Structured Product Labeling (SPL) HT9426-26-Q-E022

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.

• NAICS541690
• PSCR408

• Performance Work Statement - ORA SPL Requirement.docx

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• B08 Attachment 4 - Pricing Sheet SPL Requirement.xlsx

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• Questions and Answers - HT9426-26-Q-E022.docx

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• B08. Solicitation - HT942626QE022 Amendment 3.pdf

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• B08 Attachment 1 - Non-Disclosure Agreement.docx

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• B08 Attachment 2 - Organizational Conflict of Interest Certification Form.docx

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• B08 Attachment 3 - Past Performance References.pdf

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• Matthew Gembe
  matthew.w.gembe.civ@health.mil3016191350
• Terrie Bloom, Contracting Officer
  terrie.l.bloom.civ@health.mil