FDA_SOL_1227188 Amendment 01 Q and A.pdf
PDF 64 KB Posted
- Solicitation number
- FDA_SOL_1227188
About this file
This document is an amendment to a solicitation for the preparation and characterization of purified virus stocks. The Food and Drug Administration seeks to procure virus stocks for a period of 12 months including preparation, quality control, and delivery of a minimum of five shipments of twenty vials each upon completion of production for each virus stock. An additional four option periods are included for temperature-controlled storage at two locations and up to five domestic and five international shipments per year. The amendment provides answers to questions received which clarify the period of performance includes 60 months total, and payment for storage activities during option years will be invoiced monthly in arrears. The amendment also extends the response deadline to June 23, 2020 at 2:00 pm Central Time.
View the file
Other files
| File | Type | Posted |
|---|---|---|
| FDA_SOL_1227188_Amend 01.pdf | ||
| FDA_SOL_1227188.pdf |
On GovTribe
Work with this file
- Download the original file
- Contacts named in this file
- Similar government files
- Ask GovTribe AI about this file
Text version
Amendment 0001 to Solicitation FDA_SOL_1227188:
The purpose of this amendment is as follows:
1. Post Answers to Questions received as of June 8, 2020 as follows:
Q1: RFQ Page 3 states the “Period of Performance – Delivery Terms: 12 consecutive months from date of award.” However, the Technical requirements (also page 3) states “11. Contractor shall provide demonstrated capability for long-term in-house storage of the required virus stocks for 5 years in temperature-controlled vessels at two locations to include detailed logs kept for production, testing, managing, orders, and shipping of biological materials;” “Remainder of purified virus stocks shall be stored at Contractor’s facility for a maximum of five (5) years, subject to shipments as required by the FDA during that period.”
Please confirm that the period of performance is 60 months. The first 12 months shall include Preparation and QC of the virus stocks. The remaining 48 months shall include storage and distribution activities.
A1: Anticipated period of performance is for 12 months for preparation and QC of the virus stocks;
the solicitation has been amended to include four (4) option periods of storage and distribution activities.
Q2: Please confirm the ‘Schedule of Supplies or Services and Prices/Costs’ CLIN 001 should include costs for the entire 60-month period of performance and include all costs for preparation, QC, storage and distributions.
A2: Per the amended solicitation, CLIN 01 includes preparation and QC of the virus stocks, and delivery and all shipping charges FOB Destination for a minimum of five (5) individual shipments of twenty vials of each virus upon completion of production for each virus stock.
Q3: Please confirm an acceptable assumption for expected total distribution during months 13-60 is
5 domestic and 5 international shipments per consecutive 12-month period. Please confirm requested distributions in excess of this assumption will be funded separately.
A3: Per the amended solicitation, the anticipated distribution for each option year is up to five domestic and five (5) international shipments.
Q4: Per RFQ page 20 “Payment terms Net 30 days after government acceptance of a proper invoice.
No advance payment will be made…” Please confirm that payment during the first 12 months for storage and distribution activities during months 13-60 is not considered “advanced payment”?
A4: The government cannot make advance payments for services as the result of exercising an option year. Invoices for storage services for each option year may be submitted no more frequently than monthly in arrears for each 12-month option period.
END OF QUESTIONS AND ANSWERS
2. Amend the Schedule of Supplies or Services and Prices/Costs in the solicitation to add CLIN’s for option years of temperature-controlled storage (see amended solicitation, pages 1-3).
3. Extend the hour and date for receipt of offers as follows:
The hour and date for receipt of offers has been changed to Tuesday, June 23, 2020 at 2:00 pm (Central Time – Local Prevailing Time in Jefferson, Arkansas) (page 27, last paragraph).
(End of Amendment 01)
File details come from the government source that posted it. Updated .