css 75F40126Q133352.pdf

Combined Synopsis/Solicitation 75F40126Q133352

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 75F40126Q133352. 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 334513 - Instruments and Related Products Manufacturing for Measuring, Displaying, and Controlling Industrial Process Variables; with a Small Business Size Standards in number of employees 750.

This requirement is set aside for Small Business.

Respondents are responsible for submitting proposal/quote and any supporting documents before 1:00 PM Central Time - Local Prevailing Time in Jefferson, Arkansas on April 13, 2026, by e-Mail to howard.nesmith@fda.hhs.gov.

Statement of Need/Requirements:

The U.S. Food and Drug Administration (FDA), Atlanta Human and Animal Food Laboratory (ATLHAFL), requires the acquisition, installation, and training of a Wireless Laboratory Equipment Temperature Monitoring System.

The system will ensure compliance with the accreditation for monitoring analytical critical control points, ensuring timely and accurate tracking of environment conditions in labs and specific laboratory equipment accuracy on a 365 day/7 days per week /24 hours per day basis.

Background:

The FDA/ATLHAFL, located in Atlanta, Georgia provides essential analytical services to assure the public safety in the areas of foods, human and veterinary drugs, devices, cosmetics, and biological products. ATLHAFL will be moving to a new facility. They currently utilize a 24/7/365 environmental monitoring system to monitor approximately 140 different inputs. The current system is wireless and wired and on 2 nodes.

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 compatible with existing 24/7/365 environmental monitoring system.

• Temperature Monitoring System shall be a standalone complete system with the following characteristics:

o Shall measure, transmit, centrally collect, and analyze the temperature data, from multiple instruments in a multi floor laboratory facility.

o Shall have 900 MHz wireless technology that is approved by FDA IT Master Approved

Technologies (MAT) or IT Investment Management (ITIM) list approved for FDA

ORA.

mailto:howard.nesmith@fda.hhs.gov mailto:howard.nesmith@fda.hhs.gov o Shall include an FDA OIM approved software package that can be optimized to address the current laboratory operations and provide data security that renders it compliant with 21 CFR Part 11 (e.g. certified and approved for use on the FDA business network) and supported on current windows operating system.

o Shall allow simple floorplan and overlay uploads, giving immediate oversight to facilitate future requirements to scale the network, add new requirements, or monitor new parameters.

o Shall be equipped with tuned and optimized antenna maximizes radio range, total radiated power, conducted power, and antenna efficiency.

o Shall have an interactive LCD screen and user interface with local audible & visual alerting capability.

o Shall supply at a minimum, four input ports allowing maximum flexibility with the ability to interchange external probes with 2 analog inputs, 1 digital input, 1 dry contact/ binary input.

o Shall have a radio Communication: 900 MHz (902-928 MHz) frequency. With an application Range -200 °C to +300 °C.

o Shall have an operating Environment +15 to +70°C and 0-90% relative humidity (RH) non-condensing.

o Shall have at a minimum, an on-board Memory Local data storage of up to 10,000 logged data points.

o Shall have an LCD Display with User Interface; local audio (beeping) and visual (flashing LED) alerts.

o Shall have power options of 3 AA size 3.6V 2.4Ah lithium batteries, or 3 AA size 1.5V alkaline batteries, or 3 A size 3.6V 3.6Ah lithium batteries, or external 5V/1A AC power adapter.

o Shall have the ability to provide real-time, gap-free monitoring of multiple parameters and electronically log and store the temperature (user configurable for degrees C or F) and/or percent humidity inside of laboratory refrigerators, freezers, incubators, and environmental chambers (both standalone and walk-in style), water baths, ovens, or ambient room conditions.

• (-80ºC to 180ºC). Temperature probes must be of sufficient specificity/sensitivity to calibrate to ±0.2ºC of the specified set temperature monitoring value.

• Temperature probes (sensors etc.) shall be capable of continuous monitoring with on board memory to prevent data loss with access to live and historical data, reporting and graphs through a single, web-based interface.

• VPx Sensors and probes must permit real-time monitoring of up to 13 environmental parameters with regulatory degrees of accuracy defined by FDA 21 CFR part 11 and be calibrated to an NIST1-traceable standard with an ILAC- MRA2 ISO/IEC 17025:2005 certification.

• Calibration requirements for all temperature sensing devices must be supportable by the supplier regarding calibration standards to cover the requirements outlined by A2LA and ISO 17025 using the AOAC guidelines. Additionally, the supplier shall provide documentation of full traceability for all temperature measurement devices utilized in this system to the level of NIST.

o Vendor shall be an ISO 17025 accredited calibration laboratory certified).

