A02 MRS ETHOS JA 2-12-21 FPB signed_Redacted.pdf

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Version – September 2018 FOR OFFICIAL USE ONLY imaging facility. In the United States there are a limited number of sources with unique capabilities, expertise and FDA cleared imaging facilities. B&W’s is an FDA-cleared 7 Tesla (7T) MRS imaging facility within the 30-mile radius of USARIEM and is the only facility capable of meeting this requirement.

B&W’s FDA-cleared 7 Tesla (7T) MRS imaging facility is the only laboratory capable of meeting this requirement. B&W is the only location within a 30-mile radius of USARIEM that has a FDA-cleared 7T MRS imaging facility. In order to obtain IRB approval, it is necessary to utilize a scanner that is approved through the FDA. Proposing to utilize a non-FDA reviewed scanner would critically jeopardize obtaining approval from the IRB, which would cause a failure to reach the requirements of the study. The team at B&W has a long history of successful completion of MRS research projects related to the proposed aims of this study. Award to any other contractor than the B&W would come at a substantial duplication of costs and risk of lost scientific validity that cannot be recouped by the Government. A

b. Alternatives: Discuss alternatives that are available to the Government, reasons (technical, cost, etc.) why each alternative is unacceptable except for the alternative selected, and the impact if other alternatives are selected. Among the possible alternatives might be to (a) suspend operations, (b) use in-house personnel/expertise, (c) replace rather than upgrade an existing system (include costs already invested, training costs, and replacement costs if requested item is not received), etc. If there are other similar products, describe the technical aspects of each and the decision making process used to determine that the similar product(s) are unacceptable.

Alternatives available to the government include, a) u

. As indicated above, alternative “a” is unacceptable because in order to obtain IRB approval for this research project, it is necessary to use a scanner that is approved through the FDA. Failure to obtain IRB approval result in mission failure as this project has been awarded funding by MOMRP.

Alternative “b” is unacceptable because this project requires scans of deep brain structures at a clarity that a 3 Tesla scanner, which are available at other locations within a 30 mile radius of USARIEM, is unable to achieve. B&W houses the only FDA-approved 7T scanner within a 30 mile radius of USARIEM. The cost of a 7T scanner, including staff, training, FDA approval, etc. is estimated to cost 10 to 20 million US dollars.

c. A delay in the continuation of the next phase of this research would result in failure of the USARIEM Military Performance Division to meet the U.S. Army Medical Research and Developmental Command MOMRP’s FY21 Milestone to broaden the understanding

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Version – September 2018 FOR OFFICIAL USE ONLY of neural structures and processes that regulate military-relevant skill learning, such as marksmanship. MOMRP awarded FY20 funds to USARIEM for this project and USARIEM needs to complete everything within the Period of Performance outlined above. This will be attainable with the execution of this contract by the start of the period of performance.

6. Efforts to Obtain Competition: A market search for MRS-capable 7T MRI scanners revealed that only two such scanners exist within a 30-mile radius from USARIEM, one at B&W and a second at Massachusetts General Hospital (MGH). Though both locations are capable of generating MRS data, only B&W houses an FDA-cleared 7T scanner.

Based on this market analysis, we conclude that only B&W can meet the requirements for this project. The Contracting Officer shall publish the notices required by FAR 5.201 and any bids or proposals received shall be considered.

a. Effective Competition: Because this is a sole source action, effective competition is not applicable. No other vendors are capable of performing the requirement.

b. Subcontracting Competition: There are no subcontracting possibilities with this requirement.

7. Actions to Increase Competition:

8. Market Research: The USARIEM conducted market research activities from 1 April 2019 to 26 July 2020 using: 1) FBO.gov – announcements search for magnetic resonance imaging found two matches using NAICS 54171 within the state of Massachusetts. Neither result provided MRS services; 2) GSAAdvantage.gov – searched for “magnetic resonance spectroscopy” services and found 760 matches of which none provided the required MRS services; 3) Google.com – search engines revealed two vendors capable of producing 7T MRS data within the state of Massachusetts.

Internet search engines revealed two potential vendors in this location, one at Brigham and Women’s Hospital (B&W) and a second at Massachusetts General Hospital (MGH).

In accordance with Defense Federal Acquisition Regulation Supplement (DFARS) 205.205-71, DFARS 206.302-1(d), and DFARS Procedures, Guidance and Information (PGI) 206.302-1(d), a request for information was posted to www.betasam.gov on December 7, 2020 for 7 days and there were no response.

9. Interested Sources: See Paragraph 6 for the synopsis information. A Notice of Intent to Sole Source to B&W was posted on www.betasam.gov on December 14, 2020. To date, no other sources have written to express interest in the acquisition.

10. Other Facts: NA