QA 75D301-23-Q-77143.pdf

RFQ 75D301-23-Q-77143 Questions and Responses

8/31/23

1. What type of shipments will we receive, pallets, boxes etc. and the projected amount per month?

Response: The vendor will receive ~ 4020 cartons / 67 boxes. Each box contains 60 cartons. See below.

We plan to ship the majority in the first shipment. Exact amounts TBD but estimated first shipment = 50 boxes and second shipment = 17 boxes

2. How much space is projected for storage?

Response: See question #1 for amounts and below for dimensions. Note that most cartons will be sent out within 2-3 months after the vendor receiving them.

3. Temp monitoring equipment will be needed for these types of shipments. Will CDC reimburse the contractor for cost of all Temp Monitoring equipment included in shipments?

Response: This should be included in the quotes provided by vendors and subsequently in the contract.

4. Re: Page 2 Line items – The line items are asking for firm fixed prices/costs of shipments. This is difficult to do because this type of work is very variable based on the requirements. For instance, the shipping costs can vary greatly based on the quantity of drug to be shipped, where it’s being shipped, and what type of temperature-controlled shipping container used. It is impossible to provide a fixed cost for this. The same goes for packaging/labeling – it can vary greatly based on the quantity of units to be labeled, number of labels used, one big labeling run or multiple smaller runs, etc. Please advise how to approach this.

Response: Amendment 01 to the solicitation changes the contract type for CLINs 0001 and 1001 from firm-fixed-price to time-and-materials. FAR Clause 52.243-3 Changes-Time-and-Materials or Labor-Hours

(Sept 2000), and 52.232-7 Payments under Time-and-Materials and Labor-Hour Contracts (Nov 2021) are also added. Shipping costs will still be reimbursed as cost-only on CLINs 0002 and 1002.

5. To build on the above, a majority of this quote will be courier costs, which are out of our control.

What if costs change/how would the change control process work?

Response: See response to question #4.

6. How many drug products/quantities/how many lot #’s per drug product?

Response: One drug product. Rifapentine/Priftin. Likely only 2 lot numbers since estimating only 2 shipments (it is possible but unlikely there would be more than 2). Amounts : Total is 4,020 cartons. Inside each carton is 3 blister packs of 8 tablets each. 24 tablets per carton. Total of 96,480 tablets.

7. How many receipts are to be expected for the drug (one lot receipt upfront or multiple lots through the life of the project)?

Response: See response to question #1.

8. SOW is requesting single panel labels, but is also asking for label translations. This means that the goods would be split into 3-4 different “finished good” products. However, a booklet label could combine all translations into one finished product. Please advise what the intended finished good breakdown would look like.

Response: Single panel label on each carton in a single language will be sufficient. Here are the labels we add to the carton currently from CDC to give an example of the level of detail that will be required. This will not be the exact label but it will be similar.

9. Is the drug product being provided to us or do we need to source?

Response: Provided by Sanofi who will cover the shipment to the vendor.

10. Is there a public contract information you can point me to for the current contract of this project

Response: This is a new contract requirement.

11. What are the biggest factors in choosing the vendor for this project?

Response: Please see the evaluation factors in the solicitation.

12. When will a final decision be made in choosing a vendor?

Response: Award is anticipated this FY.

13. Will you confirm the (2) countries covered by the optional line items 1001 and 1002? (pg. 49, in reference to “Volume II. Price Quote, E.) Assumptions”)

Response: See response to question #14.

14. Will you share where the (12) trial sites are located across the (7) countries? (pg. 49, in reference to

“Volume II. Price Quote, E.) Assumptions”)

Response:

Locations to receive study drugs:

Cape Town, South Africa

Ho Chi Minh City, Vietnam

Kampala, Uganda

Cotonou, Benin

Port-au-Prince, Haiti

Montreal, Canada

Sydney, Australia

Locations to send study drugs to the vendor for destruction are TBD and will be up to 12 total sites

(most if not all will be in the U.S. and Canada).

15. Will you confirm which languages that will be required for translation? (pg.4, in reference to “V.III

Deliverables, Task IV.A”)

Response: French and Vietnamese

16. Will you confirm that it is not a requirement that the contractor or subcontractors have previously contracted directly with the US Government?

Response: This is a new contract requirement.

17. Given the nature of the scope of work, will there be a consideration for the small business to subcontract more than 49% of the work?

Response: This contract will not supersede Small Business Administration regulation.

18. Will you provide the Price Quote line item table that is referenced on page 49, “Volume II - Price

Quote Complete the line item table in this solicitation.”

Response: This refers to the table on page 2 of the solicitation – quoters are to fill in the Unit Price and

Extended Price blanks.