SSJ Bovine Serum 73190 Signed Redacted.pdf

Rev. 1/6/14

JUSTIFICATION FOR SOLE SOURCE PROCUREMENT (OPEN

MARKET OR GSA) UNDER $250,000

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:

Centers for Disease Control and Prevention Division of Vector-Borne Diseases 3156 Rampart Road / Foothills Campus Fort Collins, CO 80521

B. Contracting Activity:

Centers for Disease Control and Prevention Procurement and Grants Office Acquisition Branch 2920 Brandywine Road, Mail Stop K-69

Atlanta, GA 30341

C. Identification of Requirement:

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

a. Sole source acquisition of: Premium Grade Fetal Bovine Serum (FBS), gamma irradiated.

b. Procurement Request (PR) Number (if available): 73190

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

a. Proposed Vendor: VWR

100 Matsonford Road Randor, PA 19087

b. Estimated Procurement Amount: $63,450.00

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

If yes, provide schedule number: N/A

D. Justification:

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

ene3 Highlight

☒ 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

2. Other facts supporting sole source procurement:

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

Fetal Bovine Serum, Premium Grade, Gamma Irradiated from VWR is the highest quality FBS available and is widely used by those cell culturists who have a concern for viral contaminants and require an extensive biochemical profile. Benefits of choosing VWR Serum are blood collection techniques, large lot sizes, “True Pool” processing, origin clearly stated and certified, traceability, supplier’s reputation, degree of vertical integrationuality of technical assistance, cGMP, clear, thorough documentation, verified by audit, quality of customer service, quality of technician training, ISO 9001:2000 and ISO 13485:2003 certifications, availability of Certificates of Suitability, adequate supply of serum, validated post-filtration processes.

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

Other products from various manufacturers were considered but ultimately ruled out because extensive correlation studies of many weeks would have to be performed in order to validate the use of another serum product with all our cell lines.

3. Program Office efforts to seek potential offerors:

The program office conducted an internet search for this product but found purchasing directly from the manufacturer was the most economic option. Due to the sensitive nature of developing tissue culture, program experience revealed that premium gamma irradiated FBS from VWR is best suited for our requirements. It has been tested and validated with all our cell culture lines. These biologicals are evaluated and validated for cell culture use, and use of any other products would require an extensive evaluation period that would cause delay in critical diagnostics and research. As a division resource for cell culture, this lab provides media and reagents to support a wide variety of research and routine diagnostic work. Using identical media products, reagents and plastic ware are essential to preventing variability and inconsistencies in results. It is essential to our operations to use validated products to maintain the continuity of research projects, reagent development and consistency in laboratory results.

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: Keri Kolb , Administrative / Operations Assistant for procurement.

Center/Institute/Office COR/Program Official Signature:

Certification Date: 09/03/2021

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.