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111th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES
 2d Session                                                     111-640

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



 
             PEDIATRIC RESEARCH CONSORTIA ESTABLISHMENT ACT

                                _______
                                

 September 28, 2010.--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. 758]

      [Including cost estimate of the Congressional Budget Office]

  The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 758) to amend title IV of the Public Health 
Service Act to provide for the establishment of pediatric 
research consortia, having considered the same, report 
favorably thereon with an amendment and recommend that the bill 
as amended do pass.

                                CONTENTS

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

                               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 ``Pediatric Research Consortia 
Establishment Act''.

SEC. 2. NATIONAL PEDIATRIC RESEARCH CONSORTIA.

  Subpart 7 of part C of title IV of the Public Health Service Act (42 
U.S.C. 285g et seq.) is amended by adding at the end the following:

``SEC. 452H. NATIONAL PEDIATRIC RESEARCH CONSORTIA.

  ``(a) In General.--The Director of NIH, acting through the Director 
of the Eunice Kennedy Shriver National Institute of Child Health and 
Human Development and in collaboration with all other Institutes of the 
National Institutes of Health that support pediatric research, may, 
subject to the availability of funds, award grants, contracts, or 
cooperative agreements to public or nonprofit private entities to pay 
all or part of the cost of planning, establishing, and providing basic 
operating support for up to 20 national pediatric research consortia. 
The Director of NIH shall take unmet research needs into account when 
making awards under this section.
  ``(b) Research.--Research conducted under this section shall 
supplement, but not replace, research that is otherwise conducted or 
supported as part of the comprehensive pediatric research portfolio of 
entities receiving awards under subsection (a). Consortia established 
under subsection (a) shall, in the aggregate, conduct basic, clinical, 
behavioral, social, or translational research to meet unmet research 
needs, as well as training in and demonstration of advanced diagnostic 
and treatment methods relating to pediatrics, as appropriate.
  ``(c) Coordination of Consortia Reports.--The Director of NIH shall--
          ``(1) as appropriate, provide for the coordination of 
        information among consortia established under subsection (a) 
        and ensure regular communication between such consortia; and
          ``(2) require the periodic preparation of reports on the 
        activities of the consortia and the submission of the reports 
        to the Director.
  ``(d) Organization of Consortium.--Each consortium established under 
subsection (a) shall be formed from a collaboration of cooperating 
institutions with a lead institution, meeting such requirements as may 
be prescribed by the Director of NIH, including participation in a 
network of such consortia.
  ``(e) Limitation.--Payments under subsection (a) shall not exceed 
$2,500,000 per year for each consortium in the first 5-year cycle.
  ``(f) Duration of Payments.--Payments under subsection (a) for a 
consortium may be provided under this section for a period of 5 years 
and may be extended for additional periods of 5 years each, with 
enhanced funding opportunities based on a review of the operations by 
an appropriate scientific review.''.

                          Purpose and Summary

    H.R. 758, the ``Pediatric Research Consortia Establishment 
Act'', was introduced on January 28, 2009, by Rep. Diana 
DeGette (D-CO), and referred to the Committee on Energy and 
Commerce.
    The goal of H.R. 758 is to authorize the creation of up to 
20 pediatric research consortia focused on diseases that affect 
children. The bill allows the Director of the National 
Institutes of Health to establish pediatric research consortia 
across the country to help focus and coordinate research on 
pediatric diseases.

                  Background and Need for Legislation

    There is growing evidence that the relationship between 
health and disease begins before birth and during the pediatric 
years. There are very few institutions dedicating resources 
specifically to pediatric research. A network of consortia is a 
proven mechanism that will promote efficiency and collaboration 
at all levels of pediatric research, and provide patients and 
institutions new access to relevant, disease-specific research.

                        Committee Consideration

    H.R. 758, the ``Pediatric Research Consortia Establishment 
Act'', was introduced by Ms. DeGette of Colorado on January 28, 
2009, and referred to the Committee on Energy and Commerce. The 
bill was subsequently referred to the Subcommittee on Health on 
February 2, 2009. On September 15, 2010, the Subcommittee held 
a legislative hearing on the bill. The Subcommittee met in open 
markup session to consider H.R. 758 on September 16, 2010. An 
amendment in the nature of a substitute (manager's amendment) 
by Ms. DeGette was adopted by a voice vote. Subsequently, H.R. 
758 was favorably forwarded to the full Committee, amended, by 
a voice vote.
    On September 23, 2010, the Committee on Energy and Commerce 
met in open markup session and considered H.R. 758 as approved 
by the Subcommittee. There were no amendments offered in full 
Committee and subsequently the Committee ordered H.R. 758 
favorably reported to the House, as amended by the Subcommittee 
on Health, by a voice vote.

