Structured Product Labeling (SPL) HT9426-26-Q-E022
Subject: Structured Product Labeling (SPL) HT9426-26-Q-E022Solicitation Number: PANDHA-26-P-0000035401Notice Type: SOLICITNAICS: 541690Set-Aside: No Set aside usedNotice Published: 06-10-26Response Due: 06-29-26Agency: Other Defense AgenciesOffice: Defense Health AgencyContact: Matthew Gembe This email address is being protected from spambots. You need JavaScript enabled to view it. Ph: (301) 619-1350Office Address: FORT DETRICK, MD 21702Place of Performance: Frederick, MD 21702Related Notices:
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Office of Regulated Activities of the DHA R&D ? Medical Research and Development Command (MRDC) has a requirement to manage, process, and complete initial labeling and labeling changes in electronic structured product label document submissions to the FDA. Structured Product Labeling (SPL) is a Health Level Seven (HL7) standard based on Clinical Document Architecture and HL7 Reference Information Model (RIM) accredited by the American National Standards Institute (ANSI) for the exchange of product information. The DHA R&D ? MRDC currently has 2 licensed New Drug Application (NDA) products which require SPL submissions for up to 5 levels of primary and secondary labeling.