FDA-SSN-113055.pdf

Odyssey M - Automated Imaging System Sources Sought Notice

FDA-SSN-113055

MARKET RESEARCH PURPOSES ONLY

NOT A REQUEST FOR PROPOSAL OR SOLICITATION

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) is issuing this source sought announcement on behalf of the Center for Biologics Evaluation and Research (CBER) in order to determine if there are existing small business sources capable of providing an Odyssey M - Automated Imaging System.

The appropriate NAICS code for the acquisition is 334516 – Analytical Laboratory Instrument Manufacturing; Small Business Size standards – 1,000 employees.

Background:

The FDA/CBER, Debrabant Laboratory requires an automated imager that provides reliable data for membranes, plate-based assays, slides, and nucleic acid and protein gels. The lab needs a versatile imaging system that can capture assays in multiple channels, including white light, luminescence (i.e., bioluminescence and chemiluminescence), and fluorescence (i.e., visible and near-infrared (NIR). This imager will be used to quantify by western blot the protein expression in wild-type and transgenic parasites generated in our laboratory. It will also be used to quantitate the level of green or red fluorescence proteins expressed by transgenic parasites in infected cell cultures and tissue sections of infected mouse models.

This requirement is as Brand Name or Equal configuration:

LI-COR, Inc., Odyssey M - Automated Imaging System, part # 3350-02, 1 - Each

*The requirement also includes a Trade-In: LI-COR Odyssey Classic, serial # ODY-2173.

Minimum Technical Requirements:

1. Shall be able to capture assays in 18 channels, including white light, luminescence (i.e., bioluminescence and chemiluminescence), and fluorescence (i.e., visible and near-infrared (NIR).

2. Shall use infrared detection, laser excitation, and scientific complementary metal–oxide– semiconductor (sCMOS)-based line imaging for optimal sensitivity.

3. Shall offer a wide range of illumination and no imager saturation in biologically relevant samples to overcome common band saturation issues.

4. Shall have an acquisition software to capture assay images and analysis software that offers step-by-step workflows for analyzing quantitative and qualitative Western blots, multiwell plates (e.g., In-Cell Western Assay), protein and nucleic acid gels, and microscope slides.

5. Shall have an acquisition software that automatically tags acquired images with assay type based on the selected analysis workflow.

6. Shall have acquisition and analysis software with an Adaptive Lane Finding (ALF) that automatically finds lanes instead of manual, leading to variability.

7. Shall have an analysis software using Adaptive Background Subtraction (ABS) that adapts to an image's background and automatically subtracts the background to significantly reduces user-to-user variability.

8. Shall use laser excitation across nine channels. This excitation allows for uniform illumination and high laser output across the samples and scan area, resulting in high signal-to-noise ratios for highly sensitive detection in visible and NIR regions.

9. Shall produce high sensitivity across the visible through NIR spectral range by combining laser point scanning and sCMOS image sensor technology.

10. Shall offer over 6 logs of dynamic range in a single acquisition—without post-acquisition manipulation—to ensure that the hardware is not contributing to saturation.

11. Shall include software that automatically generates a combined linear range chart to demonstrate the location in the dilution range where saturation begins.

12. Shall include a two-year warranty.

13. Shall provide on-site installation and training.

The system shall be a turn-key solution i.e., the contractor shall be responsible for providing all hardware, components, software, and that otherwise required to meet these specifications, the FDA’s stated need and shall be fit for intended purpose. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up.

Delivery/Period of Performance:

FOB Point Destination. Shipping, handling, in-side delivery, installation and training no later than 90 calendar days after receipt of contract award.

Place of Delivery/Performance:

U. S. FDA – CBER

10903 New Hampshire Ave.

Building 72/Room 4358 Silver Spring, MD 20993

Responses to this source sought shall unequivocally demonstrate the respondent offered supplies/services meet the technical requirements outlined above. Though the target audience is small business vendors or small businesses capable of supplying a U.S. service of a small business vendor or producer, all interested parties may respond. At a minimum, responses shall include the following:

- Business name and bio, unique entity ID SAM, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address. Provide this same information again if responding to provide a service offered by another firm.

- The offeror shall furnish capability statements with sufficient technical information necessary for the Government to conclusively determine experience and qualifications of the firm for the minimum technical/performance requirements identified above, to include descriptive material, literature, brochures and other information .

- Past Performance information for the manufacture, and/or sale and support in which the offeror has provided same or substantially similar products and used for same or near same applications for a Odyssey M – Automated Imaging System as set forth herein For each past performance reference include the date of service, description of service provided and the manufacturer name and model of the equipment serviced, dollar value, client name, client address, client contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of company (to include the firm’s SAM Unique Entity Identifier (UEI) number and size status) if not the respondent.

- If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested.

- If applicable, identification of Best in Class (BIC) contract information or other Government Wide or HHS Wide Contracts that the equipment/service is available on.

- If a large business, provide if subcontracting opportunities exist for small business concerns.

- Standard commercial warranty and payment terms.

- Provide place of product manufacture or service performance and any other applicable information to enable review and analysis pertaining to the Buy American statute and requirements relating to Made in America in the event a nonavailability waiver request through the MIAO Digital Waiver Portal is needed.

- Though this is not a request for quote, informational pricing for the service would be helpful.

The Government is not responsible for locating or securing any information, not identified in the response.

Interested Parties shall respond with capability statements which are due by email to the point of contact listed below on or before June 22, 2022, by 12:00 PM (Central Time in Jefferson, Arkansas) to jennifer.johnson3@fda.hhs.gov, and reference: FDA-SSN-113055.

Notice of Intent:

Responses to this source sought announcement will assist the Government in determining whether any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures.

Disclaimer and Important Notes:

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work.

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre‐solicitation synopsis and solicitation may be published in SAM.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality:

No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non‐proprietary technical information in any resultant solicitation(s).

Additional Notes:

If the stated requirements appear restrictive, please submit comments detailing the concern.