C.W. Bill Young Cell Transplantation Program: National Cord Blood Inventory Related Cord Blood Donor Demonstration Project, 28063-28064 [E7-9550]

Download as PDF 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 interests are requested to combine their comments and present them through a single representative. The allocation of time may be adjusted to accommodate the level of expressed interest. DVIC will notify each presenter by mail or telephone of their assigned presentation time. Persons who do not file an advance request for a presentation, but desire to make an oral statement, may announce it at the time of the comment period. These persons will be allocated time as it permits. 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] pwalker on PROD1PC71 with NOTICES BILLING CODE 4165–15–P VerDate Aug<31>2005 17:06 May 17, 2007 Jkt 211001 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: PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 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 pwalker on PROD1PC71 with NOTICES 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 Jkt 211001 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] BILLING CODE 9110–11–P PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 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 18MYN1

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]


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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.

-----------------------------------------------------------------------

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