The Structured Product Labeling (SPL)

The FDA seeks proposals to enhance and maintain the HL7 Structured Product Labeling data standard. The contractor will extend SPL to include additional data elements required by FDA for establishment registration, product listing, and other regulated product information. The contractor will also update SPL, common product, and chemical substance models and develop implementation guides and validation documents. Proposals will be evaluated based on understanding of requirements, management plan, key personnel, relevant experience, and cost/price. Proposals are due by August 21st and must remain valid through September 30th.

There is no set-aside designation. The place of performance will be at the contractor's facility. The period of performance is one base year plus four one-year options. The solicitation does not provide award values, budgets, incumbent names, or quantity details. Proposals must demonstrate the offeror's ability to perform the required enhancement and maintenance services over the five-year period.