JA 0011647872 W81XWH-21-R-0082 Redacted Copy.pdf

Control No:

Contractor:

Program/Equipment: EEG Analysis Services

Version –March 2017 FOR OFFICIAL USE ONLY

JUSTIFICATION REVIEW DOCUMENT

FAR SUBPART 13.5 SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS – SOLE SOURCE JUSTIFICATION AND APPROVAL

Program/Equipment: This program requires xxxxxxxxxxo support the requirement for analyzing quantitative EEG analysis with 3D graphical representation, characterization of EEG morphologies, circadian cycles, paroxysmal and ictal activity.

Authority: The statutory authority permitting the sole sourcing of services is Far 6.302-1, 10 USC 2304 (c) (1), " Only one responsible source and no other supplies or services will satisfy agency requirements".

Amount: $xxxxxxxxxxxxxx would be the total cost to include option years.

Prepared by:

Contracting Officer:

Technical:

Requirements:

A Microbiologist, Project Manager Email:

Contracting Off icer Email:

F Telemetry SM E Emf ail:

Franco Rossi Telemetry SM E Emf ail:

Reviews: I have reviewed this justification and find it adequate to support sole source.

Program Manager:

Typed Name: PN: 301 619 4921 Signature:

ally signed by

GOODSON.AIMEE.IRENE.1259431111

Date: 2021.08.24 13:57:20 -04'00'

FRANCO.DAVIDE.

1504287064 signed by

ROSSI.FRANCO.DAVIDE.1504287064

Date: 2021.08.24 15:41:30 -04'00'

SSI.FRANCO.DAVIDE.1

504287064 lly signed by

ROSSI.FRANCO.DAVIDE.150428706

4 Date: 2021.08.24 15:41:51 -04'00'

G 259431111 Date: 2021.08.24 16:23:13 -04'00'

Program/Equipment: EEG Analysis Services

Version – March 2017 FOR OFFICIAL USE ONLY

FAR Subpart 13.5 Simplified Procedures for Certain Commercial Items – Sole Source Justification and Approval

1. Contracting Activity: U.S. Army Medical Research Acquisition Activity, Ft. Detrick, MD 21702

2. Description of Action: USAMRIID, xxxxxxxxxxxxxxxxx requests a firm-fixed-price contract with xxxxxxxx. The Government projects award for September 2021 and fiscal year 2021, Defense Threat Reduction Agency (DTRA) funds will be used. An acquisition plan is not required because this procurement does not meet the threshold at Defense Federal Acquisition Regulation Supplement 207.103(d)(i)(B).

(Insert approval authority title) approved an acquisition plan in accordance with DFARS 207.103(d)(i)(B) on (insert date).

The required acquisition plan in accordance with DFARS 207.103(d)(i)(B) is currently awaiting (insert approval authority title) approval.

3. Description of Supplies/Services: The Contractor shall provide the ability to perform Quantitative Electroencephalogram (qEEG) analysis, Electroencephalogram (EEG) morphologies, circadian cycles, paroxysmal and ictal activity as well as 3D graphical representation of qEEG. Must be able to interpret EEG data using the NeuroScore software and provide the ability to import EEG raw data from the Notocord-Hem software file format used at USAMRIID. The evaluation of EEG data must be performed by a board-certified Veterinary Neurologist from the American College of Veterinary Internal Medicine Neurology. Contractor also must have a well-documented track record of EEG analysis, especially with seizure detection and characterization.

Base Period: September 2021 to September 2022 Value: Option Period 1:

September 2022 to September 2023 Value: Option Period 2: September 2023 to September 2024 Value: Option Period 3: September 2024 to September 2025 Value:

Option Period 4: September 2025 to September 2026 Value: $

FAR Clause 52.217-8 option: September 2026 to March 2027

Value:

Program/Equipment: EEG Analysis Services

Version – March 2017 FOR OFFICIAL USE ONLY

4. Authority Cited: Sole Sourcing of Services is Far 6.302-1, 10 USC 2304 (C)(1) “Only one responsible source and no other services will satisfy agency requirements as implemented by FAR Subpart 13.5:

Unusual and compelling urgency Exclusive licensing agreements Industrial mobilization Other: Only one source is available to provide the services due to previously developed processes, methods, data and results that are proprietary to one company.

