SOLICITATION NOTICE
A -- Bridging Study to Obtain FDA Clearance to Use Magnetic Bead Technology with Joint Biological Agent Identification and Diagnostic System (JBAIDS) Analyzer and Reagents
- Notice Date
- 12/13/2010
- Notice Type
- Presolicitation
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- US Army Space and Missile Defense Command, Deputy Commander, ATTN SMDC-CM-AP, P.O. Box 1500, Huntsville, AL 35807-3801
- ZIP Code
- 35807-3801
- Solicitation Number
- W911QY-11-C-BRDG
- Response Due
- 2/28/2011
- Archive Date
- 4/29/2011
- Point of Contact
- Cynthia Gnam, 301-619-8453
- E-Mail Address
-
US Army Space and Missile Defense Command, Deputy Commander
(cynthia.gnam@us.army.mil)
- Small Business Set-Aside
- N/A
- Description
- Synopsis: Bridging Study to Obtain FDA Clearance to Use Magnetic Bead Technology with Joint Biological Agent Identification and Diagnostic System (JBAIDS) Analyzer and Reagents The US Army Research, Development, and Engineering Command (RDECOM) intends to issue a contract on behalf of the Joint Program Executive Office for Chemical Biological Defense (JPEO-CBD), Joint Project Manager Chemical Biological Medical Systems (CBMS), on the basis of other than full and open competition to Idaho Technology, Inc. (ITI), 390 Wakara Way, Salt Lake City, UT 84108. The purpose of the contract is to conduct a study on the use of Platinum Path Extraction Kits (a magnetic bead process used to extract and purify genetic material) with anthrax, plague, and tularemia biological reagents. If study results are successful, the contractor will obtain amendments to existing Federal Drug Administration (FDA) clearances wherein an alternate method of extraction was used. FDA amendments to the clearances will enable the magnetic bead Platinum Path Extraction Kits to be used with the existing Department of Defense (DoD) Joint Biological Agent Identification and Diagnostic System (JBAIDS) analyzer. The contract is a sole source action under the authority of 10 U.S.C. 2304(c) and FAR 6.302-1, "Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements." ITI is the manufacturer; ITI possesses key proprietary information on the JBAIDS analyzer and the associated anthrax, plague, and tularemia biological reagents; and ITI is the Sponsor to the FDA of these three cleared diagnostic kits. FDA regulation 21 CFR Part 820 requires that sponsors of previous FDA clearances be solely responsible for submissions for changes to their approved devices, chemistry, protocols, etc. For these reasons, the government intends to solicit and negotiate with only one source. ITI is the only contractor who can meet the government's requirements. This notice is not a request for proposals. However, the government will consider capability statements from interested, qualified parties if they are received prior to the close of this notice. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Capability statements may be forwarded via email to Cynthia.Gnam@us.army.mil or hard copies mailed to Cynthia Gnam, Contracting Officer, 64 Thomas Johnson Drive, Frederick, CA 21702. No phone inquiries will be entertained. Companies interested in subcontracting opportunities should contact Idaho Technology, Inc., directly.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/SMDC/DASG60/W911QY-11-C-BRDG/listing.html)
- Place of Performance
- Address: US Army Space and Missile Defense Command, Deputy Commander ATTN SMDC-CM-AP, P.O. Box 1500 Huntsville AL
- Zip Code: 35807-3801
- Zip Code: 35807-3801
- Record
- SN02342817-W 20101215/101213233642-0555d79c1aa6c2a97e3554acd0cf67e8 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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