7. Sole-Source-Procurement Ricin TRF Antibody 20210414 PR 54145 CO sign 20Apr2021.pdf

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:

BRRAT Laboratory

NCEZID/DPEI/LPRB

1600 Clifton Rd., Centers for Disease Control and Prevention Atlanta, GA 30329

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Financial Resources Acquisition Branch II 2920 Brandywine Rd, Mail Stop K-94 Atlanta GA 30341

C. Identification of Requirement:

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

a. Sole source acquisition of: Acquisition of 200 mg of Anti-RCA I & II antibody, AS- 2084-100-1 Anti-Ricin I & II at $28572.00 and maximum shipping at $75.00. Total (maximum) = $28647.00. Prior sole source procurements for Vector’s ricin Mab include: 200-2015-63440.and HCVLGE-2020-40519.

b. Procurement Request (PR) Number (if available): Click here to enter text.

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

a. Proposed Vendor: Vector Laboratories 30 Ingold Road, Burlingame, CA 94010 Brian

Taylor btaylor@vectorlabs.com; 650-697-3600

b. Estimated Procurement Amount: $28,647.00 (maximum)

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

Rev. 5/14/19

If yes, provide schedule number: N/A

D. Justification:

1. The justification for this non-competitive action is: (NOTE: Must select only ONE of the listed justifications for other than full and open competition and fully support the justification in the following paragraphs. Please delete this note prior to submitting the justification.)

☒ 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?

All other antibodies evaluated during product development failed to meet the quality of the

Vector produced antibodies; this antibody is superior as a capture antibody for the ricin TRF assay. Prior sole source procurements for Vector’s ricin Mab include: 200-2015-63440.and

HCVLGE-2020-40519..

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

This capture antibody for the detection of ricin toxin provides superior specificity and sensitivity. Any efforts to find a substitute antibody would require extensive production development and product validation, a process that would take in excess of 2+ years and significant resources.

3. Program Office efforts to seek potential offerors:

Market research revealed that this antibody is only available from Vector. An internet search for Anti-RCA I & II antibody resulted in no other supplier that can provide this antibody. Product sole sourced prior under order numbers 200-2015-63440.and HCVLGE-2020-40519.

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: Peter Syribeys COR II

Center/Institute/Office COR/Program Official Signature:

Certification Date: March 1, 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.