Structured Product Labeling Management and Processing Services

&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. Matthew Gembe Alternative

Point of Contact Terrie Bloom,

Contracting Officer Contracting (No Street Address

2) FORT DETRICK, MD 21702 USA to this opportunity.

Questions and Answers - HT9426-26-Q-E022.docx B08. Solicitation - HT942626QE022 Amendment 2.pdf B08 Attachment 3 - Past Performance References.pdf B08 Attachment 2 - Organizational Conflict of Interest Certification Form.docx B08 Attachment 1 - Non-Disclosure Agreement.docx B08 Attachment 4 -

Pricing Sheet SPL Requirement.xlsx