RFI-129523.pdf

MARKET RESEARCH REQUEST FOR INFORMATION (RFI)

RFI Number: FDA-SS-25-129523 Issue Date: July 2, 2025 Response Due Date: July 7, 2025 by 10AM (EST)] Issuing Agency: Food and Drug Administration (FDA) Office: Office of Regulatory Affairs (ORA) Laboratory: Denver Human and Animal Food Laboratory (DENHAFL)

1. PURPOSE AND BACKGROUND

The Food and Drug Administration (FDA) Denver Human and Animal Food Laboratory (DENHAFL) is conducting market research to identify qualified vendors capable of providing comprehensive preventative maintenance and repair services for nitrogen generator equipment. This RFI is issued solely for market research purposes and does not constitute a solicitation or commitment to purchase.

DENHAFL is a primary laboratory within the Office of Regulatory Affairs responsible for analyzing food additives and chemotherapeutic agents in seafood, game meats, milk, and other food/feed samples. The laboratory operates twelve (12) Peak Nitrogen Generators that are critical to the operation of sophisticated analytical instrumentation, including triple quadrupole mass spectrometers.

The laboratory analyzes approximately 500-600 samples annually, and any downtime of nitrogen generators severely impacts analytical capabilities and mission-critical work production.

2. EQUIPMENT INVENTORY

The service agreement would cover the following equipment:

Manufacturer Model Serial Number Date Purchased

Peak Genius 3010 SL0 A15-07-237 12/22/2015

Peak Genius 3031 SL0 A14-07-066 08/03/2014

Peak Genius 3031 SL0 A14-08-057 08/03/2014

Peak Genius NM32LA SL0 A14-05-246 06/17/2014

Peak Genius 1024 SL0 771053701 12/26/2019

Manufacturer Model Serial Number Date Purchased

Peak Genius 1024 SL0 771061717 12/10/2020

Peak Genius 1024 SL0 771052851 11/17/2019

Peak Genius 1024 SL0 771061620 12/10/2020

Peak Genius 1024 SL0 722081100 12/06/2022

Peak Genius 1024 SL0 722090445 12/07/2022

Peak Genius XE SCI 2 721100170 11/20/2021

Peak Genius 1024 SLO 722090462 12/06/2022

Location: FDA Denver Laboratory, 1 Denver Federal Center, 6th Avenue & Kipling St, Bldg. 20, Entrance W-10, Denver, Colorado 80225

3. ANTICIPATED REQUIREMENTS

Service Scope:

• Comprehensive preventative maintenance agreement

• On-site repair services

• Technical support services

• Parts and labor coverage

Minimum Performance Requirements:

• At least one annual preventative maintenance visit per generator (12 total annually)

• Unlimited on-site repair visits

• Maximum 5 calendar day on-site response time for issues requiring physical presence

• Direct telephone and internet technical support

• All work performed by Original Equipment Manufacturer (OEM)-trained technicians

• Use of OEM factory-certified parts only

• No salvaged parts permitted

Performance Period:

• Base Period: July 20, 2025 - July 19, 2026

• Option Period: July 20, 2026 - July 19, 2027

Service Hours:

• Monday - Friday, 8:00 AM - 4:00 PM (excluding Federal holidays)

4. MARKET RESEARCH QUESTIONS

Please provide responses to the following questions to assist FDA in understanding market capabilities:

