The Office of Regulated Activities of the DHA R&D – MRDC requires services to manage, process, and complete initial labeling and labeling changes for electronic Structured Product Labeling (SPL) submissions to the FDA. The contractor will handle SPL submissions for up to 5 levels of primary and secondary labeling for the agency’s 2 licensed New Drug Application products. No specific budget amounts, submission timelines, or performance location are mentioned in the description. This opportunity involves specialized regulatory work with FDA standards, including HL7 and ANSI-accredited formats. The prospective bidder should assess their expertise in pharmaceutical labeling and FDA submission processes to determine interest.