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110th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES
 2d Session                                                     110-570

======================================================================



 
               NEWBORN SCREENING SAVES LIVES ACT OF 2008

                                _______
                                

 April 8, 2008.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

 Mr. Dingell, from the Committee on Energy and Commerce, submitted the 
                               following

                              R E P O R T

                        [To accompany H.R. 3825]

      [Including cost estimate of the Congressional Budget Office]

  The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 3825) to amend the Public Health Service Act to 
establish grant programs to provide for education and outreach 
on newborn screening and coordinated followup care once newborn 
screening has been conducted, to reauthorize programs under 
part A of title XI of such Act, and for other purposes, having 
considered the same, reports favorably thereon with an 
amendment and recommends that the bill as amended do pass.

                                CONTENTS

                                                                   Page
Amendment........................................................     1
Purpose and Summary..............................................     6
Background and Need for Legislation..............................     6
Hearings.........................................................     7
Committee Consideration..........................................     7
Committee Votes..................................................     7
Committee Oversight Findings.....................................     7
Statement of General Performance Goals and Objectives............     8
New Budget Authority, Entitlement Authority, and Tax Expenditures     8
Earmarks and Tax and Tariff Benefits.............................     8
Committee Cost Estimate..........................................     8
Congressional Budget Office Estimate.............................     9
Federal Mandates Statement.......................................    10
Advisory Committee Statement.....................................    10
Constitutional Authority Statement...............................    11
Applicability to Legislative Branch..............................    11
Section-by-Section Analysis of the Legislation...................    11
Changes in Existing Law Made by the Bill, as Reported............    14

                               Amendment

  The amendment is as follows:
  Strike all after the enacting clause and insert the 
following:

SECTION 1. SHORT TITLE.

  This Act may be cited as the ``Newborn Screening Saves Lives Act of 
2008''.

SEC. 2. IMPROVED NEWBORN AND CHILD SCREENING FOR HERITABLE DISORDER.

  Section 1109 of the Public Health Service Act (42 U.S.C. 300b-8) is 
amended--
  (1) by striking subsections (a), (b), and (c) and inserting the 
following:
  ``(a) Authorization of Grant Program.--From amounts appropriated 
under subsection (j), 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 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) to enhance, improve or expand the ability of State and 
        local public health agencies to provide screening, counseling, 
        or health care services to newborns and children having or at 
        risk for heritable disorders;
          ``(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;
          ``(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 relating to congenital, genetic, and 
        metabolic disorders.
  ``(b) Eligible Entity.--In this section, the term `eligible entity' 
means--
          ``(1) a State or a political subdivision of a State;
          ``(2) a consortium of 2 or more States or political 
        subdivisions of States;
          ``(3) a territory;
          ``(4) a health facility or program operated by or pursuant to 
        a contract with or grant from the Indian Health Service; or
          ``(5) any other entity with appropriate expertise in newborn 
        screening, as determined by the Secretary.
  ``(c) Approval Factors.--An application submitted for a grant under 
subsection (a)(1) 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.'';
          (2) by redesignating subsections (d) through (i) as 
        subsections (e) through (j), respectively;
          (3) by inserting after subsection (c), the following:
  ``(d) Coordination.--The Secretary shall take all necessary steps to 
coordinate programs funded with grants received under this section and 
to coordinate with existing newborn screening activities.''; and
          (4) by striking subsection (j) (as so redesignated) and 
        inserting the following:
  ``(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. 3. EVALUATING THE EFFECTIVENESS OF NEWBORN AND CHILD SCREENING 
                    PROGRAMS.

  Section 1110 of the Public Health Service Act (42 U.S.C. 300b-9) is 
amended by adding at the end the following:
  ``(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. 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 paragraph (3) as paragraph (6);
                  (B) in paragraph (2), by striking ``and'' after the 
                semicolon;
                  (C) by inserting after paragraph (2) the following:
          ``(3) make systematic evidence-based and peer-reviewed 
        recommendations that include the heritable disorders that have 
        the potential to significantly impact public health for which 
        all newborns should be screened, including secondary conditions 
        that may be identified as a result of the laboratory methods 
        used for screening;
          ``(4) develop a model decision-matrix for newborn screening 
        expansion, including an evaluation of the potential public 
        health impact of such expansion, and periodically update the 
        recommended uniform screening panel, as appropriate, based on 
        such decision-matrix;
          ``(5) 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'';
                  (D) in paragraph (6) (as so redesignated by 
                subparagraph (A)), by striking the period at the end 
                and inserting ``, which may include recommendations, 
                advice, or information dealing with--
                  ``(A) follow-up activities, including those necessary 
                to achieve rapid diagnosis in the short-term, and those 
                that ascertain long-term case management outcomes and 
                appropriate access to related services;
                  ``(B) implementation, monitoring, and evaluation of 
                newborn screening activities, including diagnosis, 
                screening, follow-up, and treatment activities;
                  ``(C) diagnostic and other technology used in 
                screening;
                  ``(D) the availability and reporting of testing for 
                conditions for which there is no existing treatment;
                  ``(E) conditions not included in the recommended 
                uniform screening panel that are treatable with Food 
                and Drug Administration-approved products or other safe 
                and effective treatments, as determined by scientific 
                evidence and peer review;
                  ``(F) minimum standards and related policies and 
                procedures used by State newborn screening programs, 
                such as language and terminology used by State newborn 
                screening programs to include standardization of case 
                definitions and names of disorders for which newborn 
                screening tests are performed;
                  ``(G) quality assurance, oversight, and evaluation of 
                State newborn screening programs, including ensuring 
                that tests and technologies used by each State meet 
                established standards for detecting and reporting 
                positive screening results;
                  ``(H) public and provider awareness and education;
                  ``(I) the cost and effectiveness of newborn screening 
                and medical evaluation systems and intervention 
                programs conducted by State-based programs;
                  ``(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
          (2) in subsection (c)(2)--
                  (A) by redesignating subparagraphs (E), (F), and (G) 
                as subparagraphs (F), (H), and (I), respectively;
                  (B) by inserting after subparagraph (D) the 
                following:
                  ``(E) the Commissioner of the Food and Drug 
                Administration;''; and
                  (C) by inserting after subparagraph (F), as so 
                redesignated, the following:
                  ``(G) individuals with expertise in ethics and 
                infectious diseases who have worked and published 
                material in the area of newborn screening;''; and
          (3) by adding at the end the following:
  ``(d) Decision on Recommendations.--
          ``(1) In general.--Not later than 180 days after the Advisory 
        Committee issues a recommendation pursuant to this section, the 
        Secretary shall adopt or reject such 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) 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.
  ``(e) Annual Report.--Not later than 3 years after the date of 
enactment of the Newborn Screening Saves Lives Act of 2008, and each 
fiscal year thereafter, the Advisory Committee shall--
          ``(1) publish a report on peer-reviewed newborn screening 
        guidelines, including follow-up and treatment, in the United 
        States;
          ``(2) submit such report to the appropriate committees of 
        Congress, the Secretary, the Interagency Coordinating Committee 
        established under Section 1114, and the State departments of 
        health; and
          ``(3) disseminate such report on as wide a basis as 
        practicable, including through posting on the internet 
        clearinghouse established under section 1112.
  ``(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.''.

