75F40123R00016_NCTR-2023-115873_SSN.pdf

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 sources sought announcement on behalf of the National Center for Toxicological Research (NCTR) in order to determine if there are existing small business sources capable of providing an Intestinal Modeling System with 4 (1-year Post-Warranty Maintenance option periods).

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 Yolanda.rankin@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/NCTR Division of Microbiology requires an Intestinal Modeling System in order to understand how the microbiome interacts with pharmaceutical agents and contributes to changes in antibiotic resistance as well as host disease. The system will serve as a mechanism to test drugs for how they work in the microbiome, the toxic byproducts they may produce, and how the metabolites of the microbiome change over time.

Minimum Technical Requirements for an Intestinal Modeling System:

• Shall include a flexible system that allows for evaluating the entire gastrointestinal tract (stomach through distal colon) as well as sub-compartments.

• Shall provide an accurate representation of the gut microbiota that is representative of the donor as well as provide complementary representation of the mucosal microbiome.

• Shall be able to show accurate reproduction of the absorption of the small intestine using an online/offline dialysis or cell assay.

• Shall be able to have a long-term, repeatable administration to show the daily intake of test products over a period of time ranging from acute studies to long-term studies.

• Shall be able to be applied to multiple animal models, including swine and rodents.

• Shall have protocols for its use and operation that come with the equipment.

• Shall be flexible enough to represent two (2) GI tracts or one (1) whole GI tract.

• Shall be able to show at least two (2) whole systems to compare different treatments in parallel, up to three (3) simulations available.

• Shall be able to focus on different parts of the organ system, such as the ascending, transverse, and descending colon and evaluate how those compartments interact with other microbiomes simulated from other organs.

• Shall have the ability to take large samples (up to 50 mL) repeatedly for downstream analyses without having to re-start the system.

• Shall be automated, consisting of a computer-controlled operation unit and a tailor-made software for optimal process control and it shall measure models like pH, temperature, and transition time (controlled by the computer).

• Shall include scientific literature verifying the usefulness and applicability of the model, including how gradual changes in the metabolic activity of the microbiome are observed upon the repeated administration of supplement products.

• Shall include all the core application with the flexibility of the ability to join systems to it as well as allow for the added nitrogen flushing units.

Installation, Training and Warranty Requirements:

• The system and its associated accessories shall include operations and maintenance manuals covering proper operation, routine maintenance, and trouble shooting for the instrument and controlling software. All manuals and documentation on the instrument shall be provided in hard copy and/or electronic format.

• The offeror shall provide training for 2 to 3 full time employees (FTE), that will require 4 to 5 consecutive workdays.

• The offeror shall provide application support for the first 3 months post-installation.

• The offeror shall install the equipment and provide all labor, travel, kits, and tools, etc, to install the equipment at the address provided below, to include inside delivery.

• 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 4 (1-year Post Warranty Maintenance Option Periods):

• 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 Central Time.

• All maintenance/repair pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc.

Estimated Delivery Date: 90 days after award

Option Year 1: 05/15/2024 thru 05/14/2025 Option Year 2: 05/15/2025 thru 05/14/2026 Option Year 3: 05/15/2026 thru 05/14/2027 Option Year 4: 05/15/2027 thru 05/14/2028

Delivery Location:

Food and Drug Administration National Center for Toxicological Research 3900 NCTR Road Bldg 60, Room 101 Jefferson, AR 72079

Service Records and Reports The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. In addition, the Contractor shall provide a written report to the FDA Technical Representative and Contract Specialist, summarizing all maintenance and repair activities (including warranty work) each time service and/or repair is performed.

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, SAM 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 DUNS 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 or other Government-wide or HHS-wide contracts that the equipment/service is available on.

• If applicable, the offeror shall clearly identify where the offered product is made. 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.

• 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.

• The Government is not responsible for locating or securing any information, not identified in the response.

• Informational pricing is desired.

Interested Contractors must respond with capability statements which are due by email to the point of contact listed below on or before January 20, 2023, by 13:00 hours (Central Time in Dallas, Texas) at the Food and Drug Administration, Field Operations Branch, FDA|OO|OFBA|OAGS|DAP, Attn: Yolanda Rankin, email yolanda.rankin@fda.hhs.gov.

Reference: 75F40123R00016.

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.