Sources Sought NCTR-2025-128449.pdf

MARKET RESEARCH PURPOSES ONLY

NOT A REQUEST FOR PROPOSAL OR SOLICITATION

Service contract with annual on-site preventative maintenance for Vitrocell V10 type S robot and two (2) 12/12 Exposure module System

NCTR-2025-128449

The U.S. Food and Drug Administration (FDA) is conducting market research to support the National Center for Toxicological Research ((NCTR), Division of Genetic and Molecular Toxicology. The Division of Genetic and Molecular Toxicology requires a service contract with annual on-site preventative maintenance for Vitrocell V10 type S robot and two (2) 12/12 Exposure Module systems. The purchase of this service contract will ensure system continues to function properly, thus providing data without interruption.

The FDA is seeking to identify potential small business sources to determine the availability and capability of small businesses capable of providing the required service/product. Other Than Small Business (OTSB) 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 - 811210 – Electronic and Precision Equipment Repair and Maintenance; the applicable Small Business Size Standard is $34 million.

Statement of Work See below.

Alternative Solutions 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.

Response Instructions Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product/service of a small business manufacturer or producer all interested parties may respond. At a minimum, responses shall include the following:

• Section 1: Respondent Overview

- 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.

• Section 2: Descriptive Information

- 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, ISO certifications, descriptive material, literature, brochures, and other information, which demonstrates the capabilities of the contractor to meet the requirement.

• Section 3: Past Performance

- Three (3) years of past performance service information, if not the manufacturer of the equipment identified herein, where the respondent has provided same or substantially similar service solutions on the same or near-same brand name equipment.

- 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.

• Section 4: Capabilities and Delivery

- The offeror’s capability to meet the delivery requirements within the time specified above.

- Offeror shall provide estimated historical on-site response time from the initial call for service until a service technician was on-site for the brand name and model of instrument in this solicitation or a standard target time for onsite performance from initiation of service call.

- 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.

- Capability and understanding of accessibility testing and customization to conform with the applicable Section 508 standards identified herein.

Provide information if the respondent has an Accessibility Conformance

Report (ACR) for the products offered for the Revised 508 Standards.

The ACR should be based on the Voluntary Product Accessibility Template Version 2.0 (MS Word) provided by the Industry Technology Industry Council (ITIC).

- 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 for both the purchase of the instrument and a lease of the instrument.

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 August 21, 2025 by 13:00 hours (Central Time in Jefferson, Arkansas) to david.kramer@fda.hhs.gov.

Reference: NCTR-2025-128449

Notice of Intent Responses to this Sources Sought announcement will assist the Government in determining whether 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 http://www.itic.org/dotAsset/d432b9da-3696-47fe-a521-7d0458d48202.doc http://www.itic.org/dotAsset/d432b9da-3696-47fe-a521-7d0458d48202.doc http://www.itic.org/policy/accessibility http://www.itic.org/policy/accessibility 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).

Statement of Work

Service contract with annual on-site preventative maintenance for Vitrocell V10 type S robot and two (2) 12/12 Exposure module System

NCTR-2025-128449

1. Background The Food and Drug Administration (FDA), National Center for Toxicological Research ((NCTR), Division of Genetic and Molecular Toxicology requires a service contract with annual on-site preventative maintenance for Vitrocell V10 type S robot and two (2) 12/12 Exposure Module systems. The purchase of this service contract will ensure system continues to function properly, thus providing data without interruption.

This system is heavily used, specifically for a current study designed to evaluate the toxicity of ortho-phthaldehyde aerosols in human air-liquid-interface (ALI) airway tissue models. The unique properties of aerosols and delivery of test articles from them requires the sophisticated, specialized instrumentation provided by the Vitrocell exposure system. Thus, it is imperative that this robot and exposure modules be maintained on an annual basis.