SEC. 5. INFORMATION CLEARINGHOUSE.

  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. 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) enable parents and family members of newborns, health 
        professionals, industry representatives, and other members of 
        the public to increase their awareness, knowledge, and 
        understanding of newborn screening;
          ``(2) increase awareness, knowledge, and understanding of 
        newborn diseases and screening services for expectant 
        individuals and families; and
          ``(3) maintain current data 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.
  ``(b) Internet Availability.--The Secretary, acting through the 
Administrator, shall ensure that the clearinghouse described under 
subsection (a)--
          ``(1) is available on the Internet;
          ``(2) includes an interactive forum;
          ``(3) is updated on a regular basis, but not less than 
        quarterly; and
          ``(4) provides--
                  ``(A) links to Government-sponsored, non-profit, and 
                other Internet websites of laboratories that have 
                demonstrated expertise in newborn screening that supply 
                research-based information on newborn screening tests 
                currently available throughout the United States;
                  ``(B) information about newborn conditions and 
                screening services available in each State from 
                laboratories certified under subpart 2 of part F of 
                title III, including information about supplemental 
                screening that is available but not required, in the 
                State where the infant is born;
                  ``(C) current research on both treatable and not-yet 
                treatable conditions for which newborn screening tests 
                are available;
                  ``(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; and
                  ``(E) other relevant information as determined 
                appropriate by the Secretary.
  ``(c) Nonduplication.--In developing the clearinghouse under this 
section, the Secretary shall ensure that such clearinghouse minimizes 
duplication and supplements, not supplants, 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. 6. LABORATORY QUALITY AND SURVEILLANCE.

  Part A of title XI of the Public Health Service Act (42 U.S.C. 300b-1 
et seq.), as amended by section 5, is further amended by adding at the 
end the following:

``SEC. 1113. LABORATORY QUALITY.

  ``(a) In General.--The Secretary, acting through the Director of the 
Centers for Disease Control and Prevention and in consultation with 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, 
        performance evaluation services, and technical assistance and 
        technology transfer to newborn screening laboratories to ensure 
        analytic validity and utility of screening tests; and
          ``(2) appropriate quality control and other performance test 
        materials to evaluate the performance of new screening tools.
  ``(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.

``SEC. 1114. INTERAGENCY COORDINATING COMMITTEE ON NEWBORN AND CHILD 
                    SCREENING.

  ``(a) Purpose.--It is the purpose of this section to--
          ``(1) assess existing activities and infrastructure, 
        including activities on birth defects and developmental 
        disabilities authorized under section 317C, in order to make 
        recommendations for programs to collect, analyze, and make 
        available data on the heritable disorders recommended by the 
        Advisory Committee on Heritable Disorders in Newborns and 
        Children under section 1111, including data on the incidence 
        and prevalence of, as well as poor health outcomes resulting 
        from, such disorders; and
          ``(2) make recommendations for the establishment of regional 
        centers for the conduct of applied epidemiological research on 
        effective interventions to promote the prevention of poor 
        health outcomes resulting from such disorders as well as 
        providing information and education to the public on such 
        effective interventions.
  ``(b) Establishment.--The Secretary shall establish an Interagency 
Coordinating Committee on Newborn and Child Screening (referred to in 
this section as the `Interagency Coordinating Committee') to carry out 
the purpose of this section.
  ``(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, and the Director of the National 
Institutes of Health, or their designees.
  ``(d) Activities.--The Interagency Coordinating Committee shall--
          ``(1) report to the Secretary and the appropriate committees 
        of Congress on its recommendations related to the purpose 
        described in subsection (a); and
          ``(2) carry out other activities determined appropriate by 
        the Secretary.
  ``(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. 7. CONTINGENCY PLANNING.

