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) is issuing this source sought announcement on behalf of the Center for Biological Evaluation and Research (CBER) in order to determine if there are existing small business sources and other than small business sources capable of providing light source and apotome for a Zeiss Axio Observer 7 microscope, meeting the requirements below.

If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 334516 - Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 1000 employees and believe that your firm would be able to provide the FDA with the supplies/services described below, please submit an email to Warren.Dutter@fda.hhs.gov. The vendor should include information about the company and demonstrate that it can meet all the minimum performance requirements.

Background: The Food and Drug Administration (FDA) Center for Biological Evaluation and Research (CBER) requires a new light source and apotome for a Zeiss Axio Observer 7 microscope. At CBER, A significant focus of research centers on the effects of blood products and microbial pathogens on the vascular endothelium in various organ systems (e.g., heart, kidney, brain, lung, and liver) and in cell culture systems. Making detailed observations by brightfield and fluorescence microscopy of animal tissue specimens and cells is vital to ascertain the safety and efficacy of these biological treatments. These imaging capabilities will also be used to visualize better and analyze the effects of pathogen reduction technologies on the membrane surface of red blood cells. To have the latest technology and image capture technologies, the FDA needs to purchase a new light source plus an apotome for it’s current Axio Observer 7 microscope system. This procurement will allow us to take improved images for semiquantitative analysis and publication and make more accurate observations about the effects of blood products and microbial pathogens. An apotome is a piece of equipment that allows for the acquisition of confocal microscopy-like images without requiring a whole confocal microscope setup.

In broader terms, this new light source plus apotome will be used to evaluate the effect of biologics on various animal tissues and cell culture systems, as well as red blood cell integrity changes following pathogen reduction treatment. It will be used to characterize the safety of biologics and evaluate the pathogenic mechanisms of bioterrorism threats. This system will support multiple projects within the Biochemistry and Vascular Biology Laboratory.

Minimum Technical Requirements:

1. All components shall be compatible with existing Zeiss Axio Observer 7 microscope, Serial Number: 3851002267
2. The light source shall include:
   1. Seven illumination channels to cover all essential dyes, fluorescent proteins, and probes.
   2. On-chip temperature sensing.
   3. Closed-loop temperature control.
   4. Long-term power stabilization.
   5. Control via the TFT display of the Axio Observer 7.

1. Apotome shall include:
   1. Automatic grid selection for optimum contrast with each objective.
   2. Individual configuration of each fluorescence channel as an optical section or widefield image.
   3. Low phototoxicity when used with LED illumination and a Zeiss Axiocam.
   4. Up to three images per second for time-lapse images.
   5. 3D imaging capability including multi-channel, Z stack and Time Lapse, Deconvolution, images in raw data mode, and 3D Rendering.
   6. Automatic acquisition of large sections using Tiles and Positions.

1. Shall include associated accessories:

1. Anti-vibration platform.
2. Eyepiece with binocular tubes.
3. Filter Sets 96, 38, 50, 43, 64, and 112.
4. 63x Plan Apo Objective lens with Ring.
5. 20x Objective lens with Ring.
6. 10x Objective lens with Ring.
7. Folding eyecup.
8. Double Filter Wheel.
9. CAN Connector.
10. AI Sample Finder.
11. Plan-Neofluar 5x lens with Ring.

Installation and Warranty:

• Contractor shall provide installation.

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

• Systems shall be warranted for not less than one (1) year from FDA acceptance of the system(s).

Period of Performance:

Delivery and Installation shall occur within 30 calendar days from date of award.

Delivery Location:

FDA White Oak Campus

10903 New Hampshire Ave.

Building 52/72, Room 4148

Silver Spring, MD 20993

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 identification (UEI) 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 information for the manufacturer and/or sale of same or substantially similar product and service or similar brand instruments 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 UEI number and size status) if not the respondent.

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

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

• The offeror shall advise if the product and/or service is on a Best in Class contract.

• If applicable, the offeror shall clearly identify where the offered product is made.

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

• 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.

• Informational pricing is desired.

• 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 due by email to the point of contact listed below on or before April 26, 2023 by 1:00 PM Central Time at the Food and Drug Administration, Field Operations Branch, FDA|OO|OFBA|OAGS|DAP, Attn: Warren Dutter, email warren.dutter@fda.hhs.gov. Reference: FDA-SSN-118041.

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

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