39–006 

108TH CONGRESS REPORT " ! HOUSE OF REPRESENTATIVES 2d Session 108–726 

PANCREATIC ISLET CELL TRANSPLANTATION ACT OF 

2004 

OCTOBER 5, 2004.—Committed to the Committee of the Whole House on the State 

of the Union and ordered to be printed 

Mr. BARTON of Texas, from the Committee on Energy and 

Commerce, submitted the following 

R E P O R T 

[To accompany H.R. 3858] 

[Including cost estimate of the Congressional Budget Office] 

The Committee on Energy and Commerce, to whom was referred 

the bill (H.R. 3858) to amend the Public Health Service Act to increase the supply of pancreatic islet cells for research, and to provide for better coordination of Federal efforts and information on 

islet cell transplantation, having considered the same, report favorably thereon without amendment and recommend that the bill do 

pass. 

CONTENTS 

Page 

Purpose and Summary ............................................................................................ 2 

Background and Need for Legislation .................................................................... 2 

Hearings ................................................................................................................... 2 

Committee Consideration ........................................................................................ 2 

Committee Votes ...................................................................................................... 2 

Committee Oversight Findings ............................................................................... 2 

Statement of General Performance Goals and Objectives .................................... 2 

New Budget Authority, Entitlement Authority, and Tax Expenditures ............. 3 

Committee Cost Estimate ....................................................................................... 3 

Congressional Budget Office Estimate ................................................................... 3 

Federal Mandates Statement ................................................................................. 4 

Advisory Committee Statement .............................................................................. 4 

Constitutional Authority 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 

2 

PURPOSE AND SUMMARY

The purpose of H.R. 3858 is to increase the supply of pancreatic 

islet cells for research by requiring pancreata procured by an organ 

procurement organization and used for islet cell transplantation or 

research to be counted for purposes of certification or recertification. 

BACKGROUND AND NEED FOR LEGISLATION

Through an experimental procedure commonly referred to as 

islet cell transplantation, islet cells are removed from a donor pancreas and transferred into another person. Once implanted, the 

beta cells in these islets begin to make and release insulin. Researchers hope that islet cell transplantation will help people with 

type 1 diabetes live without daily injections of insulin. 

Section 371 of the Public Health Service Act outlines federal 

grant programs and certification requirements for organ procurement organizations, including a provision authorizing organ procurement organizations to carry out special projects designed to increase the number of organ donors. By permitting pancreata donated for the purposes of islet cell transplantation or research to 

be counted for purposes of certification or recertification, the Committee expects the number of pancreatic and other organ donations 

to increase, expanding the capabilities of pancreatic islet cell research. 

HEARINGS

The Committee on Energy and Commerce has not held hearings 

on the legislation. 

COMMITTEE CONSIDERATION

On Thursday, September 30, 2004, the Full Committee met in 

open markup session and ordered H.R. 3858 favorably reported to 

the House, without amendment, by a voice vote, a quorum being 

present. 

COMMITTEE VOTES

There were no record votes taken in connection with ordering 

H.R. 3858 reported. A motion by Mr. Barton to order H.R. 3858 reported to the House, without amendment, was agreed to by a voice 

vote. 

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 or legislative hearings on this legislation. 

STATEMENT OF GENERAL PERFORMANCE GOALS AND OBJECTIVES

To increase the supply of pancreatic islet cells for research by requiring pancreata procured by an organ procurement organization 

and used for islet cell transplantation or research to be counted for 

purposes of certification or recertification. 

3 

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. 3858, the 

Pancreatic Islet Cell Transplantation Act of 2004, would result in 

no new or increased budget authority, entitlement authority, or tax 

expenditures or revenues. 

COMMITTEE COST ESTIMATE

The Committee adopts as its own the cost estimate prepared by 

the Director of the Congressional Budget Office pursuant to section 

402 of the Congressional Budget Act of 1974. 

CONGRESSIONAL BUDGET OFFICE ESTIMATE

Pursuant to clause 3(c)(3) of rule XIII of the Rules of the House 

of Representatives, the following is the cost estimate provided by 

the Congressional Budget Office pursuant to section 402 of the 

Congressional Budget Act of 1974: 

U.S. CONGRESS, 

CONGRESSIONAL BUDGET OFFICE, 

Washington, DC, October 4, 2004. 

Hon. JOE BARTON, 

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. 3858, the Pancreatic Islet 

Cell Transplantation Act of 2004. 

If you wish further details on this estimate, we will be pleased 

to provide them. The CBO staff contact is Christopher J. Topoleski. 

Sincerely, 

DOUGLAS HOLTZ-EAKIN, 

Director. 

Enclosure. 

H.R. 3858—Pancreatic Islet Cell Transplantation Act of 2004 

H.R. 3858 would require that organizations that procure 

pancreases for islet cell transplant or research be subject to the 

certification and recertification process that applies to other organ 

procurement organizations under section 371 of the Public Health 

Service Act. 

