COVID-19 Laboratory IVD (Diagnostics)
Closed Solicitation Posted
- Solicitation number
- 75A50121R00037
- Agency
-
Office of the Assistant Secretary for Preparedness and Response
Department of Health and Human Services
- Responses due
- Set-aside
- Total Small Business
Opportunity facts
- NAICS code
- 325413 In-Vitro Diagnostic Substance Manufacturing
- PSC
- Q301 Reference Laboratory Testing
Notice details come from SAM.gov. Updated .
About this opportunity
The Biomedical Advanced Research and Development Authority within the Department of Health and Human Services seeks to fund activities and clinical evaluations to transition over-the-counter COVID-19 diagnostic tests from Emergency Use Authorization to 510(k) clearance and CLIA waiver. Responses are due by May 13, 2021 and shall be evaluated based on technical capability, price, and past performance. BARDA will fund the necessary work over a 14-20 month period of performance to enable organizations to commercialize easy-to-use, self-administered COVID-19 diagnostic tests that do not require external readers or involvement of a healthcare provider.
The requirement is set aside exclusively for small businesses with less than 1,250 employees. The resulting contract will be a firm fixed price vehicle with payable milestones to be performed by the selected offeror. Evaluation criteria include technical approach, pricing, and past performance history. A question and answer session was held on May 3rd to clarify the solicitation requirements.
Notice text
2 versions
Update #2 · Latest ·
The Biomedical Advanced Research and Development Authority (BARDA), Department of Health and Human Services (HHS) seeks to fund the necessary activities and clinical evaluations so an organization can transition their over the counter COVID-19 diagnostic tests from EUA to 510(k) and CLIA waiver. Among other things, the diagnostic test should be easy to use and not require external readers.
See attached Combined Synopsis/Solicitation (CSS) for complete requirement details.
The beta.sam.gov posting and the attached CSS was modifed at 10:40AM EDT, May 6, 2021 to remove reference to this being a requirements for a "Molecular" diagnostic test.
Update #1 ·
The Biomedical Advanced Research and Development Authority (BARDA), Department of Health and Human Services (HHS) seeks to fund the necessary activities and clinical evaluations so an organization can transition their over the counter COVID-19 diagnostic tests from EUA to 510(k) and CLIA waiver. Among other things, the diagnostic test should be easy to use and not require external readers.
See attached Combined Synopsis/Solicitation (CSS) for complete requirement details.
Files
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| Opportunity | Agency | Set-aside | Responses due |
|---|---|---|---|
| BARDA DRIVe EZ-BAA (EZBAA - 22-100-SOL-00003) | Office of the Assistant Secretary for Preparedness and Response | No set-aside |
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