HHS/OASH Technical and Regulatory Review of Laboratory Developed Tests for COVID-19

This solicitation requests commercial services to conduct technical reviews of laboratory developed tests for COVID-19. The contractor shall provide specialized technical and regulatory expertise to review LDT protocols and provide written assessments of submissions based on metrics including type of diagnostic, intended use, instruments, controls, limits of detection, and clinical and public health performance. The base period of performance is six months with an optional three-month extension. Pricing is time-and-materials based on loaded hourly rates for regulatory reviewer labor categories. The Department of Health and Human Services Office of the Assistant Secretary for Administration is the contracting agency seeking these services, with a deadline of December 23, 2020 for proposals.

There is no set-aside designation for this requirement. The intended sole source awardee is NDA Partners LLC, to provide these specialized medical review services for a period of six to nine months from a place of performance in Fort Lesley J. McNair, DC. Pricing will be determined by time-and-materials loaded hourly rates for regulatory reviewer labor categories over the base and optional extension periods.