RFQ_2025129639_9-8-25.docx

RFQ_2025127285

1. Contracting Office Address:

DHHS/FDA/OAGS/DAP

ATTN: Pamela Lee 11601 Lansdown Street 3WFN/13th Floor North Bethesda, MD 20852 Email: Pamela.Lee@fda.hhs.gov Telephone: 240- 402-3847

2. Solicitation Number: FDA-RFQ-2025127285

3. Subject: The U.S. Food and Drug Administration’s (“FDA”) Center for Tobacco Products (“CTP”) has a requirement for the maintenance of existing Rees Centron Presidio system, including calibration of sensors, software updates, upgrades, technical support, and maintenance coverage of software and hardware.

4. Classification Code: J066

5. NAICS Code: 811310

6. Response Date: September 10, 2025, 10:00 A.M. Eastern time due via email to the Primary Point of Contact listed in the sam.gov webpage for this combined synopsis-solicitation.

7. Name and Telephone Number of the Individual to Contact for Information Regarding the Solicitation: POC: Contract Specialist: Pamela Lee, pamela.lee@fda.hhs.gov Phone: 240-402-3847 Alternate POC: Contracting Officer: Janice Heard. Email address: Janice.Heard@fda.hhs.gov. Telephone: 215-717-3093.

8. Description: FDA is seeking the services of a contractor capable of maintaining existing Rees Centron Presidio system, including calibration of sensors, software updates, upgrades, technical support, and maintenance coverage of software and hardware.

(i) This is a solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included below.

(ii) This acquisition is issued as a Request for Quote.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2025-05, August 7, 2025.

(iv) Evaluation Criteria - All evaluation factors other than cost or price, when combined, are approximately equal to cost or price.

Statement of Work

Rees Centron Monitoring System Maintenance Agreement

1. Background

The Office of Pharmaceutical Quality and Research located in St. Louis, MO (referred to OPQR-STL) routinely tests the safety and efficacy of therapeutics available to consumers. Proper storage of these compounds is an integral component of the analysis performed and required by the Quality Management System. In 2015, a wired monitoring system was implemented using Rees Scientific’s COTS product, Rees Centron Presidio. The monitoring system consists of 84 wired monitored sensors with capability of 96 total sensors on 1 node located at OPQR-STL.

2. Objective The objective is to maintain existing Rees Centron Presidio system, including calibration of sensors, software updates, upgrades, technical support, and maintenance coverage of software and hardware.

3. Scope The contractor shall provide all necessary hardware, software, installation, and other services required to maintain existing monitoring system. The contractor will also be responsible for validating and calibrating the system (Installation Qualification/Operation Qualification).

OPQR shall provide existing network server, and client PCs capable of supporting the monitoring system, as well as Ethernet drops for network connectivity. Existing Rees Centron monitoring system owned by OPQR is to be maintained by the contractor.

4. Technical Requirements:

· Contractor shall provide remote technical support of Rees Centron Presidio system Monday-Friday during regular business hours, 9AM-5PM ET with phone, email, and WebEx virtual meetings capability.

· Contractor shall provide on-site troubleshooting and corrective maintenance within 3 business days of incident notification when remote technical support is not successful.

· Contractor shall include all costs of parts, software, labor, and travel related to corrective and preventative maintenance in this contract.

· All replacement parts shall be genuine OEM or furnished with documentation from OEM that the parts are supported by the OEM. For replacement of faulty sensors, the parts must come with factory 3-point calibration certificate including ISO17025 accreditation). Calibration of new part shall be performed in situ at installation with ISO 17025 certificate. Replacement of parts that affect the calibration of sensors will require same in situ calibration of affected sensors with certificate.

· Contractor shall provide one annual site visit for preventative maintenance that shall include:

· Replacement of consumables per recommendation of the manufacture, such as backup battery packs

· calibration of the 84 sensor inputs (57 TPT thermistors, 26 linear transducers reading in %RH, and 1 dry sensor for registering 3rd party system’s remote alarm) in situ with ISO 17025 certificate.

· installation of software updates and/or upgrades of software to ensure compliance with FDA IT standards

· Validation/qualification of System documenting services rendered, changes, and testing performed by contractor.

· Contractor shall support OPQR-STL future needs for expansion, that may be purchased at later date during contract period of performance by means of contract modification. This includes but is not limited to additional sensors and hardware to support added sensors if necessary. Upgrades to software considered additional features but necessary to maintain compliance with FDA OIMT standards.

· Contractor shall provide option to add sensors (temperature and/or humidity) during the contract period of performance. Sensors shall be installed and calibrated with ISO 17025 accredited certificate. Pricing and option to increase shall be a minimum of 2 inputs as needed in increments inclusive of travel, installation, and calibration of additional sensors.

· Contractor shall have certification and maintain their own Quality Management System per ISO 17025 or equivalent.

· Contractor shall comply with OPQR-STL safety procedures while on-site.

5. Contract Type

This is a firm-fixed price order.

6. Place of Performance

U.S Food and Drug Administration Center for Drug Evaluation and Research Office of Pharmaceutical Quality and Research 645 S Newstead Avenue St. Louis, MO 63110

7. Deliverables/Delivery Schedule The Contractor shall deliver necessary documentation certifying the procurement to the Contracting Officer’s Representative (COR) 30 days after contract award.

