Notice of Intent to Sole Source Pivotal Novel Countermeasure.docx

Notice of Intent to Sole Source

The United States Army Medical Research Acquisition Activity (USAMRAA), on behalf of the United States Air Force (USAF) 59th Medical Wing, Science and Technology Office is issuing this notice of intent to award a new contract on a sole source basis. 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 intends to award a sole source contract to the University of Colorado. This is a follow-on Phase II requirement will help to develop evidence-based approaches to treat, monitor, and manage brain injuries, especially in deployed and prolonged care settings. This study builds upon the current research team’s prior Phase I study “Pivotal validation of a novel countermeasure to improve recovery following traumatic brain injury (TBI) combined with hemorrhagic shock in prolonged field care, delayed evacuation, or remote settings before evacuation.”

The main objectives are summarized as follows:

· To determine whether intravenous (IV) administration of tatM2NX after TBI will improve neurological severity score (NSS), memory function, reduce neuronal cell death and TBI-related biomarkers post insult.

· Assess pharmacokinetics in an uninjured large swine model and general safety outcome data (blood chemistry, renal and hepatic function).

This contract will be issued on a sole source basis as the Government’s market research indicates that the University of Colorado is the only source capable of providing the requested Research and Development services. The North American Industry Classification System (NAICS) code for this requirement is 541714 (Research and Development in Biotechnology (Except Nanobiotechnology)) and the small business size standard is 1,000 Employees. Any sources that believe they are eligible and capable of providing 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, the contract will be awarded without further remark.

This notice is provided solely as information to the marketplace.

CONTACT INFORMATION: Questions may be submitted to Mr. Eric Zampelli at eric.m.zampelli.civ@health.mil no later than 12:00PM EST on Wednesday, 06 May 2024.