Amendment to JA - Redacted.pdf
PDF 2 MB Posted
- Solicitation number
- 75A50122C00079
About this file
This document contains an amendment to a justification and approval for a sole source contract and the related federal contract opportunity. The amendment seeks to increase the dollar threshold for contract 75A50122C00079, originally awarded on September 27, 2022 to an unknown vendor for an unknown amount. The purpose of the contract is to improve the OraQuick Ebola Rapid Antigen Test by making the device independent of critical reagents, improving manufacturing capabilities, sensitivity and shelf life to better respond to public health emergencies. Specifically, the scope will be expanded to include completion of analytical and clinical validation studies and regulatory activities for 510(k) clearance. The contracting officer will determine fair and reasonable pricing by comparing prices from the original contract, previous similar acquisitions, and evaluating labor rates against other contracts and online sources.
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Other files
| File | Type | Posted |
|---|---|---|
| Amendment to JOFOC-CP-JL_Fully Executed.pdf | ||
| Justification and Approval - Other Than FAO.pdf |
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10.Additional Information to support the justification:
If applicable, explain why technical packages or specifications to facilitate competition were not developed or available;
describe actions taken to remedy the situation.
11. Technical / Requirements Certification: By my signature below, I certify that the supporting data included in this J&A is accurate and complete.
Program Manager
Name:
Position Title:
Email address:
Phone:
Program Manager Supervisor (or one level above Program Manager)
Name:
Position Title:
Email address:
Signature:
Date:
12. Fair and Reasonable Price/Cost Determination: As Contracting Officer, by my signature below, I hereby determine that the anticipated price/cost to the Government for this contract action will be fair and reasonable.
Provide the basis for this determination, e.g., describe techniques to be used to determine fair and reasonable price (FAR Subpart 15.402), such as price analysis, cost analysis, cost realism. Per FAR Subpart 15.403-4(a)(1), the threshold for obtaining cost or pricing data is $750,000.
Name:
Signature:
13. Contracting Officer's Approval (Required for proposed contract not to exceed $700,000 (value calculated including all options)): I hereby certify that this justification is accurate and complete to the best of my knowledge. I approve this justification subject to availability of funds, and provided that the services and supplies herein described have otherwise been authorized for acquisition
Name:
Signature:
Request approval to amend the J&A (Attachment 1) approved on 7/21/2022 to increase the dollar threshold.
BARDA completed an Internal Process Review (IPR) on 07 August 2023. The result of the IPR was to have OraSure revise the Scope of Work to include the completion of analytical and clinical validation studies and regulatory activities for 510(k) clearance of the
The Contracting officer will use comparison of prices determined to be fair and reasonable for the original contract; prices paid under previous acquisitions of similar work, and evaluation of the different labor rates compared to similar positions on the internet and other contracts.
File details come from the government source that posted it. Updated .