Combined Synopsis Solicitation- FDA-RFQ- OC-2026-136029.pdf

Request for Quotation: FDA-RFQ- OC-2026-136029- Procurement of Benchtop Environmental Temp/Humidity Chamber- Brand Name or Equal

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Notice of Combined Synopsis/Solicitation. This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with part 12. This announcement constitutes the only solicitation; quotes are being requested, and a separate written solicitation will not be issued.

Part-A Fundamental Contract Information

The solicitation number is FDA-RFQ- OC-2026-136029 and is issued as a Request for Quotations (RFQ) for a new EPSEC BTL-433 Benchtop Environmental Temp/Humidity Chamber - Brand Name or Equal -Brand Name and Equal (BNE). The solicitation and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2026-01.

1. Contract Type - The Government intends to award a Firm Fixed-Price (FFP) Purchase Order to procure the requested items/system/services.

2. NAICS - This requirement is being solicited as an unrestricted, full and open competition requirement. Prospective offerors are responsible for downloading the corresponding solicitation and any amendments from SAM.gov. The Government reserves the right to award the consequential firm fixed price purchase order without discussion if the Contracting Officer determines that the initial offer provides the Best Value to the Government and discussions are not necessary.

a. The NAICS for this requirement is: 334513- Analytical Laboratory Instrument Manufacturing

b. The SB size standard for the NAICS code is: 750 Employees or fewer.

The full table of size standards can be found at:

https://www.sba.gov/document/support-table-size-standards

3. Background: The FDA laboratory at the Winchester Engineering Analytical Center

(WEAC) uses an environmental chamber to condition regulatory samples (such as tampons, gowns, patches, etc.) at specific temperature and humidity levels before physical testing. The chamber also supports CDRH-directed research and test method development for other medical devices received by the laboratory for analysis.

4. Purpose/Description of Work – The purpose of this Request for Quotation (RFQ) is to procure an environmental chamber that controls temperature and humidity.

5.1 General Requirement Guidance for Salient Characteristics. - The Contractor shall indicate if the minimum salient characteristics have been met to be considered responsive for this requirement. The Contractor shall demonstrate how the requested items or services, “MEET” or “DO NO MEET” the salient/functional characteristics and specifications listed here-below.

The Contractor shall annotate each salient/functional characteristics and specifications with the following: Meets (if it meets the specification) or Does not meet (if it fails to meet the specification).

5.2 Grey market or refurbished products will not be accepted.

5.3 The Vendor shall indicate if non-domestic items are included in the quote.

https://www.sba.gov/document/support-table-size-https://www.sba.gov/document/support-table-size-

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5.4 The Vendor shall meet all technical/salient/functional, operational characteristics and specifications listed, and if not the manufacturer, shall be able to provide the required service with OEM certified technicians and parts or show proof that they are an authorized third party re seller/provider.

5.5 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.

Specifications/Salient Characteristics- This is a Brand Name or Equal requirement. Products other than the aforementioned are acceptable but shall meet all the salient characteristics contained in the Minimum Technical Requirements below:

All of the following system requirements are minimum requirements. Equivalent requirements that differ from these minimum requirements shall be justified by the proposing vendor and evaluated by the WEAC prior to purchase:

General

The contractor shall provide an environmental chamber that uniformly conditions samples across a variety of temperature and humidity settings. The chamber must meet the following specifications:

1. Temperature range: at least -20°C to 180°C

2. Humidity range: 10% to 95% relative humidity (RH)

3. Capacity: 4 cu. Ft.

4. Power: Standard power cord and plug (no hardwiring)

5. Water supply: Easily accessible water supply connection

6. Humidity sensor: Solid-state humidity sensor

7. Leak Detection: Must have a water leak containment and detection system

8. Viewing window: For visual monitoring of samples

9. Interior shelf: At least one internal shelf

10. Mobility: Mobile cart with space-saving footprint (lab has no bench space and limited floor space for the chamber)

11. Cable port: At least one 2-inch diameter cable port with a flexible plug

12. Calibration: Factory calibration with an ISO 17025 certificate, or instrument calibration at start-up with ISO 17025 certificate

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13. Warranty: At least one year

On-site Installation, Training and Commissioning

• On-site installation and commissioning of the Environmental Chamber

Trade and Service Specification

• All components shall be newly manufactured, not used or refurbished, and/or previously used for demonstration.

