FDA 75F40126Q133989.pdf

This is a combined synopsis-solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) RFO Part 12, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a separate written solicitation will not be issued. The solicitation number 75F40126Q133989 is issued as a Request for Quote (RFQ) for a CICERO Spinning Disk or equal system upgrade for an existing Leica DMi8 microscope, S/N: 526325.

This acquisition is not set aside for small business concerns under North American Industry Classification System (NAICS) Code 334516 – Analytical Laboratory Equipment Manufacturing;

with a Small Business Size Standard of 1,000 employees. Any business, regardless of size, may submit a quote in response to this solicitation. This solicitation incorporates provisions and clauses by reference. The full text of provisions and clauses may be accessed electronically at https://www.acquisition.gov/far-overhaul.

Schedule of Supplies or Services and Prices/Costs.

Line Item 01 CICERO Spinning Disk or equal upgrade kit, to integrate seamlessly with an existing Leica DMi8 microscope, S/N: 526325, to include all necessary components and installed functionality to meet new, enhanced technical requirements as described below; includes all shipping fees and delivery F.o.b. Destination:

Quantity: 1

Unit: Each Price: ____________________ Country of Manufacture or Origin: ______________________________

GSA Contract Number (if applicable): ____________________________

Line Item 02 Option Year 01 Preventive maintenance-repair (PM) service agreement for Leica DMi8 microscope, S/N: 526325, to include CICERO spinning disk components, THUNDER imager system, and meeting the minimum technical requirements set forth below:

Unit: 12 consecutive months Annual Price: ____________________

Period of Performance: TBD

Line Item 03 Option Year 02 Preventive maintenance-repair (PM) service agreement for Leica DMi8 microscope, S/N: 526325, to include CICERO spinning disk components, THUNDER imager system, and meeting the minimum technical requirements set forth below:

Unit: 12 consecutive months Annual Price: ____________________

Period of Performance: TBD https://www.acquisition.gov/far-overhaul

Background and Requirement The U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Office of Vaccine Research and Review (OVRR), Laboratory of Bacterial Parasitic & Allergenic Products (DBPAP), requires a CICERO/THUNDER Imager Spinning Disk or equal upgrade to an existing Leica DMi8 microscope, S/N: 526325, to expand the laboratory's ability to perform advanced, high-speed fluorescence imaging and live-cell imaging experiments with improved speed, sensitivity, and reduced phototoxicity. The CICERO system includes advanced camera capabilities and specialized objectives for high-resolution imaging.

Critical to this acquisition is the use of “brand name or equal” when describing the instrument as a whole and/or specific components and their salient performance characteristics as it relates to a scientific need. In this case, “brand name or equal” applies to a spinning disk upgrade/hardware package specifically designed for seamless integration with Leica DMi8 microscopy systems. Upon successful installation of the CICERO/THUNDER Imager Spinning Disk or equal upgrade, the existing Leica DMi8 microscope shall meet an advanced set of technical requirements as set forth below. Where an offeror submits an “equal” upgrade for consideration, to be accepted it shall meet all the specific physical, functional, and performance specifications listed below.

Salient characteristics that a CICERO/THUNDER imager spinning disk or equal upgrade kit shall meet, to include all necessary components and installed functionality, are as follows:

*Shall be a CICERO/THUNDER imager or equal spinning disk upgrade kit to include CTR Advanced Plus board, CICERO spinning disk, laser diode illuminator, and all other components necessary to the successful upgrade of the microscope;

*Shall seamlessly integrate with an existing Leica DMi8 microscope, S/N: 526325.

