A15 - Technical Questions and Answers dtd 11-3-2020.pdf

Technical Q&A’s

CRT PT Materials

RFQ 00HCUGDH-2021-49849

Dated: 11/3/2020

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.