Sole-Source-Procurement_v.5.15.17 (003) 7 26signed.pdf

JUSTIFICATION FOR SOLE SOURCE PROCUREMENT (OPEN

MARKET OR GSA) UNDER $150,000

Sole source acquisitions may be used on a limited basis and only when the Contracting Officer’s Representative (COR)/Program Official has provided sufficient justification and the Contracting Officer has determined that the circumstances warrant such action. The content for a justification must contain detailed facts and rationale to justify the sole source acquisition. Soliciting from a single source must be done in accordance with FAR 13.106-1(b) or 8.405-6. At a minimum, the following information must be included:

Identification of Program Office, Contracting Activity, and Proposed Requirement, Justification and Program Office Certification:

A. Program Office:

NCIRD

ID

IPB

Centers for Disease Control and Prevention Atlanta, GA 1600 Clifton Rd

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Financial Resources Acquisition Branch 2

C. Identification of Requirement:

1. Nature of Action to be Approved by Contracting Officer:

a. Sole source acquisition of: Pre and post influenza vaccination PBMCs and sera from 5 donors recruited and maintained by AllCells Inc.

b. Procurement Request (PR) Number (if available): N/A

2. Proposed Vendor and Estimated Procurement Amount (if available):

a. Proposed Vendor: AllCells Inc

b. Estimated Procurement Amount: $

3. Is the requirement on GSA Schedule? ☐ Yes ☒ No

If yes, provide schedule number: Click here to enter text.

Rev. 5/15/17

D. Justification:

1. The justification for this non-competitive action is:

☒ In accordance with FAR 13.106-1(b)(1), “only one source [is] reasonably available” which states that, “For purchases not exceeding the simplified acquisition threshold. (i) Contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name or industrial mobilization). (ii) Where a single source is identified to provide a portion of a purchase because that portion of the purchase specifies a particular brand-name item, the documentation in paragraph (b)(1)(i) of this section only applies to the portion of the purchase requiring brand-name item. The documentation should state it is covering only the portion of the acquisition which is brand- name.”

☐ Urgency

☐ Exclusive licensing agreements/Proprietary data

☐ Brand name required

☐ Industrial mobilization

☒ Other (e.g., compatibility, space issues, continuity, compatibility, etc.)

☐ In accordance with FAR 8.405-6 “Limiting Sources” which states that, “the only circumstances that may justify the action are – (A) An urgent and compelling need exists, and following the procedures would result in unacceptable delays; (B) Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; or (C) In the interest of economy and efficiency, the new work is a logical follow-up to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original BPA must not have been previously issued under sole-source or limited-sources procedures.”

☐ Urgency

☐ Only One Source

☐ Logical Follow Up

☐ Brand name required

2. Other facts supporting sole source procurement:

a. What can this product/service do that other products/services cannot do?

AllCells is a provider of human primary cells for use in research and clinical efforts.

Centers for Disease Control and Prevention is purchasing the following items for five

(5) donors:: Part 1: Whole Blood MNC, and Serum Day 0 of Flu Shot ● Scheduling 5 donors and administering the Flu 28 days prior to Leuko Pak collection ● Whole Blood, Cryopreserved, Mononuclear Cells, 10M/vial (20/donor) ● Whole Blood, Frozen, Serum, 5mL (1/donor) Part 2: Whole Blood MNC, and Serum Day 7 of Flu Shot ● Whole Blood, Cryopreserved, Mononuclear Cells, 10M/vial (20/donor) ● Whole Blood, Frozen, Serum, 5mL (1/donor) Part 3: Peripheral Blood MNC, and Serum Day 28 of Flu Shot ● Peripheral Blood, Cryopreserved, Mononuclear Cells, 100M/vial (35/donor) ● Whole Blood, Frozen, Serum, 5mL (1/donor) AllCells is the only company that provides custom orders from selected donors with further cell isolation and have high cell counts in each vial. Additionally, they have high viability/ reliability, can deliver the product in a little as three days, and are flexible with delivery.

b. What other products/services were considered and why did they not meet the need?

Rev. 5/15/17

AllCells Inc. is the only company capable of delivering the requested material.

3. Program Office efforts to seek potential offerors:

To our knowledge no other company will recruit, influenza vaccinate and provide the deliverables requested.

E. Program Office Certification:

I have reviewed this sole source justification and certify the justification is true and accurate to the best of my knowledge and adequate to support other than full and open competition.

Center/Institute/Office COR/Program Official Name/Title: Carolyn M. Wise, Program Specialist

Carolyn M. Wise

Center/Institute/Office COR/Program Official Signature:

Certification Date: January 20, 2022

F. Contracting Office Certification:

I have fully relied on the information provided herein and hereby certify that this justification is accurate and complete to the best of my knowledge and belief:

Contracting Officer Name: Click here to enter text.

Contracting Officer Signature:

Certification Date: Click here to enter a date.