FDA 75F40126Q133891.pdf

This is a combined synopsis-solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) RFO Part 12, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a separate written solicitation will not be issued. The solicitation number 75F40126Q133891 is issued as a Request for Quote (RFQ) for an upper limb prosthesis system described below.

This acquisition is solicited as a total set-aside for small business concerns under North American Industry Classification System (NAICS) Code 339113 - Surgical Appliances and Supplies Manufacturing, with a Small Business Size Standard of 750 employees. Only small businesses actively registered in SAM.gov may submit a quote. This solicitation incorporates provisions and clauses by reference. The full text of provisions and clauses may be accessed electronically at https://www.acquisition.gov/far-overhaul.

Schedule of Supplies or Services and Prices/Costs.

Line Item 01 Complete, fully assembled bypass upper limb prosthetic system to include a TASKA

CX or equal terminal hand and shipping, meeting all the minimum technical requirements set forth below:

Quantity: 1

Unit: Each Price: ____________________

GSA Contract Number (if applicable): ____________________________

Background and Requirement The U.S. Food and Drug Administration (FDA), Division of Biomedical Physics (DBP), in collaboration with the Human-Device Interaction Lab and the Office of Science and Engineering Labs (OSEL), requires an upper limb prosthesis system with a TASKA CX hand to collect more robust, high-quality interactions with emerging prosthetic technologies. The system will allow for accurate simulation of prosthesis control by an individual without upper limb loss and/or difference.

The Human-Device Interaction lab within OSEL addresses regulatory science research questions related to diagnostic, therapeutic, and assistive medical devices, and understanding human interaction with these medical devices requires tools that replicate their actual use in an unaffected population. A bypass prosthesis is a device worn over an intact limb that allows non-amputee users to operate a prosthetic system as if they had a limb difference. It typically consists of an external socket or frame that fits over the arm and interfaces with a prosthetic hand or terminal device (e.g., TASKA CX hand).

Bypass prostheses are commonly used for research, training, and demonstration purposes, enabling clinicians, engineers, and study participants to evaluate prosthetic technologies, control strategies, and user performance without requiring an amputation. Bypass prostheses can be configured in different geometries depending on the intended use. In one configuration, the prosthetic hand is mounted as a direct extension of the intact limb, resulting in a longer overall limb length that extends beyond the natural hand. In another configuration, the device incorporates an angled offset, positioning the terminal device so that it aligns more closely with the length and functional position of the intact limb.

Critical to this acquisition is the use of “brand name or equal” when describing specific components and their salient performance characteristics in this RFQ. In this case, “brand name or equal” applies https://www.acquisition.gov/far-overhaul to the inclusion of a TASKA CX prosthetic terminal device (hand) as part of the entire bypass prothesis system. Where an offeror submits an equal product, to be accepted it shall meet all of the specific physical, functional, and performance features listed below under Minimum Technical Requirements.

Minimum Technical Requirements for a Bypass Prothesis system are as follows for the system as a whole. These are the salient characteristics of the system that an equal item submitted shall meet:

*Shall be a Bypass prosthetic system to include a TASKA CX or equal terminal hand;

*Fabrication of bypass prosthesis and integration of TASKA CX or equal hand shall be done by an organization with certified prosthetists and prior experience in myoelectric bypass prosthesis fabrication. Images of prior bypass prostheses made should be included in an offeror’s response to a solicitation;

* An option to transition the control method to pattern recognition using the same socket prosthesis must be included;

*Shall include staff familiarization, use and routine maintenance training on the TASKA CX bypass system. A firm delivering the TASKA CX bypass prosthesis training should provide evidence supporting their experience at correctly fitting the TASKA CX hand;

*Shall include a minimum one-year full hardware warranty from the date of Government acceptance;

*Contractor shall guarantee full device replacement at no additional cost to the Government for any manufacturing defects or operational failures during normal use as defined in the user manual;

* Shall include a minimum two-year full manufacturer’s warranty from date of FDA acceptance of the system. Coverage shall include all associated shipping costs for replacement units.

Salient characteristics that the TASKA CX or equal terminal device (hand) submitted shall meet are as follows:

*Shall be a 7 ¼” myoelectric hand with independently articulating digits, lateral/rotational compliance, IP67 water resistant, electronically multi-positional thumb, and wrist flexion; all cables, chargers, and batteries to power and charge the TASAK CX or equal hand must be included;

*Hand must have a Quick Disconnect or equal wrist;

*Hand must be attachable to a below elbow non-amputee carbon fiber socket with a removeable forearm shell that can accommodate various forearm sizes;

*Power switch with power button and charging port shall be integrated into the socket and easily accessible;

*Hand control method shall use 2-site proportional programmable control with suction EMG electrodes. EMG electrodes must NOT be installed directly into socket; EMG electrodes must be removeable from a fitted cloth sleeve;

*All cables, chargers, and batteries to power and charge the control system must be included;

Delivery – FOB Destination

U.S. FDA-CDRH

Attn: TBD 10903 New Hampshire Avenue Bldg. 62, Room 4215 Silver Spring, MD 20993-0002

Deliveries, installations, or services shall not be scheduled during Federal Holidays or Federal Closures as determined by Executive Orders or opm.gov. Federal Holidays are as follows:

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

Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day

Contract Type Firm Fixed-Price

Contract Clauses:

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

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

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

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

NOV 2025

52.219-6 Notice of Total Small Business Set-Aside (DEVIATION) (RFO SEP 2025) 52.222-3 Convict Labor (DEVIATION) (RFO SEP 2025) 52.222-36 Equal Opportunity for Workers with Disabilities (DEVIATION) (RFO SEP 2025) 52.222-50 Combating Trafficking in Persons (DEVIATION) (RFO SEP 2025) 52.222-90 Addressing DEI Discrimination by Federal Contractors (DEVIATION) (RFO APR 2026) 52.223-23 Sustainable Products and Services (DEVIATION) (RFO SEP 2025) 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) 52.232-40 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 SEP 2025) 52.244-6 Subcontracts for Commercial Products and Commercial Services (DEVIATION) (RFO

SEP 2025)

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

(a) Definitions. As used in this clause-https://www.acquisition.gov/far-overhaul https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_203_17 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_203_19 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_204_13 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_209_6 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_209_10 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_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_36 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_222_50 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_222_90 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_223_23 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_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_40 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_233_3 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_233_4 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_240_91 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_244_6

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

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

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

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

(END OF CLAUSE)

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

[(DEVIATION)]

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

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

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

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

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

(End of Clause)]

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

The COR as identified on any subsequent Contract in Box 6 a. on Form 347 is responsible for:

(1) Monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements;

(2) Interpreting the statement of work and any other technical performance requirements;

(3) Performing technical evaluation as required;

(4) Performing technical inspections and acceptances required by this contract; and

(5) Assisting in the resolution of technical problems encountered during performance.

The contact information for the Contracting Officer’s Representative (COR) is:

Name: TBD Email:

Phone:

The Contracting Officer as identified on any subsequent Contract in Box 23 on Form 347 is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to:

(1) Direct or negotiate any changes in the statement of work;

(2) Modify or extend the period of performance;

(3) change the delivery schedule;

(4) Authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or

(5) Otherwise change any terms and conditions of this contract.

The contact information for the Contracting Officer is:

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

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

https://www.itic.org/policy/accessibility/vpat mailto:timothy.walbert@fda.hhs.gov

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

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

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

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

(c)-

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

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

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

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

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

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

(e) Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts.

(1) At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

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

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

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

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

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

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

*Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and *Fee-amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

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

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

*Invoice number, amount, & date submitted *Corresponding payment amount & date received *Total amount of all payments received to date under the subject contract or order, and for definitized contracts or orders only:

*Total estimated amounts yet to be invoiced for the current, active period of performance.

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

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

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

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

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

Notice Regarding the Use of Macros in Submitted Documents Be advised that FDA does not accept documents which contain the use of macros. When submitting documents via email, DO NOT include .exe, .mso, or any other executable file types that could potentially trigger email security protections (i.e. email blocks, quarantine). Document submissions required throughout the award period(s) shall not have macro-enabled functionality and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.

RFQ Provisions:

This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Texts of any provision may be accessed electronically at the following addresses: https://www.acquisition.gov/far-overhaul and https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html.

FAR Provisions:

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

(DEVIATION) (RFO AUG 2025)

52.222-18 Certification Regarding Knowledge of Child Labor for Listed End Products (Feb 2021) 52.240-90 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 https://www.acquisition.gov/far-overhaul https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_203_18 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_204_7 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_222_18 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_240_90 https://www.hhs.gov/web/section-508/index.html conform to the described accessibility standards, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(d) In order to facilitate the Government's determination whether proposed ICT supplies meet applicable Section 508 accessibility standards, offerors must submit an Accessibility Conformance Report, in accordance with its completion instructions and tailored to the requirements in the solicitation. The purpose of the Report is to assist HHS acquisition and program officials in determining whether proposed ICT supplies conform to applicable Section 508 accessibility standards.

The template allows offerors or developers to self-evaluate their supplies and document, in detail, whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available at https://Section508.gov/.

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

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

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

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

(End of provision)

The 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 2.5 (MS Word) provided by the Industry Technology Industry Council (ITIC).

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

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

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:

https://section508.gov/ http://508.hhs.gov/ http://www.itic.org/policy/accessibility

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 capability and functionality of the offered system.

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

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

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

Buy American Act and Executive Order 14005.

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

Line Item No. Country of Origin

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

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

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

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

http://www.sam.gov/

The provision at 52.212-2 Evaluation—Commercial Products and Commercial Services (DEVIATION) (RFO AUG 2025) applies to this solicitation. The following addenda apply:

The Government will award a contract resulting from this solicitation to the responsible Offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. In this case, the Government intends to award a Firm‐Fixed‐Price contract resulting from this Solicitation to the lowest-priced technically acceptable and responsible offeror.

Offers will be evaluated on their ability to meet the requirements provided herein. The lowest priced offer will be evaluated first. If the lowest priced offeror is not technically acceptable, the next lowest priced offer will be evaluated and so on until a technically acceptable offer is determined.

The following evaluation factors apply:

(i) Technical Acceptability

(ii) Price

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

The Government is not responsible for locating or securing any information which is not identified in the proposal, but reserves the right to do so, and reserves the right to request additional information or conduct discussions at any time. Once the Government determines the offeror that is the best-suited (i.e., the apparent successful offeror), the Government reserves the right to communicate with only that offeror to address any remaining issues, if necessary, and finalize a contract with that offeror.

These issues may include technical, price or other issues.

The Government's determination of technical acceptability in no way relinquishes the Awardee's contractual obligation to ensure all equipment and/or services meet the FDA’s stated need.

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

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.

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 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.

It is the offeror's responsibility to monitor sam.gov for the release of any information related to this acquisition, e.g., questions and answers, amendments, award notice, etc. Offerors that fail to complete the required representations and certifications or reject the terms and conditions of the solicitation may be excluded from consideration.

Offerors are responsible for submitting, by e-mail ONLY, quotes and supporting documents to Tim Walbert, timothy.walbert@fda.hhs.gov NLT 2:00 pm CDT on Tuesday, Aug. 25, 2026.

mailto:timothy.walbert@fda.hhs.gov