B01-W81XWH-20-C-0030-P00021 CPP-Notice of Intent to Sole Source.docx

Notice of Intent to Sole Source

The Defense Health Agency Contracting Agency (DHACA), on behalf of the Warfighter Protection and Acute Care Project Management Office (WPAC PMO) of the Operational Medical Solutions (OPMED), is issuing this Notice of Intent to Modify an Existing Contract within Scope. This is not a request for proposals. This notice does not represent a commitment by the government to pay for costs incurred from the preparation and/or submission of data in response to this notice.

The Government has a requirement is to increase the cost ceiling of the current contract to ensure all Food and Drug Administration (FDA) general recommendations and procedures applicable to the authorization of an Emergency Use Authorization (EUA) are followed and execution of all activities commensurate with serving as the Investigational New Drug (IND) application #14047 holder and regulatory sponsor in accordance with 21 Code of Federal Regulations 312 subpart D. Anticipated additional activities and costs may include (but are not limited to):

1. Additional consultant costs

1. Additional professional travel

1. Additional regulatory costs

PEO OPMED conducted market research activities on 24 April 2026. PEO OPMED’s technical experts conducted FDA website, and other web-based searches, and found no other FDA licensed company or any intellectual property for CPP. The market research found that research on CPP was performed by the Naval Blood Research Laboratory and the U.S. Army began development and testing of CPP in Q2FY08 with a Phase 1 clinical study. No United States companies were found to be interested in CPP. Although the Netherlands Armed Forces does use CPP, there are no controlled data analyses, or reports from which conclusions may be drawn regarding safety or efficacy. As a result, CPP will still need FDA approval for use in all DoD services. The market research conducted supports the conclusion there are no other FDA licensed companies for CPP in the U.S. that can manufacture the required product and complete FDA licensure.

Contract Modification W81XWH-20-C-0030-P00021 will be issued on a sole source basis. The North American Industry Classification System (NAICS) code for this requirement is 541715 and the size standard is 1,250 employees. Any sources that believe they are eligible to provide these services must respond in writing. Responses must be supported with clear and convincing evidence articulating the ability to provide the items outlined above. A request for documentation will not be considered an affirmative response. Information received will be considered solely for the purposes of determining whether a competitive procurement is in the best interest of the Government. If no written responses are received by the date listed below, which reflects fifteen (15) days after the publication of this notice, a contract modification will be awarded without further remark.

This notice is provided solely as information to the marketplace.

CONTACT INFORMATION: Questions may be submitted to Peter Mitchell at peter.d.mitchell8.civ@health.mil no later than 3:00PM Eastern Time on Thursday, 12 June 2026.