A15 - Technical Questions and Answers dtd 11-12-2020.pdf

Technical Q&A’s

CRT PT Materials

RFQ 00HCUGDH-2021-49849

Dated: 11/12/2020

Question 1: What level of certification is expected? Gravimetric prep only? Gravimetric prep with homogeneity testing? Raw material certification with gravimetric prep and homogeneity testing?

Answer 1: For 49889, gravimetric prep is sufficient. Participants are evaluated based on the consensus results, so gravimetric prep using good laboratory practices should suffice for being within the performance standard described in section IV of the PWS.

Question 2: Will each batch need to be unique across all studies within a year, effectively totaling 30 samples across three studies?

Answer 2: Yes, 30 total samples across three studies provided as ten samples per study

Question 3: Is it possible to delay the date of delivery to accommodate manufacturing lead times? January delivery may not be an attainable date for us to manufacture an initial round of samples.

Answer 3: No, the calendar of events for 2021 has already been established. No certification beyond gravimetric prep is required, so manufacturing should only require spiking of matrix materials in bulk followed by aliquotting, packaging, and shipping. Keep in mind, only four studies (CN, NMM, OPNA-S, and OPNA-U) are required in January according to the shipping calendar.

Question 4: Based on the acronyms provided we cannot locate sources for CMPA (CAS#

1932-54-8), MMPA (CAS# 1604-38-2) and PMPA (CAS# 612-52-4). Will the CDC be able to provide these materials? Also, we understand that the CDC will be providing the Abrine

Internal Standard material. Please confirm.

Answer 4: CDC intends on providing the OPNA compounds listed for the PT Materials program. CDC also intends on providing the Abrine internal standard for the ABRC bulk materials program.

Question 5: What is the length of the contract? The paperwork lists a base year and 4 additional option years. Are we bidding on a 1-year contract with options to extend or a longer-term contract?

Answer 5: The length is a 1-year contract with annual options to extend

Question 6: Referencing: CDCA_H042 Records management: B. Definitions - 3. applies to records created, received, or maintained by contractors pursuant to their CDC contract.

Does this include all documentation (physical and virtual) used internally to carry out this project?

Answer 6: “These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.”

“In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for

Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.”

Question 7: Does the government plan to provide IT equipment after awarding of the contract?

Answer 7: No. This contract does not require nor is it providing GFE.

Question 8: If the calendar of events has already been established and the January

Shipping dates are mandatory, when will the calendar be available for review? This will impact some aspects of the bid we produce.

Answer 8: The calendar with the shipping dates has been provided as Attachment 3.

Question 9: If we are required to procure a material independently and it is unavailable or delayed for a significant amount of time, will the CDC provide said material?

Answer 9: CDC will provide stock native compound material that are not commercially available. Please provide a list of compounds you will need in your proposal.