75D30124Q78087 Amendment 2.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF

1. CONTRACT ID CODE

PAGE OF PAGES

1 2

2. AMENDMENT/MODIFICATION NO.

00002

3. EFFECTIVE DATE

08/23/2024

4. REQUISITION/PURCHASE REQ. NO.

86154

5. PROJECT NO. (If applicable)

6. ISSUED BY CODE 7. ADMINISTERED BY (If other than Item 6) CODE Centers for Disease Control and Prevention

(CDC) 1600 CLIFTON ROAD

Centers for Disease Control and Prevention (CDC)

1600 CLIFTON ROAD

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

All offerors.

X

9A. AMENDMENT OF SOLICITATION NO.

75D30124Q78087

9B. DATED (See Item 11)

08/02/2024

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (See Item 13)

CODE FACILITY CODE

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended, X is not extended.

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 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEGMENT 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 telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required) N/A

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, 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)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

The purpose of this Amendment 00001 is to do the following:

1. Upload Questions and Answers document.

2. This amendment does not extend the due date for quotes; they are still due at 3:00 PM EDT Tuesday August 27, 2024.

Offerors are to acknowledge receipt of this Amendment 00002 with proposal submission.

See Block 14 on page 1 of the Solicitation and Block 11 of this Amendment.

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.

15A. NAME AND TITLE OF SIGNER (Type or print)

16A. NAME OF CONTRACTING OFFICER

Jennifer Gartzke

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

15C. DATE SIGNED

16B. UNITED STATES OF AMERICA

BY ___________________________________________

(Signature of Contracting Officer)

16C. DATE SIGNED

08/23/2024

NSN 7540-01-152-8070 STANDARD FORM 30 (REV. 10-83)

PREVIOUS EDITION UNUSABLE 30-105 Prescribed by GSA

FAR (48 CFR) 53.243

ITEM 10A.

Amendment 00001 – 75D30124Q78087

Offerors are advised to read the entire revised Solicitation and review all changes to the solicitation.

Attachment:

1. Questions and Answers

Questions and Answers – 75D30124Q78087

1. Will our RFQ be retained and revised if we can provide only Item 0001 service: Recombinant Antibody Production in 200mL Mammalian Liquid Culture?

ANSWER: No, all CLINS are required for the project, and none can be made optional.

Integrated plasmid services (for the production of antibodies and other proteins) is integral to the project, as is the ability to compare cRNA vs plasmid constructs requiring cRNA synthesis services. Coverage of all services is seen as beneficial and less cumbersome than issuing separate contracts for each CLIN, and accordingly a benefit to the Government.

2. For line item 0008, what is the quantity (mg) of cirRNA to be delivered?

Minimum yield should be 1mg.

3. What is the length of the genes of interested?

Variable, but generally 1.5 to 3.5kb, with most 2-3kb, mostly representing influenza hemagglutinin (HA) or neuraminidase (NA) genes. Average length of all previous constructs on the project is 2.7kb.

4. Clarify quote: is it calling for 8,000 cirRNA with 8,000 nucleotide in length?

No, the RFQ is seeking 8 construct/preparations at 1mg scale of genes 1.5 to 3.5kb in length, with most 2-3kb, mostly representing influenza hemagglutinin (HA) or neuraminidase (NA) genes that have been altered for vaccination targets.

5. Required quantity of cirRNA to be delivered.

Unclear if different from #2, but 8 constructs/preparations with a minimal yield of 1mg each.

6. Is the proposal calling for 1 cirRNA with 8000 nt in length?

No, the RFQ is seeking 8 construct/preparations at 1mg scale of genes 1.5 to 3.5kb in length, with most 2-3kb, mostly representing influenza hemagglutinin (HA) or neuraminidase (NA) genes that have been altered for vaccination targets.

7. Can you please help on the below to quote you exactly, Example Requirement

1. Length of DNA bases (sequence length)?

2. Purification needed (desalted or HPLC)? Dual HPLC

3. Modifications on bases (dyes/quenchers/other)? FAM/BHQ1

4. Quantity delivered (typically nmol or umol) 500nmol

5. Delivery method (wet/dry and plate or tube format)? Dry/tube

ANSWER: It is unclear which CLIN this question is in reference to. Generally, the CDC will not specify a purification technique; offerors are free to propose the technique they feel to be the most beneficial. The other information requested is not needed for this procurement as it is not relevant for the items being procured under this solicitation. Final sequences and lengths may vary and will be based on wildtype influenza virus strains and mutations as they arise, and are accordingly not forecastable.

Amendment 0002_75D30124Q78087_Questions and Answers