A. Company Information

1. Provide company name, address, DUNS number, and SAM registration status

2. What is your company's size classification (large business, small business, small disadvantaged business, etc.)?

3. How many years has your company been providing nitrogen generator maintenance services?

4. Do you have existing contracts with other Federal agencies for similar services?

B. Technical Capabilities

5. Are you an authorized Peak Scientific service provider or OEM-trained technician organization?

6. Describe your technicians' training and certification levels for Peak nitrogen generators

7. How do you maintain access to current OEM factory training and parts?

8. What is your typical response time for on-site service calls in the Denver, Colorado area?

9. Do you maintain a local service presence or would technicians travel from another location?

C. Service Approach

10. Describe your preventative maintenance methodology and typical PM procedures

11. How do you ensure 24/7 technical support availability?

12. What remote diagnostic capabilities do you offer?

13. Describe your parts inventory management and sourcing procedures

14. How do you handle emergency repairs outside normal business hours?

D. Quality Assurance

15. What quality control measures do you implement for service delivery?

16. Describe your field service reporting and documentation procedures

17. What warranties or guarantees do you provide on parts and labor?

18. How do you track and measure service performance metrics?

E. Contract Structure

19. Do you prefer fixed-price or time-and-materials contract structures for this type of work?

20. What contract terms and conditions are typically problematic for your organization?

21. Are you capable of performing under GSA schedules or other existing contract vehicles?

22. What is your typical contract performance period preference?

F. Pricing Information

23. Provide rough order of magnitude pricing for annual service agreements covering 12 generators

24. What factors most significantly impact pricing for nitrogen generator service contracts?

25. How do you typically structure pricing (per unit, comprehensive coverage, etc.)?

5. SUBMISSION REQUIREMENTS

Response Format:

• Responses should not exceed 15 pages

• Include company capability statement or brochure

• Provide relevant past performance examples

• Include any relevant certifications or authorizations

Submission Instructions:

• Submit responses electronically to: Nina.Montgomery; Nina.Montgomery@fda.hhs.gov

• Subject Line: "Market Research Response - Peak Nitrogen Generator Services"

• Include RFI number in all correspondence

Response Due Date: July 7, 2025 by 10AM (EST)

6. IMPORTANT NOTICES

Market Research Purpose:

This RFI is issued solely for market research and planning purposes. Responses will be used to:

• Assess market capabilities and capacity

• Refine requirements for potential future solicitation

• Identify qualified sources

• Determine appropriate acquisition strategy

No Commitment:

• This RFI does not constitute a solicitation or request for proposals

• FDA is not obligated to issue a solicitation based on responses

• No reimbursement will be provided for response preparation costs

• Responses may be shared with other Government personnel for evaluation purposes

Proprietary Information:

• Clearly mark any proprietary or confidential information

• FDA will protect proprietary information to the extent permitted by law

• Consider that responses may be subject to Freedom of Information Act requests

7. POINTS OF CONTACT

Primary Contact:

[Nina Montgomery] [Nina.Montgomery@fda.hhs.gov]

STATEMENT OF WORK

Peak Nitrogen Generators Service Agreement (DENHAFL)

Background The Food and Drug Administration (FDA) Denver Human and Animal Food Laboratory (DENHAFL) is one of the primary laboratories within the Office of Regulatory Affairs (ORA) responsible for the analysis of a wide variety of food additives and chemotherapeutic agents in seafood, game meats, milk, as well as other food and feed samples. These types of analyses require highly sophisticated instrumentation that are heavily reliant upon fully operational Nitrogen generator units. Membrane nitrogen generators are designed to take atmospheric air and through a process of compressors, membranes, and filters remove oxygen, dust, and moisture to provide high purity nitrogen that is used by instrumentation (such as triple quadrupole mass spectrometers) as curtain, source, and exhaust gases. Without the nitrogen produced by the generators suppling the instruments, the instruments could not be operational thus severely hampering work production/sample analysis. Over the last couple of years DENL has experience numerous issues with the nitrogen generators on-site and by extension have suffered with multiple periods of instrument downtime. Denver laboratory analyzes approximately 500-600 samples each year.

Objectives To acquire a Preventative Maintenance Agreement for the DENHAFL’s twelve (12) Peak Nitrogen Generators.

Purpose/Scope DENHAFL requires services from an Original Equipment Manufacturer trained technician capable of providing service support plans that cover routine maintenance and repair of the following equipment:

Manufacturer Model Serial No. Date Purchased Date Last Serviced Peak Genius 3010 SL0 A15-07-237 12/22/2015 04/29/2024 Peak Genius 3031 SL0 A14-07-066 08/03/2014 04/29/2024 Peak Genius 3031 SL0 A14-08-057 08/03/2014 07/23/2024 Peak Genius NM32LA SL0 A14-05-246 06/17/2014 07/24/2024 Peak Genius 1024 SL0 771053701 12/26/2019 07/25/2024 Peak Genius 1024 SL0 771061717 12/10/2020 07/25/2024 Peak Genius 1024 SL0 771052851 11/17/2019 07/25/2024 Peak Genius 1024 SL0 771061620 12/10/2020 07/24/2024 Peak Genius 1024 SL0 722081100 12/06/2022 04/24/2024 Peak Genius 1024 SL0 722090445 12/07/2022 04/23/2024 Peak Genius XE SCI 2 721100170 11/20/2021 10/7/2024 Peak Genius 1024 SLO 722090462 12/06/2022 04/24/2024

The contractor shall provide the requirements described in this Statement of Work (SOW).

