75F40126Q131912 Solicitation Amendment 01.pdf

Solicitation: 75F40126Q131912 (Page 1) – Amendment 01

This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with FAR RFO Part 12. This announcement constitutes the only solicitation. Offers are being requested and a separate written solicitation will not be issued. The solicitation number is 75F40126Q131912. This solicitation is issued as a Request for Quote (RFQ) for New Digital Slide Scanner, Warranty, and Service Agreement to replace aging equipment that is no longer supported by the manufacturer.

This acquisition is not set-aside for small business concerns. This solicitation incorporates provisions and clauses by reference. The full text of provisions and clauses may be accessed electronically at https://www.acquisition.gov/far-overhaul.

The associated North American Industry Classification System (NAICS) Code is- 334516 - Analytical Laboratory Instrument Manufacturing; the applicable Small Business Size Standard is 1000 employees

Schedule of Items (all shipping and handling shall be included in the price).

Contract Line Item

Description Quantity Unit Unit Price Extended Price

0001 Digital Slide Scanner as specified herein. 1 EA $ ______ $ _________

Post-warranty Option Base Period: Annual on-site service agreement for Digital Slide Scanner

12 MOS $ ______ $ _________

Post-warranty Option Period 1: Annual on-site service agreement for Digital Slide Scanner

12 MOS $ ______ $ _________

Post-warranty Option Period 2: Annual on-site service agreement for Digital Slide Scanner

12 MOS $ ______ $ _________

Post-warranty Option Period 3: Annual on-site service agreement for Digital Slide Scanner

12 MOS $ ______ $ _________

Total Evaluated Price (CLINs 0001 – 4001) $ ____________________ https://www.acquisition.gov/far-overhaul

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Statement of Work

New Digital Slide Scanner, Warranty, and Service Agreement

1. Background

The Food and Drug Administration (FDA) National Center for Toxicological Research (NCTR) needs a Digital Slide Scanner in the Pathology Lab to replace aging equipment that is no longer supported by the manufacturer. The existing instrument will only be allowed on the NCTR network for a limited time due to its’ use of out-of-date software.

The Digital Slide Scanner is used for all studies in Pathology that require digital copies of the slides that are produced by the Pathology Lab or that require digital image analysis for data collection.

The selected scanner will be used in an FDA core facility. A core facility does not perform its own research but instead facilitates research for other labs. As a result, core facilities perform a much greater variety of work than a single lab that does very specific research in a specific area. The selected scanner will scan slides made from a variety of animal tissues including mouse, rat, pig and guinea pig. Tissues may be stained with standard histological stains such as hematoxylin and eosin (H&E) stains or special stains like masson’s trichrome, periodic acid schiff’s, alcian blue, or congo red. The scanner must be able to image all these respective colors and differentiate between them with analysis software, either by counting different colored cells or by quantifying the area of different colors.

The scanner will also be used to image a wide variety of immunohistochemistry stained slides. Stains may be membrane, nuclear, or cytoplasmic. Both chromogenic and fluorescent stains must be scanned and quantified. The chromogens can vary in color from brown, black, red, blue, green, and purple and must be accurately captured by the scanner and quantified by the analysis software. Fluorescent stains can vary in wavelength from 360-770nm. The scanner must be able to capture images of slides stained with up to 7 fluorescent probes for multiplex imaging and analysis.

2. Objectives The Digital Slide Scanner is needed to create digital copies of tissues on glass slides that can be shared with other researchers or used in research publications. It is also needed to provide image analysis to obtain quantitative data from images. A service contract for the Digital Slide Scanner is also needed to keep the instrument functioning in optimal condition, to provide quick repairs, and to provide software updates as needed.

3. Constraints The Digital Slide Scanner must be approved to be connected to the NCTR network, and it must be approved prior to deployment in the ServiceNow Product Catalog.

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1. NCTR has a database of digital slides produced using the Leica Aperio ScanScope. The new Digital Slide Scanner will need to be able to view and manipulate these digital slides.

