1-5AttachmentCSummaryTables 2009Dec17.xls

XLS spreadsheet 41 KB Posted

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National Cord Blood Inventory Augmentation, Fifth Cohort
Solicitation number
10-250-SOL-00079DM
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File Type Posted
Responses to Questions Received Solicitation 10.doc DOC document
ATTACHMENT A.doc DOC document
1-6AttachmentDBusinessProposalTable 2009Jul20.xls XLS spreadsheet
ATTACHMENT E DISCLOSURE OF LOBBYING ACTIVITIES.doc DOC document
ATTACHMENT H .doc DOC document
RFP--Working Document.doc DOC document
1-4AttachmentBCollectionProgressReports 2009Mar06.xls XLS spreadsheet
ATTACHMENTG.doc DOC document
ATTACHMENT F PAST PERFORMANCE .doc DOC document
Invitational Letter for RFC.doc DOC document

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NCBI Proposal Summary

National Cord Blood Inventory
Offeror:
Please complete and attach this table as supplementary information to your technical proposal. Note that no cost information should be included on this table.
Bank Overview
Proposed NCBI project staff:NameDegreeTitleE-MailTelFax
Key Personnel
Project Director:
Medical Director :
Laboratory Director:
Coordinator:
Other Personnel
Deputy Project Director:
Date proposed to begin collections in full compliance with the terms of the solicitation (including modifications to informed consent documents):
Who has ownership rights to CBU in current inventory:
Who will have ownership of NCBI CBU:
Number of years CBB has been collecting and banking CBU:
Accreditation Status:Organization #1Organization #2 (if applicable)
Name of inspecting organization:
Date of last on-site inspection:
Expiration date of accreditation:
Date of last FDA inspection:
Insurance:
Total amount of insurance coverage for potential loss of inventory:
Amount of insurance coverage per CBU:
Will NCBI CBU be covered:
CBU Release and Outcomes Data History
Total number of CBU released for unrelated donor transplantation:
Number of CBU released for unrelated donor transplantation 01/01/2009 to 12/31/2009:
Outcomes data collection:DomesticInternational
Based on the total number of CBU released for unrelated donor transplantation, percent for which you have obtained outcomes data:
CBU Collection and Processing
Number of active collection sites:
Number of annual births at active collection sites (01/01/2009 to 12/31/2009):
Collections sites proposed to be used for NCBI collections:#1#2#3#4#5#6
Name of site:
Annual number of births at site 01/01/2009 to 12/31/2009:
Number of Asian births 01/01/2009 to 12/31/2009:
Number of African-American births 01/01/2009 to 12/31/2009:
Collection staff - specify all staff used for collections at each site (e.g., dedicated CBB collection staff, hospital staff (RNs, MDs, Midwives) combination):
Collection type (e.g., in-utero, ex-utero, both):
Informed consent:
Minimum age of donor mother at time of donation:
Is complete written and signed informed consent to donate obtained prior to collection:
Percent of donor mothers who sign full consent to donate document prior to collection:
Is a "mini" written and signed consent to collect obtained prior to collection:
Is a verbal assent to collect obtained prior to collection:
Percent of donor mothers who sign full consent to donate document after collection:
CBU Storage#1#2#3#4#5#6
Long-term storage freezer manufacturer:
Age of freezer:
CBU stored under liquid or in vapor:
Are back-up freezers available on-site:
Are CBU currently stored in validated overwrap:

&LSolicitation 08 &L&F&C&P

Banking History

Banking History
Offeror:
Total Number of Listed# Units in Inventory through 12/31/2009Percent of Total Listed# Inventory through 12/31/2009Percent of Total Listed# Inventory Meeting Current NCBI Eligibility Criteria through 12/31/2009Total Number of Units Collected 01/01/2009 to 12/31/2009Total Number of CBU Added to Inventory# 01/01/2009 to 12/31/2009Total Number of Units Added to Inventory# 01/01/2009 to 12/31/2009 Meeting NCBI CriteriaPercent of Listed# Inventory by TNC (x 107) and Broad Race 01/01/2009 to 12/31/2009
<70≥70,<85≥85,<90≥90,<120≥120
American Indian/ Alaska Native*American Indian/ Alaska Native*
Black/ African-American*Black/ African-American*
Asian*Asian*
Native Hawaiian/ Pacific Islander*Native Hawaiian/ Pacific Islander*
White (non-Hispanic)White (non-Hispanic)
White (Hispanic)White (Hispanic)
Multi-race**Multi-race**
Total00.0%0.0%000Total00000
*Hispanic or non-Hispanic ethnicity.
**Two or more broad races (i.e., AI/AN, B/AA, Asian, NH/PI, or White). Note that Hispanic should not be considered a race.
#Refers to the total number of units in your existing inventory that are listed. Listed units meet eligibility criteria for unrelated donor transplantation.

&LSolicitation 07-N234-5765 &L&F

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