Amendment 1 combined synopsis-solicitation.pdf

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 75F40126Q134650. This solicitation is issued as a Request for Quote (RFQ) for an integrated, multi-attribute analytical system to enable characterization of Adeno- Associated Virus (AAV) vectors and Lipid Nanoparticles (LNPs).

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 1,000 employees. This requirement is solicited as unrestricted full and open competition, any sized business may submit a quote.

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

Ite m

Description QTY Unit of Measure

Unit Price Extended Price

Integrated, multi-attribute analytical system to enable characterization of Adeno-Associated Virus (AAV) vectors and Lipid Nanoparticles (LNPs) as specified herein

1 Ea $_________ $___________

Option Year 1: Post-Warranty Service Agreement Option Periods (FAR 52.217-9) as specified herein.

12 Months $_________ $___________

Option Year 2: Post-Warranty Service Agreement Option Periods (FAR 52.217-9) as specified herein.

12 Months $_________ $___________

Option Year 3: Post-Warranty Service Agreement Option Periods (FAR 52.217-9) as specified herein.

12 Months $_________ $___________

Option Year 4: Post-Warranty Service Agreement Option Periods (FAR 52.217-9) as specified herein.

12 Months $_________ $___________

Grand Total (items 1-5):

A. Introduction FDA CBER Gene Therapy Immunogenicity Branch requires an integrated, multi-attribute analytical system to enable characterization of Adeno-Associated Virus (AAV) vectors and Lipid Nanoparticles (LNPs). The system will be used to evaluate critical quality attributes (CQAs)

5F40126Q134650 Amendment 1 1 of 17 essential for regulatory assessment of gene therapy products, including genome packaging efficiency (empty/full ratio), aggregation, viral genome concentration, and capsid concentration.

This work directly supports FDA’s mission to ensure the safety and effectiveness of emerging gene therapy products.

B. Scope The laboratory develops next-generation AAV vectors and evaluates their immunogenicity and quality attributes. A critical need is the ability to measure genome packaging efficiency (empty/full ratio), which is the most important CQA for AAV products. The Stunner AF system or equal system, shall provide integrated multi-attribute characterization capable of measuring all four required AAV CQAs from a single 2 µL sample in one run. Historically, determination of empty/full ratio required external collaborations outside the FDA. The Stunner AF or equal system will establish this analytical capability and will reduce or eliminate reliance on external laboratories for these measurements and significantly enhance internal capabilities. In addition to AAV work (~80%), the system will support expanding LNP research, where fluorescence enables quantification of RNA payload and nanoparticle characterization.

Part I: Work Requirements Brand Name Reference Product: Unchained Labs Stunner AF (Add Fluorescence) Platform, Part Number 700-3003, or equal.

The salient characteristics that define the Government's minimum needs are stated in above and below. A product offered as an equal shall meet each minimum requirement.

Technical Requirements The system must measure genome packaging efficiency (empty/full ratio) from AAV samples.

The system must measure aggregation using Dynamic Light Scattering (DLS)/ Rotating Angle Dynamic Light Scattering (RADLS).

The system must measure viral genome concentration.

The system must measure capsid concentration.

The system must perform all measurements from a single 2 µL sample.

The system must provide integrated UV/Vis absorbance, fluorescence detection, and Dynamic Light Scattering (DLS)/Rotating Angle Dynamic Light Scattering (RADLS) capabilities necessary to perform the required AAV and LNP characterization from the same low-volume sample.

The system must support multi-sample analysis and accommodate up to 96 samples per run.

The system must provide particle size and polydispersity information for LNP samples using

DLS/RADLS.

The system must support characterization of LNP samples, including measurement of RNA payload and determination of encapsulation efficiency.

The system must include all software required for instrument control, data acquisition, analysis, reporting, and export of analytical results.

5F40126Q134650 Amendment 1 2 of 17

The contractor shall provide installation, system setup, and in-person operator training covering instrument operation, experimental setup, and basic data analysis.

Post-Warranty Service Maintenance Option Periods:

-The contractor shall provide one (1) scheduled on-site planned preventive maintenance visit per year. The consumables required for PM visit shall be included in the contract.

-The contractor shall provide unlimited on-site corrective maintenance and repairs within 3 business days of call for service where problems cannot be resolved remotely after 2 business days.

-The maintenance and repair activities shall be performed by the service engineers who are trained and certified by the original manufacturer, and the service provider should follow the Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM-certified replacement parts, components, subassemblies, etc.

