B-3 AMENDMENT 001 QUESTIONS AND ANSWERS AND REV. SoW 8-9-2021.pdf
PDF 297 KB Posted
- Solicitation number
- 1333ND21QNB640296
About this file
This document contains a questions and answers file and revised statement of work for solicitation number 1333ND21QNB640296. The solicitation seeks a contractor to manufacture and test a master cell bank and working cell bank. Key requirements include producing an 800-vial homogeneous working cell bank from research cell bank material provided by the National Institute of Standards and Technology. The statement of work details specifications for pilot expansion of the research cell bank, characterization and release testing of the master and working cell banks, and delivery of final deliverables. The solicitation also provides answers to industry questions, clarifying that animal-product free facilities and certification of analysis for the research cell bank cannot be guaranteed and that identity testing may be included in quotations. No modifications are made to the receipt time and date for quotations in response to this solicitation.
View the file
Other files
| File | Type | Posted |
|---|---|---|
| 1333ND21QNB640296 STATEMENT OF WORK.pdf | ||
| 1333ND21QNB640296 CELL BANKS COMBINED SYNOPSIS-SOLICITATION.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
Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:
(a) By completing items 8 and 15, and returning or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.
E. IMPORTANT: Contractor is not is required to sign this document and return copies to the issuing office.
AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE
2. AMENDMENT/MODIFICATION NUMBER 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUISITION NUMBER 5. PROJECT NUMBER (If applicable)
7. ADMINISTERED BY (If other than Item 6) CODE
STANDARD FORM 30 (REV. 11/2016)
Prescribed by GSA FAR (48 CFR) 53.243
FACILITY CODE
9A. AMENDMENT OF SOLICITATION NUMBER
9B. DATED (SEE ITEM 11)
10A. MODIFICATION OF CONTRACT/ORDER NUMBER
10B. DATED (SEE ITEM 13)
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS
The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended. is not extended.
12. ACCOUNTING AND APPROPRIATION DATA (If required) copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;
13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NUMBER AS DESCRIBED IN ITEM 14.
CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NUMBER
IN ITEM 10A.
B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).
C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
D. OTHER (Specify type of modification and authority)
Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.
15C. DATE SIGNED
15A. NAME AND TITLE OF SIGNER (Type or print)
16C. DATE SIGNED
16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)
14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)
PAGE OF PAGES
6. ISSUED BY CODE
8. NAME AND ADDRESS OF CONTRACTOR (Number, street, county, State and ZIP Code) (X)
CODE
15B. CONTRACTOR/OFFEROR
(Signature of person authorized to sign)
16B. UNITED STATES OF AMERICA
(Signature of Contracting Officer)
Previous edition unusable
See Attachment Page.
1 16
1333ND21QNB640296001 AUG 09, 2021 NB645030-21-00175
000SB
NATIONAL INST OF STDS AND TECHNOLOGY
100 BUREAU DRIVE STOP 1640
BUILDING 301 ROOM B129
GAITHERSBURG MD 20899-1640
See Block 6
1333ND21QNB640296
JUL 29, 2021
See Schedule
Attachment Page
PAGE 2 OF 16 1333ND21QNB640296001
1333ND21QNB640296 ATTACHMENT PAGE
THE ABOVE NUMBERED SOLICITATION IS AMENDED AS FOLLOWS:
1. INSERT UPDATED STATEMENT OF WORK REFLECTING A REVISION TO THE
CONTENT THAT RESIDES IN SECTION III NO. 14
2. PROVIDE ANSWERS TO QUESTIONS RECEIVED FROM INDUSTRY
THE DATE AND TIME FOR RECEIPT OF QUOTATIONS REMAINS UNCHANGED.
END TEXT
Table of Contents
Q&A
STATEMENT OF WORK (REV 9 AUG 2021)
PAGE 3 OF 16 1333ND21QNB640296001
CLAUSES
Q&A
PAGE 4 OF 16 1333ND21QNB640296001
QUESTIONS AND ANSWERS PURSUANT TO COMBINED SYNOPSIS/SOLICITATION
1333ND21QNB640296
Q1. 800 vial WCB
a. Due to the large quantity, would it be acceptable to provide 2x400 vial sub-batches?
A1. No. Multiple WCB sub-batches totaling 800 vials would not satisfy NIST’s requirement for a single, homogeneous WCB totaling 800 vials.
Q2. Per our Quality Agreement, the client is responsible for arranging shipment of materials. We can certainly provide information for shipping companies that we work with.
A2. As stated on page 2 of the solicitation, NIST’s requirement is: Delivery terms shall be FOB Destination. FOB DESTINATION MEANS: The Contractor shall pack and mark the shipment in conformance with carrier requirements, deliver the shipment in good order and condition to the point of delivery specified in the purchase order, be responsible for any loss of and/or damage to the goods occurring before receipt and acceptance of the shipment by the consignee at the delivery point specified in the purchase order, and pay all charges to the specified point of delivery. All shipping costs to Gaithersburg, MD shall be included in the total firm-fixed price.
Q3. The SOW mentions 2 vials of the research cell bank (RCB) will be shipped. We would need 1 additional vial for archiving. Could this be provided?
A3. NIST can only guarantee that 2 RCB vials will be provided to the Contractor.
Q4. Our GMP suites are not classified as animal origin free (AOF); however, there will not be any animal derived components used in the suite during this campaign. In addition, we have fully validated cleaning and disinfection protocols for our facility.
A4. AOF is a critical NIST requirement for the material. Industry standard is for “true” AOF to be achieved by exclusion (i.e., no animal products in the suite, ever) instead of by cleaning.
Q5. Have you performed any identify testing on the research cell bank (RCB)? If so, can a CoA be provided?
A5. The RCB has a well-documented lineage. However, NIST cannot guarantee to provide to the Contractor a Certificate of Analysis for identity testing of the RCB. While not explicitly stated in SoW III.14, identity testing may also be considered and/or included by the Contractor in the Contractor’s quotation under the category “Contractor Pilot Expansion of the RCB”
STATEMENT OF WORK (REV 9 AUG 2021)
PAGE 5 OF 16 1333ND21QNB640296001
PAGE 6 OF 16 1333ND21QNB640296001
PAGE 7 OF 16 1333ND21QNB640296001
PAGE 8 OF 16 1333ND21QNB640296001
PAGE 9 OF 16 1333ND21QNB640296001
PAGE 10 OF 16 1333ND21QNB640296001
PAGE 11 OF 16 1333ND21QNB640296001
PAGE 12 OF 16 1333ND21QNB640296001
PAGE 13 OF 16 1333ND21QNB640296001
PAGE 14 OF 16 1333ND21QNB640296001
PAGE 15 OF 16 1333ND21QNB640296001
PAGE 16 OF 16 1333ND21QNB640296001
File details come from the government source that posted it. Updated .