[House Report 111-44]
[From the U.S. Government Publishing Office]



111th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES
 1st Session                                                     111-44
======================================================================
 
          EARLY HEARING DETECTION AND INTERVENTION ACT OF 2009

                               _______

 March 23, 2009.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

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

                              R E P O R T

                        [To accompany H.R. 1246]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 1246) to amend the Public Health Service Act 
regarding early detection, diagnosis, and treatment of hearing 
loss, having considered the same, report favorably thereon 
without amendment and recommend that the bill do pass.

                                CONTENTS

                                                                   Page
Purpose and Summary..............................................     1
Background and Need for Legislation..............................     2
Hearings.........................................................     2
Committee Consideration..........................................     2
Committee Votes..................................................     3
Committee Oversight Findings.....................................     3
Statement of General Performance Goals and Objectives............     3
New Budget Authority, Entitlement Authority, and Tax Expenditures     3
Earmarks and Tax and Tariff Benefits.............................     3
Committee Cost Estimate..........................................     3
Congressional Budget Office Estimate.............................     4
Federal Mandates Statement.......................................     5
Advisory Committee Statement.....................................     6
Constitutional Authority Statement...............................     6
Applicability to Legislative Branch..............................     6
Section-by-Section Analysis of the Legislation...................     6
Changes in Existing Law Made by the Bill, as Reported............     7

                          Purpose and Summary

    The purpose of H.R. 1246, the ``Early Hearing Detection and 
Intervention Act of 2009'', 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 III of such act, and 
for other purposes.

                  Background and Need for Legislation

    Each year in the United States, more than 12,000 babies are 
born with hearing loss. The cause of hearing loss for many 
babies is not known, and hearing loss can go undetected for 
years. Studies have shown that children who have hearing loss 
can have delays in speech, language, and cognitive development. 
When a child's hearing loss is identified soon after birth, the 
child's family and doctors can seek services he or she needs at 
an early age, increasing the likelihood of mitigating or 
preventing those delays.
    H.R. 1246 reauthorizes the Early Hearing Detection and 
Intervention (EHDI) program within the U.S. Department of 
Health and Human Services (HHS) by authorizing the 
appropriation of such sums as may be necessary for the 6-year 
period FY 2010 through FY 2015. The original legislation, which 
was enacted in 2000, directed federal agencies to work with 
states to develop newborn infant hearing screening and early 
intervention programs. EHDI programs include screening (the 
initial test of infants for hearing loss), diagnostic 
evaluations (to confirm hearing loss), and early intervention 
(including medical services, early intervention programs, and 
family support) to enhance language, communication, and 
cognitive and social skill development.
    When the EHDI program was first implemented, 44% of 
newborns were screened for hearing loss. With increased 
congressional funding, this increased to 67% by the end of 
2001, and 87% by the end of 2002. Today, more than 93% of all 
newborns are screened, and each year there are thousands of 
infants with hearing loss who benefit from early 
identification.
    Despite the success of the EHDI program, much work remains 
to be done. Many infants do not receive timely follow-up and 
referrals due to shortages in properly trained healthcare 
providers, limited access to early intervention programs, and 
poor EHDI program integration with existing public healthcare 
systems.

                                Hearings

    The Committee on Energy and Commerce has not held hearings 
on the legislation.

                        Committee Consideration

    The Committee on Energy and Commerce met in open markup 
session on Wednesday, March 4, 2009, and, pursuant to a motion 
by Mr. Waxman, agreed by unanimous consent to consider and 
approve H.R. 1246 and several other bills en bloc. H.R. 1246 
was ordered favorably reported to the House by a voice vote. No 
amendments were offered during full Committee consideration of 
H.R. 1246.

                            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 recorded votes taken during consideration or 
ordering H.R. 1246 reported to the House.

                      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 are reflected in this report.

         Statement of General Performance Goals and Objectives

    The objective of H.R. 1246 is to expand the EHDI program to 
include diagnostic services among services provided and to 
require the Secretary of HHS, acting through the Administrator 
of the Health Resources and Services Administration (HRSA), to 
assist in the recruitment, retention, education, and training 
of qualified personnel and healthcare providers. The bill 
provides that the purposes of the EHDI program include award of 
grants by the Secretary of HHS to develop efficient models to 
ensure follow-up care for newborns, infants, and young children 
identified with a hearing loss through screening, and to ensure 
an adequate supply of qualified personnel to meet the 
screening, evaluation, and early intervention needs of 
children. It also requires the Director of the National 
Institutes of Health (NIH) to establish a postdoctoral 
fellowship program to foster research and development in the 
area of early hearing detection and intervention. H.R. 1246 
further requires that families be given the opportunity to 
obtain the full range of early intervention services, 
educational and program placements, and other options for their 
child.

   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. 
1246 would result in no new or increased budget authority, 
entitlement authority, or tax expenditures.

