RFI HT9426-26-RFI-0023.docx

THIS IS A REQUEST FOR INFORMATION (RFI)/SOURCES SOUGHT (SS) NOTIFICIATION TO INCLUDE INDUSTRY FEEDBACK

1. Title: StartingPoint Common Technical Document (CTD) Authoring Templates, Training, and Maintenance for the Defense Health Agency R&D (DHA) Office of Regulated Activities (ORA)

2. Contracting Office: Defense Health Agency Contracting Activity (DHACA)

3. Location: Fort Detrick, Frederick, MD

4. Summary: This RFI/SS is issued solely for information and planning purposes and shall not be construed as a solicitation, restrict the Government as to the ultimate acquisition approach, or serve as an obligation on the part of the DHA R&D. Not responding to this RFI/SS does not preclude participation in any future Request for Proposal, if any is issued. No evaluation letters and/or results will be issued to Responders responding to this RFI/SS. The information resulting from this RFI/SS will determine interest and capabilities available in the marketplace; and will assist in developing acquisition strategy.

5. Background/Scope: The Office of Regulated Activities (ORA) within DHA R&D is a multidisciplinary team of regulatory affairs and clinical compliance professionals dedicated to supporting the DHA R&D mission of developing U.S. Food and Drug Administration (FDA) regulated medical products for the warfighter.

The ORA requires a subscription for StartingPoint Common Technical Document (CTD) authoring templates, training, and maintenance to facilitate standardized authoring and reviewing of documents intended for regulatory submissions to the FDA. The objective is to increase writing efficiency, maintain formatting consistency, and ensure compliance with FDA and International Council for Harmonisation (ICH) standards.

DHA R&D ORA has been using Microsoft Word macro-based CTD authoring templates supplied by Accenture Federal Services. Current and previous contract awards were sourced solely to Accenture because there were no comparable sources meeting requirements, nor were there any resellers of the Accenture branded templates. Market research has shown that there are currently no potential resellers of the Accenture templates, maintenance and support, nor any companies that can fully provide CTD authoring templates that meet ORA’s requirements.

ORA’s current CTD templates are Microsoft Word macro-based template documents. The Department of War, specifically ORA, would like to eventually move towards cloud-based office products, including MS Word. In addition, The DoW’s security posture on employee computing devices and software has been becoming increasingly more robust. Therefore, CTD Template vendors should be positioned to offer products that work on a variety of technological platforms.

Vendor’s capability statements must include how their solution addresses the following requirements:

A. Supply Support & Template Functionality:

· A complete set of granular CTD templates for all sections in Module 1 through Module 5, supporting all U.S. FDA application types (e.g., IND, NDA, BLA, IDE, 510(k), PMA).

· Macro functionalities to increase efficiency, including but not limited to: single-click symbol tools, reference manager, multiple-word search, cross-linking, automated generation of TOC/LOT/LOF, and tools for table/figure formatting.

· The ability to apply template-specific functionality and formatting to existing documents not authored in the provided templates.

· Incorporation of instructional text, formatting standards, and regulatory guidance from the FDA, ICH, and TransCelerate BioPharma.

· Access to comprehensive user guides and technical documents.

B. Technical Accessibility & Compatibility:

· Compatibility with current Army desktop operating systems and software (Microsoft Windows 10, Microsoft Word 2013/2016 (32 bit), Microsoft Office 365).

· Compatibility with EDMS (Open Text Content Server), Adobe Acrobat PDF conversion, and eCTD publishing software.

· Assurance that templates are usable by personnel without direct access to ORA’s internal network drives.

C. Training and Support:

· A Training Plan for DoD Medical Writing Staff and Systems Managers.

· Availability of user/maintainer manuals, training videos, and related documentation.

· Options for ordering individual and group training as needed.

D. Compliance and Maintenance:

· A process for ensuring CTD templates remain compliant with the most current U.S. FDA and ICH recommendations and regulations.

· The ability to provide periodic updates to the entire CTD template suite for a potential five-year period of performance.

6. How to Respond:

Please submit a Capability Statement that describes relevant expertise and capabilities based upon the scope of this requirement as outlined above. Each response should include the following business information and must not be more than ten (10) pages in length:

a) Company name, mailing address, e-mail address, telephone, website address (if available), and the name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives.

b) Unique Entity ID number, CAGE Code, and company structure (Corporation, LLC, partnership, joint venture, etc.). Companies also must be registered in System for Award Management (SAM, at www.sam.gov) to be considered as potential sources.

c) Any and all Government IDIQ Contracts (e.g. Federal Supply Schedule, OASIS, etc.) you currently hold that could be used to fulfill this requirement.

d) Describe your organization's specific and relevant experience to fulfill this requirement. Experience must be of similar size and scope. Please provide examples or references of previously completed deliverables.

e) Provide information relating to your solution’s capabilities, novel ideas, and industry best practices that meet the Government’s requirements as outlined above.

Capability statements will be evaluated to the degree to which they demonstrate how they meet the aforementioned CTD requirements.

7. Submission Information:

The formal closing date for this RFI/SS and for the submission of all responses is NLT 15 April 2026 at 12:00PM ET. All responses shall be submitted electronically using PDF or MS Word formats to the POC, Mr. Kevin Jandovitz at kevin.t.jandovitz.civ@health.mil. The Government will not entertain questions regarding this RFI/SS.

Note:

In accordance with RFO FAR 15.101: The Government does not intend to award a contract solely on the basis of the RFI nor will the Government otherwise pay for the information requested; and responses to this RFI/SS will be treated as information only and not as a proposal.

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