Sources Sought NCTR-2025-126188.pdf

MARKET RESEARCH PURPOSES ONLY

NOT A REQUEST FOR PROPOSAL OR SOLICITATION

Annual service for six (6) TSI 3321A Aerodynamic Particle Sizers (APS) and twelve (12) TSI Aerodynamic Particle Diluter Model 3302a

NCTR-2025-126188

The U.S. Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR), Division of Biochemical Toxicology requires annual service for six TSI 3321A Aerodynamic Particle Sizers (APS) and twelve TSI Aerodynamic Particle Diluter Model 3302a.

The FDA is seeking small business sources to determine the availability and capability of small businesses capable of providing the required 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 July 16, 2025 by 13:00 hours (Central Time in Jefferson, Arkansas) to david.kramer@fda.hhs.gov.

Reference NCTR-2025-126188

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 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

Annual service for six TSI 3321A Aerodynamic Particle Sizers (APS) and twelve TSI Aerodynamic Particle Diluter Model 3302a

NCTR-2025-126188

1. Introduction

The U.S. Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR), Division of Biochemical Toxicology requires annual service for six TSI 3321A Aerodynamic Particle Sizers (APS) and twelve TSI Aerodynamic Particle Diluter Model 3302a.

Knowing particle size is critical in meeting the standards for aerosol inhalation studies.

The APS is the only instrument capable of real-time aerodynamic particle size determination in a footprint that will fit into our class III glove boxes used for toxic inhalation studies. The Aerodynamic Particle Diluters are required for bringing the particle count of our primary aerosols down to a level where they can be analyzed by the

APS.

2. Objectives

The annual service is required to maintain functionality of the equipment for ongoing research purposes. This instrument systems are heavily used in providing data to support NCTR approved protocols. Purchasing annual calibration service will ensure the instrument will be maintained to keep performing adequately.

3. Tasks

Instruments will be shipped by the Government to the service provider to complete the preventative maintenance of the six (6) TSI APS (3321A) and twelve (12) TSI model 3302a aerosol diluters. At no time will all devices be shipped at the same time.

The service shall meet the following minimum technical requirements:

a. Task 1: 3302a Diluter

i. Cleaning of the diluter capillary

ii. Inspecting and greasing of instrument O-rings

iii. Replacing the main air filters used for dilution

iv. Adjusting pressure drop across the diluter capillary paths (Path) and

(Total) to achieve dilution ratios stated on diluter capillaries.

v. Checking for system leaks

vi. The service provider shall follow the Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins.

b. Task 2: 3321 APS

i. Cleaning inlet capillary. Inspecting and cleaning laser housing aerosol measurement zone.

ii. Inspecting and greasing of instrument O-rings

iii. Measuring system flow and dilution followed by adjustment of needle valves to achieve accurate sample and sheath flows according to manufacturer’s specifications.

iv. Ensuring vacuum pumps are drawing appropriate voltage.

v. Replacing all internal filters.

vi. Measuring PSL beads across the instrument measurement range and resetting the spline curve if necessary.

vii. Use and classifier and CPC to ensure accurate particle counts and report data related the size class count bias. Adjust avalanche detector bias voltage to normal count across particle sizes, if necessary.

viii. The service provider shall follow the Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins.

4. Other Requirements:

Certificate of calibration shall be provided following service.

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

N/A

6. Contractor Provided Special Material Requirements

7. Travel

8. Place of Performance

Services under this contract shall be performed at the Contractor’s facility.

9. 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.

10. Period of Performance:

Base Period: September 1, 2025 through August 31, 2026

Option Year 1: September 1, 2026 through August 31, 2027

Option Year 2: September 1, 2027 through August 31, 2028

Option Year 3: September 1, 2028 through August 31, 2029

11. Contract Administration:

Technical Point of Contact (TPOC):

To be provided at time of award.