New, salient characteristics that a CICERO/THUNDER imager spinning disk or equal upgrade kit provides and shall meet, to include all necessary components and installed functionality, are as follows:

*Dual Imaging Modes. System shall seamlessly transition between traditional camera-based widefield (with THUNDER) and physical confocal spinning disk modes within the same software platform;

*True Optical Sectioning Hardware. Using a CrestOptics CICERO spinning disk unit, system shall be capable of physically blocking out-of-focus light before it reaches the camera sensor, a fundamentally superior approach over the computational methods used in widefield THUNDER systems;

*Quantitative Fluorescence Measurements with Reduced Background Bias. Because background fluorescence is physically suppressed rather than computationally subtracted, intensity measurements from spinning disk images are more reliable for quantitative assays (e.g., FRAP, ratiometric imaging, protein concentration measurements), reducing the risk of algorithm-introduced artifacts;

*Significantly Improved Axial (Z) Resolution. Shall enable cleaner 3D reconstructions of thick specimens such as organoids, spheroids, or tissue slices, making them suitable for high-fidelity volumetric rendering and quantitative colocalization analysis;

*High-Powered Diode Lasers. System shall benefit from upgrade from traditional widefield LED illumination to an 89-North LDI4 multimode diode laser system, providing higher irradiance for improved signal in deep or densely labeled samples;

*Synergistic Blur Removal. System shall be capable of mathematically removing residual pinhole crosstalk and haze that can persist in ultra-thick samples, yielding sharper images than either approach alone;

*Reduced Phototoxicity and Photobleaching Compared to Point-Scanning Confocal. The spinning disk simultaneously illuminates the sample with hundreds of parallel laser beams, dramatically reducing per-point dwell time, minimizing phototoxicity and photobleaching, thus making it far more advantageous for live-cell imaging over extended periods than single-point laser scanning confocal systems;

*High-Speed Acquisition for Large Samples and Live-Cell Imaging. Upgrade shall enable frame rates of up to several hundred frames per second, reducing motion artifacts during long acquisitions of large samples and enabling capture of rapid intracellular dynamics — such as vesicle trafficking, mitochondrial dynamics, and calcium signaling;

*Dedicated High-Sensitivity Camera for Spinning Disk Detection. Additional spinning disk– dedicated scientific camera translates to improved signal-to-noise ratio at lower laser powers and reduced photodamage.

Delivery, Installation, Training and Additional System Requirements for CICERO/THUNDER spinning disk or equal upgrade kit and components:

*System must be a newly manufactured unit, not used and refurbished or previously used for demonstration;

*System shall be a turn-key solution i.e., the Contractor shall be responsible for providing all hardware, components, instruments, software, and that otherwise required to meet these specifications and the FDA’s stated need;

*Contractor shall provide all labor, travel, and tools to install the equipment at the address provided below, to include shipping. The system shall be delivered with all necessary supplies, accessories, and standard kits required for installation, start-up, and qualification tests;

*Installation shall be conducted by factory certified service personnel, who shall demonstrate that all modules start up properly, are correctly installed and connected.

*System shall include onsite Installation Qualification (IQ), and Operational Qualification (OQ) for the hardware and instrument controller software. Qualifications test shall be reviewed and approved by an FDA representative before/after installation of the equipment and execution of protocols.

Qualification reports shall include the standard operating procedures and the allowed manufacturer limits for the instrument. Also, qualification tests shall meet Chapter 21 CFR part 11 requirements;

all documentation shall be provided in electronic format;

*System and associated accessories shall include operations and maintenance manuals covering proper operation, routine maintenance, and troubleshooting for the system and controlling software.

All manuals and documentation shall be provided in hard copy and/or electronic format;

*Upon acceptance of the system, the Contractor shall provide on-site operator training/familiarization for 3-5 users. Such familiarization shall include system operations, calibration, optimization, troubleshooting and basic operational maintenance procedures;

*System shall be warranted for not less than one (1) year from FDA acceptance of the system(s) to include on-site training. Warranty shall be included with the equipment and not separately priced.

Warranty services shall include troubleshooting capabilities based on complete knowledge of the entire system, immediate access to replacement parts, immediate access to system improvements and updates, labor and travel costs. Phone and email technical support shall be included for a minimum of one (1) year.

