SOLICITATION NOTICE
66 -- Notice of Intent to Sole Source
- Notice Date
- 7/25/2018
- Notice Type
- Synopsis
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- 2920 Brandywine Road, Room 3000 Atlanta GA 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- 25009
- Response Due
- 8/9/2018
- Point of Contact
- Sarah Turner, Contract Specialist
- E-Mail Address
-
KWP9@cdc.gov
- Small Business Set-Aside
- N/A
- Description
- The Centers for Disease Control and Prevention (CDC) National Center for Emerging and Zoonotic Infectious Diseases for (NCEZID) in Atlanta, Georgia, intends to negotiate a sole source contract with Colorado State University - Biopharmaceutical Manufacturing and Academic Resource Center, under authority of Federal Acquisition Regulation (FAR) Subpart 6.302-1, Other Than Full and Open Competition procedures., for the acquisition of development of the YF MAC-HD Kits, including production, test method verification, lot-to-lot comparison, kit stability, and positive control manufacturing. CSU-BioMARC is the only facility in the Fort Collins area that has the technical expertise, knowledge of kit building, kit components, stabilizers, and diagnostic expertise specific to arboviruses. Furthermore, they have a demonstrated ability to troubleshoot and suggest improvements on the kit development and have demonstrated successful YF kit production. It is mandatory that the production facility is geographically local to the CDC/DVBD in Fort Collins, Colorado to allow for QC testing of product at DVBD. Shipping these test kits could destabilize the kits and render them unusable. In addition, BioMARC is the only local vendor that has Biosafety level-2 facilities, which are required for the production of these kits.This makes them uniquely qualified to manufacture and validate the YF MAC-HD Kits. Award of the task to a different vendor will result in significant costs to the government and unacceptable delays due to rework. Competition would cause significant delays for the current YFV MAC-HD project. In 2017, CSU-BioMARC produced an initial lot of kits for field trials in Africa and South America. The next step for the further development of the YFV MAC-HD project is to qualify the CDC-developed and CSU-BioMARC-manufactured kit for approval by WHO. WHO qualification of the manufactured kit requires that quality control (QC) measures are established and the kit is validated for use in regions at-risk for YF. Delays would directly affect the ability of CDC to respond to an emergency. It will require a significant time, effort, and cost to re-implement CDC workflows, customizations, and migrate data to a new vendor's product. The increased project risks, delays and costs from the loss of the CSU-BioMARC's experience makes it critical that we retain the continuity of expertise and consistency in operations that only they can provide. It is critical for CSU-BioMARC to continue to manufacture, verify, and test the YF MAC-HD Kit to avoid any loss of continuity that would disrupt CDC's critical Public Health surveillance and outbreak programs. THIS IS A NOTICE OF INTENT AND IS NOT A REQUEST FOR COMPETITIVE QUOTES OR PROPOSALS. No solicitation is available. Firms that believe they can meet the requirement are encouraged to identify themselves and provide a substantive statement with descriptive literature and any other supporting information to the Contract Specialist within 15 days of publication of this notice. All information received within 15 days of publication of this synopsis will be considered by the Government to determine if more than one firm can meet the Government's requirements and is capable of producing and testing YF MAC-HD Kits. Responses to this posting must be submitted in writing via e-mail only. A determination not to compete the described requirement based upon responses to this notice is solely within the discretion of the Federal Government. Information received will be considered solely for the purpose of determining whether or not to conduct a competitive procurement. Any questions or comments should be directed via e-mail ONLY to Sarah Turner at KWP9@cdc.gov. NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (25-JUL-2018); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT 877-472-3779 or fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link To Document
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/25009/listing.html)
- Place of Performance
- Address: Fort Collins, CO
- Zip Code: 80521
- Country: US
- Zip Code: 80521
- Record
- SN05005917-F 20180727/180725230757 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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