Notice of Intent.pdf

U.S. Food & Drug Administration

NOTICE OF INTENT TO SOLE SOURCE

Patient Recruitment VR-TB

This synopsis is hereby issued and posted in accordance with FAR Subpart 5.2 and FAR 6.302. The purpose of this synopsis is to announce the Food and Drug Administration's intent to negotiate a Firm Fixed Price sole source award with University of Maryland, Baltimore located at 220 Arch St, Baltimore, MD 21201 for the project titled “Patient Recruitment VR-TB.”

Under the authority of FAR 6.302-1, only one responsible source and no other type of services will satisfy agency requirements. The primary objective is to recruit human patient subjects with mild to moderate traumatic brain injury to evaluate the performance of novel digital technologies in the diagnosis or monitoring the progress of the injury.

This highly complex service request requires the contractor to have a highly specific capacity of the targeted patient population within a limited geographic area and specific time-window, which limits the number of possible capable contractors. The contractor needs to be easily reachable from the FDA White Oak Campus as FDA employees will be frequently visiting the contractor’s site to perform the associated study. The University of Maryland’s (UMD) Shock, Trauma and Anesthesiology Research (STAR) Organized Research Center is the only contractor within the limited geographic area of the FDA White Oak Campus with the capability to quicky identify and recruit targeted patient population in suitable numbers and continue the ongoing study within the limited budget and time period.

Specifically, this procurement calls for the following tasks to be completed:

• Task Management o Kick Off Meeting o Monthly Status Reports o Project Work Plan

• Institutional Review Board (IRB) Preparation and Approval

• Patient Recruitment

• Patient Data Collection Location

• Perform Current Standard Clinical Evaluation

• Clinical Oversight and Expertise

• Summary Report

THIS NOTICE IS NOT A REQUEST FOR COMPETITIVE QUOTATIONS; however, responsible sources may submit a capability statement in response to the above requirement with pricing information by 11:59pm (Eastern) on June 30, 2023 to the Contract Specialist, Noah Wills, at Noah.Wills@fda.hhs.gov.

mailto:Noah.Wills@fda.hhs.gov