FMD Vaccine Sources Sought

Overview

The United States Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), Acquisition and Asset Management Division (AAMD) has issued this Sources Sought notice on behalf of the United States Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), Foreign Animal Disease Diagnostic Laboratory (FADDL) as a means of conducting market research to identify interested parties with the resources to manufacture, store, and deliver Foot and Mouth Disease (FMD) vaccines. The result of this market research will contribute to determining the method of future procurements. This is not a solicitation. The Government will not award a contract based on this Sources Sought notice or any information received, and there will be no reimbursement for preparing or submitting information in response to this notice. All submissions will become Government property and will not be returned. The applicable NAICS code assigned to this procurement is 325414 with a size standard of 1,250 employees.

Background

Foot and mouth disease (FMD) presents a grave threat to the U.S. livestock industry; even a small outbreak would result in devastating economic and animal health consequences. To ensure the safety of its susceptible livestock, the United States is seeking to improve its FMD vaccine preparedness by enhancing its existing stockpile of FMD vaccine.

The USDA anticipates the need for FMD vaccine from multiple sources to serve the needs of the United States. The 2018 Farm Bill included funding to support the development of a National Animal Vaccine and Veterinary Countermeasures Bank (NAVVCB). The NAVVCB is distinct from the existing FMD vaccine stockpile for the United States, the North American Foot and Mouth Disease Vaccine Bank (NAFMDVB). That Bank is a bilateral partnership between the United States Department of Agriculture (USDA) and the Canadian Food Inspection Agency. The NAVVCB is entirely focused on U.S. domestic preparedness and is a distinct entity from the NAFMDVB.

Requirement

The USDA seeks to acquire sufficient quantities of vaccine or long-term vaccine precursor storage form(s) to support response activities in the case of a United States FMD outbreak. These holdings may initially be focused on inactivated 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.

A. Broad Objectives and Criteria for Manufacturer

Commensurate with this goal, the United States is seeking information from FMD vaccine manufacturers who can meet broad objectives and criteria, including:

1. Capability to produce vaccine or vaccine precursor targeting current and/or previously circulating FMD topotypes.
2. Sufficient resources to rapidly generate a vaccine or vaccine precursor for novel topotypes.
3. Capacity for ongoing vaccine or vaccine precursor production in the face of an outbreak.
4. A wide range of financial models to include lease access, rotating stock, buyback of vaccine/vaccine precursor, etc.

B. Vaccine and Vaccine Precursor

The vaccine, vaccine precursor or other long-term storage form(s) for consideration must meet the following requirements:

1. Vaccine or vaccine precursor that targets one or more of the top ten FMD topotypes posing the highest risk to the United States as determined by the NAVVCB and based on data from the World Organisation for Animal Health World Reference Laboratory for FMD.
2. Vaccine or vaccine precursor storage for its usable shelf life, preferably VAC with prolonged shelf life.
3. High-potency FMD vaccines meeting minimum threshold (≥ 6 PD50 or an equivalent validated measure of potency).
4. Vaccines 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.
5. Vaccine products with a reasonable expectation to be safe and effective in multiple target species (i.e., cattle, swine, sheep, and goats).

Submittals

If your organization has the potential capacity to meet this future requirement, please provide the following information:

1. Organization name, address, email address, web site 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 for capability information does not constitute a request for proposals; submission of any information in response to this notice 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 business or procured through unrestricted competition. No feedback or evaluations will be provided to companies regarding their responses to this notice.

Interested sources who submit data are responsible for appropriately marking information if it is proprietary in nature. All responses must be received by the closing date of this notice. Please email responses with the subject line "1166475 FMD Vaccine" to Stephen Tees at stephen.tees@usda.gov. Responses received after the closing date of this notice or without the required information will not be considered. Telephonic inquiries will not be honored.