FDA 75F40126Q134239.pdf

This is a combined synopsis-solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) RFO Part 12, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a separate written solicitation will not be issued. The solicitation number 75F40126Q134239 is issued as a Request for Quote (RFQ) for an in vitro Subcutaneous Injection Site Simulator (SCISSOR) system described below.

This acquisition is solicited as a total set-aside for small business concerns under North American Industry Classification System (NAICS) Code 334516 – Analytical Laboratory Equipment Manufacturing; with a Small Business Size Standard of 1,000 employees. Only small businesses actively registered in SAM.gov may submit a quote. This solicitation incorporates provisions and clauses by reference. The full text of provisions and clauses may be accessed electronically at https://www.acquisition.gov/far-overhaul.

Schedule of Supplies or Services and Prices/Costs.

Line Item 01 Complete subcutaneous injection site simulator consisting of multiple independent chambers with integrated optical detection systems, automated sampling capabilities, and comprehensive software control for hardware operation and data management, and meeting all the technical requirements as described below; includes all shipping fees and delivery FOB Destination:

Quantity: 1

Unit: Each Price: ____________________

GSA Contract Number (if applicable): ____________________________

Background and Requirement The U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Review (CDER), Division of Pharmaceutical Quality Research V (DPQRV) requires an in vitro Subcutaneous Injection Site Simulator (SCISSOR) system to address critical regulatory research needs for the evaluation of complex long-acting injectable drug products. The development of generic versions of these products, such as in-situ forming gels and implants, presents significant regulatory challenges. Establishing bioequivalence (BE) through conventional in vivo pharmacokinetic (PK) studies is often complicated by high data variability, ethical considerations (as with drugs of abuse), and difficulties in patient recruitment.

There is a pressing need to develop robust and reliable in vitro methodologies that can serve as an alternative BE pathway. A physiologically relevant in vitro subcutaneous injection site simulator provides a controlled environment that mimics the subcutaneous tissue, enabling the development and validation of IVRT methods for in situ forming products. This capability is critical for FDA laboratories to fully characterize these complex drug products and develop science-based bioequivalence recommendations. The new system will significantly advance DPQRV's analytical capability and research readiness to generate critical evidence to support both new drug applications (NDAs) and abbreviated new drug applications (ANDAs) and will enable the development of product-specific guidance documents with robust in vitro bioequivalence approaches.

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

The minimum technical requirements that a Subcutaneous Injection Site Simulator (SCISSOR) instrument system shall meet are as follows:

General System shall be a complete subcutaneous injection site simulator consisting of multiple independent chambers with integrated optical detection systems, automated sampling capabilities, and comprehensive software control for hardware operation and data management.

Main Instrument Configuration *Shall have minimum of six (6) independent chambers for simultaneous testing of multiple samples;

*Each chamber must have independent temperature and flow control capabilities;

*Integrated camera or imaging system for each chamber enabling real-time visual monitoring of gel formation, structure evolution, and dissolution processes;

*Compatible with standard laboratory power (115-240 VAC, 50/60 Hz);

*Physiologically relevant temperature regulation capability to simulate subcutaneous tissue environment, with control range including 32-37°C;

*Capable of introducing test samples via manual or automated injection methods;

*Simultaneous visual and spectroscopic monitoring capabilities for all chambers;

*System must be expandable or configurable to accommodate different experimental needs;

* Shall have a reasonable laboratory footprint suitable for standard laboratory benchtop installation.

Automated Injection System System must include an automated injection capability with the following specifications:

*Automated sample injection capability for reproducible and consistent sample introduction across all chambers;

*Full integration with the chamber system;

*Accurate and reproducible injection volumes with documented precision;

*Programmable injection parameters including volume, rate, and depth of injection;

*Capability to deliver consistent injections to minimize inter-sample variability;

*OEM or OEM-compatible consumables (e.g., pipette tips, syringes) should be readily available in the commercial marketplace.

Optical Detection and Monitoring System The system must include optical detection capabilities with the following specifications:

*Capable of simultaneous spectroscopic monitoring of all chambers;

*Fiber optic probe system or equivalent optical detection method suitable for in-line monitoring;

*Appropriate optical path length for drug quantification;

*UV-visible spectroscopy capability for drug quantification across relevant wavelength ranges;

*Real-time signal acquisition and transmission to spectrophotometer or data acquisition system;

*Sufficient sensitivity for detection of drug release at physiologically relevant concentrations;

*Stable baseline and reproducible measurements over extended time periods (hours to days).

