JAND A.pdf

Control No:JA-20-08-00183

JUSTIFICATION REVIEW DOCUMENT

FAR SUBPART 13.5 SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS – SOLE SOURCE JUSTIFICATION AND APPROVAL

Program/Equipment: Directed Energy (DE) Consultation Services

Authority: Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR Subpart 13.5.

Amount: $ 435,000.00 Prepared by: Jessica Chandler DSN: 410-436-4356

Biologist Email: Jessica.k.chandler.civ@mail.mil

Contracting Officer: Jeremy McMurry PH: 301-619-2035 Contracting Officer Email: jeremy.l.mcmurry.civ@mail.mil

Technical:

Jessica Chandler DSN: 410-436-4356 Biologist Email: Jessica.k.chandler.civ@mail.mil

Requirements: Jessica Chandler DSN: 410-436-4356 Biologist Email: Jessica.k.chandler.civ@mail.mil

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

Program Manager: Typed Name: John Crawford DSN:

410-436-2833 Signature:

Version – September 2018 FOR OFFICIAL USE ONLY

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

1. Contracting Activity: The Contracting Activity responsible for this action is the U.S. Army Medical Research Acquisition Activity (USAMRAA).

2. Description of Action: The U.S. Army Medical Research Institute of Chemical Defense (USAMRICD) Medical Toxicology Research Division requests a firm-fixed-price services contract with 4D Enterprises for DE consultation services. The Government projects award for October 2020 and fiscal year 2020/2021, Research Development Test & Evaluation, Army funds will be used.

3. Description of Services: USAMRICD is collaborating with the US Army Research Lab (ARL) to characterize pulsed high-powered microwave (HPM) for inducing unconventionally-acquired brain injury (UBI). While radiofrequency (RF) and microwave radiation can couple to and affect biology in myriad ways, an Office of the Secretary of DefenseOSD chartered UBI working group determined thermos-acoustic mechanical loading, induced by pulsed HPM, as the leading candidate mechanism of injury.

Consequently, an OSD strategic plan was established to combat UBI and prioritized the assessment of that threat mechanism. The work proposed herein supports that OSD objective with funding programmed by OSD-CAPE (Cost Assessment Program Evaluation) (FY20-22) for ARL and USAMRICD to conduct a pulsed-HPM threat characterization.

USAMRICD and ARL have many subject matter experts (SMEs) in the fields of traumatic brain injury (TBI) and UBI. However, the SMEs’ experience is limited to TBI and UBI research regarding chemical warfare and blast injuries, not including UBI from RF and microwave radiation. In order to foster a successful program and to educate the USAMRICD and ARL SMEs on these new forms of UBI, USAMRICD requires the consultant services of an SME with specific and extensive experience, as well as a secret security clearance and a facility secret clearance, in the types of UBI that will be investigated.

The USAMRICD Medical Toxicology Research Division has a requirement for the following support services:

• Subject matter expertise (SME) and consultation services in support of the DE program, methods development, experimental design, safety, research execution, and evaluation of findings;

• Research activity support services to include task area support, coordination with other United States Government (USG) agencies and DE programs, animal use protocol support, and administrative support;

• Consultation specific to utilization of multiple devices including, but not limited to pEM; mono-pulse and multi-channel frequency specific microcurrent with and without light; and, lasers including powers ranging from 0.5 mJ to 75 W in multiple bandwidths for various clinical complaints.

• Theoretical analysis of DE mechanisms of injury and action, analysis of in vivo DE bioeffects data, interpretation of study results, report generation, and guidance on assay development and translation of data for clinical applications (e.g., inform clinical practice guidelines, medical countermeasures, and therapeutic treatments).

Base Period: 5Oct20 to 4Oct21 Value: $120,000.00 Option Period 1: 5Oct21 to 4Oct22 Value: $157,500.00 Option Period 2: 5Oct22 to 4Oct23 Value: $157,500.00

Total: $435,000.00

4. Authority Cited:

Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 (or 41 U.S.C. 1903 for Special Emergency Procurement) as implemented by FAR Subpart 13.5:

Unusual and compelling urgency Exclusive licensing agreements Industrial mobilization X Other: FAR 6.302-1, Only one responsible source and no other services will satisfy agency requirements.

5. Reason for Authority Cited:

4D Enterprises has 10+ years of experience and expertise in bioeffects related to RF and microwave radiation. They also have an extensive knowledge base in RF and microwave radiation medical therapies and treatments. This capability is invaluable for the knowledge, scientific and medical counsel, and experience-based recommendations to lead USAMRICD and ARL SMEs to make best decisions related to project progression for the characterization of UBI relative to HPM. No other company possesses these unique qualifications required by USAMRICD, as the requirement is based on knowledge and experience.

