css 75F40126Q132448.pdf

Combined Synopsis/Solicitation 76F40126Q132448

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 request for proposals.

The solicitation number is 76F40126Q132448. This solicitation is issued as a Request for Quote (RFQ). For information regarding this solicitation, please contact Howard Nesmith by e-Mail at howard.nesmith@fda.hhs.gov.

The appropriate North American Industry Classification System (NAICS) Code is 334516 - Analytical Laboratory Instrument Manufacturing; with a Small Business Size Standards in number of employees 1,000. This requirement is being competed unrestricted and made available to Full and Open competition, meaning any qualified vendor regardless of size status may submit a quote.

Statement of Need/Requirements:

The U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), requires the acquisition of an Electro-Mechanical Dynamic Load Frame System and post-warranty Service and Maintenance Agreement

Schedule of Items/Services:

Item #1 Electro-Mechanical Dynamic Load Frame System To meet below Minimum Technical Requirements

Manufacturer: _____________________

Country of Origin: _________________

Model: __________________________

Item/Part Number: ________________

System Price: _____________________

GSA Contract Number: ______________________ (If Applicable) Rigging service is required to transport load frame to installation location on the ground floor of the same building as the delivery dock. FDA will work with system provider to reasonably accommodate an on-site visit and discuss logistics.

PRICE QUOTES SHALL BE FOB DESTINATION INCLUSIVE OF ALL SHIPPING,

HANDLING, DELIVERY, INSTALLATION, TRAINING CHARGES.

Item #2 Option Period #1 (Base Year) Electro-Mechanical Dynamic Load Frame System Post Warranty Service/Maintenance To meet above Minimum Post Warranty Service/Maintenance Requirements mailto:howard.nesmith@fda.hhs.gov

Period of Performance: To Begin Upon Expiration of Instrument Warranty and Shall Continue for a Period of 1-Year

Annual Service/Maintenance Agreement Price: $______________

Item #3 Option Period #2 Electro-Mechanical Dynamic Load Frame System Post Warranty Service/Maintenance

Period of Performance: Upon Expiration of Previous Period of Performance and Shall Continue

Item #4 Option Period #3 Electro-Mechanical Dynamic Load Frame System Post Warranty Service/Maintenance

Period of Performance: Upon Expiration of Previous Period of Performance and Shall Continue

Item #5 Option Period #4 Electro-Mechanical Dynamic Load Frame System Post Warranty Service/Maintenance

Period of Performance: Upon Expiration of Previous Period of Performance and Shall Continue

GSA Contract Number: ______________________ (If Applicable)

Background:

The FDA/CDRH, currently has an electro-dynamic load frame system with a 3,000 N capacity.

This capacity is appropriate for small medical devices and/or small material samples. However, larger medical devices and/or material samples require increased load capacity. As such, CDRH is limited in the size and materials we can currently test on the existing electro-dynamic load frame.

Investing in a new electro-dynamic load frame system with a 10,000 N capacity would greatly expand CDRH’s ability to test medical devices and materials.

Minimum Technical Requirements:

Any catalog number, manufacturer brand name, or proprietary description used in this solicitation is used as descriptive only, not restrictive, and used to indicate type, function, or desired quality.

• Shall be floor-standing and a dual support column design.

• Shall be of an oil-free (i.e., not hydraulic) design to minimize contamination potential of specimens and to minimize maintenance.

• Shall have a method to ensure the frame is level with the floor (e.g., 4 leveling feet or foot plates.

• Due to the agency’s constraints such as lab dimensional constraints and moving logistics, the up righted load frame dimensions shall be: Height (defined as perpendicular to ground) shall be capable of being under 92” (2337 mm). This is the lab door height. The load frame height shall be no more than 140” (3556 mm).

o Width shall be under 48” (1219 mm).

o Depth shall be under 48” (1219 mm).

o These dimensions do not include mounted touchscreen operator display(s), dashboard(s), tablet(s), or jog control pendant(s). With mounted operator tablet(s), dashboard(s), or jog control pendant(s) the system shall be no more than 140” x 65” x 60” (3556 mm x 1651 mm x 1524 mm) in height, width, and depth.

• Shall be no more than 3,200 lbs. (1451 kg) without accessories.

• Shall have a space between columns (i.e., daylight opening) of 16” (406 mm) or more. This space is needed to facilitate a multitude of samples, sensors, and other experimental equipment.

• Shall have an adjustable vertical test space capable of 30” (762 mm) or more.

• Crosshead shall have the ability to be lowered so the vertical test space is at 4” (102 mm) or less from the baseplate.

• Shall have an electrically powered crosshead lift system with manual lever clamps. Interface with this motion system shall be controllable with a control panel or jog pendent. This electromechanical positioning system should have the ability to lock (e.g., clamp and tighten) the crosshead in place to the columns.

