Active

Contract Opportunity

Procurement Technical Assistance Centers (PTACs) are an official government contracting resource for small businesses. Find your local PTAC (opens in new window) for free government expertise related to contract opportunities.

MARKET RESEARCH PURPOSES ONLY

NOT A REQUEST FOR PROPOSAL OR SOLICITATION

The U.S. Food and Drug Administration (FDA) is conducting market research to support the National Center for Toxicological Research (NCTR) requirement for a Human Emulation System.

The FDA is seeking small business sources to determine the availability and capability of small business manufacturers or small businesses capable of supplying, and subsequently maintaining, a U.S. made product of a small business manufacturer or producer for the items described herein. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort.

The associated North American Industry Classification System (NAICS) Code is-334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 1,000 employees.

The FDA/NCTR intends to award a sole source, firm fixed price purchase order to Emulate Inc. under the authority of FAR 13.106-1(b)(1), Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements depending on the results of this sources sought/market research notice if no other capable sources are found.

Statement of Work

Background

NCTR Study E7770.01 aims to construct models of a healthy brain and an Alzheimer’s disease (AD) brain using novel approach methodologies (NAMs) including patient-derived induced pluripotent stem cells (hiPSCs) and a microphysiological system or organ-chip. E7770.01 is a protocol developed through a Cooperative Research and Development Agreement (CRADA) between the FDA and Emulate Inc, in which equipment and chips are provided to the NCTR by Emulate Inc. Under the CRADA (2020-0038-CRD) the Human Emulation System comprised of 1 Orb Hub Module 1 and 2 Zoë Culture Modules which 1 is loaned to the PI’s laboratory and must be returned to Emulate Inc after project completion. However, Emulate Inc. provides the FDA with the option of buying and upgrading the equipment at a discounted price once the project is completed.

Establishment of the brain-chip model at the NCTR using the Human Emulation System from Emulate Inc. provides the Agency with the capability of conducting studies in which the potential neurotoxic effects of FDA-regulated products can be evaluated in a human-relevant system. Therefore, acquisition of the Human Emulation System will greatly benefit the Agency. In addition, to increase throughput, an additional Zoë Culture Module will allow us to conduct larger studies in a shorter timeline by increasing the number of chips that can be cultured by 50%. Moreover, these highly specialized equipment needs to be regularly serviced for optimal operation, therefore an extended service agreement is necessary.

Objectives

This requirement is for a three Zoë CM2 Culture Modules, one Orb Hub Module and a Service Agreement option.

Constraints

Anticipate a sole-source acquisition given that we are purchasing and upgrading an equipment provided through CRADA# 2020-0038-CRD between the FDA and Emulate Inc.

The Subject Matter Expert’s laboratory has the option to buy the Orb Hub Module 1 at a discounted price and to upgrade the two Zoë Culture Module 1 currently in his laboratory to two Zoë Culture Module 2 at a discounted price.

Scope

The Contractor shall deliver three Zoë CM2 Culture Modules. Freight and handling/shipping and installation shall be included in the scope of this acquisition. We will purchase the Orb Hub Module currently at NCTR. Upon delivery, the SME, shall test and confirm receipt of the items in fully functional condition. Additionally, a one-year warranty on the new system components is requested along with a one-year service agreement for the existing components. Up to 4 one-year option periods are also requested as part of this acquisition.

TASKS

The Human Emulation System from Emulate Inc. is comprised of the Orb Module 1 and the Zoë Culture Modules. Each Orb Module 1 can support up to four the Zoë Culture Modules. Both modules work in conjunction to provide the culture conditions, media flow and stretch necessary to construct organ-chips. Specific cell types (depending on the application) are cultured on the Chip-S1® Stretchable Chips and obtain their nutrients by specific culture media dispensed on Pod® Portable Modules. The combination of Chips, Pods and culture modules enable researchers to construct human-relevant organ-chips cultured under physiological conditions.

