RFP Q&A.docx
DOCX document 16 KB Posted
- Attached to
- FMD VAC and Related Items for NAVVCB Federal contract opportunity
- Solicitation number
- 12639520R0009
About this file
This document summarizes a Request for Proposals for Foot and Mouth Disease Vaccine Antigen Concentrate, storage, finishing, and direct vaccine purchase to support the National Animal Vaccine and Veterinary Countermeasures Bank. The United States Department of Agriculture Animal and Plant Health Inspection Service intends to award multiple indefinite delivery/indefinite quantity contracts. Proposals will be accepted through January 2023 for consideration of awards to begin within 30 days of receipt. Offerors must provide pricing for FMD VAC types by serotype for cattle and swine, as well as storage and finishing services. Acceptable manufacturing facilities must be approved by the Center for Veterinary Biologics. Questions should be directed to the named contracting officer.
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Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| 12639520R0009P00001.pdf | ||
| RFP Q&A.docx | DOCX document | |
| 12639520R0009.pdf |
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RFP Questions and Answers
Target Species:
Q. The RFP seems to be exclusively focused on Cattle FMD Vaccines. We understood that FMD vaccines were multiple species were under consideration from our previous conversations. Is the government still pursuing FMD vaccines for swine?
A. The RFP states NAVVCB conducts safety and potency tests in cattle; it does not indicate target species claims. Ideal vaccines will be suitable for vaccinating multiple species against FMD. If needed, the vaccine will likely be used in cattle and swine, and depending on the outbreak conditions may be used in small ruminants and zoo animals.
Target Serotypes:
Q. Assuming that the desired annual vaccine quantities(1m or 2.5m+) are serotype specific, would you like respondents to submit separate proposals for different serotypes that they can address for a given species or can they be submitted in the same proposal?
A. The RFP requests fixed pricing for all FMD VAC types offered by the manufacturer. This means only one proposal shall be submitted. The Offeror shall submit serotype specific information that indicates safety and efficacy for a given species; all data shall be submitted in one proposal. The Offeror must provide the NAVVCB with a list of master seed viruses (MSV) that have been tested and approved by APHIS for use in production, and a separate list of MSV which are used to prepare commercial vaccines but have not been approved by APHIS (see Technical Annex, F.2.1).
Acceptable Manufacturing Sites:
Q. Please re-confirm that our manufacturing site in Taiwan would be acceptable for production?
Additionally what would be your position on API manufacture at a US facility and Vaccine formulation at a Taiwan facility?
A. CVB is the regulatory body that would make this determination. We will not confirm whether your facilities meet CVB requirements prior to receipt of a proposal. We would direct you to your CVB reviewer for questions.
Registration Progress:
Q. What are the requirements of the challenge for swine species, specifically are 1 or 2 inoculations acceptable?
A. Contact the CVB Reviewer assigned to your company.
Q. We have submitted the application for FMDV license with CVB, how far a long do we need to be in the submission process in order to be considered and what testing will be required from us at this time?
A. Contact the CVB Reviewer assigned to your company.
Q. Will real-time stability be required to establish (guarantee) the shelf life or will accelerated studies be acceptable?
A. Contact the CVB Reviewer assigned to your company.
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