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 preventative maintenance and service contract on SE Labs automatic watering system (AWS).

The FDA is seeking small business sources to determine the availability and capability of small businesses capable of providing the required services. 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- 811210 ? Electronic and Precision Equipment Repair and Maintenance; the applicable Small Business Size Standard is $34M.

Statement of Work

1.0 INTRODUCTION

1.1 Background

NCTR is the primary research facility within the FDA, and as such, conducts animal studies to support the mission of CBER, CDER, CTP, NTP, and CFSAN. All animals must be supplied with a readily available source of clean water. The current automatic watering system (AWS) in building 53 meets those requirements. The current automatic watering system in building 53 must be serviced regularly to maintain optimal function and to ensure clean drinking water is provided to animals in individually ventilated cages at all times. This requirement is for a Preventative Maintenance and Repair Service contract.

1.2 Objectives

To provide yearly preventive maintenance and repair services to the Automatic Watering System in Building 53.

2.0 SCOPE

All animals must be supplied with a readily available source of clean water. The current automatic watering system in building 53 meets those requirements. The current automatic watering system in building 53 must be serviced regularly to maintain optimal function and to ensure clean drinking water is provided to animals in individually ventilated cages at all times. This requirement is for a Preventative Maintenance and Repair Service contract. The current preventative maintenance and repair service for the automatic watering system on contract HHSF223201820021A is an interconnected system in building 53. The SE Labs automatic watering system and its Monnit monitoring system are pre-existing in building 53 and is on the Product List. The AWS includes storage tanks, pumps, water delivery and return lines, filters, and a UV sterilization unit.

3.0 TASKS

? Preventive Maintenance Services for the SE Labs automatic watering system equipment in 53 will be performed four times per year. It shall include verification, calibrations, adjustments, repairs and/or replacement of worn/ defective parts.

? The service and maintenance agreement must include all parts, labor, and travel expenses.

? The interim Service visits will be completed approximately (3) months after the previous visit.

? A Preventive Maintenance report will be completed for each visit and presented to the COR for approval at the completion of the service visit.

? Emergency Service Calls shall be included throughout the agreement term. Service Calls must be responded to within 2-5 business days after notification during normal business hours Monday-Friday. 24/7 technical phone support must be included.

? Preventative and corrective/remedial maintenance repair service on the

system shall, at a minimum, include the following:

- Unlimited phone and email support during the contractor's normal operating hours.

- Preventative maintenance shall include all labor, travel, and parts (except

consumables).

- Unlimited corrective/remedial maintenance, service and repairs shall include all

labor, travel, and parts (except consumables). Provide service response time with

quote.

- Pricing shall be inclusive of all labor, travel, replacement parts, components,

subassemblies, etc.

- 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.

- Access by the FDA Contracting Officer's Representative (COR), 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.

- System software and firmware updates required for reliability improvements and

correction of any defects.

- Service Records and Reports

The Contractor shall, commensurate with the completion of each service call or

preventative maintenance visit, provide the end-user of the equipment and the

Contracting Officer with a copy of a field service report/ticket 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.

? SE Labs equipment included in this agreement includes:

o Combo Recoil/Rackflush Part No. 01-0038, Serial No. 3230, Filter 34-0032

o UV Sterilization Unit, Model 2011, Part No. 01-0041, Serial No. 3292, Bulb 68 0037

o Storage tanks, pumps, water delivery and return lines

o Monnit monitoring server, accessories, and any necessary updates

? Onsite preventative maintenance and repair service will require the technician:

o Participate in the NCTR Animal Exposure Program through the onsite Occupation Health Unit

o Complete annual fit testing for an N95 disposable respirator that is to be worn in occupied animal rooms. This can be completed the morning of one of the quarterly maintenance visits.

o Be a US citizen.

o Comply with any new FDA/NCTR facility entrance requirements in place at the time of the repair/maintenance.

4.0 DELIVERABLES

The government will receive a properly functioning Automatic Watering System for Building 53 to provide clean drinking water to the research animals.

5.0 OTHER REQUIREMENTS

N/A

6.0 PERIOD OF PERFORMANCE

07/24-2024 ? 07/23/2029

BASE CONTRACT YEAR: 07/24/24 ? 07/23/25

OPTION YEAR 1: 07/24/25 ? 07/23/26

OPTION YEAR 2: 07/24/26 ? 07/23/27

OPTION YEAR 3: 07/24/27 ? 07/23/28

OPTION YEAR 4: 07/24/28 ? 07/23/29

7.0 PLACE OF PERFORMANCE

The AWS main components are located Building 53B-125, clean side of cagewash area. The majority of PM/repair services will be in this location. If there is an issue with the AWS delivery to each animal room outfitted with automatic watering, SE Labs personnel may need to enter the following animal rooms in 53A-102, 103, 104, 105, 106, 110, 111, 112, 113, 114, 115, and 116; the following animal rooms in 53B-102, 103, 104, 107, 108, 109, and 110; the following animal rooms in 53C-102, 103, 104, 105, 106, 109, 110, 111, 112, 113, 114, 115, 116, 119, 120, 121, 122, 123, 124, 125, 126, 131, 132, 133; and the following rooms in 53D-103, 104, 105, and 106.

8.0 GOVERNMENT FURNISHED EQUIPMENT (GFE)/GOVERNMENT FURNISHED INFORMATION

SE Labs equipment government furnished property included in this agreement:

o Combo Recoil/Rackflush Part No. 01-0038, Serial No. 3230, Filter 34-0032

o UV Sterilization Unit, Model 2011, Part No. 01-0041, Serial No. 3292, Bulb 68 0037

o Monnit monitoring server and accessories

9.0 SECURITY REQUIREMENTS

The contractor will ensure a government employee or Animal Care contractor is available to escort them to the Automatic Watering System¡¯s location on NCTR property. The Monnit monitoring system for the water pressure and levels is on the Product List.

10.0 CONTRACT ADMINISTRATION

a. Contracting Officer/Contract Administrator

Nick Sartain, Contracting Officer

Phone: 870-543-7370

Email: nick.sartain@fda.hhs.gov

b. Contracting Officer¡¯s Representative(COR)/Technical Point of Contact (TPOC) ?

The following COR/TPOC will represent the Government for the purpose of this contact:

(To be completed at time of award)

Name:

Phone:

Email:

The TPOC/COR is responsible for:

(1) Monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements;

(2) Interpreting the statement of work and any other technical performance requirements;

(3) Performing technical evaluation as required;

(4) Performing technical inspections and acceptances required by this contract; and

(5) Assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to:

(1) Direct or negotiate any changes in the statement of work;

(2) Modify or extend the period of performance;

(3) change the delivery schedule;

(4) Authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or

(5) Otherwise change any terms and conditions of this contract.

FOB Point Destination. All items shall include shipping and handling to the destination identified herein.

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 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:

? 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.

? 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.

? 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 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 May 2, 2024 by 13:00 hours (Central Time in Jefferson, Arkansas) to nick.sartain@fda.hhs.gov. Reference NCTR-2024-123333.

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).