrsa.gov/advisorycommittees/mchbadvisory/
heritabledisorders/reports recommendations/reports/
sachdnc2011report.pdf.
---------------------------------------------------------------------------
Federal programs to improve the ability of States to
provide screening for heritable disorders were first enacted in
the Children's Health Act of 2000 and included the
establishment of a Federal advisory committee.\2\ In February
2003, the U.S. Department of Health and Human Services
chartered the Secretary's Advisory Committee on Heritable
Disorders in Newborns and Children (SACHDNC) to make
recommendations to the Secretary that would standardize newborn
screening programs in the U.S.\3\ In 2008, Congress enacted the
Newborn Screening Save Lives Act of 2007, which amended the
Public Health Service Act to reauthorize and expand the duties
of the Advisory Committee, continue the grant program, provide
for quality assurance for screening laboratories, establish a
clearinghouse of current information on newborn screening,
continuation of research on new treatments, and require an
annual report.\4\
---------------------------------------------------------------------------
\2\http://www.gpo.gov/fdsys/pkg/PLAW-106publ310/html/PLAW-
106publ310.htm.
\3\http://www.hrsa.gov/advisorycommittees/mchbadvisory/
heritabledisorders/reports recommendations/reports/
sachdnc2011report.pdf.
\4\https://www.govtrack.us/congress/bills/110/s1858.
---------------------------------------------------------------------------
H.R. 1281 would reauthorize the ``Newborn Screening Save
Lives Act of 2007'' and further strengthen newborn screening
activities. The bill clarifies the need for health care
professionals and laboratory personnel to be trained in the
latest technology related to newborn screening, understand the
importance of timeliness in the collection, delivery, receipt,
and screening of specimens, and share medical and diagnostic
information with providers and families. The bill also would
encourage the Advisory Committee to take appropriate steps to
timely review and vote on nominated conditions. Finally, the
bill would shorten the time for the Secretary to adopt or
reject a recommendation from the Advisory Committee to 120
days.
Hearings
The Subcommittee on Health held a hearing on H.R. 1281 on
November 20, 2013, and received testimony from:
Marsha Ford, MD, FACMT, President, American
Association of Poison Control Centers;
Edward R.B. McCabe, MD, PhD, Senior Vice
President and Chief Medical Officer, Office of Medicine and
Health Promotion, March of Dimes Foundation;
Laura Crandall, Co-Founder, Sudden Unexplained
Death In Childhood Program, CJ Foundation for SIDS;
Robert Mt. Joy, CEO, Cornerstone Care Inc.;
Drew Nagele, Board of Directors, Brain Injury
Association of America;
Pat Smith, President, Lyme Disease Association,
Inc.; and,
Steven J. Stack, Immediate Past Chair, Board of
Trustees, American Medical Association.
Committee Consideration
On February 27, 2014, the Subcommittee on Health met in
open markup session and favorably forwarded H.R. 1281 to the
full Committee, as amended, by a voice vote. On April 3, 2014,
the Energy and Commerce Committee met in open markup session
and approved H.R. 1281, as amended, by unanimous consent.
Committee Votes
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list the record votes
on the motion to report legislation and amendments thereto.
There were no record votes taken in connection with ordering
approved H.R. 1281. A motion by Mr. Upton to order H.R. 1281
reported to the House, as amended, was agreed to by a voice
vote.
Committee Oversight Findings
Pursuant to clause 3(c)(1) of rule XIII of the Rules of the
House of Representatives, the Committee held a hearing on H.R.
1281 and made findings that are reflected in this report.
Statement of General Performance Goals and Objectives
Pursuant to clause 3(c)(1) of rule XIII of the House of
Representatives, the goal of H.R. 1281 is to reauthorize the
Newborn Screening Saves Lives Act of 2008 to continue Federal
activities that assist States in improving their newborn
screening programs, supporting parent and provider newborn
screening education, and ensuring laboratory quality and
surveillance.
New Budget Authority, Entitlement Authority, and Tax Expenditures
In compliance with clause 3(c)(2) of rule XIII of the Rules
of the House of Representatives, the Committee finds that H.R.