Offerors are afforded the opportunity to inspect the system by contacting the Contract Specialist/Contracting Officer identified herein 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.

Minimum Technical Requirements are as follows for preventive maintenance and repair service for a Leica DMi8 microscope, S/N: 526325, to include CICERO/THUNDER imager spinning disk upgrade and all upgrade components:

*One (1) planned annual preventive maintenance (PM) to include labor, travel and parts to ensure the system is performing optimally and to factory specifications;

*Prioritized on-site response time for remedial services (critical services);

*Unlimited access to Leica Technical and Remote Support Monday through Friday during normal business hours (8:30am – 5:00pm local time, excluding Federal holidays);

*Shall include software and firmware updates as required by the Original Equipment Manufacturer (OEM) either remotely or in conjunction with a scheduled preventive maintenance or corrective maintenance visit (updates are defined as changes of the existing software version that are intended to improve its performance);

*All maintenance activities shall be performed by formally trained and certified technicians and/or engineers, following OEM specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc.;

*All PM and/or repair service pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc.

Service Records and Reports *The Contractor shall, commensurate with the completion of each service call or preventive 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.

Delivery – FOB Destination U.S. FDA Center for Biologics Evaluation and Research (CBER)

OVRR- DBPAP

10903 New Hampshire Avenue Silver Spring, MD 20993-0002

Estimated Option Periods of Performance Option Year 1 12 consecutive months to commence upon expiration of initial one-year warranty;

Option Year 2 12 consecutive months to commence upon expiration of option year one, Deliveries, installations, or services shall not be scheduled during Federal Holidays or Federal Closures as determined by Executive Orders or opm.gov. Federal Holidays are as follows:

New Year’s Day Martin Luther King, Jr.’s Birthday Washington’s Birthday Memorial Day Juneteenth Independence Day

Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day

Contract Type Firm Fixed-Price

Contract Clauses:

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

Also, the full text of a clause may be accessed electronically at this/these address(es):

https://www.acquisition.gov/far-overhaul and https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

The clause at RFO 52.212-4 Terms and Conditions - Commercial Products and Commercial Services (DEVIATION) (RFO AUG 2025) is applicable to this solicitation. The following addenda apply:

52.203-17 Contractor Employee Whistleblower Rights (Nov 2023) 52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) 52.204-13 System for Award Management Maintenance (DEVIATION) (RFO AUG 2025) 52.209-6 Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, Proposed for Debarment, or Voluntarily Excluded (DEVIATION) (RFO NOV 2025 52.209-10 Prohibition on Contracting with Inverted Domestic Corporations (DEVIATION) (RFO

NOV 2025

52.222-3 Convict Labor (DEVIATION) (RFO SEP 2025) 52.222-36 Equal Opportunity for Workers with Disabilities (DEVIATION) (RFO SEP 2025) 52.222-50 Combating Trafficking in Persons (DEVIATION) (RFO SEP 2025) 52.222-51 Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (DEVIATION) (RFO

SEP 2025)

52.222-90 Addressing DEI Discrimination by Federal Contractors (DEVIATION) (RFO APR 2026) 52.223-23 Sustainable Products and Services (DEVIATION) (RFO SEP 2025) 52.225-5 Trade Agreements (Nov 2023) 52.226-8 Encouraging Contractor Policies to Ban Text Messaging While Driving (MAY 2024) 52.232-33 Payment by Electronic Funds Transfer-System for Award Management (Oct 2018) 52.232-36 Payment by Third Party (Deviation Date) 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Mar 2023) 52.233-3 Protest after Award (DEVIATION) (RFO SEP 2025) 52.233-4 Applicable Law for Breach of Contract Claim (Oct 2004) 52.240-91 Security Prohibitions and Exclusions (Deviation Date) 52.244-6 Subcontracts for Commercial Products and Commercial Services (DEVIATION) (RFO

