B01-Canine-Oxygen-Carrier-Sources-Sought-Notice-Final.docx

Sources Sought Notice

This Sources Sought Notice (SSN) is for market research, information, and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the United States Army Medical Research Acquisition Activity (USAMRAA) or the United States Army Medical Materiel Development Activity (USAMMDA).

This SSN is being issued by USAMRAA on behalf of USAMMDA, Warfighter Protection and Acute Care Project Management Office (WPAC PMO) and is seeking sources 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.

If capable sources are not identified through this notice, then USAMRAA intends to execute an award on a sole source basis under the authority of FAR 6.302-1 to Hemoglobin Oxygen Therapeutics, LLC (HbO2), 674 Souder Road, Souderton, PA 18964.

The U.S. Army has a requirement to obtain an 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 SSN 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 five (8.5 x 11 inch) pages using a font size no smaller than 10-point. The Government will consider all capability statements received by the due date of this notice. 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 contract modification.

Capability statements are due by 2:00 PM local time, 16 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.