Redacted_ Tab 1 - JA Addendum COVID Test Kits_Redacted.pdf
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- Over-the-Counter COVID Tests Federal contract opportunity
- Solicitation number
- SPE2DE-22-R--0013
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This addendum to a justification for other than full and open competition expands the eligible domestic sources for the Department of Defense's procurement of over-the-counter coronavirus rapid detection test kits from the Department of Health and Human Services. The addendum adds two additional domestic manufacturers, iHealth and Access Bio's exclusive authorized distributor, to the initial six that were identified in the prior justification. All eight identified domestic manufacturers—Abbott Diagnostics, Access Bio, Cue Health, Inbios International, iHealth Labs, Maxim Biomedical, Orasure Technologies, and Quidel Corporation—have FDA-authorized over-the-counter COVID-19 tests that meet the government's requirements. The addendum provides the product names and unit details for the tests available from Abbott and Access Bio. The senior procurement executive approved the addendum on September 26, 2022.
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| File | Type | Posted |
|---|---|---|
| DLAPDF of REDACTEDSigned COVID Test Kits c-3 JA final counselredactions ajg_Redacted.pdf |
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ADDENDUM TO JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPEITION
Reference: Justification For Other Than Full And Open Competition For Coronavirus Rapid Detection Over the Counter (OTC) Test Kits, approved by Senior Procurement Executive on September 8, 2022.
1. This addendum to the referenced Justification For Other Than Full and Open Competition (J&A) is necessary to expand the current eligible domestic manufacturing sources for the requirement for Coronavirus Rapid Detection Over the Counter (OTC) Test Kits from the Department of Health and Human Services (HHS) in accordance with an Interagency Agreement via Memorandum of Understanding (MOU) between the Department of Defense (DoD) and the HHS regarding DoD Acquisition Support, dated November 6, 2020. The initial market research indicated that there were six (6) domestic manufacturers on the list of FDA-authorized OTC COVID-19 tests that meet the Government’s requirement; however, ongoing market research presents two (2) additional domestic sources (iHealth and Access Bio’s exclusive authorized distributor for the alternative brand name) with U.S. made tests that are FDA approved, 510(K)- cleared, or have Emergency Use Authorization (EUA).
2. The market research for this acquisition was conducted on August 2, 2022, and amended on September 16, 2022, to determine the domestic sources approved by the FDA to supply at-home test kits that require no separate readers or use of a smartphone. Access Bio has an alternative brand name EUA approved US manufactured test, reporting under National Stock Number (NSN) 6550-01-699-5091 since February 4, 2022. In addition, the Government became aware that iHealth established a domestic manufacturing facility that became fully operational in September 2022.
The only known domestic manufacturers of authorized at-home OTC COVID-19 diagnostics tests in accordance with FAR 6.302-3(b)(iv)(A) are Abbott Diagnostics, Access Bio, Cue Health, Inbios International, iHealth Labs, Maxim Biomedical, Orasure Technologies, and Quidel Corporation.
Market research indicates that there are currently eight (8) domestic sources on the list of FDA-authorized OTC COVID-19 tests that meet the Government’s requirement. The manufacturer names and products are listed in the table below:
Manufacturer Name
Manufacturer Part Number Product Name Unit of
Issue
Qty per Unit of Issue
Result Time
ABBOTT 195-140 BinaxNOW COVID-19 Antigen Self Test KT 1 15 min
ABBOTT 195-160 BinaxNOW COVID-19 Antigen Self Test KT 2 15 min
ACCESS BIO RCPM-00171 CareStart COVID-19 Antigen Home Test KT 1 10 min
ACCESS BIO RCPM-00271 CareStart COVID-19 Antigen Home Test KT 2 10 min
ACCESS BIO RCPM-00471 CareStart COVID-19 Antigen Home Test KT 4 10 min
ACCESS BIO* RCPM-00179 On/Go COVID-19 Antigen Test KT 1 10 min
Controlled Unclassified Information (CUI)
I have reviewed this addendum and recommend approval.
Date
I have reviewed this addendum for legal sufficiency.
Controlled Unclassified Information (CUI)
I have reviewed this addendum for legal sufficiency.
I have reviewed and hereby approve this addendum.
Date MATTHEW R. BEEBE Senior Procurement Executive
BEEBE.MATTHEW.RI
CHARD.1012725473
Digitally signed by
BEEBE.MATTHEW.RICHARD.10127
25473 Date: 2022.09.26 09:52:58 -04'00'
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