[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.

           *       *       *       *       *       *       *


                                  
