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FBO DAILY - FEDBIZOPPS ISSUE OF AUGUST 02, 2018 FBO #6096
SOLICITATION NOTICE

D -- NOTICE OF INTENT FOR STEMTRAK ELECTRONIC DATA MANAGEMENT SYSTEM FOR CELLULAR ENGINEERING - JOFOC

Notice Date
7/31/2018
 
Notice Type
Presolicitation
 
NAICS
511210 — Software Publishers
 
Contracting Office
Department of Health and Human Services, National Institutes of Health, Clinical Center/Office of Purchasing & Contracts, 6707 Democracy Blvd, Suite 106, MSC 5480, Bethesda, Maryland, 20892-5480
 
ZIP Code
20892-5480
 
Solicitation Number
18-012320
 
Archive Date
8/30/2018
 
Point of Contact
Malinda Dehner, Phone: 301-594-6320, Barbara Taylor, Phone: 301-594-9515
 
E-Mail Address
dehnerm@cc.nih.gov, Barbara_Taylor@nih.gov
(dehnerm@cc.nih.gov, Barbara_Taylor@nih.gov)
 
Small Business Set-Aside
N/A
 
Description
JOFOC-stemTrak electronic data management system This is a notice of intent, not a request for a quotation. A solicitation document will not be issued and quotations will not be requested. The National Institute of Health intends to award a fixed price purchase order with one (1) twelve month base year and three (3) twelve month option periods for maintenance support to stemTrak, 35 India Street Boston, MA, 02110 on a sole source basis to provide an electronic data management system for the Center for Cellular Engineering (CCE) for application. What is required is a collective modular based system that provides an end to end electronic data management system for Cellular Therapy requirements. The system will be built with the overall goal of safely providing positive patient transplant outcomes built on a compliant infrastructure required by accreditation and regulatory authority. The stemTrak system provides unique, not currently available from other vendors in the market, a configurable, web-based, data management software solutions that enables Stem Cell Transplant Programs and Cord Blood Centers to optimize processes and centralize data while eliminating errors, variance, and duplicative data entry. The uniquely qualified solution empowers physicians, health care professionals, and data managers to easily access critical program data in an intuitive unique user-friendly interface. stemTrak gives users an unparalleled ability to quickly and easily perform statistical analysis, respond to RFIs, and interface with National Marrow Donor (NMDP), Center for International Blood and Marrow Transplant Research (CIBMTR), Food and Drug Administration (FDA) and AABB agencies that require information from the Center. The solution provides flexibility and configurability while being fully compliant with and all Health Information Privacy rules and regulatory requirements established by the Food and Drug Administration (FDA). The stemTrak vendor is the only known vendor that has a unique profound knowledge of technology, patient care practices, and implementing software solutions in regulatory environments. This profound knowledge spans across Pharmaceutical Industry and the Cellular Therapy Laboratory application market. It is extremely important to engage with a vendor who has the unique knowledge of both disciplines. This acquisition is being conducted using policies unique to FAR Part 13.5 Test Program for Certain Commercial Items and specifically FAR 13.501(a) Special Documentation Requirements, Sole source (including brand name) acquisitions where acquisitions conducted under Simplified Acquisition procedures are exempt from the requirements of FAR 6, but still require a justification using the format of FAR 6.303-2. The Justification for Other than Full and Open Completion (JOFOC) is attached to this notice. Interested parties may identify their interest and capabilities in response to this posting. The determination by the Government not to compete the proposed requirement based upon responses to this notice is solely within the discretion of the Government. Comments to this announcement, referencing this posting number, may be submitted to the CC, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Malinda Dehner, Contract Specialist, dehnerm@cc.nih.gov by the due date and time marked in this notice.
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/CCOPC/18-012320/listing.html)
 
Place of Performance
Address: 9000 Rockville Pike, Bethesda, Maryland, 20892, United States
Zip Code: 20892
 
Record
SN05013019-W 20180802/180731230811-2c991bd6faf29e464a34563805400429 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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