csf_diva_q_and_a_-_bac_8_18_14_and_larry_8-18-14.pdf

Classical Swine Fever (CSF) Vaccine Questions and Answers:

1. On page three, it is stated that “The NVS seeks a contract to obtain and maintain up to 1,000,000 doses of finished, ready-to-use Classical Swine Fever Virus Vaccine”. This implies that the NVS will store the vaccines. On page four, it is stated that the first component of the contract shall be “The production, storage and delivery of 1,000,000 doses of CSFV Vaccine”. This implies that the offeror shall store the vaccines. Which is correct?

Answer: The contractor will be required to store the vaccine for USDA.

2. On page three it is stated that “The Contractor and the NVS must develop suitable mechanisms to rotate finished vaccine to ensure product held by the NVS remains within satisfactory product dating for use throughout the term of the contract (5 years).” It is also noted on page four that “The shelf-life for these doses must be at least 24 months. Upon expiration of the labeled product date, potency testing must be performed for possible extended use”. These statements are at odds as the first implies that the offeror is responsible for ensuring that there are 1,000,000 doses on hand at all times during the contract period (at the offerors expense) while the second statement implies that the USDA-NVS recognizes that the vaccines will likely go off shelf life during the 5-year contract period. If the vaccine exceeds shelf-life and may not be extended, who pays for the new vaccine lot to replace stock? Is that the offerors responsibility or will that be a separate order placed?

Answer: We are not certain what the shelf-life of offered vaccines will be nor whether the offeror would be able to maintain a rotation of the product (i.e. if selling for commercial use also could always maintain the required doses under this contract without any product expiring). We are allowing contractors to provide us details of how they intend to provide/store product to maximize (e.g, request an extension of dating from CVB) shelf-life for the USDA purchased vaccine. However, if there is a need to replace the vaccine during the term of the contract (whether because of it exceeding shelf-life or because of the vaccine being used by USDA) USDA has an option to purchase replacement vaccine at the contract rates.

3. Does the NVS have a preference on submission for an import permit vs. filing for a US conditional license?

Answer: If the product is produced in a foreign manufacturing facility we want the Offeror to have or commit to obtain a USDA Import Permit for Distribution and Sale. If the product is manufactured in the United States we want the Offeror to have or commit to obtain a USDA Product License (a conditional Product License is acceptable).