Brand Name Justification_OraSure Test Kits Redacted.pdf
PDF 661 KB Posted
- Solicitation number
- 75A50122Q00005
About this file
This document contains a sole source justification and a solicitation for the acquisition of Filovirus point-of-care diagnostic tests. The sole source justification identifies OraSure Technologies as the only provider that can meet the government's needs, as their product is the only rapid antigen test for Ebola virus that is either emergency use authorized or cleared by the FDA, can be used on oral fluids from cadavers, and has a nine month shelf life from delivery. The solicitation seeks quotes for the acquisition of these Filovirus point-of-care diagnostic tests from OraSure Technologies to assess Ebola virus infections in individuals and cadavers. The solicitation will be publically posted on FedBizOpps with an estimated fair and reasonable price to be determined by comparison to OraSure's commercial price list, independent cost estimate, and previous contract prices. The Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response is the issuing agency.
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| File | Type | Posted |
|---|---|---|
| Combined Synopsis Solicitation_75A50122Q00005.pdf |
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SOLE SOURCE JUSTIFICATION: SIMPLIFIED PROCEDURES FOR CERTAIN
COMMERCIAL ITEMS EXCEEDING SAT, INCLUDING BRAND NAME
4. Identification of the authority.
This action is being taken under the authority of Simplified Procedures for Commercial Items, 41 U.S.C. 1901 as implemented by FAR 13.501.
5.
acquisition requires use of the authority cited.
OraSure Technologies is uniquely qualified because their product is the only test that meets all of the following salient characteristics:
For point of care use Handheld Lateral flow, rapid antigen test for Ebola virus Either emergency use authorized or Section 510(k) cleared by the U.S. Food and
Drug Administration (FDA) Sample oral fluid from cadavers For use on individuals or suspected to have recently died from the Ebola virus disease.
Nine (9) month shelf life from date of delivery
Alternative tests will not work because the Government will be unable to assess infection with the Ebola Virus in individuals and cadavers. The inability to assess infections would health of the public. As such, it is in the best interest of the Government to procure diagnostic tests for Ebola virus from OraSure Technologies.
6. Description of efforts made to ensure that offers are solicited from as many potential sources as is practicable.
DCMA intends to make this justification publically available pursuant to FAR 6.305 on FedBizOpps with the solicitation.
7. Determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable.
The contracting officer determines that the anticipated price(s) will be fair and reasonable based on comparison with:
OraSure s published commercial pricelist;
The independent government cost estimate and;
Prices paid under previous acquisitions.
8. Description of market research.
Market research was conducted using the following methods:
File details come from the government source that posted it. Updated .