The Department of Health and Human Services (HHS) intends to make a sole source modification to NDA Partners, LLC. under 75P00120C00010 in  support of the U.S. Department of Health and Human Services (HHS) for the HHS Technical and Regulatory Review of Laboratory Developed Tests for COVID-19.  This contract provides specialized COVID-19 technical and regulatory expertise in the development or evaluation of laboratory assays, specifically molecular assays and assays to detect antigens.  The contract is in support of the FDA, under which the contractor shall assess assays using newly developed technologies and conducted technical and regulatory reviews of laboratory developed tests for COVID-19, including tests that combine detection of COVID-19 with other respiratory pathogens.  

This action is to re-open contract 75P99121C00010 for the administrative convenience of the Government that expired 3 July 2021 due to extenuating circumstances and delay in funding to exercise the existing option period. This action will be conducted under the authority of FAR 52.212-4(c) Changes clause.  The modification will re-open the base contract and extend the period of performance for a 3-month period from the date of modification award; the estimated amount of this action is $476,700.00.