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This document is a Request for Proposal (RFP) for a commercial services Indefinite Delivery-Indefinite Quantity (IDIQ) type contract issued by the Food and Drug Administration (FDA) Office of Acquisition and Grant Services. The contract will be a single award set-aside for small businesses and has a minimum guarantee of $2,500 and a maximum ceiling of $50,000,000 over the 5-year ordering period.

The scope of the contract includes the capability to conduct multiple Phase I clinical trials and provide a full range of services to support the clinical trials and reporting of results, as well as laboratory studies including bioanalytical/biomarker/omics support. The contractor must have in-house capabilities for the clinical operations and trial execution, and may have in-house or subcontracting capability for the bioanalytical/biomarker/omics analysis and laboratory support. Proposals must include completed pricing worksheets, and offerors must have an active SAM.gov registration.

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