Research and Development for Clinical Studies in the Blueprint MedTech (BPMT) Initiative

The National Institute on Drug Abuse seeks to award an indefinite delivery/indefinite quantity contract to provide research and development services to support up to 15 clinical studies per year involving medical devices within the Blueprint MedTech Initiative. Offerors must have the capability to provide clinical research units, conduct studies in compliance with FDA and ICH GCP guidelines, and support all aspects of data management, safety monitoring, and reporting. Proposals are due by August 15, 2022 and will be evaluated based on technical approach, management approach, and past performance. The period of performance consists of a 5-year base period for operational support and individual task orders of 1-3 years for specific studies.

There is no set-aside designation. The primary NAICS code is 541715 and PSC code is R425. The total contract value ranges from $100,000 to $50 million over 5 years. Offerors must submit separate technical and cost proposals, with budgets broken out for the fixed-price operational support portion and cost-reimbursement task orders. Amendments to the RFP provided clarification on documentation requirements and modified some reporting elements. The place of performance will be at the contractor's clinical research units.