                            Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list each record vote 
on the motion to report legislation and amendments thereto. A 
motion by Mr. Waxman ordering H.R. 758 reported to the House, 
as amended, was approved by a voice vote. There were no record 
votes taken during consideration of this bill.

            Committee Oversight Findings and Recommendations

    In compliance with clause 3(c)(1) of rule XIII and clause 
(2)(b)(1) of rule X of the Rules of the House of 
Representatives, the oversight findings and recommendations of 
the Committee are reflected in the descriptive portions of this 
report, including the finding that a network of consortia will 
help coordinate research on pediatric illnesses.

   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. 758 would result in no new budget authority, 
entitlement authority, or tax expenditures or revenues.

         Statement of General Performance Goals and Objectives

    In accordance with clause 3(c)(4) of rule XIII of the Rules 
of the House of Representatives, the performance goals and 
objectives of the Committee are reflected in the descriptive 
portions of this report, including the goal to support 
pediatric research efforts.

                   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. 758 is provided under article 
I, section 8, clauses 3 and 18 of the Constitution of the 
United States.

                  Earmarks and Tax and Tariff Benefits

    H.R. 758 does not contain any congressional earmarks, 
limited tax benefits, or limited tariff benefits as defined in 
clause 9 of rule XXI of the Rules of the House of 
Representatives.

                  Federal Advisory Committee Statement

    The Committee finds that the legislation does not establish 
or authorize the establishment of an advisory committee within 
the definition of 5 U.S.C. App., section 5(b) of the Federal 
Advisory Committee Act.

             Applicability of Law to the Legislative Branch

    Section 102(b)(3) of Public Law 104-1 requires a 
description of the application of this bill to the legislative 
branch where the bill relates to terms and conditions of 
employment or access to public services and accommodations. 
H.R. 758 contains no such provisions.

                       Federal Mandates Statement

    Section 423 of the Congressional Budget and Impoundment 
Control Act of 1974 (as amended by section 101(a)(2) of the 
Unfunded Mandates Reform Act, Public Law 104-4) requires a 
statement on whether the provisions of the report include 
unfunded mandates. In compliance with this requirement the 
Committee adopts as its own the analysis of federal mandates 
prepared by the Director of the Congressional Budget Office 
regarding H.R. 758.

                        Committee Cost Estimate

    Pursuant to clause 3(d)(2) of rule XIII of the Rules of the 
House of Representatives, the Committee adopts as its own the 
cost estimate of H.R. 758 prepared by the Director of the 
Congressional Budget Office pursuant to section 402 of the 
Congressional Budget Act of 1974.

               Congressional Budget Office Cost Estimate

    With respect to the requirements of clause (3)(c)(3) of 
rule XIII of the Rules of the House of Representatives and 
section 402 of the Congressional Budget Act of 1974, the 
Committee has received the following cost estimate for H.R. 758 
from the Director of Congressional Budget Office:

                                                September 24, 2010.
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. 758, the Pediatric 
Research Consortia Establishment Act.
    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.
    Enclosure.

H.R. 758--Pediatric Research Consortia Establishment Act

    Summary: H.R. 758 would authorize the Director of the 
National Institutes of Health (NIH) to provide funding to plan, 
establish, and operate national consortia to conduct and 
coordinate research on pediatric health issues. CBO estimates 
that implementing H.R. 758 would cost $168 million over the 
2011-2015 period, assuming appropriation of the necessary 
amounts. Enacting H.R. 758 would not affect direct spending or 
revenues; therefore, pay-as-you-go procedures do not apply.
    H.R. 758 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. 758 is shown in the following table. 
The costs of this legislation fall within budget function 550 
(health).

----------------------------------------------------------------------------------------------------------------
                                                               By fiscal year, in millions of dollars--
                                                    ------------------------------------------------------------
                                                       2011      2012      2013      2014      2015    2011-2015
----------------------------------------------------------------------------------------------------------------
                                  CHANGES IN SPENDING SUBJECT TO APPROPRIATION

Estimated Authorization Level......................         5        25        50        50        50        180
Estimated Outlays..................................         4        20        44        50        50        168
----------------------------------------------------------------------------------------------------------------

