SAM #HT942726RE005

DHA Solicitation for eCTD Software Licenses, Maintenance, Support, and Training

The Defense Health Agency (DHA), through its Enterprise Information Technology Project Management Office (eIT PMO), is soliciting proposals for Electronic Common Technical Document (eCTD) software and related services to support regulatory submissions. - Government Buyer: - Defense Health Agency (DHA), Enterprise Information Technology Project Management Office (eIT PMO), Defense Health Agency Contracting Activity (DHACA) - Products and Quantities: - 12 eCTD publishing user licenses - 50 named eCTD reviewer licenses (concurrent users) - FDA-mandated eCTD submission templates - Services Requested: - Annual software maintenance and technical support for eCTD software and templates - Consulting services for installation, upgrades, validation, project management, and regulatory support - Training services, including standard, advanced, administrator, and reviewer courses (scheduled as needed, pricing per class) - Reimbursable travel for in-person training and consulting at Fort Detrick - Service contract reporting as required - Notable Requirements: - Software must comply with FDA 21 CFR Part 11 and support integration with DHA systems - Emphasis on cybersecurity compliance (CMMC) and technical support for DoD network installations - 100% small business set-aside under NAICS 513210 (Software Publishers) - Contract includes a base year, four one-year options, and a six-month extension (total up to 66 months) - OEMs and Vendors: - No specific OEMs or vendors are named in the solicitation; offerors may propose any compliant eCTD solution - Additional Details: - FDA-mandated templates and validation test scripts are required - Offerors must be registered in SAM and meet all DoD cybersecurity requirements

Description

This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with the format in FAR subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested, and a written solicitation will not be issued. The solicitation number is HT942726RE005. The solicitation is issued as a Request for Proposal (RFP). Provisions and clauses in effect through Federal Acquisition Circular (FAC) 2026-01 are incorporated. It is the contractor’s responsibility to be familiar with the applicable clauses and provisions. The clauses may be accessed in full text at these addresses: https://www.acquisition.gov/content/regulations. The NAICS code is 513210 (Software Publishers), with a small business size of $47.0M. This requirement is being solicited competitively as a 100% total small business set-aside in accordance with FAR 12, Acquisition of Commercial Products and Services and FAR 13, Simplified Acquisition Procedures.

The Defense Health Agency Contracting Activity (DHACA) is issuing this RFP on behalf of the Enterprise Information Technology (eIT) Project Management Office (eIT PMO). This requirement is for Electronic Common Technical Document (eCTD) Software License, Maintenance, Technical Support Services, and Training for eCTD Publishing and Reviewing Software Products and Modules.

Solicitation Issue Date: 08 Jun 2026

Questions Due Date/Local Time: 11 Jun 2026, 04:00 PM Easter Daylight Time (This is the correct due date/time. Please note that this due date/time conflicts with the information listed on page 107 of the solicitation.)

Offer Due Date/Local Time: 06 Jul 2026, 4:00 PM Eastern Daylight Time

NOTE: Please be aware of the System for Award Management (SAM) and Cybersecurity Maturity Model Certification (CMMC) requirements for this solicitation. Do not wait to initiate these processes.

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