FDA Submission of an IVD Assay and Collection Device For SARS-CoV- 2/Flu/RSV
Award Notice Posted
- Solicitation number
- 75A50121P00022
- Agency
-
Office of the Assistant Secretary for Preparedness and Response
Department of Health and Human Services
- Awarded
- to Hologic, Inc.
- Set-aside
- No set-aside
Opportunity facts
- Contract number
- 75A50121P00022 Federal contract award
- NAICS code
- 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Place of performance
- San Diego CA 92121 USA
Notice details come from SAM.gov. Updated .
About this opportunity
This Award Notice from the Department of Health and Human Services announces a contract awarded to Hologic, Inc. on January 15, 2021 for $114,146,717. The contract requires Hologic, Inc. to submit an in vitro diagnostic assay and collection device for SARS-CoV-2/flu/RSV testing to the Food and Drug Administration. The justification for unusual and compelling urgency cites the ongoing COVID-19 public health emergency and national emergency declared on March 13, 2020.
Notice text
This justification for unusual and compelling urgency is due to the public health emergency caused by COVID-19, which was declared a global pandemic by the WHO. The first confirmed case of COVID-19 in the United States was announced on January 21, 2020 and a national emergency was declared via Presidential Proclamation on March 13, 2020. The ultimate spread, length of time, and severity of the COVID-19 outbreak is unknown as this time and current data indicate that COVID-19 has begun to spread exponentially, in the typical pattern for an epidemic. The goal of the ongoing U.S. public health response is to respond to and mitigate sustained spread of COVID-19 in this country.
Awarded contract 75A50121P00022 to HOLOGIC, INC. for 11414617.00 on 2021-01-15.
Files
| File | Type | Posted |
|---|---|---|
| Class J and A Final 3.21.20.pdf |
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