1281 would result in no new or increased budget authority,
entitlement authority, or tax expenditures or revenues.
Earmark, Limited Tax Benefits, and Limited Tariff Benefits
In compliance with clause 9(e), 9(f), and 9(g) of rule XXI,
the Committee finds that H.R. 1281 contains no earmarks,
limited tax benefits, or limited tariff benefits.
Committee Cost Estimate
The Committee adopts as its own the cost estimate prepared
by the Director of the Congressional Budget Office pursuant to
section 402 of the Congressional Budget Act of 1974.
Congressional Budget Office Estimate
Pursuant to clause 3(c)(3) of rule XIII of the Rules of the
House of Representatives, the following is the cost estimate
provided by the Congressional Budget Office pursuant to section
402 of the Congressional Budget Act of 1974:
U.S. Congress,
Congressional Budget Office,
Washington, DC, June 6, 2014.
Hon. Fred Upton,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for H.R. 1281, the Newborn
Screening Saves Lives Reauthorization Act of 2014.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Santiago
Vallinas.
Sincerely,
Douglas W. Elmendorf.
Enclosure.
H.R. 1281--Newborn Screening Saves Lives Reauthorization Act of 2014
Summary: H.R. 1281 would amend the Public Health Service
Act to reauthorize grant programs and other initiatives to
promote expanded screening of newborns and children for
heritable disorders. Authority to operate those programs
expired at the end of fiscal year 2013. However, the Congress
appropriated funds for fiscal year 2014 to continue the
programs in 2014.
CBO estimates that implementing H.R. 1281 would cost $80
million over the 2015-2019 period, assuming appropriation of
the necessary amounts. H.R. 1281 would not affect direct
spending or revenues; therefore, pay-as-you-go procedures do
not apply.
H.R. 1281 contains no intergovernmental or private-sector
mandates as defined in the Unfunded Mandates Reform Act (UMRA)
and would impose no costs on state, local, or tribal
governments.
Estimated cost to the Federal Government: The estimated
budgetary impact of H.R. 1281 is shown in the following table.
The costs of this legislation fall within budget function 550
(health).
----------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
-------------------------------------------------------
2015 2016 2017 2018 2019 2015-2019
----------------------------------------------------------------------------------------------------------------
CHANGES IN SPENDING SUBJECT TO APPROPRIATION
HRSA Activities:
Authorization Level................................. 12 12 12 12 12 60
Estimated Outlays................................... 2 9 11 12 12 46
CDC Activities:
Authorization Level................................. 8 8 8 8 8 40
Estimated Outlays................................... 3 7 8 8 8 33
Other Activities:
Estimated Authorization Level....................... * * * * * 1
Estimated Outlays................................... * * * * * 1
Total Changes:
Estimated Authorization Level................... 21 20 20 20 20 101
Estimated Outlays............................... 6 16 19 20 20 80
----------------------------------------------------------------------------------------------------------------
Notes: HRSA = Health Resources and Services Administration; CDC = Centers for Disease Control and Prevention.
* = less than $500,000.
Components might not sum to totals because of rounding.
Basis of estimate: Most of the activities authorized under
H.R. 1281 would be carried out by the Health Resources and
Services Administration (HRSA) and the Centers for Disease
Control and Prevention (CDC). For this estimate, CBO assumes
that H.R. 1281 will be enacted before the end of fiscal year
2014. The estimate is based on historical spending patterns for
similar activities and assumes that the necessary amounts will
be appropriated near the beginning of each fiscal year.
HRSA activities
H.R. 1281 would reauthorize grant programs that promote
screening of newborns and children for heritable disorders for
fiscal years 2015 through 2019. It also would reauthorize
funding for HRSA activities that provide information regarding
heritable disorders in newborns and children to individuals,
health professionals, and federal officials. The Congress
appropriated $12 million for those programs in fiscal year
2014. The legislation would authorize the appropriation of
about $12 million a year for fiscal years 2015 through 2019.
