Attachment 6 - SPT LabTech - SSJ Rev 1.pdf

Attachment 6

Justification and Approval (J&A):

Brand-Name at or Below the Simplified Acquisition Threshold

Project Title: _______Automated Cryo-EM Sample Preparation Instrument _____

I . Identification of the agency and contracting activity

DHHS, NIH, NIAID, ____VRC, VL, SBC__________________

Requestors name: Sergei Pletnev Requestors phone number: 312-776-7115 Requestors email address: pletnevs@nih.gov Address of the requesting lab/office: building 40 room 4607B, VRC, NIAID, NIH.

II. Description of the project, and supplies or services required to meet the agency’s needs (including the estimated value) A. Type of action: (check the appropriate box)

☒ New requirement ☐ Follow-on

• Name of the previous contractor(s): ____New requirement – no previous contractor______________

• Sequence number, if available: ____________________________________

• Was the initial and any subsequent awards competed? ☐ Yes ☒ No

B. AMBIS Sequence number for this requirement: __2270381__ C. Total estimated dollar value of the requirement (including options, if applicable): __$181,518.00__ D. Period of performance, inclusive of options: Delivery shall occur within thirty (30) days after receipt of order

(ARO). Warranty coverage shall extend for 12 months from installation (through August 2026).

E. Project Background

The Structural Biology Core (SBC), Virology Laboratory (VL), Vaccine Research Center (VRC), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) uses a structure-based approach for developing antibody therapeutics and vaccines for infectious diseases, including but not limited to COVID-19, HIV- 1, malaria, flu, and RSV. The structural analysis of pathogen proteins, antibodies, and vaccines is essential to current and future SBC research. It requires high-resolution cryo-EM data attainable only with high-quality samples. Currently, SBC relies on manual plungers for the preparation of cryo-EM grids, which can yield suboptimal results, particularly with challenging samples. The adoption of automated, non-blotting technology offers a promising solution to this issue. To meet the specialized needs of SBC VRC, we request the acquisition of the Chameleon Cryo-EM Sample Preparation Instrument.

F. Description of the supplies/services to be purchased.

1 Chameleon® - Cryo-EM Sample Preparation Instrument Featuring:

Minimum Sample Volume: 5μL Minimum Dispense Volume: 6nL Batch Capacity: 8 Grids Sample Temperature Control: 4°C to 40°C Minimum Dispense-to-Plunge Time: 54 msec Liquid Nitrogen Level Monitoring Liquid Ethane Temperature Control Integrated Semi-Automated Characterisation and Plunge Speed Tuning Integrated Closed Loop Glow Discharge Module Integrated Post-Dispense QC System Session Tracking and Reporting Datapack.

2 Chameleon® Cryogen Bowl Assembly.

1 Ethane Condensing Kit

1 Chameleon® in-built Desktop PC Controller (Win10) with chameleon® Software Licence & Comms Installed

1 Chameleon® Consumables Starter Pack Includes:

4150-40001 pack of 50 4150-40003 4150-40004 4150-40005

- pack of 50 4150-40010 Types Each 4150-40011 NPN Source Bottles (Working Fluid Bottle and Waste)

1 Chameleon Installation

1 Vision lite - chameleon® Applications Support Package

III. Identification of the statutory authority permitting other than full and open competition (SELECT ONE)

☒ 41 USC 3304(a)(1) a n d F A R P a r t 6 . 3 0 2 - 1 : Only one responsible source / Brand Name ☐ F A R P a r t 8 . 4 0 5 - 6 : Federal Supply Schedule (FSS), limited competition / Brand Name

Important Note: The statutory authority listed below will rarely ever be used in NIH. Before selecting this authority, please ensure that you have read and understood the citation and discussed it with the cognizant Contracting Officer.

☐ 41 USC 3304(a)(5) a n d F A R P a r t 6 . 3 0 2 - 5 : Authorized or required by statute / Brand Name

IV. Demonstration that the proposed brand name product’s salient characteristics (specific features, qualities and/or the nature of the acquisition) requires use of the authority cited. The Chameleon Cryo-EM Sample Preparation Instrument is a unique tool that employs blot-free technology for sample preparation. Its self-wicking grids enable rapid, on-the-fly sample dispensing, minimizing the adverse effects of protein exposure to the air-water interface. This approach effectively addresses issues such as preferred orientation, aggregation, and denaturation. The instrument offers several key advantages, including the ability to dispense nanomolar sample volumes, automated grid handling, camera-assisted screening, experimental condition tracking and recording, and the development of automated workflows. Currently, no alternative equipment on the market utilizes blot-free technology.

V . Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable Price reasonableness determination will be included in the acquisition file.

VI. Certification

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support my request (for the requestor) and approval (for the CO) of is accurate and complete.

Official Name & Title Signature Date

Requestor Certification

Sergei Pletnev 08-05-2025

Contracting Officer Approval