A02-SSJ-FINAL-FINAL-REDACTED.pdf

Control Number: FY25-0000 CUI

CUI

(Source Selection information - See FAR 2.101 and 3.104-4)

MEMORANDUM FOR RECORD

LIMITING COMPETITION AT OR BELOW THE SIMPLIFIED ACQUISITION

THRESHOLD (SAT)

1. Contracting Activity: The contracting activity for this action is the US Army Medical Research Acquisition Activity (USAMRAA), Fort Detrick, MD 21702.

2. Description of Action: New Requirement Follow-on Requirement

Contract Vehicle: Purchase Request Number:

Blanket Purchase Agreement (BPA) Number _______________ Order/BPA# _______ against FSS Contract #_____ _________ Order #___________ against Multiple Award IDIQ Contract

Name or #______________ Order #_______ against a single award IDC Contract

Modification # _______ to existing PO/TO/DO/Call Order

Pricing/Contract Type: Fixed Price Time & Materials/Labor Hours Cost Reimbursable Hybrid

Funds: Operations & Maintenance, Army (OMA) Other Funds:

Name of Proposed Contractor(s) and Address:

Magstim Inc.

1626 Terrace Drive Saint Paul, MN 55113 Unique Entity ID: MMDHHFM418D8 Cage Code: 7WXG3

Brand Name Buy: Yes No

3. Description of Services or Supplies: The Naval Medical Center San Diego (NMCSD) has a need for one Transcranial Magnetic Stimulation (TMS) chair.

Delivery Date: 30 September 2025

(Source Selection information - See FAR 2.101 and 3.104-4)

4. Authority:

FAR 13.106-1(b)(1): For purchases not exceeding the simplified acquisition threshold (SAT), only one source reasonably available, urgency, exclusive licensing agreements, brand name, or industrial mobilization.

5. Reasons for Authority Cited: Market research has determined that Magstim Inc. is the sole provider capable of delivering the Transcranial Magnetic Stimulation (TMS) system that meets the Government’s specific clinical and operational requirements. The selected TMS machine is FDA-cleared for the treatment of resistant depression and incorporates proprietary technology that aligns with DHA behavioral health protocols and prior clinical use at other military treatment facilities.

This system is FDA-cleared for Major Depressive Disorder and OCD, meeting DoD standards for TMS treatment delivery in military settings. Additionally, it supports secure documentation and treatment traceability, ensuring compliance with HIPAA and DoD patient care standards.

Magstim is the only TMS provider offering an FDA-approved 3D neuronavigational system (StimGuide) with integrated EMG functionality, ensuring 100% accurate coil placement and superior precision. The system delivers up to 40 million pulses per device—double the capacity of most competitors, which typically offer 20 million pulses.

This increased capacity translates to a lower cost of ownership over the device’s lifecycle, maximizing long-term value and reducing operational overhead.

6. Publicizing Contract Actions: For FAR Part 13 actions, the public display and synopsis requirements of FAR 5.101 and FAR 5.203 do not apply due to the $ threshold, apply and will be followed, or do not apply due to an exception at 5.202

Requirement to post justification in accordance with FAR 8.405-6(b)(3), FAR 13.105(c), or FAR 16.505(a)(4)(iii)(A)

Action is NOT a brand name restriction and is under $250K, no posting required Action is a brand name restriction, under $25K, no posting required Action is a brand name restriction, over $25K. It will be redacted and posted with the solicitation.

Action is a brand name restriction over $25K but will not be posted due to exception:

7. Market Research: Attempts to identify alternate sources through internet searches, vendor outreach, and internal consultations with subject matter experts confirmed that no other supplier offers a clinically equivalent system that meets the performance, compatibility, and regulatory standards required. It is recommended that procurement proceed with the identified vendor to ensure continuity of care, clinical effectiveness, and compliance with DHA medical equipment standards.

(Source Selection information - See FAR 2.101 and 3.104-4)

8. Other Facts: Not Applicable

(Source Selection information - See FAR 2.101 and 3.104-4)

9. Technical/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:

Title:

Signature:

10. Contracting Officer Certification/Approval:

I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable based upon previous purchase history. I certify that this justification is accurate and complete to the best of my knowledge and belief, and that completing this purchase as a sole source is in the best interest of the Government.

Additionally, I approve this justification to limit competition subject to the availability of funds and provided that the services or supplies herein described have otherwise been authorized for acquisition.

Typed Name:

Title:

Signature: