Redacted J A Sole Source FAR Part 13.pdf

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Control Number: JA-24-06-1587

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Source Selection Information - See FAR 2.101 and 3.104-4

OCT 2023

4. Authority Cited: 41 United States Code 1901 as implemented in Federal Acquisition Regulation (FAR) 13.501(a)(1) sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

5. Reason for Authority Cited:

As described in FAR 13.501, acquisitions conducted under the simplified acquisition procedures are exempt from the requirements in part 6, Competitive Requirements.

Oak Hill Genetics is the only source that can provide the specific pathogen free (SPF) research swine in a timely manner to meet the 59 MDW/ST research mission. They are a Class-A Licensed Vendor registered with the United States Drug Administration (USDA) Animal and Plant Health Inspection Service as required by Department of Defense and Federal Regulations. Each swine vendor has animals that are genetically distinct from other vendors. These genetic differences can cause significant variation in animals as research subjects and have profound effects on research outcomes.

Different genetic lines react differently to processes and procedures (anesthesia and drug and device interactions) that affect the research outcomes. As an example, 59 MDW/ST previously used a local vendor for training animals. This vendor has multiple genetic lines within their animal population. These animals react significantly different than the SPF animals received from Oak Hill Genetics. The local animals have inherent diseases and react differently to anesthesia and interactions with medical toxicology studies as they react differently to both toxins and antidotes. 59 MDW/ST no longer uses this vendor for research studies due to the swine carrying diseases and many years ago switched to Oak Hill Genetics SPF animals for all research protocols.

In a number of research protocols, Ketamine is used to sedate and treat research animals. Ketamine infusion has an impact on blood pH as it is acidic and using animals from a different genetic background can then interfere with a study as it introduces more uncertainty beyond the normal inter-animal variability within a single vendor. When vendors are changed, it often impacts the results of a study by changing the genetic variability of animals being used and introducing additional variables into the research process. Research studies that have been ongoing for many years using the same genetic line of swine can be affected by introducing a different vendor’s genetically dissimilar animals into the research process. Studies should use the same vendor throughout the study to minimize animal-to-animal variations in the research process.

Oak Hill Genetics has been 59 MDW/ST’s vendor for SPF animals for multiple lines of research and to maintain the integrity of the protocols it is required to continue use of this specific vendor and this specific genetic line. Oak Hill Genetics can provide all the weight ranges needed for the research performed by the 59 MDW/ST and can provide Health Certificates for all of their animals. They can supply and deliver up to 24 swine per order and allow for changes 48 hours prior to shipping. Oak Hill provides transportation of the swine directly to the 59 MDW/ST.

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Source Selection Information - See FAR 2.101 and 3.104-4

6. Efforts to Obtain Competition: A Request for Information (RFI) was posted to the Government Point of Entry (GPE), SAM.gov, on 16 May 2024 for a period of 3 days. No qualified responses to the sources sought notice were received. The requirement was synopsized to the GPE via a Notice of Intent to Sole Source (NOI) on 21 May 2024 for a period of 15 days. No qualified responses to the NOI were received. Please reference Paragraph 8 of this document, for further discussion of market research.

7. Actions to Increase Competition: Based on the results of the market research, no further actions have been taken to increase competition as Oak Hill Genetics is the only source available to provide this genetic line of research swine. In the future when new lines of research are opened that do not require genetic consistency in swine, other vendors can be considered to supply SPF Swine to support the 59 MDW/ST Clinical Investigations and Research requirements.

8. Market Research: The Contracting Office posted an RFI on SAM.gov, as discussed above in Section 6, and received zero responses. As a result, the Contracting Office posted a Notice of Intent to Sole Source to Oak Hill Genetics on SAM.gov on 21 May 2024. No correspondence was received in response to this notice. Prior to the Contracting Office issuing the RFI and NOI, the 59 MDW/ST performed market research via email to potential vendors and received one other response in addition to Oak Hill Genetics. This response was from Premier BioSource, another Class A Vendor;

however, only utilizing Oak Hill Genetics’ swine will remove any genetic bias that would be introduced by changed the source of research swine.

9. Interested Sources: The notices required by FAR 5.201 have been published and no correspondence was received in response to the Request for Information nor the Notice of Intent to Sole Source. In addition, this justification shall be posted to SAM.gov within 14 days after contract award in accordance with FAR 13.501(a)(1)(iii). In accordance with 5.207(c)(16)(ii), inquiries from any interested offerors would have been evaluated accordingly prior to issuance of the sole source contract.

10. Other Facts:

a. Procurement history. 59 MDW/ST has not had a BPA or contract previously with Oak Hill Genetics. Requirements were satisfied through the use of an open market government purchase card (GPC). The GPC purchases were made by 59 MDW/ST MTF’s Medical Logistics office.

Requirement for the SPF swine have steadily increased from about 185 pigs in 2022 to over 500 in 2024.

b. Other facts. N/A

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Source Selection Information - See FAR 2.101 and 3.104-4

Approval

Based on the foregoing justification, I hereby approve the procurement of a base BPA for Specific Pathogen Free Research Swine on an other than full and open competition basis pursuant to the authority of 41 U.S.C. 1901 as implemented by FAR 13.501, subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Signature: ________________________________Date: ________________________

Typed Name: Douglas A. Medcalf Jr. Title: Contracting Officer

MEDCALF.DOUGLAS.A.JR.104

5857456

Digitally signed by

MEDCALF.DOUGLAS.A.JR.1045857456

Date: 2024.08.30 07:55:03 -04'00'