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This Pre-Solicitation opportunity was posted on January 14, 2015. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

A--Development of multiple immunochromatographic test (ICTs) for the rapid diagnosis/detection of infectious diseases (IDs), and biological warfare agent (BWA) related IDs of military significance.

Awarded
W81XWH-15-R-0014Federal

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This pre-solicitation notice announces a forthcoming solicitation for a single-award indefinite delivery indefinite quantity contract to develop multiple immunochromatographic tests for the rapid diagnosis and detection of infectious diseases and biological warfare agent-related diseases of military significance. Supporting the U.S. Army Medical Research and Materiel Command, the project focuses on creating rapid human diagnostic devices for illnesses such as dengue fever and gastroenteritis, biological warfare agent diagnostics for brucellosis and equine encephalitis, and arthropod vector rapid detection devices for Leishmania and Plasmodium species. The contract is set aside for small business concerns under NAICS code 541711, with a size standard of 500 employees. The awardee must possess manufacturing facilities compliant with Current Good Manufacturing Practice and serve as the FDA sponsor for 510(k) submissions. The base contract spans five years, consisting of one base period and four option periods, while individual task orders may have performance periods of up to four years. All work must adhere to DoD, Army, ISO, and FDA regulations.

General Info

Agency

N/A

Contract Value

$24,533,390.93

NAICS

541711 - Research and Development in Biotechnology

Place of Performance

US Army Medical Research Acquisition Activity ATTN: MCMR-AAA, 820 Chandler Street Frederick MD 21702-5014 US, WA, USA

Set-Aside

SBA

Award Issued Date

Documents

0

No documents available

Documents will appear here when they are available.

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Timeline

6 updates
PhaseAwarded
Posted

Presolicitation

Notice updated

Response deadline changed from Dec 21, 2014 to Jan 9, 2015. The notice description changed.

Notice updated

Response deadline changed from Jan 9, 2015 to Jan 31, 2015. The notice description changed.

Notice updated

Response deadline changed from Jan 31, 2015 to Mar 13, 2015. The notice description changed.

Notice updated

Response deadline changed from Mar 13, 2015 to Jul 3, 2015. The notice description changed.

Notice updated

Response deadline changed from Jul 3, 2015 to Aug 27, 2015. The notice description changed.

Notice updated

Notice details unchanged. Attachments may have changed.

Type Changed

Presolicitation → Solicitation

Awarded

Contract was awarded

Submission Closed

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Organization & Contact Information

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AgencyN/A
ContactsNo contacts available
OfficeN/A
Organization / Agency
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Office AddressN/A
ContactsNo contact information available

Full Description

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This synopsis is not a request for quotes or proposals. This is a pre-solicitation notice that a solicitation has been scheduled to be released via FedBizOps (www.fbo.gov) to the vendor community on or about 31 January 2015, which will be available for proposal responses for a period of 30 days. Specifications of this requirement shall be provided in the solicitation under Solicitation Number W81XWH-15-R-0014. This pre-solicitation notice follows a Request for Information (RFI) which was issued on 10 May 2013 through FedBizOps under RFI number W81XWH-13-R-FIID. The solicitation will be set-aside for small business concerns, and will allow for full and open competition amongst all qualifying small business participants. The North American Industry Classification System (NAICS) code is 541711 and the size standard is 500 employees. Requirement Description: This requirement provides for the development of multiple immunochromatographic tests (ICTs) for the rapid diagnosis/ detection of infectious diseases (IDs), and biological warfare agent (BWA)-related IDs of military significance. ICT's developed under this requirement will support the mission of the U.S. Army Medical Research and Materiel Command (USAMRMC) and subordinate commands of the USAMRMC to develop and manage medical materiel to protect, and sustain the Warfighter on point for the Nation. This requirement will be set-aside for small business participation only, and the contract award will utilize a single-award indefinite delivery indefinite quantity (ID/IQ) contract vehicle. The award recipient shall develop/deliver ICTs issued in the form of individual task orders (TOs) under the ID/IQ contract. It is anticipated that the contractor will potentially develop the following ICTs: a. Rapid Human Diagnostic Devices (RHDDs) for military-relevant IDs, including (but not limited to): dengue fever and dengue hemorrhagic fever, bacterial gastroenteritis, viral gastroenteritis. b. Biological Warfare Agent (BWA)-RHDDs for BWA-related diseases, which may include but are not limited to brucellosis and western/eastern equine encephalitis viruses. c. Arthropod Vector Rapid Detection Devices (AVRDDs) for military-relevant vector-borne diseases including but not limited to dengue virus, Leishmania species, and Plasmodium species. The award recipient shall furnish the necessary personnel, equipment, supplies, and support necessary to complete the performance of the work outlined in the solicitation. These services shall be provided at a standard which enables the USAMMDA, and the USAMRMC to achieve the cost, schedule, and performance goals of its ICT development activities to the level of quality necessary to comply with programmatic requirements, DoD and Army regulations, ISO standards, and FDA regulations (to include both human subject protection and animal care and use regulations); including submissions to federal regulatory agencies. Specific task requirements will be further defined through individual performance work statements (PWS) on a task order basis. The award recipient must have manufacturing facilities in compliance with Current Good Manufacturing Practice (cGMP) and will be the sponsor for the 510(k) of each ICT assay for the FDA. Background: The USAMRMC is one of the Department of Defense's (DoD) advanced development organizations for medical products designed to protect and preserve the lives of military service members. The USAMRMC develops new drugs, vaccines, devices, and medical support equipment that enhances readiness to ensure the provision of the highest quality medical and preventative care to the DoD, and maximize survival of medical casualties on the battlefield. Period of Performance: The period of performance (POP) for the base ID/IQ contract will be five years in duration, with one 12 month base period, accompanied by 4 twelve month option periods. Each TO issued under the ID/IQ contract for this requirement will have the potential to have a 4 year POP, depending on the advancement/development of the assays required. Response: This notice is for informational purposes only. No response is required for this pre-solicitation notice. Telephone requests in response to this pre-solicitation notice will not be honored. Additional information is not available at this time. Potential offerors are directed to respond to the solicitation when it is released on this website under solicitation number W81XWH-15-R-0014.

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