CBO estimates that implementing such provisions would cost $46
million over the 2015-2019 period, assuming appropriation of
the specified amounts.
CDC activities
The legislation also would reauthorize programs within the
CDC to promote quality in clinical laboratories that test for
heritable diseases and authorize surveillance activities
relating to heritable disorders. The Congress appropriated $7
million to CDC's newborn screening program for fiscal year
2014. The bill would authorize the appropriation of $8 million
annually over the 2015-2019 period. CBO estimates that
implementing those provisions would cost $33 million over the
2015-2019 period. In addition, H.R. 1281 would mandate that
CDC's national contingency plan for newborn screening be
updated at least every five years, but CBO estimates those
costs would be insignificant.
Other activities
The bill would direct multiple agencies of the Department
of Health and Human Services (HHS) to continue to collaborate
in order to make recommendations for collecting, analyzing, and
making data available on heritable disorders. CBO estimates
that such activities would cost less than $500,000 over the
2015-2019 period, assuming the availability of appropriated
funds.
In addition, H.R. 1281 would direct the Government
Accountability Office (GAO) and HHS to submit reports to the
Congress. GAO would report on the timeliness of newborn
screening for heritable disorders, and the Secretary of HHS
would report on the ongoing activities related to newborn
screening authorized by the bill and their associated costs.
CBO estimates that these reports would cost about $1 million
over the 2015-2019 period.
Pay-As-You-Go considerations: None.
Intergovernmental and Private-Sector Impact: H.R. 1281
contains no intergovernmental or private-sector mandates as
defined in UMRA. State and local governments that participate
in newborn and child screening programs could benefit from
funds authorized in the bill.
Estimate prepared by: Federal Costs: Santiago Vallinas and
Lisa Ramirez-Branum; Impact on State, Local, and Tribal
Governments: J'nell L. Blanco; Impact on the Private Sector:
Samuel Trachtman.
Estimate approved by: Holly Harvey, Deputy Assistant
Director for Budget Analysis.
Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
Duplication of Federal Programs
No provision of H.R. 1281 establishes or reauthorizes a
program of the Federal government known to be duplicative of
another Federal program, a program that was included in any
report from the Government Accountability Office to Congress
pursuant to section 21 of Public Law 111-139, or a program
related to a program identified in the most recent Catalog of
Federal Domestic Assistance.
Disclosure of Directed Rule Makings
The Committee estimates that enacting H.R. 1281 would not
specifically direct a rulemaking within the meaning of 5 U.S.C.
551.
Advisory Committee Statement
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act were created by this
legislation.
Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
Section-by-Section Analysis of the Legislation
Section 1. Short title; Table of Contents
Section 1 provides the short title of ``Newborn Screening
Saves Lives Reauthorization Act of 2014.''
Section 2. Improved newborn and child screening and followup for
heritable disorders
Section 2 requires eligible entities to assist in providing
health care professionals and newborn screening personnel with
education and training in: new technologies related to newborn
screening; understanding the importance of timeliness of
collection, delivery, receipt, and screening of specimens; and
sharing medical information with providers and families.
Section 3. Evaluating the effectiveness of newborn and child screening
and followup programs
Section 3 provides that grants established under section
1110 of the Public Health Service Act (42 U.S.C. 33b-9) are for
demonstration programs that evaluate the effectiveness,
including with respect to timelines, of screening and follow-up
services in reducing the morbidity and mortality caused by
heritable disorders in newborns and children. The section also
requires demonstration programs to evaluate and assess
specified matters related to the treatment of newborns and
children at risk of heritable disorders.
Section 4. Advisory Committee on Heritable Disorders in Newborns and
Children
Section 4 amends the Advisory Committee on Heritable
Disorders in Newborns and Children to provide for technical
assistance to individuals and organizations regarding
submissions to the uniform screening panel and to provide for
the review of nominations prior to their submission. In
addition, the Advisory Committee's model decision-matrix for
newborn screen expansion would include the cost of such
expansion, and the recommendations to enhance, expand, or
improve the Secretary's ability to reduce the mortality or
morbidity from heritable disorders may include follow-up
activities necessary to achieve best practices in rapid
diagnosis and appropriate treatment in the short-term,
information on the cost and incidence of testing for conditions
for which there is no existing treatment, and 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 follow-up.