• System installation shall occur after being received at the laboratory.

• The entire system shall be warranted for parts and labor for a minimum of 12 months from date of formal government acceptance after on-site installation.

• The warranty must include unlimited telephone/e-mail support for questions regarding operation.

Additional Section 508 Requirements:

• Must meet WCAG 2.0 A and AA

• E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements)

• E203 Access to Functionality (Appendix A, Application and Scoping Requirements)

• E204 Functional Performance Criteria (Appendix A, Application and Scoping Requirements)

• E205 Electronic Content (Appendix A, Application and Scoping Requirements)

• 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and Technical Requirements)

• Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at https://www.hhs.gov/web/section-508/making-files-accessible/index.html, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional- resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

• E208 Support Documentation and Services (Appendix A, Application and Scoping Requirements)

• Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria

• E206 Hardware (Appendix A, Application and Scoping Requirements)

• Chapter 4 Hardware (Appendix C, Functional Performance Criteria and Technical Requirements) and Technical Requirements)

• E207 Software (Appendix A, Application and Scoping Requirements)

• Chapter 5 Software (Appendix C, Functional Performance Criteria and Technical Requirements)

Pricing Schedule - Prices shall be inclusive of shipping and handling and shall be firm fixed through one (1) year after award for the contract line item (CLIN) below. Pricing shall include all applicable fees; any charges presented after contract award shall not be considered/acceptable:

Contract Line Item

(CLIN)

Description Quantit y

Unit Unit Price Extended Price https://www.hhs.gov/web/section-508/making-files-accessible/index.html https://www.hhs.gov/web/section-508/making-files-accessible/index.html https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html

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“Brand Name or Equal”

BTL-433

Benchtop Temp/Humid ity Chamber

(Warranty preferred)

1 each

Water leak containment and detection

3 Solid-state humidity sensor in lieu of the wet bulb sensor

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Viewing window

Factory calibration certificate

6 Instrument calibration/ Installation and Training

Remote Start-up - free phone/video training and start-up assistance

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8 Moble cart with matching stainless steel and storage space

9 Annual Maintenance

10 Shipping/Handling

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5.6 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, Government closure, or shutdown for the Washington, D.C. area:

New Year's Day January 1 Martin Luther King's Birthday Third Monday in January President's Day Third Monday in February Memorial Day Last Monday in May Juneteenth June 19 American Independence Day July 4 Labor Day First Monday in September Columbus Day Second Monday in October Veteran's Day November 11 Thanksgiving Day Fourth Thursday in November Christmas Day December 25

5.7 Period of Performance (POP)- Performance begins on the date of formal government acceptance and continues through the end of the manufacturer's warranty period.

5.8 Points of Contact:

Contracting Officer /Contract Specialist:

Brandon Rafus Email: brandon.rafus@fda.hhs.gov

Contracting Officer’ Representative:

Name: Neal Alcalay Email: neal.alcalay@fda.hhs.gov

5. Contracting Officer’s Authority

The Contracting Officer (CO) is the only person authorized to approve changes in any of the requirements of the statement of work. In the event the Contractor effects any changes at the direction of any person other than the CO or the TPOC the changes shall be considered to have been made without authority, and no adjustment shall be made in the contract price to cover any increase in costs incurred as a result thereof. The CO shall be the only individual authorized to accept nonconforming work, waive any requirement of the contract and modify any term or condition of the contract. The Contracting Officer is the only individual who can legally obligate Government funds.

mailto:brandon.rafus@fda.hhs.gov mailto:neal.alcalay@fda.hhs.gov

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The Contracting Officer is the only person with authority to act as agent of the Government under the 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 for any costs incurred during the performance of the Contract; or (5) otherwise change any terms and conditions of the Contract.