                  Earmarks and Tax and Tariff Benefits

    In compliance with clause 9 of rule XXI of the Rules of the 
House of Representatives, H.R. 1246 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 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, March 20, 2009.
Hon. Henry A. Waxman,
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. 1246, the Early 
Hearing Detection and Intervention Act of 2009.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Jamease 
Kowalczyk.
            Sincerely,
                                      Douglas W. Elmendorf,
                                                          Director.
    Enclosure.

H.R. 1246--Early Hearing Detection and Intervention Act of 2009

    Summary: H.R. 1246 would amend the Public Health Service 
Act to authorize and expand research and public health 
activities related to the early detection, diagnosis, and 
treatment of hearing loss in newborns and infants. CBO 
estimates that implementing the bill would cost $151 million 
over the 2010-2014 period, assuming the appropriation of the 
necessary amounts. Enacting H.R.1246 would not affect direct 
spending or federal revenues.
    H.R. 1246 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. 1246 is shown in the following table. 
The costs of this legislation fall within budget function 550 
(health).

----------------------------------------------------------------------------------------------------------------
                                                                    By fiscal year, in millions of dollars--
                                                              --------------------------------------------------
                                                                2010    2011    2012    2013    2014   2010-2014
----------------------------------------------------------------------------------------------------------------
                                  CHANGES IN SPENDING SUBJECT TO APPROPRIATIONS

HRSA:
     Estimated Authorization Level...........................      12      12      12      12      12        61
    Estimated Outlays........................................       6      11      12      12      12        53
CDC:
    Estimated Authorization Level............................      11      11      11      11      11        55
    Estimated Outlays........................................       4       9      11      11      11        46
NIH:
    Estimated Authorization Level............................      13      13      13      13      13        64
    Estimated Outlays........................................       3      11      12      13      13        51
Total Changes:
    Estimated Authorization Level............................      36      36      36      36      36       180
    Estimated Outlays........................................      14      30      35      36      36      151
----------------------------------------------------------------------------------------------------------------
Note: CDC = Centers for Disease Control and Prevention. HRSA = Health Resources and Services Administration. NIH
  = National Institutes of Health.

    Basis of estimate: H.R. 1246 would authorize funding for 
early hearing loss detection and intervention activities at the 
Health Resources and Services Administration (HRSA), the 
Centers for Disease Control and Prevention (CDC), and the 
National Institutes of Health (NIH) for fiscal years 2010 
through 2015. It also would require the Director of the 
National Institutes of Health to establish a postdoctoral 
research program to foster research and development in the area 
of early hearing detection and intervention. CBO estimates that 
those activities would require the appropriation of $180 
million over the 2010-2014 period. Based on historical spending 
patterns for similar activities and assuming the appropriation 
of necessary amounts, CBO estimates that implementing H.R. 1246 
would cost $151 million over the 2010-2014 period.
    HRSA administers the Universal Newborn Screening program, 
which makes grants to states to support testing of infants 
prior to hospital discharge, audiologic evaluation by three 
months of age, and early intervention activities. CBO estimates 
that those activities would require the appropriation of $61 
million over the 2010-2014 period. Assuming the appropriation 
of the necessary amounts, CBO estimates that implementing that 
grant program would cost $53 million over the 2010-2014 period.
    H.R. 1246 would authorize CDC to make grants to states and 
provide technical assistance to states to promote screening, 
surveillance, and research into the causes of hearing loss 
among newborns and infants. To fund that grant program, CBO 
estimates that the CDC would require the appropriation of $55 
million over the 2010-2014 period. Assuming the appropriation 
of the necessary amounts, CBO estimates that implementing the 
program would cost $46 million over the 2010-2014 period.
    H.R. 1246 would authorize the NIH to conduct research on 
early detection and treatment of hearing loss. The bill would 
direct the NIH to establish a postdoctoral fellowship program 
to train researchers in the field of detecting and intervening 
in early hearing loss. Based on information provided by the 
NIH, CBO expects that the new postdoctoral program would fund 
three postdoctoral fellows at an annual cost of approximately 
$120,000 per fellow. Based on that information, historical 
program expenditures at NIH, and adjustments for inflation, CBO 
estimates that NIH would require the appropriation of $64 
million over the 2010-2014 period. CBO estimates that 
implementing those programs would cost $51 million over the 
2010-2014 period, assuming appropriation of the necessary 
amounts.
    Intergovernmental and private-sector impact: H.R. 1246 
contains no intergovernmental or private-sector mandates as 
defined in UMRA. States that participate in programs to detect, 
diagnose, and treat hearing loss in newborns and infants would 
benefit from activities and grants authorized in the bill.
    Estimate prepared by: Federal Costs: Jamease Kowalczyk, 
Stephanie Cameron, and Lisa Ramirez-Branum; Impact on State, 
Local, and Tribal Governments: Lisa Ramirez-Branum; Impact on 
Private Sector: Patrick Bernhardt.
    Estimate approved by: Peter H. Fontaine, Assistant Director 
for Budget Analysis.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of federal 
mandates regarding H.R. 1246 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 were created by H.R. 
1246.

