SSN.pdf

THIS IS A SOURCES SOUGHT ANNOUNCEMENT, A MARKET SURVEY FOR

WRITTEN INFORMATION ONLY. THIS IS NOT A SOLICITATION

ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED

FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR ANY

COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO THIS

ANNOUNCEMENT OR ANY FOLLOW-UP INFORMATION REQUESTS. NO

TELEPHONE CALLS WILL BE ACCEPTED REQUESTING AN RFQ PACKAGE OR

SOLICITATION. THERE IS NO RFQ PACKAGE OR SOLICITATION. IN ORDER TO

PROTECT THE PROCUREMENT INTEGRITY OF ANY FUTURE PROCUREMENT,

IF ANY, THAT MAY ARISE FROM THIS ANNOUNCEMENT, INFORMATION

REGARDING THE TECHNICAL POINT OF CONTACT WILL NOT BE GIVEN AND

NO APPOINTMENTS FOR PRESENTATIONS WILL BE MADE.

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) issues this Sources Sought announcement on behalf of the National Center for Toxicological Research (NCTR) in order to determine if there are existing small business sources capable providing a Zeiss Axiovert 5 smart inverted microscope, or equal, for transmitted light and reflected light fluorescence and accessories for the examination and analysis of cell and tissue cultures to monitor cell growth, proliferation, and viability. Freight, shipment, installation, and familiarization training will be included in this acquisition. Other than small business concerns, especially vendors who may be able to offer domestic products, are also encouraged to submit a capability statement that provides company information, as well as information demonstrating that it can meet all of the minimum requirements included below, to include the country of manufacture of products offered.

If your firm is considered a small business source under North American Industry Classification System (NAICS) 334516 – Analytical Laboratory Instrument Manufacturing; with a Small Business Size Standard of 1000 employees, and you believe that your firm would be able to provide the FDA with the equipment described herein, please submit an email with the aforementioned information to suzanne.martella@fda.hhs.gov.

The inverted microscope will be used in studies to assess in vitro models and samples exposed to test articles of interest to the FDA with the final goal to provide data to support NCTR approved Protocols. The acquisition of this instrument will enable NCTR to deliver critical data to the Product Centers in support of FDA’s regulatory mission to protect public health.

Minimum Requirements for the microscope:

1) High-performance cooled camera with a minimum resolution of 5-megapixel, pixel size of 3.45 µm x 3.45 µm or smaller, at least 60 frames per second at full 5-megapixel resolution, a dynamic range of 1:25,000 in high-dynamic range mode, and an exposure range from 0.1 milliseconds to 60 seconds.

2) The size of the inverted microscope (H×W×D) cannot exceed 505 mm x 244 mm x 505 mm, due to the limited laboratory space. Other sizes will be reviewed for a possible fit.

mailto:suzanne.martella@fda.hhs.gov

3) Universal mounting frame adjustable for multitest dishes and Petri dishes.

4) Mechanical stage for reflected light specimens.

5) Digital fluorescence channel change between 4 -7 excitation/emission channels combined with 6 position filterwheel.

6) Encoded components enable the smart microscopy to communicate camera settings and control, light (both brightfield and fluorescence intensity and sequence) control, and calibrated image scaling info automatically with the software.

7) Condenser with at least 5-position modulator for phase contrast, differential interference contrast, and improved Hoffman-Modulation contrast.

8) 5x, 10x, 20x, and 40x objectives designed for the use of polystyrene cover glasses with 1.0 mm thickness and are optimized for fluorescence imaging at the same time.

9) Red, green, blue, and ultraviolet (RGB-UV) 4-channel fluorescence light source quickly switchable, equipped with four solid state LED lamps: Red (630 nm), Green (555 nm), Blue (475 nm), and UV (385 nm).

10) Reflected light illuminator with a shift-free filter set for green fluorescent protein (GFP), Cyanine3 (CY3), and 4', 6-diamidino-2-phenylindole (DAPI).

11) Zen Lite Software to capture, process, visualize, and analyze images and saves experimental templates to reproduce the imaging condition repeatedly; software listed as approved in FDA Product Catalog.

12) 1-year hardware warranty and software updates.

13) Camera adaptor to connect microscope with digital camera for optimal image capture.

14) Integrated PC for a stand-alone configuration with USB connection.

Installation, Training and Additional System Requirements

1) The components and equipment shall be newly manufactured, not used or refurbished, or previously used for demonstration.

2) Offered systems shall be a turn-key solution i.e., the contractor shall be responsible for providing all hardware, components, instruments, computers, software, and that otherwise required to meet these specifications and the FDA’s stated need.

3) The systems shall be delivered with all necessary supplies and accessories required for installation and start-up.

4) The system and associated accessories shall include operations and maintenance manuals covering proper operation, routine maintenance, and troubleshooting for the system and controlling software. All manuals and documentation shall be provided in hard copy and/or electronic format.

5) The Contractor shall provide all labor, travel, and tools to install the equipment at the address provided below, to include shipping. The contractor shall demonstrate upon installation that the item meets or exceeds all performance specifications. Upon acceptance of the system, the contractor shall provide on-site operator training/familiarization for at least two (2) attendees.

Such familiarization shall include system operations, calibration, optimization, troubleshooting and basic operational maintenance procedures.

6) Systems shall be warranted for not less than one (1) year from FDA acceptance of the system(s) to include on-site training. Warranty service shall include troubleshooting capabilities based on complete knowledge of the entire system, immediate access to replacement parts, and immediate access to system improvements and updates. Phone and email technical support shall be included for a minimum of one (1) year.

Deliverables: Service Records and Reports: The Contractor shall, commensurate with the completion of each possible warranty visit, 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, a detailed description of the work performed, the test instruments or other equipment used to perform the service, the name(s) and contact information of the technician who performed the 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/TPOC and Contract Specialist, summarizing all maintenance activities (including warranty work) each time service is performed.

Delivery: Expected delivery, installation and training on the equipment is within 120 days of contract award.

Place of Delivery/Service Address

The equipment shall be delivered to the National Center for Toxicological Research (NCTR) and post warranty maintenance service shall be performed at the following address:

US FDA/NCTR

3900 NCTR Rd.

Jefferson AR 72079

Responses to this Sources Sought shall unequivocally demonstrate that the respondent is regularly engaged in the sale of same or substantially similar product/service. Though the target audience is small business vendors or small businesses capable of supplying a U.S. product/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) 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.

• Past Performance (within the last 3 years) information for the sale of same or substantially similar product/service to include date of sale, description, 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 the manufacturer (to include Unique Entity ID (SAM) number and size status) if not the respondent.

• Descriptive literature, brochures, marketing material, etc. detailing the nature of the service the responding firm is regularly engaged in manufacturing or selling.

• The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services meet the technical requirements identified above.

• The offeror’s estimated historical on-site response time for the brand name and model of product in this requirement.

• 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 whether 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 equipment/service would be helpful for market research purposes.

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

Interested Contractors must respond with capability statements which are to be submitted by email only to the point of contact listed below on or before 10:00 am (Central Time in Jefferson AR) on May 14, 2024 to Suzanne Martella, email suzanne.martella@fda.hhs.gov. Reference:

75F40124SSN123070.

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 mailto:suzanne.martella@fda.hhs.gov 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 or combined synopsis/ solicitation may be published in SAM.gov – Contracting Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality and Proprietary Information

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