Part-B Contract Clauses

1. FAR 52.212-4 - Contract Terms and Conditions – Commercial – Items (Deviation NOV 2025).

2. FAR 52.252-2 - Clauses Incorporated by Reference (Feb 1998) 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 these addresses:

https://www.acquisition.gov/far/part-52 https://www.acquisition.gov/far-overhaul https://www.acquisition.gov/hhsar/part-352-solicitation-provisions-and-contract-clauses

Required and applicable Clauses

Clause Number

Clause Title

X 52.203-6 w/Alt I

Restrictions on Subcontractor Sales to the Government (JUN 2020)

X 52.203-17 Contractor Employee Whistleblower Rights (NOV 2023) X 52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements

(JAN 2017)

X 52.204-9 Personal Identity Verification of Contractor Personnel (JAN 2011) X 52.204-91 Contractor Identification (NOV 2025) X 52.204-13 System for Award Management—Maintenance (DEVIATION) (RFO AUG 2025) X 52.209-10 Prohibition on Contracting with Inverted Domestic Corporations (DEVIATION)

(RFO NOV 2025)

Required 52.212-4 Contract Terms and Conditions-Commercial Products and Commercial Services

(NOV 2023)

X 52.222-3 Convict Labor (NOV 2025) X 52.222-19 Child Labor—Cooperation with Authorities and Remedies (NOV 2025) X 52.222-36 Equal Opportunity for Workers with Disabilities (NOV 2025) X 52.222-50 Combating Trafficking in Persons (or with Alt I) (NOV 2025)

X 52.222-90 Addressing DEI Discrimination by Federal Contractors (DEVIATION) (RFO APR 2026)

X 52.223-23 Sustainable Products and Services (DEVIATION) (RFO Sep 2025)

X 52.225-1 Buy American—Supplies (or with Alt I) (NOV 2025) X 52.226-8 Encouraging Contractor Policies to Ban Text Messaging (MAY 2024) X 52.232-33 Payment by Electronic Funds Transfer- System of Award Management (Oct 2018) X 52.233.3 Protest After Award (DEVIATION) (RFO NOV 2025) X 52.244-6 Subcontracts for Commercial Products and Commercial Services (NOV 2025) X 52.243-1 52.243-1 Changes-Fixed-Price (DEVIATION) (RFO JUN 2025) X 52.233-4 Applicable Law for Breach of Contract Claim (DEVIATION) (RFO NOV 2025) X 52.240-91 Security Prohibitions and Exclusions (DEVIATION) (RFO AUG 2025)

X HHSAR

352.204.73 Contractor Personal Security and Agency Access (DEVIATION (FEB 2024

X HHSAR Electronic Submission of Payment Requests (APR 2026) (RFO DEVIATION) https://www.acquisition.gov/far/part-52 https://www.acquisition.gov/far-overhaul https://www.acquisition.gov/hhsar/part-352-solicitation-provisions-and-contract-clauses

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352.232-71

X HHSAR

352.239-79

Information and Communication Technology Accessibility (Feb 2024) (Deviation)

Health and Human Services Acquisition Regulation (HHSAR) Clauses can be viewed in full text at: https://www.hhs.gov/grants-contracts/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-cont53ract-clauses/index.html

3.) FDA Electronic Invoicing and Payment Requirements — Invoice Processing Platform (IPP) (Jan 2022)

a. All Invoice submissions for goods and or services must be made electronically through the U.S. Department of Treasury's Invoice Processing Platform System (IPP). http://www.ipp.gov/vendors/index.htm

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

(c) ----

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

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

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

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

(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) 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.

(e) 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.

https://www.hhs.gov/grants-contracts/contracts/contract-policies-https://www.hhs.gov/grants-contracts/contracts/contract-policies-http://www.ipp.gov/vendors/index.htm https://www.ipp.gov/ mailto:ipp.noreply@mail.eroc.twai.gov mailto:IPPCustomerSupport@fiscal.treasury.gov

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(f) 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.

(g) 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.

(h) 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.

(i) . 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.

(End of clause)

4. FAR 52.252-6 Authorized Deviations in Clauses (Nov 2020)

(a) The use in this solicitation or contract of any Federal Acquisition Regulation (48 CFR Chapter 1) clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the date of the clause.

(b) The use in this solicitation or contract of any Health and Human Services Acquisition Regulation clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the name of the regulation.