• Main actuator shall be housed in the crosshead on the upper side of the test space.

• Load cell for the load frame shall not be incorporated into the moving actuator.

• Load frame system shall have mounting slots and/or threaded holes on the base plate so the user can attach accessories to the load frame base plate.

• Power requirements (without computer and accessories) shall be compatible with 208-240 V, single phase, 50-60 Hz, 32 Amp outlets.

• Force or torsion capacity shall dictate the types and sizes of materials and/or components it can test. Therefore, shall have:

o A static force capacity of ±1,500 lbf (6.7 kN) or more.

o A dynamic force capacity of ±2,200 lbf (9.8 kN) or more.

o A dynamic torque capacity of ±800 lbf-in (100 N-m) or more.

o A load and torque measurement accuracy of at least : ±0.75% of indicated load or torque, or ±0.0075% of load cell capacity, whichever is greater.

• Motion capabilities shall dictate the type of displacements and/or strains it can impose on a material or assembly. Therefore, the load frame shall have:

o Total (peak to peak) linear stroke capacity of at least 2” (50.8 mm) or more.

o Total rotation capacity of at least ± 120° or more.

o Since the load frame will have the ability to perform dynamic (e.g., fatigue) experiments, the speed of the system shall be adjustable up to at least 100 Hz.

• Shall have an operating temperature range of +12 to +30 °C or wider.

• Shall have an allowable operating humidity of 10% to 90% (non-condensing).

• Shall have features (i.e., safety interlocks) that protects the load frame and specimens when the operator moves the crosshead. One of these features shall be to detect and prevent high forces on the sample during operator setup. Shall also have:

o Safety interlocks and emergency stop capabilities.

o Optional safety guard compatibility.

• Shall come with a controller (e.g., jog pendent) that can be either handheld or attached to the load frame so the user can easily control the system during test specimen setup.

o The controller shall be able to jog the crosshead for general and precision positioning.

o The controller shall have an emergency stop button to safely stop the system when triggered.

• Shall have two controllable axes of motion o Axial and torsional o Capability to do bi-modal and tri-modal control.

• Data acquisition shall have:

o At least 8 kHz continuous synchronous data acquisition on all channels.

o At least 3 closed loop control and data acquisition channels for position, digital position, and load on the linear axis.

o At least 3 closed loop control and data acquisition channels for angular position, digital angular position, torque and on the torsional axis.

o At least 2 closed-loop control and data acquisition channels for other input sensors.

o At least 2 analogue data inputs and 4 analogue data outputs.

o At least 8 digital inputs and 8 digital outputs.

• Shall come with one compatible (1) load cell:

o Shall have a usable range from maximum capacity down to 1/200th of the maximum capacity or better.

o Accuracy shall be at least ±0.75% or better of the output reading from the maximum capacity or ±0.0075% of its maximum capacity, whichever is better.

o The overload capacity shall be at least 125% without being damaged and 250% without mechanically failing the load cell. Expensive repairs and downtime are costly, and this reduces that potential cost and downtime.

o System shall be temperature compensated.

o System setup shall have automated features to automatically recognize when connected (i.e., manual selection of calibration/data files is not necessary).

o Shall be suitable for different testing modes such as cyclic and completely reversed loading, quasi-static tension, and quasi-static compression.

o Dynamic fatigue testing systems shall have significant mass in the moving testing assembly and shall have automated inertial compensation to account for this (i.e., remove amplitude and phase errors).

o Shall be able to survive at least 1 billion completely reversed cycles at max load.

o Shall comply with ASTM E4, ISO 7500-1 class 0.5.

• Shall come with system controller that is capable of:

o Mouse and keyboard input.

o Transfer data via USB flash drives.

• System shall not require internet connectivity to operate as described in these salient requirements.

• System shall also:

o Be compatible with dynamic testing software supporting waveform generation.

o Have real-time calculation capabilities.

o Have advanced control modules for frequency sweeps and amplitude control o Have operator security features with password and/or PIN access control.

o Have test review and data analysis capabilities.

• System shall have common, non-proprietary, data transfer ports (e.g., USB ports) to transfer sample data (e.g., results of tensile testing, compression testing) acquired from the load frame system.

• System shall be able to export data in common, non-proprietary, data formats (e.g., *.txt, *.csv, *.xls, *.xlsx).

• System shall have the following optional accessories:

o A safety shield / guard that protects the user from potentially dangerous sample fragments that are released during testing.

o An extension kit which allows the actuator reach to be lengthened so that water baths or thermal ovens may be used. This kit should allow the length of the pull rod actuator to be lengthened at least 6 to 10”.

o One (1) set of compression platens (at least 3” in diameter) with LVDT extensometer mounting capabilities. The compression platens shall be able to sustain the load frame’s linear and torsional loads.

o One (1) LVDT deflection sensor that is compatible with the compression platens.