Calibration documentation must display A2LA and/or ISO 17025 logo or certification.

• System shall be user programmable.

o User shall have the ability to set and change normal operational limits and ranges.

o User shall have the ability to set alert and alarm limits.

o User shall have the ability to set alarm delay and handling instruction.

o The system shall have pre-alarm alerts.

o The system shall allow for both individual input level and for work group or department wide programming.

o The system shall allow for designation or partitioning of individual inputs (instruments) into multiple work groups.

• Shall be able to display the status, reading, and range of individual equipment.

• Shall be able to send a malfunction alert notification (delivered by email) to a cascade of individuals or within a group or multiple groups.

• As a minimum, shall be able to generate the following reports:

o Document corrective actions report in response to disabled alarms.

o User logins o Programming change history o Alert frequency and response.

• Shall allow for scheduling of alert notification of probe recalibration, preventative maintenance, or auto data backup.

• Shall be expandable to address the needs of the laboratory as it continues to expand and be adaptable (upgradeable) to accommodate changing technologies with minimal changes required to the system infrastructure/software.

• Shall be capable of providing sufficient specificity/sensitivity to calibrate to and detect variances out of the ±0.2ºC of the specified set temperature monitoring value, unless otherwise stated.

o NAB Approx. 28 temperature probes needed.

13 refrigerators (2° - 8°c) 6 freezers (-30° - 10°c) 5 water baths (varying minimum and maximum set point temperature settings required) 1 ultra-low temp freezer (-90 to -60ºC) o MICRO

Approx 89 temperature probes needed.

24 refrigerators (2° - 8°c) 24 freezers (-30° - 10°c) 21 water baths (varying minimum and maximum set point temperature settings required) o 40-50ºC+/-0.2 o 53-57 ºC+/-0.2 o 40-50 ºC+/-0.2 o 20-60 ºC+/-0.2 o 41.8-43.2ºC+/-0.2 o 41-42 ºC+/-0.2 o 45.3-45.7 ºC+/-0.2 o 45-50 ºC+/-0.2 o 15-55 ºC+/-0.2 o 16 incubators (varying minimum and maximum set point temperature settings required)

24-26 ºC+/-0.2 30-30 ºC+/-0.2 20-25 ºC+/-0.2 35-39 ºC+/-0.2 53-57 ºC+/-0.2 35-43 ºC+/-0.2 33-38 ºC+/-0.2 28-38 ºC+/-0.2 20-40 ºC+/-0.2 15-40 ºC+/-0.2 o 4 ultra-low freezers (-90 to -60ºC) and (-60 to -40ºC) o CHEM Approx 39 temperature probes needed.

17 refrigerators (2° - 8°c) o 17 freezers (-30° - 10°c) o 4 water baths (varying minimum and maximum set point temperature settings required) 1 ultra-low freezer (-90 to -60ºC)

• Shall be FDA Office of Information Management (OIM) Master Approved Technologies (MAT) list and IT Investment Management (ITIM) approved.

• Shall be able to be installed on a virtual server or in a virtual environment and possess the ability to be installed on administrator’s personal computer.

• Shall include install, training, consultation, design, temperature mapping support, installation, and configuration support through onsite visits.

• Shall provide full installation (virtual server setup in conjunction with FDA OIM IT staff), setup, and optimization to meet laboratory needs.

• After installation, shall demonstrate full system functionality by conducting an IQ/OQ validation.

• IQ/OQ documentation shall include full NIST traceable calibrations certificates display A2LA logo (or equivalent ISO 17025 accredited calibration laboratory logo)

• At conclusion of a successful IQ/OQ, Contractor shall provide on-site user-training (one basic end user training, and one system administrator training) to approximately 10 – 25 laboratory users.

• Additionally, shall provide support to trained personnel regarding issues that arise during normal operation conditions. To include visits, telephone support and rapid response of a field engineer when required to restore normal operations.

• Shall provide continued, on premises, software license and upgrades, as required. Changes shall occur with FDA IT permissions and assistance.

• Shall require 24/7 Technical Support and Training,

• Shall include at minimum 1-year warranty, calibration at the end of the 12th month following Govt acceptance and include 4 option periods for annual calibration/validation services to take place 12 months after prior calibration and continued customer service through each 12-month period.

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.

• Includes annual NIST calibration or Snap Calibration by A2LA Accredited Calibration Laboratory.

• 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 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.