  Part A of title XI of the Public Health Service Act (42 U.S.C. 300b-1 
et seq.), as amended by section 6, is further amended by adding at the 
end the following:

``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 of States in the 
event of a public health emergency.
  ``(b) Contents.--The contingency plan developed under subsection (a) 
shall include a plan for--
          ``(1) the collection and transport of specimens;
          ``(2) the shipment of specimens to State newborn screening 
        laboratories;
          ``(3) the processing of specimens;
          ``(4) the reporting of screening results to physicians and 
        families;
          ``(5) the diagnostic confirmation of positive screening 
        results;
          ``(6) ensuring the availability of treatment and management 
        resources;
          ``(7) educating families about newborn screening; and
          ``(8) carrying out other activities determined appropriate by 
        the Secretary.

``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) identifying, developing, and testing the most 
                promising new screening technologies, in order to 
                improve already existing screening tests, increase the 
                specificity of newborn screening, and expand the number 
                of conditions for which screening tests are available;
                  ``(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) other activities that would improve newborn 
                screening, as identified by the Director.
          ``(2) Additional newborn condition.--For purposes of this 
        subsection, the term `additional newborn condition' means any 
        condition that is not one of the core conditions recommended by 
        the Advisory Committee and adopted by the Secretary.
  ``(b) Funding.--In carrying out the research program under this 
section, the Secretary and the Director shall ensure that entities 
receiving funding through the program will provide assurances, as 
practicable, that such entities will work in consultation with the 
appropriate State departments of health, and, as practicable, focus 
their research on screening technology not currently performed in the 
States in which the entities are located, and the conditions on the 
uniform screening panel (or the standard test existing on the uniform 
screening panel).
  ``(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.
  ``(d) Nonduplication.--In carrying out programs under this section, 
the Secretary shall minimize duplication and supplement, not supplant, 
existing efforts of the type carried out under this section.
  ``(e) Peer Review.--Nothing in this section shall be construed to 
interfere with the scientific peer-review process at the National 
Institutes of Health.''.

                          Purpose and Summary

    The purpose of H.R. 3825, the ``Newborn Screening Saves 
Lives Act of 2008'', is to amend the Public Health Service Act 
to establish grant programs to provide for education and 
outreach on newborn screening and coordinated follow-up care 
once newborn screening has been conducted, to reauthorize 
programs under Part A of title XI of such Act, and for other 
purposes.

                  Background and Need for Legislation

    Newborn screening is a public health activity that provides 
early identification and follow-up for treatment of infants 
affected by certain genetic, metabolic, hormonal, and 
functional conditions for which there may be an effective 
treatment or intervention. If left untreated, these disorders 
can cause death, disability, mental retardation, and other 
serious conditions. Since the early 1960s, more than 150 
million infants have been screened for a number of genetic and 
congenital disorders. Every year, more than 4 million infants 
are born and screened to detect conditions that could threaten 
their lives and long-term health, and an estimated 3,000 babies 
are identified and treated for such conditions.
    Parents are often unaware that the number and quality of 
newborn screens varies from State to State. While newborns are 
regularly screened and treated for debilitating conditions in 
some States, in others screening may not be required and 
conditions may go undiagnosed and untreated. In 2004, the 
American College of Medical Genetics completed a report 
commissioned by the U.S. Department of Health and Human 
Services (HHS) recommending, at a minimum, that every baby born 
in the U.S. be screened for a core set of 29 treatable 
disorders regardless of the State in which he or she is born. 
At present, only 15 States and the District of Columbia require 
infants to be screened for all 29 of the recommended disorders. 
Some States currently mandate screening newborns for as few as 
9 conditions while others mandate more than 40 conditions. An 
estimated 1,000 of the 5,000 babies born every year in the 
United States with one of the 29 core conditions potentially go 
unscreened through newborn screening.
    H.R. 3825 will educate parents and healthcare providers 
about newborn screening, improve follow-up care for infants 
with an illness detected through newborn screening, and help 
States expand and improve their newborn screening programs, as 
well as provide for Federal guidelines on the conditions for 
which newborns in all States should be screened.

                                Hearings

    There were no hearings held in connection to the bill 
reported by the Committee.

                        Committee Consideration

    Tuesday, March 11, 2008, the Subcommittee on Health met in 
open markup session and favorably forwarded H.R. 3825, amended, 
to the full Committee for consideration, by a voice vote. On 
Thursday, March 13, 2008, the full Committee met in open markup 
session and ordered H.R. 3825 favorably reported to the House, 
as amended by the Subcommittee on Health, by a voice vote. No 
amendments were offered during full Committee consideration.

                            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 on amendments or in connection 
with ordering H.R. 3825 reported to the House. A motion by Mr. 
Dingell to order H.R. 3825 favorably reported to the House, as 
amended, was agreed to by a voice vote.

                      Committee Oversight Findings

    Regarding clause 3(c)(1) of rule XIII of the Rules of the 
House of Representatives, the oversight findings of the 
Committee regarding H.R. 3825 are reflected in this report.

         Statement of General Performance Goals and Objectives

    The objective of H.R. 3825 is to amend the Public Health 
Service Act to require the Secretary of HHS, acting through the 
Administrator of the Health Resources and Services 
Administration (HRSA), to award grants to eligible entities to 
provide education and training in newborn screening and 
congenital, genetic, and metabolic disorders to healthcare 
professionals and newborn screening laboratory personnel. H.R. 
3825 requires the Advisory Committee on Heritable Disorders in 
Newborns and Children (Advisory Committee) to make 
recommendations that include the heritable disorders for which 
all newborns should be screened and develop a model decision-
matrix for newborn screening program expansion. H.R. 3825 
requires the Secretary of HHS, acting through the Administrator 
of HRSA, to establish a central clearinghouse for information 
on newborn screening and award grants for newborn screening 
educational programs and for a system to assess and coordinate 
treatment relating to congenital, genetic, and metabolic 
disorders. The legislation further requires the Secretary of 
HHS, acting through the Director of the Centers for Disease 
Control and Prevention (CDC), to provide (1) quality assurance 
for screening laboratories; (2) population-based pilot testing 
for evaluating new screening tools; and (3) a national 
contingency plan for newborn screening in the event of a public 
health emergency.
    H.R. 3825 requires the Secretary of HHS, acting through an 
Interagency Group, to (1) collect, analyze, and make available 
data on certain heritable disorders; (2) operate regional 
centers to conduct applied epidemiological research on 
interventions to prevent poor health outcomes from such 
disorders; and (3) research and promote the prevention of poor 
health outcomes. Lastly, the legislation allows the Secretary 
of HHS, in conjunction with the Director of the National 
Institutes of Health (NIH), to continue carrying out, 
coordinating, and expanding research in newborn screening (to 
be known as the ``Hunter Kelly Newborn Screening Research 
Program'').

