2078989 - JA over SAT for ONI PDF_Redact.pdf

Justification and Approval Over the Simplified Acquisition Threshold

“Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity

a. Federal agency and contracting activity. HHS/ National Institutes of

Health

b. Sponsoring organization. National Institute of Allergy and Infectious diseases (NIAID), Integrated Research Facility at Fort Detrick (IRF Frederick)

c. Project Officer information.

• Project Officer name:

• Office address:

• E-mail address.

• Telephone number

2. Nature and/or description of the action being approved.

a. Acquisition purpose and objectives. The purpose of this acquisition is to purchase a Nanoimager model super-resolution microscope.

b. Project background. The Integrated Research Facility at Fort Detrick (IRF-Frederick or “IRF”) is part of the NIAID’s Division of Clinical Research (DCR) within the NIH (collectivity “Program”). The IRF- Frederick facilitates collaborative projects on Risk Group 4 and 3 pathogens with the goal to support DCR’s mission to improve patients’ lives. In order to further research at the IRF, Program requires a compact super resolution microscope that is capable of operating in Biosafety 4 laboratories (BSL-4).

The ONI Nanoimager is a super-resolution microscope that can be used for single particle tracking and live cell imaging. This high-powered fluorescent microscope was specifically built for use within BSL-4 containment laboratories. The microscope has an extremely small footprint, does not contain movable parts, has built-in vibration control and can be decontaminated. The ONI microscope will allow live cell imaging at BSL-4, which is a capability that the IRF-Frederick currently does not have.

There will be multiple projects associated with this piece of equipment and acquisition of the equipment is not limited to a single project or a specific virus, and it will be useful beyond the current SARS-CoV-2 work. The ONI microscope will build technical capacity at the IRF- Frederick and support future immunology and molecular virology collaborative projects with the goal to acquire high-resolution images of live cells and enable particle tracking in an effort to advance our knowledge of molecular interactions, cell dynamics including immunological processes.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title. Nanoimager (compact super-resolution microscope) from Oxford Nanoimaging Inc.

b. Project description.

The Integrated Research Facility at Fort Detrick (IRF-Frederick) is a component of the National Institute of Allergy and Infectious Diseases (NIAID)’s Division of Clinical Research (DCR). The IRF-Frederick facilitates collaborative projects on Risk Group 3 and 4 pathogens with the goal to support DCR’s mission to improve patients’ lives. The research performed by IRF requires the use of super-resolution microscopes, specifically the Nanoimager model produced by Oxford Nanoimaging Inc. (ONI). The ONI Nanoimager is a super-resolution microscope that can be used for single particle tracking and live cell imaging. This high-powered fluorescent microscope was specifically built for use within BSL-4 containment laboratories. The microscope has an extremely small footprint, does not contain movable parts, has built-in vibration control and can be decontaminated. The ONI microscope will allow live cell imaging at BSL-4, which is a capability the IRF currently do not have. Furthermore, this equipment will support collaborations that aim at advancing our knowledge of molecular interactions, cell dynamics including immunological processes.

The major components and services for the ONI Nanoimager are as follows:

1) ONI Nanoimager S microscope body (Product number: NIM S - 1.4NA).

This part is the main Nanoimager/microscope.

2) ONI Light Engine (NIM S - Light engine). The ONI light engine provides light to the microscope.

3) Nanoimager Computer (NIM Computer). Required for operation of the software and connection to the Nanoimager.

4) NimOS – Software (NIM software). The NimOS is the operating software for the ONI Nanoimager and required for system operation.

5) Installation (NIM install). Professional installation of the equipment is required prior to transfer of the microscope into the BSL-4 laboratory.

6) 1 year System License (Warranty). Included as a standard at no additional cost.

• Requirement type.

Research & development (R&D) R & D support services Support services (non-R&D) Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify): ____________________

• Type of action

New requirement Follow-on Other (specify): ______________________

• Proposed contract/order type.

Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ Cost-plus-fixed-fee Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ Other (specify): ___________ Completion Form Term form

• Acquisition identification number. 2078989

c. Total estimated dollar value and performance/delivery period.

4. Identification of the statutory authority permitting other than full and open competition.

This acquisition is conducted under the authority of 41 United States

Code (U.S.C.) 253(c)(1) as set forth in Federal Acquisition Regulation (FAR) 6.302-1 – Only one responsible source.