(End of clause)

Part C- Solicitation Provisions

1. FAR 52.252-1. Solicitation Provisions Incorporated by Reference (Feb 1998)

Required and applicable Clauses

Clause Number Clause Title

Required 52.204-7 System for Award Management--Registration (NOV 2025) Required 52.212-1 Instructions to Offerors—Commercial Products and Commercial

Services (NOV 2025) X 52.203-11 Certification and Disclosure Regarding Payments to Influence Certain

Federal Transactions (SEP 2024) X 52.203-18 Prohibition on Contracting with Entities that Require Certain Internal

Confidentiality Agreements—Representation (JAN 2017) X 52.219-2 Equal Low Bids (NOV 2025)

2. Inquiries and Notices:

All questions regarding this RFQ shall be submitted by 09/24/2026, in writing to Brandon.Rafus@fda.hhs.gov. Phone or fax inquiries will not receive a response.

mailto:ERIC@fda.hhs.gov mailto:Brandon.Rafus@fda.hhs.gov

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3. Response Dates and Time RFQ Due Date: All quotes shall be submitted electronically via email to brandon.rafus@fda.hhs.gov by 12:00 pm Eastern Time on 09/25/2026.

4. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1 (f). Instructions to Offerors – Commercial Items (Nov 2021)

5. Proposal Preparation Instructions:

5.1 The vendor shall submit the following in their proposal:

a) The vendor should submit a proposal, which will be considered if received by the due date. The subject line shall read: Subject: Request for Quotations: Request for Quotation: FDA-RFQ-OC-2026-136029, and a statement from the Offeror verifying that they are SAM.gov, including the UEI Number.

b) The Offeror’s current address and UEI Number shall be included in the quote.

c) Offerors that fail to submit all required documentation, or do not complete the required representations and certifications, or reject the terms and conditions of the solicitation, shall be excluded from consideration.

d) Quotes must include all quantities listed; all or none.

6. A complete quote must consist of: i) Cover Letter, ii) Technical Proposal (which, in accordance with FAR 52.212-1 (b) (4)) must be a technical description of the items or services being offered in sufficient detail to evaluate compliance with the requirements in this RFQ). This may include product literature, or other documents, if necessary. The quote must also include a Technical Capability Statement demonstrating how the proposed product meets or exceeds each salient characteristic listed above. The quote must also include itemized pricing for hardware, software licenses, calibration tools, and shipping.

Lastly, the quote should include an adequate delivery timeline that includes the anticipated lead time after receipt of order (ARO).

e) Incomplete proposals shall be considered non- responsive and shall not be evaluated.

f) Digital Microsoft (MS) Word files and MS Excel files shall be compatible with MS Office Windows 10.

g) Proposal shall not consist of any lock or password-protect files (e.g. *.docx, *.pptx, *.xlsx,*.txt,*.msg).

h) 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.

mailto:Brandon.rafus@fda.hhs.gov

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5.2. Period for Acceptance of Offers:

Addenda to 52.212-1 Quote Acceptance Period (if applicable)

Offer Acceptance Period (if applicable):

Paragraph (b) of the provision is hereby amended to extend the period for acceptance of quotes from 60 calendar days to 90 calendar days from the date specified for receipt of offers.

Preparation Costs ***Note that this solicitation does not commit the Government to pay any cost for the preparation and submission of a proposal. Until formal notice of award is issued, no communication by the Government, either written or oral, shall be interpreted as a promise that an award will be made.

It is also advised that the Contracting Officer (CO) is the only individual who can legally commit and obligate the Government to the expenditure of public funds in connection with the proposed acquisition.

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:

Quoters shall provide sufficient technical information necessary for the government to conclusively determine that the offered service/equipment meets all the salient characteristics 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 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.

Technical Acceptability: Quoter must provide sufficient technical information for the Government to conclusively determine that the quoted product meets or exceeds the minimum salient characteristics identified above. In addition to identifying manufacturer, make, and model of quoted products, it is incumbent of quoters that they unequivocally demonstrate that quoted products meet the requirements herein through the submission of technical specifications, descriptive material, scientific literature, brochures, scientific publications where proposed solution has been used for same or similar purposes, and other information which demonstrates the capability of the quoted equipment. Quoters shall address the technical requirements identified above, as well as provide detailed information on the item(s) in the solicitation.

If an item in this solicitation is identified as "brand name or equal," the purchase description reflects the characteristics and level of quality that will satisfy the Government’s needs. The salient physical, functional, or performance characteristics that "equal" products must meet are specified in the solicitation.

