A02-Canine-Oxygen-Carrier-JA-20240823-Approved-Redacted (003).pdf

This is a Justification and Approval (J&A) document for a sole-source contract with Hemoglobin Oxygen Therapeutics, LLC (HbO2) for Canine Oxygen Carrier Manufacturing Restoration and Regulatory Activities. The United States Army Medical Research Acquisition Activity (USAMRAA) seeks to award a cost-reimbursement contract to HbO2 for restoring manufacturing capabilities and obtaining regulatory approval for Oxyglobin®, an FDA-approved oxygen carrier for military working dogs. HbO2 is the sole manufacturer of this product and the only FDA-approved canine oxygen carrier, making them uniquely positioned to conduct the required activities.

The document details multiple market research efforts, including Request for Information (RFI) and Sources Sought notices posted on SAM.gov between April and July 2024, which yielded no alternative vendors. HbO2 previously manufactured Oxyglobin® for about 15 years before production ceased in 2009, and they purchased the production assets in 2014. The contract aims to restore manufacturing processes, validate production methods, develop regulatory strategies, and continue the utility of Oxyglobin® for treating canines with low hemoglobin levels. The total estimated contract value is redacted, but the government intends to award the contract on a non-competitive basis under 10 U.S. Code 3204(a)(1).