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113th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES
 1st Session                                                      113-4

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



 
            NATIONAL PEDIATRIC RESEARCH NETWORK ACT OF 2013

                                _______
                                

February 4, 2013.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

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

                              R E P O R T

                        [To accompany H.R. 225]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 225) to amend title IV of the Public Health 
Service Act to provide for a National Pediatric Research 
Network, including with respect to pediatric rare diseases or 
conditions, 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
Earmark, Limited Tax Benefits, and Limited Tariff Benefits.......     3
Committee Cost Estimate..........................................     3
Congressional Budget Office Estimate.............................     3
Federal Mandates Statement.......................................     4
Duplication of Federal Programs..................................     4
Disclosure of Directed Rule Makings..............................     4
Advisory Committee Statement.....................................     4
Applicability to Legislative Branch..............................     4
Section-by-Section Analysis of the Legislation...................     4
Changes in Existing Law Made by the Bill, as Reported............     5

                          Purpose and Summary

    H.R. 225, the ``National Pediatric Research Network Act of 
2013,'' was introduced on January 14, 2013, by Rep. Lois Capps 
(D-CA) and referred to the Committee on Energy and Commerce.
    The legislation would amend the Public Health Service Act 
(PHSA) to allow the Director of the National Institutes of 
Health (NIH), as part of the NIH Pediatric Research Initiative, 
to provide for the establishment of a National Pediatric 
Research Network comprised of pediatric research consortia. The 
purpose of such consortia is to promote coordinated, multi-
centered research activities that focus on translating research 
to practice in order to improve care for children.

                  Background and Need for Legislation

    According to NIH, some 6,000 to 7,000 human diseases are 
considered ``rare,'' affecting 25 to 30 million people.\1\ Most 
of these are pediatric diseases. Unfortunately, doctors do not 
have sufficient therapies to treat them. The use of pediatric 
research consortia is a proven way to support pediatric applied 
research and promote coordinated research activities that focus 
on translating research to practice. Such efforts, in turn, can 
improve the health and well-being of those children afflicted 
with rare pediatric diseases and conditions.
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    \1\http://report.nih.gov/nihfactsheets/ViewFactSheet.aspx?csid=126
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    H.R. 225, the ``National Pediatric Research Network Act of 
2013,'' would amend the PHSA to allow the Director of the NIH, 
(acting through the Director of the National Institute of Child 
Health and Human Development) to provide for the establishment 
of a national pediatric research network. Such network would be 
comprised of up to 20 pediatric research consortia. Each 
consortium would include groups of collaborating institutions 
coordinated by a lead institution. Among these consortia, an 
appropriate number must be focused primarily on addressing 
pediatric rare diseases and conditions.
    The Director could provide funding to plan, establish, or 
strengthen pediatric research consortia and to provide for 
basic operating support for such consortia, including training 
for researchers specializing in pediatrics. Funding support 
would be available through grants, contracts or other 
appropriate funding mechanisms.
    H.R. 225 would also require the NIH Director to establish a 
data coordinating center related to the work of the consortia. 
The purpose of the center is threefold: to distribute 
scientific findings of the consortia; to provide assistance in 
the design and conduct of collaborative research; and to 
organize and conduct multistate monitoring activities. No funds 
are specifically allocated under the legislation. It is the 
Committee's expectation that the NIH Director will choose to 
create the network with existing funds and build upon the 
current portfolio of pediatric research at NIH.

                                Hearings

    No hearings were held on this legislation.

                        Committee Consideration

    On January 22, 2012, the Energy and Commerce Committee met 
in open markup session and approved H.R. 225, the ``National 
Pediatric Research Network Act of 2013,'' by unanimous consent.

                            Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list the record votes 
on the motion to report legislation and amendments thereto. 
There were no record votes taken in connection with ordering 
H.R. 225 reported. A motion by Mr. Upton to order H.R. 225 
reported to the House, without amendment, was agreed to by 
unanimous consent.

                      Committee Oversight Findings

    Pursuant to clause 3(c)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee has not held oversight 
hearings on this legislation.

         Statement of General Performance Goals and Objectives

    The goal of the legislation is the establishment of a 
National Pediatric Research Network comprised of pediatric 
research consortia to advance treatment for pediatric diseases.

