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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

                          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.

   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.
    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.

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

           *       *       *       *       *       *       *


  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.

           *       *       *       *       *       *       *