SOURCES SOUGHT
66 -- Flow Cytometer
- Notice Date
- 5/9/2022 11:40:58 AM
- Notice Type
- Sources Sought
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- FDA OFFICE OF ACQ GRANT SVCS Beltsville MD 20705 USA
- ZIP Code
- 20705
- Solicitation Number
- FDA-SSN-112798
- Response Due
- 5/13/2022 11:00:00 AM
- Point of Contact
- Warren Dutter, Phone: 8705437577
- E-Mail Address
-
warren.dutter@fda.hhs.gov
(warren.dutter@fda.hhs.gov)
- Description
- 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 Flow Cytometer system meeting the requirements below. If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 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 Warren.Dutter@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 Office of Blood Research and Review requires a flow cytometer to support the Pathogen Reduction Research Program. The flow cytometer will be used to assess cellular markers (such as P-selectin as a marker of platelet activation, JC-1 staining as a measure of mitochondrial biology, Annexin V staining as a marker of phosphatidylserine externalization, among many others) to assess the response of cellular components (RBCs and platelets) in response to chemical and devices used to inactivate pathogens in blood components. Additional small particle detection capability will allow assessment of this emerging area of blood component biology as a marker of component viability, quality, biologic activity, and safety. Minimum Technical Requirements: Shall have 3 lasers, 405 nm (violet), 488 nm (blue), 640 nM (red). Lasers shall be upgradeable if 561 nm (yellow) laser is not included. Shall have 8 or more colors. Footprint shall be less than 40�x40� to meet existing lab space. Shall have capabilities to resolve sub-micron particles. Shall have spectral analysis capabilities. Shall include delivery, installation, and training. Offered systems shall be a turn-key solution i.e. the contractor shall be responsible for providing all hardware, components, instruments, computers, software, and that otherwise required to meet these specifications and the FDA�s stated need. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up. Systems shall be warranted for not less than one (1) year from FDA acceptance of the system(s).� Period of Performance: Delivery, Installation and Training shall occur within 60 calendar days from date of award. Delivery Location: FDA/CBER 10903 New Hampshire Ave. 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, unique entity identification (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. 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 UEI 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. The offeror shall advise if the product and/or service is on a Best in Class contract. If applicable, the offeror shall clearly identify where the offered product is made. 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. 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. Informational pricing is desired. 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 due �by email to the point of contact listed below on or before May 13, 2022 by 1:00 PM Central Time at the Food and Drug Administration, Field Operations Branch, FDA|OO|OFBA|OAGS|DAP, Attn: Warren Dutter, email warren.dutter@fda.hhs.gov. Reference: FDA-SSN-112798. 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. Though this is not a request for quote, informational pricing for the service would be helpful.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/74b44acf1aec468fb81bca0c9479a679/view)
- Place of Performance
- Address: Silver Spring, MD 20993, USA
- Zip Code: 20993
- Country: USA
- Zip Code: 20993
- Record
- SN06321742-F 20220511/220509230059 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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