Questions and Answer.docx

Questions and Answers

RFQ 75D301-20-Q-71381

1 “Prior to lot release, the Contractor will ship three or more kits to CDC for final lot release testing, plus at least two QC-testing panels for testing at CDC.” According to the statement, Please confirm our understand that a kit and panel are interchangeable.

1. Kits and panels are not at all interchangeable. A kit is what the vendor will produce for us and a panel is comprised of samples used for quality control (QC).

1. The QC panel is created by the vendor from diluted chimeric positive control and will be used by both vendor and CDC to check the activity of the kits prior to lot release.

1. CDC will also double check the kits with a panel of human serum of known YF IgM activity prior to lot release.

2 In order to estimate shipping cost, please provide the number of shipments required as well as specific destinations.

0. Shipping to CDC is the only requirement of this contract –

0. This includes shipment for quality control activity (destination: Fort Collins, CO)

0. This includes a shipment of final kits (destination: Fort Collins, CO); some of the inventory may be shipped to partner at CDC cost.

3 Should costs for WHO prequalification be associated with the Base or Option period? What is the government's strategy if delays by WHO extend past the period of performance?

1. Pre-qualification is quite a way off and won’t be associated with the base period.

1. Costs associated with pre-qual are yet to be determined, right now we are just looking at Expert Review Committee and there is no cost.

1. We will need all QC data from the manufacturer.

4 Will CDC provide positive control, negative control, YF antigen, normal antigen and conjugate for Task 2? (This only states that they will be provided for Task 1.)

1. We will provide for the base.

1. For the option, we may have the company purchase negative control, as that is most sustainable. CDC will provide the positive control and other materials.

5 Please define what completion of work is for this RFP.

0. Delivery of 250 kits that meet the required specifications of CDC

0. OPTION – delivery of completed kits that meet the required specifications of CDC

6 The Government will provide a one-time on-site training in the proper use of the kit to the QC department. Does "on site" mean at the Contractor's site or in Atlanta? Please confirm Contractor is responsible for travel costs and provide number of participants.

1. At the manufacturer’s facility, at CDC cost.

1. Minimum of two (2) CDC subject matter experts will provide training at the manufacturer’s facility.

7 Please confirm all kits remaining at the Contractor's facility at the end of the Period of Performance will be returned to the Government.

0. Yes, under this contract CDC will receive all the kits produced.

0. Suggested that the vendor maintain 20 kits for archival/lot comparison purposes. CDC will pay to ship those kits if needed.