   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. 
225, the ``National Pediatric Research Network Act of 2013,'' 
would result in no new or increased budget authority, 
entitlement authority, or tax expenditures or revenues.

       Earmark, Limited Tax Benefits, and Limited Tariff Benefits

    In compliance with clause 9(e), 9(f), and 9(g) of rule XXI, 
the Committee finds that H.R. 225, ``National Pediatric 
Research Network Act of 2013'', contains no earmarks, limited 
tax benefits, or limited tariff benefits.

                        Committee Cost Estimate

    The Committee traditionally adopts as its own the cost 
estimate prepared by the Director of the Congressional Budget 
Office (CBO) pursuant to section 402 of the Congressional 
Budget Act of 1974. Because this cost estimate was not timely 
submitted to the Committee before the filing of this report, 
the Committee adopts the informal cost estimate provided to the 
Committee by CBO. Based on verbal conversations with CBO, H.R. 
225 will have no effect on direct spending. CBO also estimates 
the bill will cost $1 million for FY 2013-2018 for agency 
workload costs.
    The Committee notes that CBO also provided an informal cost 
estimate to the Committee during the 112th Congress for H.R. 
6163, the ``National Pediatric Research Network Act of 2012.'' 
According to that informal cost estimate, H.R. 6163 had no 
cost.

                  Congressional Budget Office Estimate

    The cost estimate required pursuant to clause 3(c)(3) of 
rule XIII of the Rules of the House of Representatives, which 
is the cost estimate provided by the Congressional Budget 
Office pursuant to section 402 of the Congressional Budget Act 
of 1974, was not timely submitted to the Committee before the 
filing of this report, and therefore, not included in this 
report.

                       Federal Mandates Statement

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

                    Duplication of Federal Programs

    No provision of H.R. 225 establishes or reauthorizes a 
program of the Federal government known to be duplicative of 
another Federal program, a program that was included in any 
report from the Government Accountability Office to Congress 
pursuant to section 21 of Public Law 111-139, or a program 
related to a program identified in the most recent Catalog of 
Federal Domestic Assistance.

                  Disclosure of Directed Rule Makings

    The Committee estimates that H.R. 225 specifically directs 
to be completed no specific rule makings within the meaning of 
5 U.S.C. 551.

                      Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation.

                  Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

             Section-by-Section Analysis of the Legislation


Section 1. Short title

    Section 1 states the legislation may be cited as the 
``National Pediatric Research Network Act of 2013.''

Section 2. National Pediatric Research Network

    Section 2 would amend section 409D of the PHSA to allow the 
Director of NIH, acting through the Director of the Eunice 
Kennedy Shriver National Institute of Child Health and Human 
Development, to provide for the establishment of a National 
Pediatric Research Network comprised of pediatric research 
consortia. The number of pediatric research consortia could not 
exceed twenty. Among these, an appropriate number of consortia 
must have a primary focus on pediatric rare diseases or 
conditions.
    Section 2 would also require the NIH Director to establish 
a data coordinating center related to the consortia to 
distribute scientific findings from the consortia, to provide 
assistance in the design and conduct of collaborative research, 
and to organize and conduct multistate monitoring activities. 
The center also would provide regular reports to the Director 
of NIH and the Commissioner of the Food and Drugs 
Administration on the work of the consortia.

         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

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TITLE IV--NATIONAL RESEARCH INSTITUTES

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Part B--General Provisions Respecting National Research Institutes