4. Scope

NCTR’s Molecular Pathology Lab requires a Digital Slide Scanner to replace an existing system (Leica Aperio AT2) that is no longer supported by the manufacturer. The current instrument will remain on the NCTR network for a limited time due to its’ use of out-of-date software. The replacement Digital Slide Scanner will be employed for all Pathology studies which require digital copies of slides produced by the Pathology Lab or studies which require digital image analysis for data collection.

Specifically, this Digital Slide Scanner imaging system is required to:

1. Create digital copies of tissues on glass slides that can be shared with other researchers or used in research publications;

2. Provide image analysis to obtain quantitative data from images;

3. Include preventive maintenance and repair services (PM/R) for the Digital

Slide Scanner to:

a. Keep the instrument calibrated;

b. Maintain the software functioning in optimal condition;

c. Provide technical support; and

d. Provide rapid repairs as necessary.

The replacement Digital Slide Scanner system will support pathology studies insofar as NCTR conducts scientific research to generate data for FDA decision-making and the development of innovative health approaches. As a national scientific resource, NCTR conducts peer-reviewed research to advance scientific approaches and tools required to support public health and to improve FDA's ability to assess the safety of products it regulates. NCTR research supports two FDA Goals: 1) Enhance oversight of FDA-regulated products and 2) Improve and safeguard access to FDA-regulated products.

The Digital Slide Scanner imaging system described herein will be employed to assist researchers in pursuit of research activities necessary to the “NCTR Research Support” program. Specifically, the required system with analysis software is a crucial tool in enhancing the accuracy, efficiency, and reproducibility of all pathology projects at NCTR as follows:

1. Enhances accuracy by using the software to gather quantitative data rather than qualitative as well as increasing the dynamic range of analysis into the hundreds rather than the traditional 1-3 scale for pathologists;

2. Increases efficiency and reproducibility in the same way. It can scan hundreds of slides without human input and apply the same algorithm analysis to every slide; and

3. Is capable of analysis on any color stain as well as different types of stains including fluorescent and polarized. This is a much-needed improvement over

Solicitation: 75F40126Q131912 (Page 4) – Amendment 01 previous scanners which could only analyze blue and brown. This not only adds value to current and future studies but creates new avenues for data collection on previous studies as well.

As previously stated, the current Leica Aperio AT2 system is no longer supported by the manufacturer, so a replacement system must be researched and acquired to continue to contribute to the missions of both FDA and HHS.

This requirement encompasses:

1. Delivery and installation of a Digital Slide Scanner;

2. Training of FDA personnel on the Digital Slide Scanner;

3. Warranty coverage for the Digital Slide Scanner; and

4. Optional Post-Warranty Service Agreements for the Digital Slide Scanner.

5. Delivery

1. The Digital Slide Scanner will be delivered to:

National Center for Toxicological Research (NCTR) 3900 NCTR Rd., BLDG. 85/Receiving/Property Jefferson, AR 72079 Attn: to be completed at time of award.

Receiving dock hours of operation are Monday-Friday from 8:00 AM – 4:00 PM (except during Federal Holidays.)

2. The Digital Slide Scanner will be installed at:

3900 NCTR Rd., Building 5B Jefferson, AR 72079

3. Training for the Digital Slide Scanner will be delivered at:

3900 NCTR Rd., Building 5B Jefferson, AR 72079

FOB Point Destination. All items shall include shipping and handling to the destination identified herein.

6. Technical and Performance Specifications

a. Basic Requirements:

The selected device:

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Type 1: Scanning:

1. Shall scan at 1.25X magnification at a minimum resolution of 4 MP

(megapixel) and a maximum pixel size of 6.5 um (micrometers).

2. Shall scan at 5.00X magnification at a minimum resolution of 4 MP and a maximum pixel size of 6.5 um.

3. Shall scan at 10.00X magnification at a minimum resolution of 4 MP and a maximum pixel size of 6.5 um.

4. Shall scan at 20.00X magnification at a minimum resolution of 4 MP, a maximum pixel size of 6.5 um and a scan speed no greater than five (5) minutes for the fluorescent channel.

5. Shall scan at 20.00X magnification at a minimum resolution of 4 MP and a maximum pixel size of 5.5 um for the brightfield channel.

