TBTC_35_Clarifying_Questions_and_Answers_080719.pdf

TBTC 35 Clarifying Questions and Answers

RFQ 75D301-19-Q-70517

Item # Question Answer

1 In regards to the initial response to Question 8, the Government indicated that it “does not expect the offerors to include liability insurance as a direct cost.” Did the Government intend by this answer to preclude offerors from including such direct costs of liability insurance that is solely related to this study or was the

Government indicating its preference that offerors not include such costs? If the Government intended to preclude such costs, can the

Government provide a rationale for not allowing the recovery of a cost directly related to this activity, particularly under a fixed price contract where the risk of cost performance rests with the offeror?

Original answer to question 8 below in black text.

No, the sponsor or the study drug manufacturer will not maintain product liability insurance that will provide indemnification for the company that receives this award. The government does not expect the offerors to include liability insurance as a direct cost.

Clarifying response below in red text.

Clinical trials insurance is maintained by the study for the protection of participants, as required by South African regulation. The responsibility of the monitor is to oversee progress of the trial, ensure that the study is conducted, data are handled in accordance with the protocol, Good Clinical

Practice, and applicable ethical and regulatory requirements. The monitor will have no responsibilities that include direct contact with study participants; therefore, maintenance of liability insurance is not applicable to the awardee.

TBTC 35 Clarifying Questions and Answers

RFQ 75D301-19-Q-70517

2 Regarding Question 9, it appears that the table does not have any monitoring visits for PHRU in Option Year 1. This is an error which has cost implications. Would the CDC please provide clarification on the number of monitoring visits that will be conducted at PHRU in Option Year 1?

The table below lists visits per year. The same number of visits will occur in both years of the study. The maximum number of expected visits is 26. See revisions in red text.

Type of visit Base Year Option

Year 1

Comment

Pharmacy 3 3 One per each site

PK lab 1 1 In Cape Town

Safety lab 1 1 In Johannesburg

Periodic-DTTC 3 3 In Cape Town

Periodic-

FAMCRU

2 2 In Cape Town

Periodic-PHRU 3 3 In Johannesburg

3 Would the CDC agree to granting an extension until August 16th due to the potential cost implications of these questions?

Extension granted to August 15th, 2019 5PM EST.