CPP-Notice of Intent to Sole Source.docx

Notice of Intent to Sole Source

The United States Army Medical Research Acquisitions Activity (USAMRAA), on behalf of the United States Army Medical Materiel Development Activity (USAMMDA), 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. The necessity of a contract modification is due to an increase in the number of subjects required to statistically show non-inferiority between CryoPreserved and Liquid Stored Platelets several significant changes with the patient enrollment rate and the current contract research organization (CRO). The CRO’s performance has enabled the completion of the Phase 2 trial, consequently leading to the initiation of the Phase 3 trial required to bring Cryopreserved Platelets (CPP) to FDA licensure. Anticipated additional activities and costs may include (but are not limited to):

1. Additional enrollment up to 400 subjects

1. Additional consultant costs

1. Additional professional travel

1. Additional material costs

1. Additional regulatory costs

1. Additional site activations PEO OPMED conducted market research activities on 3010 Oct SEP 2024. 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 U.S. 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. Australia is conducting clinical studies on cryopreserved platelets. An Australian Phase 1 Trial (CLIP-1) showed no evidence of harm for cryopreserved platelets when compared to liquid-stored platelets. The Phase 2 Trial (CLIP-II) to determine cryopreserved platelet safety and efficacy is currently underway in nine Australian and five New Zealand hospitals. No commercial cryopreserved platelet manufacturer was identified in either foreign study. As a result, CPP will still need FDA approval for use in all DoD services Army. 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-P00017 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 Wednesday, 20 January 2025.