SEP 2025)

https://www.acquisition.gov/far-overhaul https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_203_17 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_203_19 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_204_13 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_209_6 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_209_10 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_222_3 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_222_36 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_222_50 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_222_51 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_222_90 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_223_23 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_225_5 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_226_8 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_232_33 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_232_36 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_232_40 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_233_3 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_233_4 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_240_91 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_244_6

HHSAR Clauses 352.232-71 Electronic Submission of Payment Requests (APR 2026) (RFO DEVIATION)

(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 must 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)

352.239-79 Information [and Communication] Technology Accessibility. [Feb 2024])

[(DEVIATION)]

[(a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all information and communication technology (ICT) supplies, products, platforms, information, documentation, and services support developed, acquired, maintained or delivered under this contract or order must comply with the Revised 508 Standards, which are located at 36 C.F.R. 1194.1 and Appendices A, B, and C, and are available at https://www.hhs.gov/web/section-508/index.html.

(b) Additional Section 508 accessibility standards applicable to this contract or order may be identified in the specification, statement of work, or performance work statement. If it is determined by the Government that ICT supplies, products, platforms, information, documentation, and services support provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(c) In the event of a modification(s) to this contract or order, which adds new ICT supplies or services or revises the type of, or specifications for, supplies, products, platforms, information, documentation, or services support, the Contracting Officer shall require that the Contractor submit a completed HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibility-checklists/index.html) or an Accessibility Conformance Report (ACR) (based on the Voluntary Product Accessibility Template (VPAT) see https://www.itic.org/policy/accessibility/vpat), and any other additional information necessary to assist the Government in determining that the ICT supplies or services conform to Section 508 accessibility standards. If it is determined by the Government that ICT supplies, products, platforms, information, documentation, and services support provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

https://www.hhs.gov/web/section-508/index.html https://www.hhs.gov/web/section-508/accessibility-checklists/index.html https://www.itic.org/policy/accessibility/vpat

(d) If this is an Indefinite-Delivery type contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests that include ICT supplies, products, platforms, information, documentation, or services support will define the specifications and accessibility standards for the order. In those cases, the Contractor shall be required to provide a completed HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibility-checklists/index.html) or an ACR (based on the VPAT see https://www.itic.org/policy/accessibility/vpat), and any other additional information necessary to assist the Government in determining that the ICT supplies, products, platforms, information, documentation, or services support conform to Section 508 accessibility standards. If it is determined by the Government that ICT supplies and services provided by the Contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(e) The contractor shall identify to the Contracting Officer any perceived exception or exemption to Section 508 requirements.

(End of Clause)]

Acceptance: Supplies and/or services delivered hereunder shall be inspected and accepted at destination by the Governments Contracting Officer Representative (COR) specified at award. If the supplies or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the Contracting Officer.

The COR as identified on any subsequent Contract in Box 6 a. on Form 347 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 contact information for the Contracting Officer’s Representative (COR) is:

Name: TBD Email:

Phone:

The Contracting Officer as identified on any subsequent Contract in Box 23 on Form 347 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.

https://www.hhs.gov/web/section-508/accessibility-checklists/index.html https://www.itic.org/policy/accessibility/vpat

The contact information for the Contracting Officer is:

Name: Tim Walbert Email: timothy.walbert@fda.hhs.gov Phone: (301) 796-1768

Payment terms. Net 30 days after government acceptance of a proper invoice. Invoices and payments for post-warranty and other preventive maintenance or certification services shall be made no more frequently than monthly in arrears. Advance payments will not be made.

Invoice Submission 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) (see 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 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 Products and Commercial Services 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.

mailto:timothy.walbert@fda.hhs.gov http://www.ipp.gov/vendors/index.htm

(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.

(1) 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:

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

*Invoice number, amount, & date submitted *Corresponding payment amount & date received *Total amount of all payments received to date under the subject contract or order, 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.

Notice Regarding the Use of Macros in Submitted Documents Be advised that FDA does not accept documents which contain the use of macros. When submitting documents via email, DO NOT include .exe, .mso, or any other executable file types that could potentially trigger email security protections (i.e. email blocks, quarantine).