6. Shall scan at 40.00X magnification at a minimum resolution of 4 MP and a maximum pixel size of 6.5 um for the fluorescent channel.

7. Shall scan at 40.00X magnification at a minimum resolution of 4 MP and a maximum pixel size of 5.5 um for the brightfield channel.

8. Shall scan both 1X3 and 2X3 slides.

9. Shall have brightfield scan capabilities.

10. Shall have the ability to scan, for the fluorescent channels from 360 nm to 770 nm across seven (7) channels.

11. Shall be able to scan slide label bar codes in 2D and 3D.

12. Must have an automatic tissue finder which can focus on and scan samples from a single cell up to a whole tissue without manual input.

13. Shall have z-stack capability which can capture images from a minimum of 10 focal planes and create a 3D composite image.

Type 2: Image Management:

1. Shall be able to convert image files to TIFF.

Type 3: Software:

1. Shall have the ability to analyze both brightfield and fluorescence.

2. Shall include image analysis software with the ability to quantify stained cell numbers and stained areas on any animal tissue and any type of stain including membrane, nuclear, and cytoplasmic staining.

3. Shall include image analysis software with the ability to open .svs images

Type 4: Hardware and Accessories:

1. Shall include a slide autoloader capacity of at least fifty (50) slides.

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2. Shall include the required Workstation on which image analysis software is loaded.

Type 5: Connectivity:

1. Shall be able to connect to a network server for both data storage and software usage.

2. Shall utilize multi-factor authentication (MFA) login in compliance with executive order 14028.

3. Shall encrypt data at rest and in transit in compliance with executive order 14028.

Type 6: Facility and Power:

1. Shall be installed in a footprint that is less than 9’x9’ due to current lab space constraints.

2. Shall accept power supply of a dedicated 110/115V 20 AMP Circuit.

Type 7: Warranty:

1. Shall include a minimum of one (1) year original equipment manufacturer (OEM) warranty.

2. Warranty coverage shall commence on the date of acceptance.

Type 8: Delivery, Installation, and Training:

1. Shall include delivery and installation of the Digital Slide Scanner.

b. Installation, Testing and Training Requirements:

1. The Contractor shall provide all labor, travel, and tools to install the equipment at the address provided below, to include inside delivery. The equipment shall be tested once installed to verify all aspects of the system are operating within parameters of the required technical and performance specifications listed above. The Contractor shall demonstrate upon completion of installation and testing that the item meets all specifications.

2. All standard information on the equipment, including but not limited to User Manuals, Operation and Maintenance (O&M) Manuals, Material and Safety Data Sheets (MSDS), troubleshooting guides and any other applicable documentation, shall be provided upon installation of the system. Upon acceptance of the system, training shall be provided to attendees/users by the Contractor’s trained and certified personnel.

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3. Upon acceptance of the system, training shall be provided to attendees/users by the Contractor’s trained and certified personnel.

4. The components and equipment shall be newly manufactured, not used or refurbished, or previously used for demonstration.

5. Offered systems shall be a turn-key solution i.e., the contractor shall be responsible for providing all hardware, components, instruments, computers, software, and that otherwise required to meet these specifications and the FDA’s stated need.

6. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up.

7. System shall be warranted for not less than one (1) year from FDA acceptance of the system(s) to include on-site training. Warranty service shall include troubleshooting capabilities based on complete knowledge of the entire system, immediate access to replacement parts, and immediate access to system improvements and updates. Phone and email technical support shall be included for a minimum of one (1) year.

8. The Contractor shall provide three (3) days of training on both instrument operation and technical help on running and setting up analysis algorithms.

c. Post-Warranty Service Requirements: Annual on-site service agreement for

Digital Slide Scanner At a minimum, the Contractor shall provide the following services during the post- Warranty option periods:

1. One (1) onsite preventative maintenance visit per contract year inclusive of all labor, travel, and parts, components, subassemblies, etc. necessary to provide the service.

2. Unlimited on-site corrective/remedial maintenance/repairs to be scheduled at the time of service request within five (5) calendar days from service call. On-site repair service shall be inclusive of all labor, travel, certified replacement parts, components, subassemblies, etc. needed to return the system to operational capacity.

