Stability Testing for ManNAc Drug Product produced in Campaigns 5 and 6. Stability testing will occur under regulatory compliance

GENERAL INFORMATION Title: Stability Testing for ManNAc Drug Product produced in Campaigns 5 and 6. Stability testing will occur under regulatory compliance Background Information: NHGRI was gifted 48kg of unlabeled drug ManNAc (powder-in-sachet) in September 2025, and agreed to take over the FDA-required, mandatory, stability testing program of this drug that has been ongoing at Alcami Corporation since June 2024. The gifted drug was produced in 2 campaigns, Campaign 5 (C5, June 2024) and Campaign 6 (C6, September 2024). NHGRI plans to use the donated clinical grade drug for upcoming clinical trials. CLOSING STATEMENT This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include a technical proposal, a cost-price proposal, the period of performance, the Unique Entity ID (UEI), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses must be received by November 9, 2026 at 9:00 AM Eastern time and must reference solicitation number 75N98027Q00040. Responses may be submitted electronically to Mr. James Law, Contracting Officer at [email protected]. Fax responses will not be accepted. "All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency.”