Document submissions required throughout the award period(s) shall not have macro-enabled functionality and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.

RFQ Provisions:

This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. The full text of any provision may be accessed electronically the following addresses:

https://www.acquisition.gov/far-overhaul and https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html.

FAR Provisions:

52.203-18 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements-Representation (Jan 2017) 52.204-7 System for Award Management—Registration 52.204-7 System for Award Management

(DEVIATION) (RFO AUG 2025)

52.222-18 Certification Regarding Knowledge of Child Labor for Listed End Products (Feb 2021) 52.225-6 Trade Agreements Certificate (Feb 2021) 52.240-90 Security Prohibitions and Exclusions Representations and Certifications 52.204-90 Offeror Identification (DEVIATION) (RFO AUG 2025)

HHSAR Provisions:

352.239-78 Information and [Communication] Technology Accessibility Notice (Feb 2024) [(Deviation)]

(a) Any offeror responding to this solicitation must comply with established HHS Information and Communication Technology (ICT) accessibility standards. Information about Section 508 is available at https://www.hhs.gov/web/section-508/index.html.

https://www.acquisition.gov/far-overhaul https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_203_18 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_204_7 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_222_18 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_225_5 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_240_90 https://www.hhs.gov/web/section-508/index.html

(b) The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239-79 Information and Communication Technology Accessibility. In order to facilitate the Government’s determination whether proposed ICT supplies, products, platforms, information, and documentation meet applicable Section 508 accessibility standards, offerors must submit an appropriate HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibility-checklists/index.html) or an Accessibility Conformance Report (ACR) (based on the Voluntary Product Accessibility Template (VPAT) see https://www.itic.org/policy/accessibility/vpat), in accordance with the completion instructions.

The purpose of the checklists and conformance reports are to assist HHS acquisition and program officials in determining whether proposed ICT supplies, products, platforms, information, and documentation conform to applicable Section 508 accessibility standards. Checklists and ACRs evaluate—in detail—whether the ICT conforms to specific Section 508 accessibility standards and identifies remediation efforts needed to address conformance issues.

(c) If an offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies, products, platforms, information, documentation, or services support delivered do not conform to the described accessibility standards, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(d) In order to facilitate the Government's determination whether proposed ICT supplies meet applicable Section 508 accessibility standards, offerors must submit an Accessibility Conformance Report, in accordance with its completion instructions and tailored to the requirements in the solicitation. The purpose of the Report is to assist HHS acquisition and program officials in determining whether proposed ICT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and document, in detail, whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available at https://Section508.gov/.

(e) In order to facilitate the Government’s determination whether proposed ICT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the ICT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(f) Respondents to this solicitation must identify any inability to conform to Section 508 requirements. If an offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the described accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(g) Items delivered as electronic content must be accessible to HHS acceptance criteria.

Checklists for various formats are available at http://508.hhs.gov/. Materials, other than items incidental to contract management, that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Contracting Officer’s Representative.

(End of provision)

The provision at FAR 52.212-1 Instructions to Offerors - Commercial Products and Commercial Services (DEVIATION)(RFO Aug 2025) applies to this solicitation and has been https://www.hhs.gov/web/section-508/accessibility-checklists/index.html https://www.itic.org/policy/accessibility/vpat https://section508.gov/ http://508.hhs.gov/ tailored to reflect customary commercial practice (see RFO Subpart 12.205(a)(1). The following addenda apply:

Technical Acceptability. Offerors shall provide sufficient technical information necessary for the government to conclusively determine that the offered service/equipment/product meets all the technical requirements herein, to include descriptive material, literature, brochures and other information corresponding to each minimum technical requirement which demonstrates the capabilities of the offered system.

Price proposed must be detailed and shall represent the offeror’s response to the schedule of supplies/services above.

