FAD Vaccines and Associated Diagnostic Tests for Equines Sources Sought Agency: Department of Agriculture Office: Animal and Plant Health Inspection Services Notice Type: Sources Sought Response Date: Posted Date + 90 days PSC: 6505 Drugs and Biologicals NAICS Code: 325413 In Vitro Diagnostic Substance Manufacturing / 325414 Biological Product (except Diagnostic) Manufacturing Overview The U.S. Department of Agriculture, Animal and Plant Health Inspection Service, issues this sources-sought notice as a means of conducting market research to identify interested parties with the resources to manufacture, store, and deliver vaccines and any associated diagnostic tests for horses for: Japanese Encephalitis Virus (JEV), African Horse Sickness (AHS), Hendra virus, and Nipah virus. The result of this market research would contribute to determining the method of future procurement if there was a need. There is currently no plan to follow up with a procurement. There is no defined requirement at this time . This is preliminary market research. This is not a solicitation . The applicable NAICS code assigned to this procurement is 325414, with a size standard of 1,250 employees. Background Foreign animal diseases (FAD), including JEV, AHS, Hendra virus, and Nipah virus, present a threat to the U.S. equine industry, with potentially devastating economic and animal health consequences. To ensure the safety of susceptible horses, the United States is seeking to improve its preparedness for the possible incursion of these specific FAD by identifying potential sources of vaccines and associated diagnostic tests that could differentiate vaccinated from infected animals for these diseases. Requirement The USDA seeks to identify sources for vaccines and diagnostic tests to support response activities in the case of a United States outbreak in horses of the FAD: JEV, AHS, Hendra virus, or Nipah virus. These holdings may initially be focused on inactivated vaccine products, but novel vaccine platforms or novel processes of generating inactivated vaccine will be considered, provided they meet the performance criteria detailed in this document. Commensurate with this goal, the United States is seeking information from vaccine manufacturers who can meet the objectives and criteria in this document. These broadly include the following: • USDA seeks manufacturers with the capability to produce vaccine or vaccine precursors suitable for use in horses targeting the FAD: JEV, AHS, Hendra virus, and Nipah virus, as well as diagnostic tests associated with these vaccines that could differentiate vaccinated from infected animals. • USDA seeks manufacturers with the capacity for ongoing vaccine or vaccine precursor and diagnostic test production in the face of an outbreak. • USDA is interested in a wide range of financial models, including lease access, rotating stock, buyback of vaccine/vaccine precursor or diagnostic tests, etc. Vaccine and Vaccine Precursor and Diagnostic Tests The vaccine, vaccine precursor, or other long-term storage form(s) and diagnostic tests for consideration must meet the following requirements: • USDA seeks vaccine or vaccine precursor suitable for use in horses that target JEV, AHS, Hendra virus, and Nipah virus. • USDA seeks manufacturers capable of storing vaccine or vaccine precursor and diagnostic tests for their usable shelf life. USDA hopes to locate manufacturers of vaccines and diagnostic tests with prolonged shelf life. • USDA seeks vaccines and diagnostic tests for use in horses that are either licensed (fully or conditionally) or permitted by the USDA Center for Veterinary Biologics (CVB) for distribution and sale within the United States or authorized by the Administrator to be used under the supervision and control of the Department as described in the 9 CFR 106.1 with the condition that the manufacturer is actively engaged in the pursuit of obtaining a USDA CVB product license (full or conditional) or permit. • If vaccines and/or diagnostic tests are not currently licensed, permitted or authorized in the United States, they would still be eligible for consideration if they meet the the preliminary requirements listed above. If your organization has the potential capacity to meet this possible future requirement, please provide the following information: 1) Organization name, address, email address, website address, telephone number, business size as determined by the NAICS code, type of ownership for the organization; and 2) Tailored capability statements addressing the particulars of this effort. THERE IS NO SOLICITATION AT THIS TIME . This request does not constitute a request for proposals; submission of any information in response to this market survey is voluntary. The government assumes no financial responsibility for any costs incurred. Based on responses to this sources-sought notice, this requirement may be set aside for small businesses or procured through unrestricted competition. No feedback or evaluations will be provided to companies regarding their responses to this notice. Any information deemed proprietary in nature should be specifically identified as such. Any information marked as proprietary will be protected from unauthorized disclosure. This information is intended to be stored in a government-owned database. Future contracts for database maintenance or further market research may make information not otherwise marked proprietary available outside of the government. This sources sought notice is being publicized to determine if there are any small businesses with the capability of providing the services in accordance with the requirement outlined above. Small businesses shall be aware they must comply with the FAR 52.219-14- Limitations on Subcontracting. Part 52 - Solicitation Provisions and Contract Clauses | Acquisition.GOV Please provide information in pdf format. All responses must be received by 17:00 CST July 31, 2024 . Please email responses with the subject line: “FAD EQUINE SOURCES SOUGHT RESPONSE (Sources Sought # here)” For the purposes of this Sources Sought E-Mail responses will only be accepted. Primary Point of Contact: Stephanie Brault 2150 Centre Avenue Bldg, B. Fort Collins, CO 80526 (970)692-4063
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