The deflection sensor shall have an operation range of ±0.5 mm or greater.

o One (1) set fatigue rated manual mechanical grips which are rated for the system’s full linear and torsional load capacity. The grips shall come with one full set of flat serrated wedges which accommodate a specimen engagement thickness of up to 0.25”, an engagement width of at least 1” wide, and an engagement height of at least 1”.

o One (1) set fatigue rated pneumatically operated mechanical grips which are rated for the system’s full linear and torsional load capacity. The grips shall come with one full set of flat serrated wedges which accommodate a specimen engagement thickness of up to 0.25”, an engagement width of at least 1” wide, and an engagement height of at least 1”.

o One (1) non-contact video extensometer capable of being strain verified to ASTM E83.

o One compatible (1) dynamic extensometer that has a gauge length between 0.25 to 1.00” and be able to extend/retract at least ±10% strain. This strain gauge extensometer shall be capable of being verified to ASTM E83.

o One compatible (1) static extensometer that has a gauge length between 0.25 to 0.75” and be able to extend/retract at least ±10% strain. This strain gauge extensometer shall be capable of being verified to ASTM E83.

• System shall have complete manuals and instructions in digital format so that the user can operate the load frame system within the salient requirements stated in the award. These manuals and instructions shall be available on the vendors website as long as they are accessible and downloadable by the agency. All manuals and instructions for the system shall be in clear English.

• Shall include on-site installation to include full system hardware, peripherals, software, qualification and training.

• Shall provide onsite software integration, and training on software fundamentals and test method development.

• Shall include on-site force verification of the load cell(s) and load frame at the final installation site, after installation.

• Shall include on-site crosshead speed and displacement verification (e.g., ASTM E2658, ASTM E2309) under no load and non-cyclic conditions at the final installation site, after installation.

• Shall provide onsite instruction and consultancy to at least (2) FDA employees. The training shall take no more than eight (8) days to complete.

• Shall include at minimum of one (1) year comprehensive Warranty, Maintenance and Technical Support from the date of installation and acceptance.

o Shall cover all equipment repair costs within the warranty time period that are the result of general in-specification use.

Minimum Post Warranty Service/Maintenance Requirements:

• All maintenance and repair activities shall be performed by formally trained and certified Original Equipment Manufacturer (OEM) technicians/engineers.

• All repairs and PM services shall be performed following OEM specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc.

• All Corrective/Remedial Service(s) and Preventive Maintenance (PM) shall be inclusive of shipping, labor, travel, replacement parts, subassemblies, components, or modules necessary for repairs, etc.

• PM Service shall include at least one (1) on-site visit for routine instrument calibration/certification per year inclusive of all consumable parts required to complete the

PM.

• Any part(s) that cannot be repaired on-site, shipping arrangements and material (e.g., boxes/crates) shall be provided without extra cost.

• Corrective/Remedial Repair visits shall be provided within 2-3 business days of call for service (for issues that can’t be resolved remotely via phone or Internet).

• Service plan shall include direct access to OEM call center accessible by FDA Contracting Officer’s Representative (COR), Technical Representative (TR) and/or System Operator Personnel for technical assistance which is staffed by technicians/engineers capable of providing high level troubleshooting expertise.

• Service plan shall include OEM technical developments, repair procedure bulletins, and unlimited software, firmware, and application updates.

• Technical support/assistance. (e.g., telephone-based, email-based, website-based, etc.) shall be provided Monday - Friday (excluding Federal Holidays) during normal business hours and shall begin on a solution to the problem within 8 business hours of contact for assistance.

• Deliverables: 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 otherwis e 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.

FOB Place of Performance:

U.S. Food and Drug Administration Center for Devices and Radiological Health 10903 New Hampshire Ave Silver Spring, MD 20993

Delivery, Repairs, and Maintenance 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 52.212-4, Contract Terms and Conditions - Commercial Products and Commercial Services (Deviation SEP 2025) applies to this solicitation.

The following addenda apply:

52.203-6 Alt I, Restrictions on Subcontractor Sales to the Government (Jun 2020) Alternate I (Nov 2021) 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

52.217-9, Option to Extend the Term of the Contract (Mar 2000)

(a) “. . .any time before the contract expiration; . . . any time before the contract expires. . .”

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_6 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_217_9

(c) “. . .shall not exceed 5 years.”

