Premium license to protocols. IO for US FDA HFP & CVM users

The FDA is procuring a premium institutional subscription to Protocols.io, a cloud-based protocol management platform, to support the Human Foods Program and Center for Veterinary Medicine operations across national surveillance networks including GenomeTrakr, NARMS, and VetLIRN. The subscription will enable FDA scientists to create, edit, publish, and manage protocols in a centralized, version-controlled environment with features including collaborative editing, Digital Object Identifier assignment, single sign-on functionality, and compliance with 21 CFR Part 11 regulations. The solicitation specifies a 100-250 user tier subscription capable of supporting up to 300 total users with institutional-level access for FDA staff. Proposals will be evaluated using the Lowest Price Technically Acceptable method under simplified acquisition procedures for commercial items. Questions were due by September 22, 2025, with proposals due by September 24, 2025 at 11:00 AM ET.

This procurement is issued as a full and open competition with no set-aside designation, falling under NAICS code 513210 (Software Publishers) with a small business size standard of $47 million. Market research identified Protocols.io, Inc. of Berkeley, California as the sole source provider capable of meeting the FDA's specific combination of requirements, though the solicitation remains open to all responsible sources. The contract structure includes a 12-month base year with four 12-month option years, to be awarded as a firm fixed-price commercial item arrangement. While specific award values are not disclosed in the available documents, the justification indicates pricing will be based on the platform's standard rates for academic and government users. Performance will take place at the FDA facility located at 9591 Baltimore Avenue, College Park, Maryland.