[House Report 111-640]
[From the U.S. Government Publishing Office]
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.
* * * * * * *