FDA-SSN-114906.pdf

TSE Inhalation Exposure Units Preventative and Correction/Remedial Maintenance Repair Services Sources Sought Notice

FDA‐SSN‐114906

MARKET RESEARCH PURPOSES ONLY

NOT A REQUEST FOR PROPOSAL OR SOLICITATION

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) is issuing this source 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 TSE Inhalation Exposure Units Preventative and Correction/Remedial Maintenance Repair Services with three (3) option years. 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 appropriate NAICS code for the acquisition is 811219 – Other Electronic and Precision Equipment Repair and Maintenance; Small Business Size standards – $22 MIL.

Background:

The Center Tobacco Program (CTP)/NCTR Inhalation Toxicology Facility is a collaborative research facility between CTP and NCTR to conduct inhalation toxicology studies in vivo to support CTP regulatory decisions. Six nose only inhalation exposure system were purchased to conduct inhalation toxicology studies on the effect of aerosol suspensions of nicotine in animals. A preventative and corrective/remedial maintenance repair service on the six inhalation units and components is needed to ensure: 1) the success of these ongoing nicotine inhalation studies, and 2) the systems will continue to perform and provide required data.

The TSE Inhalation exposure systems units requiring the preventative and correction/remedial maintenance repair service are Model 700100‐KNES‐050‐SS and associated components assigned Serial Numbers: 120329‐18, 120329‐19, 120329‐20, 120329‐21, 140402‐01, and 140402‐02. Each TSE nose‐only inhalation exposure systems consists of:

1. One 50‐port nose‐only inhalation exposure tower;

2. Animal holding tubes;

3. One hood for inhalation exposure tower (including enclosure and ventilation system);

4. Aerosol generation systems (vapor, liquid and solid particle aerosols);

5. A dual sampling system (aerosol sampler, sampling pump and control unit);

6. Aerosol characterization instruments (including instruments and software);

7. One DACO‐GLP Online control/monitoring system (700400‐PRO‐C‐D‐GLP/1) including:

temperature and humidity transducers, mass flow controllers, oxygen Meyers, pressure transducers and particle concentration monitors, software and computer); and

8. One air locker system.

The TSE Inhalation Exposure Units are currently covered under a service agreement through March 31, 2023.

Minimum Performance Requirements:

Shall include the following:

1. Minimum of one (1) planned preventative maintenance (PM) visit for all units each contract period. The contractor shall arrive to the planned PM visit with all required testing items/equipment and PM parts. All costs for labor, travel, and parts required for preventative maintenance shall be included.

2. Unlimited on‐site corrective/remedial maintenance, service/repair visits which again includes all labor, parts, and travel costs. Provide priority on‐site service response if issue cannot be corrected remotely within 8 hours from call for service.

Have readily available at least one set of potential flow controllers, probes and computer system in a ready state to repair one system within 7 days of request.

3. Unlimited phone, email and web‐based support during the contractor's normal operating hours. Initial response within 8 business hours of contact for assistance (e.g., telephone‐based, email‐based, website‐based, etc.)

4. Access by the FDA Technical Representative (TR) and system operator personnel 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.

5. Performance by formally trained and certified technicians/engineers, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc.

6. Absolute adherence to and conformity with Original Equipment Manufacturer (OEM) specifications, manuals, bulletins, latest technical developments, PM procedures, application updates using OEM replacement parts, components, subassemblies etc. in performing all preventative maintenance and repair services.

7. System software and firmware updates required for reliability improvements and correction of any defects.

8. Use of NCTR’s flow meters and provide NCTR 30 days advance notice of what type(s) meters are needed.

9. Deliverables: 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 by email 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 Contracting Officer’s Representative and Contract Specialist by email, summarizing all maintenance and repair activities (including warranty work) each time service and/or repair is performed.

Anticipated Period of Performance: Base + 3 (1 Year) Option Periods

Base Period: April 1, 2023 – March 31, 2024 Option Period 1: April 1, 2024 – March 31, 2025 Option Period 2: April 1, 2025 – March 31, 2026 Option Period 3: April 1, 2026 – March 31, 2027

Place of Performance:

U. S. FDA – NCTR

3900 NCTR Road Bldg. 53A, Rm. 110 Jefferson AR 72079

Responses to this source sought shall unequivocally demonstrate the respondent is regularly providing TSE Inhalation Exposure Units Preventative and Correction/Remedial Maintenance Repair Services. 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:

1. 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.

2. The offeror shall furnish capability statements with sufficient technical information necessary for the Government to conclusively determine experience and qualifications of the firm for the minimum performance requirements identified above. Information on available service/maintenance plans for the identified TSE Unit equipment

3. Past Performance information shall include recent (within the last 3 years) and relevant (prior experience information for TSE Inhalation Exposure Units Preventative and Correction/Remedial Maintenance Repair Services). For each past performance reference include the date of service, description of service provided and the manufacturer name and model of the equipment serviced, 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 company (to include DUNS number and size status) if not the respondent.

4. Documentation, if not the manufacturer of the equipment identified herein, of technical competency on the operation and repair of the brand name equipment. Such documentation should include certification from the original equipment manufacturer or other training certificates within the past calendar year.

5. 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.

6. 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.

7. If a large business, provide if subcontracting opportunities exist for small business concerns.

8. Standard commercial warranty.

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

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

Interested Parties shall respond with capability statements which are due by email to the point of contact listed below on or before October 27, 2022, by 12:00 PM (Central Time in Jefferson, Arkansas) to jennifer.johnson3@fda.hhs.gov, and reference: FDA‐SSN‐114906.

Notice of Intent:

Responses to this source 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).

Additional Notes:

If the stated requirements appear restrictive, please submit comments detailing the concern.