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    Regarding compliance with clause 3(c)(2) of rule XIII of 
the Rules of the House of Representatives, the Committee finds 
that H.R. 3825 would result in no new or increased budget 
authority, entitlement authority, or tax expenditures or 
revenues.

                  Earmarks and Tax and Tariff Benefits

    Regarding compliance with clause 9 of rule XXI of the Rules 
of the House of Representatives, H.R. 3825 does not contain any 
congressional earmarks, limited tax benefits, or limited tariff 
benefits as defined in clause 9(d), 9(e), or 9(f) of rule XXI.

                        Committee Cost Estimate

    The Committee adopts as its own the cost estimate on H.R. 
3825 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 on 
H.R. 3825 provided by the Congressional Budget Office pursuant 
to section 402 of the Congressional Budget Act of 1974:

                                                     April 1, 2008.
Hon. John D. Dingell,
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. 3825, the Newborn 
Screening Saves Lives Act of 2008.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contacts are Sarah 
Evans, Tim Gronniger, Lara Robillard, and Andrea Noda.
            Sincerely,
                                         Robert A. Sunshine
                                             (For Peter R. Orszag.)
    Enclosure.

H.R. 3825--Newborn Screening Saves Lives Act of 2008

    Summary: H.R. 3825 would amend the Public Health Service 
Act to authorize grant programs and other initiatives to 
promote expanded screening of newborns and children for 
heritable diseases.
    CBO estimates that the act would authorize the 
appropriation of $47 million for 2009 and $229 million over the 
2009-2013 period. Assuming the appropriation of those amounts, 
CBO estimates that implementing the act would cost $24 million 
in 2009 and $199 million over the 2009-2013 period. H.R. 3825 
would not affect direct spending or revenues.
    H.R. 3825 contains no intergovernmental or private-sector 
mandates as defined in the Unfunded Mandates Reform Act (UMRA).
    Estimated cost to the Federal Government: The estimated 
budgetary impact of H.R. 3825 is shown in the following table. 
The costs of this legislation fall within budget function 550 
(health).

------------------------------------------------------------------------
                                      By fiscal year, in millions of
                                                 dollars--
                                 ---------------------------------------
                                   2009    2010    2011    2012    2013
------------------------------------------------------------------------
              CHANGES IN SPENDING SUBJECT TO APPROPRIATION

HRSA Activities:
    Authorization Level.........      39      39      39      40      40
    Estimated Outlays...........      20      35      37      40      40
CDC Activities:
    Authorization Level.........       6       6       6       6       6
    Estimated Outlays...........       2       5       6       6       6
Contingency Planning (CDC and
 HRSA):
    Estimated Authorization            2       0       0       0       0
     Level......................
    Estimated Outlays...........       2       0       0       0       0
Total Changes Under:
    Estimated Authorization           47      45      45      46      46
     Level......................
    Estimated Outlays...........      24      40      43      46      46
------------------------------------------------------------------------
Note: HRSA = Health Resources and Services Administration; CDC = Centers
  for Disease Control and Prevention.

    Basis of estimate: The activities authorized under H.R. 
3825 would be carried out by the Health Resources and Services 
Administration (HRSA) and the Centers for Disease Control and 
Prevention (CDC). The estimate is based on historical spending 
patterns for similar activities, and assumes that the 
authorized amounts would be appropriated near the beginning of 
each fiscal year.
    The act would direct HRSA to establish grant programs to 
promote expanded screening of newborns and children for 
heritable diseases, and to establish a clearinghouse on 
heritable diseases. The bill would authorize the appropriation 
of $39 million for 2009 and $197 million over the 2009-2013 
period for those activities. CBO estimates that implementing 
those provisions would cost $20 million in 2009 and $172 
million over the 2009-2013 period.
    H.R. 3825 also would authorize CDC to implement programs to 
promote quality in clinical laboratories that test for 
heritable diseases and to create a surveillance program for 
heritable disorders. The bill would authorize the appropriation 
of $6 million for 2009 and $30 million over the 2009-2013 
period. CBO estimates that implementing those provisions would 
cost $2 million in 2009 and $25 million over the 2009-2013 
period.
    In addition, the act would direct CDC and HRSA to 
collaborate to create a national contingency plan for newborn 
screening in the event of a public health disaster. CBO 
estimates that it would cost $2 million in 2009 to develop that 
plan, assuming the availability of appropriated funds.
    Intergovernmental and private-sector impact: H.R. 3825 
contains no intergovernmental or private-sector mandates as 
defined in UMRA. State and local governments that participate 
in newborn and child screening programs would benefit from 
funds authorized by the bill.
    Previous CBO estimate: On April 1, 2008, CBO transmitted a 
cost estimate of S. 1858, the Newborn Screening Saves Lives Act 
of 2007, as passed by the Senate on December 13, 2007. The two 
bills are very similar, except that S. 1858 would authorize 
appropriations for the 2008-2012 period (rather than the 2009-
2013 period specified in H.R. 3825). CBO's estimate for S. 1858 
differs from that for H.R. 3825 because the amounts specified 
for appropriation in each year are different.
    Estimate prepared by: Federal Costs: Sarah Evans, Tim 
Gronniger, Andrea Noda, and Lara Robillard; Impact on State, 
Local, and Tribal Governments: Lisa Ramirez-Branum; Impact on 
the Private Sector: Patrick Bernhardt.
    Estimate approved by: Keith J. Fontenot, Deputy Assistant 
Director for Health and Human Resources, Budget Analysis 
Division.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates regarding H.R. 3825 prepared by the Director of the 
Congressional Budget Office pursuant to section 423 of the 
Unfunded Mandates Reform Act.

