B01-Canine-Oxygen-Carrier-NOI-Sole-Source-Final.docx

Notice of Intent to Sole Source

The United States Army Medical Research Acquisition Activity (USAMRAA) on behalf of the United States Army Medical Materiel Development Activity (USAMMDA), Warfighter Protection and Acute Care Project Management Office (WPAC PMO), intends to execute an award on a sole source basis under the authority of FAR 6.302-1(a)(2), only one responsible source and no other supplies or services will satisfy agency requirements, to Hemoglobin Oxygen Therapeutics, LLC (HbO2), 674 Souder Road, Souderton, PA 18964. This requirement is intended to 1) restore manufacturing operations and processes and 2) obtain regulatory approval of Oxyglobin®, a canine oxygen carrier for use in damage control resuscitation of military working dogs. Anticipated activities may include (but are not limited to) manufacturing process optimization and implementation; manufacturing process validation; and regulatory strategy and development.

HbO2 is the only source able to meet the Government requirements. The purpose of this contract is to to obtain an Food and Drug Administration (FDA) cleared blood product for operational use in canines in accordance with the Department of Defense (DOD) Acquisition System, FDA regulations and guidelines, and industry best practices. In direct support of the USAMMDA product development effort, the Government is seeking to restore production capability of Oxyglobin®. HbO2 is uniquely positioned to execute the necessary activities to restore production capability of a canine oxygen carrier. Oxyglobin® is the only Hemoglobin Based Oxygen Carrier (HBOC) licensed specifically for canine use by the FDA Center for Veterinary Medicine (CVM). HbO2 is the sole manufacturer for the FDA approved Oxyglobin® canine oxygen carrier; therefore they are the only contractor who has the necessary knowledge and expertise to conduct this effort.

This notice of intent is not a request for competitive proposals and no solicitation document exists for the requirement. Sources interested in responding to this notice are required to submit a capability statement that includes management and technical data and cost information, in sufficient detail and with convincing evidence that clearly demonstrates the capability to perform the required work. Capability statements shall not exceed 5 (8.5 x 11 inch) pages using a font size no smaller than 10-point. All capability statements received by the due date of this notice will be considered by the Government. A request for documentation or additional information or submissions that only ask questions will not be considered as an affirmative response. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole source purchase order.

Capability statements are due by 2:00 PM Local Time, 23 July 2024. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to the following address: jamie.l.diggs.civ@health.mil.