Redacted SSJ.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:

NCEZID/DHCPP/PRB

Roybal Campus Building 23/ Room 4-166 Centers for Disease Control and Prevention Atlanta, GA 30333

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Financial Resources Acquisition Branch 1

C. Identification of Requirement:

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

a. Sole source acquisition of: the purchase 33 female Hu-NSG-CD34 mice from The Jackson Laboratory

b. Procurement Request (PR) Number (if available): 00HCVLEC-2021-56028

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

a. Proposed Vendor: The Jackson Laboratory, 610 Main Street Bar Harbor, ME 04609

US

b. Estimated Procurement Amount: $

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

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

Rev. 5/14/19

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?

The Hu-NSG-CD34 mice from The Jackson Laboratory (JAX) are a unique model that allows for the study and development of an animal model for Variola virus. We have used mice from this vendor previously and know that the techniques that they use to humanize the mice still allow for successful viral infection. Other mice/animals either do not develop a systemic infection after infection or have not been validated.

In order to ensure that results are comparable to the previous humanized mouse studies (which were done with humanized mice from JAX) where we were able to successfully infect the mice with our virus of interest, we must use the same JAX humanized mice for the testing of medial counter measures in this model. By performing this follow-up study, we will expand upon our knowledge of this animal model, and determine if the only FDA approved anti-viral for smallpox blocks variola virus infection in vivo. However we must use mice that are from JAX because if we were to use humanized mice from a different vendor, the results would differ from our original results, and the mice may not have a successful infection. JAX uses the nod-

Rev. 5/14/19 scid-gamma background mouse strain, which is different than the background mouse that other vendors use (such as NOG). Additionally, the procedure to inject the human immune cells also differs from other vendors. Because of these differences, we must use the JAX Hu-NSG-CD34 humanized mice to ensure a successful infection and so that we can compare to the previous studies with JAX humanized mice.

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

A limited number of companies produce humanized mice and none make the Hu- NSG-CD34 mice within our specifications and at the cohort size needed with the same donor besides JAX. Taconic makes CD34+ mice but uses the NOD background;

our studies require the NSG background mouse. UMASS makes huNSG CD34+ mice but are unable to generate the number of animals we need within our time frame with a single donor. Our timeframe is dictated by the World Health Organization Advisory Committee on Variola Virus Research; they can have a cohort ready in November but our WHO ACVVR approval to complete this work expires at the end of October. Humurine used to make CD34+ NOD background but is no longer in business.

3. Program Office efforts to seek potential offerors:

Our program spoke to a representative from Jackson laboratories and UMASS. Taconic and HuMurine were online investigations. Online search for Humurine revealed that the company doesn’t appear to be in business anymore. Only Jackson Laboratories indicated they were able to fulfill this order satisfactorily.

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: Benjamin Monroe

Center/Institute/Office COR/Program Official Signature:

Certification Date: May 20, 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.