3. Unlimited technical support and trouble-shooting assistance, Mondays – Fridays (excluding Federal Holidays) during the Contractor’s normal business hours, within eight (8) business hours of contact for assistance (e.g., telephone-based, email-based, website-based, etc.)

4. Formally trained and certified technicians/engineers for all maintenance and repair activities performed, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using new OEM replacement parts, components, subassemblies, etc.

5. Unlimited software and firmware updates.

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6. The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket by email 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. In addition, the Contractor shall provide a written report to the FDA Contracting Officer’s Representative and Contract Specialist by email, summarizing all maintenance and repair activities (including warranty work) each time service and/or repair is performed.

7. All preventative maintenance and repair service pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc.

7. Period of Performance

All dates are approximate to be finalized upon award.

Delivery of instrument: No more than ninety (90) calendar days after award

Base period: Beginning on acceptance and including one year of warranty (9/1/2026 – 8/31/2027)

Option Year 1: 9/1/2027 – 8/31/2028

Option Year 2: 9/1/2028 – 8/31/2029

Option Year 3: 9/1/2029 – 8/31/2030

Option Year 4: 9/1/2030 – 8/31/2031

The period of performance for the option period in any resultant award will be established based on the date of award, required delivery of the system (inclusive of inside delivery, installation, and training), and the offered warranty period. If/when Option Year 1 Post-Warranty Service/maintenance is exercised; the period of performance for the post-warranty option will be firmed via bilateral modification.

Each year shall be funded at the time the option year is exercised; options will be exercised based on funds availability and the needs of the Federal Government. The initial Service period shall be for one (1) year and each subsequent period of performance may be renewed at the government’s option.

Solicitation: 75F40126Q131912 (Page 9) – Amendment 01

8. Place of Performance National Center for Toxicological Research (NCTR) 3900 NCTR Rd.

Bldg. 5B Jefferson, AR 72079

9. Government Furnished Equipment/Government Furnished Information (GFI)

No government-furnished property or government-furnished information will be provided in the scope of this acquisition.

10. Holidays and Government Closures The Contractor is not required to provide on-site services on the following days that are Federal Holidays or on any other day designated as a Federal holiday for the Washington, DC area:

• New Year’s Day

• Martin Luther King Day

• President’s Day

• Memorial Day

• Juneteenth Independence Day

• Independence Day

• Labor Day

• Columbus Day

• Veteran’s Day

• Thanksgiving Day

• Christmas Day

In the event of inclement weather when the Federal government is closed, the Contractor is not required to provide on-site service. The Contractor is required to follow, as a minimum, other directives issued by the U.S. Office of Personnel Management or other such official for late arrivals due to inclement weather (unless otherwise specified in the Contract).

In the event the Federal Government is closed by order of the President of the United States or the U.S. Office of Personnel Management for any reason, or the agency, the center or the building is closed for administrative or safety reasons, the Contractor shall follow directives issued by responsible officials concerning reporting for work.

11. Contract Administration

a. Contract Specialist David Kramer, Contract Specialist Phone: 703-447-2694 Email: david.kramer@fda.hhs.gov mailto:david.kramer@fda.hhs.gov

Solicitation: 75F40126Q131912 (Page 10) – Amendment 01

b. Technical Point of Contact – The following TPOC will represent the Government for the purpose of this contract:

(To be completed at time of award) Name:

Phone:

Email:

The TPOC/COR 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 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.

12. Inspection and Acceptance

The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the Technical Point of Contact (TPOC) specified at award. If the supplies or services are acceptable, the TPOC shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the TPOC shall document the nonconforming items/services and immediately notify the contracting officer.

13. Payments

Payment terms Net 30 days after government acceptance. No advance payments will be made.

14. Invoice Submission

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

Solicitation: 75F40126Q131912 (Page 11) – Amendment 01

a. All Invoice submissions for goods and or services must be made electronically through the

U.S. Department of Treasury's Invoice Processing Platform System (IPP). http://www.ipp.gov/vendors/index.htm

b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions - Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov c.