In addition, the bill would require the Diabetes Mellitus Interagency Coordinating Committee, which currently exists, to include 

in its annual report an assessment of federal involvement related 

to pancreatic islet cell transplantation. That assessment would include a discussion of adequacy in funding; current policies, regulations, and procedures related to pancreas procurement and cell 

transplant; policies of the United Network for Organ Sharing regarding pancreas retrieval and cell transplant; existing data collection methods; clinical investigations related to pancreatic islet cell 

transplantation; and any legislative or administrative recommendations that the committee may have. 

4 

CBO estimates that implementing H.R. 3858 would cost less 

than $500,000 in each year over the 2005–2009 period, assuming 

the availability of appropriated funds. Enacting H.R. 3858 would 

not affect direct spending or revenues. 

H.R. 3858 contains no intergovernmental or private-sector mandates as defined in the Unfunded Mandates Reform Act and would 

not affect the budgets of state, local, or tribal governments. 

On October 4, 2004, CBO transmitted a cost estimate for S. 2158, 

the Pancreatic Islet Cell Transplantation Act of 2004, as ordered 

reported by the Senate Committee on Health, Education, Labor, 

and Pensions on September 23, 2004. The two bills are identical, 

as are CBO’s two cost estimates. 

The CBO staff contact for this estimate is Christopher J. 

Topoleski, who can be reached at 226–9010. This estimate was approved by Peter H. Fontaine, Deputy Assistant Director for Budget 

Analysis. 

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. 

ADVISORY COMMITTEE STATEMENT

No advisory committees within the meaning of section 5(b) of the 

Federal Advisory Committee Act were created by this legislation. 

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 this legislation is provided in Article I, section 8, clause 

3, which grants Congress the power to regulate commerce with foreign nations, among the several States, and with the Indian tribes. 

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 

This section provides the short title of the bill, the ‘‘Pancreatic 

Islet Cell Transplantation Act of 2004.’’

Section 2. Organ procurement organization certification 

Section 2 amends section 371 of the Public Health Service Act to 

require that pancreata procured by an organ procurement organization and used for islet cell transplantation or research be counted 

for purposes of certification or recertification of organ procurement 

centers. 

5 

Section 3. Annual assessment on pancreatic islet cell transplantation 

Section 3 requires the Diabetes Mellitus Interagency Coordinating Committee, as authorized by section 429 of the Public 

Health Service Act, to complete an annual report assessing Federal 

activities and programs relating to pancreatic islet cell transplantation, including an evaluation of the adequacy of funding levels, 

current policies and regulations affecting the supply of islet cells, 

the effect of xenotransplantation on advancing pancreatic islet cell 

transplantation, the effect of United Network for Organ Sharing 

policies regarding pancreatic retrieval and islet cell 

transplantations, data collection activities, implementation of 

multiagency clinical investigations of islet cell transplantation, and 

recommendations for legislative and administrative changes to increase the supply of pancreatic islet cells. 

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 III—GENERAL POWERS AND DUTIES OF PUBLIC 

HEALTH SERVICE 

* * * * * * * 

PART H—ORGAN TRANSPLANTS

* * * * * * * 

Subpart 3—Mammography Facilities 

* * * * * * * 

ORGAN PROCUREMENT ORGANIZATIONS

SEC. 371. (a) * * * 

* * * * * * * 

(c) Pancreata procured by an organ procurement organization and 

used for islet cell transplantation or research shall be counted for 

purposes of certification or recertification under subsection (b). 

* * * * * * * 

TITLE IV—NATIONAL RESEARCH INSTITUTES 

* * * * * * * 

PART C—SPECIFIC PROVISIONS RESPECTING NATIONAL RESEARCH

INSTITUTES

* * * * * * * 

6 

Subpart 3—National Institute of Diabetes and Digestive and 

Kidney Diseases 

* * * * * * * 

INTERAGENCY COORDINATING COMMITTEES

SEC. 429. (a) * * * 

* * * * * * * 

(d) In each annual report prepared by the Diabetes Mellitus Interagency Coordinating Committee pursuant to subsection (c), the 

Committee shall include an assessment of the Federal activities and 

programs related to pancreatic islet cell transplantation. Such assessment shall, at a minimum, address the following: 

(1) The adequacy of Federal funding for taking advantage of 

scientific opportunities relating to pancreatic islet cell transplantation. 

(2) Current policies and regulations affecting the supply of 

pancreata for islet cell transplantation. 

(3) The effect of xenotransplantation on advancing pancreatic 

islet cell transplantation. 

(4) The effect of United Network for Organ Sharing policies 

regarding pancreas retrieval and islet cell transplantation. 

(5) The existing mechanisms to collect and coordinate outcomes data from existing islet cell transplantation trials. 

(6) Implementation of multiagency clinical investigations of 

pancreatic islet cell transplantation. 

(7) Recommendations for such legislation and administrative 

actions as the Committee considers appropriate to increase the 

supply of pancreata available for islet cell transplantation. 

* * * * * * * 

Æ