[Federal Register Volume 72, Number 96 (Friday, May 18, 2007)]
[Notices]
[Pages 28063-28064]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-9550]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


C.W. Bill Young Cell Transplantation Program: National Cord Blood 
Inventory Related Cord Blood Donor Demonstration Project

AGENCY: Health Resources and Services Administration (HRSA), HHS.

ACTION: Request for information.

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SUMMARY: Public Law 109-129 requires the Secretary of Health and Human 
Services to establish a 3-year demonstration project for qualified cord 
blood banks to collect and store at no charge to families, umbilical 
cord blood units for families where a first-degree relative has been 
diagnosed with a condition that may benefit from blood stem cell 
transplantation. Umbilical cord blood units collected through the 
demonstration project do not count toward the current National Cord 
Blood Inventory (NCBI) goal of 150,000 cord blood units to be made 
available through the C.W. Bill Young Cell Transplantation Program. 
Qualified umbilical cord blood banks participating in the demonstration 
project must provide assurances that the cord blood units will be 
available for directed transplantation until such time as the cord 
blood unit is needed. Within 90 days of the termination of the 
demonstration project, the Secretary will submit to Congress a report 
on the outcomes of the project including recommendations with respect 
to the continuation of such a project.
    HRSA's Healthcare Systems Bureau (HSB), Division of Transplantation 
(DoT) is in the process of information-gathering to assist in 
implementation of the related cord blood demonstration project. The 
purpose of this solicitation is to receive public input on the 
following: (1) The key questions that should be studied through this 
project; (2) the mechanism for funding this project; and, (3) umbilical 
cord blood bank liability.
    HRSA has identified the following key study questions to be 
considered in the design of this demonstration project: (1) What is the 
value and feasibility of implementing a long-term program modeled after 
this demonstration project; (2) how often and for what clinical 
indications are cord blood units banked through this project used for 
transplantation; (3) what is the breakdown of cord blood units 
collected, stored, and transplanted by race, ethnicity, and disease; 
(4) do those cord blood units, especially those released for 
transplant, represent rare Human Leukocyte Antigen (HLA) types such 
that the recipient would otherwise have been unable to find a matched 
unrelated donor; (5) how do transplant outcomes using these cord blood 
units compare to unrelated allogeneic umbilical cord blood transplants 
and unrelated allogeneic transplants using blood stem cells from adult 
donors; and, (6) what are the general physical characteristics of these 
units (e.g., total nucleated count, CD34+ content) and how does their 
quality compare to that of the general public inventory.
    HRSA proposes to invite the first cohort of umbilical cord blood 
banks receiving NCBI contracts to submit competitive proposals for 
participation in this demonstration project with an emphasis on: (1) 
Establishment of nationwide collections; and, (2) encouraging banks to 
subcontract with other experienced, high-quality cord blood banks to 
assist in their education, collection, processing, and storing efforts. 
HRSA has approximately $200,000 available for this demonstration 
project this fiscal year and anticipates selecting 2 or 3 banks to 
participate in this demonstration project to be funded through 
modification of their existing NCBI contracts with HRSA.
    HRSA recognizes the need for this service is likely greater than 
what can be satisfied in a limited demonstration project. Because of 
the great diversity in HLA types among African-Americans, HRSA 
recognizes that patients from this population are significantly less 
likely to find a suitably matched unrelated blood stem cell donor than 
patients from other racial or ethnic groups. Therefore, HRSA invites 
comments on the desirability of limiting participation to African-
American families in which a first-degree relative has been diagnosed 
with a condition that may benefit from blood stem cell transplantation.
    HRSA understands that there may be special considerations 
associated with liability for those umbilical cord blood banks 
participating in this project. HRSA invites comment on how umbilical 
cord blood banks participating in this project may best address these 
concerns.
    Interested parties are invited to submit written comments on the 
key study questions, the funding approach, and umbilical cord blood 
bank liability for this demonstration project to the address below.

DATES: Written comments must be received at HRSA by June 18, 2007. 
Comments will be made publicly

[[Page 28064]]

available by submitting a written request to the address below.

ADDRESSES: Please send all written comments to: James F. Burdick, M.D.; 
Attn: Related Cord Blood Demo Project; HHS/HRSA/HSB/DoT; 5600 Fishers 
Lane, Room 12C-06; Rockville, Maryland 20857; telephone (301) 443-7577; 
fax (301) 594-6095; or e-mail: <a href="/cdn-cgi/l/email-protection#b6dcd4c3c4d2dfd5ddf6dec4c5d798d1d9c0"><span class="__cf_email__" data-cfemail="aac0c8dfd8cec3c9c1eac2d8d9cb84cdc5dc">[email protected]</span></a>. Please include in the 
subject line of electronic correspondence ``Related Cord Blood Demo 
Project.''

FOR FURTHER INFORMATION CONTACT: James F. Burdick, M.D., Director, DoT, 
HSB, HRSA, 5600 Fishers Lane, Room 12C-06, Rockville, Maryland 20857; 
telephone (301) 443-7577; fax (301) 594-6095; or e-mail: 
<a href="/cdn-cgi/l/email-protection#573d352225333e343c173f25243679303821"><span class="__cf_email__" data-cfemail="f59f978087919c969eb59d878694db929a83">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

Background

    On December 20, 2005, the Stem Cell Therapeutic and Research Act of 
2005 was enacted as Public Law 109-129. The Act authorizes the 
establishment of the National Cord Blood Inventory and the C.W. Bill 
Young Cell Transplantation Program successor to the National Bone 
Marrow Donor Registry. The National Cord Blood Inventory is to be 
comprised of 150,000 high quality, genetically diverse cord blood units 
to be made available through the C.W. Bill Young Cell Transplantation 
Program for patients in need of a blood stem cell transplant. The Act 
also authorizes establishment of a 3-year related cord blood donor 
demonstration project to begin in FY 2007.

Program Authority

    The C.W. Bill Young Cell Transplantation Program is authorized by 
Public Law 109-129, which amends Part I of the Public Health Service 
Act.

    Dated: May 10, 2007.
Elizabeth M. Duke,
Administrator.
[FR Doc. E7-9550 Filed 5-17-07; 8:45 am]
BILLING CODE 4165-15-P


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