           *       *       *       *       *       *       *



                     PEDIATRIC RESEARCH INITIATIVE

  Sec. 409D. (a) * * *

           *       *       *       *       *       *       *

  (d) National Pediatric Research Network.--
          (1) Network.--In carrying out the Initiative, 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 
        other appropriate national research institutes and 
        national centers that carry out activities involving 
        pediatric research, may provide for the establishment 
        of a National Pediatric Research Network consisting of 
        the pediatric research consortia receiving awards under 
        paragraph (2).
          (2) Pediatric research consortia.--
                  (A) In general.--The Director of the 
                Institute may award funding, including through 
                grants, contracts, or other mechanisms, to 
                public or private nonprofit entities--
                          (i) for planning, establishing, or 
                        strengthening pediatric research 
                        consortia; and
                          (ii) for providing basic operating 
                        support for such consortia, including 
                        with respect to--
                                  (I) basic, clinical, 
                                behavioral, or translational 
                                research to meet unmet needs 
                                for pediatric research; and
                                  (II) training researchers in 
                                pediatric research techniques 
                                in order to address unmet 
                                pediatric research needs.
                  (B) Research.--The Director of NIH shall 
                ensure that--
                          (i) each consortium receiving an 
                        award under subparagraph (A) conducts 
                        or supports at least one category of 
                        research described in subparagraph 
                        (A)(ii)(I) and collectively such 
                        consortia conduct or support all such 
                        categories of research; and
                          (ii) one or more such consortia 
                        provide training described in 
                        subparagraph (A)(ii)(II).
                  (C) Number of consortia.--The Director of NIH 
                may make awards under this paragraph for not 
                more than 20 pediatric research consortia.
                  (D) Organization of consortium.--Each 
                consortium receiving an award under 
                subparagraph (A) shall--
                          (i) be formed from a collaboration of 
                        cooperating institutions;
                          (ii) be coordinated by a lead 
                        institution;
                          (iii) agree to disseminate scientific 
                        findings, including from clinical 
                        trials, rapidly and efficiently; and
                          (iv) meet such requirements as may be 
                        prescribed by the Director of NIH.
                  (E) Supplement, not supplant.--Any support 
                received by a consortium under subparagraph (A) 
                shall be used to supplement, and not supplant, 
                other public or private support for activities 
                authorized to be supported under this 
                paragraph.
                  (F) Duration of support.--Support of a 
                consortium under subparagraph (A) may be for a 
                period of not to exceed 5 years. Such period 
                may be extended at the discretion of the 
                Director of NIH.
          (3) Coordination of consortia activities.--The 
        Director of NIH shall--
                  (A) as appropriate, provide for the 
                coordination of activities (including the 
                exchange of information and regular 
                communication) among the consortia established 
                pursuant to paragraph (2); and
                  (B) require the periodic preparation and 
                submission to the Director of reports on the 
                activities of each such consortium.
          (4) Assistance with registries.--Each consortium 
        receiving an award under paragraph (2)(A) shall provide 
        assistance to the Centers for Disease Control and 
        Prevention in the establishment or expansion of patient 
        registries and other surveillance systems as 
        appropriate and upon request by the Director of the 
        Centers.
  (e) Research on Pediatric Rare Diseases or Conditions.--
          (1) In general.--In making awards under subsection 
        (d)(2) for pediatric research consortia, the Director 
        of NIH shall ensure that an appropriate number of such 
        awards are awarded to such consortia that agree to--
                  (A) focus primarily on pediatric rare 
                diseases or conditions (including any such 
                diseases or conditions that are genetic 
                disorders (such as spinal muscular atrophy and 
                Duchenne muscular dystrophy) or are related to 
                birth defects (such as Down syndrome and 
                fragile X)); and
                  (B) conduct or coordinate one or more 
                multisite clinical trials of therapies for, or 
                approaches to, the prevention, diagnosis, or 
                treatment of one or more pediatric rare 
                diseases or conditions.
          (2) Data coordinating center.--
                  (A) Establishment.--In connection with 
                support of consortia described in paragraph 
                (1), the Director of NIH shall establish a data 
                coordinating center for the following purposes:
                          (i) To distribute the scientific 
                        findings referred to in paragraph 
                        (1)(C).
                          (ii) To provide assistance in the 
                        design and conduct of collaborative 
                        research projects and the management, 
                        analysis, and storage of data 
                        associated with such projects.
                          (iii) To organize and conduct 
                        multisite monitoring activities.
                  (B) Reporting.--The Director of NIH shall--
                          (i) require the data coordinating 
                        center established under subparagraph 
                        (A) to provide regular reports to the 
                        Director of NIH and the Commissioner of 
                        Food and Drugs on research conducted by 
                        consortia described in paragraph (1), 
                        including information on enrollment in 
                        clinical trials and the allocation of 
                        resources with respect to such 
                        research; and
                          (ii) as appropriate, incorporate 
                        information reported under clause (i) 
                        into the Director's biennial reports 
                        under section 403.
  [(d)] (f) Transfer of Funds.--The Director of NIH may 
transfer amounts appropriated under this section to any of the 
Institutes for a fiscal year to carry out the purposes of the 
Initiative under this section.

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