Structured Product Labeling Data Standard Enhancement and Maintenance, Schematron, and Stylesheets

The Food and Drug Administration is soliciting proposals for Structured Product Labeling Data Standard Enhancement and Maintenance services, including development and maintenance of Schematron and stylesheets. The contractor will be responsible for extending and maintaining the HL7 Structured Product Labeling standard, developing associated schemas, implementation guides, and stylesheets to support FDA's regulatory data exchange requirements. Key deliverables include extending the SPL model, updating model interchange format files, creating HL7 ballot materials, maintaining Schematron documents, and developing implementation guides. Offerors must demonstrate expertise in HL7 Reference Information Model, XML, and FDA regulated product data standards. Questions are due by 10 AM EST on August 5, 2025, with quotes due by 10 AM EST on August 8, 2025, and quotes must remain valid through September 30, 2025. The evaluation will be based on technical acceptability and lowest price, with award made to the lowest-priced technically acceptable offer.

This opportunity is set aside for small businesses under NAICS code 541690 with a size standard of $15.0 million. The contract structure includes a one-year base period beginning September 26, 2025, with four one-year option periods extending through September 25, 2031. The pricing schedule indicates three labor categories with consistent annual hour estimates: Tech Lead/Architect (275 hours), Senior Developer (300 hours), and Technical Writer (195 hours) across all contract years. The solicitation number is SBFDA125631, and all quotes must be submitted via email to Telisha.Wilson@fda.hhs.gov with the subject line "ALP-125631." The contract will be awarded as a firm fixed price arrangement for these technical consulting services related to data standards and regulatory documentation.