-The contractor shall include unlimited software and firmware updates during the entire coverage period(s).

-The contractor shall include unlimited technical support (via phone and email) on software and hardware related issues and trouble-shooting capabilities, Monday through Friday (excluding Federal Holidays).

-All maintenance and repair pricing must encompass costs for labor, travel, replacement parts, components, subassemblies, and any other necessary expenses related to the system.

B. Deliverables

- Stunner AF system or equal with UV/Vis, RADLS, and fluorescence capabilities

- Installation and in-person training

- Software licenses and all calibration materials and accessories required for initial operation

Part II: Supporting Information

Security and Delivery Delivery shall use standard commercial shipping practices suitable for laboratory instrumentation. The contractor shall coordinate delivery and installation with the designated FDA point of contact.

Place of Performance Deliver to:

To be provided at award

FDA/CBER

Bulging 52 room 3144 10903 New Hampshire Ave Silver Spring, MD 20993

Period of Performance

5F40126Q134650 Amendment 1 3 of 17

Equipment delivery, installation and training shall be completed within 100 calendar days of contract award.

Estimated dates below:

Contract Award Date: 09/01/2026 Equipment Delivery (100 days after award): 12/10/2026 Manufacturer's Warranty Period (12 consecutive months): 12/11/2026 – 12/10/2027 Option Year 1: 12/11/2027 – 12/10/2028 Option Year 2: 12/11/2028 – 12/10/2029 Option Year 3: 12/11/2029 – 12/10/2030

The period of performance for the Option years in any resultant award will be estimated based on the date of award, required delivery of the system and the warranty offered.

If/when Option Year 1 Post-Warranty Service/ maintenance is exercised, the periods of performance for all post-warranty Options will be firmed via unilateral modification.

Additional System Requirements:

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

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

3. Systems/equipment shall be warranted for not less than one (1) year from FDA acceptance of the system(s). Warranty shall be included with the equipment and not separately priced. Warranty services shall include troubleshooting capabilities based on complete knowledge of the entire system, immediate access to replacement parts, immediate access to system improvements and updates, labor and travel costs. Phone and email technical support shall be included for a minimum of one (1) year.

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

Service/Delivery 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 Labor Day Martin Luther King, Jr.’s Birthday Columbus Day Washington’s Birthday Veterans Day Memorial Day Thanksgiving Day Juneteenth Day Christmas Day Independence Day

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):

5F40126Q134650 Amendment 1 4 of 17 https://www.acquisition.gov/far-overhaul and https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

Required:

52.212-4, Contract Terms and Conditions-Commercial Items (Deviation SEP 2025) Applicable:

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

NOV 2025)

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

NOV 2025)

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

(DEVIATION) (RFO SEP 2025)

52.222-3, Convict Labor (DEVIATION) (RFO SEP 2025) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Deviation) (RFO Sep 2025) 52.222-36, Equal Opportunity for Workers with Disabilities (Deviation) (RFO Sep 2025) 52.222-50, Combating Trafficking in Persons (Deviation) (RFO Sep 2025) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (DEVIATION) (RFO

SEP 2025)

52.222-54, Employment Eligibility Verification (DEVIATION)(RFO Nov 2025) 52.222-90, Addressing DEI Discrimination by Federal Contractors (DEVIATION) (RFO APR 2026) 52.223-23, Sustainable Products and Services (Deviation) (RFO Sep 2025) 52.225-53, Trade Agreements (Nov 2023) 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 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.”

5F40126Q134650 Amendment 1 5 of 17

(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 (4) years exclusive of the time set forth for delivery, installation, training and warranty.

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):

http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

HHSAR Clauses

352.232-71 Electronic Submission of Payment Requests (Apr 2026) (RFO DEVIATION)

(a) Definitions. As used in this clause-

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

(b) Submission instructions. 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) Alternate submission procedures. The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing.

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

(END OF CLAUSE)

352.239-79 Information and Communication Technology Accessibility (Feb 2024) (Deviation)

(a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all information and communication technology (ICT) supplies, products, platforms, information, documentation, and services support developed, acquired, maintained or delivered under this contract or order must comply with the Revised 508 Standards, which are located at 36 C.F.R. 1194.1 and Appendices A, B, and C, and are available at https://www.access-board.gov/ict/. Information about Section 508 is 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, 5F40126Q134650 Amendment 1 6 of 17 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.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)]

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

Contract Administration

a. Contracting Officer/Contract Administrator Nick Sartain, Contracting Officer Phone: 301-796-1988 Email: nick.sartain@fda.hhs.gov

5F40126Q134650 Amendment 1 7 of 17

b. COR – The following COR will represent the Government for the purpose of this contract:

(To be completed at time of award) Name:

Phone:

Email:

The 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.