                      Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act would be created by H.R. 
3825.

                   Constitutional Authority Statement

    Pursuant to clause 3(d)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee finds that the 
Constitutional authority for H.R. 3825 is provided in the 
provisions of Article I, section 8, clause 1, that relate to 
expending funds to provide for the general welfare of the 
United States.

                  Applicability to Legislative Branch

    The Committee finds that H.R. 3825 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 of 1995.

             Section-by-Section Analysis of the Legislation


Section 1. Short title

    Section 1 establishes the short title of the Act as the 
``Newborn Screening Saves Lives Act of 2008''.

Section 2. Improved newborn and child screening for heritable disorder

    Section 2 amends Section 1109 of the Public Health Service 
Act (42 U.S.C. 300b-8). Section 2 authorizes grants for 
enhancing, improving, or expanding the ability of States and 
local public health agencies to provide screening, counseling, 
or healthcare services to newborns and children having or at 
risk for heritable disorders. In order to receive a grant, an 
eligible entity must commit to adopting and implementing or be 
in the process of adopting and implementing the guidelines and 
recommendations of the Advisory Committee that are adopted by 
the Secretary of HHS. The authorization of appropriations for 
this program is $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. Eligible entities for these grants are a State, a 
consortium of 2 or more States, a territory, a health facility 
or program operated by or pursuant to a contract with or grant 
from the Indian Health Services, or any other entity with 
appropriate expertise in newborn screening, as determined by 
the Secretary.
    Section 2 authorizes grants for (1) educating and training 
healthcare professionals and State laboratory personnel in 
newborn screening and relevant new technologies; (2) developing 
and delivering educational programs to inform parents, 
families, and patient advocacy and support groups about newborn 
screening, testing, follow-up, and treatment; and (3) 
establishing, operating, and maintaining a system to assess and 
coordinate treatment relating to congenital, genetic, and 
metabolic disorders. The authorization of appropriations for 
these grants is $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. Eligible entities for these grants are a State, a 
consortium of 2 or more States, a territory, a health facility 
or program operated by or pursuant to a contract with or grant 
from the Indian Health Services, or any other entity with 
appropriate expertise in newborn screening, as determined by 
the Secretary of HHS.

Section 3. Evaluating the effectiveness of newborn and child screening 
        programs

    Section 3 amends Section 1110 of the Public Health Service 
Act (42 U.S.C. 300b-9), to authorize $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 to evaluate the effectiveness of Newborn and 
Child Screening Programs.

Section 4. Advisory Committee on Heritable Disorders in Newborns and 
        Children

    Section 4 amends Section 1111 of the Public Health Service 
Act (42 U.S.C. 300b-10).
    Section 4 reauthorizes the Advisory Committee for the 5-
year period beginning on the date of enactment of the bill. It 
expands the role of the Advisory Committee to require that the 
Advisory Committee make systematic evidence-based and peer-
reviewed recommendations that include heritable disorders, 
including secondary conditions that may be identified. It 
requires the Advisory Committee to develop a model decision-
matrix for newborn screening expansion and periodic updating of 
the recommended uniform screening panel as well as to consider 
ways to ensure that all States attain the capacity to screen 
for the recommended panel of disorders. The Advisory Committee 
is also required to provide recommendations, advice, or 
information to the Secretary of HHS to reduce the mortality or 
morbidity from heritable disorders, which may include:
     Follow-up activities including those necessary to 
achieve rapid diagnosis in the short term and those that 
ascertain long-term case management outcomes;
     Implementation, monitoring, and evaluation of 
newborn screening activities, including diagnosis, screening, 
follow-up, and treatment activities;
     Quality assurance, oversight, and evaluation of 
State newborn screening programs;
     The availability and reporting of testing for 
conditions for which there is no existing treatment;
     Standardized data collection and reporting for 
assessment of newborn screening programs;
     The cost and effectiveness of newborn screening 
and medical evaluation systems and intervention programs 
conducted by State-based programs; and
     Coordination of surveillance activities in order 
to enhance monitoring of newborn diseases.
    Section 4 adds individuals with expertise in ethics and 
infectious diseases who have worked and published material in 
newborn screening and the Commissioner of the Food and Drug 
Administration (FDA) to the Advisory Committee. It requires the 
Secretary of HHS to adopt or reject any recommendation issued 
by the Advisory Committee that is pending on the date of 
enactment and requires the Secretary of HHS to adopt or reject 
future recommendations of the Advisory Committee after not more 
than 180 days and make public such determination. It also 
requires the Advisory Committee to report to Congress and the 
public not later than 3 years after the date of enactment, and 
each year thereafter, on newborn screening guidelines, 
including follow-up and treatment, in the United States.
    This section authorizes $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.