1. To be considered for award, offers of "equal" products, including "equal" products of the brand name manufacturer, must-

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• Meet the salient physical, functional, or performance characteristics specified in this solicitation;

• Clearly identify the item by-

• Brand name, if any; and

• Make or model number;

2. Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and

3. Clearly describe any modifications the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modifications.

Unless the offeror clearly indicates in its offer that the product being offered is an "equal" product, the offeror shall provide the brand name product referenced in the solicitation.

Quoters who are authorized resellers of an item, and not the manufacturer, shall provide a copy of their letter of supply or other documentation substantiating their relationship as an authorized reseller of the proposed manufacturer’s product. The documentation shall be on the Original Equipment Manufacturer (OEM) letterhead and include contact information for the individual who has signed the letter.

6. Request for Pricing. The Vendor shall complete the chart below, including any fees and charges. Any charges after contract award shall not be accepted.

6.1 Pricing Chart

Contract Line Item

(CLIN)

Description Quantity Unit Price

1 “Brand Name or Equal” BTL-433 Benchtop Temp/Humidity Chamber

(Warranty preferred)

1 $

2 Water leak containment and detection

3 Solid-state humidity sensor in lieu of the wet bulb sensor

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4 Viewing Window 1

5 Factory Calibration Certificate

6 Instrument calibration/ Installation and Training

7 Remote Start-up - free phone/video training and start-up assistance

8 Mobile cart with matching stainless steel and storage space

9 Annual Maintenance (if warranty is not included)

10 Shipping/Handling

Total: (All Items Free on Board Destination) $

The offer shall be on a firm-fixed-price basis and include all quantities/services listed; all or none. Offerors shall provide documentation that they are an authorized dealer/reseller of the product that is being proposed, if they are not the manufacturer.

The software and digital interfaces will be evaluated for Section 508 accessibility compliance.

Section 508 Compliance

The Contractor shall be familiar with Section 508 requirements as described at http://www.section508.gov/ in order to ensure that documents generated as part of the tasks are fully Section 508-accessible using the available COTS tools. Each order will http://www.section508.gov/

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508 Accessibility The following standards must be met:

• WCAG 2.0 A and AA

• E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements)

• E203 Access to Functionality (Appendix A, Application and Scoping Requirements)

• E204 Functional Performance Criteria (Appendix A, Application and Scoping Requirements)

• E205 Electronic Content (Appendix A, Application and Scoping Requirements)

• E208 Support Documentation and Services (Appendix A, Application and Scoping Requirements)

• Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria and Technical Requirements)

• 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and Technical Requirements)

• Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at https://www.hhs.gov/web/section-508/making-filesaccessible/ index.html, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery shall be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

• E207 Software (Appendix A, Application and Scoping Requirements)

• Chapter 5 Software (Appendix C, Functional Performance Criteria and Technical Requirements)

Integrating networked third-party software with medical devices requires strict adherence to the FDA Cybersecurity Guidance and Section 524B of the Federal Food, Drug and Cosmetic (FD&C)Act. The FDA treats cybersecurity as an essential pillar of device safety and quality management. Consequently, the vendor remains accountable for all inherited code and connected third-party environments.

PART D: Packing, Marking, Delivering, and Shipping- The Contractor shall deliver the item and quantities ordered within 60 days of award. The Contractor shall deliver the items and quantities ordered, all, or none. The deliverables required under this contract shall be packaged, marked, and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor’s name. The Contractor shall guarantee that all required materials shall be delivered in immediate new, usable, and acceptable condition. All required materials shall be delivered in immediate new, usable, and acceptable condition, at the U.S. Food and Drug Administration (FDA) facility address listed below:

Shipment Destination-

FDA Campus Point of Entry Address:

https://www.hhs.gov/web/section-508/making-filesaccessible/ https://www.hhs.gov/web/section-508/additional-resources/section-508-https://www.hhs.gov/web/section-508/additional-resources/section-508-

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The prospective vendor should provide insured shipping of equipment to:

U.S. Food and Drug Administration, Winchester Engineering and Analytical Center

(WEAC)

Office of Specialty Laboratories and Enforcement Support 109 Holton Street Winchester, MA 01890

The User manual, documentation, testing and calibration information shall be provided upon delivery. Vendor support is expected for setup, integration, or training. Technical and business support should be provided during regular business hours.

PART E- Inspection and Acceptance: Inspection and Criteria- Delivery and installation of the instrument and all components specified above shall be coordinated through the FDA Project Officer. Inspection and acceptance shall be performed at the delivery location in accordance with the terms of FAR Clause 52.212-4.