Section 4 also amends process for decisions on
recommendations. The time for the Secretary to adopt the
recommendations of the Advisory Committee is reduced from 180
to 120 days. If the Secretary is unable to make a determination
within the 120-day period, the Secretary must provide to the
Advisory Committee and Congress an explanation and a plan of
action for consideration of such pending recommendations. The
Advisory Committee would have 9 months from the date on which
the Advisory Committee referred the nominated condition to the
review workgroup to review and vote on the condition.
Section 4 also provides that the Advisory Committee would
have to meet at least 4 times each year and shall continue to
operate through the end of fiscal year 2019. If the Advisory
Committee is not extended beyond 2019, it may be deemed an
advisory committee established by the President or an officer
of the Federal Government for the purposes of the Federal
Advisory Committee Act.
Section 5. Clearinghouse of newborn screening information
Section 5 requires the clearinghouse to maintain current
information on quality indicators to measure performance of
newborn screening and the number of conditions for which
screening is conducted in each State, and to disseminate
evidence-based guidelines related to conditions detected by
newborn screening. Finally, the section amends the non-
duplication requirements to ensure that the Secretary's
activities to establish and maintain a central clearinghouse of
information on newborn screening will minimize duplication and
supplement, not supplant, existing information sharing efforts.
Section 6. Laboratory quality and surveillance
Section 6 requires that the Secretary, acting through the
Centers for Disease Control and Prevention (CDC), take into
consideration the expertise of the Advisory Committee and
provide, as appropriate, for the timeliness for processing
newborn-screening tests. The section also authorizes the
Secretary, acting through the CDC and taking into consideration
the expertise of the Advisory Committee, to provide for the
coordination of surveillance activities.
Section 7. Interagency Coordinating Committee on Newborn and Child
Screening
Section 7 clarifies that the composition of the Interagency
Coordinating Committee on Newborn and Child Screening includes
the Administrator of the Health Resources and Services
Administration, the Director of the Agency for Healthcare
Research and Quality, and the Commissioner of Food and Drugs.
Section 8. National contingency plan for newborn screening
Section 8 requires that the national contingency plan for
newborn screening for use in the event of a public health
emergency be updated as needed and at least every five years.
Section 9. Hunter Kelly Research Program
Section 9 amends the Hunter Kelly Newborn Screening
Research Program to include (1) providing research findings and
data for newborn conditions under review by the Advisory
Committee to be added to the recommended uniform screening
panel and (2) conducting pilot studies on conditions
recommended by the Advisory Committee to ensure that screenings
are ready for implementation nationwide.
Section 10. Authorization of appropriations
Section 10 consolidates the authorization of appropriations
for all newborn and child screening for heritable disorders
activities. The activities were authorized for $30,875,000 for
fiscal year 2013, and section 10 reauthorizes the activities
for $19,900,000 for each of fiscal years 2015 through 2019.
Section 11. Reports to Congress
Section 11 directs the Comptroller General of the United
States to submit a report to Congress concerning the timeliness
of screening for heritable disorders in newborns. The section
also directs the Secretary of Health and Human Services to
submit to Congress a report on activities related to newborn
screening and screening children who have or are at risk for
heritable disorders within one year of the date of enactment.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italic, existing law in which no change is
proposed is shown in roman):
PUBLIC HEALTH SERVICE ACT
* * * * * * *
TITLE XI--GENETIC DISEASES, HEMOPHILIA PROGRAMS, AND SUDDEN INFANT
DEATH SYNDROME
Part A--Genetic Diseases
* * * * * * *
SEC. 1109. IMPROVED NEWBORN AND CHILD SCREENING FOR HERITABLE
DISORDERS.