Section 5. Information clearinghouse

    Section 5 amends Part A of title XI of the Public Health 
Service Act (42 U.S.C. 300b-1 et seq.). Section 5 requires the 
Secretary of HHS to establish a central clearinghouse within 
HRSA, in consultation with CDC and NIH. This clearinghouse is 
to be made available via the Internet to provide current 
educational and family support information, resources, and data 
on newborn screening for parents and family members of 
newborns; information about newborn screening services 
available in each State; current research on both treatable and 
not-yet treatable conditions for which newborn screening tests 
are available; and the availability of Federal funding for 
newborn and child screening for heritable disorders including 
grants authorized by the bill.
    This section authorizes $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.

Section 6. Laboratory quality and surveillance

    Section 6 amends Part A of title XI of the Public Health 
Service Act (42 U.S.C. 300b-1 et seq.). Section 6 requires the 
Secretary of HHS, acting through the Director of the CDC and in 
consultation with the Advisory Committee, to ensure the quality 
of laboratories involved in newborn screening including quality 
assurance for newborn screening tests, and performance 
evaluation services. Quality assurance activities shall also 
include technical assistance and technology transfer to newborn 
screening laboratories to ensure analytic validity and utility 
of screening tests as well as to provide for appropriate 
quality control and other performance test materials to 
evaluate the performance of new screening tools. This section 
authorizes $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.
    Section 6 also requires the Secretary of HHS to establish 
an Interagency Coordinating Committee consisting of the 
Director of the Agency for Healthcare Research and Quality 
(AHRQ), the Director of the CDC, the Administrator of the HRSA, 
and the Director of NIH. The Interagency Coordinating Committee 
shall assess existing activities and infrastructure, including 
activities on birth defects and developmental disabilities 
authorized under Section 317C, in order to make recommendations 
for programs to collect, analyze, and make available data on 
the heritable disorders recommended by the Advisory Committee. 
The Interagency Coordinating Committee shall also make 
recommendations for the establishment of regional centers for 
the conduct of applied epidemiological research on effective 
interventions to promote the prevention of poor health outcomes 
resulting from disorders and to provide information and 
education to the public on such effective interventions. The 
Interagency Coordinating Committee shall report to the 
Secretary of HHS and the appropriate Committees of Congress on 
its recommendations.
    For the purposes of 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.

Section 7. Contingency planning

    Section 7 amends Part A of title XI of the Public Health 
Service Act (42 U.S.C. 300b-1 et seq.). Section 7 requires the 
Secretary of HHS, acting through the Director of the CDC, to 
develop a national contingency plan for newborn screening for 
use by a State, region, or consortia of States in the event of 
a public health emergency. The national contingency plan shall 
be developed not later than 180 days after enactment of the 
bill and shall include a plan for the collection and transport 
of specimens, the shipment and processing of specimens, the 
reporting of screening results to physicians and families, the 
diagnostic confirmation of positive screening results, the 
availability of treatment and management resources, and the 
education of families about newborn screening.
    Section 7 allows the Secretary of HHS, in conjunction with 
the Director of the NIH, and taking into consideration the 
recommendations of the Advisory Committee, to continue carrying 
out, coordinating, and expanding research in newborn screening 
(to be known as the ``Hunter Kelly Newborn Screening Research 
Program'') including identifying, developing, and testing the 
most promising new screening technologies in order to improve 
already existing screening tests and expand the number of 
conditions for which screening test are available and 
experimental treatments and disease management strategies for 
additional newborn conditions beyond those recommended by the 
Advisory Committee and adopted by the Secretary of HHS that can 
be detected through newborn screening for which treatment is 
not yet available. In carrying out the research under this 
section, the Secretary of HHS and the Director of NIH shall 
ensure that entities receiving funding focus their research on 
screening technology not currently performed in the State in 
which the entities are located and on the conditions not on the 
uniform screening panel. The Director of NIH 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 and, where 
applicable, the Internet clearinghouse established under 
section 5 of this bill.

         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) In General.--The Secretary shall award grants to 
eligible entities to enhance, improve or expand the ability of 
State and local public health agencies to provide screening, 
counseling or health care services to newborns and children 
having or at risk for heritable disorders.
  [(b) Use of Funds.--Amounts provided under a grant awarded 
under subsection (a) shall be used to--
          [(1) establish, expand, or improve systems or 
        programs to provide screening, counseling, testing or 
        specialty services for newborns and children at risk 
        for heritable disorders;
          [(2) establish, expand, or improve programs or 
        services to reduce mortality or morbidity from 
        heritable disorders;
          [(3) establish, expand, or improve systems or 
        programs to provide information and counseling on 
        available therapies for newborns and children with 
        heritable disorders;
          [(4) improve the access of medically underserved 
        populations to screening, counseling, testing and 
        specialty services for newborns and children having or 
        at risk for heritable disorders; or
          [(5) conduct such other activities as may be 
        necessary to enable newborns and children having or at 
        risk for heritable disorders to receive screening, 
        counseling, testing or specialty services, regardless 
        of income, race, color, religion, sex, national origin, 
        age, or disability.
  [(c) Eligible Entities.--To be eligible to receive a grant 
under subsection (a) an entity shall--
          [(1) be a State or political subdivision of a State, 
        or a consortium of two or more States or political 
        subdivisions of States; and
          [(2) prepare and submit to the Secretary an 
        application that includes--
                  [(A) a plan to use amounts awarded under the 
                grant to meet specific health status goals and 
                objectives relative to heritable disorders, 
                including attention to needs of medically 
                underserved populations;
                  [(B) a plan for the collection of outcome 
                data or other methods of evaluating the degree 
                to which amounts awarded under this grant will 
                be used to achieve the goals and objectives 
                identified under subparagraph (A);
                  [(C) a plan for monitoring and ensuring the 
                quality of services provided under the grant;
                  [(D) an assurance that amounts awarded under 
                the grant will be used only to implement the 
                approved plan for the State;
                  [(E) an assurance that the provision of 
                services under the plan is coordinated with 
                services provided under programs implemented in 
                the State under title V, XVIII, XIX, XX, or XXI 
                of the Social Security Act (subject to Federal 
                regulations applicable to such programs) so 
                that the coverage of services under such titles 
                is not substantially diminished by the use of 
                granted funds; and
                  [(F) such other information determined by the 
                Secretary to be necessary.]
  (a) Authorization of Grant Program.--From amounts 
appropriated under subsection (j), 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 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) to enhance, improve or expand the ability of 
        State and local public health agencies to provide 
        screening, counseling, or health care services to 
        newborns and children having or at risk for heritable 
        disorders;
          (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;
          (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 relating to congenital, 
        genetic, and metabolic disorders.
  (b) Eligible Entity.--In this section, the term ``eligible 
entity'' means--
          (1) a State or a political subdivision of a State;
          (2) a consortium of 2 or more States or political 
        subdivisions of States;
          (3) a territory;
          (4) a health facility or program operated by or 
        pursuant to a contract with or grant from the Indian 
        Health Service; or
          (5) any other entity with appropriate expertise in 
        newborn screening, as determined by the Secretary.
  (c) Approval Factors.--An application submitted for a grant 
under subsection (a)(1) 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.
  (d) Coordination.--The Secretary shall take all necessary 
steps to coordinate programs funded with grants received under 
this section and to coordinate with existing newborn screening 
activities.
  [(d)] (e) Limitation.--An eligible entity may not use amounts 
received under this section to--
          (1) * * *

