JA_Exception LSJ Redacted.pdf

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Attached to
OneNexus Program J&A LSJ
Solicitation number
75F40125Q00083
Issued by

About this file

This is a section of a Limited Sources Justification document outlining the requirements for documenting the authority and rationale for a sole source procurement. The document relates to IT services for the FDA's OneNexus program, an enterprise-wide workflow and knowledge management platform.

The acquisition is intended as a follow-on to existing Order 75F40121A00008/75F40122F19004 for the FDA's Center for Drug Evaluation and Research (CDER). The platform supports CDER's compliance with various legislative requirements including PDUFA, GDUFA, BsUFA, OMUFA, CARES, and 21st Century Cures. The contract was awarded under GSA Schedule GS-35F-393CA with an award date of February 14, 2025, though the vendor and award amount are not specified.

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4. The authority and supporting rationale (see FAR 8.405-6(a)(1)(i); (b)(1)) and, if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

a. Acquisition authority.

b. Demonstration of the proposed contractor(s) unique qualifications to provide the required supply or service.

Name and address of the proposed contractor(s).

File details come from the government source that posted it. Updated .