Inactive Total Small Business Set-Aside (FAR 19.5)

Amendment One: The reason for Amendment One is to add the trade in for the existing Azure C600 (Serial Number 60446). All language changes is in Red lettering. Updated QUOTES DUE: All quotes are due e... Amendment One: The reason for Amendment One is to add the trade in for the existing Azure C600 (Serial Number 60446). All language changes is in Red lettering. Updated QUOTES DUE: All quotes are due electronically to via email to Patricia.Natividad@fda.hhs.gov no later than August 14, 2024, 10:00 a.m. Eastern Standard Time. All other Terms and Conditions remain the same. *************************************************************************************** This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in FAR 12.6 and FAR 13 as supplemented and additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2024-05, effective 05/22/2024. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE SOLICITATION WILL NOT BE ISSUED.and Notice of intent to Sole Source. The solicitation number for this acquisition is 75F40124Q00416 and is being issued as a Request for Quote (RFQ). The NAICS Code for this solicitation is 334516 and the Small Business Size Standard is 1000 employees. This will be awarded as Firm-Fixed Price and completed as a Sole Source to Azure Biosystems. Prospective Offerors are responsible for downloading the solicitation and any amendments from SAM.GOV. The Government reserves the right to award an order without discussions if the Contracting Officer determines that the initial offer is providing the Best Value and discussions are not necessary. The U.S. Food and Drug Administration (FDA) requires a Azure 600 Imaging System. BACKGROUND AND OVERVIEW Imager systems with chemiluminescence for Western blotting are integral tools in the FDA's efforts to protect public health. These systems provide high sensitivity and specificity in detecting and quantifying proteins, essential for quality control, drug development, medical device evaluation, and safety assessments. By leveraging advanced imaging technology, the FDA ensures that biological products and medical devices are safe, effective, and reliable See Attachment for the Solicitation CDER-2024-122015 07292024, and Solicitation Amendment One CDER-2024-122015

Inactive Total Small Business Set-Aside (FAR 19.5)

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 RE... 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 source sought announcement on behalf of the Center for Drug Evaluation and Research (CDER) in order to determine if there are existing small business sources capable of providing a Procurement of Azure 600 Imaging System with Trade-in of old Azure 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 Patricia.Natividad@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/CDER/The Azure Imager system is a high-performance imaging system capable of NIR fluorescence, visible fluorescence, and chemiluminescence for Western blotting. It can also take images of protein gels and DNA gels. The imaging system supports the routine experiments of the FDA-mission relevant projects. This request would be to trade- in the current Azure system in Ju Lab with upgraded capabilities. Minimum Technical Requirements: Azure 600 Imaging System is manufactured by Azure Biosystems Inc. located in Dublin, California. The imaging system is designed to image, but not limited to, agarose gels, protein gels, chemi-based Western blots, fluorescent based Western blots, and fluorescent based gels. These imaging applications allow scientists to visualize, but not limited to, genetic materials and proteins. The Azure Imaging System is compatible with over 56 different stains, dyes, and probes across many manufacturers. Technical Specifications: 9.1-megapixel CCD Camera – Hardware Peltier Cooling, -50oC regulated cooling Motorized 0.95 fixed lens Greater than 4 logs of OD Dynamic Range (4.8) Two-channel UV wavelengths, 302nm and 365nm Blue Light excitation (470nm) for DNA safe dyes Chemiluminescent Detection White light excitation Coomassie blue or silver stained gels Design allows bands to be cut from gels Two-channel IR excitation and detection – Laser diodes at 685nm and 784nm enable lower background than LEDs or white light sources Three-channel visible fluorescent excitation source (LEDs) and detection - Cy2/Cy3/Cy5 or similar dyes – Excitation wavelengths 472nm, 524nm, and 628nm Able to use Laser diodes and LEDs to capture and merged images Control focus points and aperture of camera in Custom mode Have both options to bin and not to bin pixels during acquisition of image 7-position filter wheel Not to exceed footprint 41x56x33cm (W x H x D), due to limited available lab space Weights less than 50 pounds for ease of re-location of unit, if needed The new system must include the following: Ability to allow both internal and external users to access the application without downloading any software Ability to interface with the existing data warehouse application Ability to incorporate automated routing and notifications based on business rules The offeror shall provide training for proper operation of the instrument. 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. Minimum Performance Requirements for after 12 month manufacturer warranty is completed please provide 1 option period (12 months). The Contractor shall provide one (1) scheduled on-site planned preventive maintenance visit per year. The Contractor shall provide unlimited On-Site Corrective Maintenance/Repairs within 3 business days of call for service where problems cannot be resolved remotely after 2 business days. The Maintenance and Repair activities shall be performed following the Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM-certified replacement parts, components, subassemblies, etc. The Contractor shall include unlimited software and firmware updates during the coverage period(s). The Contractor shall include unlimited technical support Monday through Friday (excluding Federal Holidays) 8:00AM – 5:00PM Eastern Time. All maintenance/repair pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc. Vendor shall provide shipping and handling of the old and new instrument, and installation delivery to and from CDER’s facilities at: tbd FDA White Oak Campus Bldg 52/72 Rm 2244 10903 New Hampshire Ave Silver Spring, MD 20993 Items shall be delivered to the FDA laboratory in within 60 days after receipt of award. FDA TPOC tbd 10903 New Hampshire Ave. Bldg 52/72 Rm 2244 Silver Spring, MD 20993 Email: tbd@fda.hhs.gov Phone: tbd 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 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. 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 July 18, 2024 by 10:00 hours ET at the Food and Drug Administration, Office of Acquisition and Grant Services (OAGS), Attn: Patricia Natividad, email: Patricia.Natividad@fda.hhs.gov. Reference: 75F40124Q00416 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.