Structured Product Labeling (SPL) HT9426-26-Q-E022
Contract Overview
Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.
AI Contract Overview
The contract issued by the Office of Regulated Activities within the DHA Research & Development Medical Research and Development Command focuses on managing, processing, and completing initial labeling and labeling changes for electronic Structured Product Label (SPL) document submissions to the FDA. SPL follows the Health Level Seven (HL7) standard, which is based on Clinical Document Architecture and the HL7 Reference Information Model and is accredited by ANSI for exchanging product information. The DHA R&D MRDC currently holds two licensed New Drug Application products necessitating SPL submissions covering up to five levels of primary and secondary labeling. This solicitation, titled "Structured Product Labeling (SPL)," was posted on May 15, 2026, with responses due by June 5, 2026. It is a combined contract type under NAICS code 541690, managed by the Army Medical Resources Acquisition Activity, a Department of Defense office located in Fort Detrick, Maryland. Performance will take place in Frederick, MD. The primary point of contact is Matthew Gembe, and the contracting officer is Terrie Bloom. The contract does not specify any set-aside provisions.
General Info
Agency
NAICS
Place of Performance
Frederick, MD, 21702, USASet-Aside
Timeline
Response Deadline
Organization & Contact Information
Full Description
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.
