STATEMENT OF NEED-Updated 3.30.26.docx

STATEMENT OF NEED

COMMON TECHNICAL DOCUMENT TEMPLATES

FOR THE

Defense Health Agency Research and Development (DHA R&D) OFFICE OF REGULATED ACTIVITIES (ORA)

1. INTRODUCTION

The Office of Regulated Activities (ORA) within Defense Health Agency Research and Development (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.

2. PURPOSE

The ORA requires Common Technical Document (CTD) authoring templates, training and maintenance. The CTD templates are used to facilitate standardized authoring and reviewing intended for regulatory submissions to the FDA. Without the CTD templates, the DHA R&D Direct Reporting Units (DRU) and ORA medical writing personnel are forced to rely on manual review and conversion of submission documents to conform to FDA and International Conference of Harmonisation (ICH) standards for regulatory submission documents.

3. SCOPE OF WORK

3.1. Task 1 – Supply Support.

1. The Contractor shall provide a complete set of granular CTD templates for all sections in Module 1 through Module 5 including appendices, a style guide, and any associated administration files to support U.S. FDA regulatory submissions for all application types during the period of performance of the established contract, such as;

· Investigational New Drug (IND)

· New Drug Application (NDA)

· Abbreviated New Drug Application (ANDA)

· Biologics License Application (BLA)

· Investigational Device Exemption (IDE)

· Premarket Notification (510(k))

· Premarket Approval (PMA)

2. The CTD templates shall include functionalities to increase writing efficiency and maintain formatting consistency, such as grouping series of commands or steps for frequently performed tasks into single button clicks. Macro functionality examples include, but are not limited to:

· Single click symbol tools

· Reference manager

· Multiple word search function

· Cross-linking and link insertion (i.e., to page numbers, tables, figures, and references)

· Title case

· Tables and figures addition and formatting

· Creating a Table of Contents (TOC), List of Tables (LOT), List of Figures (LOF)

· Updating fields

· Easy to read and aesthetically pleasing formatting styles including numbered and non-numbered bolded headings and sub-headings, indented Table of Contents, appendices, normal text, footnotes, and captions

3. The CTD templates shall group series of commands or steps for frequently performed tasks into single and minimal button clicks to reduce the amount of work for repetitive functions, increase productivity, and include tools for tables, figures, linking, List of Tables, List of Figures, Table of Contents, styles, footnotes, and title case with the ability to automatically update fields. Macro functionality examples include, but are not limited to:

· Single click symbol tools

· Reference manager

· Multiple word search function

· Insert links (i.e., to page number)

· Easy to read and aesthetically pleasing formatting styles (e.g. indented Table of Contents, numbered and bolded headings)

4. The templates shall allow application of template-specific functionality to existing documents not authored on Contractor’s CTD templates, or a simplified method, i.e., minimal mouse clicks, to transfer content to CTD templates with application of standardized formatting.

5. The Contractor shall ensure that CTD templates incorporate instructional text, formatting standards and regulatory and health authority guidance as recommended by the FDA, ICH, TransCelerate BioPharma and adopted by the U.S. FDA.

6. The Contractor shall provide access to user guides and technical documents.

3.2. Task 2 – Technical Accessibility.

1. Media Availability (Access): Vendor shall provide access to all technical data.

2. Technical Data Accessibility: DoD Staff shall have access to application software, any diagnostic software, operator, and service technical data required to operate and maintain the system on the DoD network.

3. The templates and all associated files and documentation shall be compatible with EDMS (Open Text Content Server electronic document management system).

4. The Contractor shall ensure compatibility with current Army desktop operating systems and office productivity software, (as of August 2020 is Microsoft Windows 10, Microsoft Word 2013 (32 bit), Microsoft Word 2016 (32 bit), and Microsoft Office 365).

5. The Contractor shall ensure the template files are compatible with Adobe Acrobat pdf maker/conversion and can be published in electronic Common Technical Document (eCTD) publishing software.

6. The templates shall be usable by personnel without direct access to ORA’s internal network drives.

3.3. Task 3 – Training and Training Support

1. The Contractor shall provide a Training Plan for Department of Defense (DoD) Medical Writing Staff and Systems Managers for the proposed system as configured to include the following topics: preparation for use and installation, software applications training, use instructions, troubleshooting, software updates and security patch instructions (if applicable).

2. The Contractor shall provide all available user and maintainer manuals, training videos, and documentation.

3. The Contractor shall offer, as part of the contract, training options for both individual and group service personnel that can be ordered as needed.

4. The online (and on DVD) training should include all the preventive and corrective maintenance services necessary to operate, maintain, and sustain the system its useful life.

3.4. Task 4 – Compliance Planning and Management

1. The CTD Templates must be and remain compliant with the most current U.S. FDA and ICH recommendations policies and regulations.

2. The Contractor shall provide a warranty for a period of 12 months from time of delivery. Warranty shall include all parts, software updates (if applicable), labor technical support, and shipping during the warranty period.

3. The Contractor shall notify the Army, of all notices affecting the system for the useful life of the system.

4. CONTRACT ADMINISTRATION

The Contract Administration Team will consist of the following members:

4.1. The Contracting Officer will have overall responsibility for administering the Contract. The Contracting Officer is the only person authorized to obligate the Government and make changes to the Contract. The Contracting Officer will manage Contract administration and performance delivery surveillance supported by Contract administrators and the COR.

4.2. The COR will be appointed in writing and will be directly responsible to the Contracting Officer. The COR serves as the Government’s point-of-contact for Contract-level coordination and administration. The COR will assist the Contracting Officer in overseeing the administration of the Contract as appropriate; assist in resolving issues; initiate changes; notify the Contracting Officer of any disputes or contractual issues that cannot be resolved; and conduct other activities as specified by appointment.

SoN 30 March 2026 Page 1 of 4

5. PERIOD OF PERFORMANCE/DELIVERY DATE:

The anticipated period of performance of this contract is five (5) years (base plus four (4) option years). The base year includes the purchase of the CTD Templates and any associated administrative files and the scope of the work identified in this Statement of Need (SoN). The four (4) option years shall include periodic updates of the entire CTD Templates suite.

Base Year: 4 May 26 – 3 May 2027;15 units Option Year 1: 4 May 27 – 3 May 2028;15 units Option Year 2: 4 May 28 – 3 May 2029;15 units Option Year 3: 4 May 29 – 3 May 2030;15 units Option Year 4: 4 May 30 – 3 May 2031;15 units

6. FEDERAL HOLIDAYS

The following Federal holidays are observed and no work or deliveries shall occur on the dates specified. Any of the below holidays falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday.

a. New Year’s Day, 1 January

b. Martin Luther King’s Birthday, 3rd Monday in January

c. President’s Day, 3rd Monday in February

d. Memorial Day, last Monday in May

e. Juneteenth, 18 June

f. Independence Day, 4 July

g. Labor Day, 1st Monday in September

h. Columbus Day, 2nd Monday in October

i. Veteran’s Day, 11 November

j. Thanksgiving Day, 4th Thursday in November

k. Christmas Day, 25 December

7. REFERENCES

FDA Guidance for Industry – “Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.” Revision 7. February 2020. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-electronic-format-certain-human-pharmaceutical-product-applications-0.