29–006 

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. 


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1http://report.nih.gov/nihfactsheets/ViewFactSheet.aspx?csid=126 

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 wellbeing of those children afflicted with rare pediatric diseases and 

conditions. 

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. 


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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 


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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. 


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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). 


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(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: 


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(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. 

ø(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. 

* * * * * * * 

Æ 


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