Sol_Doc - Amend 0001 - RFP_Attachment_2 Wage Det_No. 2015_4269_Rev 26_dated 07_22_24.pdf

This document is a Request for Proposal (RFP) for a single-award Indefinite Delivery-Indefinite Quantity (IDIQ) type contract to provide the Food and Drug Administration (FDA) Office of Clinical Pharmacology (OCP) with multi-phase/multi-site clinical studies and laboratory support services. The requirement is set aside 100% for small businesses under NAICS codes 541714 and 541715. The IDIQ contract has a minimum guarantee of $2,500 and a maximum value of $50,000,000 over a 5-year ordering period. The contractor must have in-house capabilities to conduct multiple Phase I clinical trials per year, provide full clinical trial services, and perform bioanalytical/biomarker/omics laboratory studies including drug concentration, anti-drug antibody, and pharmacodynamic biomarker analyses. Proposals must include completed pricing worksheets with fully burdened hourly rates for the required labor categories.