Structured Product Labeling Management
The Department of Defense is procuring services for managing, processing, and completing initial labeling and labeling changes in electronic structured product label document submissions to the FDA. This requirement is specifically for the Defense Health Agency's Medical Research and Development Command, which currently has two licensed New Drug Application products that necessitate these submissions. Key requirements include adherence to the Health Level Seven standard and the ability to handle multiple levels of primary and secondary labeling.
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Attachments (6)
Contract Details
- Estimated Value
- est. $24K – $313KSimilar contracts award $24K – $305K (median $89K, 11,390 awards)Within typical range
- NAICS Codes
- Place of Performance
- Fort Detrick, MD, USA
Agency & Contact
Contracting Organization
- Agency
- DEPT OF DEFENSE
- Sub-Agency
- Defense Health Agency
- Office
- Medical Research and Development Command
Point of Contact
Key Dates
Description
&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. 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 Performance Work Statement - ORA SPL Requirement.docx B08.
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