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Fiscal Year 2008 Justification of Estimates for Appropriations Committees

 

Healthcare Systems

National Cord Blood Inventory

Authorizing Legislation - Section 379 of the Public Health Act, as amended.

  FY 2006
Actual
FY 2007
CR
FY 2008
PB
Increase or Decrease
Budget Authority $3,957,000 $157,000 $1,966,000 +$1,809,000
FTE 3 4 4 ---

FY 2008 Authorization..................................................................................................$15,000,000

Statement of the Budget Request - The FY 2008 Budget of $1,966,000 is an increase of $1,809,000 above the FY 2007 Continuing Resolution (CR). Funds are available from previous appropriations for the National Cord Blood Stem Cell Bank to support this program during
FY 2007.

Program Description - Blood stem cell transplants offer the possibility of a cure for people with leukemia and various other life-threatening blood disorders. Blood stem cells for these transplants can be obtained from the bone marrow or circulating blood of volunteer adult donors, or collected from the newest source, the umbilical cord and placenta after a normal birth. Most cord blood transplants have been performed for pediatric recipients (because of the smaller number of stem cells present in cord blood), and more research is needed to establish their effectiveness, especially for adult recipients. Because it can be used with a less perfect match in tissue type between the donor and recipient than is the case for adult donors, cord blood offers a chance of survival for patients who lack a suitably tissue-matched relative (fewer than 25 percent of patients have one) and who cannot find an adequately matched unrelated adult donor on the C.W. Bill Young Cell Transplantation Program, successor to the National Bone Marrow Donor Registry (NBMDR) or other adult donor registries worldwide. Minority patients, especially Black/African American patients, have a lower probability of finding a perfectly matched unrelated adult donor because of the greater diversity in their tissue types. Consequently, these patients are especially likely to benefit from additional cord blood units. In addition to their use in blood stem cell transplants, stem cells derived from cord blood can be used for clinical and pre-clinical research into a variety of cellular therapies.

The purpose of this program, which was funded initially through FY 2004 appropriations, is to provide funds to a network of cord blood banks to: (1) build a racially diverse inventory of the highest quality cord blood units for transplantation (P.L 109-129 establishes a target of 150,000 new units), and (2) make these and other units at participating cord blood banks available to physicians and patients for blood stem cell transplants through the C.W. Bill Young Cell Transplantion Program. The Program also will make cord blood units available for preclinical and clinical research, focusing on cord blood stem cell biology and the use of cord blood stem cells for human transplantation and cellular therapies.

Rationale for the Budget Request
- The FY 2008 Budget of $1,966,000 is $1,809,000 above the
FY 2007 CR and will enable funding additional cord blood collections. The current inventory of U.S. public cord blood banks is approximately 80,000 units. Well over half of these were collected before current cord blood transplantation and banking practices were adopted, and have cell counts below what is considered adequate today (except for small children). The Act sets a target of 150,000 new units in the National Cord Blood Inventory, which are to be collected from diverse populations and to be of exceptionally high quality.

The cost of collecting one cord blood unit, performing tissue-typing and infectious disease tests, and putting the unit into storage in a liquid nitrogen freezer currently averages approximately $1,300. Therefore, the $1,966,000 requested for FY 2008 would add approximately 1,128 new cord blood units to the National Cord Blood Inventory. Nearly 17,000 units will be collected with the approximately $22,000,000 to be expended from the “no-year” appropriations for
FY 2004-2006. Therefore, approximately 18,100 units will be collected for the National Cord Blood Inventory with funds appropriated for FY 2004-2008.

Funding for the Cord Blood Stem Cell Bank during the last five years has been as follows:

  $ FTE
2003
---
---
2004
9,941,000
---
2005 9,859,000 1
2006 3,957,000 3
2007 157,000 4

Outputs -

  FY 2005
Actual
FY 2006
Appropriation
FY 2007
Estimate
Contracts - new/continuations
---
6-8
6-8

Performance Analysis - Performance measures for this program are under development.