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 sources 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 Long-Evans (LE) rats, meeting the requirements below. If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 112990- All Other Animal Production; Small Business Size Standard is $2.75 million and believe that your firm would be able to provide the FDA with the supplies/services described below, please submit an email to
[email protected]. The vendor should include information about the company and demonstrate that it can meet all the minimum performance requirements. Background : The U.S Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR), is conducting a neurodevelopmental toxicity study funded by the Perinatal Health Center of Excellence and requires Long-Evans (LE) rats delivered on a specified schedule. The rats (both male and female) are required for breeding and will need to arrive in shipments every 3-5 weeks during 2023 and 2024. This will support protocol E3009.01, Assessing the developmental neurotoxicity of opioid medication-assisted treatment using a Long-Evans rat model: A comparison of buprenorphine and methadone. The rat is the most appropriate species as they display a broad spectrum of behavior, are capable of complex learning and memory tasks, and findings based on them are easily translatable to humans. The LE rat strain is a commonly used laboratory animal model and the NCTR laboratory has experience with this strain. This strain is a good multipurpose model that breeds well, is easy to handle, and is commonly used in safety and toxicity studies. LE rats are suitable for neurobehavior testing as they are pigmented and have superior visual acuity to albino rats, which makes them well-suited for spatial learning and memory tasks. Also, it has been shown that LE rats are sensitive to the effects of opioids, and this project will be using three different opioid drugs. Finally, optimization of behavior tests to be used with study E0300901 conducted under protocol #S00849 used the LE strain of rat. Minimum Requirements for the Long-Evans (LE) Rats: The Automated Dioxin-PCB Sample Purification System shall include and meet the following technical requirements: Male and female rats shall be Long-Evans strain (HsdBlu:LE). Within each shipment, males and females shall be non-littermates with birth date provided. Male rats shall be between 6-8 weeks of age with an exact date of birth for each animal. Female rats shall be between 8-10 weeks of age with an exact date of birth for each animal. Rats shall come from a housing room that has tested negative for the following pathogens for the last 18 months: Viruses: MHV, MVM(MMV), TMEV, EDIM, Sendai Virus, PVM, Norovirus, REO3, LCMV, Ectromelia virus, NS-1(generic Parvovirus), RPV, KRV, RTV (rat theilovirus). Bacteria: Helicobacter, Pneumocystis carinii, Mycoplasma pulmonis, C. kutcheri, P. multocida, Salmonella spp., CAR Bacillus, Tyzzer’s Disease, B. bronchiseptica, K. oxytoca, P. pneumotropica, Pseudomonas aeruginosa. Parasites: E. cuniculi, Helminths (Pinworms), Ectoparasites, Giardia. Each shipment shall have 40 males and 40 females. Seven shipments total. Shipment dates for the rats shall arrive on the Monday or Tuesday of the following weeks: 09/26/23, 11/7/23, 12/5/23, 1/2/24, 1/30/24, 2/27/24, 3/26/24 Shipment shall be by ground freight. Warranty and Reports: Warranty Service Requirements: The Vendor shall guarantee that each shipment contains animals in good health. Shipments that contain injured, moribund, or dead animals shall be replaced at no cost. Records and Reports: The Vendor shall supply health reports from the colony of origin for each shipment of rats to ensure that the rats meet the requirements of the NCTR colony exclusion list. The Vendor shall provide birth dates for all animals within each shipment. Period of Performance:09/06/2023-04/06/2024 The period of performance for this contract shall start with the date of first shipment, which is currently requested as 9/26/2023. There are 7 deliveries total, with the final delivery scheduled as 3/26/2024. Shipment dates for the rats shall arrive on the Monday or Tuesday of the following weeks: 09/26/23, 11/7/23, 12/5/23, 1/2/24, 1/30/24, 2/27/24, 3/26/24 Delivery Location: FDA-NCTR 3900 NCTR Rd. 53D-131 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 August 4, 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
[email protected]. Reference: FDA-SSN-119809. 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.