Loren Data's SAM Daily™

FBO DAILY ISSUE OF JUNE 24, 2007 FBO #2036
SOURCES SOUGHT

A -- Seeking suppliers to develop and produce Polymerase Chain Reaction (PCR) biological warfare agent (BWA) assays for the Joint Biological Agent Identification and Diagnostic System (JBAIDS) Program, Block I

Notice Date

6/22/2007
 

Notice Type

Sources Sought
 

NAICS

541710 — Research and Development in the Physical, Engineering, and Life Sciences
 

Contracting Office

US Army Space and Missile Defense Command, Deputy Commander, ATTN SMDC-CM-AP, P.O. Box 1500, Huntsville, AL 35807-3801
 

ZIP Code

35807-3801
 

Solicitation Number

W9113M-07-S-0006
 

Response Due

7/24/2007
 

Archive Date

9/22/2007
 

Small Business Set-Aside

N/A
 

Description

The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Team, under the Chemical Biological Medical Systems Project Management Office in Frederick MD, is conducting a market research survey to identify potential offerors to supply Po lymerase Chain Reaction (PCR) reagent kits for the US Department of Defense (DoD). This sources sought notice covers only the JBAIDS Block I, market survey effort to identify potential candidate companies to manufacture freeze-dried reagent kits for JBAID S. The JBAIDS Block I system, including the PCR analyzer, freeze-dried reagent kits, and sample purification kits manufactured by Idaho Technology Inc., is currently being fielded to military customers world-wide. JBAIDS constitutes the DoD's first effor t to develop and field a common medical test equipment platform amoung the four military Services that will identify BWAs and pathogens of operation concern for use with environmental samples, and as a diagnostic tool by medical professionals to treat pati ents. US Food and Drug Administration (FDA) review and clearance of any new selected Block I candidate reagent kits (assays) may be required. Interested companies are requested to address in writing their ability to meet the following JBAIDS program reag ent kit minimum requirements: 1) Reagent kits shall be lyophilized (freeze-dried) to meet DoD world-wide room temperature (18-28 degrees C) storage requirements and configured to operate using standard JBAIDS protocols. 2) Lyophilized reagent kits shall have a minimum one-year shelf-life at room temperature (18-28 degrees C) with no degradation in performance. 3) Selected comanies shall be eligible to receive and/or transfer select agents or select agent-derived materials by holding a valid permit from t he Centers for Disease Control and Prevention (CDC) and/or the Animal and Plant Health Inspection Service (APHIS) of the US Department of Agriculture in compliance with 42 CFR Part 73, 7 CFR Part 331, and 9 CFR Part 121. 4) Companies shall have unencumber ed intellectual property (IP) rights or legal agreements covering the offeror's proposed PCR assay manufacturing chemistry processes. 5) Companies must have or must be eligible to receive a DoD Secret-Level Clearance. 6) Companies shall own or have acces s to a reagent kit manufacturing/production facility that has the capacity to produce thousands of reagent kits monthly. 7) A company shall own or have access to a reagent kit manufacturing facility that meets FDA Quality System Regulations (21 CFR Part 8 20) and current Good Manufacturing Practices (cGMP) standards. 8) The candidate lyophilized PCR reagent kit functional performance shall meet or exceed the JBAIDS approved Joint Operational Requirements Document (JORD) minimum performance thresholds: bac teria - 1,000 CFU/ml; viruses - 10,000 PFU/ml. This sources sought notice covers only the JBAIDS Block I reagent kit market survey to identify potential new candidate offerors/companies to supply dual-use (surveillance and diagnostic) assays for the JBAID S Block I program. Interested companies are requested to provide information and supporting data on previous Government PCR assay development/production experiences/contracts dealing with the identification of BW agents. This information should be forwar ded via email to the attention of Lynn Selfridge, Contracting Officer, lynn.selfridge@det.amedd.army.mil. Responses must be received by 4:00PM EST, July 24, 2007. The company's response must cover, at a minimum, all eight areas noted above. After review ing the offeror's PCR surveillance/diagnostic assay development, manufacturing information, and relevant DoD and commercial production experience, selected companies may be asked to provide briefings to Government officials at CBMS in Frederick MD (2 hour time limit). This sources sought notice is issued soley for the purpose of conducting market research and does not constitute a solicitation or issuance thereo f. All information received in response to this notice that is marked proprietary will be handled accordingly. Responses to this notice will not be returned. Responses to this notice are not offers and cannot be accepted by the Government to form a bind ing contract. Responders are solely responsible for all expenses associated with responding to this notice. Respond by 4:00PM EST, July 24, 2007 to Lynn Selfridge, Contracting Officer, lynn.selfridge@det.amedd.army.mil
 

Place of Performance

Address: US Army Space and Missile Defense Command, Deputy Commander ATTN SMDC-CM-AP, P.O. Box 1500 Huntsville AL

Zip Code: 35807-3801

Country: US
 

Record

SN01326071-W 20070624/070622235534 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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