A--Joint Vaccine Acquisition Program (JVAP) Storage, Testing, and Distribution of Government Owned/Regulated Chemical Biological Defense (CBD) Material

H--Joint Vaccine Acquisition Program (JVAP) Storage, Testing, and Distribution of Government Owned/Regulated Chemical Biological Defense (CBD) Material General Information Document Type: Pre Solicitation Notice Solicitation Number: W911QY-11-PS-0003 Posted Date: Monday, January 31, 2011 Original Response Date: COB Tuesday, February 15, 2011 Current Response Date: COB Tuesday, February 15, 2011 Original Archive Date: May 2, 2011 Current Archive Date: May 2, 2011 Classification Code: H -- Quality Control, Testing & Inspection Services Set Aside: N/A NAICS Code: 541711 -- Research and Development in Biotechnology Contracting Office Address US Army, Natick, RDE - COM Contracting Office, located at 64 Thomas Johnson Drive, Frederick, MD 21702-4501 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 within CBMS that focuses on development and procurement of biological defense vaccines. This Presolicitation Notice addresses service and support requirements for accountability, storage, testing, disposal, maintenance, security, handling, packing, and transportation of government owned CBD materiel, including Biological Select Agents and Toxins (BSAT) and materiel subject to regulations administered by the Food and Drug Administration (FDA). Such materiel includes, but is not limited to, Investigational New Drug (IND) vaccines, infectious agents, prokaryotic and eukaryotic cells, viruses, fractions of cells, and inorganic and organic chemicals. The Contractor will offer and show evidence of the following capabilities: 1. Storage: Contractor will provide storage services in accordance with current Good Manufacturing Practices (cGMP) standards for government owned CBD materiel and paper records/files. The Contractor shall provide the necessary qualified personnel, facilities, material, equipment, and services to ensure proper storage. The facilities must comply with FDA standards for storage and handling of medical materiel, as well as state and local requirements for commercial storage/warehouse facilities. Facilities and/or associated equipment such as refrigeration units/freezers must be qualified/validated and in a fully operational condition. Contractor must have a routine monitoring and preventive maintenance program for equipment. Back-up refrigerators and freezers must be available in case of equipment failure, and back-up electrical power generation must be available in case of interruption of electrical utility service. All equipment/storage units must have evidence/records of current qualification/validation from certifiable technical sources, and meet cGMP standards for handling and storing paper and vaccine products. The Contractor shall store and maintain materiel in both temperature controlled and ambient environmental conditions. Contractor shall provide a suitable environment with humidity control that will prevent molding or exposure to moisture. The Contractor shall provide a detailed assessment of their current, available repository storage space to meet the following minimum requirements for storage space and associated temperature ranges: See Table 1. Table 1 Storage Temperature and Space Requirements -20 or -30 degrees Celsius 1800 cubic feet (or 60 cubic meters) -80 degrees C 100 cu ft (or 3 cubic meters) Ambient 1 cu ft (or 0.03 cubic meters) Ambient (Paper Records Storage) 550 cu ft (or 15 cubic meters) Liquid Nitrogen 3 cu ft (or 0.1 cubic meters) 2 degrees C to 8 degrees C 30 cu ft (or 1 cubic meter) Additional unspecified capacity, probably freezer space at -30 degrees Celsius, that may be required 1000 cu feet (or 30 cubic meters) Excluding paper records, the inventory contains approximately 100,000 containers of material identified as approximately 330 inventory items. Of the approximately 100,000 containers, approximately 3,500 contain material identified as Biological Select Agents and Toxins (BSAT), subject to strict regulatory controls as detailed below in item 5. Ambient controlled room temperature shall be provided for long term storage of paper records/archived data in approximately 200 cardboard file boxes. Given the need to protect documents from moisture, any fire suppression system in document storage areas must not employ water. Contractor will take 100% inventory on annual basis and will supply inventory records in Microsoft-compatible files, preferably Excel spreadsheets. Inventory records will be updated after each and every addition to, or subtraction from, the inventory. 2. Testing: Contractor will test materiel that includes, but is not limited to, biodefense vaccines manufactured under Investigational New Drug (IND) regulations per Code of Federal Regulations, Title 21, Part 312 regulations. Said vaccines help sustain an immunization program that provides possible protection from tularemia, Eastern Equine Encephalitis (EEE), Western Equine Encephalitis (WEE), Venezuelan Equine Encephalitis (VEE), and Q fever. Contractor will test biodefense vaccine and related materiel in accordance with 21 CFR Part 610 and Good Laboratory Practice for Nonclinical Laboratory Studies (GLP; 21 CFR Part 58) standards. The required testing includes sterility testing (21 CFR 610.12, with tests of bacteriostasis and fungistasis) and specialized potency testing that typically involves administration of test articles to test animals, followed by challenge with infectious agents. Only challenges administered by injection are expected, though challenges by inhalation or ingestion could conceivably be needed. Most of the infectious agents (those of EEE, VEE, tularemia) used as challenge material are Select Agents within the regulatory jurisdiction of the Select Agent Program administered by the U.S. Departments of Health and Human Services (HHS) and Agriculture (USDA), which published 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). The Department of Defense has imposed additional requirements for contracts, performance of which requires access to Biological Select Agents and Toxins (BSAT). See item 2, below. Generally, two lots of each vaccine will be tested every 12 to 18 months. Potency testing of Q fever vaccine does not involve challenge with the infectious agent; it involves immunization of test animals and serological analysis by the complement fixation technique. Potency testing of the Q-fever skin test antigen involves immunization of test animals and observation and measurement of the reaction of immunized animals to intradermal administration of test articles. Contractor may be required to test vaccines for moisture; endotoxin; or other substances, as may be specified by the Food and Drug Administration (FDA) in communications to the IND sponsor. Contractor may be required to manufacture challenge material (infectious agents) for potency or other testing. Such manufacture may be needed if challenge materiel currently in storage is exhausted or proves to be unsuitable for testing. In general, manufacture would involve the cultivation of bacteria or viruses, enumeration by standard microbiological methods, determination of virulence, dispensing into containers suitable for long term cold storage, and submission to the government of documentation of procedures employed and results obtained. The government will supply draft test protocols for potency testing, but protocols could be subject to change during contract performance. The government will not supply standard operating procedures for common biological research techniques such as animal husbandry, inoculations, or enumeration of bacteria or viruses; instead, the contractor will need to develop or acquire such procedures. The government will supply the services of study sponsor and IND sponsor's representative. The approvals, evidenced by signatures, of the government study sponsor and IND sponsor are required as part of testing protocol development. Similarly, the government will review draft test reports for compliance with regulatory standards before accepting the reports. Contractor will submit animal use protocols for review and approval by the Animal Care and Use Review Office (ACURO) of the U.S. Army Medical Research and Materiel Command. See Table 1, below for the annual testing requirement. Table 1 Outline of representative annual testing requirement: The contractor must have the capability to perform all of these tests each year, but the actual testing to be done by the contractor each year may be as low as zero tests because the government may choose to perform some testing in its own facilities, or for other reasons. EEE vaccine potency, test 2 lots VEE vaccine (C-84) potency, test 2 lots VEE vaccine (TC-83) potency, test 2 lots WEE vaccine potency, test 2 lots Tularemia vaccine (LVS) potency, test 2 lots Q-fever vaccine potency, test 2 lots Q-fever Skin Test Antigen potency, test 2 lots EEE vaccine sterility, test 2 lots WEE vaccine sterility, test 2 lots For a summary of the testing procedures, see Number 5 below: 2. Distribution: Contractor will distribute designated materiel from the storage location to DOD - directed destinations. The anticipated locations are: (1) vaccine testing facilities; approximately 3-5 controlled temperature shipments per year; each shipment will contain approximately 10 vials of vaccine (vaccine vial capacity is generally from 1 to 20 milliliters) and may be accompanied by up to approximately 5 vials of infectious agent which alternatively may be shipped separately; (2) U.S. Army Medical Research Institute of Infectious Diseases, Frederick, MD; approximately 3-5 controlled temperature shipments per year; each shipment will contain approximately 200 vials of vaccine and may be accompanied by up to approximately 5 vials of infectious agent which alternatively may be shipped separately; and (3) U.S. Army Medical Materiel Development Activity (USAMMDA), in Frederick, MD; approximately 2-4 shipments of boxed paper records per year, with each shipment being approximately 1 to 10 boxes, and return boxed paper records to the Contractor's storage facility once USAMMDA is finished using them. See Table 2. Once document conversion (item 4, below) has been accomplished, such shipments may not be required. Table 2 Estimated Annual Distribution Requirements To testing facilities 3-5 shipments of vaccine (non-hazardous) 3-5 shipments of infectious agent (may be Select Agents) To USAMRIID 3-5 shipments of vaccine To USAMMDA and return 2-4 shipments of boxed paper records The Contractor shall pack and ship all materiel, including biohazardous materiel, in accordance with applicable FDA 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: Maintaining the Quality of Temperature-Sensitive Products through the Transportation Environment. For shipments containing infectious material or Biological Select Agents and Toxins (BSAT), the Contractor shall comply with relevant Army security standards. Such shipments require transportation protective services (for ground shipments, certified HAZMAT 6.2 carrier, 2 HAZMAT-qualified drivers, alert button on vehicle that meets Defense Transportation Tracking System requirements, and drivers cleared at the "secret" level). All materiel shall be continuously maintained within specified temperature range(s) until delivery to final destination. Contractor will provide documentation of temperature during transit. Contractor must submit records of such transfer to the government, including temperature records and a statement identifying equipment, procedures, and personnel involved in the transfer. 