[House Report 108-726]
[From the U.S. Government Publishing Office]
108th Congress Report
HOUSE OF REPRESENTATIVES
2d Session 108-726
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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.
* * * * * * *