5. Reason for Authority Cited:

The EEG analysis required by our team at USAMRIID (Viral Pathogenesis, Virology Division) must be performed using the same methodologies adopted in previous study conducted under contract Wxxxxxxxxxxxxxxxx with xxxxxxxxxxxxxxx The analyses must use the same programs, methodologies, and provide same endpoint evaluations to allow cross study analyses to occur as well. The previous study was a proof-of-concept; this study is now designed to increase the number of data sets and as such it must be completed in an identical manner to increase the statistical power of the data or it will not meet the intended purpose. In addition, the inability to complete cross-study analyses and increase the statistical power of these analyses will result a loss of >$4M spent on these studies to the Alphavirus Animal Model Program. xxxxxxxxxxxx was purchased by xxxxxxxxxxxxxxApril 29, 2019. The services provided by xxxxxxxxxxxxxx in 2017 lead to the publication listed below (*). USAMRIID and xxxxxxxxxxxxxx scientists developed a dedicated method of data exchange to allow safe and reliable cross-platform data transfer and processing; USAMRIID telemetry data are collected and saved in proprietary file formats (xxxxxxxxxxx structured storage) that required a specific development for xxxxxxxxxxxxxxxxo gain the ability to process EEG signals using the NeuroScore software platform. Future analysis, results and interpretations must be consistent across the multiple studies and subjects. Since raw data, analysis results and interpretations from the work conducted under xxxxxxxxxxxxxxxx are proprietary data of xxxxxxxxxxxxxx, of which xxxxxxxxxxxxxxx acquired xxxxxxxxxxx April 29, 2019, the continuation of our program must be provided by the same source.

xxxxxxxx has proven to be a world leader in pre-clinical contract research, specialized in non-human primate electroencephalography (EEG) data analysis collected using radio telemetry in conscious freely moving cynomolgus macaques.

xxxxxxxxxxxFacility provides the largest non-human primate EEG historical database with more than 25 years’ experience in this particular field; their Neuroscience team has analyzed over 450,000 hours of EEG on various research projects for several

Version – March 2017 FOR OFFICIAL USE ONLY

Program/Equipment: EEG Analysis Services government institutions worldwide. Additionally, xxxxxxxxxxxx staffs a Board Certified Veterinary Neurologist (American College of Veterinary Internal Medicine Neurology) as part of their team to support the interpretation of the EEG analysis.

(*) The utilization of advance telemetry to investigate important physiological parameters including electroencephalography in cynomolgus macaques following aerosol challenge with eastern equine encephalitis virus.

Trefry JC, Rossi FD, Accardi MV, Dorsey BL, Sprague TR, Wollen-Roberts SE, Shamblin JD, Kimmel AE, Glass PJ, Miller LJ, Cardile AP, Smith DR, Bavari S, Authier S, Pratt WD, Pitt ML, Nasar F.

6. Efforts to Obtain Competition:

Competition is not possible due to the fact that as discussed in Section 5, the data is only available from procedures developed by the previous Contractor, Citoxlab’s, which was acquired by xxxxxxxxxx so anyone who would want to provide similar services would require access to the raw data, analysis results and interpretation of the previous study, including, but not limited to data compatibility, consistency of the processes and methods used to analyze EEG. As this is in fact a continued collaboration with xxxxxxx, it would be cost prohibited at this point to introduce competition that could jeopardize data integrity. Methods, procedures and new code for data exchange will have to be developed ex novo to meet what could be a different approach to data analysis, which would also have to be validated prior to implementation.

USAMRIID strongly recommends at this point not to seek competition for this procurement at least until the Alphavirus Research Program at USAMRIID, which includes EEG analysis, is completed.

In accordance with FAR 5.201 and PGI 206.303-2 Content - A Special Notice was published on betaSams.gov of the Governments Intent to issue an award to xxxxxxxxxx on a Sole Source basis. The requirement was posted on betSAMs.Gov for 15 days (20 July 2021 – 03 Aug 2021) under xxxxxxxxxxxxxx and no replies were received.

7. Actions to Increase Competition:

It is certainly in USAMRIID’s interests to broaden the search for sources capable of providing research and data analysis. From a previous contract xxxxxxxxxxxxxxx one other source was evaluated but found technically unacceptable (Mind Research Network (MRN)). MRN’s approach lacked of the technological resources (telemetry equipment was not compatible with one’s used at USAMRIID) and only showed a limited experience in the field of non-human primate telemetry EEG data analysis when compared to the awardee of that contract. For the intended purpose, replacing the source of the procurement would inevitably make the project require a significant additional amount of resource on both sides: additional effort from USAMRIID scientists

Version – March 2017 FOR OFFICIAL USE ONLY

Program/Equipment: EEG Analysis Services involved in the project and certainly higher investment costs from the new source (which would be reflected in a higher procurement costs for USAMRIID) in order to meet the requirements.

