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), Division of Systems Biology (DSB), 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 Warren.Dutter@fda.hhs.gov.
Background:
National Center of Toxicological Research (NCTR), Division of Systems Biology (DSB), requires “Brand Name or Equal” Emulate Inc., Chip-S1 Stretchable Chip, catalog number 10231-2, to complete a mission critical project using an existing Emulate Inc., model: Zoe Culture Module, CM-1, Serial number is 049. NCTR/DSB is working in close collaboration with the Center for Drug Evaluation and Research (CDER) for a joint research project aimed at evaluating major commercial liver microphysiological systems (MPS) for drug safety assessment, particularly drug-induced liver injury (DILI). This NCTR/CDER joint project requires the evaluation of liver-on-a-chip in culturing liver cells from multiple species in addition to humans, and the investigation on many compounds of CDER interests. The liver-on-a-chips are required to perform cell culture for the purpose of completing the NCTR/CDER joint project aimed at evaluating the performance of MPS in maintaining primary liver cells from multiple species for the prediction of DILI, which has been the leading cause of unfavorable regulatory actions for new drug development during the past six decades. DSB has published one manuscript and six abstracts or posters based on this system, there is a need to continue to use this instrument and the required Emulate Inc., Chip-S1 Stretchable Chip, catalog number 10231-2 to complete the project. It is critically important to keep the scientific methods consistent in this project so that published data and data to be generated are comparable. Findings in this project are expected to help FDA better evaluate MPS-based data and possibly facilitate the development of an FDA guidance for industry regarding the use of liver MPS.
This requirement is configured as Brand Name or Equal:
- Emulate Inc., Chip-S1 Stretchable Chip, catalog number 10231-2
Minimum Technical Requirements:
- Shall be compatible with existing Human Emulations System: Emulate Inc., model: Zoe Culture Module, CM-1, Serial number is 049
- Shall be capable of maintaining primary liver cells from multiple species in the microphysiological system (MPS) for the purpose of studying drug induced liver injury and drug-drug interactions.
- Shall have a controlled flow rate of cell culture medium with pump frequency of 0 to 2 Hz.
- Shall have the capacity to maintain the growth of primary liver cells under a range of conditions such as 5% of CO2 and a flow rate of 0 µL/hour to 1000 µL of perfusing culture medium.
- Shall have two separate channels allowing the growth of hepatocytes in one channel and other liver cell types in another channel. The channel for hepatocyte shall have a width x height dimension of 1000 µM x 1000 µM, with a growth area of 28 mm2. The channel for non-hepatocyte liver cells shall have width x height dimension of 1000 µM x 200 µM, with a growth area of 24.5 mm2. The two channels shall be separated by a membrane of 50 µM thickness with pores of 7 µM diameter.
Place of Performance:
FOB Point Destination. All items shall include shipping, handling and inside delivery to the destination identified herein.
FDA/NCTR
Building 53A-207
3900 NCTR Road
Jefferson, AR 72079
Period of Performance:
Delivery 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 May 13, 2024 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-123667.
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.