    Basis of estimate: For this estimate, CBO assumes that H.R. 
758 will be enacted near the beginning of fiscal year 2011 and 
that the necessary amounts will be appropriated each year. The 
bill would authorize the Director of NIH to make grants to, or 
enter into contracts or cooperative agreements with entities to 
plan, establish and operate up to 20 consortia to conduct and 
coordinate research on pediatric health issues. The bill would 
limit payments to each consortium to $2.5 million a year during 
the first five years of the program. Based on the experience of 
establishing consortia for the National Network for 
Transforming Clinical and Translational Research, the estimate 
assumes that about 10 consortia would receive funding in 2012 
and 20 would receive funding in 2013 and subsequent years. 
Assuming the appropriation of the necessary amounts, CBO 
estimates that implementing H.R. 758 would cost $4 million in 
fiscal year 2011 and $168 million over the 2011-2015 period.
    Pay-As-You-Go considerations: None.
    Intergovernmental and private-sector impact: H.R. 758 
contains no intergovernmental or private-sector mandates as 
defined in UMRA. Activities authorized in the bill would 
benefit public entities that plan, establish, and operate 
consortia that conduct pediatric research.
    Estimate prepared by: Federal costs: Jamease Kowalczyk; 
Impact on state, local, and tribal governments: Lisa Ramirez-
Branum; Impact on the private sector: Sarah Axeen.
    Estimate approved by: Holly Harvey, Deputy Assistant 
Director for Budget Analysis.

             Section-by-Section Analysis of the Legislation


Section 1. Short title

    Section 1 designates that the Act may be cited as the 
``Pediatric Research and Consortia Act''.

Section 2. National Pediatric Research Consortia

    Section 2 amends the Public Health Service Act to authorize 
the Director of the National Institutes of Health (NIH), acting 
through the Director of the Eunice Kennedy Shriver National 
Institute of Child Health and Human Development, and in 
collaboration with all other NIH institutes that support 
pediatric research, to award grants to, or enter into contracts 
or cooperative agreements with, public or nonprofit private 
entities to establish up to 20 national pediatric research 
consortia.

                       Explanation of Amendments

    During the Subcommittee on Health markup of H.R. 758, Ms. 
DeGette of Colorado offered an amendment in the nature of a 
substitute (manager's amendment), which was adopted by a voice 
vote. The substance of the substitute amendment is reflected in 
the section-by-section analysis contained in this report.

         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 (new matter is 
printed in italic and existing law in which no change is 
proposed is shown in roman):

PUBLIC HEALTH SERVICE ACT

           *       *       *       *       *       *       *



TITLE IV--NATIONAL RESEARCH INSTITUTES

           *       *       *       *       *       *       *



Part C--Specific Provisions Respecting National Research Institutes

           *       *       *       *       *       *       *



 Subpart 7--Eunice Kennedy Shriver National Institute of Child Health 
and Human Development

           *       *       *       *       *       *       *



SEC. 452H. NATIONAL PEDIATRIC RESEARCH CONSORTIA.

  (a) In General.--The Director of NIH, acting through the 
Director of the Eunice Kennedy Shriver National Institute of 
Child Health and Human Development and in collaboration with 
all other Institutes of the National Institutes of Health that 
support pediatric research, may, subject to the availability of 
funds, award grants, contracts, or cooperative agreements to 
public or nonprofit private entities to pay all or part of the 
cost of planning, establishing, and providing basic operating 
support for up to 20 national pediatric research consortia. The 
Director of NIH shall take unmet research needs into account 
when making awards under this section.
  (b) Research.--Research conducted under this section shall 
supplement, but not replace, research that is otherwise 
conducted or supported as part of the comprehensive pediatric 
research portfolio of entities receiving awards under 
subsection (a). Consortia established under subsection (a) 
shall, in the aggregate, conduct basic, clinical, behavioral, 
social, or translational research to meet unmet research needs, 
as well as training in and demonstration of advanced diagnostic 
and treatment methods relating to pediatrics, as appropriate.
  (c) Coordination of Consortia Reports.--The Director of NIH 
shall--
          (1) as appropriate, provide for the coordination of 
        information among consortia established under 
        subsection (a) and ensure regular communication between 
        such consortia; and
          (2) require the periodic preparation of reports on 
        the activities of the consortia and the submission of 
        the reports to the Director.
  (d) Organization of Consortium.--Each consortium established 
under subsection (a) shall be formed from a collaboration of 
cooperating institutions with a lead institution, meeting such 
requirements as may be prescribed by the Director of NIH, 
including participation in a network of such consortia.
  (e) Limitation.--Payments under subsection (a) shall not 
exceed $2,500,000 per year for each consortium in the first 5-
year cycle.
  (f) Duration of Payments.--Payments under subsection (a) for 
a consortium may be provided under this section for a period of 
5 years and may be extended for additional periods of 5 years 
each, with enhanced funding opportunities based on a review of 
the operations by an appropriate scientific review.

           *       *       *       *       *       *       *