Payments

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

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). 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.

5F40126Q134650 Amendment 1 8 of 17

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.

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

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

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

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

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

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

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

5F40126Q134650 Amendment 1 9 of 17

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

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

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

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

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

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

h. If the services are rejected for failure to conform to the technical requirements of the delivery 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

5F40126Q134650 Amendment 1 10 of 17 that could potentially trigger email security protections (i.e. email blocks, quarantine). Document submissions required throughout the award period(s) shall not have macro enabled functionality and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.

Solicitation provisions Contract Type: Commercial Item-Firm Fixed Price.

This solicitation incorporates one or more solicitation provisions 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. 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. 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

FAR Provisions.

52.203-11 Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions (Sep 2024) 52.203-18 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements-Representation (Jan 2017) 52.204-7 System for Award Management (Deviation) (RFO Aug 2025) 52.219-1 Small Business Program Representations (DEVIATION)(RFO Nov 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)

HHSAR Provisions 352.239-73[8] Electronic Information and [Communication] Technology Accessibility Notice (Dec 2015[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

5F40126Q134650 Amendment 1 11 of 17 acquisition and program officials in determining whether proposed ICT supplies, products, platforms, information, and documentation conform to applicable Section 508 accessibility standards. Checklists and ACRs evaluate—in detail—whether the ICT conforms to specific Section 508 accessibility standards and identifies remediation efforts needed to address conformance issues.

(c) If an offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies, products, platforms, information, documentation, or services support delivered do not conform to the described accessibility standards, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(d) In order to facilitate the Government's determination whether proposed ICT supplies meet applicable Section 508 accessibility standards, offerors must submit an Accessibility Conformance Report, in accordance with its completion instructions and tailored to the requirements in the solicitation. The purpose of the Report is to assist HHS acquisition and program officials in determining whether proposed ICT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and document, in detail, whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available at https://section508.gov/.

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

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

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

Checklist for various formats are available at https://section508.gov/. Materials, other than items incidental to contract management, that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Contracting Officer’s Representative.

(END OF PROVISION).

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:

5F40126Q134650 Amendment 1 12 of 17

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 products meet or exceed the technical requirements identified above. In addition to identifying manufacturer or distributor 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. It is incumbent that quoters unequivocally demonstrate that quoted products meet the requirements herein through the submission of technical specifications, descriptive material, scientific literature, brochures, and/or 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 this RFQ/solicitation.

To be considered for award, quotes of “equal” products, including “equal” products of the manufacturer shall meet the salient physical, functional, or performance characteristic specified in this solicitation; clearly identify the item by brand name, if any; and make or model number. “Equal” quotes shall include a narrative describing how the offered product(s) meet(s) each salient characteristic as well as a demonstration of how each salient characteristic is fully met.

Any proprietary information shall be marked as such.

Price: The price(s) proposed must be detailed and shall represent the quoter’s response to the schedule of supplies/services above. Quoters are also encouraged to submit a vendor quote with this document. Offerors shall include their SAM Unique Entity ID (UEI) with the quotation.

The Quoter shall submit a written Accessibility Conformance Report (ACR) for each item not in compliance with 508 standards identified in clause 352.239-74, describing how the item(s) will fully address the accessibility requirements outlined in the solicitation; and a description of the evaluation methods the offeror will use to validate for conformance to the Revised 508 Standards. The ACR should be based on the Voluntary Product Accessibility Template Version 2.0 (MS Word) provided by the Industry Technology Industry Council (ITIC). For this requirement we anticipate only invoices to be applicable to the requirement

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

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

5F40126Q134650 Amendment 1 13 of 17

Service Contract Act Exemption This solicitation is being issued under the premise that the offeror will certify that the combination of equipment maintenance/service it will propose to fulfill this requirement is exempt from the Service Contract Act per the conditions set forth in FAR 52.222-48 & FAR 22.1002-1(e)(1). If the Contractor certifies that the company is exempt under the terms and conditions of 52.222-48, then clause 52.222-51 will be applicable to the resulting order. In the event that a contractor does not make this certification, the traditional Service Contract Act clauses 52.222-41, and 52.222-43 shall be included in the resulting order award as Wage Determination No.: WD 2015-4269 (Rev. 33) dated 7/30/2026 which is located at:

http://sam.gov/wage-determination/2015-4269/33.

FAR 52.222-48 Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment Certifications (DEVIATION) (RFO Apr 2026).

(a) The offeror must check the following certification:

Certification The offeror [ ] does [ ] does not certify that—

(1) The items of equipment to be serviced under this contract are used regularly for other than Government purposes, and are sold or traded by the offeror (or subcontractor in the case of an exempt subcontractor) in substantial quantities to the general public in the course of normal business operations;

(2) The services will be furnished at prices which are, or are based on, established catalog or market prices for the maintenance, calibration, or repair of equipment.

(i) An "established catalog price" is a price included in a catalog, price list, schedule, or other form that is regularly maintained by the manufacturer or the offeror, is either published or otherwise available for inspection by customers, and states prices at which sales currently, or were last, made to a significant number of buyers constituting the general public.

(ii) An "established market price" is a current price, established in the usual course of trade between buyers and sellers free to bargain, which can be substantiated from sources independent of the manufacturer or offeror; and

(3) The compensation (wage and fringe benefits) plan for all service employees performing work under the contract are the same as that used for these employees and equivalent employees servicing the same equipment of commercial customers.

(b) Certification by the offeror as to its compliance with respect to the contract also constitutes its certification as to compliance by its subcontractor if it subcontracts out the exempt services. If the offeror certifies to the conditions in paragraph (a) of this provision, and the Contracting Officer determines in accordance with FAR 22.1002-1(e)(3) that the Service Contract Labor Standards statute-

(1) Will not apply to this offeror, then the Service Contract Labor Standards clause in this solicitation will not be included in any resultant contract to this offeror; or

(2) Will apply to this offeror, then the clause at 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements, in this solicitation will not be included in any resultant contract awarded to this offeror, and the offeror may be provided an opportunity to submit a new offer on that basis.

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(c) If the offeror does not certify to the conditions in paragraph (a) of this provision-

(1) The clause in this solicitation at 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements, will not be included in any resultant contract awarded to this offeror;

and

(2) The offeror must notify the Contracting Officer as soon as possible, if the Contracting Officer did not attach a Service Contract Labor Standards wage determination to the solicitation.

(d) The Contracting Officer may not make an award to the offeror, if the offeror fails to execute the certification in paragraph (a) of this provision or to contact the Contracting Officer as required in paragraph (c) of this provision.

(End of provision)

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.

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 52.225-6, Free Trade Agreements 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 Offers. The offeror agrees to hold the prices in its quote firm through September 30, 2026.

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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 intends to award a contract resulting from this solicitation to the lowest priced technically acceptable responsible quoter/offeror whose quote, conforming to the solicitation, will be most advantageous to the Government, price and other factors considered. Quotes will be evaluated on their ability to meet the requirements provided herein.

The lowest priced quote will be evaluated first. If the lowest priced quote is not technically acceptable, the next lowest priced quote will be evaluated and so on until a technically acceptable quote is determined.

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.

(b) Options (if applicable). 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).

(c) 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.

The Government's determination of technical acceptability in no way relinquishes the Awardee’s contractual obligation to ensure the quoted products meet the FDA’s stated need.

Notice to Offerors:

- 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.

- Notice of intent to use standing price quotations for subsequent purchases In accordance with FAR RFO 12.201-1(e)(1), the Government may rely on the prices submitted in response to this solicitation for subsequent purchases through December 30, 2026. Before issuing a subsequent purchase order, the contracting officer will validate that the pricing remains current and reasonable.

This provision does not obligate the Government to make any subsequent purchase. Any extension of the standing price quotation period must be agreed to in writing by both parties.

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

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.

All responsible sources may submit an offer, which if timely received, shall be considered. The offer must reference solicitation number 75F40126Q134650. The offers are due by email to nick.sartain@fda.hhs.gov on or before August 26, 2026 by 1:00 P.M. (Central Time in Jefferson, Arkansas).

For information regarding this solicitation, please contact Nick Sartain at (301) 796-1988 or email nick.sartain@fda.hhs.gov.

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