FDA-SSN-1252800.pdf

Cell Imaging Multi-Mode Reader Sources Sought Notice

FDA-SSN- 1252800

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 National Center for Toxicological Research (NCTR) in order to determine if there are existing small business sources capable of providing a Cell Imaging Multi-Mode Reader and four (4) option year of extended warranty services.

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

Background:

The FDA/NCTR, Jefferson, AR requires Cell Imaging Multi-Mode Reader with components, supporting hardware and software for performing wide range of assays with the ability to conduct microscopy and acquiring images through a combination of conventional multimode microplate reading and advanced microscopy mode for cell imaging. This will provide both conventional multimode microplate reading and digital microscopy capabilities in one instrument. The FDA makes regulatory assessments of products that either contain nanomaterial or otherwise involve the application of nanotechnology. The FDA Nanotechnology Core (Nanocore) Facility supports the nanotechnology needs of NCTR and the Office of Regulatory Affairs/ Arkansas Regional Laboratory (ORA/ARL), which are co-located on the Jefferson Laboratories Campus. The facility also supports studies conducted under the National Toxicology Program and other FDA Centers. Nanocore conducts research on characterization of nanomaterials and their biological assessment to facilitate regulatory decision-making. Nanocore also develops consensus standards for evaluation of nanomaterials in collaboration with stakeholders.

Minimum Technical Requirements:

1. Shall be a multi-mode detection plate reader with an advanced automated microscopical imaging capability.

2. Shall have inverted and upright microscopes.

3. Inverted microscope shall have fluorescence, brightfield, color brightfield and phase contrast imaging modes.

4. Shall have 4 color channels for the inverted microscope.

5. Upright microscope shall have reflected light and transmitted light microscopy capability.

6. Upright microscope shall have 2x, 4x and 8x lenses. Inverted microscope shall have 6 objectives including 2.5x, 4x, 10x, 20x,40x and 60x to cover all the required imaging applications.

7. Inverted microscope shall have a wide field of view monochrome camera.

8. Upright microscope shall have a wide field of view color camera.

9. Shall have autofocus, autoexposure, auto-LED intensity adjustment with laser autofocuses capabilities.

10. Shall have advanced image analysis software that is capable of image processing, stitching, z-projection, and digital phase contrast with cell counting and sub-population analysis. The software shall also have an advanced image analysis capability for spot counting purposes.

11. Shall have end point, time lapse, z-stack and imaging montage methods.

12. Shall have software for quantitative and qualitative analysis for multi-mode detection.

13. Shall be compatible with 6- to 1536-well microplates, microscope slides, cell culture dishes, T25 cell culture flasks and counting chambers.

14. Shall support live cell assays equipped with gas controller to monitor and control carbon dioxide/oxygen levels.

15. Shall have a temperature control capability that can set temperature gradient with a cooling module.

16. Shall be able to automatically identify and image samples of interest using the plate reader optics.

17. Shall have multi-mode detection including fluorescence, absorbance and luminescence detection modes, specifically monochromator-based fluorescence, UV-Vis absorbance and luminescence detection capabilities.

18. Cell Imaging Multi-Mode Reader shall come with all hardware, controller, monitor, and software for performing measurements, imaging, and data analysis. The computer hardware shall have internet, and USB port(s) and other appropriate connections for smooth overall function.

19. All components and/or equipment shall be newly manufactured, not used/refurbished or used for previous demonstration.

20. The system shall be warranted for parts and labor for a minimum of 12 months from date of installation. All warranty work shall be performed on-site at NCTR.

Minimum Performance Requirements:

Four (4) option years of Repair and Preventative Maintenance service shall include:

1. The Cell Imaging Multi-Mode Reader.

2. Minimum of one (1) planned preventative maintenance visits per contract period.

3. Preventative maintenance shall include all labor, travel, and parts.

4. Unlimited on-site corrective/remedial maintenance/repairs maintenance, service within 3 business days of call for service where problems cannot be resolved remotely after 2 business days. Shall include all labor, travel, and parts.

5. Performance by formally trained and certified technicians/engineers for all maintenance and repair activities performed, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using new OEM replacement parts, components, subassemblies, etc.

6. System software and firmware updates required for reliability improvements and correction of any defects

7. Unlimited technical support (via phone and email) on software and hardware related issues ad trouble -shooting capabilities during the contractor's normal operating hours.

8. Service Records and Reports:

The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended, and parts/components replaced. In addition, the Contractor shall provide a written report to the FDA COR and Contract Specialist, summarizing all maintenance and repair activities (including warranty work) each time service and/or repair is performed.

Delivery/Period of Performance:

FOB Point Destination. Shipping, handling, in-side delivery, installation and on-site training shall be not later than 120 calendar days after receipt of contract award for the Cell Imaging Multi-Mode Reader. The period of performance for the option periods in any resultant award will be estimated based on the date of award, required delivery, installation, and offered warranty period of the systems. If/when Option Year 1 is exercised, the periods of performance for all options will be firmed via bilateral modification.

Place of Delivery/Performance:

U. S. FDA – NCTR

3900 NCTR Road Building 26 Jefferson, AR 72079

Responses to this source sought shall unequivocally demonstrate the respondent is regularly providing an Cell Imaging Multi-Mode Reader and Repair & Preventative Maintenance services.

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:

1. Business name and bio, DUNS number, 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.

2. 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 and performance requirements identified above.

3. Past Performance information shall include recent (within the last 3 years) and relevant (prior experience 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 Cell Imaging Multi-Mode Reader & Repair and Preventative Maintenance services. 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 DUNS number and size status) if not the respondent.

4. 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.

5. 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.

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

7. Standard commercial warranty and payment terms.

8. 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.

9. 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 March 17, 2022 by 2:00 PM (Central Time in Jefferson, Arkansas) to jennifer.johnson3@fda.hhs.gov, and reference: FDA-SSN-1252800.

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.