SOLICITATION NOTICE
H -- HJoint
- Notice Date
- 12/17/2010
- Notice Type
- Presolicitation
- 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-PS-0002
- Response Due
- 1/21/2011
- Archive Date
- 3/22/2011
- 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
- HJoint Vaccine Acquisition Program (JVAP) Testing of Government Owned/Regulated Chemical Biological Defense (CBD) Material General Information Document Type: Pre Solicitation Notice Solicitation Number: W9113M-11-PS-0002 Posted Date: Friday, December 17, 2010 Original Response Date: COB January 21, 2011 Current Response Date: COB January 21, 2011 Original Archive Date: May 2, 2011 Current Archive Date: May 2, 2001 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 Space and Missile Defense Command, Deputy Commander, ATTN SMDC - CBMS, P.O. Box 1500, Huntsville, AL 35807-3801 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 (JPEOCBD), 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 testing of government owned CBD materiel, including but not limited to, Investigational New Drug (IND) vaccines. The Contractor will offer and show evidence of the following capabilities: COMPETITION AND PROCUREMENT SENSITIVE 2 1. 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 COMPETITION AND PROCUREMENT SENSITIVE 3 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. 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 3 days in duration). COMPETITION AND PROCUREMENT SENSITIVE 4 3. Reporting: 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. Contractor will report as required by BSAT regulations. Contractor will report issues promptly (within 24 hours) as issues arise. Contractor will report on an annual basis a summary of the information transmitted regularly on a monthly basis, as well as issues that have arisen. Contractor will report any inventions made in the course of contract performance. 4. 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. 5. For Additional Testing Information Please contact the Contract Specialist below and request Attachment # 1, Test Procedure Summary. 6. 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 COMPETITION AND PROCUREMENT SENSITIVE 5 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 about July 2011 - about July 2012 (one year base). There is a possibility of four or more option periods for additional services, one year each. CONFIDENTIALITY: No proprietary, classified, confidential, or sensitive information should be included in your response. Contacting Office Address: JPEO - CBMS Contracting Office 64 Thomas Johnson Drive Frederick, MD 21702 Point of Contact Drake Russell, (301) 619-8472 Email your questions to US Army Space and Missile Defense Command, Contract Specialist at drake.russell@us.army.mil Additional Information Joint Program Executive Office CBD Place of Performance Address: US Army Space and Missile Defense Command, RDCM-SB, 64 Thomas Johnson Drive Frederick, MD Postal Code: 21702 Country: US
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/SMDC/DASG60/W9113M-11-PS-0002/listing.html)
- Place of Performance
- Address: US Army Space and Missile Defense Command, Deputy Commander 64 Thomas Johnson Drive Frederick MD
- Zip Code: 21703-4501
- Zip Code: 21703-4501
- Record
- SN02346511-W 20101219/101217234038-8e2b7de3982f541fb5af081b04a8c087 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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