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

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

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

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

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

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

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

1. 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;

2. Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other

Indirects) - show rate, base and total amount;

http://www.ipp.gov/vendors/index.htm https://www.ipp.gov/

Solicitation: 75F40126Q131912 (Page 12) – Amendment 01

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

4. 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;

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

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

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

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

1. List of all invoices submitted to date under the subject award, including the following:

1. Invoice number, amount, & date submitted

2. Corresponding payment amount & date received

2. Total amount of all payments received to date under the subject contract or order; and

3. 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

Solicitation: 75F40126Q131912 (Page 13) – Amendment 01 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.

15. 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: 75F40126Q131912 (Page 14) – Amendment 01

Solicitation Provisions

Contract Type: Commercial Item-Firm Fixed Price.

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

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

The provision at FAR 52.212-1 Instructions to Offerors-Commercial Items (Deviation) (RFO Aug 2025) The following addenda have been added to this provision:

• Technical Capability will be determined by review of information submitted by the offeror which must provide sufficient technical information necessary for the Government to conclusively determine that the offered services meet or exceed the technical requirements identified above. This submitted information must include a fully completed 75F40126Q131912 Digital Slide Scanner detailed response template amendment 01, completed by the Offeror in accordance with the instructions in that document. The proposed product may be supplemented with technical specifications, descriptive material, literature, brochures, publications, etc. which the offeror believes will further demonstrate their technical product capabilities. The offeror shall provide a written approach to satisfy all of the requirements herein. The offeror may include technical specifications, ISO certifications, descriptive material, literature, brochures and other information which demonstrates the capabilities of the contractor to meet the requirement. Technical specifications shall be included for each listed item in the minimum required salient characteristics section above.

Any proprietary information shall be marked as such.

Product Demonstration:

The Government reserves the right to conduct demonstrations with one or more quoters when the Government determines a demonstration is necessary to evaluate technical capability or otherwise assess whether the quoted product meets the solicitation requirements, if doing so is in the best interests of the Government.

If requested, the demonstration shall be provided within five (5) business days after Government notice. The notice will identify the required demonstration format, date, time, duration, and the features or requirements to be demonstrated. The demonstration shall be of the actual product and configuration quoted unless otherwise authorized by the Government. The Government will not evaluate substitute products, later-developed capabilities, or information submitted after the conclusion of the demonstration unless specifically requested by the Government for clarification purposes.

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

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Any requested demonstration will be limited to the product quoted and may address any feature, function, or performance requirement identified in the solicitation. The Government may use different demonstration scenarios or lines of inquiry as appropriate to the products quoted; however, all demonstrations will be evaluated solely against the requirements and evaluation basis stated in this solicitation.

The demonstration is part of the Government’s evaluation of technical capability. Failure to provide a requested demonstration within the time specified, or failure of the quoted product to demonstrate compliance with solicitation requirements, may result in the quotation being found unacceptable or otherwise may adversely affect the Government’s evaluation.

The Government will evaluate only the quotation submitted and the information presented during the demonstration. Information or materials submitted after the conclusion of the demonstration will not be considered, unless specifically requested by the Government as a clarification.

• Price: Offerors shall provide a detailed price quote for each item proposed to meet the Schedule of Items. (Offerors shall fill in the schedule above with the total prices and provide a detailed quote in their own format.) Offerors shall include the firm’s SAM Unique Entity ID (UEI) number with their quote. The post-warranty service/preventative maintenance optional periods will not be funded at time of award. If exercised, funding will be obligated individually each year for the option period exercised via contract modification; the option periods shall be priced accordingly.

As applicable, the offerors 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 VPAT - Information Technology Industry Council (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.

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

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Microsoft Suite Documents Containing Macros

The offeror 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 responsibility to ensure all electronic documents are submitted without the use of macros.

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.

Line Item No. Country of Origin

Quote Validity Period. Submitted quotations shall be valid, at a minimum, through September 30, 2026.

