A15 - Technical Questions and Answers dtd 10-30-2020.pdf

Technical Q&A’s

CRT AbRc Materials

RFQ 00HCUGDH-2021-49898

Dated: 10/26/2020

Question 1: The storage conditions listed are -80°C. We have typically stored similar materials at -20°C. Would this be acceptable or is -80°C required?

Answer 2: For the AbRc Materials, we have only evaluated stability of the materials at -80°C, so for the reservation and storage of the materials (Task 4), -80°C is required.

Question 2: Regarding the storage conditions (question #3), for short term storage of <

1 month, can the products be stored at freezer temperature until final packaging occurs and then moved to sub-freezer (-80°C)?

Answer 2: Yes, for short term storage, -20°C will suffice, but long-term storage of all materials requires -80°C.

Question 3: Are you able to provide the country of origin for the Abrine-13C,D3 which the

CDC would be providing?

Answer 3: It was synthesized in the United States.

Question 4: Can you clarify the statement “Description of Methods table according to ISO

17034 standards?”

Answer 4: Tasks 1, 2, and 3 for all methods require that all samples are prepared according to

ISO 17034 standards. The samples required are described in the Description of Methods table.

Question 5: What level of certification is expected? Gravimetric prep only? Gravimetric prep with homogeneity testing? Raw material certification with gravimetric prep and homogeneity testing?

Answer 5: 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 6: Will each batch need to be unique across all studies within a year, effectively totaling 30 samples across three studies?

Answer 6: Yes, 30 total samples across three studies provided as ten samples per study

Question 7: 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 7: 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 8: What is CDC looking for specifically in the request for a summary of the homogeneity and accuracy data for review? This is on the COAs generated so would that suffice or is the CDC looking for one of the below options?

1) In process results prior to packaging (i.e. an email with a table once each level is tested and

QA reviewed

2) Formal report at end of summary containing all the data and methodologies from the 3 separate task kits

Answer 8: We would be looking for the option (1), where CDC can review the QA results before packaging.

Question 9: 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 9: 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.