[House Report 113-4]
[From the U.S. Government Publishing Office]
113th Congress Report
HOUSE OF REPRESENTATIVES
1st Session 113-4
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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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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
* * * * * * *
TITLE IV--NATIONAL RESEARCH INSTITUTES
* * * * * * *
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.
* * * * * * *