MARKET RESEARCH PURPOSES ONLY
NOT A REQUEST FOR PROPOSAL OR SOLICITATION
The U.S. Food and Drug Administration (FDA), is conducting market research to support the Center for Biologics Evaluation and Research (CBER) / Division of Cell and Gene Therapy (DCGT), to require a brand name or equal to Sony MA900 Multi-Parameter cell sorter to support future DCGT projects and collaborations within FDA.
The FDA is seeking small business sources to determine the availability and capability of small business manufacturers or small businesses capable of supplying, a U.S. made product of a small business manufacturer or producer for the items described herein. 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 associated North American Industry Classification System (NAICS) Code is 334516- Analytical Laboratory Instrument Manufacturing; 1,000 employee Small Business Size standard.
The FDA/CBER/DCGT requires require a brand name or equal to Sony MA900 Multi-Parameter cell sorter to support future DCGT projects and collaborations within FDA. The instrument is needed to identity and characterization of gene and cell therapy products to perform critical path research for its mission to develop and promote technology to regulate cellular and genetic therapeutics. Genetically modified Hematopoietic Stem Cells (HSCs) and T-cell are at the forefront of advanced and complex cellular therapeutics. Immunophenotypic characterization of cellular therapeutics based on surface marker expression is crucial to ensure their quality, purity, efficacy, potency, and safety.
Salient physical, functional, or performance characteristics that "equal" products must meet are specified in the solicitation: Shall include the following:
1. Up to 4 excitation lasers- 488 nm, 405 nm, 561 nm, and 638 nm- on a two beam spots
2. High purity 4-way sorting of a up to 12-color immunophenotyping panel
3. High level of automation- startup, aseptic cleaning, QC, and sort set up are software guided to ensure optimal daily alignment
4. Microfluidic chip-based design and comprehensive fluidic controls avoid clogging of the system during cell sorting
5. Smaller footprint: Benchtop
6. A self-contained cell sorting unit
7. Fluidics cart
8. Cell sorting tube holders and plate holder molds
9. LCD panel
10. Air compressor unit
11. Computer Workstation and software

FOB Point Destination. All items shall include shipping, handling and in-side delivery to the destination identified herein. Delivery/installation completed within 90 days after receipt of order. FOB Point of Delivery for Services and Supplies will be the FDA CBER facility located at 10703 New Hampshire Avenue, Silver Spring, MD 20993.

The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services and components meet the technical requirements identified above. Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product of a small business manufacturer or producer all interested parties may respond. At a minimum, responses shall include the following:
• Business name, 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 if responding to provide a product manufactured by another firm);
• Sufficient descriptive literature that unequivocally demonstrates that offered products and services can meet the above requirements. All descriptive material necessary for the government to determine whether the service/product offered meets the technical requirements including: technical specifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement.
• Three (3) years of past performance information for the manufacture, and/or sale and support in which the offeror has provided same or substantially similar products and used for same or near-same applications as set forth herein. For each past performance reference include the date of sale, description, dollar value, client name, client address, client point of 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.
• If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. Detailed list of items included and not included on the GSA contract to meet this requirement.
• Provide information if any of these specifications are too restrictive. No response will be considered that the listed specifications are adequate in a competitive environment.
• If a large business, identify the subcontracting opportunities that would exist for small business concerns;
• Standard commercial warranty and payment terms; and
• Though this is not a request for quote, informational pricing is encouraged.
The government is not responsible for locating or securing any information, not identified in the response.

The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation.
Interested Parties shall respond with capability statements on or before June 10, 2019 by 12:00 hours (Central Time in Jefferson, Arkansas). Reference FDA_SSN_1214274.

Notice of Intent
Responses to this source sought announcement will assist the Government in determining whether or not 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 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).

 

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