SPECIAL NOTICE
R -- RFI- Kit production, storage, shipment, and training for FDA-approved blood assay for traumatic brain injury (TBI)
- Notice Date
- 5/31/2018
- Notice Type
- Special Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of the Army, U.S. Army Medical Research Acquisition Activity, U.S. Army Medical Research Acquisition Activity, Attn: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014, Maryland, 21702-5014, United States
- ZIP Code
- 21702-5014
- Solicitation Number
- RFI-HK-31MAY2018
- Archive Date
- 6/30/2018
- Point of Contact
- Herbert Caj Keen, Phone: 3016191011
- E-Mail Address
-
herbert.e.keen.civ@mail.mil
(herbert.e.keen.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- REQUEST FOR INFORMATION 1.0 RFI TITLE: Kit production, storage, shipment, and training for FDA-approved blood assay for traumatic brain injury (TBI) 2.0 AGENCY: Unites States Army Medical Materiel Development Activity (USAMMDA) 3.0 OFFICE: Neurotrauma and Psychological Health Program Management Office (NPH PMO) 4.0 LOCATION: Product will be incrementally shipped to up to three CONUS military installations to be identified by the government from the following: FT Bragg, FT Carson, FT Hood, FT Benning, Joint-Base San Antonio, Camp Pendleton, FT Bliss, FT Campbell, Camp Lejeune. 5.0 SUBJECT: The Neurotrauma and Psychological Health Program Management Office of the United States Army Medical Materiel Development Activity (USAMMDA) is conducting market research to determine whether sources are available to meet requirements for a FDA-approved blood test assay to aid in the evaluation of patients 18 years of age and older with suspected traumatic brain injury (Glasgow Coma Scale score 13-15). The provided solution will need to be produced and managed by the contractor in addition to being compatible with government owned equipment. This market research may also assist with the further development and/or refinement of the requirements. 6.0 DISCLAIMER: This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. In keeping with the standards of FAR Part 10, the Government may request additional information from responders. Responders are solely responsible for all expenses associated with responding to this RFI or any follow-up information request. All information received in response to this RFI or any follow-up information request that is marked Proprietary will be handled accordingly. Responses to the RFI will not be returned. At this time, questions concerning the composition and requirements for a future request for proposal will not be entertained. At this time, the Government intends to award a contract to Banyan Biomarkers, Inc. using other than full and open competition using the authority at FAR 6.302-1. This Request for Information is being published in accordance with DFARS PGI 206.302-1. 7.0 DESCRIPTION: Neurotrauma and Psychological Health Program Management Office of the United States Army Medical Materiel Development Activity has a requirement to obtain a commercialized FDA-approved blood assay using two protein biomarkers (Ubiquitin Carboxy-terminal Hydrolase-L1 or UCHL-1 and Glial Fibrilliary Acidic Protein or GFAP) that provide objective data to healthcare providers when evaluating patients with suspected traumatic brain injury (TBI). The blood test assay shall be compatible with the government-owned BioTek Synergy 2 ELISA software and hardware system. In addition, the government requires protocol-specific training on the proper use of the assay, to include system set-up, installation, and performance calibrations. Specific requirements include: - Produce and store two-hundred (200) Banyan BTI TM kits (referred to as "Kits") to be incrementally shipped to one Contiguous United States (CONUS) military installation to-be-identified by the government from the following: FT Bragg, FT Carson, FT Hood, FT Benning, Joint-Base San Antonio, Camp Pendleton, FT Bliss, FT Campbell, Camp Lejeune. Shipments will continue over the period of performance in quantities to be determined by the government. - Maintain temperature-controlled storage and shipment of the kits in accordance with the manufacturer's specifications. - Provide protocol-specific training packages through the Aviation and Missile Research Development and Engineering Safe Access File Exchange (AMRDEC SAFE) prior to conducting training. - Travel to the identified training location prior to the shipment of kits and perform a one-day Precision Qualification Package to include Installation Qualification Procedure and Checklist/Operational Qualification Procedure/Performance Qualification Procedure (IQ/OQ/PQ) on the Banyan Brain Trauma Indicator (BTI) system to certify the system is properly calibrated to process the Banyan BTI kit. A report indicating the outcomes of this procedure will be provided to the government. - Provide a one-day protocol training on the Banyan BTI kit to on-site personnel immediately following a successful system qualification. 8.0 SUBMISSION INSTRUCTIONS: Entities interested in submitting a response must furnish a Capabilities Statement. Submissions shall be kept to one to three pages. The subject header of the email for submission of questions and/or the RFI response shall be: RFI Response: FDA-approved blood assay for traumatic brain injury (TBI). All information regarding capabilities statements or any other proprietary information relative to this RFI shall be marked appropriately. Submission should include the following information: 8.1 Name of the firm, point of contact, phone number, email address, DUNS number, CAGE code,, and if applicable, a statement regarding small business status (including small business type(s)/certifications(s) such as SDB, 8(a), HUBZone, SDVOSB, WOSB, etc.) and the corresponding NAICS code. 8.2 Information in sufficient detail regarding how your firm is able to meet this requirement, as well as previous experience (indicate whether as a prime contractor or subcontractor) on similar requirements (include size, scope, complexity, timeframe, government or commercial), pertinent certifications, etc., that will facilitate making a capability determination. 9.0 SUBMISSION CONTACT INFORMATION Interested entities shall forward submissions to Herbert Caj Keen at herbert.e.keen.civ@mail.mil no later than the close of business 15 June 2018. Telephonic communication will not be considered as submission or receive response.
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-
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- Record
- SN04939720-W 20180602/180531231432-662ee8fe5d99f0e4e157c618d74994f6 (fbodaily.com)
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