C.W. Bill Young Cell Transplantation Program: National Cord Blood Inventory Related Cord Blood Donor Demonstration Project, 28063-28064 [E7-9550]
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Federal Register / Vol. 72, No. 96 / Friday, May 18, 2007 / Notices
Safety Evaluation: Post-Marketing
Surveillance’’ conference; and updates
from the Division of Vaccine Injury
Compensation (DVIC), Department of
Justice, National Vaccine Program
Office, Immunization Safety Office
(Centers for Disease Control and
Prevention), National Institute of
Allergy and Infectious Diseases
(National Institutes of Health), and
Center for Biologics and Evaluation
Research (Food and Drug
Administration). Agenda items are
subject to change as priorities dictate.
Public Comments: Persons interested
in providing an oral presentation should
submit a written request, along with a
copy of their presentation to: LCDR
Delia Jones, Principal Staff Liaison,
DVIC, Healthcare Systems Bureau
(HSB), Health Resources and Services
Administration (HRSA), Room 11C–26,
5600 Fishers Lane, Rockville, Maryland
20857 or e-mail: djones2@hrsa.gov.
Requests should contain the name,
address, telephone number, and any
business or professional affiliation of
the person desiring to make an oral
presentation. Groups having similar
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the level of expressed interest. DVIC
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FOR FURTHER INFORMATION CONTACT:
Anyone requiring information regarding
the ACCV should contact LCDR Delia
Jones, Principal Staff Liaison, DVIC,
HSB, HRSA, Room 11C–26, 5600
Fishers Lane, Rockville, MD 20857;
telephone (301) 443–6593 or e-mail:
djones2@hrsa.gov.
Dated: May 11, 2007.
Caroline Lewis,
Associate Administrator for Management.
[FR Doc. E7–9533 Filed 5–17–07; 8:45 am]
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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
Health Resources and Services
Administration (HRSA), HHS.
ACTION: Request for information.
AGENCY:
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 informationgathering 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
SUMMARY:
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28063
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
E:\FR\FM\18MYN1.SGM
18MYN1
28064
Federal Register / Vol. 72, No. 96 / Friday, May 18, 2007 / Notices
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:
jburdick@hrsa.gov. 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: jburdick@hrsa.gov.
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
DEPARTMENT OF HOMELAND
SECURITY
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Federal Emergency Management
Agency
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Federal Emergency
Management Agency, DHS.
ACTION: Notice and request for
comments.
AGENCY:
VerDate Aug<31>2005
17:06 May 17, 2007
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SUMMARY: The Federal Emergency
Management Agency (FEMA) has
submitted the following information
collection to the Office of Management
and Budget (OMB) for review and
clearance in accordance with the
requirements of the Paperwork
Reduction Act of 1995. The submission
describes the nature of the information
collection, the categories of
respondents, the estimated burden (i.e.,
the time, effort and resources used by
respondents to respond) and cost, and
includes the actual data collection
instruments FEMA will use.
Title: Community Rating System
(CRS) Program—Application
Worksheets and Commentary.
OMB Number: 1660–0022.
Abstract: CRS Application Cover
Page, Recertification Worksheet and
Modification/Cycle Cover Page are used
by a community to apply or renew CRS
program participation and specify what
activities will be performed by the
community. CRS Activity Worksheets
are used by the community to provide
details in the selected activities based
on the CRS Coordinator’s Manual.
Affected Public: State, Local or Tribal
Government.
Number of Respondents: 150 for
application and 950 for maintenance.
Estimated Time per Respondent: 31
hours for application and 4 hours for
maintenance.
Estimated Total Annual Time Burden:
8,450 hours.
Annual Frequency of Response: 1.
Comments:
Interested persons are invited to
submit written comments on the
proposed information collection to the
Office of Information and Regulatory
Affairs, Office of Management Budget,
Attention: Nathan Lesser, Desk Officer,
Department of Homeland Security/
FEMA, and sent via electronic mail to
oira_submission@omb.eop.gov or faxed
to (202) 395–6974. Comments must be
submitted on or before June 18, 2007.
FOR FURTHER INFORMATION CONTACT:
Requests for additional information or
copies of the information collection
should be made to Chief, Records
Management, FEMA, 500 C Street, SW.,
Room 609, Washington, DC 20472,
facsimile number (202) 646–3347, or email address FEMA–Information–
Collections@dhs.gov.
Dated: May 14, 2007.
John A. Sharetts-Sullivan,
Chief, Records Management and Privacy
Information Resources Management Branch,
Information Technology Services Division,
Federal Emergency Management Agency,
Department of Homeland Security.
[FR Doc. E7–9567 Filed 5–17–07; 8:45 am]
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DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
[Docket No. FR–5125–N–20]
Federal Property Suitable as Facilities
To Assist the Homeless
Office of the Assistant
Secretary for Community Planning and
Development, HUD.
ACTION: Notice.
AGENCY:
SUMMARY: This Notice identifies
unutilized, underutilized, excess, and
surplus Federal property reviewed by
HUD for suitability for possible use to
assist the homeless.
EFFECTIVE DATE: May 18, 2007.
FOR FURTHER INFORMATION CONTACT:
Kathy Ezzell, Department of Housing
and Urban Development, Room 7262,
451 Seventh Street SW., Washington,
DC 20410; telephone (202) 708–1234;
TTY number for the hearing- and
speech-impaired (202) 708–2565, (these
telephone numbers are not toll-free), or
call the toll-free Title V information line
at 1–800–927–7588.
SUPPLEMENTARY INFORMATION: In
accordance with the December 12, 1988
court order in National Coalition for the
Homeless v. Veterans Administration,
No. 88–2503–OG (D.D.C.), HUD
publishes a Notice, on a weekly basis,
identifying unutilized, underutilized,
excess and surplus Federal buildings
and real property that HUD has
reviewed for suitability for use to assist
the homeless. Today’s Notice is for the
purpose of announcing that no
additional properties have been
determined suitable or unsuitable this
week.
Dated: May 10, 2007.
Mark R. Johnston,
Deputy Assistant Secretary for Special Needs.
[FR Doc. E7–9340 Filed 5–17–07; 8:45 am]
BILLING CODE 4210–67–P
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
[Docket No. FR–5130–N–03]
Privacy Act of 1974; New System of
Records, Line of Credit Control System
(LOCCS, A–67), HUD/CFO–03
Office of the Chief Information
Officer, HUD.
ACTION: Establish a New Privacy Act
System of Records.
AGENCY:
SUMMARY: HUD proposes to establish a
new record system to add to its
inventory of systems of records subject
to the Privacy Act of 1974 (5 U.S.C.
552a), as amended. The proposed new
E:\FR\FM\18MYN1.SGM
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]]>Agencies
[Federal Register Volume 72, Number 96 (Friday, May 18, 2007)]
[Notices]
[Pages 28063-28064]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-9550]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: jburdick@hrsa.gov. 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:
jburdick@hrsa.gov.
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