(a) Authorization of Grant Program.--From amounts
appropriated under [subsection (j)] section 1117 , the
Secretary, acting through the Administrator of the Health
Resources and Services Administration (referred to in this
section as the ``Administrator'') [and in consultation with the
Advisory Committee] and taking into consideration the expertise
of the Advisory Committee on Heritable Disorders in Newborns
and Children (referred to in this section as the ``Advisory
Committee''), shall award grants to eligible entities to enable
such entities--
(1) * * *
[(2) to assist in providing health care professionals
and newborn screening laboratory personnel with
education in newborn screening and training in relevant
and new technologies in newborn screening and
congenital, genetic, and metabolic disorders;]
(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;
(3) to develop and deliver educational programs (at
appropriate literacy levels) about newborn screening
counseling, testing, follow-up, treatment, and
specialty services to parents, families, and patient
advocacy and support groups; [and]
(4) to establish, maintain, and operate a system to
assess and coordinate [treatment] followup and
treatment relating to congenital, genetic, and
metabolic disorders[.]; and
(5) to improve the timeliness of--
(A) the collection, delivery, receipt, and
screening of specimens; and
(B) the diagnosis of heritable disorders in
newborns.
* * * * * * *
(c) Approval Factors.--An [application submitted for a grant
under subsection (a)(1)] application for a grant under this
section shall not be approved by the Secretary unless the
application contains assurances that the eligible entity has
adopted and implemented, is in the process of adopting and
implementing, or will use amounts received under such grant to
adopt and implement the guidelines and recommendations of the
Advisory Committee that are adopted by the Secretary and in
effect at the time the grant is awarded or renewed under this
section, which shall include the screening of each newborn for
the heritable disorders recommended by the Advisory Committee
and adopted by the Secretary.
* * * * * * *
(h) Publication.--
(1) In general.-- An [application submitted under
subsection (c)(2)] application for a grant under this
section shall be made public by the State in such a
manner as to facilitate comment from any person,
including through hearings and other methods used to
facilitate comments from the public.
(2) Comments.-- Comments received by the State after
the publication described in paragraph (1) shall be
addressed in the [application submitted under
subsection (c)(2)] application for a grant under this
section .
* * * * * * *
[(j) Authorization of Appropriations.--There are authorized
to be appropriated--
[(1) to provide grants for the purpose of carrying
out activities under subsection (a)(1), $15,000,000 for
fiscal year 2009; $15,187,500 for fiscal year 2010,
$15,375,000 for fiscal year 2011, $15,562,500 for
fiscal year 2012, and $15,750,000 for fiscal year 2013;
and
[(2) to provide grants for the purpose of carrying
out activities under paragraphs (2), (3), and (4) of
subsection (a), $15,000,000 for fiscal year 2009,
$15,187,500 for fiscal year 2010, $15,375,000 for
fiscal year 2011, $15,562,500 for fiscal year 2012, and
$15,750,000 for fiscal year 2013.]
SEC. 1110. EVALUATING THE EFFECTIVENESS OF NEWBORN AND CHILD SCREENING
AND FOLLOWUP PROGRAMS.
(a) In General.--The Secretary shall award grants to eligible
entities to provide for the conduct of demonstration programs
to evaluate the effectiveness [of screening,], including with
respect to timeliness, of screening, followup, counseling or
health care services in reducing the morbidity and mortality
caused by heritable disorders in newborns and children.
(b) Demonstration Programs.--A demonstration program
conducted under a grant under this section shall be designed to
evaluate and assess, within the jurisdiction of the entity
receiving such grant--
(1) the effectiveness of screening, [counseling,
testing] treatment, counseling, testing, followup, or
specialty services for newborns and children at risk
for heritable disorders in reducing the morbidity and
mortality associated with such disorders, including, as
appropriate, through the assessment of health and
development outcomes for such children through
adolescence ;
(2) the effectiveness of screening, [counseling,
testing] treatment, counseling, testing, followup, or
specialty services in accurately and reliably
diagnosing heritable disorders in newborns and children
in a timely manner ; [or]
(3) the availability of screening, counseling,
testing or specialty services for newborns and children
at risk for heritable disorders[.];
(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.