The provision at FAR 52.212-2 Evaluation-Commercial Items (Deviation) (RFO Aug 2025). The specific evaluation criteria to be included in paragraph (a) of that provision are as follows:

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

o Technical Capability o Price

Technical Capability is more important than price. However, if the Government determines the non-price factor to be essentially equal among competing offerors price becomes more important as a discriminating factor.

Solicitation: 75F40126Q131912 (Page 17) – Amendment 01

Technical Capability will be evaluated based on how well the quoted product meets the solicitation requirements. The Government may evaluate technical capability through the information submitted with the quotation, including the response matrix, descriptive literature, technical specifications, certifications, and other supporting materials, and may also require a live product demonstration. If a demonstration is requested, the Government will evaluate the extent to which the demonstrated product shows compliance with the solicitation requirements.

Failure to provide a requested demonstration within the specified time, or failure of the quoted product to demonstrate compliance with the solicitation requirements, may render the quotation unacceptable or otherwise adversely affect the Government’s evaluation. Any product demonstration required by the Government shall be limited to the product quoted and the solicitation requirements.

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

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

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

• 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 (Deviation) (RFO Aug 2025)

• 52.222-18 Certification Regarding Knowledge of Child Labor for Listed End Products

(Feb 2021)

• 52.225-6 Trade Agreements-Certificate (FEB 2021)

• 52.240-90 Security Prohibitions and Exclusions Representations and Certifications

(Deviation )(RFO Aug 2025)

• 52.229-11 Tax on Certain Foreign Procurements—Notice and Representation (Deviation)

(RFO Jul 2025)

Solicitation: 75F40126Q131912 (Page 18) – Amendment 01

HHSAR Provisions

352.239-7[8] 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/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 https://www.hhs.gov/web/section-508/index.html https://www.hhs.gov/web/section-508/accessibilitychecklists/index.html https://section508.gov/

Solicitation: 75F40126Q131912 (Page 19) – Amendment 01 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).

Notice to Offerors:

• Offerors shall provide an updated quote that reflects the changes described in Amendment 01. No information provided in response to the original solicitation posted on March 2, 2026 will be evaluated or considered in any way.

• 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 this solicitation. Contracting officers will rely on representations from offers based on provisions in the solicitation. Entities are not required to, nor are they able to, update their entity registration to remove these representations in SAM.

• Funds are not presently available for this effort. No award will be made under this solicitation until adequate funds are available for it. The Government reserves the right to cancel this solicitation, either before or after the closing date of it. If the Government cancels this solicitation, the Government has no obligation to reimburse an offeror or quoter for any costs associated with it, including proposal or quote preparation costs.

One or more of the items under this acquisition is subject to the World Trade Organization Government Procurement Agreement and Free Trade Agreements.

https://section508.gov/

Solicitation: 75F40126Q131912 (Page 20) – Amendment 01

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 following contract clauses apply to this acquisition.

Required:

52.212-4, Contract Terms and Conditions-Commercial Items (Deviation) (RFO Aug 2025)

Applicable:

52.203-6, Restrictions on Subcontractor Sales to the Government (Jun 2020)

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 and 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 Aug 2025)

52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Deviation) (RFO Aug 2025)

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 (Jan 2025)

52.222-3, Convict Labor (Jun 2003)

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) https://www.acquisition.gov/far-overhaul

Solicitation: 75F40126Q131912 (Page 21) – Amendment 01

52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010)

52.222-50, Combating Trafficking in Persons (Deviation) (RFO Sep 2025)

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 (Deviation) (RFO Jul 2025)

52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct 2018)

52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Mar 2023)

52.233-3, Protest After Award (Deviation) (RFO Aug 2025)

52.233-4, Applicable Law for Breach of Contract Claim (Deviation) (RFO Aug 2025)

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)

Other applicable clauses:

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

(a) The Government may extend the term of this contract by written notice to the Contractor any time before the contract expires; provided that the Government gives the Contractor a preliminary written notice of its intent to extend any time before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed four years exclusive of the period set forth for delivery, acceptance, training and warranty.

(End of clause)

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):

Solicitation: 75F40126Q131912 (Page 22) – Amendment 01 http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

HHSAR Clause 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…