Master Seed (MS) and Working Seed (WS) Lots for Foot-and-Mouth Disease (FMD) Molecular Vaccine Countermeasures

RFP Amendment to address industry questions: 1. Is it correct to assume that all 9 of the FMD serotypes to be produced as master seeds will be provided, fully constructed, with details on source of genetic materials and the already-accomplished steps in construction of the pre-master seed viruses be provided for incorporation into the required SIFs? - - Yes, that is correct. 2. How many vials of MSV, MSV+1 and MSV+5 are required to be delivered? In C.2.i the requirement is stated to be a minimum of 600 vials of MSV, 600 vials of MSV+1 and 100 vials of MSV+5, however, in the detailed milestone section (C.4.1) it is stated that Milestone 1 has a deliverable of 700 vials of MSV and 500 vials of MSV +1, and further in C.4.1.3 Task 3, it is stated that 700 vials of MSV+1 must be delivered. Please clarify the deliverable requirements for number of vials of MSV, MSV+1 And MSV+5 for each serotype. Section C.2.i and C.4.1.3 do not agree. - The correct number of vials is 700 for MSV, and 500 vials of MSV + 1, 100 vials of MSV + 5 for each FMD serotype vaccine 3. Is it correct to assume there will be no down-stream virus purification steps required prior to preparation of the seed cultures for freeze-down? - That is correct. 4. The testing of MSV is described in greater detail than the testing of MSV +1 and MSV+5. Please clarify what testing will be required for MSV+1 And MSV+5. - For the MSV +1 and +5, Purity testing in accordance w/ 113.27 and Mycoplasma testing in accordance w/ 113.28 5. Is it acceptable for the animal safety tests for the MSV to be done outside containment? If not, what level of containment will be required for the MSV animal safety tests? - At least for the base period, it should be assumed that MSV animal safety test will be done in BSL-2. CVB will review each SIF and decide level of containment required. It is possible that they may permit MSV testing outside containment for all the option year FMD serotypes. 6. Please clarify item 3.4 (and the analogous sections in later tasks) It is not clear to us whether this statement is requiring a confirmatory gene sequence analysis be conducted on the MSV, or whether this statement is merely reflecting a requirement that we incorporate the DHS-supplied prior MSQ information into our MSV testing report and SIF. - A confirmatory gene sequence analysis does NOT need to be conducted. The offeror should incorporate the DHS-supplied prior MSQ information into the MSV testing report and SIF. 7. In section C.2 there is a reference made to production of the materials being required to conform to 9CFR 113.300, 113.64, 113.100 and 113.200, however for live virus products 113.64, 113.100 and 113.200 seem only indirectly applicable. Please explain how 9CFR 113.64, 113.100 and 113.200 are best applied to this proposed activity. - For the proposed activity under general requirements only 9CFR 113.300 (live virus vaccine) is applicable. 8. It is noted that in section C.2. ii (b) 9CFR 113.47 is mentioned as a purity test, and then the same section of 9CFR is redundantly mentioned as an extraneous agent test in section C.2. ii (c). We assume the first mention, section C.2. ii (b), was meant to reference the purity test, 9CFR113.27. Please confirm this assumption is correct. - That is correct, C.2.ii (b) was meant to reference the purity test, 9CFR 113.27; 113.47 was a typo error. - For C.2 ii (c) extraneous test, the proposed activity should conform with 9 CFR 113.46, 113.52 and 113.55. 9. In order to test MSV under 9CFR 113.47, it is necessary to know the intended species of destination for the vaccines to be made with the MSV. Should our proposal 9CFR113.47 general testing plus specific testing for species other than bovine? i.e., canine, equine, porcine or feline? If porcine testing is required, is Circovirus and PRRSV testing required? - Proposed activity should be general testing plus bovine species testing. At this time, porcine testing is NOT required. 10. The RFP describes storage of MSV and WSV under conditions that maintain their stability and at least two distinct, secure locations. Please describe criteria for what would be considered "distinct" locations. - Distinct locations criteria - physically separated buildings serviced by different power mains