6505-- Denosumab Injections
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The Department of Veterans Affairs (VA), through its NAC PHARMACEUTICALS office, is soliciting proposals for the supply of Denosumab Injections (60MG and 120MG). This unrestricted procurement aims to establish a Firm Fixed Price, Indefinite-Delivery Requirements contract to ensure an uninterrupted supply of this medication to the VA, Department of Defense (DoD), Bureau of Prisons (BOP), Indian Health Service (IHS), and Federal Health Care Centers. Proposals are due April 28, 2026, at 2:30 PM CDT.
Scope of Work & Key Requirements
This solicitation seeks to procure Denosumab 60MG Injection (estimated annual usage: 22,737 vials/syringes) and Denosumab 120MG Injection (estimated annual usage: 5,472 vials/syringes). Key requirements include:
- Packaging: Must be compatible with automated dispensing units; glass bottles are not acceptable.
- Labeling: Products must have a unique 11-digit National Drug Code (NDC) specific to the offeror.
- Barcoding: All pharmaceutical products require bar code labeling at the unit-of-use package level conforming to GS1-128 or HIBCC standards.
- Compliance: Adherence to Drug Supply Chain Security Act (DSCSA) requirements and cGMP compliance for manufacturing facilities.
- Commitment: Non-manufacturers must provide a Letter of Commitment assuring a sufficient source of supply.
- Pricing: If both vial and syringe presentations are marketed for the same strength, both must be offered at the same price.
Contract Details
- Contract Type: Firm Fixed Price, Indefinite-Delivery Requirements contract, structured in a commercial item format (FAR Part 12).
- Period of Performance: One base year with four pre-priced one-year option periods.
- Distribution: Products will be distributed through the VA’s and DoD’s respective Pharmaceutical Prime Vendor Programs.
- Award: One award will be made in the aggregate for both line items.
Submission & Evaluation
- Submission Method: Proposals must be submitted via email to Raymond.roldan@va.gov and Nicholas.mcgregor@va.gov. A scanned PDF of the signed corrected SF-1449 (from Amendment 0001) must be included. Faxed proposals are not accepted.
- Pricing: Offerors must submit prices for the base year and all four option years for both line items, ensuring prices do not exceed two decimal places and include a 0.5% Cost Recovery Fee.
- Evaluation: Award will be made to the responsible offeror with the Lowest Price Technically Acceptable (LPTA) offer. Technical acceptability criteria include meeting product descriptions, unique NDC, FDA approval, and FDA cGMP compliance.
Eligibility & Set-Aside
- Set-Aside: This is an unrestricted procurement.
- NAICS Code: 325412, with a size standard of 1,300 employees.
- Small Business Subcontracting Plan: Required for other than small business concerns if the contract value exceeds $900,000.
- Covered Drugs: Offerors of covered drugs must have an executed Master Agreement (MA) and Pharmaceutical Pricing Agreement (PPA) on file with the VA National Acquisition Center, FSS, with established Federal Ceiling Prices (FCPs) by the solicitation due date. Proposed drugs must be present on the Offeror’s FSS contract or interim agreement. Proposed biosimilar products must be FDA licensed and listed in the FDA Purple Book.
Additional Notes
Offerors should continuously monitor SAM.gov for any further updates. Point of Contact: Ray Roldan, Contract Specialist, Raymond.Roldan@va.gov.