20210204_MSD_SQ120_JOFOC.docx

Justification for Other than Full and Open Competition:

Brand Name at or Below the Simplified Acquisition Threshold

Project Title: __ MSD MESO QuickPlex SQ 120 ___________________________________________ Enter the project title as it will appear in the solicitation and contract/order.

(To be completed by the requestor)

Note: An acquisition or portion of an acquisition that requires the provision of a specific brand name or manufacturer-specific product or feature of a product does not provide for full and open competition, regardless of the number of sources solicited. A brand-name acquisition is allowed if the particular brand name product or feature is essential to the government’s requirements and market research indicates that similar products do not meet or cannot be modified to meet the agency’s needs.

This type of JOFOC does not attempt to justify a vendor but a type of product.

Ensure that your narratives are written in a manner to permit an individual without any technical knowledge of the requirement to understand the supporting rationale. Don’t use trade language, or jargon. You don’t need to get into the scientific “weeds” of the requirement. While you should include all technical requirements of the product or service, there is no need to elaborate unnecessarily on the science. The purpose of this justification is to document an acquisitions file and should not be written in the same manner as a scientific paper. Use plain language when possible.

I. Identification of the agency and contracting activity (This section to be completed by the requestor.)

A. Description of the project, and supplies or services required to meet the agency’s needs (including the estimated value) (This section to be completed by the requestor.)

B. Type of action: (check the appropriate box) ☒ New requirement ☐ Follow-on

· Name of the previous contractor(s): ________________________________

· Sequence number, if available: ____________________________________

· Was the initial and any subsequent awards competed? ☒ Yes ☐ No C. AMBIS Sequence number for this requirement: __________________ D. Total estimated dollar value of the requirement (including options, if applicable): ________________________ E. Period of performance, inclusive of options: from ___________ to ________________ F. Project Background

a. Begin with a brief description of the overarching goals of your lab/office and how this procurement fits into it. Provide a brief (i.e., one paragraph) description of the project.

· One of the essential methods for vaccine development is serum analyte assay. This instrument provides the ability to perform this in a high throughput, multiplex manner. This instrument, along with several other pieces of equipment will allow us to perform this task in-house as well as contribute to the Vaccine Research Center’s shared equipment inventory. This increases productivity and ultimately allows for us to perform our job effectively.

b. Discuss any project background that is important to understanding the acquisition and the need it will satisfy. You do not need to “dumb it down,” but keep in mind that your audience is not scientists; they are business professionals such as the Government Accountability Office, the Inspector General, contracting officers, and purchasing agents who must understand what you need and why in order to purchase it in compliance with policy and regulation.

· This equipment is necessary for all aspects of vaccine development and research. Animal serology analysis is done in virtually all virology research and vaccine development labs including the Viral Pathogenesis Lab.

G. Description of the supplies/services to be purchased

· Describe the products/services (including the salient physical, functional, or performance characteristics of the brand name product or feature). A statement of work (SOW) or statement of objectives (SOO) may be referenced and attached in lieu of providing a project description. In this case, write “See statement of work” or “See statement of objectives” in this section. Include technical specifications or salient characteristics that are required to ensure that the product or service performs as it should. Include the following:

· Complete common generic identification of the item required.

· This is a multiplex ELISA plate reader. It allows for high-throughput plate-based assay. ECL detection utilizes proprietary SULFO-TAG labels that emit light upon electrochemical stimulation initiated at the electrode surfaces of MULTI-ARRAY® and MULTI-SPOT® microplates through biomolecular interactions between the analyte and labeled reporter at the surface

· Applicable model, make, or catalog number for each brand name product referenced and identity of the commercial catalog in which it appears.

· MSD MESO QuickPlex SQ120

· Name of manufacturer, producer, or distributor of each brand name product referenced (and address if not well known).

· Manufacturer is MSD

· Any other information necessary to describe the item required.

III. Identification of the statutory authority permitting other than full and open competition (SELECT ONE) (This section is to be completed by the purchasing agent.)

The agent must review the JOFOC and ensure that the narrative is factually based and supports the statutory authority selected. If it cannot be supported, then the product or service must be competed.

☐ 41 USC 33041901(a)(1) and FAR Part 6.302-113.106-3: Only one responsible source/Brand Name This is the citation for most brand name purchases. Although the title references the “source,” in this case refers to the brand.

☐ FAR Part 8.405-6: Federal Supply Schedule (FSS), limited competition/Brand Name Use this for brand name acquisitions that may be competed through FSS.

Iimportant Note: The statutory authority listed below will rarely ever be used in NIH. Before selecting this authority, please ensure that you have read and understood the citation and discussed it with the cognizant Contracting Officer.

☐ 41 USC 3304(a)(5) and FAR Part 6.302-2: Authorized or required by statute/Brand Name This is used in the rare case when a specific brand is required or authorized by statute.

IV. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited. (This section is to be completed by the requestor.)

V.

VI. Describe why only the requested brand or brand name feature of the supply/service will meet the government’s needs Demonstrate that the prospective brand name item(s) has unique attributes and/or specialized capabilities not available from another commercial source. Explain what unique attributes and special capabilities the brand name item(s) possesses. Describe why only the attributes of this brand name feature of the supply/service will meet the government’s needs or are essential to the requirement, thereby precluding consideration of a product manufactured by another company.

This instrument is a multiplex ELISA plate reader. Other multiplex ELISA readers use microfluidics. This often causes clogging inssues and results in the instruments being inoperable. In addition MSD’s ECL detection utilizes proprietary SULFO-TAG labels that emit light upon electrochemical stimulation initiated at the electrode surfaces of MULTI-ARRAY® and MULTI-SPOT® microplates through biomolecular interactions between the analyte and labeled reporter at the surface. This is a very reliable detection method and different than all other brands. This equipment are required based on intended experimental design, compatibility with current lab equipment, and the proven ability of the product to produce consistent and reliable data. Use of alternate products could negatively impact the manner in which samples are processed and analyzed. Additionally, use of a different product from the one requested would require testing by lab personnel and would introduce unacceptable variables during research trials. To have successful research results, methods and parameters must be consistent. Furthermore, this equipment/parts will be utilized to analyze, store, and manipulate samples. Some of these samples are rare and extremely hard to replace/obtain. Utilizing any alternative that would jeopardize these rare samples and/or cause our research/data to be corrupted/destroyed is unacceptable. At this time and considering the human life aspect of this research, any change in research variables are unacceptable, the risk is too high. The project officer and the Contracting Officer have determined that only one brand-name source and no other brands or services will satisfy agency requirements.

VII. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable Price reasonableness determination will be included in the acquisition file.

Certification This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support my request (for the requestor) and approval (for the CO) of is accurate and complete.

Requestor Certification

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