FDA-SSN-1255771.pdf

Digital Holographic Microscope Sources Sought Notice

FDA-SSN-1255771

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 Devices and Radiological Health (CDRH) in order to determine if there are existing small business sources capable of providing a Digital Holograph microscope (Refurbished Equipment Only).

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

Background:

The FDA/ CDRH, Division of Biomedical Physics (DBP) , Office of Science and Engineering Laboratories requires a state-of-the-art digital holographic microscope (DHM) for high-resolution 3D measurements of microscale features of phantoms and other specimens studied in our labs. The DHM will make use of a video (CCD) camera to record a hologram produced by the interference between a reference wave and a wave emanating from the specimen. The captured image is transmitted to a computer where numerical procedures are applied to reconstruct a 3D image of the specimen. It is capable of retrieving extremely high-resolution optical topography information from a single image grab, without any scanning.

This requirement is as Brand Name or Equal configuration:

1. Lyncée Tec., DHM-T1002 model single wavelength transmission configuration , part # M-011-T- X-005 1 - Each

2. Lyncée Tec., DHM-T, 13x13x15mm XYZ manual sample stage , part # M-150-T-X-001. 1 - Each

3. Lyncée Tec., Objective lens 20x dry Glass 0-2 , part # M-253-T-O-003. 1 - Each

4. Lyncée Tec., Objective lens 40x dry Glass 0-2 , part # M-253-T-O-005. 1 - Each

5. Lyncée Tec., DHM-T camera 190 fps, part # M-201-T-X-102, 1 - Each

6. Lyncée Tec., PC Computer (without keyboard), part # M-401-B-X-001, 1 - Each

7. Lyncée Tec., Koala Software standard, part # M-420-B-X-001, 1 - Each

8. Lyncée Tec., PC Keyboard US / EU, part #M-410-B-X-002, 1 - Each

9. Lyncée Tec., Power cord US, part # M-411-B-X-004, 1 - Each

Minimum Technical Requirements:

1. Microscope configuration: Transmission

2. Number of holography lasers included: 1

3. Possible to add holography lasers: YES

4. Number of holography microscope objectives included: 2

5. Possible to add holography microscope objective: YES

6. Sample translation stage type: 3-axis XYZ

7. Sample translation stage range: 13 mm in each axis, or greater

8. Camera frame rate: 190 frames/second or higher

9. Camera size: 1024x1024 pixels or larger

10. Computer workstation included, with acquisition and analysis software pre-installed

11. Warranty period: 1 year or longer.

12. Installation and training.

13. Refurbished Equipment Only.

The instrument 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 – CDRH

10903 New Hampshire Ave.

Science and Engineering Laboratories Building 62, Room 1102 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 within the last three years for the manufacture and/or sale in which the offeror has provided same or substantially similar system solutions and used for same or near-same applications 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 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 July 14, 2022, by 12:00 PM (Central Time in Jefferson, Arkansas) to jennifer.johnson3@fda.hhs.gov, and reference: FDA-SSN-1255771.

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.