WX02772Y2020T NIDS Assays Sampling Kits_SSJ_Simplified_Acquisitions_Below_SAT_COsigned Price Redacted.pdf

Sole Source Justification (SSJ) For Simplified Acquisitions (over $3,000 and up to $150,000) pursuant to FAR 13.106, including Brand Name

Sole Source Justification for Simplified Acquisitions (over $3,000 up to $150,000) Template 1-1

Date: May 14, 2020 PR Number: WX02772Y2020T

1. Nature and/or description of the item/service being procured and anticipated cost:

The Government requires the following brand name equipment in support of biothreat response training at the Center for Domestic Preparedness (CDP), Chemical Ordnance Biologoical Radiological (COBRA) Training Facility:

8 each 5L-001-20PK NIDS® Multiplexed Handheld Immunochromatographic Assays and 60 each SK-001 Sampling Kits for Surfaces and Powders

The CDP provides specialized, advanced hands-on training for state and local emergency responders. Several CDP-generated, operations- and technician-level courses have undergone an implementation of biothreat response training, including the integration of multiple biological agent detection technologies. NIDS® Multiplexed Handheld Immunochromatographic Assays, hereafter referred to as NIDS assays, are an example of this recent integration. NIDS (Nano- Intelligent Detection System) technology is a recent development that supplements and supports existing lateral flow, antibody capture technology. The resultant product, while similar to existing Handheld Assays (HHA) in configuration and operation, is unique to biothreat detection.

This product intends to supplement the NIDS assays and other forms of antibody capture technology already procured for biothreat response training.

Through advances in nanotechnology, NIDS assays have been designed to control the orientation of bioactive molecules (i.e., antibodies) at the nanoscale level. As such, the NIDS platform is configured with preferentially attached (i.e., orchestrated) antibodies to facilitate the “capture” of analytes (in solution) that have been introduced to the assay via the sample well.

Refer to the following table for associated costs:

Manufacturer

ANP Technologies, Inc 824 Interchange Blvd Newark, DE 19711 (302)-2983-1730

Part # Qty Unit Price

Total Cost (Includes Shipping)

NIDS 5-Plex 1 Assay 5L-001- 20PK 8 pk $3300 redacted

NIDS Sampling Kit SK-001 60 ea $110 redacted Handling Cost redacted Shipping cost for combined products N/A Total Cost redacted

2. Sole Source Justification Rationale in accordance with FAR 13.106-1(b)(1)(i) and (ii).

(Check one and explain below):

For Simplified Acquisitions (over $3,000 and up to $150,000) pursuant to FAR 13.106, including Brand Name

Sole Source Justification for Simplified Acquisitions (over $3,000 up to $150,000) Template 1-1

Only one source reasonably available.

_________ Urgent and compelling circumstances exists.

_________ Exclusive licensing agreement exists.

X Brand name. If the brand name requirement applies to a portion of the procurement, please identify that portion.

_________ Industrial Mobilization _________ Other. Explain:

While there are dozens of commercially available biological detection instruments, the Program Office asserts a brand-name acquisition reasonable and prudent. Supporting rationale includes the requirement to remain aligned with existing training configurations at the COBRA Training Facility. Introducing competitors’ products at this juncture is neither viable nor wise, because of the limited amount of time for instruction on instrument operation, learning and understanding of the display screen on the NIDS reader, teaching instrument capabilities and limitations, and then applying the knowledge by using the instrument in a training situation. Additionally, procedures related to instrument maintenance and training of support personnel have become standard practice at this point in the CDP's biothreat training regimen. Most logically, the rationale that best supports the Government’s sole source requirement is that the NIDS reader, an instrument already incorporated into biothreat response training, operates solely in conjunction with the subject requirement.

The introduction of competing models will prolong delivery of training, as the participants will likely be unfamiliar with competing, lesser known and less capable units. Additionally, course management and subject matter experts affiliated with biothreat response have stated that the training value and effectiveness would be far greater if the CDP conducted its training using the same equipment emergency responders are currently using in their training and real-world operations.

3. The anticipated price will be determined fair and reasonable based on one or more of the price analysis techniques described below in accordance with FAR Part 13.106-3(a)(2). (Check one and provide short explanation or description of action taken):

X Market Research and posting combined syn/sol to solicit for additional quotes.

_________ Comparison of the proposed price with prices found reasonable on previous purchases.

_________ Current price List.

_________ Comparison with similar items in a related industry.

_________ Comparison to IGCE.

_________ Contracting Officer’s personal knowledge.

_________ Other.

In accordance with the FAR, Part 10, this office conducted market research to gain insights into the availability of products and to obtain feedback from industry. ANP Technologies, For Simplified Acquisitions (over $3,000 and up to $150,000) pursuant to FAR 13.106, including Brand Name

Sole Source Justification for Simplified Acquisitions (over $3,000 up to $150,000) Template 1-1 manufacturer of the subject requirement, has one known distributor and also sells direct to customers. The Program Office solicited pricing using the following market research tools:

Free and open, direct telephonic exchanges, required by the FAR.

Internet research utilizing multiple search engines.

Vendor brochures.

Contact with Subject Matter Experts (SME) for required expertise.

4. Approval:

Contracting Officer Date

JAMES D SUERDIECK

Digitally signed by JAMES D

SUERDIECK

Date: 2020.05.14 15:29:06 -04'00'