DXC TOOLBOX PHARMA EDITION SOFTWARE LICENSE (AMBIS 2212050)

This is a Notice of Intent, not a request for proposal. The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) intends to negotiate on an other than full and open competition basis with DXC Technology Company, 20408 Bashan Drive, Suite 231, Ashburn, VA 20147-5552, to procure a DXC Toolbox Pharma Software.

This is a new purchase of a DXC Toolbox Pharma software that will be used to replace the current software that is no longer accessible to NIAID in the Office of Cyber Infrastructure and Computational Biology (OCICB), Clinical Informatics Branch (CIB).

This requirement is for the purchase of DXC ToolBox Pharma Edition software. The current PDF verification tool utilized for electronic Common Technical Document (eCTD) submissions is Calyx SmartDesk for PDF. However, our perpetual license would no longer have access to the Calyx support team or any future updates/upgrades to the application after December 31st, 2023. Upon evaluating alternative options, it was determined that DXC Toolbox Pharma Edition is the only standalone software available that meets and exceeds the functional requirements for Investigational New Drug (IND) and Drug Master File (DMF) eCTD submissions. DXC Toolbox Pharma Edition software helps develop, modify, and validate documents, create bookmarks and hyperlinks, report metrics, and perform other PDF transformation operations. The tool is used to perform bulk Quality Control (QC) reviews and editing of PDF files from DXC Technology to support the eCTD submissions of IND and DMF studies to the Food and Drug Administration (FDA). The tool will enable the NIAID research divisions, primarily the Division of AIDS (DAIDS) and the Vaccine Research Center (VRC), to continue to meet the regulatory compliance requirement from the FDA to perform the QC review activities on all documentation compiled in support of FDA eCTD submissions. Also, the software has key features that will allow the NIAID contract research organizations (CROs) and Divisions to effectively perform eCTD submission documentation Quality Control reviews and updates.

Description of the supplies/services to be purchased:

1. ToolBox Pharma CONCURRENT - License Fee, item SW-TBX-PHA, qty 10


2. ToolBox Pharma CONCURRENT - Annual Support and Maintenance Fee, qty 1


3. ToolBox Pharma NON-CONCURRENT - License Fee, item SW-TBX-PHA, qty 20


4. ToolBox Pharma NON-CONCURRENT - Annual Support and Maintenance Fee, qty 1

J&A: DXC Toolbox Pharma Edition software and all its component parts are the exclusive property of DXC Technology. The licenses are proprietary software which can only be obtained from the manufacturer. DXC Technology does not have any resellers/distributorships or service providers for their software.

Period of Performance(s) are as follows:

• April 1, 2024 to March 31, 2025

Service shall be performed at the following locations: NIH/NIAID/OCICB/CIB, 5601 Fishers Lane, Rockville, MD 20852.

The statutory authority for this sole source requirement is 41 U.S.C. 253 (c) (1) as implemented by FAR 13.106-1 only one responsible source and no other supply of service will satisfy agency requirements. THIS IS NOT A SOLICITATION FOR COMPETITIVE QUOTATIONS. All responsible sources that could provide the required services may submit a capability statement that will be considered by email (subject line to reference NOI-NIAID-24-2212050 to Rita Davis at rita.davis@nih.gov, by 11:00am eastern standard time Monday, March 4, 2024. All responses received by the closing date of this synopsis will be considered by the Government. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.