HT9425-24-NOI-TJK2 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 award a contract to Octapharma USA, Inc. 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 has a critical requirement for supply of Freeze Dried Plasma (FDP) product available under a Food and Drug Administration (FDA) authorized Emergency Use Authorization (EUA).

On June 7, 2018, pursuant to section 564(b)(1)(B) of the Act (21 U.S.C. § 360bbb-3(b)(1)(B)), the Deputy Secretary of Defense determined that there is “a military emergency or significant potential for a military emergency, involving a heightened risk to U.S. military forces of an attack with an agent or agents that may cause, or are otherwise associated with an imminently life-threatening and specific risk to those forces.” Pursuant to section 564(b)(1) of the Act (21 U.S.C. § 360bbb-3(b)(1)), and on the basis of such determination, on July 9, 2018, the Secretary of the Department of Health and Human Services (HHS) then declared that circumstances exist justifying the authorization of emergency use of freeze dried plasma for the treatment of hemorrhage or coagulopathy during an emergency involving agents of military combat (e.g., firearms, projectiles, and explosive devices) when plasma is not available for use or when the use of plasma is not practical.

Octapharma USA, Inc. requested an EUA so that octaplasLG Powder, which is not FDA-approved, may be acquired, distributed, and held by DoD for preparedness purposes in advance of an actual threat of agents of military combat (e.g., firearms, projectiles, and explosive devices) that may cause, or are otherwise associated with, an imminently life-threatening and specific risk to U.S. military forces, with the intent that it may be administered by U.S. military medical personnel or other Authorized Providers during an event or post-event for the treatment of hemorrhage or coagulopathy caused by exposure to agents of military combat when plasma is not available for use or when the use of plasma is not practical.

The FDA authorized the emergency use of octaplasLG Powder on August 8, 2024 with the issuance of the Emergency Use Authorization.

A new supply contract 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 1,000 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 FDP product under an EUA. 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 Timothy Kelly at timothy.j.kelly169.civ@health.mil no later than 3:00PM Eastern Time on 7 September 2024.