The Quoter shall submit a written Accessibility Conformance Report (ACR) for each item not in compliance with 508 standards identified in clause 352.239-74, describing how the item(s) will fully address the accessibility requirements outlined in the solicitation; and a description of the evaluation methods the offeror will use to validate for conformance to 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).

For this requirement, only invoices and service records/reports are anticipated to be applicable to the 508 requirement.

NOTE: Submission of the ACR is required for documentation purposes. In accordance with agency purchasing procedures, solutions which do not conform fully to the applicable 508 standards may still be purchased by FDA if the FDA Requiring Office obtains the appropriate approval. In order to obtain approval, the FDA must have an ACR from the vendor documenting the level of conformance of the items being purchased.

Unique Entity Identifier (UEI). To be considered for an award the offeror shall be registered and active in SAM (www.sam.gov) by the date and time set forth for receipt of quotes/proposals.

Proprietary and/or confidential information shall be clearly marked. Respondent’s SAM Unique Entity Identifier (UEI) number shall be included with quote.

The Contractor’s quote shall also clearly show that the Contractor has selected the appropriate certification under FAR 52.222-48 (see below).

Representations and Certifications. In addition to completing the representations and certifications at FAR 52.212-3, the Contractor's proposal shall also clearly show that the Contractor has selected the appropriate certification under FAR 52.222-48 as follows:

NOTE: This solicitation is being issued under the premise that the offeror will certify that the combination of equipment maintenance/service it will propose to fulfill this requirement is exempt from the Service Contract Act per the conditions set forth in FAR 52.222-48 & FAR 22.1002-1(e).

If the Contractor certifies that the company is exempt under the terms and conditions of 52.222-48, then clause 52.222-51 will be applicable to the resulting order. In the event that a contractor does not make this certification, the traditional Service Contract Act clauses 52.222-41, and 52.222-43 shall be included in the resulting order award as well as SCA Wage Determination #WD 2015-4269 (Rev. 32) dated 05/12/2026. The applicable Wage Determination can also be accessed at the following link: https://sam.gov/wage-determination/2015-4269/32.

https://www.itic.org/policy/accessibility/vpat https://www.itic.org/policy/accessibility/vpat http://www.itic.org/policy/accessibility http://www.sam.gov/ https://sam.gov/wage-determination/2015-4269/32

The provision at FAR 52.222-48 Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Certification (DEVIATION (RFO SEP 2025) applies as follows:

(a) The offeror shall check the following certification:

CERTIFICATION

The offeror [ ] does [ ] does not certify that—

(1) The items of equipment to be serviced under this contract are used regularly for other than Government purposes, and are sold or traded by the offeror (or subcontractor in the case of an exempt subcontractor) in substantial quantities to the general public in the course of normal business operations;

(2) The services will be furnished at prices which are, or are based on, established catalog or market prices for the maintenance, calibration, or repair of equipment.

(i) An “established catalog price” is a price included in a catalog, price list, schedule, or other form that is regularly maintained by the manufacturer or the offeror, is either published or otherwise available for inspection by customers, and states prices at which sales currently, or were last, made to a significant number of buyers constituting the general public.

(ii) An “established market price” is a current price, established in the usual course of trade between buyers and sellers free to bargain, which can be substantiated from sources independent of the manufacturer or offeror; and

(3) The compensation (wage and fringe benefits) plan for all service employees performing work under the contract are the same as that used for these employees and equivalent employees servicing the same equipment of commercial customers.

(b) Certification by the offeror as to its compliance with respect to the contract also constitutes its certification as to compliance by its subcontractor if it subcontracts out the exempt services. If the offeror certifies to the conditions in paragraph (a) of this provision, and the Contracting Officer determines in accordance with FAR 22.1003-4(c)(3) that the Service Contract Act—

(1) Will not apply to this offeror, then the Service Contract Act of 1965 clause in this solicitation will not be included in any resultant contract to this offeror; or

(2) Will apply to this offeror, then the clause at 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment- Requirements, in this solicitation will not be included in any resultant contract awarded to this offeror, and the offeror may be provided an opportunity to submit a new offer on that basis.

