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A--Notice of Intent to Procure via Sole Source Development and FDA Clearance or Approval of a Traumatic Brain Injury Diagnostic Assay Using Ortho Clinical Diagnostics VITROS(r) 350 Device

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W81XWH13R0042Federal

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The United States Army Medical Research Acquisition Activity (USAMRAA) intends to award a sole source cost-type contract to Ortho Clinical Diagnostics (a Division of Johnson and Johnson) for the development and FDA clearance or approval of a diagnostic assay for traumatic brain injury (TBI). This assay will utilize the OCD/JJ Vitros 350 device alongside Banyan Biomarkers UCHL1 and GFAP protein biomarkers to screen serum samples to detect the presence or absence of TBI. The contract is planned for a five-year period, consisting of a base year plus four option years. This notice serves as an Intent to Procure and is not a solicitation for competitive proposals. Interested and responsible parties may submit capability information by February 27, 2013, to demonstrate their ability to fulfill the requirement; however, the government retains the sole discretion to decide whether to pursue a competitive procurement based on the responses received. No costs related to responses will be reimbursed, and inquiries are to be submitted exclusively via email. This procurement falls under NAICS code 541711, related to research and development in the physical, engineering, and life sciences. The government emphasizes that telephonic inquiries will not be accepted.

General Info

USAMRAA plans sole source contract with Ortho Clinical for five-year TBI diagnostic assay development.

Agency

N/A

NAICS

541711 - Research and Development in Biotechnology

Place of Performance

Not specified

Set-Aside

NONE

Documents

0

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Timeline

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special-notice

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Full Description

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The United States Army Medical Research Acquisition Activity (USAMRAA) is issuing an Intent to Procure via Sole Source the award of a cost type contract with Ortho Clinical Diagnostics (a Division of Johnson and Johnson) (OCD/JJ) for the development and FDA clearance or approval of a Traumatic Brain Injury (TBI) diagnostic assay using the OCD/JJ Vitros 350 device and Banyan Biomarkers, UCHL1 and GFAP (protein biomarkers), for the screening of serum for the presence or absence of TBI. The estimated period of performance for this acquisition is a base year with four (4) option years for a total of five (5) years. THIS NOTICE OF INTENT IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. Responsible, interested parties may identify their interest by submitting capability information by Tuesday, 27 February 2013 at 3:00 p.m. EST in order to establish the ability of the responder to meet this requirement. A determination by the Government to not compete this proposed contract based upon responses to this notice is solely within the discretion of the Government; information received will be considered for the sole purpose of determining whether to conduct a competitive procurement. The Government will not be responsible for any costs associated with responses to this notification. All inquiries must be submitted via e-mail to contact@example.gov. Telephonic inquiries will not be accepted.

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