Inactive

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) is issuing this source sought announcement on behalf of the National Center for Toxicological Research (NCTR) in order to determine if there are existing small business sources and other than small business sources capable of providing an “Brand Name or Equal” Pacific BioSciences of California (PacBio) Revio Reagent Kit, Part Number: 102-817-900. If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 325414- Biological Product (except Diagnostic) Manufacturing; Small Business Size Standard is 1250 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 NCTR, Division of Genetic and Molecular Toxicology (DGMT) has a requirement for a an “Brand Name or Equal” PacBio Revio Reagent Kit, Part Number: 102-817-900. DGMT will use the required reagents with an existing PacBio Revio instrument to help identify by direct DNA sequencing ultralow-frequency (somatic) mutations induced by chemical (C22034) therapies across entire genomes. These reads derived from the Revio in conjunction with the required reagents will have the accuracy and length necessary to detect such mutations. This requirement is configured as Brand Name or Equal: Pacific BioSciences of California (PacBio) Revio Reagent Kit, Part Number: 102-817-900, meeting the below salient characteristics. Salient Characteristics: Sequencing kits and reagents shall be compatible with existing PacBio Revio, Serial Number: 84183 The Revio polymerase kit shall be equivalent to the PacBio Revio product item # 102-817-600. The 24 binding reactions kit provides reagents for binding polymerase to SMRTbell libraries for sequencing on the Revio system. The Revio sequencing plate shall be equivalent to the PacBio Revio product item # 102-587-400. The plate shall contain reagents for sequencing 4 Revio SMRT Cells. The Revio SMR Cell tray shall fit inside the Revio instrument which shall be equivalent to the PacBio Revio product item # 102-202-200. Revio SMR Cell tray shall contain 4 SMRT cells. Each cell shall be a nanofabricated consumable patterned with 25 million zero-mode waveguides (ZMWs). One SMRT cell shall be utilized in each sequencing reaction, and experiments shall be able to be run on a single cell or in batch mode. Warranty: Reagents shall be warranted for not less than 6 months from FDA acceptance. Period of Performance: Delivery shall occur within 90 calendar days from date of award. Shall use appropriate shipping methods to ensure viable reagents upon delivery. Delivery Location: FDA-NCTR Building 14, Rm: 1019 3900 NCTR Road Jefferson, AR 72079 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 December 13, 2023 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-120779. 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.