The FDA’s Technical Point of Contact (TPOC) will approve all tasks and deliverables.

The delivery of services shall be performed during regular business hours (Monday- Friday) during the times of 8:00 AM – 4:00 PM Eastern, excluding holidays.

The TPOC/COR will be responsible for determining the acceptance of the work that is completed. The Vendor shall contact the TPOC/COR by email or phone to schedule delivery. Deliveries shall be coordinated with the TPOC/COR prior to shipment. No deliveries will be accepted without prior authorization from the TPOC/COR. To meet the purpose and objective of this requirement, a single Contractor shall provide a service contract comparable or equivalent to the Collaborative Robotic Arm and that meet the established delivery timeline. The vendor must contact the COR prior to shipping the items to ensure the shipments can be received and must provide tracking numbers for the shipments

All deliverables shall be marked as follows:

• Name and address of the Contractor,

• Contract Number

• Description of item contained therein; and

• Consignee’s name and address.

Travel and expenses shall be covered by the Contractor (in any manner causes an increase or decrease in the total contract price; or changes any of the expressed terms, conditions, or specifications of the contract.

A. All technical directions shall be issued in writing by the TPOC or shall be confirmed by him/her in writing within five (5) working days.

B. The Contractor shall proceed promptly with the performance of technical directions duly issued by the TPOC in the manner prescribed by this clause and within his/her

P ag e 17 | 24 authority under the provisions of this clause.

C. If, in the opinion of the Contractor, any instruction or direction issued by the TPOC is within one of the categories as defined in B. (1) through B. (4) above, the Contractor shall not proceed but shall notify the Contracting Officer, in writing, within five (5) working days after the receipt of any such instruction or direction and shall request the Contracting Officer to modify the Contract accordingly. Upon receiving such notification from the Contractor, the Contracting Officer shall issue an appropriate contract modification or advise the Contractor, in writing, that, in his/her opinion, the technical directions are within the scope of this clause and do not constitute a change under the "Changes" clause of the contract. The Contractor shall thereupon proceed immediately with the direction given.

Any failure of the parties to agree upon the nature of the instruction or direction, or upon the contract action to be taken with respect thereto, shall be subject to the provisions of the contract clause entitled "Disputes."

Part-F Evaluation of Commercial Items

FAR 52.212-2 Evaluation - Commercial Items (Nov 2021) applies to this acquisition.

The Government reserves the right to award a contract without discussions. Commercial Items (Oct 2014) applies to this acquisition. Only one award shall be made from this RFQ. The corresponding requirement will be awarded on the basis of identifying the quote deemed Lowest Price Technically Acceptable (LPTA): Award will be made to the lowest-priced offeror whose offer is determined technically acceptable. Technical acceptability will be determined on a pass/fail basis against the salient characteristics and minimum requirements of the requirement. Quotes that do not meet all salient characteristics will be determined technically unacceptable and will not be considered for award. Moreover, price will be evaluated for reasonableness.

Part-G Offeror Representations and Certifications

FAR 52.212-3, Offeror Representations and Certifications-Commercial Products and Commercial Services (May 2024) (DEVIATION FEB 2025) applies to this acquisition. The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically in the System for Award Management (SAM) accessed through https://www.sam.gov. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (v) of this provision.

(a) Definitions. As used in this provision— "Covered telecommunications equipment or services" has the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

Economically disadvantaged women-owned small business (EDWOSB) concern means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR part 127, and the concern is certified by SBA or an approved https://www.sam.gov/

P ag e 18 | 24 third-party certifier in accordance with 13 CFR 127.300. It automatically qualifies as a women-owned small business eligible under the WOSB Program.

Forced or indentured child labor means all work or service—

(1) Exacted from any person under the age of 18 under the menace of any penalty for its nonperformance and for which the worker does not offer himself voluntarily; or

(2) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties.

Highest-level owner means the entity that owns or controls an immediate owner of the offeror, or that owns or controls one or more entities that control an immediate owner of the offeror. No entity owns or exercises control of the highest level owner.

Immediate owner means an entity, other than the offeror, that has direct control of the offeror. Indicators of control include, but are not limited to, one or more of the following:

ownership or interlocking management, identity of interests among family members, shared facilities and equipment, and the common use of employees.