                   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 this legislation is provided in 
Article I, section 8, clause 1, that relates to expending funds 
to provide for the general welfare of the United States.

                  Applicability to Legislative Branch

    The Committee finds that H.R. 1246 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

    Section 1 establishes the short title of the Act as the 
``Early Hearing Detection and Intervention Act of 2009''.

Section 2. Early detection, diagnosis, and treatment of hearing loss

    Section 2 of this legislation amends Section 399M of the 
Public Health Service Act (42 U.S.C. 280g-1). In the Section 
399M heading, H.R. 1246 strikes ``infants'' and inserts 
``newborns and infants.''
    Section 2 expands the purpose of the grant program to say 
that grants and cooperative agreements will be given to: (1) 
develop statewide newborn, infant hearing screening, 
evaluation, diagnosis, and intervention programs and systems; 
(2) assist in the recruitment, retention, education, and 
training of qualified personnel and healthcare providers; (3) 
ensure the prompt evaluation of children referred from 
screening programs; (4) provide appropriate educational, 
audiological, and medical interventions for children identified 
with hearing loss; (5) establish and foster family-to-family 
support mechanisms; (6) develop efficient models to ensure that 
newborns and infants who are identified with a hearing loss 
through screening receive follow-up by a qualified health care 
provider; and (7) ensure an adequate supply of qualified 
personnel to meet the screening, evaluation, diagnosis, and 
early intervention needs of children.
    Section 2 directs the Director of the NIH, acting through 
the Director of the National Institute on Deafness and Other 
Communication Disorders to establish a postdoctoral fellowship 
program to foster research and development in the area of early 
hearing detection and intervention.
    Section 2 amends the definition of the term ``early 
intervention''. As amended by H.R. 1246, the term ``early 
intervention'' ensures that families of the child are provided 
comprehensive, consumer-oriented information about the full 
range of family support, training, information services, and 
language and communication options and are given the 
opportunity to consider and obtain the full range of such 
appropriate services, educational and program placements, and 
other options for their child from highly qualified providers.
    Finally, Section 2 updates the authorization of 
appropriation sections to strike ``fiscal year 2002'' 
everywhere that such term appears and replace it with ``fiscal 
years 2010 through 2015''.

         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):

             SECTION 399M OF THE PUBLIC HEALTH SERVICE ACT


SEC. 399M. EARLY DETECTION, DIAGNOSIS, AND TREATMENT REGARDING HEARING 
                    LOSS IN [INFANTS] NEWBORNS AND INFANTS.

  (a) Statewide Newborn and Infant Hearing Screening, 
Evaluation and Intervention Programs and Systems.--The 
Secretary, acting through the Administrator of the Health 
Resources and Services Administration, shall make awards of 
grants or cooperative agreements to develop statewide newborn 
and infant hearing [screening, evaluation and intervention 
programs and systems] screening, evaluation, diagnosis, and 
intervention programs and systems, and to assist in the 
recruitment, retention, education, and training of qualified 
personnel and health care providers, for the following 
purposes:
          [(1) To develop and monitor the efficacy of state-
        wide newborn and infant hearing screening, evaluation 
        and intervention programs and systems. Early 
        intervention includes referral to schools and agencies, 
        including community, consumer, and parent-based 
        agencies and organizations and other programs mandated 
        by part C of the Individuals with Disabilities 
        Education Act, which offer programs specifically 
        designed to meet the unique language and communication 
        needs of deaf and hard of hearing newborns, infants, 
        toddlers, and children.]
          (1) To develop and monitor the efficacy of statewide 
        programs and systems for hearing screening of newborns 
        and infants; prompt evaluation and diagnosis of 
        children referred from screening programs; and 
        appropriate educational, audiological, and medical 
        interventions for children identified with hearing 
        loss. Early intervention includes referral to and 
        delivery of information and services by schools and 
        agencies, including community, consumer, and parent-
        based agencies and organizations and other programs 
        mandated by part C of the Individuals with Disabilities 
        Education Act, which offer programs specifically 
        designed to meet the unique language and communication 
        needs of deaf and hard of hearing newborns, infants, 
        toddlers, and children. Programs and systems under this 
        paragraph shall establish and foster family-to-family 
        support mechanisms that are critical in the first 
        months after a child is identified with hearing loss.