This acquisition is conducted under the authority of section 4202 of the

Clinger-Cohen Act of 1996.

This acquisition is conducted under the authority of the Services

Acquisition Reform Act of 2003 (41 U.S.C. 428a).

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

Name and address of the proposed contractor(s).

a. Oxford Nanoimaging Inc.

101 Jefferson Drive

Menlo Park, CA 94025

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

ONI is the only company that produces and supplies this Nanoimager which is the world’s first compact desktop super resolution microscope, capable of visualizing, tracking and imaging individual molecules in living cells with 20nm resolution. There is not a possibility to acquire the Nanoimager through a different supplier.

The ONI Nanoimager is a microscope that was specifically built to function at biosafety level 4 containment laboratories. The footprint of the microscope is small and it is resistant to vibration from centrifuges, homogenizers and other equipment commonly housed in BSL-4 laboratories.

There are no other super resolution microscopes on the market that have these specific design features or would otherwise meet the requirements for functionality, footprint and quality desired at the IRF-Frederick BSL-4 facility.

Other vendors that were contacted on the open market either do not produce these specialized super resolution microscopes, or do not produce versions that met all the requirements (such as being portable and compact enough).

For example, one key requirement is that the equipment must be portable & compact - it must be able to be installed into, removed, and reinstalled from the Biosafety cabinet (BSC) hood and when necessary by the actual end users without special assistance inside a Biosafety 4 laboratory. It cannot be large enough to require integration into the BSC hood, and installation or removal should not require vendor assistance. Another key requirement is that is needs to be able to be operated remotely. Other vendors such as Nikon and Olympus were able to only fulfill a part of Program’s requirements (specifically in meeting the necessary level of resolution for imaging), but they could not provide any equipment that could fulfil the other requirements involving portability, compactness, and remote capabilities.

See more details of the requirements in the “preliminary salient characteristics” document uploaded in SAFE-AMP 2078989.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

Based on the market research, only one vendor is capable of providing the equipment that can satisfy Program’s needs. Thus, this acquisition shall be a sole source acquisition under FAR 6.302-1.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

The current product price is derived from an open market quote. Open market prices for this particular type of super high resolution microscopes were not readily available due to the lack of manufacturers. and attempts at obtaining detailed open market quotes after reaching out to vendors experienced setbacks due to the complexity of the equipment requirements.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

Several market research techniques were used to identify other possible sources, including review of acquisitions on similar items, queries of internet information sources, correspondence with people in the government and in the industry, and review of catalogs and product literature. The results of this research indicated there is likely only one manufacturer/source for this specific product that could meet Program’s requirements. Only the Nanoimager is capable of fulfilling Program’s needs, and only Oxford Nanoimaging Inc. produces the Nanoimager.

See Market Research + PreSolicitation Memo for more details.

9. Any other facts supporting the use of other than full and open competition.

This requirement can only be satisfied by one responsible source (ONI) because no vendor other than ONI is capable of selling high resolution microscope that meets all of Program’s requirements and is built into a compact and portable form factor. There would be no duplication of work as the IRF does not have another available Nanoimager at the Frederick facility. Delays in obtaining this equipment may inhibit the highly important and sensitive research work conducted at the Biosafety Level 4 laboratory in IRF.

The proposed period of performance of 1 year takes into account the 12 months warranty that covers the equipment hardware and software.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

No other sources have expressed an interest in the proposed acquisition.

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

It is the policy of NIAID to promote the use of competitive procedures whenever and wherever possible. In an effort to remove or overcome barriers to competition in the future, the market will be scanned frequently for new companies and products that could satisfy the Government’s requirement. The staff meets regularly with products manufacturers and vendors and attends manufacturer and industry training to keep current on technology. Vendor and trade magazines are scanned for new, open technologies that can satisfy future infrastructure requirements. The agency will continually re-evaluate the products currently being used and will research for the manufacturers and products that will be in the Government’s best interest as best value for future replacement products at the agency’s site and at sites the agency supports. The current situation requires a sole source justification to satisfy requirements. Since there is a continual re-evaluation to products currently being used by the agency for the present requirement, if/when alternatives become available, they will be evaluated for use.

12. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Official Name & Title Signature Date

Project Officer

Project Officer’s Immediate Supervisor

Head of the Sponsoring

Program Office

13. Contracting Officer 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 the rationale and recommendation for approval is accurate and complete.

Official Name & Title Signature Date

Contracting Officer