Inverted domestic corporation, means a foreign incorporated entity that meets the definition of an inverted domestic corporation under 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c).

Manufactured end product means any end product in product and service codes (PSCs) 1000-9999, except—

(1) PSC 5510, Lumber and Related Basic Wood Materials;

(2) Product or Service Group (PSG) 87, Agricultural Supplies;

(3) PSG 88, Live Animals;

(4) PSG 89, Subsistence;

(5) PSC 9410, Crude Grades of Plant Materials;

(6) PSC 9430, Miscellaneous Crude Animal Products, Inedible;

(7) PSC 9440, Miscellaneous Crude Agricultural and Forestry Products;

(8) PSC 9610, Ores;

(9) PSC 9620, Minerals, Natural and Synthetic; and

(10) PSC 9630, Additive Metal Materials.

Place of manufacture means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product that is to be provided to the Government. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture.

Predecessor means an entity that is replaced by a successor and includes any predecessors of the predecessor.

Reasonable inquiry has the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

Restricted business operations means business operations in Sudan that include power production activities, mineral extraction activities, oil-related activities, or the production of military equipment, as those terms are defined in the Sudan Accountability and Divestment Act of 2007 (Pub. L. 110-174). Restricted business operations do not include business operations that the person (as that term is defined in Section 2 of the Sudan Accountability and Divestment Act of 2007) conducting the business can demonstrate—

(1) Are conducted under contract directly and exclusively with the regional government of southern Sudan;

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(2) Are conducted pursuant to specific authorization from the Office of Foreign Assets Control in the Department of the Treasury, or are expressly exempted under Federal law from the requirement to be conducted under such authorization;

(3) Consist of providing goods or services to marginalized populations of Sudan;

(4) Consist of providing goods or services to an internationally recognized peacekeeping force or humanitarian organization;

(5) Consist of providing goods or services that are used only to promote health or education; or

(6) Have been voluntarily suspended. "Sensitive technology"— Sensitive technology—

(1) Means hardware, software, telecommunications equipment, or any other technology that is to be used specifically—

(i) To restrict the free flow of unbiased information in Iran; or

(ii) To disrupt, monitor, or otherwise restrict speech of the people of Iran; and

(2) Does not include information or informational materials the export of which the President does not have the authority to regulate or prohibit pursuant to section 203(b)(3)of the International Emergency Economic Powers Act (50 U.S.C. 1702(b)(3)).

Service-disabled veteran-owned small business (SDVOSB) concern means a small business concern— (1)(i) Not less than 51 percent of which is owned and controlled by one or more service-disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled veterans; and

(ii) The management and daily business operations of which are controlled by one or more service-disabled veterans or, in the case of a service-disabled veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran; or

(2) A small business concern eligible under the SDVOSB Program in accordance with 13 CFR part 128 (see subpart 19.14).

(3) Service-disabled veteran, as used in this definition, means a veteran as defined in 38 U.S.C. 101(2), with a disability that is service connected, as defined in 38 U.S.C.

101(16), and who is registered in the Beneficiary Identification and Records Locator Subsystem, or successor system that is maintained by the Department of Veterans Affairs’ Veterans Benefits Administration, as a service-disabled veteran.

Service-disabled veteran-owned small business (SDVOSB) concern eligible under the SDVOSB Program means an SDVOSB concern that—

(1) Effective January 1, 2024, is designated in the System for Award Management (SAM) as certified by the Small Business Administration (SBA) in accordance with 13 CFR 128.300; or

(2) Has represented that it is an SDVOSB concern in SAM and submitted a complete application for certification to SBA on or before December 31, 2023.

Service-disabled veteran-owned small business (SDVOSB) Program means a program that authorizes contracting officers to limit competition, including award on a sole-source basis, to SDVOSB concerns eligible under the SDVOSB Program.

Small business concern—

(1) Means a concern, including its affiliates, that is independently owned and operated, not dominant in its field of operation, and qualified as a small business under the criteria in 13 CFR part 121 and size standards in this solicitation.

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(2) Affiliates, as used in this definition, means business concerns, one of whom directly or indirectly controls or has the power to control the others, or a third party or parties control or have the power to control the others. In determining whether affiliation exists, consideration is given to all appropriate factors including common ownership, common management, and contractual relationships. SBA determines affiliation based on the factors set forth at 13 CFR 121.103.