FDA has a requirement for support, and maintenance coverage of software and hardware for the following:

Base:

Option 1:

Option 2:

Option 3:

Option 4:

Software and licensing key, Software and User Manuals or equal to in a digital copy on a CD, DVD or digital download should be provided as applicable. If provided, CD, DVD and hard copies of deliverables shall not be required to be returned to the Contractor.

8. Period of Performance

Base Year: 09/17/2025 – 09/16/2026 Option Year 1: 09/17/2026 – 09/16/2027 Option Year 2: 09/17/2027 – 09/16/2028 Option Year 3: 09/17/2028 – 09/16/2029 Option Year 4: 09/17/2029 – 09/16/2030

9. Place of Performance

US FDA Office of Testing and Research 645 S Newstead St Louis, Mo 63110

10. Section 508 Requirements

The Section 508 accessibility standards applicable to this contract are:

· Must meet 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)

· 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 http://508.hhs.gov/, 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 should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

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

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

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

· Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria and Technical Requirements) Additional Conditions, Provisions and Clauses

1. The Government intends to award a single, firm-fixed price order resulting from this RFQ.

2. The provision at 52.212-1, Instructions to Offerors-Commercial Products and Commercial Services (Sep 2023), applies to this acquisition.

3. The provision at FAR 52.212-3, Offeror Representations and Certification – Commercial Products and Commercial Services (May 2024)(DEVIATION FEB 2025). (and Alternate I – Feb 2024),

4. The clause at 52.212-4, Contract Terms and Conditions – Commercial Products and Commercial Services (JAN 2025)(DEVIATION FEB 2025), applies to this acquisition.

5. The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Products and Commercial Services (JAN 2025) (DEVIATION FEB 2025) applies to this acquisition. The following additional FAR clauses cited in this clause are applicable:

52.204-27, Prohibition on a ByteDance Covered Application (Jun 2023) 52.219-11, Special 8(a) Contract Conditions (Jan 2017) 52.219-12, Special 8(a) Subcontract Conditions (Oct 2019) 52.219-28, Post Award Small Business Program Representation (Jan 2025) 52.222-3, Convict Labor (Jun 2003) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2025) 52.222-21, Prohibition of Segregated Facilities (Apr 2015) 52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) 52.222-50, Combating Trafficking in Persons (Nov 2021) 52.224-3, Privacy Training (Jan 2017) 52.225-13, Restrictions on Certain Foreign Purchases (Feb 2021) 52.232-33 Payment by Electronic Funds Transfer-System for Award Management (Oct 2018)

6. The following additional contract requirement(s) or terms and conditions apply:

a) https://www.acquisition.gov/far:

52.204-7, System for Award Management (Nov 2024) 52.204-13, System for Award Management Maintenance (Oct 2018) 52.204-16, Commercial and Government Entity Code Reporting (Aug 2020) 52.204-18, Commercial and Government Entity Code Maintenance (Jul 2016) 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Dec 2013)

b) http://www.hhs.gov/policies/hhsar/:

352.203-70, Anti-Lobbying (Dec 2015) 352.208-70, Printing and Duplication (Dec 2015) 352.211-3, Paperwork Reduction Act (Dec 2015) 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015) 352.223-70, Safety and Health (Dec 2015) 352.224-70, Privacy Act (Dec 2015) 352.224-71, Confidential Information (Dec 2015) 352.227-70, Publications and Publicity (Dec 2015) 352.233-70, Choice of Law (Overseas), (Dec 2015) 352.237-70, Pro-Children Act (Dec 2015) 352.237-71, Crime Control Act – Reporting of Child Abuse (Dec 2015) 352.237-72, Crime Control Act - Requirement for Background Checks (Dec 2015) 352.237-74, Non-Discrimination in Service Delivery (Dec 2015) 352.239-73, Electronic and Information Technology Accessibility Notice (Dec 2015) 352.239-74, Electronic and Information Technology Accessibility Notice (Dec 2015)

7. FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (Jan 2022)

a. All Invoice submissions for goods and or services must be made electronically through the U.S. Department of Treasury's Invoice Processing Platform System (IPP). http://www.ipp.gov/vendors/index.htm.

b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and

Conditions -

Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov.

c. 1. The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 - 5 business days of the contract award for new contracts or date of modification for existing contracts.

2. Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

3. The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

4. If your company is already registered to use IPP, you will not be required to re-register.

5. If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

d. Invoices that include time and materials or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable).

e. Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts. At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

• Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

• Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirects)- show rate, base and total amount;

• Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant;

• Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed;

• Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor;

• Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and

• Fee - amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

f. Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) list of all invoices submitted to date under the subject award, including the following:

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

(b) total amount of all payments received to date under the subject contract or order

(c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance.

g. Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

h. If the services are rejected for failure to conform to the technical requirements of the task order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

i. Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

j. The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

k. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION

REGULATION (HHSAR) (48 CFR CHAPTER 3) CONTRACT CLAUSES

1) HHSAR 352.232-71 Electronic Submission of Payment Requests (FEB 2022)

(a) Definitions. As used in this clause— Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request.

(End of Clause)

52.212-2 Evaluation—Commercial Products and Commercial Services. (Nov 2021)

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

(i) technical requirements (ability to meet all salient requirements); and, (ii) price. Technical, is significantly less important than price.

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(End of provision)