Notice of Intent to Sole Source: Canine Oxygen Carrier Manufacturing Restoration and Regulatory Activities
Closed Special Notice Posted
This opportunity was awarded. See the award notice from .
- Solicitation number
- HT942524R0118
- Agency
-
Defense Health Agency
Department of Defense
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Place of performance
- Frederick, Maryland 21702, United States
Notice details come from SAM.gov. Updated .
About this opportunity
This Special Notice is from 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). The notice expresses the government's intent to award a sole source contract to Hemoglobin Oxygen Therapeutics, LLC (HbO2) to restore manufacturing operations and processes, and obtain regulatory approval of Oxyglobin, a canine oxygen carrier for use in damage control resuscitation of military working dogs.
The purpose of this effort is to optimize and validate the manufacturing process for Oxyglobin, as well as develop a regulatory strategy to obtain approval. Key deadlines include the July 23, 2024 due date for contractors to submit capability statements by email. HbO2 is the only eligible contractor, as they are the sole manufacturer of the FDA-approved Oxyglobin product. This opportunity falls under NAICS code 541715 - Research and Development in the Physical, Engineering, and Life Sciences, and PSC code AN13 - Health R&D Services; Health Care Services; Experimental Development.
Notice text
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.
Files
| File | Type | Posted |
|---|---|---|
| B01-Canine-Oxygen-Carrier-NOI-Sole-Source-Final.docx | DOCX document |
Notice history
| Notice | Type | Posted |
|---|---|---|
| Notice of Intent to Sole Source: Canine Oxygen Carrier Manufacturing Restoration and Regulatory Activities | Award Notice | |
| This notice | Special Notice | |
| Canine Oxygen Carrier Manufacturing Restoration and Regulatory Activities | Pre-Solicitation |
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