SAM #PANDHA-26-P-0000035401

Structured Product Labeling (SPL) Services for FDA Submissions – DHA MRDC

The Defense Health Agency (DHA), through its Army Medical Research Acquisition Activity (AMRAA) and Office of Regulated Activities (ORA), is seeking specialized services to manage and generate Structured Product Labeling (SPL) submissions to the FDA for two licensed New Drug Application (NDA) products. - Government Buyer: - Defense Health Agency (DHA), Army Medical Research Acquisition Activity (AMRAA), Office of Regulated Activities (ORA), Medical Research and Development Command (MRDC) - Products/Services Requested: - Creation, updating, and submission of electronic SPL documents for FDA regulatory compliance - SPL services must adhere to Health Level Seven (HL7) standards and FDA requirements - Up to five levels of primary and secondary labeling for two NDA products - Optional surge support for increased SPL volume as needed - Deliverables include Non-Disclosure Agreements, Organizational Conflict of Interest forms, and Quality Control Plans - Quantities and Structure: - Base period and four one-year option periods - Each period includes 2 jobs for SPL generation, with multiple optional surge support jobs available - Unique/Notable Requirements: - Strict compliance with HL7 and FDA standards for electronic labeling - Capability to handle surge requirements for increased SPL workload - Firm-fixed-price contract structure - No specific OEMs or vendors are named in the solicitation - Services are focused on regulatory and technical support for FDA electronic labeling submissions

Description

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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