75F401-22-SSN-113831 (SSN for Confocal Microscope).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 Center for Biologics Evaluation and Research (CBER)’s Laboratory of Bacterial Polysaccharides in order to determine if there are existing small business sources capable of providing a confocal microscope system that meets their needs.

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 1,000 employees, and you believe that your firm would be able to provide the FDA with the system described below, please submit an email to suzanne.martella@fda.hhs.gov. Other than small business concerns are also encouraged to submit capability statements. The vendor shall include information about the company and demonstrate that it can meet all of the minimum performance requirements.

Introduction: Infants and neonates demonstrate high susceptibility to infection, leading to 40% of the annual death of approximately 7 million children under the age of 5 years worldwide.

Neonates are unable to reach the adult-level humoral immune response partly due to the potent immunoregulatory mechanisms. Elucidation of the unique properties of neonatal immune system is essential to develop effective vaccination strategies for early ages.

Confocal microscopy is a powerful technique to gain a better understanding of how the immune system works. A setup of conventional confocal microscopy is not easy because the systems are big and need to be located in a darkroom to avoid ambient light. Supporting the laboratory’s ongoing efforts to improve pediatric vaccines by studying the immune responses of neonates to vaccines is crucial for the mission of Office of Vaccine Research and Review (OVRR). The laboratory requires a compact confocal microscope which does not require a darkroom, but still has the ability to capture high quality images at a rapid speed.

Background: To support the lab’s neonatal immunity project, a confocal microscope system with no requirement for a darkroom is needed. There is a critical requirement in that the lab has available space mailto:suzanne.martella@fda.hhs.gov of 65 cm X 60 cm X 70 cm (DxWxH) and any instrument purchased must be able to fit in that space.

The laboratory has identified an instrument that meets its requirements: the BC43 Benchtop Confocal Microscope, or equal instrument.

Instrument Salient Characteristics/General Requirements that “or equal” instruments must include.

The instrument:

1. Exterior dimensions shall not exceed 65 cm X 60 cm X 70 cm (DxWxH) to be able to fit the existing bench space in the lab.

2. Shall not require a darkroom.

3. Shall be equipped with wide range of laser lines to accommodate commercially available and commonly used fluorophores such as DAPI, FITC, Rhodamine, TRITC, Texas Red, and Alexa Flour 647.

4. Shall be equipped with at least three (3) objective lenses of different magnifications ranging from low, medium to high (higher than 50x) in order to analyze samples of different sizes (single cell level to tissue level).

5. Shall be equipped with a spinning disk system and CMOS camera to allow imaging of rapid dynamic changes such as cytoskeletal reorganization and calcium influx in addition to capturing high quality fluorescent images while minimizing phototoxicity and photobleaching.

6. Shall be equipped with a cell tracking software and an automatic precision stage to track cells moving over time in three-dimensional space (3D).

7. Shall be equipped with special software to conduct tiling scan and stitching to obtain high resolution images of large samples.

8. Shall be equipped with built-in incubator to maintain cells healthy while keeping cells in focus and continuously imaging over several days.

9. Shall be equipped with computer-controlled sample stage.

10. Operating system shall be equipped with joystick for xyz stage control.

11. The mechanical stage system should be precise enough to hold a specimen in place and allow for repositioning in the process of observing different portions of a specimen during time-lapse imaging of the sample.

12. Shall allow the recording and transferring of operating data.

13. Shall have internal interface for connecting software.

14. Shall include a minimum 12-month warranty.

Installation, Training and Additional System Requirements:

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

2. System shall be warranted for not less than one (1) year from FDA acceptance, 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.

3. The system 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, analysis of samples, optimization, trouble-shooting and basic operational maintenance procedures.

Deliverables: Service Records and Reports: The Contractor shall, commensurate with the completion of each preventive maintenance service 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 and Contract Specialist, summarizing all maintenance activities (including warranty work) each time service is performed.

Delivery Period:

The equipment shall be delivered within manufacturer’s standard lead times which is approximately no later than 90 calendar days of contract award in order to conduct our experiments without delay.

Place of Delivery

US FDA/CBER

10903 New Hampshire Ave.

WO Bldg 52/72, Room G346 Silver Spring MD 20993

Responses to this Sources Sought shall unequivocally demonstrate that the respondent is regularly engaged in the sale of same or substantially similar 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.

• 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 11:00 am (Central Time in Jefferson AR) on

July 17, 2022 to Suzanne Martella at email suzanne.martella@fda.hhs.gov. Reference: 75F401-22-

SSN-113831.

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 – 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.

mailto:suzanne.martella@fda.hhs.gov