FDA RFQ: Structured Product Labeling (SPL)

Solicitation: FDASB1226623

FDA has a requirement to contract with an organization which is capable of extending the HL7 SPL data exchange standard to include the additional data elements required for FDA required and voluntary establishment registration and reporting, product listing and reporting, indexed, and identification data for processing, reviewing, and archiving by FDA. This contractor would also possess the capability of developing and maintaining an open source Schematron 1.5 document based on the business rules and data relationships for FDA regulated establishment registration and product data defined by FDA which, when processed through an Extensible Stylesheet Language Transform (XSLT) and software, can be used to assist in quality control by validating a SPL file and producing a report outlining the detected errors. The organization must also be able to generate a HL7 SPL implementation guide to be utilized by industry, FDA and SPL software developers, including health information system providers to generate valid regulatory submissions for processing, reviewing, and archiving by FDA and software to create the aforementioned documents respectively.”

“Outside the scope of this contract is to create an implementation guide for the creation of SPL for a specific product and instructions on the use of extensible mark up language (XML). The organization must also possess an extensive knowledge of Extensible Markup Language (XML), Extensible Stylesheet Language Transformation (XSLT). During the enhancement of the SPL model, the contractor shall ensure that the standard is interoperable with other HL7 data standards and that it maps to the HL7 Reference Information Model.”

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