3. Disposal: Contractor will dispose of material no longer needed by the government. Comply with applicable federal, state, and local regulations of waste, including waste that is biohazardous. The government estimates that approximately 10% of the material currently stored may be subject to disposal each year. 4. Paper to Electronic Document Conversion: Contractor will, for all or some of the documents stored in approximately 200 boxes, convert the text into electronic form by storage in Portable Document Format or other suitable electronic format to be selected by the government. Assuming 2,500 sheets of paper per box, the number of sheets is approximately 500,000. Since some sheets may have content on both sides, the number of pages to be converted may be as high as approximately 1 million. The indexing and file naming requirements have not been determined, but will be available in the Request for Proposal. The contractor will deliver the electronic files to the government. 5. Compliance with Regulations of Biological Select Agents and Toxins (BSAT): Contractor will, in all relevant activities, 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; Department of Defense Instruction 5210.89; and Army Regulations 50-1 and 190-17, all of which impose requirements that go beyond the regulations administered by the Select Agent Program. Of particular note, the DoD requires the establishment of a Biological Personnel Reliability Program at each facility in which access to BSAT is required for contract performance. Contractor will participate in Surety Management Reviews of compliance with BSAT regulations (estimated frequency, 1 per year; approximately 3 days in duration) and will support inspections by a team from the office of the Army Inspector General (estimated frequency, 1 per year, alternating with the Surety Management Review; approximately three (3) days in duration). 6. Transition: Contractor must have appropriate licenses and certifications at federal, state, and local levels. Any offeror proposing to use storage facilities other than those of the incumbent storage contractor must transfer materiel from the incumbent's storage locations to those of the new Contractor. Such transfer must comply with Select Agent program regulations, DoD regulations for biological surety, and regulations and standards associated with the movement of medical materiel. Contractor must submit records of such transfer to the government, including temperature records and a statement identifying equipment, procedures, and personnel involved in the transfer. Contractor will have one calendar month to effect a transition, counting from the date of contract award. A Site Visit may be required to verify statements. 7. Reporting: Report on a monthly basis the following: (a) inventory of stored items, with additions or subtractions from inventory clearly noted; (b) material distributed; (c) material disposed of; (d) number of pages converted to electronic form; (e) status of compliance with biological surety regulations, clearly identifying progress on items needing correction, if any; and (f) progress on transition, if applicable. Contractor will report as required by BSAT regulations. Contractor will report test results in accordance with GLP standards. Contractor will report, on a monthly basis in Microsoft Word or compatible format, the following: (a) inventory of stored test articles, with additions or subtractions from inventory clearly noted; (b) status of testing; and (c) status of compliance with biological surety regulations, clearly identifying progress on items needing correction, if any. Report on an annual basis a summary of the information transmitted regularly on a monthly basis, as well as issues that have arisen. Report issues promptly (within 24 hours) as issues arise. Report any inventions made in the course of contract performance. 8. Management and Coordination. Contractor will manage the work within cost, schedule, and technical parameters. Contractor will coordinate as needed with the CBMS-JVAP program office and with persons involved in shipping materials for testing. Contractor will participate in regular monthly teleconferences and additionally as warranted by circumstances. The Government will perform a Site Visit Annually or more often as needed. 9. Pre Award Site Visits Pre award Site Visits will likely be conducted to verify statements provided by the Offerors. 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. 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. However, responses to this notice will not be considered adequate responses to a solicitation which may be published in the future. The estimated period of performance for these services is 8 July 2011 - 7 July 2012 (one year). There is a possibility of three option periods for additional services, one year each. NUMBER of AWARDS: The Government reserves the right to make one or more awards. Interested parties should clearly state in their response whether they are interested in the entire award and or interested in only certain described part(s) of the planned award(s). Please be specific in your response. This does not commit the Government to make an award(s). PRIOR ANNOUNCEMENTS on FBO: Regarding prior announcements: previously interested parties which have submitted written documents to the Contracting Office, need only to reply if their interests in this announcement have changed. W9113M-11-S-0001 W911QY-11-PS-0001 W911QY-11-PS-0002 CONFIDENTIALITY: No proprietary, classified, confidential, or sensitive information should be included in your response. Contacting Office Address: JPEO - CBMS Natick, RDE - COM Contracting Office 64 Thomas Johnson Drive Frederick, MD 21702 Point of Contact: Mr. Drake Russell, Contract Specialists, JPEO CBD, email address: contact@example.gov Drake Russell, +1 (555) 000-0000 Additional Information Joint Program Executive Office CBD Place of Performance Address: US Army Natick, RDE - COM Contracting Office, 64 Thomas Johnson Drive, Third Floor, Frederick, MD Postal Code: 21702 Country: US