52.219-4, Notice of Price Evaluation preference for HUBZone Small Business Concerns

(DEVIATION) (RFO SEP 2025)

52.219-8, Utilization of Small Business Concerns (DEVIATION) (RFO SEP 2025) 52.219-9, Small Business Subcontracting Plan (DEVIATION) (RFO SEP 2025) 52.222-3, Convict Labor (DEVIATION) (RFO SEP 2025) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (DEVIATION) (RFO SEP 2025) 52.222-35, Equal Opportunity for Veterans (DEVIATION) (RFO SEP 2025) 52.222-36, Equal Opportunity for Workers with Disabilities (DEVIATION) (RFO SEP 2025) 52.222-37, Employment Reports on Veterans (DEVIATION) (RFO SEP 2025) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act

(DEVIATION) (RFO SEP 2025)

52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts) (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)

52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-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) 52.229-12, Tax on Certain Foreign Procurements—Notice and Representation (DEVIATION)

(RFO SEP 2025)

52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct 2018) 52.232-36, Payment by Third Party (DEVIATION) (RFO SEP 2025) 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) (RFO AUG 2025) 52.244-6, Subcontracts for Commercial Products and Commercial Services (DEVIATION) (RFO

SEP 2025)

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 in FAR 32.905(b), 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.

https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_219_4 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_219_8 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_219_9 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_19 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_222_35 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_37 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_222_40 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_222_43 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_53 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_229_12 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 http://www.ipp.gov/

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

(d) If alternate payment procedures are authorized, the Contractor must 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 le vel 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.

(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 t 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 https://www.hhs.gov/web/section-508/accessibility-checklists/index.html https://www.itic.org/policy/accessibility/vpat o 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)]

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.

Contract Administration:

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 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.

Contractor Performance Information In accordance with FAR Subpart 42.11, FDA will complete annual (interim) and final contractor performance evaluations. Annual evaluations will be prepared to coincide with the anniversary date of the contract. Additional interim performance evaluations may be prepared at Contracting Officer discretion, as necessary. Final performance evaluations will be completed upon contract expiration.

FDA will utilize the Contractor Performance Assessment Reporting System (CPARS) in order to execute annual and final contractor performance evaluations. CPARS is a secure Internet website located at https://www.cpars.gov/. FDA will register the contractor in CPARS upon receipt of the name and email address of two (2) individuals who will be responsible for serving as the Contractor’s primary and alternate CPARS contracts.

Once FDA registers the contractor in CPARS, the Contractor will receive an automated CPARS email message which contains User IDs and instructions for creating a password.

Once a performance evaluation is issued, the Contractor’s primary and alternate CPARS contact will receive an email instructing them to logon to CPARS in order to review the performance evaluation.

https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-42#FAR_Subpart_42_11 https://www.cpars.gov/

The Contractor has 14 days from the date of performance evaluation issuance in which to review the evaluation. If the Contractor is in agreement with the performance evaluation outcome, the evaluation becomes final. Should the Contractor be in disagreement with the performance evaluation outcome, rebuttal comments must be submitted via the CPARS within 14 days from date the evaluation was issued by the FDA. Any disagreement between the Contracting Officer and the Contractor will be referred to a contracting official one level above the Contracting Officer, whose decision will be final.

Copies of each performance evaluation and contractor responses, if any, will be retained as part of the official contract file and will be used to support future award decisions. Evaluations will also be stored for a 3-year period in the https://www.cpars.gov/ system.

Contractors may obtain CPARS training material and register for on-line training at https://www.cpars.gov/cparsweb/lc. There is no fee for registration or use of the CPARS.

Payments:

No advance payment will be made under the resulting order/contract.

Payment Terms Net 30 Days After Government Acceptance of Supplies/Services.

Invoice Submission:

CONTRACTOR SHALL SUBMIT ALL INVOICES AS FOLLOWS:

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.

https://www.cpars.gov/ https://www.cpars.gov/cparsweb/lc http://www.ipp.gov/vendors/index.htm https://www.ipp.gov/

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.

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.

Solicitation 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. Full text of any provision 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.

FAR Provisions:

52.203-11, Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions (Sep 2024) 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) 52.222-48, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Certification (DEVIATION) (RFO SEP 2025) 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.

mailto:ERIC@fda.hhs.gov 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_11 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_222_48 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/accessibilitychecklists/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.

Checklist for various formats are available at https://section508.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) https://www.hhs.gov/web/section-508/accessibilitychecklists/index.html https://www.itic.org/policy/accessibility/vpat https://section508.gov/ https://section508.gov/

The provision at FAR 52.212-1 Instructions to Offerors - Commercial Products and Commercial Services (DEVIATION)(RFO Aug 2025) applies to this solicitation. 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 - The price(s) proposed must be detailed and shall represent the offeror’s response to the schedule of supplies/services above.

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 and shall include their SAM Unique Entity ID (UEI) with the quotation.

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 we anticipate only invoices to be applicable to the 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.

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

Service Contract Act Exemption This solicitation is being issued under the premise that the offeror will certify that the 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)(1). 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.