Electronic Common Technical Document (eCTD) Software License, Maintenance, Technical Support Services, and Training for eCTD Publishing and Reviewing Software Products and Modules

CUI/FNC CUI/FNC U.S. DEPARTMENT OF DEFENSE DEFENSE HEALTH AGENCY PERFORMANCE WORK STATEMENT eCTD SOFTWARE LICENSE, MAINTENANCE, TECHNICAL SUPPORT SERVICES, AND TRAINING FOR eCTD PUBLISHING AND REVIEWING SOFTWARE PRODUCTS AND MODULES ENTERPRISE INFORMATION TECHNOLOGY (eIT) PROJECT MANAGEMENT OFFICE (eIT PMO) Solicitation Number: HT942726RE005 Version: 1 Date: 08 June 2026 -- 1 of 33 -- CUI/FNC 1 PART 1 GENERAL INFORMATION 1.1 This is a non-personal services contract to provide Electronic Common Technical Document (eCTD) software license and templates, maintenance, technical support services, and training for eCTD publishing and reviewing software products and modules. 1.2 Description of services/introduction: The Contractor shall provide commercial off-the-shelf (COTS) eCTD publishing and reviewing software licenses, non-personal services necessary to perform eCTD software license, maintenance, technical support services, and training for eCTD publishing and reviewing software products and modules as defined in this Performance Work Statement (PWS) except for those items specified as Government furnished property and services. The Contractor shall perform to the standards described in this PWS. 1.3 Background: The eCTD Publisher System is intended for use by eIT PMO customers/user base for preparation and lifecycle maintenance of electronic regulatory submissions originating from the Army Office of the Surgeon General (OTSG) sponsored investigational product development. The critical function of the system is the ability to generate electronic regulatory submissions. In addition, the system shall have the ability to automate workflow steps required to manage preparation of electronic submissions for submission to regulatory agencies (e.g., the U.S. Food and Drug Administration [FDA]). 1.4 Objectives: The eCTD publishing system shall be used for: • Preparation and lifecycle maintenance of electronic regulatory submissions • Greater efficiency within regulatory submissions by reducing manual publishing steps, minimizing rework, and decreasing submission preparation timelines • A higher level of compliance with applicable regulations through system validation, standardized templates, and automated validation checks The eCTD publishing system shall have the ability to: • Scale to support increases in the number of electronic regulatory submissions resulting from expanding clinical trial activities, including multiple concurrent preparation and review activities, without degradation of system performance • Provide seamless access to third parties (e.g., external regulatory reviewers, CROs, etc.) • Integrate the eCTD publishing system with other key Defense Health Agency (DHA) systems (e.g., Open Text – Content Server) 1.5 Scope: The eIT PMO needs to acquire software licenses and maintenance for twelve (12) eCTD Publisher user accounts and up to fifty (50) named eCTD reviewer accounts. Additional services required are FDA-mandated submission templates, technical support services for resolving application problems, training services for both the eCTD publishing and reviewing users, FDA- validated software installation support and scripts, and non-personal services to support regulatory questions by eCTD publishers. 1.6 Period of Performance: The anticipated period of performance of this contract is 15 July 2026 through 14 January 2032. There will also be four (4) one-year renewable options and a six (6) month extension to be -- 2 of 33 -- CUI/FNC 2 exercised at the discretion of the Government (total potential of a five-and-one-half-year (5.5 year) contract). • Base Period: 15 July 2026 – 14 July 2027 • Option Period 1: 15 July 2027 – 14 July 2028 • Option Period 2: 15 July 2028 – 14 July 2029 • Option Period 3: 15 July 2029 – 14 July 2030 • Option Period 4: 15 July 2030 – 14 July 2031 • 6-month extension: 15 July 2031 – 14 Jan 2032 The Contract Specialist will notify the Contractor of the intent to exercise an option year 90 calendar days before the option is to be exercised. 1.7 Administrative specifications: Place of performance: The work shall be performed remotely. 1.7.1 Recognized Federal holidays: Contractor is not required to perform on the following holidays: New Year’s Day Labor Day Martin Luther King Jr.’s Birthday Columbus Day President’s Day Veteran’s Day Memorial Day Thanksgiving Day Juneteenth Day Christmas Day Independence Day -- 3 of 33 -- CUI/FNC 3 1.7.2 Hours of operation: The Contractor is responsible for conducting business Monday through Friday, except for federal holidays. The Contractor must at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS. 1.7.3 Emergency Services: On occasion, services may be required to support an activation or exercise of contingency plans outside the normal duty hours. 1.8 Contractor travel: (Reimbursable) Travel cost estimate for in-person trainings or for technical consulting support held at Fort Detrick to fully support end users and administrators. See PWS Sections 5.3 (Task 3: Training Consulting and Technical Support Services) 5.4 (Task 4: Travel). 1.9 Other Direct Costs (ODC): The Government intends to utilize “Plugged” Not-to- Exceed (NTE) amount for all ODCs listed. 1.10 Quality 1.10.1 Quality Control (QC): The Contractor shall develop and maintain an effective QC program to ensure services are performed in accordance with this PWS. The Contractor shall develop and implement procedures to identify, prevent, and ensure nonrecurrence of defective services. The Contractor’s QC program is how the work complies with stated requirements. A Quality Control Plan (QCP) (Deliverable 1) will initially be submitted NLT thirty (30) calendar days after contract award (DACA). After acceptance of the QCP, the Contractor shall receive the CO’s acceptance in writing of any proposed change to the QC system. 1.10.2 Quality assurance (QA): The Government will e…