B3. NAx10 Questions - Answered.xlsx

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Production, Distribution, and Storage of NAx10 Materials
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75D301-23-Q-76157
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RFQ 75D301-23-Q-76157 - Production, Distribution, and Storage of NAx10 Reference Materials
Date: April 28, 2023
Question
NumberRFQ Reference
(if applicable)QuestionCDC Response
1RFQ 75D301-23-Q-761571. According to C.6 of Bid, ~120 mg of each analyte will be provided by CDC along with the COA; therefore,Related Questions answered below
2RFQ 75D301-23-Q-76157a. Will the COA for each analyte contain the Country of Origin or will Country of Origin be supplied to the contractor for each analyte in another means?The COA for each provided analyte does not list a country of origin, however this information can be shared with the vendor upon award.
3RFQ 75D301-23-Q-76157b. Will the contractor test the supplied raw material before use according to internal test plans OR will the contractor use the values from the provided COA to adjust to target concentrations?While the agency has confidence in the provided COA, sufficient starting material should be provided for internal testing, if that is the vendor's standard protocol for quality assurance. If additional starting material beyond 120 mg is required, it should be clearly stated in the proposal.
4RFQ 75D301-23-Q-761572. According to section B – Line Items (page 2), period of performance is 5/22/2023 – 5/21/2028. Shall the contractor consider the retest/expire date of the products to be 5/21/2028? OR shall a date 5-years from award be applied as the retest/retire date?The vendor should assign the retest/expire date as the concluding date assigned for CLIN 0002 on the final, signed contract.
5RFQ 75D301-23-Q-761573. For each product, CDC requests one sample be provided prior to dispensing bulk – is 1.2 mL sufficient in 2 mL cryule and/or cryovial? If not, please indicate the volume of solution required for each sample.1.2 mL in a 2 mL cryule/cyrovial is sufficient for verification
6RFQ 75D301-23-Q-761574. For each product, CDC states “Vendor and CDC will mutually agree upon a timeline for approval” for the testing of the pre-dispensing sample. Is there an estimated time-frame the contractor can anticipate to receive CDC feedback/approval or will this timeframe be determined upon award?The agency intends to provide feedback within 3 business days of receipt of the pre-dispensing test samples, but communication of timelines throughout the process will be imperative to ensure testing staff is available to meet this intention.
7RFQ 75D301-23-Q-761575. To which CDC address would the contractor be sending the pre-dispensing test samples?The shipping address to the CDC Warehouse (Atlanta, GA) will be provided to the vendor upon award.
8RFQ 75D301-23-Q-761576. To which CDC address would the contractor be sending the requested number final products/packs?The shipping address to the CDC Warehouse (Atlanta, GA) will be provided to the vendor upon award. This address will be the same as above.
9RFQ 75D301-23-Q-761577. How does CDC want the contractor to handle any leftover starting material? A: Send back, B: Store for future use:, C: Destroy.The agency requires that the vendor return the leftover starting material to the agency. The shipping address to the CDC Warehouse (Atlanta, GA) will be provided to the vendor upon award

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