4D Enterprises has expertise working with both clinical and non-clinical modalities for the effective non-thermal effects of various different types of energy including but not limited to RF, pEMF and Photon. Their expertise includes deleterious and therapeutic uses.

From extensive research at USAMRICD, 4D Enterprises is the only known company that possesses several years of experience performing clinical usage with these modalities.

4D Enterprises has been recognized as such by bringing these technologies into the DoD for teaching, as these modalities are now becoming successfully introduced into the DoD.

4D Enterprises employs individuals with active secret security clearance, with recent SCI on several related projects in terms of Directed Energy protection. 4D Enterprises also possesses an active facility secret clearance.

4D Enterprises has clinical experience in using multiple devices including, but not limited to pEM; mono-pulse and multi-channel frequency specific microcurrent with and without light; and, lasers including powers ranging from 0.5 mJ to 75 W in multiple bandwidths for various clinical complaints.

4D Enterprises is the only known entity able to describe, characterize and employ the entire continuum of energy from harmful effects to therapeutic interventions that parts of the DoD will acknowledge are working on pain and trauma that have been recalcitrant to other known therapeutic modalities using FDA approved or registered equipment to help keep the force ready and return to active duty when MEB were pending.

4D Enterprises has both extensive operational and medical expertise and experience in DE and RF, including an employee base that typically includes physicians, Test Pilots, and Fighter Pilots. This allows an unusual but tremendously useful perspective for balancing research and development, operational medicine, occupational medicine, military medicine, human physiology, threat assessment, threat mitigation, clinical intervention, patient care, and disability assessment. 4D Enterprises employs USAF veterans and civilians who have performed DE and RF work for over 30 years, including leading DIA task force on Directed Energy for many years.

4D Enterprises has 30 years of focused professional perspective at the classified level on DE. No other company possesses both the R&D understanding and clinical expertise of DE concepts, modalities, and clinical therapies. 4D Enterprises provides a remarkably unique interface between the physicists, engineers, physiologists, operators, and clinicians, by acting as a lead SME in the field of DE and therapeutic effects.

6. Efforts to Obtain Competition: The Contracting Officer shall publish the notices required by FAR 5.201. There was no attempt to obtain other competition. Only 4D Enterprises possesses the knowledge base in the subject field to provide this consultant service.

7. Actions to Increase Competition: The Medical Toxicology Research Division Product Manager will continue to monitor the marketplace for contractors with the necessary knowledge base to provide the unique support services required.

8. Market Research: Market research was conducted through World Wide Web (WWW), contacting other labs, consulting vendors, and meetings. No other company was identified that would be capable of fulfilling the unique research specifications.

9. Interested Sources: A Notice of Intent to Sole Source will be posted in accordance with FAR 5.201 on the Beta.SAM website that will provide interested concerns the opportunity to identify their capability in writing. Any responses received will be reviewed and given consideration.

10. Other Facts: Thorough Market Research was conducted to include a review of

USAMRAA’s contracting writing system, Procurement Desktop-Defense (PD2), the

Virtual Contracting Enterprise Contract File (VCE-PCF). The search identified no previous Purchase Orders or Contracts issued for the required consultant services. a.

Procurement History:

(1) Contract numbers and dates of the last several contracts for these same requirements. Not Applicable.

(2) The competitive status of these actions. Not Applicable.

(3) Authority previously cited if less than full and open competition was used. Not

Applicable.

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.

Typed Name: Jessica Chandler Title: Biologist 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.

Typed Name: Jessica Chandler Title: Biologist Signature:

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: ☐ cost analysis ☒ price analysis ☐ should cost ☒ IGCE ☐ audit: ☐ other

As a part of this basis, certified cost or pricing data:

☐ will be required.

☒ will not be required and the following exception applies (FAR 15.403):

☐ Prices that will be agreed upon are based on adequate price competition.

☐ Prices that will be agreed upon are based on prices set by law or regulation.

☒ A commercial item is being acquired.

☐ A waiver has been granted by the head of the contracting activity (HCA) in accordance with DFARS PGI 215.403-1.

☐ The contract action is a modification to a contract or subcontract for commercial item(s).

☐ The estimated cost of the contract action is less than the threshold for certified cost or pricing data.

Typed Name: Jeremy McMurry 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: Jeremy McMurry Title: Contracting Officer Signature: