FAR-13-Limited-Sources-Justification-Less-Than-SAT-DS.pdf

United States Department of Agriculture Limited Source/Brand Name Justification

FAR 13.106-1(b)(1) – Simplified Acquisitions

1. Identification of the agency and the contracting activity.

1a. Requesting Activity Agency: National Bio and Agro-Defense Facility (NBAF) 1980 Denison Ave Manahattan, KS 66502

1b. Contracting Activity: USDA APHIS MRPBS AAMD

250 Marquette Ave., Suite 410 Minneapolis, Minnesota 55401

2. Description of supply or service required to meet the agency’s needs.

The bioreactor control system targeted in this document will be used for production of recombinantly expressed proteins critical for the expanded diagnostic mission of the Foreign Animal Disease Diagnostic Laboratory (FADDL) at the National Bio and Agro-Defense Facility (NBAF). This instrument will greatly improve the ability and capacity to produce recombinantly expressed antigens for zoonotic agents that will be used to establish diagnostic assays that will be carried out under Biosafety Level 4 (BSL4) and Biosafety Level 3 Enhanced (BSL3E) laboratory conditions.

The instrument will be required to provide the following:

Cell culture species flexibility: mammalian, insect, bacterial, and yeast.

Continuity of operation of standardized protocols with Eppendorf BioFlo 320 currently in use with Reagents and Vaccine Services Section (RVSS) at Plum Island Animal Disease Center (PIADC).

Seamless scaleup of production volumes beyond 50L with Biologics Development Module (BDM) manufacturing scale Eppendorf bioreactor systems.

High degree of input control and configurability: gas flow and feed controls, pH and dO2 sensor options, wide array of single use vessel options.

Scalability options: 1L to 50L production volume.

Intricate tracking of run parameters to ensure compliance with ISO17034 standards.

Hard-sided plastic vessel compatible with NBAF biosecurity policies with impeller driven aeration.

As described above, this instrument will greatly increase the capacity of recombinant antigen production for use in diagnostic assays at NBAF with the ability to seamlessly scale up to manufacturer-scale production with BDM. Due to the above-mentioned specifications and conditions needed for continuity of operations and procedures, the only instrument that will fully meet our needs is the Eppendorf BioFlo 320.

3. The rationale or circumstances for limiting competition.

The Eppendorf BioFlo 320 will completely fulfill the above listed functions and is compatible with current standard operating procedures (SOPs) of RVSS and infrastructure at NBAF. The primary objective of integrating this instrument is to increase the capacity for recombinant antigen production at

NBAF to support FADDL’s expanded diagnostic mission. FADDL’s diagnostic mission transfer from PIADC to NBAF includes the traditional foreign animal diseases (FADs): foot and mouth disease (FMD), African swine fever (ASF), and classical swine fever (CSF). In conjunction with this transfer of operations, we are expanding our diagnostic mission by creating a zoonotic disease diagnostic program.

A goal of this expanded program is to become a global resource of ISO17034 accredited reference materials and build a network of reference laboratories that have a standardized set of reagents to unify the diagnostic detection of these diseases. Production of recombinant antigens is critical for establishing this zoonotic program and accredited reference material. NBAF has a unique resource known as the Biologics Development Module that bridges the gap between bench scale and manufacturing scale production of reagents. They house several Eppendorf bioreactor systems that will allow seamless transition from lab-scale antigen production to manufacturing scale for large, single lots of antigens. Due to the justifications listed above, the market on this purchase should be limited to the Eppendorf BioFlo 320.

4. A description of the market research conducted and the results or a statement of the reason market research was not conducted.

Market research included systems from Sartorius, Eppendorf, Cytiva, and MilliporeSigma. The competitors have the capability to produce up to 25L but the rocking motion, soft sided bag vessel which is not compatible with NBAF biosecurity policies, decreased capacity compared to the BioFlo 320, and incompatibility with bacterial and yeast culture excludes them from consideration. The Eppendorf BioFlo 320 is the only bioreactor control system with capacities up to 50L; absolute control and monitoring of gas and input feeds; flexibility to cultivate mammalian, insect, yeast; and bacteria using the same single use hard sided plastic vessels. The BioFlo 320 is the only offering found that offered the optimal solution for each category.

5. Estimated price, including all options, if applicable.

The total estimated price is $145,502.37 for the Eppendorf BioFlo 320.

6. Recommended source(s).

Eppendorf North America

Certifications

Supporting data that is the responsibility of technical or requirements personnel and which form the basis for this justification are accurate and complete to the best of my knowledge.

X Jacob Stockton Biological Scientist

Insert Name of Program or Technical Personnel Insert Title of Program/Technical Personnel

The information contained in this justification is accurate and complete to the best of my knowledge and belief and in accordance with Federal Acquisition Regulation 13.106-1(b)(1), I hereby determine the circumstances described above deem only one source, or limited sources, reasonably available and competition is precluded for the reasons indicated in this document.

Insert Name of Contracting Officer Contracting Officer

Notes and Guidance. Delete these Notes prior to finalizing document for signature

For acquisitions greater than the micro-purchase threshold but less than the Simplified Acquisition Threshold (SAT) the Contracting Officer may solicit from one source only 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, etc.). Contracting Officers must document the rationale for soliciting from a single source, including brand name in accordance with FAR 13.106- 1(b)(1)(i) and FAR 13.106-3(b)(3)(i).

Program personnel are advised to work with contracting personnel early on in order to promote and provide for full and open competition to the maximum extent practicable. In circumstances permitting other than full and open competition, program personnel shall provide necessary information to contracting personnel to support and document the circumstances limiting competition through the use of this form

Advance planning. Contracting without providing for full and open competition shall not be justified on the basis of (1) a lack of advance planning by the requiring activity or (2) concerns related to the amount of funds available to the agency or activity for the acquisition of supplies or services.

Brand Name. Items peculiar to one manufacturer can be a particular brand name, product, or feature of a product, peculiar to one manufacturer. A brand name item, whether available on one or more schedule contracts, is an item peculiar to one manufacturer. Brand name specifications shall not be used unless the particular brand name, product or feature is essential to the Government’s requirements and market research indicates other companies’ similar products, or products lacking the particular feature, do not meet, or cannot be modified to meet the Agency’s needs.

Posting. When an acquisition contains brand name specifications, the Contracting Officer shall include the justification required by FAR 13.106-1(b) or 13.501 with the solicitation when synopsizing in the GPE (actions exceeding $25,000) or displaying in a public place (actions exceeding $15,000 but not expected to exceed $25,000), as required by FAR 5.102(1)(6).

Screening. Before posting the justification, in accordance with FAR 6.305(e) and 24.202, the Contracting Officer is responsible to redact any information that is exempt from disclosure under Freedom of Information Act or information proprietary to the contractor.

Signatures. After review and completion by the Program Office and Contracting Officer, the Word document shall be converted to an Adobe PDF file and routed for electronic signatures. Signature blocks shall include dates.