FDA-SSN-122826.pdf

Colocalized Nanoparticle Tracking Analysis (C-NTA) System or Equal Sources Sought Notice

FDA‐SSN-122826

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 Biologics Evaluation and Research (CBER), Office of Blood Research and Review (OBRR) in order to determine if there are existing small business sources capable of providing a Colocalized Nanoparticle Tracking Analysis (C-NTA) System or Equal. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort.

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

Background:

The Center for Biologics Evaluation and Research (CBER), Office of Blood Research and Review (OBRR), Division of Blood Components and Devices (DBCD) requires a Colocalized Nanoparticle Tracking Analysis (C-NTA) System to support the mission relevant projects in the laboratory of cellular hematology in DBCD/OBRR/CBER.

Nano particle and microparticle characterizations is of top priorities within the laboratory of cellular hematology (LCH). The 4-LASER C-NTA will be used to further characterize extracellular vesicles (EVs) in variety of blood components. This instrument allows us to quantitatively measure the EVs size, distribution, and other important physical properties. Since elevated levels of EVs in the blood are associated with various diseases, platelet activation or platelet damage, this method will help us to not only understand the mechanism of EV formations, but it will also help us improve and invent methods that are less damaging to the platelets and blood products.

This requirement is as Brand Name or Equal configuration:

- Particle Metrix, PMX-430-Z-QUATT-405/488/520/640nm System, part # 700212, 1 - Each

- Particle Metrix, Colocalization Feature for ZV QUATT, part # 700192, 1 - Each

Minimum Technical Requirements:

1. Instrument shall be capable of colocalization of at least two different fluorophores for advanced phenotyping of EV surface markers (simultaneous LASER irradiation)

2. Shall include four LASER sources and filters, pre-aligned and computer selectable shall be provided. No manual exchange of LASERS, which then would require a new sample and excessive time to exchange will be accepted. Please provide 405/488/520/640 combination with appropriate long pass filters for fluorescence measurements.

3. Shall be capable of zeta potential measurements on the same sample volume used to measure size, concentration, and fluorescence.

4. Instrument shall be able to collect data across multiple sub-volume positions within the sample chamber by use of automated camera-lens-laser positioning used for sizing, concentration, zeta potential and fluorescence measurements.

5. Sample cell walls shall consist of chemically inert fused silica, and support use of multiple sub-volume sampling across more than 500 microns of range, to provide for proper sampling efficiency.

6. Instrument shall use 10x objective lens, for 40x increased sampling volume, versus 20x lens.

7. Instrument software shall provide real-time particle counting of the live video output, whereby the # particles/frame is determined BEFORE measurement and analysis.

8. Instrument software shall provide a digital CMOS projection of light scattering particles within the real-time live video output, in addition to standard analog video CMOS presentation.

9. One second videos shall be statistically practical, allowing for F-NTA data collection before photo bleaching occurs for most fluorophores.

10. Linear concentration range shall be at least 6x106 – 3x108 particles per mL.

11. Shall include installation and training.

12. Shall include warranty and service: at least 1 year, parts and labor on unit.

Anticipated Delivery/Performance:

Shipping, handling in-side delivery, installation, and training shall be not later than 90 calendar days after receipt of contract award.

Place of Delivery/Performance:

U. S. FDA – Center for Biological Evaluation and Research WO Campus 10903 New Hampshire Ave.

Bldg. 52/72, Room 4250 Silver Spring, MD 20993

Responses to this source sought shall unequivocally demonstrate the respondent is regularly providing Colocalized Nanoparticle Tracking Analysis (C-NTA) System or Equal. 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, SAM 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.

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/performance requirements identified above, to include descriptive material, literature, brochures and other information.

3. Past Performance information within the last three years for the manufacture and/or sale in which the offeror has provided same or substantially similar instrument 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.

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.

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 is being requested.

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 April 4, 2024, by 12:00 PM (Central Time in Jefferson, Arkansas) to jennifer.johnson3@fda.hhs.gov, and reference: FDA‐SSN‐122826.

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.