Request for Information for Structured Product Labeling (SPL) Document Support for DHA R&D - MRDC - ORA
Type: Special Notice
Overview

Buyer

DEPT OF DEFENSEDEFENSE HEALTH AGENCY (DHA)

Original Source

https://sam.gov/opp/a0c93674ee124379a9c161749bd6b8aa/view
Timeline
    Description

    The Defense Health Agency (DHA) is seeking information through a Request for Information (RFI) regarding Structured Product Labeling (SPL) document support for its Research & Development Medical Research and Development Command (MRDC). The objective is to assess the feasibility of acquiring commercial solutions that facilitate the submission of SPL documents to the FDA for three licensed New Drug Application (NDA) products requiring labeling changes. This initiative is crucial for ensuring compliance with FDA regulations and maintaining the integrity of product labeling processes. Interested parties must submit their Capabilities Statements by April 17, 2025, detailing their ability to create, update, and submit SPL documents, along with adherence to technical standards and system validation processes. For further inquiries, respondents can contact Alana M. Sowers at alana.m.sowers.civ@health.mil.

    Point(s) of Contact
    Alana M. Sowers
    alana.m.sowers.civ@health.mil
    Files
    Title
    Posted
    Request For Information for Structured Product Labeling Document Support.pdf
    The Defense Health Agency Research & Development Medical Research and Development Command (DHA R&D – MRDC) is seeking information through this Request for Information (RFI) to assess the feasibility of acquiring commercial solutions for Structured Product Labeling (SPL) document support. The target is to facilitate and manage the submission of SPL documents to the FDA for three licensed New Drug Application (NDA) products that require labeling changes. Respondents must provide a Capabilities Statement that includes details on creating, updating, and submitting SPL documents; adherence to technical conformance criteria; system validation processes; and compliance with FDA and industry standards. The RFI seeks responses from software companies that can offer both software and training for internal SPL updates. Responsiveness will involve a range of technical specifications and procedural details to ensure quality and accuracy when submitting labeling changes. Submissions are due by April 17, 2025, and must be formatted as specified. This market research effort serves primarily for information-gathering and planning, rather than as a solicitation for proposals, emphasizing the importance of compliance and capability in the SPL process within the regulatory framework of the FDA.
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