FDA_21-223-SOL-1244515_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) has issued this sources sought announcement on behalf of the Center for Biologics Evaluation and Research (CBER) in order to determine if there are existing small business sources capable of providing a Single Cell Sorter system.

If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 334516 – Analytical Laboratory Instrument Manufacturing; with a Small Business Size Standard of 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 Yolanda.rankin@fda.hhs.gov. The vendor should include information about the company and demonstrate that it can meet all of the minimum performance requirements.

Background: The FDA/CBER has a need for a single cell sorter system. The laboratory will utilize the sorter to perform ongoing studies and experiments in the laboratory. The system will be utilized to perform high-throughput isolation of single cells within a sterile environment via fluorescent intensity for cloning populations and various downstream applications. The system will be used for multiple projects in the lab.

Minimum Technical Requirements for a Single Cell Sorter System:

• Shall be able to prevent cross contamination by the use of disposable microfluidic sorting cartridges.

• Shall include fluorescence and light scatter based sorting and dispensing: 488 nm excitation and 4 detection channels: 533 nm (FITC/GFP), 585 nm (PE/PI), Forward Scatter (FSC) and Side Scatter (SSC).

• Shall be able to sort parasitized erythrocytes and bacteria.

• Shall be able to perform single cell dispensing into a 96-well or 384-well plate.

• Shall have low sorting pressure (< 2 psi) to prevent cell death.

• Shall be able to process at least 1 x 109 cells in less than 10 minutes to prevent cell death.

• Shall work with a wide range of sample input: from 100 cells to 150 million cells.

• Shall have a small footprint of less than 20x20x20 so that it fits inside a BSC-I cell culture hood for sterile sorting.

• An external personal computer (PC) shall be provided that is compatible with software necessary for control of the instrument.

Installation, Training and Warranty Requirements

• The system and its associated accessories shall include onsite installation, qualification operations and maintenance manuals covering proper operation, routine maintenance, and trouble shooting for the instrument and controlling software. All manuals and documentation on the instrument shall be provided in hard copy and/or electronic format.

• The offeror shall warrant the entire system for a period of at least one (1) year from acceptance by FDA. The warranty shall include: unlimited telephone/e-mail support for questions regarding operation, onsite visits for diagnosis of problems and repairs inclusive of all parts, labor, and travel expenses at no additional cost to the FDA.

Estimated Delivery Date: 120 days after award

Delivery Location:

Food and Drug Administration Center for Biologics Evaluation and Research 10903 New Hampshire Avenue Building 52/72, Room 5324 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, DUNS 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 DUNS 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.

• 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 a large business, provide if subcontracting opportunities exist for small business concerns.

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

• Informational pricing is desired.

Interested Contractors must respond with capability statements which are due by email to the point of contact listed below on or before July 5, 2021 by 13:00 hours (Central Time in Dallas, Texas) at email: yolanda.rankin@fda.hhs.gov. Reference: FDA_21-223-SOL-1244515.

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 FedBizOpps. 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.