2. Salient Characteristics - VC-10 S-type Smoking Robot The salient characteristics of the VC-10 S-type Smoking Robot (S/N 271216) Service Contract are as follows:

a. The Smoking Robot service contract shall include one on-site PM (preventative maintenance) visit per year, inclusive of shipping, labor, travel; inclusive of unlimited OEM system software upgrades; but exclusive of consumable OEM-replacement parts, components, subassemblies, etc. (e.g., gaskets, tubing, O-rings, which shall be billed separately up to a limit of less than $2,500/year.

b. All preventative maintenance (PM) activities shall be performed by formally (OEM) trained and certified technicians/engineers.

c. All PM services shall be performed following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc.

d. The Smoking Robot service contract shall include unlimited technical support and the contractor shall begin working on a solution to the problem within eight (8) business hours of contact for assistance. (e.g., telephone-based, email-based, website-based, etc.).

e. The service provider shall provide a list of the maintenance and cleaning requirements for the end users.

f. The service provider shall initiate the PM appointment as to comply with contract terms.

3. Salient Characteristics - 12/12 Well Exposure Modules (S/N 32/13 and 33/13) The salient characteristics of the VC-10 S-type Smoking Robot (S/N 271216) Service Contract are as follows:

a. The 12/12 well exposure modules service contract shall include one on-site PM (preventative maintenance visit) per year, inclusive of shipping, labor, travel;

inclusive of unlimited OEM system software upgrades; but exclusive of consumable OEM-replacement parts, components, subassemblies, etc. (e.g., gaskets, tubing, O-rings, which shall be billed separately up to a limit of less than $2,500/year.

b. All preventative maintenance (PM) activities shall be performed by formally (OEM) trained and certified technicians/engineers.

c. All PM services shall be performed following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc.

d. The 12/12 exposure modules service contract shall include unlimited technical support and the contractor shall begin working on a solution to the problem within eight (8) 8 business hours of contact for assistance. (e.g., telephone-based, email-based, website-based, etc.).

e. The service provider shall provide a list of the maintenance and cleaning requirements for the end users.

f. The service provider initiates the PM appointments to comply with the contract terms.

4. Service Records and Reports The Contractor shall, commensurate with the completion of each preventive maintenance service visit, 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, a detailed description of the work performed, the test instruments or other equipment used to perform the service, the name(s) and contact information of the technician who performed the 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 COR and Contract Specialist, summarizing all maintenance activities (including warranty work) each time service is performed.

5. Government-Furnished Property, Material, Equipment, or Information (GFP, GFM, GFE, or GFI)

N/A

6. Shipping Destination:

FOB Point of Delivery for Services and Supplies will be:

FDA

3900 NCTR Road Jefferson, AR 72079

7. Period of Performance Base Period: 09/22/2025 – 09/21/2026 Option Year 1: 09/22/2026 – 09/21/2027 Option Year 2: 09/22/2027 – 09/21/2028 Option Year 3: 09/22/2028 – 09/21/2029 Option Year 4: 09/22/2029 – 09/21/2030

8. Holidays and Government Closures The Contractor is not required to provide on-site services on the following days that are Federal Holidays or on any other day designated as a Federal holiday for the Washington, DC area:

• New Year’s Day

• Martin Luther King Day

• President’s Day

• Memorial Day

• Juneteenth Independence Day

• Independence Day

• Labor Day

• Columbus Day

• Veteran’s Day

• Thanksgiving Day

• Christmas Day

In the event of inclement weather when the Federal government is closed, the Contractor is not required to provide on-site service. The Contractor is required to follow, as a minimum, other directives issued by the U.S. Office of Personnel Management or other such official for late arrivals due to inclement weather (unless otherwise specified in the Contract).

In the event the Federal Government is closed by order of the President of the United States or the U.S. Office of Personnel Management for any reason, or the agency, the center or the building is closed for administrative or safety reasons, the Contractor shall follow directives issued by responsible officials concerning reporting for work.

9. Contract Administration Technical Point of Contact (POC):

• To be provided at time of award.