[Federal Register Volume 71, Number 81 (Thursday, April 27, 2006)]
[Notices]
[Pages 24858-24859]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-6313]


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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; Recognition of Cord Blood Bank Accreditation Program(s)

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

ACTION: Notice of opportunity for public comment through conference 
calls.

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SUMMARY: Public Law 109-129 requires the Secretary of Health and Human 
Services to recognize one or more cord blood accreditation entities for 
the accreditation of cord blood banks participating in the collection 
and maintenance of umbilical cord blood units for the National Cord 
Blood Inventory. These cord blood units will be made available for 
unrelated donor blood stem cell transplants through the C.W. Bill Young 
Cell Transplantation Program. The HRSA, Healthcare Systems Bureau 
(HSB), Division of Transplantation (DoT) is in the process of 
information-gathering to assist in the determination of which cord 
blood bank accreditation program(s) to recognize on an interim basis 
for the initial cycle of funding for the National Cord Blood Inventory. 
The purpose of this solicitation is to receive public input on the 
following: (1) Approaches to accreditation required to ensure quality 
cord blood bank operations (including collection sites); (2) 
Utilization of accreditation programs to ensure product quality and 
best practices; (3) Degree to which accreditation standards are 
evidence based and supported by published literature; (4) Extent to 
which accreditation standards allow for variations in cord blood bank 
practices; (5) Criteria for the Secretary to consider in recognizing 
cord blood bank accrediting programs for the National Cord Blood 
Inventory, C.W. Bill Young Cell Transplantation Program.
    The HRSA intends for this interim process to be followed by a 
formal, more comprehensive recognition process that will include input 
from both the Advisory Council, once it is established, and the 
interested public as required in the legislation. The purpose of this 
Notice is to invite interested parties to register for and participate 
in either of two conference calls, described below, that HRSA is 
scheduling to obtain comment on factors relevant to determining which 
accrediting organization(s) to recognize for the initial cycle of 
funding under the National Cord Blood Inventory.

DATES: The conference calls will be held on May 9, 2006, at 2 to 4 p.m. 
e.s.t. and May 15, 2006, at 2 p.m. to 4 p.m. e.s.t. Participants are 
asked to register for the conference by contacting Anita Wabeke at 
(301) 443-4747 or e-mail [email protected]. The registration deadline is 
May 3, 2006 for both conferences. Registration is not guaranteed; it is 
on a first come basis. Since the topics listed above will be discussed 
on both calls, and to facilitate hearing all points of view, HRSA 
requests that organizations and individuals wishing to participate do 
so in only one of the calls. Due to the limited number of lines 
available for the calls, organizations with multiple participants are 
encouraged to register for one line to allow maximum participation from 
all interested parties. Parties wishing to submit written comments 
should ensure that the comments are postmarked or E-mailed no later 
than May 17, 2006 for consideration.

ADDRESSES: Please send all written comments to James F. Burdick, M.D., 
Director, DoT, HSB, HRSA, Room 12C-06, Parklawn Building, 5600 Fishers 
Lane, Rockville, Maryland 20857; telephone (301) 443-7577; fax (301) 
594-6095; or e-mail: [email protected].

FOR FURTHER INFORMATION CONTACT: James F. Burdick, M.D., Director, DoT, 
HSB, HRSA, Parklawn Building, Room 12C-06, 5600 Fishers Lane, 
Rockville, Maryland 20857; telephone (301) 443-7577; fax (301) 594-
6095; or e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    On December 20, 2005, the Stem Cell Therapeutic 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 as the successor to the National Bone Marrow 
Donor Registry. The National Cord Blood Inventory is to be a high 
quality, genetically diverse inventory of cord blood units for patients 
who need a blood stem cell transplant and who lack an available related 
donor. The cord blood units in the National Cord Blood Inventory will 
be made available for transplantation through the C.W. Bill Young Cell 
Transplantation Program. Cord blood banks collecting and maintaining 
units for the National Cord Blood Inventory must meet the statutory 
definition of a qualified cord blood bank, which includes a requirement 
that cord blood banks be accredited by an

[[Page 24859]]

accreditation entity recognized by the Secretary for this purpose.

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: April 20, 2006.
Elizabeth M. Duke,
Administrator.
 [FR Doc. E6-6313 Filed 4-26-06; 8:45 am]
BILLING CODE 4165-15-P