JA_Exception BNJ protocols.io_Redacted.pdf

This document is a Justification for Other than Full and Open Competition (J&A) for the U.S. Food and Drug Administration (FDA). The FDA Human Foods Program requires a premium institutional subscription to Protocols.io, a cloud-based protocol management system to support national surveillance programs. The subscription will enable FDA scientists to create, edit, publish, and manage protocols in a centralized, version-controlled environment across multiple networks including GenomeTrakr, NARMS, and Vet-LIRN.

The procurement is for a firm-fixed-price, new Information Technology requirement from Protocols.io, Inc. in Berkeley, CA. Market research confirmed Protocols.io is the only vendor providing the required combination of features, including version-controlled public and private protocol repositories, DOI assignment, real-time collaboration, access control, compliance with 21 CFR Part 11, and administrative oversight tools. The contract is being pursued under Simplified Procedures for Commercial Items, with the total estimated value and performance period still pending. The contracting officer has determined the pricing to be fair and reasonable based on the platform's standard pricing for academic and government users.