Brand Name Justification_OraSure Test Kits Redacted_Redacted.pdf
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- Solicitation number
- 75A50122Q00017
About this file
This document contains a sole source justification and related federal contract opportunity solicitation. The Department of Health and Human Services seeks to purchase point-of-care diagnostic tests for Ebola virus from OraSure Technologies on a sole source basis. The required tests must be handheld, lateral flow, rapid antigen tests that are FDA authorized or cleared to sample oral fluid from cadavers and test individuals suspected to have recently died from Ebola virus disease. OraSure's product is the only test that meets all criteria including a nine-month shelf life. Alternative tests are deemed unacceptable due to inability to assess Ebola virus infection in deceased individuals, which would jeopardize public health missions. The justification cites OraSure's product qualifications and pricing comparability. The related solicitation provides further details on the diagnostic test requirements and identifies the Biomedical Advanced Research and Development Authority and deadline for responses.
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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 .