8. Market Research:

From a recent web search dated 06 May 2021 using “EEG data analysis in NHPs” in the search field, the vast majority of the results point to automated solutions for data acquisition and EEG software development platforms. The field of preclinical neuroscience as contract work appears to be limited. Besides MRN (mentioned in Section 7), SynapCell (with Headquarters in Grenoble, France) may be one of the best examples of a preclinical CNS contract research organization and how they tend to characterize their work: the company utilizes proprietary high-level modeling methods, deep-learning-based signal processing and know-how to produce their analysis results.

As stated earlier in the justification, due to proprietary methods, data analysis and interpretations developed by the previous awardee (xxxxxxxxxxxx which was acquired by xxxxxxxxxxxxxxxxxxx), only the holders of this proprietary information will be able to augment the results we are seeking to obtain with this procurement.

xxxxxxxxxxxxxxxxxxxalso stands out when a xxxxxxxxxxx scientific publication search is performed up to the current year (results listed below). These are all publications related to preclinical EEG data collection and analysis in different primate animal models; no other group of scientists in any other search result produced the amount of specialized publications in the field of non-human primate neuroscience.

Can We Panelize Seizure?

Cerebrospinal Fluid Characterization in Cynomolgus Monkeys, Beagle Dogs, and Göttingen Minipigs.

I

EEG: Characteristics of drug-induced seizures in rats, dogs and non-human primates.

A

J s

Program/Equipment: EEG Analysis Services

Version – March 2017 FOR OFFICIAL USE ONLY

Accardi MV, Huang H, Authier S.

b

EEG in non-clinical drug safety assessments: Current and emerging considerations.

The emerging role of in vitro electrophysiological methods in CNS safety pharmacology.

A

Safety pharmacology investigations on the nervous system: An industry survey.

A

Weis H.

J

Sleep electroencephalographic characteristics of the Cynomolgus monkey measured by telemetry.

J

Effects of amphetamine, diazepam and caffeine on polysomnography (EEG, EMG, EOG)-derived variables measured using telemetry in Cynomolgus monkeys.

A J.

E

Telemetry video-electroencephalography (EEG) in rats, dogs and non-human primates: methods in follow-up safety pharmacology seizure liability assessments.

J.

E

9. Interested Sources:

To date, no other sources have written to express interest in the acquisition

Program/Equipment: EEG Analysis Services

Version – March 2017 FOR OFFICIAL USE ONLY

10. Other Facts:

a. Procurement History:

(1) Contract numbers and dates of the last several contracts for these same requirements.

(January 18, 2017)

(2) The competitive status of these actions.

Full and Open Competition. There were two (2) respondents, including xxxxxxxx(who was acquired by xxxxxxxxxxx that was awarded the contract

(3) Authority previously cited if less than full and open competition was used.

N/A

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results.

N/A

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources.

As described in Sections 5 and 6, the current procurement is for a continuation of a scientific program at USAMRIID; the awardee of the prior contract, in addition to the necessary requirements, has now developed custom methods, standards and procedures that will be implemented in conducting the collaboration (custom code, methods of data analysis, etc.) we are seeking with the current procurement.

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys.

This is the second time we are procuring these services over a 4-year time frame

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes.

N/A

Program/Equipment: EEG Analysis Services

Version – March 2017 FOR OFFICIAL USE ONLY

11. Technical Certification: I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

Date:Typed Name Fr: anco Rossi Title:

Telemetry SME

Signature:

12. Requirements Certification: I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

Date: 7 May 2021 Typed Name: Franco

Rossi Title: SME

Telemetry

Signature:

ROSSI.FRANCO.DA

VIDE.1504287064

Dgitally signed by

ROSSI.FRANCO.DAVIDE.1504287

Date: 2021.08.24 15:42:31 -04'00'

ROSSI.FRANC

O.DA

VIDE.1504287064

Digitally signed by

ROSSI.FRANCO.DAVIDE.1504287

Date: 2021.08.24 15:42:56 -04'00'

Program/Equipment: EEG Analysis Services

Version – March 2017 FOR OFFICIAL USE ONLY

13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable.

This determination will be made using the following: price analysis cost analysis IGCE audit: other:

As a part of this basis, certified cost or pricing data is not required because the item and/or services being acquired are considered commercial.

Typed Name: Date:

Title: Contracting Officer Signature:

14. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Typed Name: Date:

Title: Contracting Officer Signature:

Digitally signed by

N

Digtally signed by

O Date: 2021.08.25