SSJ 47041 eSigned MFN_Redacted.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:

National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Division of Viral Hepatitis 1600 Clifton Road, Building 18, MS H18-3 Centers for Disease Control and Prevention Atlanta, GA 30333

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Financial Resources Acquisition Branch 4, Small Purchases 2920 Brandywine Road, Mail Stop K-94 Atlanta, GA 30341

C. Identification of Requirement:

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

Sole source acquisition of: 20 rhesus macaques (between the ages of 1 to 5 years and no less than 2 kg in weight). These animals will be used for evaluation of hepatitis B virus microneedle patch vaccines. Specification of the animals are in a separate document.

Procurement Request (PR) Number (if available): 2020-47041

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

Proposed Vendor: Atten: ALPHA GENESIS, INC 95 Castle Hall Road Yemassee, SC 29945

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:

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

Rhesus macaques is approved for a study “evaluation of microneedle patch delivery of hepatitis B virus vaccine”. After contacting several venders (worldwide primate, LC Preclinical Research, Inc, PRIMEGN, and AlphaGenesis Inc.), only AlphaGenesis Inc. had 20 rhesus macaques and sent the health charts of the animals to CDC.

Reviewing the health charts of the animals by an attending veterinarian is an important process for selecting health animals stated in section C.1 for the study.

Since no other vendors can provide the health charts or the required 20 rhesus macaques, AlphaGenesis is the only source that can provide the required product.

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

Rhesus macaques were not available, or the health charts were not provided by other vendors.

Rev. 5/14/19

3. Program Office efforts to seek potential offerors:

Many non-human primate vendors have been contacted to identify appropriate rhesus macaques described in section 3.1. Only one, AlphaGenesis had 20 rhesus macaque and sent the health charts of the animals for review to CDC. Reviewing health charts of the animals by attending veterinarian is an important step to screen the healthy animals described in section C.1 above for the study.

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:

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:

Contracting Officer Signature:

Certification Date:

Martin F. Nemec - S

Digitally signed by Martin F.

Nemec -S Date: 2020.07.07 14:48:25 -04'00'