Structured Product Labeling (SPL) HT9426-26-Q-E022
Closed Solicitation Posted
- Solicitation number
- PANDHA-26-P-0000035401
- Agency
-
Defense Health Agency
Department of Defense
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 541690 Other Scientific and Technical Consulting Services
- Place of performance
- Frederick, Maryland 21702, United States
Notice details come from SAM.gov. Updated .
About this opportunity
The Defense Health Agency seeks structured product labeling (SPL) services for FDA submissions covering up to two licensed New Drug Application products with up to five levels of primary and secondary labeling, with quotes due July 1, 2026 at 2:00 PM Eastern Time. This procurement is set aside for Women-Owned Small Businesses (WOSB).
Place of performance is Fort Detrick, Maryland. The requirement encompasses end-to-end SPL development including assessment, XML creation, validation against FDA Electronic Submission Gateway standards, submission via ESG gateway, and post-submission activities. Contractors must provide their own SPL XML authoring tools, records management systems, and configuration management processes. Normal operations require approximately three new SPL submissions annually and two updates to existing SPL labels per year, with surge capacity of up to two parallel submissions. The Government will conduct review and approval of contractor-generated SPLs prior to FDA submission with a standard 5 business-day review cycle. This is a new requirement with no incumbent contractor.
The contract is firm-fixed-price with a base period from July 30, 2026 through July 29, 2027, and four optional one-year periods extending through July 29, 2031. The NAICS code is 541690, Other Scientific and Technical Consulting Services, with a small business size standard of $19 million. Payment is processed through the Wide Area Workflow (WAWF) system.
Evaluation criteria are technical capability (demonstrating FDA ESG Gateway expertise, quality control processes, and workflow management), past performance (up to three relevant references within the last three years), and price. Offerors must submit three volumes: Technical Capability (10-page maximum), Past Performance (6-page maximum), and Price & Administrative (no page limit). Questions are due June 17, 2026 at 2:00 PM Eastern Time. Offerors must complete the Organizational Conflict of Interest Certification Form and Pricing Attachment 4 with their response.
Notice text
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.
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