Sole Source Justification.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/BSPB

Roybal Campus

Centers for Disease Control and Prevention Atlanta, GA 30329

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Financial Resources Acquisition Branch Click here to enter text.

C. Identification of Requirement:

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

a. Sole source acquisition of: Scientific Services

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

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

a. Proposed Vendor: Infectious Disease Dept for the International School of Medicine (ISM), Kyrgyzstan, Bishkek, Kyrgy Republic

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:

☒ 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?

International Higher School of Medicine of Kyrgyzstan can assess real-world effectiveness of the antitoxin raxibacumab, which is found in the USG Strategic National Stockpile (SNS). Although it is currently FDA approved, there have only been two known uses in humans since its approval. To assess effectiveness the International Higher School of Medicine of Kyrgyzstan, 1) is in an area that is at least moderately endemic for human anthrax, to have direct access to a sufficient number of anthrax cases as only about a third of cases would be anticipated to have systemic illness and meet criteria for antitoxin administration; 2) has the healthcare infrastructure that allows for safe administration of anthrax antitoxin, the ability to monitor and address potential adverse events (e.g., anaphylaxis, adult respiratory distress syndrome) (e.g., intensive care capacity), hospitalizes most patients with anthrax, and has the capacity to address both anthrax and COVID-19 simultaneously. The Infectious Disease Department at the International Higher School of Medicine of Kyrgyzstan in Bishkek, Kyrgyzstan houses anthrax expertise and is affiliated with Osh Regional Hospital, a large teaching hospital that treats more than 20 anthrax cases a year, on average. This hospital has adequate infrastructure and the capacity to manage patients in an intensive care setting, including the equipment and skills needed to administer antitoxin and provide care for any adverse events that could occur. Additionally, it is the practice at Osh Regional Hospital to hospitalize all anthrax cases that present for care. The Infectious Disease Department medical staff, Will be able to provide on-the-ground expertise and project guidance. Other anthrax experts in endemic countries known to the Government have far fewer anthrax cases per year, which would prevent the study from meeting the necessary sample size

Rev. 5/14/19 to answer the research questions without prolonging the study over multiple years.

Additionally, they do not necessarily hospitalize all patients with anthrax and are not in a medical school setting with intensive care capacity, which limits the study team’s ability to observe the anthrax patients across their illness and to safely administer anthax antitoxin.

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

Only a few other medical schools or hospitals in other anthrax-endemic countries (e.g., India, Turkey, and Uganda) have sufficiently high numbers of anthrax cases to evaluate antitoxin effectiveness. Outside of a few particular regions in India, Turkey, and Uganda, the number of annual anthrax cases would not be sufficient to answer the research goals of this project. The Ministry of Health in India has previously prevented anthrax research projects between CDC and hospitals in the region of India where anthrax is endemic. We have no working relationship with any medical schools or hospitals in Turkey at present, and there are no CDC offices in Turkey. The anthrax surveillance system and medical infrastructure in anthrax-endemic areas in Uganda are still insufficiently developed to identify most of the hospitalized cases, which would prevent them from being able to safely administer anthrax antitoxin.

3. Program Office efforts to seek potential offerors:

No relationship with Turkey was attempted due to the potentially disruptive impact of geopolitical turmoil on a project and potential difficulty of USG personnel traveling to the country once international travel resumes. Contact with India has been attempted and we have a small project with some Indian partners; however, progress has been slow due to frequent staffing and priority changes within partner organizations. Although we have had ongoing anthrax projects in Uganda, it was not selected based on the lack of sufficient healthcare infrastructure to identify anthrax cases or able to adequately administer and monitor anthrax antitoxin.

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:

Center/Institute/Office COR/Program Official Signature:

Certification Date: February 2, 2023

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:

Contracting Officer Signature:

Certification Date:

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