The minimum requirements for this system are listed below:

• ORB-HM1 Hub Module.

o Capable of supporting up to four Zoë Culture Modules.

o Gas output composition: 5% CO2.

o Gas output pressure: 275.8 kPa+/-34.5 kPa.

o Max mixed gas flow rate: 130 mL/minute. Vacuum output: -70 kPa.

o No warranty included.

• Zoë-CM2 Culture Module. Quantity of three (3). Two Zoë-CM2 Culture Modules are used with no warranty. One Zoë-CM2 Culture Module is new and comes with a one year warranty.

o Capable of supporting up to 12 Chip-S1® Stretchable Chips and Pod® Portable Modules simultaneously.

o Capable of achieving a flow range between 10 and 1,000 µL/hour.

o Capable of achieving a stretch range between 0 and 12%.

o Capable of achieving stretch frequencies between 0 and 0.4 Hz.

• Extended Service Plan.

o Firmware upgrades.

o System checks and troubleshooting support as needed.

o Remote guidance of system disassembly, relocation and installation as needed.

o All parts, travel, and labor, in the event of an instrument requiring service or repair.

o All service and repairs will be performed by qualified Emulate Inc. engineers.

o Depot Service repair and platform replacement if determined to be appropriate.

o One annual preventative maintenance visit shall be included as part of the annual service agreement

Deliverables

Contractor shall ship, deliver, install, and provide online training for the Three Zoë CM2 Culture Modules at NCTR 3900 NCTR Road, Building 53 D, room 212, Jefferson, AR 72079

Other Requirements

Installation and training shall be performed by field engineers certified by the equipment manufacturer. This work and acceptance of the Emulate system shall be overseen by the SME for this acquisition, to be completed at time of award. A report shall be provided following the installation and any service calls. Any parts replaced during service calls shall be OEM parts.

Period of Performance The equipment shall be installed on-site within 120 days post-award. A minimum one-year warranty period is requested for the new components with up to four one-year service year contract options after the cessation of the initial warranty period. A one-year service agreement for the existing components is also requested.

Place of Performance

All work shall be performed at:

US Food & Drug Administration

National Center for Toxicological Research (NCTR)

3900 NCTR Road

Building 53D, Room 212

Jefferson, AR 72079

Government Furnished Equipment (GFE)/Government Furnished Information

No government-furnished property or government-furnished information will be provided in the scope of this acquisition.

Security Requirements

There are no additional security requirements for this contract.

FOB Point Destination. All items shall include shipping, handling and in-side delivery to the destination identified herein. Delivery, installation and staff familiarization training shall occur within the contractor’s normal manufacturing lead times for these items but should be no more than 90 calendars days from date of award.

Alternative solutions will be considered insofar as any such alternate system and/or system components meet the minimum intended use of the system and brand name or equal technical requirements.

The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services and components meet the technical requirements identified above. Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product of a small business manufacturer or producer all interested parties may respond. At a minimum, responses shall include the following:

• Business name, SAM Unique Entity ID 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 if responding to provide a product manufactured by another firm);

• Sufficient descriptive literature that unequivocally demonstrates that offered products and services can meet the above requirements. All descriptive material necessary for the government to determine whether the service/product offered meets the technical requirements including: technical specifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement.

• Past performance information within the last three years for the manufacture and/or sale in which the offeror has provided same or substantially similar solutions and used for same or near-same applications as set forth herein. For each past performance reference include the date of sale, description, dollar value, client name, client address, client point of 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 SAM Unique Entity ID number and size status) if not the respondent.

• If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. Detailed list of items included and not included on the GSA contract to meet this requirement.

• 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.

• Provide information if any of these specifications are too restrictive. No response will be considered that the listed specifications are adequate in a competitive environment.

• If a large business, identify the subcontracting opportunities that would 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; and

• Though this is not a request for quote, informational pricing is encouraged.

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

The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation.

Interested Parties shall respond with capability statements which are due by email to the point of contact listed below on or before April 10, 2023 by 13:00 hours (Central Time in Jefferson, Arkansas) to nick.sartain@fda.hhs.gov. Reference NCTR-2023-117556.

Notice of Intent

Responses to this sources sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures.

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).

Attachments/Links