SOLICITATION NOTICE
H -- Joint Vaccine Acquisition Program (JVAP) Storage, Distribution, and Testing of Government Owned/Regulated Chemical Biological Defense (CBD) Material
- Notice Date
- 12/19/2007
- Notice Type
- Solicitation Notice
- 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-08-R-0001
- Response Due
- 1/17/2008
- Archive Date
- 3/17/2008
- Point of Contact
- Glen Seipp, (301) 619-8443
- E-Mail Address
-
Email your questions to US Army Space and Missile Defense Command, Deputy Commander
(glen.seipp@amedd.army.mil)
- Small Business Set-Aside
- N/A
- Description
- The Chemical Biological Medical Systems (CBMS) Joint Project Management Office (JPMO), a component of the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD), is responsible for the Total Life Cycle Systems Management (TLCSM ) of a spectrum of vaccines, medical devices, assays, and other medical CBD products. As life cycle manager, CBMS implements, manages, and oversees activities associated with the acquisition, development, production, fielding, sustainment, and disposal of its products. The Joint Vaccine Acquisition Program (JVAP) is a product management office that focuses on development and procurement of biological defense vaccines. This solicitation addresses the services and support requirements for accountabilit y, storage, maintenance, security, handling, packing, transportation, and testing of government owned/regulated CBD materiel, to include Biological Select Agents and Toxins (BSAT). The Contractor will offer and show evidence of the following capabilities:< BR> 1. Storage and Distribution: a. Provide storage of government owned CBD materiel and paper records/files under controlled and secure conditions. The Contractor shall provide the necessary qualified personnel, facilities, material, equipment, and services to ensure proper maintenance of CBD materiel. The facilities must be in compliance with FDA standards for storage and handling of medical materiel, and state/local requirements for commercial storage/warehouse facilities. Facilities and/or ass ociated equipment such as refrigeration units/freezers must be qualified/validated and in a fully operational condition. The Contractor shall store and maintain materiel in both temperature controlled and ambient environmental conditions. The Contractor sh all provide a detailed assessment of their current, available repository storage space to accommodate the following temperature ranges: Temperature Minimum Storage -20?C ............................... 100 cu ft -80?C ................ ............... 500 cu ft Ambient ..............................1000 cu ft Ambient (Records Storage)..................... 850 cu ft LN2 ................................... 20 cu ft 2?C to 8?C ........................... 800 c u ft Ambient controlled room temperature shall be provided for long term storage of paper records/archived data in cardboard file boxes. The Contractor shall provide a suitable environment with humidity control that will prevent molding or exposure to moisture. All equipment/storage units must have evidence/records of current qualification/validation from certifiable technical sources, and meet current Good Manufacturing Practices (cGMP) for handling, storage, packing, and transporting of government owned materiel. b. As required, designated materiel from storage shall be delivered/shipped in accordance with cGMP. The DOD shall direct shipping to specific locations. The Contractor shall pack and ship all materiel in accordance with applicable F DA guidance and regulations, in addition to guidance provided in United States Pharmacopeia Chapter (1079) Good Storage and Shipping Practices , and the Parenteral Drug Association Technical Report Number 39, Cold Chain Guidance for Medicinal Products; Ma intaining the Quality of Temperature-Sensitive Products Through the Transportation Environment. All materiel shall be continuously maintained within specified temperature range(s) until delivery to final destination. 2. Testing: The materiel includes biodefense vaccine materiel in Investigational New Drug status under regulations enforced by the FDA (see Code of Federal Regulations, Title 21, Part 312) that helps sustain an immunization program that provides protection against certain biologic al agents (the agents of tularemia, Eastern Equine Encephalitis (EEE), Western Equine Encephalitis (WEE), Venezuelan Equine Encephalitis (VEE), and Q fever). Te st biodefense vaccine materiel in accordance with 21 CFR Part 610; required testing includes sterility testing (21 CFR 610.12) and specialized potency testing that involves immunization of test animals and challenge with infectious agents. The government w ill supply protocols for specialized potency tests. As needed, manufacture challenge material needed for potency or other testing. Testing must conform to relevant cGMP standards. Outline of representative annual testing requirement: Product Report Due Q-fever Skin Test Antigen ............. May 2008 VEE vaccine (C-84)..................... August 2008 EEE vaccine ........................... August 2008 WEE vaccine ........................... December 2008 VEE vaccine (TC-83)....... ............. January 2009 Tularemia vaccine (LVS)................ January 2009 Q-fever vaccine ....................... January 2009 The Contractor shall provide a detailed assessment of their capabilities to provide cGMP vaccine testing servi ces, to include immunization of test animals with vaccines and challenge with the above-identified biological agents. 3. Compliance with Regulations of Biological Select Agents and Toxins (BSAT): In conducting storage, distribution, and tes ting, conform to the final rules for the possession, use, and transfer of select agents and toxins (42 C.F.R. Part 73, 7 C.F.R. Part 331, and 9 C.F.R. Part 121). In addition, conform to Department of Defense Directive 5210.88 and Department of Defense Inst ruction 5210.89. Offerors shall state their current status for compliance with these regulations and offerors shall provide separate cost and schedule estimates for what needs yet to be accomplished to reach a compliant state with respect to the BSAT regul atory requirements. Responding to this Notice In responding to this presolicitation announcement, offerors shall affirm, in either a letter or electronic communication to the contracting officer, that it can meet all of the qualification req uirements. Upon receipt of an expression of interest to participate in a competition for JVAP Storage, Distribution, and Testing, a JVAP regulatory compliance team shall conduct a facility compliance review to verify the accuracy of the offerors affirmati ons. The regulatory compliance team will provide advance notice of its visit to the offerors facilities. The teams findings and recommendations to the JVAP product manager shall render an offeror qualified or not qualified to execute a contract for these requirements within the required time. The offeror is solely responsible for furnishing the regulatory compliance team the necessary information to demonstrate meeting the qualifications. Offerors not meeting these requirements shall not receive a request for proposal. Subcontractors may be used for this procurement in which case a Small Business Subcontracting Plan is required in accordance with FAR clause 52.219-9. If an offerors approach includes subcontract performance, the offeror shall provid e the same qualification information for the subcontractor(s). The government regulatory compliance team shall similarly conduct a site visit of the subcontractor. If the proposed subcontractor fails to meet the appropriately applicable requirements for th e work to be under subcontract, the offeror shall be excluded from participation. There is zero tolerance for delay in performing a contract for JVAP Storage, Distribution, and Testing. Once the qualified competitors are identified, a request for pr oposal shall be released for formal proposals and consideration for award based on schedule and cost. In addition to the qualification requirements provided earlier, all interested offerors shall include in their written response to this synopsis t he companys CAGE code, Duns number, and business size for a NAICS project coded 541711, 500 employees. All responsible sources may submit a request to particip ate in this acquisition, which shall be considered by the agency. This acquisition is open to participation by foreign firms at both the prime contract and subcontract level, subject to FAR/DFARS Part 25 limitations. This announcement shall be open for a p eriod of thirty (30) calendar days after publication in FEDBIZ OPS. Offerors that fail to identify themselves within the 30-day window shall not be permitted to participate in this competitive solicitation. The estimated period of performance for th ese services is 9 March 2008 - 8 March 2009. There is a possibility of one option period for additional services for the 9 March 2009 - 8 March 2010 time period. Point of contact is Mr. Glen Seipp,(301) 619-8443. Email glen.seipp@amedd.army.mil
- Web Link
-
Joint Program Executive Office CBD
(http://www.jpeocbd.osd.mil)
- Place of Performance
- Address: US Army Space and Missile Defense Command, RDCM-SB 64 Thomas Johnson Drive Frederick MD
- Zip Code: 21702
- Country: US
- Zip Code: 21702
- Record
- SN01473258-W 20071221/071219230018 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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