SRCSGT | A | Storage, Distribution, Testing Services, and Compliance with Federal Regulations of Biological Select Agents and Toxins in Support of the Special Immunizations Program (SIP).

FBO DAILY ISSUE OF OCTOBER 02, 2010 FBO #3234
SOURCES SOUGHT

A -- Storage, Distribution, Testing Services, and Compliance with Federal Regulations of Biological Select Agents and Toxins in Support of the Special Immunizations Program (SIP).

Notice Date: 9/30/2010
Notice Type: Sources Sought
NAICS: 541711 — Research and Development in Biotechnology
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-11-S-0001
Response Due: 10/21/2010
Archive Date: 12/20/2010
Point of Contact: Drake Russell, 301-619-8472
E-Mail Address: US Army Space and Missile Defense Command, Deputy Commander
(drake.russell@us.army.mil)
Small Business Set-Aside: N/A
Description: Sources Sought Notice Sources Sought No.: W9113M-11-S-0001 PROPOSED TITLE: Storage, Distribution, Testing Services, and Compliance with Federal Regulations of Biological Select Agents and Toxins in Support of the Special Immunizations Program (SIP). This is a Qualified/Capabilities Business Sources Sought Notice (SSN). This is NOT a solicitation for proposals, proposal abstracts, or quotations. This notice is for market research purposes only to obtain information regarding (1) the availability and capability of all qualified business sources, (2) including small businesses; HUB Zone small businesses; service-disabled small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. The North American Industry Classification System (NAICS) Code(s) is/are 541711. Your responses to the information requested will assist the Government in determining the appropriate acquisition method for Storage, Distribution, Testing Services, and Compliance with Biological Select Agents and Toxins in Support of Special Immunizations Program (SIP), and other programs. BACKGROUND AND MISSION: Synopsis: The Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD), Chemical Biological Medical Systems Joint Project Management Office (CBMS-JPMO), Joint Vaccine Acquisition Program (JVAP) requires storage, distribution, testing services, and Compliance with Federal Regulations of Biological Select Agents and Toxins to support the Special Immunizations Program (SIP). The SIP manages the clinical evaluation of certain Investigational New Drug (IND) vaccines. JVAP supports the SIP (US Army Material Command) by managing storage, distribution, and testing of IND vaccines and associated materials. It is essential that contractors perform these services comply with relevant regulations administered by the Food and Drug Administration (FDA). In addition, since storage, testing, and distribution requires access to, and use of, Biological Select Agents and Toxins (BSAT), contractors must conform to regulations administered by the U.S. Departments of Health and Human Services (HHS) and Agriculture (USDA), and with additional requirements specified by the Department of Defense (DoD). PURPOSE, OBJECTIVES, and REQUIREMENTS: The services needed are: (1) Storage of materials in controlled temperature environments in compliance with relevant current Good Manufacturing Practice standards (cGMP); (2) Distribute materials as required to fulfill the contract requirements; (3) Proper disposal of materials in the inventory as required; (4) Convert paper records to electronic documents; (5) Testing of stored materials through the administration of Investigational New Drug vaccines to laboratory animals and challenging them with infectious agents in compliance with Good Laboratory Practice (GLP) standards; (6) Compliance with Department of Defense regulations of Biological Select Agents and Toxins (BSAT) in addition to compliance with other relevant federal, state, and local laws and regulations; (and Department of Defense Directive 5210.88; http://www.dtic.mil/whs/directives/ Department of Defense Instruction 5210.89; and Army Regulation 50-1 and references cited therein). http://www.army.mil/usapa/epubs/50_Series_Collection_1.html (7) Transition of materials at conclusion of contract. (8) Contract Reporting Requirements a. Monthly Report Activities and expenditures b. Incident Report c. Annual Report d. Invention Reporting SUBMISSION INSTRUCTIONS: Respondents to this notice must provide, as a part of their response, a statement regarding their capabilities. Respondents must include their DUNS number, organization name, address, point of contact, cage code, size and type of business. You must also be registered with the CCR (Central Contractor Registration). Interest in this requirement shall be made in writing on the companies letterhead; describing your facilities, your personnel, your experience in working with BSAT Materials, your experience in testing biological materials in animals, your experience in managing subcontractors relating to this procurement. Respondents shall include technical and administrative points of contact, with names, titles, addresses, telephone number(s), fax number, and email addresses; and (4) not exceeding twelve (12) single sided pages in total (a PDF is preferred) (not including cover page and cover letter), sent via email to: drake.russell@us.army.mil (no later than Thursday, October 21, 2010 at 2:00 pm EST). All questions must be submitted in writing. DISCLAIMER AND IMPORTANT NOTES: The Government will not pay for any information submitted in response hereto. This notice does not obligate the Government to issue a solicitation or to award a contract. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organizations qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to the respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation which may be published in the future. CONFIDENTIALITY: No proprietary, classified, confidential, or sensitive information should be included in your response. Contacting Office Address: JPEO CBMS 64 Thomas Johnson Drive Frederick, MD 21702 Point of Contact: Mr. Drake Russell, Contract Specialists, JPEO CBD, email address: drake.russell@amedd.army.mil
Web Link: FBO.gov Permalink
(https://www.fbo.gov/spg/USA/SMDC/DASG60/W9113M-11-S-0001/listing.html)
Place of Performance: Address: Chemical Medical Biological Systems 64 thomas Johnson Drive Frederick MD; Zip Code: 21702-4501
Record: SN02302514-W 20101002/100930235102-623fbcdd2dd7cc733474e579b666bc7c (fbodaily.com)
Source: FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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A -- Storage, Distribution, Testing Services, and Compliance with Federal Regulations of Biological Select Agents and Toxins in Support of the Special Immunizations Program (SIP).