(c) If the offeror does not certify to the conditions in paragraph (a) of this provision—

(1) The clause in this solicitation at 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements, will not be included in any resultant contract awarded to this offeror; and

(2) The offeror shall notify the Contracting Officer as soon as possible, if the Contracting Officer did not attach a Service Contract Act wage determination to the solicitation.

(d) The Contracting Officer may not make an award to the offeror, if the offeror fails to execute the certification in paragraph (a) of this provision or to contact the Contracting Officer as required in paragraph (c) of this provision.

Buy American Act and Executive Order 14005.

If applicable, respondent shall provide place (country) of product/service manufacture or performance and any other applicable information to enable review and analysis pertaining to the requirements under the Buy American Act and requirements relating to Executive Order 14005 Ensuring the Future is Made in All of America by All of America’s Workers, in the event that a nonavailability waiver request submitted through the Made in America Office (MIAO) Digital Waiver Portal is required. If the respondent does not provide a response for a line item, or if the respondent’s SAM.gov online representation for FAR provision 52.225-4, Buy American-Free Trade Agreements-Israeli Trade Act Certificate, is not completed or is unclear, the Government will presume that the item is made in America.

Line Item No. Country of Origin

Period for Acceptance of Offerors. The offer agrees to hold the prices in its offer firm through September 30, 2026.

The Government is not responsible for locating or securing any information which is not identified in the quote; however, the Government reserves the right to obtain information for use in the evaluation from any sources including sources outside of the Government. The Government reserves the right to request additional information at any time.

Microsoft Suite Documents Containing Macros. The offeror or applicant shall submit all electronic documents for Microsoft Office suite products without the use of “macros”. When submitting proposals via email, DO NOT include .exe, .mso, or any other executable file types that could potentially trigger email security protections (i.e. email blocks, quarantine).

If the offeror or applicant submits documents that contain macros, macro referenced files, and/or executable files, the Government will not be able to view or open such documents and the submission will be considered non-responsive to the solicitation. No additional time will be given to an offeror or applicant to correct the document submission, and the Government will not inform the offeror or applicant that their submission is non-responsive prior to award. It is the offeror’s or applicant’s responsibility to ensure all electronic documents are submitted without the use of macros.

The provision at 52.212-2 Evaluation—Commercial Products and Commercial Services (DEVIATION) (RFO AUG 2025) is applicable to this solicitation and has been tailored for this acquisition (see RFO Subpart 12.205(a)(2). The following addenda apply:

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. In this case, the Government intends to award a Firm‐Fixed‐Price contract resulting from this Solicitation to the lowest-priced technically-acceptable and responsible offeror. Offers will be evaluated on their ability to meet the requirements provided herein. The lowest priced offer will be evaluated first. If the lowest priced offeror is not technically acceptable, the next lowest priced offer will be evaluated and so on until a technically acceptable offer is determined.

The following factors apply:

(i) Technical Acceptability

(ii) Price

Technical Acceptability will be determined by review of information submitted by the offeror who shall provide sufficient descriptive material to demonstrate the proposed meet all requirements and by addressing each technical requirement as stated above for the Government to conclusively determine the proposed will satisfy its requirement.

(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. The evaluation of options does not obligate the Government to exercise the option(s).

A written notice of award or acceptance of an offer will be transmitted via email 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.

The Government is not responsible for locating or securing any information which is not identified in the proposal and reserves the right to request additional information or conduct discussions at any time.

The Government reserves the right to request additional information or conduct discussions at any time. Once the Government determines the offeror that is the best-suited (i.e., the apparent successful offeror), the Government reserves the right to communicate with only that offeror to address any remaining issues, if necessary, and finalize a contract with that offeror. These issues may include technical, price or other issues.

The Government's determination of technical acceptability in no way relinquishes the Awardee's contractual…