Item #1 Wireless Laboratory Equipment Temperature Monitoring System To meet above Minimum Technical Requirements

Quantity: 1

Manufacturer: _____________________

Country of Origin: _________________

Model: __________________________

Item/Part Number: ________________

System Price: _____________________

Total System Price: _____________________

GSA Contract Number: ______________________ (If Applicable)

PRICE QUOTES SHALL BE FOB DESTINATION INCLUSIVE OF ALL SHIPPING,

HANDLING, DELIVERY, INSTALLATION, AND TRAINING CHARGES

Item #2 Option Period #1 (Base Year) Wireless Laboratory Equipment Temperature Monitoring System Post Warranty Service/Maintenance To meet above Minimum Post Warranty Service/Maintenance Requirements

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 Wireless Laboratory Equipment Temperature Monitoring System Post Warranty Service/Maintenance

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

Item #4

Option Period #3 Wireless Laboratory Equipment Temperature Monitoring System Post Warranty Service/Maintenance

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

Item #5 Option Period #4 Wireless Laboratory Equipment Temperature Monitoring System Post Warranty Service/Maintenance

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

GSA Contract Number: ______________________ (If Applicable)

FOB Destination:

U.S. Food and Drug Administration Atlanta Human and Animal Food Laboratory 1777 Hardee Ave SW Atlanta, GA 30310

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

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:

52.204-7, 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.

(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/.

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_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 https://www.hhs.gov/web/section-508/accessibility-checklists/index.html https://www.itic.org/policy/accessibility/vpat 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 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. The following addenda apply:

Paragraph (b)(4) 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.

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).

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

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 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.

https://www.itic.org/policy/accessibility/vpat http://www.itic.org/policy/accessibility

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.

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. 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 Wage Determination #:2015-4471

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)

(a) The offeror must 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 22.1002-1(e)(3) that the Service Contract Labor Standards statute-

(1) Will not apply to this offeror, then the Service Contract Labor Standards 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 Labor Standards 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.

http://www.sam.gov/ https://sam.gov/wage-determination/2015-4471/34 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_222_51

(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 Labor Standards 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 must notify the Contracting Officer as soon as possible, if the Contracting Officer did not attach a Service Contract Labor Standards 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. (End of 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.

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.

The Government intends to award a Firm‐Fixed‐Price Contract resulting from this Solicitation to the lowest price 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 subparagraph (a) factors apply:

(i) Technical Acceptability (See FAR Provision 52.212-1 (b)(4) and addenda thereto)

(ii) Price (See FAR Provision 52.212-1 (b)(6) and addenda thereto)

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 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_222_51 by addressing each technical requirement as stated above for the Government to conclusively determine the proposed will satisfy its requirement.

Quotes shall include technical specifications, descriptive material, literature, brochures and other information corresponding to each minimum required item, which demonstrates the capabilities of the offeror.

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

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 quote and reserves the right to request additional information or conduct discussions at any time.

It is the offeror's responsibility to monitor the Government Point of Entry (GPE) (sam.gov) for the release of any additional information, amendment, etc. to this solicitation (if any).

NOTICE

System updates may lag policy updates. The System for Award Management (SAM) may continue to require entities to complete representations based on provisions that are not included in agency solicitations. Examples include 52.222-25, Affirmative Action Compliance, and paragraph (d) of 52.212-3, Offeror Representations and Certifications — Commercial Products and Commercial Services. Contracting officers will not consider these representations when making award decisions or enforce requirements. Entities are not required to, nor are they able to, update their entity registration to remove these representations in SAM.

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) (RFO AUG 2025) applies to this solicitation.

The following addenda apply:

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 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 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 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.

INVOICE SUBMISSION

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

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

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.

http://www.ipp.gov/vendors/index.htm https://www.ipp.gov/ mailto:IPPCustomerSupport@fiscal.treasury.gov

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

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

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

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

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

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

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

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

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

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

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

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

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

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

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

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

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

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

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

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

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

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

FAR Clauses 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. . .”

(c) “. . .shall not exceed 5 years.”

52.219-6, Notice of Total Small Business Set-Aside (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) 52.222-50, 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)

52.223-23, Sustainable Products and Services (DEVIATION) (RFO SEP 2025) 52.225-3 Alt IV, Buy American-Free Trade Agreements-Israeli Trade Act (Nov 2023) Alternate IV (Oct 2022 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) (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) mailto:ERIC@fda.hhs.gov 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 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_219_6 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_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_223_23 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_225_3 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

52.244-6, Subcontracts for Commercial Products and Commercial Services (DEVIATION) (RFO

SEP 2025)

HHSAR Clauses 352.232-71 Electronic Submission of Payment Requests (Feb 2022)

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

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

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

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

(END OF CLAUSE)

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.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_244_6 https://www.hhs.gov/web/section-508/index.html…