SOLICITATION NOTICE
65 -- Avian Influenza Vaccines, Eurasian HPAI H5
- Notice Date
- 11/6/2015
- Notice Type
- Presolicitation
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- Contracting Office
- Department of Agriculture, Animal and Plant Health Inspection Service, Administrative Services Division/Contracting, 100 North 6TH Street, Butler Square 5TH Floor, Minneapolis, Minnesota, 55403
- ZIP Code
- 55403
- Solicitation Number
- AG-6395-S-16-0005
- Archive Date
- 12/31/2015
- Point of Contact
- Jim Roloff, Phone: 6123363223
- E-Mail Address
-
james.g.roloff@aphis.usda.gov
(james.g.roloff@aphis.usda.gov)
- Small Business Set-Aside
- N/A
- Description
- The U.S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS) intends to award multiple commercial, indefinite-delivery indefinite-quantity (IDIQ) contracts for vaccines and vaccine combinations effective against Eurasian highly pathogenic avian influenza virus H5 clade 2.3.4.4 (EA H5) in order to establish an emergency vaccine stockpile. The APHIS National Veterinary Stockpile (NVS) is the nation's repository of critical veterinary supplies, equipment, and service resources. It exists because of the nation's concern over animal diseases of catastrophic proportions that would • deplete State and local response inventories, • generate surge requirements that would overwhelm commercial sources, and • prevent unaffected States from providing significant help for fear of the threat crossing their borders. NVS's ability to deploy within 24 hours large amounts of critical veterinary resources ensures states have what they need to respond to catastrophes and other outbreaks. The arrival and subsequent evolution of Eurasian HPAI H5 viruses of clade 2.3.4.4 lineage (EA H5 viruses) in North America has resulted in a catastrophic epiornitic, affecting both domestic poultry and captive avian wildlife. These viruses may persist within the wild bird compartment which could serve as a reservoir and pose a significant threat to U.S. poultry and avian collections. Therefore, NVS seeks sufficient supplies of vaccine, to be used singly or in combination with other vaccines that are effective against EA H5 viruses, suitable for use in chickens and/or turkeys ranging from one-day of age up to ≥ 3 years of age. The goal is to acquire and maintain an emergency/supplementary stockpile of EA H5 vaccines available for delivery anywhere in the United States within 24 hours of order by the NVS. Such products might include but not be limited to the following formulations/platforms: finished vaccine with shelf-life ≥ 1 year; vaccine precursors that can be rapidly processed into finished vaccine (e.g., antigen concentrates for inactivated vaccines) with potency retention of ≥ 2 years; and modified-live, or nonviable/nonreplicating vaccines that can be stored in a manner to ensure potency retention of ≥ 2 years. This vaccine stockpile would be used for emergency vaccination and to supplement commercial supplies as part of a larger vaccination campaign. All finished vaccines or vaccine precursors would be stored and maintained at the manufacturer. Nationally, the placement rate of laying hens and meat turkeys is approximately 20 million birds per month. With each bird requiring two doses of vaccine prior to placement, 80 million doses per month will be needed just for these two sectors alone. Therefore, vaccine companies should minimally have a production capacity ≥ 100 million doses per month to address these two sectors. NVS seeks a contract that will have the following components: 1) Production and banking of AI vaccine or vaccine precursors: Contractors would produce and store product and must demonstrate a storage capacity of a minimum of 100 million doses to a maximum of 500 million doses of vaccine or vaccine precursor that are effective against EA H5 viruses, whether used alone or as combinations of different vaccines; 2) Vaccine must be fully licensed, conditionally licensed, or permitted (only products permitted for general distribution and sale will be considered) in accordance with the Center for Veterinary Biologics (CVB) regulations in order to be eligible for award. Delivery anywhere within the continental U.S. of up to 100 million doses of finished vaccine eligible for distribution and sale must be made within 10 calendar days of order as directed by the NVS; 3) Vaccine or vaccine precursor must be stored in a manner consistent with the longest potency viability of the product, and demonstrate satisfactory potency when tested at twelve (12) month intervals throughout the duration of the contract; 4) Small serials of finished vaccine from vaccine precursor will be produced by the manufacturer every twelve (12) months and potency tested by the manufacturer and provide potency data for review by the CVB; 5) Samples of finished vaccine and/or serum samples from vaccinated birds will be provided to CVB if requested by the CVB; 6) Product will be stored by the manufacturer in a manner that ensures the longest shelf life while retaining satisfactory potency as determined by the CVB (e.g., vaccine antigen concentrate) which shall be no less than two years; The contracts will have a guaranteed minimum of $6 million worth of doses up to a maximum of 500 million doses of vaccine or vaccine precursor effective against EA H5. The North American Industry Classification System code is 325414 with a small business size standard of 500 employees. Solicitation number AG-6395-S-16-0005 will be will be issued on an unrestricted basis and posted on FBO during the latter part of November, 2015. Any questions or inquiries must be e-mailed to Jim Roloff, contracting officer, at james.g.roloff@aphis.usda.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USDA/APHIS/Contracting/AG-6395-S-16-0005/listing.html)
- Record
- SN03940937-W 20151108/151106234414-768b6ff77d541daf7f17ab06941b05e1 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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