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) is issuing this source 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 the items described herein. Other than small business concerns, especially vendors who may be able to offer domestic products, are also encouraged to submit a capability statement that provides company information, as well as information demonstrating that it can meet all of the minimum requirements included below, to include the country of manufacture of products offered. 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 1,000 employees and you believe that your firm would be able to provide the FDA with the supplies/services described below, please submit an email to
[email protected]. Background: Center for Biologics Evaluation and Research (CBER), requires “Brand Name or Equal” Repligen KR2I BASE SYSTEM Tangential Flow Filtration (TFF) unit with scale. CBER is working in close collaboration with the Center for Drug Evaluation and Research (CDER) and the Cellular and Tissue Therapies Branch (CTTB) to procure a compatible Base TFF system that will complement the existing KR1 pumps. This requirement is configured as Brand Name or Equal: Repligen KR2I Base System Tangential Flow Filtration (TFF) unit with scale. Minimum Technical Requirements: Shall be compatible with the two existing Repligen KRJR 300 rpm pumps that have a RS232 serial connection. Shall have a capacity as low as 25 mL and as high as 15 L. Shall allow for interchangeable filters that enable different cell-types and allow for media preparations that's used without cross-contamination. The settings shall be automated and programmable with a integrated LCD touchscreen monitor. The system shall have large scale capabilities 100+ L with the possibility for a larger scale in future. Installation, Warranty and Additional System Requirements: 1. System shall be warranted for not less than one (1) year from FDA acceptance. Warranty service shall include troubleshooting capabilities based on complete knowledge of the entire system, immediate access to replacement parts, and immediate access to system improvements and updates. Phone and email technical support shall be included for a minimum of one (1) year. 2. The components and equipment shall be a newly manufactured, not used or refurbished, or previously used for demonstration. 3. The system shall be delivered with all necessary supplies and accessories required for installation and start-up. 4. The system and associated accessories shall include operations and maintenance manuals covering proper operation, routine maintenance, and troubleshooting for the system and controlling software. All manuals and documentation shall be provided in hard copy and/or electronic format. 5. The contractor shall provide guidance on pre-installation site requirements. 6. The contractor shall provide installation and setup. Delivery Terms: FOB Point Destination. All items shall include shipping, handling and inside delivery to the destination identified herein. FDA/CBER 10903 New Hampshire Ave WO 52/72, Room 3240 Silver Spring, MD 20993 Delivery Location: Delivery and shall occur within 30 calendar days from date of award. Responses to this Sources Sought shall unequivocally demonstrate that the respondent is regularly engaged in the sale of same or substantially similar product/service. 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. 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. 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 whether 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 August 20, 2024 by 11:59 PM Central Time at the Food and Drug Administration, Field Operations Branch, FDA | OO | OFBA | OAGS | DAP, Attn: Carole Edwards, email
[email protected]. Reference: FDA-SSN-124580. 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 and Proprietary Information: 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.