* * * * * * *
[(d) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section $5,000,000 for
fiscal year 2009, $5,062,500 for fiscal year 2010, $5,125,000
for fiscal year 2011, $5,187,500 for fiscal year 2012, and
$5,250,000 for fiscal year 2013.]
* * * * * * *
SEC. 1111. ADVISORY COMMITTEE ON HERITABLE DISORDERS IN NEWBORNS AND
CHILDREN.
(a) * * *
(b) Duties.--The Advisory Committee shall--
(1) * * *
* * * * * * *
(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;
[(4)] (6) develop a model decision-matrix for newborn
screening expansion, including an evaluation of the
potential public health impact, including the cost of
such expansion, and periodically update the recommended
uniform screening panel, as appropriate, based on such
decision-matrix;
[(5)] (7) consider ways to ensure that all States
attain the capacity to screen for the conditions
described in paragraph (3), and include in such
consideration the results of grant funding under
section 1109; and
[(6)] (8) provide such recommendations, advice or
information as may be necessary to enhance, expand or
improve the ability of the Secretary to reduce the
mortality or morbidity from heritable disorders, which
may include recommendations, advice, or information
dealing with--
(A) follow-up activities, including those
necessary to [achieve rapid diagnosis] achieve
best practices in rapid diagnosis and
appropriate treatment in the short-term, and
those that ascertain long-term case management
outcomes and appropriate access to related
services;
* * * * * * *
(D) the availability and reporting of testing
for conditions for which there is no existing
treatment, including information on cost and
incidence ;
* * * * * * *
(J) identification of the causes of, public
health impacts of, and risk factors for
heritable disorders; [and]
(K) coordination of surveillance activities,
including standardized data collection and
reporting, harmonization of laboratory
definitions for heritable disorders and testing
results, and confirmatory testing and
verification of positive results, in order to
assess and enhance monitoring of newborn
diseases[.]; and
(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.
* * * * * * *
(d) Decision on Recommendations.--
(1) In general.-- Not later than [180] 120 days after
the Advisory Committee issues a recommendation pursuant
to this section, the Secretary shall adopt or reject
such recommendation. 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.
[(2) Pending recommendations.-- The Secretary shall
adopt or reject any recommendation issued by the
Advisory Committee that is pending on the date of
enactment of the Newborn Screening Saves Lives Act of
2008 by not later than 180 days after the date of
enactment of such Act.]
[(3)] (2) Determinations to be made public.-- The
Secretary shall publicize any determination on adopting
or rejecting a recommendation of the Advisory Committee
pursuant to this subsection, including the
justification for the determination.
(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.
* * * * * * *
[(f) Continuation of Operation of Committee.--Notwithstanding
section 14 of the Federal Advisory Committee Act (5 U.S.C.
App.), the Advisory Committee shall continue to operate during
the 5-year period beginning on the date of enactment of the
Newborn Screening Saves Lives Act of 2008.
[(g) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section, $1,000,000 for
fiscal year 2009, $1,012,500 for fiscal year 2010, $1,025,000
for fiscal year 2011, $1,037,500 for fiscal year 2012, and
$1,050,000 for fiscal year 2013.]
(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.
(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.
SEC. 1112. CLEARINGHOUSE OF NEWBORN SCREENING INFORMATION.
(a) In General.--The Secretary, acting through the
Administrator of the Health Resources and Services
Administration (referred to in this part as the
``Administrator''), in consultation with the Director of the
Centers for Disease Control and Prevention and the Director of
the National Institutes of Health, shall establish and maintain
a central clearinghouse of current educational and family
support and services information, materials, resources,
research, and data on newborn screening to--
(1) * * *
(2) increase awareness, knowledge, and understanding
of newborn diseases and screening services for
expectant individuals and families; [and]
(3) maintain current [data] information on quality
indicators to measure performance of newborn screening,
such as false-positive rates and other quality
indicators as determined by the Advisory Committee
under section 1111[.];
(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.
