Notice of Intent to Sole Source

NOTICE OF INTENT TO AWARD A SOLE SOURCE

The United States Army Medical Research Acquisition Activity (USAMRAA) intends to issue a Firm Fixed-Price sole source contract under the authority of FAR 6.302-1 (a) (2) - Only One Responsible Source and No Other Services will Satisfy Agency Requirements, on or about 31 January 2019 to Abbott Laboratories, 400 College Road East, Princeton, NJ 08540, on behalf of the United States Army Medical Materiel Development Activity (USAMMDA).

The Government has a requirement to develop a Food and Drug Administration (FDA) approved assay cartridge for use in the i-STAT® device to adjunctively screen and assess the presence or absence of the two Protein Biomarkers, Ubiquitin Carboxy-Terminal Hydrolase-L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP) in plasma or whole blood that are associated with Traumatic Brain Injury (TBI).

The key objectives in completing the requirements for this contract will be manufacturing of the assay cartridge, manufacturing multiple Investigational Use Only cartridge lots and determining the best regulatory pathway, based on FDA guidance, and conducting applicable clinical trials that will support FDA submission(s) for a TBI Point of Care (POC) platform for use by medical personnel in garrison and deployed environments.

The contractor will be required to design and execute clinical trials of TBI biomarkers GFAP and UCH-L1 on a POC device and to complete and manage submissions(s) to the FDA through market approval. The clinical trial(s) should be designed to reach indication(s) for use of plasma or whole blood to 1) determine the need for a Computed Tomography (CT) scan of the head 2) aid in the diagnosis of TBI and 3) provide prognosis on recovery of TBI patients.

The Army currently fields the i-STAT® for the evaluation of other disease conditions using blood from patients in garrison and combat environments. The ability to use the i-STAT® to screen for the presence of TBI biomarkers is imperative for the U.S. Army. Abbott is the sole manufacturer and provider of the i-STAT®, and does not authorize resellers of this POC device.

Interested contractors may identify their interest and bona fide capability to fulfill this requirement. This notice of intent is not a request for competitive proposals. Interested parties who believe they can meet this requirement shall submit information about their capabilities no later than 4:00 PM EST, 09 JULY 2018. All questions and responses concerning this notice shall be emailed to Herbert Caj Keen at herbert.e.keen.civ@mail.mil. All information shall be furnished at no cost or obligation to the Government. No solicitation will be made available. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. A determination by the Government not to compete this proposed solicitation based upon responses to this notice is solely within the discretion of the Government. Telephone inquiries will not be accepted.