Minimum Performance Requirements At a minimum, the support plan shall cover engineer labor and travel, at least one annual scheduled Preventative Maintenance visit per year, any repairs needed on the instrument during the coverage period, factory-certified replacement parts, and technical support.

Through the service agreement, the contractor shall provide the necessary personnel to execute on-site preventative maintenance and repair and other services as identified below:

1. Providing DENHAFL users with direct telephone and/or Internet technical support from

Original Equipment Manufacturer (OEM)-trained individuals.

2. The equipment portion of the service agreement shall include at least one annual

Preventative Maintenance visit per year per instrument and on-site repair calls when necessary.

a. The service contract must provide unlimited on-site visits with a maximum 5 calendar day on-site response time (for issues that cannot be resolved remotely via telephone or Internet).

b. All maintenance and repair activities (including warranty work) shall be accomplished in accordance with Original Equipment Manufacturer (OEM) specifications using OEM parts.

3. All PM or repair services shall be performed by OEM trained technicians (verified by the

OEM)

4. Contractor shall have access to the most current OEM factory training for hardware.

5. Contractor shall have access to the most current OEM factory parts – not build to order parts.

6. Contractor shall not use salvaged parts from other instruments for performing maintenance and repair.

7. All parts used in the PM and repairs must be guaranteed, factory tested, OEM quality parts.

8. PM visit includes replacing parts subject to wear as defined by OEM specific PM checklist with OEM factory parts.

9. Parts, labor and travel/per-diem costs for PM and repairs shall be included in the price of the service agreement.

Records and Reports- The Contractor shall, commensurate with the completion of each service call, 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/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.

Offerors are afforded the opportunity to inspect the system by contacting the Contract Specialist/Contracting Officer identified in the solicitation to schedule an appointment. Failure to inspect the system will not relieve the successful offeror from fully meeting the requirements of the resulting contract at the price offered.

Inspection and Acceptance All preventive maintenance is overseen and accepted by the instrument monitor upon completion of service. The Technical Point of Contact nominated for the generator unit will be identified at time of award.

508 Accessibility The following standards must be met:

• WCAG 2.0 A and AA

• E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements)

• E203 Access to Functionality (Appendix A, Application and Scoping Requirements)

• E204 Functional Performance Criteria (Appendix A, Application and Scoping Requirements)

• E205 Electronic Content (Appendix A, Application and Scoping Requirements)

• E208 Support Documentation and Services (Appendix A, Application and Scoping Requirements)

• Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria and Technical Requirements) 17

• 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and Technical Requirements)

• Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at https://www.hhs.gov/web/section-508/making-filesaccessible/ index.html, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery shall be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

• E207 Software (Appendix A, Application and Scoping Requirements)

• Chapter 5 Software (Appendix C, Functional Performance Criteria and Technical Requirements)

Deliverables

DELIVERABLE QUANTITY DELIVERY DATE

Annual Preventative Maintenance (1 per generator) 12 Schedule within 30 days of contract award

On Site Repairs As needed

Within 5 calendar days of determination by vendor that on site repair is required

Field Service Report 1 per each service

Upon completion of service

Delivery shall occur (Monday – Friday) between the times of 8:00 AM – 4:00 PM, excluding Federal holidays or Federal closures. Federal holidays are listed below, and specific dates can be found at the following site: https://www.opm.gov/policy-data-oversight/pay-leave/pay-administration/fact-sheets/holidays-work-schedules-and-pay:

New Year’s Day Juneteenth Day Veterans Day Martin Luther King, Jr. Day Independence Day Thanksgiving Day Presidents Day Labor Day Christmas Day Memorial Day Columbus Day

Shipping Destination FDA Denver Laboratory 1 Denver Federal Center 6th Avenue & Kipling St, Bldg. 20, Entrance W-10 Denver, Colorado, 80225

Point of Contact (POC) Will be identified at time of award.

Period of Performance One (1) base period plus one (1) option year.

Base Period: 7/20/25 – 7/19/2026 Option Year 1: 7/20/26 – 7/19/2027