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

The contract, titled Structured Product Labeling (SPL) HT9426-26-Q-E022, is a Firm Fixed Price solicitation issued by the Army Medical Resources Acquisition Activity under the Department of Defense to secure services for the management, processing, and completion of electronic Structured Product Labeling submissions to the FDA for two licensed New Drug Application products. The work involves creating and updating labeling at up to five levels of primary and secondary labeling using the HL7 standard based on Clinical Document Architecture and HL7 Reference Information Model, with all submissions required in XML format and conforming to the latest FDA technical conformance criteria. The contractor must demonstrate technical capability in managing and validating eSPL files through FDA-compliant tools such as Reed Tech or Pragmatic, maintaining version control, ensuring zero-error submissions, and rapidly resolving rejections from the FDA Electronic Submission Gateway. Performance is required at Fort Detrick, Maryland, with deliverables including a signed Non-Disclosure Agreement and Organizational Conflict of Interest Certification for all personnel, alongside a Quality Control Plan submitted upon award. All employees must complete background checks to gain access to the installation, and the contractor must ensure strict confidentiality; unauthorized public disclosures or failure to execute the NDA constitutes default. The contract spans a maximum of 60 months, with a base performance period of one year and four option years, each structured to support the same scope of work at the same volume, including optional surge support for additional labeling tasks upon written authorization. Offerors must submit a three-volume proposal with strict formatting guidelines: Volume I must detail technical methodology within a ten-page limit, Volume II must provide up to three recent and relevant past performance references within six pages, and Volume III must include a complete Firm Fixed Price quote covering all line items for the base and option years using the provided Pricing Sheet. Participation requires current and valid SAM.gov registration with UEI and CAGE codes, and contractors must use the Wide Area Workflow system for invoicing and receiving reports, using specified DoDAAC codes for routing. Compliance with numerous FAR and DFARS clauses is mandatory, including prohibitions on contracting with inverted corporations, entities linked to the Maduro regime or Xinjiang Uyghur Autonomous Region, and requirements for safeguarding government interests regarding subcontractors and former DoD officials. Organizational Conflict of Interest is a pass/fail gate governed by FAR Subpart 9.5, and failure to provide an adequate mitigation plan results in immediate exclusion. All offers must be submitted electronically by June 5,