NAMRU-SA Statement of Need (SON)_AmalgamSeparator.pdf

07 MAY 2025

STATEMENT OF NEED for

Injection Molding Production of Novel Amalgam Separator

☐ COMMAND ☐ CCC&OM ☒ CH&RM ☐ DEHE ☐ RSD

In accordance with FAR Part 7 – Acquisition Planning, we must address the requirement to specify needs, develop specifications, and to solicit offers in such a manner to promote and provide for full and open competition with due regard to the nature of the supplies and services to be acquired. This document supports these efforts and to those required by FAR Part 11 – describing agency needs for the purpose of acquiring product(s) and/or service(s).

1. BACKGROUND

Dr. Yoon Hwang’s team under CH&RM’s department Environmental Surveillance is working the development of a novel amalgam separator that requires custom injection molding production to support commercialization and implementation in military dental treatment facilities.

2. SCOPE

☐ Brand Name or Equal ☐ Brand Name ☒ Sole Source ☐ N/A

Need Description:

The requirement is for a sole source fixed price purchase of injection molding prototypes produced by ARRK, holder of an NDA with NAMRU-SA for the protection of the proprietary design for a novel amalgam separator (Navy Case 212,263; U.S. Provisional Patent Application Serial No. 63/704,271 filed October 7, 2024).

Brand Name / Brand Name or Equal:

Manufacture/Brand: ARRK North America Inc.

Part/Serial Number: N/A – Custom parts Other: […]

Salient Characteristics (description of physical, functional, or performance features):

Custom tooling and production for all 6 components of the amalgam separator with 25 units of each component. Due to the sensitivity of the amalgam separator design, this work must be completed by an entity covered under an NDA such as ARRK North America Inc. Additionally, this work requires customized tooling methods for injection molding based on the amalgam separator design which cannot be completed by any other group without needlessly exposing proprietary information and threatening full patentability.

Quantity: 25 units for each of the 6 components

3. ASSEMBLY / SETUP

☐ In-House ☐ Vendor ☒ N/A

4. DISPOSAL

☐ DRMO

☐ Vendor – Price to dispose identified in IGE ☒ N/A

5. WARRANTY / MAINTENANCE INFORMATION

Warranty Terms: N/A

Maintenance Terms: N/A

For existing equipment:

End of Life _________________________

6. POTENTIAL SOURCES / CONTRACT VEHICLES

• Open Market – Not Applicable

• UNICOR – Not Applicable

• Vibrant Works – Not Applicable

• GSA – Not Applicable

• CHESS Consolidated Buy – Not Applicable

• CCS-3 Direct – Not Applicable

• 502d Modular Furniture BPA – Not Applicable

• Mandatory Source: Not Applicable

• Other: _____________

7. VENDOR IDENTIFIED (For GPC or Sole Source Requirements only)

Name: ARRK North America Inc.

Address: Attn: Ivania Silva 4660 La Jolla Village Drive, Suite 100 & 200, San Diego, CA 92122

Phone: 858-552-1587

☐ GSA Cart Number (if applicable): _______________________

8. DELIVERABLES

☐ Technical Reports

☒ Equipment/Materials should be delivered to the address below. Note: NAMRU-SA has delivery docks onsite.

☒ NAMRU-SAN ANTONIO

Attn: Meaghan Rose Bldg. 3611 3400 Rawley E. Chambers Avenue JBSA FT Sam Houston, TX 78234 Delivery hours M-F: 0800-1500

☐ NAMRU-SAN ANTONIO

Attn: […]

TSRL

4141 Petroleum Drive Fort Sam Houston, TX 78234 Delivery hours M-F: 0800-1500

9. OTHER REVIEWS/REQUIRED FORMS CHECKLIST

☐ NAMRU-Facilities. Plus ☐ ISR for BHT attached ☐ 502 CE for TSRL attached ☐ Safety (req. for chemicals). _____________________________ ☐ Security. ____________________________________________ ☐ NAMRU-SA I.T. Plus ☐ ISR for BHT attached ☐ 502 COMM for TSRL attached ☐ Equipment Manager/BMET. ____________________________ ☐ Form 889. ___________________________________________ ☐ Form 6700. __________________________________________

10. DELIVERY SCHEDULE / DATE / PERIOD OF PERFORMANCE

Delivery Lead Time Identified: […]

Period of Performance (provide dates when available):

☐ Base Only _________________________ ☐ Base + 1 Option _________________________ ☐ Base + 2 Option _________________________ ☐ Base + 3 Option _________________________ ☐ Base + 4 Option _________________________ ☒ No maintenance or services required at this time.

11. TECHNICAL POINT OF CONTACT (TPOC) [GS/MIL ONLY – to be identified on award only – does NOT get listed in a solicitation]

12. FUNDING

☐ Planning ☒ Funded

13. FORM OF PAYMENT

☐ GPC

☐ Open Market: Verified vendor is on Approved Vendor List ☐ New Open Market Vendor: Verified accepts GPC and completed registration

☐ CONTRACT - WAWF TABLE to be completed by Acquisitions

14. MISSION IMPACT

☒ Critical ☐ Essential ☐ Enhancement

Comments: This service is required to progress the development and commercialization of NAMRU-SA’s novel amalgam separator for implementation into currently operated military dental treatment facilities for improved safety, cost efficiency, and wastewater mercury abatement.

Signing Authority