Small disadvantaged business concern, consistent with13 CFR 124.1001, means a small business concern under the size standard applicable to the acquisition, that—

(1) Is at least 51 percent unconditionally and directly owned (as defined at 13 CFR 124.105) by—

(i) One or more socially disadvantaged (as defined at13 CFR 124.103) and economically disadvantaged (as defined at 13 CFR 124.104) individuals who are citizens of the United States; and

(ii) Each individual claiming economic disadvantage has a net worth not exceeding the threshold at 13 CFR 124.104(c)(2) after taking into account the applicable exclusions set forth at 13 CFR124.104(c)(2); and

(2) The management and daily business operations of which are controlled (as defined at 13.CFR 124.106) by individuals, who meet the criteria in paragraphs (1)(i) and (ii) of this definition.

Subsidiary means an entity in which more than 50 percent of the entity is owned—

(1) Directly by a parent corporation; or

(2) Through another subsidiary of a parent corporation Successor means an entity that has replaced a predecessor by acquiring the assets and carrying out the affairs of the predecessor under a new name (often through acquisition or merger). The term "successor" does not include new offices/divisions of the same company or a company that only changes its name. The extent of the responsibility of the successor for the liabilities of the predecessor may vary, depending on State law and specific circumstances.

Veteran-owned small business concern means a small business concern—

(1) Not less than 51 percent of which is owned and controlled by one or more veterans (as defined at 38 U.S.C. 101(2)) or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more veterans; and

(2) The management and daily business operations of which are controlled by one or more veterans.

Women-owned small business concern means a small business concern—

(1) That is at least 51 percent owned by one or more women; or, in the case of any publicly owned business, at least51 percent of the stock of which is owned by one or more women; and

(2) Whose management and daily business operations are controlled by one or more women.

Women-owned small business (WOSB) concern eligible under the WOSB Program (in accordance with 13 CFR part 127), means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States, and the concern is certified by SBA or an approved third-party certifier in accordance with 13

P ag e 21 | 24

CFR 127.300.

(b)(1) Annual Representations and Certifications. Any changes provided by the Offeror in paragraph (b)(2) of this provision do not automatically change the representations and certifications in SAM

(2) The offeror has completed the annual representations and certifications electronically in SAM accessed through http://www.sam.gov. After reviewing SAM information, the Offeror verifies by submission of this offer that the representations and certifications currently posted electronically at FAR 52.212-3, Offeror Representations and Certifications-Commercial Products and Commercial Services, have been entered or updated in the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard(s) applicable to the NAICS code(s) referenced for this solicitation), at the time this offer is submitted and are incorporated in this offer by reference (see FAR 4.1201), except for paragraphs .

[Offeror to identify the applicable paragraphs at (c) through (v) of this provision that the offeror has completed for the purposes of this solicitation only, if any.

These amended representation(s) and/or certification(s) are also incorporated in this offer and are current, accurate, and complete as of the date of this offer.

Any changes provided by the offeror are applicable to this solicitation only, and do not result in an update to the representations and certifications posted electronically on

SAM.]

(c) Offerors must complete the following representations when the resulting contract is for supplies to be delivered or services to be performed in the United States or its outlying areas, or when the contracting officer has applied part 19 in accordance with 19.000(b)(1)(ii). Check all that apply.

(1) Small business concern. The offeror represents as part of its offer that it [ ] is, [ ] is not a small business concern.

(2) Veteran-owned small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents as part of its offer that it [ ] is, [ ] is not a veteran-owned small business concern.

(3) SDVOSB concern. [Complete only if the offeror represented itself as a veteran-owned small business concern in paragraph (c)(2) of this provision.] The offeror represents as part of its offer that it [ ] is, [ ] is not a service-disabled veteran-owned small business concern.

(4) SDVOSB concern joint venture eligible under the SDVOSB Program. The offeror represents that it [ ] is, [ ] is not an SDVOSB joint venture eligible under the SDVOSB Program that complies with the requirements of 13 CFR 128.402. [Complete only if the offeror represented itself as an SDVOSB concern in paragraph (c)(3) of this provision.] [The offeror shall enter the name and unique entity identifier of each party to the joint venture: .]

(5)…