           *       *       *       *       *       *       *

  [(e)] (f) Voluntary Participation.--The participation by any 
individual in any program or portion thereof established or 
operated with funds received under this section shall be wholly 
voluntary and shall not be a prerequisite to eligibility for or 
receipt of any other service or assistance from, or to 
participation in, another Federal or State program.
  [(f)] (g) Supplement Not Supplant.--Funds appropriated under 
this section shall be used to supplement and not supplant other 
Federal, State, and local public funds provided for activities 
of the type described in this section.
  [(g)] (h) Publication.--
          (1) * * *

           *       *       *       *       *       *       *

  [(h)] (i) Technical Assistance.--The Secretary shall provide 
to entities receiving grants under subsection (a) such 
technical assistance as may be necessary to ensure the quality 
of programs conducted under this section.
  [(i)  Authorization of Appropriations.--There are authorized 
to be appropriated to carry out this section such sums as may 
be necessary for each of the fiscal years 2001 through 2005.]
  (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 
                    PROGRAMS.

  (a) * * *

           *       *       *       *       *       *       *

  (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) * * *
          (2) provide technical information to the Secretary 
        for the development of policies and priorities for the 
        administration of grants under section 1109; [and]
          (3) make systematic evidence-based and peer-reviewed 
        recommendations that include the heritable disorders 
        that have the potential to significantly impact public 
        health for which all newborns should be screened, 
        including secondary conditions that may be identified 
        as a result of the laboratory methods used for 
        screening;
          (4) develop a model decision-matrix for newborn 
        screening expansion, including an evaluation of the 
        potential public health impact of such expansion, and 
        periodically update the recommended uniform screening 
        panel, as appropriate, based on such decision-matrix;
          (5) 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
          [(3)] (6) 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 in the 
                short-term, and those that ascertain long-term 
                case management outcomes and appropriate access 
                to related services;
                  (B) implementation, monitoring, and 
                evaluation of newborn screening activities, 
                including diagnosis, screening, follow-up, and 
                treatment activities;
                  (C) diagnostic and other technology used in 
                screening;
                  (D) the availability and reporting of testing 
                for conditions for which there is no existing 
                treatment;
                  (E) conditions not included in the 
                recommended uniform screening panel that are 
                treatable with Food and Drug Administration-
                approved products or other safe and effective 
                treatments, as determined by scientific 
                evidence and peer review;
                  (F) minimum standards and related policies 
                and procedures used by State newborn screening 
                programs, such as language and terminology used 
                by State newborn screening programs to include 
                standardization of case definitions and names 
                of disorders for which newborn screening tests 
                are performed;
                  (G) quality assurance, oversight, and 
                evaluation of State newborn screening programs, 
                including ensuring that tests and technologies 
                used by each State meet established standards 
                for detecting and reporting positive screening 
                results;
                  (H) public and provider awareness and 
                education;
                  (I) the cost and effectiveness of newborn 
                screening and medical evaluation systems and 
                intervention programs conducted by State-based 
                programs;
                  (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.
  (c) Membership.--
          (1) * * *
          (2) Required members.--The Secretary shall appoint to 
        the Advisory Committee under paragraph (1)--
                  (A) * * *

           *       *       *       *       *       *       *

                  (E) the Commissioner of the Food and Drug 
                Administration;
                  [(E)] (F) medical, technical, or scientific 
                professionals with special expertise in 
                heritable disorders, or in providing screening, 
                counseling, testing or specialty services for 
                newborns and children at risk for heritable 
                disorders;
                  (G) individuals with expertise in ethics and 
                infectious diseases who have worked and 
                published material in the area of newborn 
                screening;
                  [(F)] (H) members of the public having 
                special expertise about or concern with 
                heritable disorders; and
                  [(G)] (I) representatives from such Federal 
                agencies, public health constituencies, and 
                medical professional societies as determined to 
                be necessary by the Secretary, to fulfill the 
                duties of the Advisory Committee, as 
                established under subsection (b).
  (d) Decision on Recommendations.--
          (1) In general.--Not later than 180 days after the 
        Advisory Committee issues a recommendation pursuant to 
        this section, the Secretary shall adopt or reject such 
        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) 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.
  (e) Annual Report.--Not later than 3 years after the date of 
enactment of the Newborn Screening Saves Lives Act of 2008, and 
each fiscal year thereafter, the Advisory Committee shall--
          (1) publish a report on peer-reviewed newborn 
        screening guidelines, including follow-up and 
        treatment, in the United States;
          (2) submit such report to the appropriate committees 
        of Congress, the Secretary, the Interagency 
        Coordinating Committee established under Section 1114, 
        and the State departments of health; and
          (3) disseminate such report on as wide a basis as 
        practicable, including through posting on the internet 
        clearinghouse established under section 1112.
  (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.