(b) Internet Availability.--The Secretary, acting through the
Administrator, shall ensure that the clearinghouse described
under subsection (a)--
(1) * * *
* * * * * * *
(4) provides--
(A) * * *
* * * * * * *
(D) the availability of Federal funding for
newborn and child screening for heritable
disorders including grants authorized under the
[Newborn Screening Saves Lives Act of 2008]
Newborn Screening Saves Lives Reauthorization
Act of 2014 ; and
* * * * * * *
(c) Nonduplication.--In [developing the clearinghouse]
carrying out activities under this section, the Secretary shall
ensure that such [clearinghouse minimizes duplication and
supplements, not supplants] activities minimize duplication and
supplement, not supplant , existing information sharing
efforts.
[(d) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section, $2,500,000 for
fiscal year 2009, $2,531,250 for fiscal year 2010, $2,562,500
for fiscal year 2011, $2,593,750 for fiscal year 2012, and
$2,625,000 for fiscal year 2013.]
SEC. 1113. LABORATORY QUALITY AND SURVEILLANCE .
(a) In General.--The Secretary, acting through the Director
of the Centers for Disease Control and Prevention [and in
consultation with the Advisory Committee] and taking into
consideration the expertise of the Advisory Committee on
Heritable Disorders in Newborns and Children established under
section 1111, shall provide for--
(1) quality assurance for laboratories involved in
screening newborns and children for heritable
disorders, including quality assurance for newborn-
screening tests, timeliness for processing such tests,
performance evaluation services, and technical
assistance and technology transfer to newborn screening
laboratories to ensure analytic validity and utility of
screening tests; and
* * * * * * *
[(b) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated $5,000,000 for fiscal year 2009, $5,062,500 for
fiscal year 2010, $5,125,000 for fiscal year 2011, $5,187,500
for fiscal year 2012, and $5,250,000 for fiscal year 2013.]
(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. 1114. INTERAGENCY COORDINATING COMMITTEE ON NEWBORN AND CHILD
SCREENING.
(a) * * *
* * * * * * *
(c) Composition.--The Interagency Coordinating Committee
shall be composed of the Director of the Centers for Disease
Control and Prevention, [the Administrator, the Director of the
Agency for Healthcare Research and Quality,] 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 the Director of the
National Institutes of Health, or their designees.
* * * * * * *
[(e) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated $1,000,000 for fiscal year 2009, $1,012,500 for
fiscal year 2010, $1,025,000 for fiscal year 2011, $1,037,500
for fiscal year 2012, and $1,050,000 for fiscal year 2013.]
SEC. 1115. NATIONAL CONTINGENCY PLAN FOR NEWBORN SCREENING.
(a) In General.--Not later than 180 days after the date of
enactment of this section, the Secretary, acting through the
Director of the Centers for Disease Control and Prevention and
in consultation with the Administrator and State departments of
health (or related agencies), shall develop a national
contingency plan for newborn screening for use by a State,
region, or [consortia] consortium of States in the event of a
public health emergency. The plan shall be updated as needed
and at least every five years.
* * * * * * *
SEC. 1116. HUNTER KELLY RESEARCH PROGRAM.
(a) Newborn Screening Activities.--
(1) In general.-- The Secretary, in conjunction with
the Director of the National Institutes of Health and
taking into consideration the recommendations of the
Advisory Committee, may continue carrying out,
coordinating, and expanding research in newborn
screening (to be known as ``Hunter Kelly Newborn
Screening Research Program'') including--
(A) * * *
(B) experimental treatments and disease
management strategies for additional newborn
conditions, and other genetic, metabolic,
hormonal, or functional conditions that can be
detected through newborn screening for which
treatment is not yet available[; and];
(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
[(C)] (E) other activities that would improve
newborn screening, as identified by the
Director.
* * * * * * *
(c) Reports.--The Director is encouraged to include
information about the activities carried out under this section
in the biennial report required under section 403 [of the
National Institutes of Health Reform Act of 2006]. If such
information is included, the Director shall make such
information available to be included on the Internet
Clearinghouse established under section 1112.
* * * * * * *
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.
* * * * * * *