75F40125SSN130350.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) issues this Sources Sought Notice (SSN) on behalf of the National Center for Toxicological Research (NCTR)’s Nanotechnology Core Facility (Nanocore) in order to determine if there are existing small business sources capable of providing a preventative and corrective maintenance agreement for a base plus three (3) option years on an Asymmetric Field Flow Fractionation (AFFF) system coupled with Multi Angle Light Scattering (MALS) unit, Differential Refractive Index Detector (dRI) and a High Performance Liquid Chromatography (HPLC) system with components, and a Ultraviolet-Visual (UV-Vis) detector (AFFF-MALS-RI-UV-Vis-HPLC) instrument with the following components:

- Wyatt QELS internal - Integrated DLS for Dawn, S/N: 1539-WIQ

- Wyatt DAWN Heated/cooled MALS, S/N: 3287-D3HC

- Wyatt (Optilab) Differential Refractive Index (dRI) detector, S/N: 3315-OP1

- Wyatt Eclipse DualTec (FFF) System, S/N: 4183-FO

- Agilent 1260 Infinity II Binary Pump, Model G7112B, S/N: DEAE801068

- Agilent 1260 Infinity II Vialsampler, Model G7129A, S/N: DEAER00988

- Agilent 1260 Infinity II Diode Array Detector (DAD), Model G7115A, S/N: DEAC612216

- Agilent 1260 Infinity II 1200 Instant Pilot, Model 94208A, S/N: MY20355520

The Food and Drug Administration (FDA) makes regulatory assessments of products that either contain nanomaterial or otherwise involve the application of nanotechnology. The FDA Nanotechnology Core Facility (Nanocore) utilizes multiple types of equipment for the separation and detection of nanomaterials used in various experiments. The AFFF-MALS-RI-UV-Vis-HPLC instrument (with components from two vendors: Wyatt (acquired by Waters) and Agilent) is integral to these determinations and is one of the “core” pieces of equipment in the Nanotechnology Core Facility, NCTR/Nanocore that is supporting: (a) the nanotechnology needs of National Center for Toxicological Research (NCTR) and Arkansas Regional Laboratory (ARL), which are co-located on the Jefferson Laboratories Campus, (b) the FDA centers located away from the Jefferson Laboratory Campus, and (c) studies conducted under the National Toxicology Program. The instrument requires a yearly maintenance contract to ensure reliability for the support of ongoing research. The maintenance agreement must cover all of the aforementioned system components. The instrument was purchased new in 2020 and was covered under a service contract until 05/28/2025.

If your firm is considered a small business source under North American Industry Classification System (NAICS) Code is 811210 – Other Electronic and Precision Equipment Repair and Maintenance; with a Small Business Size Standard of $34 Million, and you believe that your firm would be able to provide the FDA with the product described below, please submit an email to suzanne.martella@fda.hhs.gov. 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.

The PM and unlimited repair service contract shall consist of a Base year plus three (3) possible one-year options. Each year shall be funded at the time the option year is exercised; options will be exercised based on funds availability and the needs of the Federal Government. The initial Service period shall be for one year and the subsequent periods of performance may be renewed at the government’s option for the period between 12-24 months, 24-36 months, and 36-48 months beyond the initial contract service period. Contractor quotes shall include service contract details, any differing levels of available service plans, and the levels of service response that are available.

Minimum Performance Requirements – Preventative and Corrective Maintenance Service Contract:

1. The Contractor shall provide one (1) scheduled on-site planned preventive maintenance visit per year which shall include all labor, travel, and OEM factory-certified replacement parts, components, subassemblies, etc., as well as consumables.

2. The Contractor shall provide unlimited on-Site Corrective Maintenance/Repairs, which includes parts, labor, and travel.

3. The offeror shall provide certified Original Equipment Manufacturer (OEM) parts for all repairs and maintenance.

4. All maintenance and repair activities shall be performed by service technicians/engineers who are formally trained and certified by the original manufacturer. Engineers shall have access to the manufacturer’s latest technical developments, repair procedures, application updates, diagnostic software, and planned maintenance procedures.

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

6. The contractor shall provide a 24-hour priority response time after the initial call for service and have a plan of action for repairs within 48 hours of initial contact where problems cannot be resolved remotely after the first 48 hours.

7. Contractor shall guarantee a mutually agreeable schedule for on-site repairs to be initiated mailto:suzanne.martella@fda.hhs.gov within five (5) business days from initial contact where repairs require on-site service.

8. Service contract shall include unlimited free OEM system software, firmware and hardware support and updates.

9. The Contract shall include unlimited technical support (via phone and email) on software and hardware related issues and troubleshooting capabilities, Monday through Friday (excluding Federal Holidays) 8:00AM – 5:00PM Central Time and contractor shall begin working on a solution to the problem within 8 business hours of contact for assistance.

10. The contract shall enable the FDA Technical Point of Contact (TPOC) and system operator personnel to have access to the manufacturer's call center for technical assistance, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument.

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

12. The service technician shall itemize all additional charges to maintenance and/or repair items that are not covered under the service plan.

Deliverables: 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/Technical POC (TPOC) and Contract Specialist, summarizing all maintenance activities (including warranty work) each time service is performed.

Periods of Performance (PoPs): Anticipated to be a Base plus three option years with the following periods of performance:

Base Year: September 18, 2025 - September 17, 2026 Option Year 1: September 18, 2026 - September 17, 2027 Option Year 2: September 18, 2027 - September 17, 2028 Option Year 3: September 18, 2028 - September 17, 2029

Place of Performance: The equipment is located and shall be maintained at the National Center for Toxicological Research (NCTR) at the following address:

US FDA/NCTR

3900 NCTR Rd.

Building 26, Room B360 Jefferson AR 72079

Responses to this Sources Sought shall unequivocally demonstrate that the respondent is regularly engaged in the sale of same or substantially similar products. Though the target audience is small business vendors or small businesses capable of supplying a U.S. product/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 ID (SAM) 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.

• Descriptive literature, brochures, marketing material, etc. detailing the nature of business which the responding firm is regularly engaged in providing. Capability statements must provide sufficient information that unequivocally demonstrates that the technical requirements and/or delivery time identified above can be met.

• Past Performance (within the last 3 years) information for the sale of same or substantially similar product to include date of sale, description of product provided, contract 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 Unique Entity ID (SAM) number and size status) if not the respondent.

• The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered service/products meet the technical requirements identified above.

• The offeror’s capability to provide the brand name and model of product in this requirement.

• 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 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 a large business, provide whether subcontracting opportunities exist for small business concerns.

• Standard commercial warranty and payment terms.

• Provide place of product manufacture or 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.

• Though this is not a request for quote, informational pricing for the service would be helpful for market research purposes.

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 to be submitted by email only to the point of contact listed below on or before 3:30pm (Central Time in Jefferson AR) on June 24, 2025 to Suzanne Martella, email suzanne.martella@fda.hhs.gov. Reference:

75F40125SSN130350.

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 or combined synopsis/ solicitation may be published in SAM.gov – Contracting Opportunities. 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.

mailto:suzanne.martella@fda.hhs.gov