           *       *       *       *       *       *       *

          (3) To develop efficient models to ensure that 
        newborns and infants who are identified with a hearing 
        loss through screening receive follow-up by a qualified 
        health care provider. These models shall be evaluated 
        for their effectiveness, and State agencies shall be 
        encouraged to adopt models that effectively increase 
        the rate of occurrence of such follow-up.
          (4) To ensure an adequate supply of qualified 
        personnel to meet the screening, evaluation, diagnosis, 
        and early intervention needs of children.
  (b) Technical Assistance, Data Management, and Applied 
Research.--
          (1) Centers for disease control and prevention.--The 
        Secretary, acting through the Director of the Centers 
        for Disease Control and Prevention, shall make awards 
        of grants or cooperative agreements to provide 
        technical assistance to State agencies to complement an 
        intramural program and to conduct applied research 
        related to newborn and infant hearing screening, 
        evaluation and intervention programs and systems. The 
        program shall develop standardized procedures for data 
        management and program effectiveness and costs, such 
        as--
                  (A) to ensure quality monitoring of newborn 
                and infant [hearing loss screening, evaluation, 
                and intervention programs] hearing loss 
                screening, evaluation, diagnosis, and 
                intervention programs and systems;

           *       *       *       *       *       *       *

          (2) National institutes of health.--The Director of 
        the National Institutes of Health, acting through the 
        Director of the National Institute on Deafness and 
        Other Communication Disorders, shall [for purposes of 
        this section, continue] for purposes of this section--
                  (A) continue a program of research and 
                development on the efficacy of new screening 
                techniques and technology, including clinical 
                studies of screening methods, studies on 
                efficacy of intervention, and related 
                research[.]; and
                  (B) establish a postdoctoral fellowship 
                program to foster research and development in 
                the area of early hearing detection and 
                intervention.
  (c) Coordination and Collaboration.--
          (1) * * *
          (2) Policy development.--The Administrator of the 
        Health Resources and Services Administration, the 
        Director of the Centers for Disease Control and 
        Prevention, and the Director of the National Institutes 
        of Health shall coordinate and collaborate on 
        recommendations for policy development at the Federal 
        and State levels and with the private sector, including 
        consumer, medical and other health and education 
        professional-based organizations, with respect to 
        newborn and infant [hearing screening, evaluation and 
        intervention programs] hearing screening, evaluation, 
        diagnosis, and intervention programs and systems.
          (3) State early detection, diagnosis, and 
        intervention programs and systems; data collection.--
        The Administrator of the Health Resources and Services 
        Administration and the Director of the Centers for 
        Disease Control and Prevention shall coordinate and 
        collaborate in assisting States to establish newborn 
        and infant [hearing screening, evaluation and 
        intervention programs] hearing screening, evaluation, 
        diagnosis, and intervention programs and systems under 
        subsection (a) and to develop a data collection system 
        under subsection (b).

           *       *       *       *       *       *       *

  (e) Definitions.--For purposes of this section:
          (1) * * *

           *       *       *       *       *       *       *

          (3) The term ``early intervention'' refers to 
        providing appropriate services for the child with 
        hearing loss, including nonmedical services, and 
        [ensuring that families of the child are provided 
        comprehensive, consumer-oriented information about the 
        full range of family support, training, information 
        services, communication options and are given the 
        opportunity to consider the full range of educational 
        and program placements and options for their child.] 
        ensuring that families of the child are provided 
        comprehensive, consumer-oriented information about the 
        full range of family support, training, information 
        services, and language and communication options and 
        are given the opportunity to consider and obtain the 
        full range of such appropriate services, educational 
        and program placements, and other options for their 
        child from highly qualified providers.

           *       *       *       *       *       *       *

          (6) The term ``newborn and infant hearing screening'' 
        refers to objective physiologic procedures to detect 
        possible hearing loss and to identify newborns and 
        infants who[, after rescreening,] require further 
        audiologic and medical evaluations.
  (f) Authorization of Appropriations.--
          (1) Statewide newborn and infant hearing screening, 
        evaluation and intervention programs and systems.--For 
        the purpose of carrying out subsection (a), there are 
        authorized to be appropriated to the Health Resources 
        and Services Administration such sums as may be 
        necessary for [fiscal year 2002] fiscal years 2010 
        through 2015.
          (2) Technical assistance, data management, and 
        applied research; centers for disease control and 
        prevention.--For the purpose of carrying out subsection 
        (b)(1), there are authorized to be appropriated to the 
        Centers for Disease Control and Prevention such sums as 
        may be necessary for [fiscal year 2002] fiscal years 
        2010 through 2015.
          (3) Technical assistance, data management, and 
        applied research; national institute on deafness and 
        other communication disorders.--For the purpose of 
        carrying out subsection (b)(2), there are authorized to 
        be appropriated to the National Institute on Deafness 
        and Other Communication Disorders such sums as may be 
        necessary for [fiscal year 2002] fiscal years 2010 
        through 2015.

           *       *       *       *       *       *       *


                                  
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