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) enable parents and family members of newborns, 
        health professionals, industry representatives, and 
        other members of the public to increase their 
        awareness, knowledge, and understanding of newborn 
        screening;
          (2) increase awareness, knowledge, and understanding 
        of newborn diseases and screening services for 
        expectant individuals and families; and
          (3) maintain current data 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.
  (b) Internet Availability.--The Secretary, acting through the 
Administrator, shall ensure that the clearinghouse described 
under subsection (a)--
          (1) is available on the Internet;
          (2) includes an interactive forum;
          (3) is updated on a regular basis, but not less than 
        quarterly; and
          (4) provides--
                  (A) links to Government-sponsored, non-
                profit, and other Internet websites of 
                laboratories that have demonstrated expertise 
                in newborn screening that supply research-based 
                information on newborn screening tests 
                currently available throughout the United 
                States;
                  (B) information about newborn conditions and 
                screening services available in each State from 
                laboratories certified under subpart 2 of part 
                F of title III, including information about 
                supplemental screening that is available but 
                not required, in the State where the infant is 
                born;
                  (C) current research on both treatable and 
                not-yet treatable conditions for which newborn 
                screening tests are available;
                  (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; and
                  (E) other relevant information as determined 
                appropriate by the Secretary.
  (c) Nonduplication.--In developing the clearinghouse under 
this section, the Secretary shall ensure that such 
clearinghouse minimizes duplication and supplements, not 
supplants, 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.

  (a) In General.--The Secretary, acting through the Director 
of the Centers for Disease Control and Prevention and in 
consultation with 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, performance evaluation services, and 
        technical assistance and technology transfer to newborn 
        screening laboratories to ensure analytic validity and 
        utility of screening tests; and
          (2) appropriate quality control and other performance 
        test materials to evaluate the performance of new 
        screening tools.
  (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.

SEC. 1114. INTERAGENCY COORDINATING COMMITTEE ON NEWBORN AND CHILD 
                    SCREENING.

  (a) Purpose.--It is the purpose of this section to--
          (1) assess existing activities and infrastructure, 
        including activities on birth defects and developmental 
        disabilities authorized under section 317C, in order to 
        make recommendations for programs to collect, analyze, 
        and make available data on the heritable disorders 
        recommended by the Advisory Committee on Heritable 
        Disorders in Newborns and Children under section 1111, 
        including data on the incidence and prevalence of, as 
        well as poor health outcomes resulting from, such 
        disorders; and
          (2) make recommendations for the establishment of 
        regional centers for the conduct of applied 
        epidemiological research on effective interventions to 
        promote the prevention of poor health outcomes 
        resulting from such disorders as well as providing 
        information and education to the public on such 
        effective interventions.
  (b) Establishment.--The Secretary shall establish an 
Interagency Coordinating Committee on Newborn and Child 
Screening (referred to in this section as the ``Interagency 
Coordinating Committee'') to carry out the purpose of this 
section.
  (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, and the Director of 
the National Institutes of Health, or their designees.
  (d) Activities.--The Interagency Coordinating Committee 
shall--
          (1) report to the Secretary and the appropriate 
        committees of Congress on its recommendations related 
        to the purpose described in subsection (a); and
          (2) carry out other activities determined appropriate 
        by the Secretary.
  (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 of States in the event of a public health 
emergency.
  (b) Contents.--The contingency plan developed under 
subsection (a) shall include a plan for--
          (1) the collection and transport of specimens;
          (2) the shipment of specimens to State newborn 
        screening laboratories;
          (3) the processing of specimens;
          (4) the reporting of screening results to physicians 
        and families;
          (5) the diagnostic confirmation of positive screening 
        results;
          (6) ensuring the availability of treatment and 
        management resources;
          (7) educating families about newborn screening; and
          (8) carrying out other activities determined 
        appropriate by the Secretary.

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) identifying, developing, and testing the 
                most promising new screening technologies, in 
                order to improve already existing screening 
                tests, increase the specificity of newborn 
                screening, and expand the number of conditions 
                for which screening tests are available;
                  (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) other activities that would improve 
                newborn screening, as identified by the 
                Director.
          (2) Additional newborn condition.--For purposes of 
        this subsection, the term ``additional newborn 
        condition'' means any condition that is not one of the 
        core conditions recommended by the Advisory Committee 
        and adopted by the Secretary.
  (b) Funding.--In carrying out the research program under this 
section, the Secretary and the Director shall ensure that 
entities receiving funding through the program will provide 
assurances, as practicable, that such entities will work in 
consultation with the appropriate State departments of health, 
and, as practicable, focus their research on screening 
technology not currently performed in the States in which the 
entities are located, and the conditions on the uniform 
screening panel (or the standard test existing on the uniform 
screening panel).
  (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.
  (d) Nonduplication.--In carrying out programs under this 
section, the Secretary shall minimize duplication and 
supplement, not supplant, existing efforts of the type carried 
out under this section.
  (e) Peer Review.--Nothing in this section shall be construed 
to interfere with the scientific peer-review process at the 
National Institutes of Health.

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