Request for Information for Structured Product Labeling (SPL) Document Support for DHA R&D - MRDC - ORA

The Defense Health Agency Research & Development Medical Research and Development Command (DHA R&D - MRDC) has issued a Request for Information (RFI) seeking market research for Structured Product Labeling (SPL) document support through its Office of Regulated Activities (ORA). The RFI targets commercial solutions for managing, processing, and completing initial labeling and labeling changes for electronic structured product label submissions to the FDA. Specifically, the agency is interested in support for 3 licensed New Drug Application (NDA) products requiring up to 5 levels of primary and secondary labeling. The RFI is designed to gather capabilities statements from potential vendors who can assist with SPL submission processes. The opportunity is open to vendors with expertise in FDA regulatory documentation and electronic labeling systems.

The primary objective of this RFI is to identify vendors capable of handling three types of SPL submission requests: creating new labels, updating existing labels, and submitting final labels to the FDA. Contractors must adhere to specific requirements, including FDA technical conformance criteria, XML format capabilities, system validation details, and comprehensive quality assurance processes. Responses are due by close of business on 17 April 2025 and must be electronically submitted to alana.m.sowers.civ@health.mil, with a strict five-page limit. The agency is particularly interested in software solutions that include training capabilities for internal SPL updates. Historical trends suggest approximately 3 bundled SPL submissions per fiscal year, indicating potential ongoing work for selected vendors. There are no specific set-aside restrictions, meaning the opportunity is open to a broad range of contractors with the necessary technical capabilities and regulatory expertise.