75D301-25-R-73207 Amendment 0001.pdf

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

The purpose of this amendment is to provide answers to questions submitted by prospective vendors, extend the solicitation due date, and revise applicable dates within the solicitation.

Point of Contacst: Contract Specialists Austin Pagliaccetti, email: zsm6@cdc.gov and Shayna Connery, email xvj9@cdc.gov.

Both should be included on all correspondence.

(See Continuation Pages)

Centers for Disease Control and Prevention Chamblee Campus Building 102, MS S102-4 4770 Buford Hwy Atlanta, GA 30341-3717 Atlanta, GA 30341-4004

000HCAD1-2024-84620

75D301-25-R-73207

1 6

11/14/2024

11/7/2024

75D301-25-R-73207

Diagnostic Test Development and Production for Emergency Response Solicitation

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

The following have been added by full text:

QUESTIONS AND RESPONSES

1. QUESTION: Is there a current vendor performing services that are listed within the Sam notice or is this the first iteration of these services? Please provide current contract number and vendor.

RESPONSE: This is a new action without an incumbent vendor or contract currently in place.

(End of Questions and Responses)

SOLICITATION 75D301-25-R-73207 ISSUED NOVEMBER 7, 2024

1. STANDARD FORM (SF) 1449 BLOCK EIGHT (8) CONTINUATION:

The following SF 1449 continuation information has been changed from:

Response DUE Date/time: 12/2/2024/Before 12:00 pm Eastern Time

Questions DUE Date/time: 11/18/2024/Before 12:00 pm Eastern Time

To:

Response DUE Date/time: 12/13/2024/Before 12:00 pm Eastern Time

Questions DUE Date/time: 11/29/2024/Before 12:00 pm Eastern Time

2. SECTION B – CONTINUATION OF SF 1449

SCHEDULE OF SUPPLIES/SERVICES

The following items have changed in Schedule of Supplies/Services Table from:

ITEM 0001 Period of Performance (POP)/Ordering Period: February 7, 2025 – February 6, 2026

And

ITEMs 0002, 000201, 000202, 000203, 0003, 0004, 000401, 000402, 0005 POP/Ordering Period: February 7, 2025 – February 6, 2030

Diagnostic Test Development and Production for Emergency Response Solicitation

To:

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE Maximum Contract Value

0001 Diagnostic Development and Validation Plan

Firm Fixed Price (FFP) Non-Severable

Period of Performance (POP)/ Ordering Period:

To Be Determined (TBD) 2025 Date of Award – 364 Days After Award (2026)

Minimum Value see B.3

$10,000.00

NTE

$10,000.00 NTE

0002 Test development, validation, and production.

This is a FFP Line Item Severability to be determined at Task Order (TO) level.

POP/Ordering Period:

TBD 2025 Date of Award – Four (4) Years, 364 Days After Award (2030)

Maximum Value see B.3

000201 Test development and validation from a CDC Laboratory Developed Test, with clinical validation specimens available from CDC.

Validation includes generation of a data package sufficient for submission to FDA for EUA or 510(k), but not actual submission.

This is a FFP Line Item Severability to be determined at TO level.

POP/Ordering Period:

TBD 2025 Date of Award – Four (4) Years, 364 Days After Award (2030)

000202 Test development and validation for a pathogen with no existing LDT, with sequence data and pathogen samples available from CDC, in advance of an outbreak. Validation includes generation of a data package sufficient for submission to FDA for EUA or 510(k), but not actual submission.

This is a FFP Line Item Severability to be determined TO level.

POP/Ordering Period:

TBD 2025 Date of Award – Four (4) Years, 364 Days After Award (2030)

Diagnostic Test Development and Production for Emergency Response Solicitation

000203 Test development and validation for a pathogen with no existing LDT, with sequence data and pathogen samples available from CDC, in response to an outbreak (expedited timeframe required). Validation includes generation of a data package sufficient for submission to FDA for EUA or 510(k), but not actual submission.

This is a FFP Line Item Severability to be determined TO level.

POP/ Ordering Period:

0003 Test submission for regulatory approval for a selected pathogen

This is a FFP Line Item Severability to be determined TO level.

POP/ Ordering Period:

TBD 2025 Date of Award – Four (4) Years, 364 Days After Award (2030)

Maximum Value see B.3

0004 Manufacturing of test for the selected pathogen

This is a FFP Line Item Severability to be determined TO level.

POP/ Ordering Period:

TBD 2025 Date of Award – Four (4) Years, 364 Days After Award (2030)

Maximum Value see B.3

000401 Test manufacturing per test in lots of 100,000- 999,999

This is a FFP Line Item Severability to be determined TO level.

POP/ Ordering Period:

000402 Test manufacturing per test in lots of greater than 1,000,000

This is a FFP Line Item Severability to be determined TO level.

POP/ Ordering Period:

Diagnostic Test Development and Production for Emergency Response Solicitation

0005 Travel

This is a Severable, Cost-Reimbursable line item.

For planning purposes, this item will be executed only if applicable to IDIQ Task Order.

POP/ Ordering Period:

TBD 2025 Date of Award – Four (4) Years, 364 Days After Award (2030)

$20,000.00

NTE

$20,000.0

0 NTE

3. SECTION C – CONTRACT CLAUSES

The following instruction to offerors has been changed from:

52.216-18 Ordering. (AUG 2020)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from January 27, 2025 through January 26, 2030.

To:

52.216-18 Ordering. (AUG 2020)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from TBD 2025 Date of Award – Four (4) Years, 364 Days After Award (2030).

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) A delivery order or task order is considered “issued” when-

(1) If sent by mail (includes transmittal by U.S. mail or private delivery service), the

Government deposits the order in the mail;

(2) If sent by fax, the Government transmits the order to the Contractor’s fax number; or

(3) If sent electronically, the Government either-

(i) Posts a copy of the delivery order or task order to a Government document access system, and notice is sent to the Contractor; or

(ii) Distributes the delivery order or task order via email to the Contractor’s email address.

(d) Orders may be issued by methods other than those enumerated in this clause only if authorized in the contract.

(End of clause)

Diagnostic Test Development and Production for Emergency Response Solicitation

4. SECTION E – SOLICITATION PROVISIONS

The following instruction to offerors has been changed from:

CDCA_L002 Inquiries (Jul 2017) Inquiries concerning the solicitation document should be submitted in writing to the issuing office. Any additions, deletions, or changes to the solicitation will be made by an amendment.

OFFERORS ARE INSTRUCTED SPECIFICALLY TO CONTACT ONLY THE

SOLICITATION CONTRACTING OFFICE IN CONNECTION WITH ANY ASPECT OF

THIS REQUIREMENT PRIOR TO CONTRACT AWARD. PROPOSALS AND ALL

CORRESPONDENCE RELATING TO THE SOLICITATION DOCUMENT SHALL BE

SUBMITTED TO THE CONTRACTING OFFICE.

Inquiries should be received by the Contracting Office no later November 18, 2024 12:00 pm Eastern Time and may be submitted via e-mail to xvj9@cdc.gov and zsm6@cdc.gov.

To:

Inquiries should be received by the Contracting Office no later November 29, 2024 12:00 pm Eastern Time and may be submitted via e-mail to xvj9@cdc.gov and zsm6@cdc.gov.

(End of Summary of Changes) mailto:xvj9@cdc.gov mailto:zsm6@cdc.gov mailto:xvj9@cdc.gov mailto:zsm6@cdc.gov