Automated Fraction Collection System The system must include an automated fraction collection capability with the following specifications:

*Minimum capacity of 30 collection vials per chamber (180 total vials for 6-chamber system);

*Fully automated sampling from all chambers without manual intervention;

*Programmable sampling volumes ranging from minimal 0.1 mL to 1 mL or greater;

*Integrated automated cleaning/wash station for sampling components to prevent cross-contamination between samples;

*Automated buffer or media replenishment system to maintain consistent flow stream composition throughout extended experiments;

*Compatible with standard laboratory power (115-240 VAC, 50/60 Hz);

*Full integration with system control software for coordinated operation;

*Compatible with standard HPLC vials or other common laboratory vial formats for subsequent analysis;

*Programmable time-based or event-based sampling protocols with flexible scheduling options;

*Demonstrated reliability for unattended operation over extended periods (24+ hours).

Calibration and Standardization The system must include calibration and standardization tools with the following specifications:

*Standardization and calibration capabilities for optical detection systems;

*Tools and procedures to ensure consistent measurements across all chambers and over time;

*Clear calibration procedures and documentation for quality assurance;

*Straightforward standardization procedures suitable for routine operation.

Consumables and Accessories The vendor must provide initial consumables and accessories including:

*Appropriate consumables for automated injection system;

*Demonstration kit or validation materials suitable for initial system qualification and training;

*Reference cartridges, matrices, or materials for method development and validation;

*All consumables must be designed specifically for the proposed system;

*Ongoing availability of consumables must be guaranteed with reasonable lead times.

Software Control and Data Management The system software shall meet the following specifications:

*Complete control of all system hardware components including temperature regulation, injection parameters, and fraction collection scheduling *Simultaneous control and monitoring of all chambers with independent parameter settings *Real-time status display and monitoring of all chambers simultaneously with clear visual interface *Ability to create, save, modify, and execute experimental methods with all relevant parameters *Capable of running automated sequences across multiple chambers with programmable start times and conditions;

*Integration capability with external spectrophotometer systems for real-time data acquisition;

*Control and data capture from all integrated cameras or imaging systems;

*Automated System Integration: Full control and coordination of automated injection and fraction collection systems;

*Export capabilities for data analysis in standard formats (e.g., CSV, Excel, text files);

*Intuitive graphical user interface for method setup, execution, and monitoring;

*Comprehensive data logging and experimental documentation with time-stamped records;

*User access controls and audit trail capabilities suitable for regulated laboratory environment.

Warranty Shall include a minimum one-year full manufacturer’s warranty from date of FDA acceptance of the system.

Additional System Requirements, Installation, Training, and Support

Installation Contractor shall conduct complete installation of the system to include the following:

*Unpacking, inspection, and positioning of all equipment;

*Complete hardware setup and configuration;

*Integration with existing FDA spectrophotometer system (Rainbow R2 or equivalent);

*Software installation, configuration, and network integration as needed;

*Performance verification testing to confirm proper system operation according to specifications;

*Documentation of installation qualification (IQ) or equivalent installation documentation;

*Identification and resolution of any installation issues;

Training Contractor will provide comprehensive on-site training for FDA personnel including:

*Basic hardware operation and routine maintenance procedures;

*Software operation for method development, execution, and data management;

*Automated injection system operation and troubleshooting;

*Fraction collector operation, programming, and maintenance;

*Optical detection system setup, calibration, and standardization;

*Integration procedures with existing spectrophotometer system;

*Routine maintenance procedures and schedules;

*Basic troubleshooting guidance and problem resolution;

*Training materials, user manuals, and documentation;

*Minimum training duration: One (1) full day on-site, with additional remote support as needed.

Service and Support *Access to vendor technical support via phone and email during regular business hours (minimum Monday-Friday, 9 AM - 5 PM Eastern Time);

*Reasonable response time for technical issues and service requests (maximum 2 business days for initial response);

* Access to software updates, patches, and bug fixes during warranty period at no additional cost;

*Comprehensive user manuals, technical documentation, and standard operating procedures;

*Confirmed availability of replacement parts and consumables for ongoing operation with reasonable lead times;

*Remote diagnostic and troubleshooting capabilities where applicable.

Documentation and Compliance Contractor shall provide upon FDA acceptance of the system:

*Detailed technical specifications for all system components;

*Comprehensive user manuals and operating procedures;

*Detailed maintenance schedules and procedures;

*All relevant compliance certificates, safety certifications, or regulatory documentation;

*Material Safety Data Sheets (MSDS) or SDS for all consumables and materials provided.

Delivery – FOB Destination

U.S. FDA CDER DPQRV

Attn: TBD

Bldg. 64, 1st Floor Loading Dock 10903 New Hampshire Avenue Silver Spring, MD 20993-0002

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

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

Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day

Contract Type Firm Fixed-Price

Contract Clauses:

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

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

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

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

NOV 2025

52.219-6 Notice of Total Small Business Set-Aside (DEVIATION) (RFO SEP 2025) 52.222-3 Convict Labor (DEVIATION) (RFO SEP 2025) 52.222-36 Equal Opportunity for Workers with Disabilities (DEVIATION) (RFO SEP 2025) 52.222-50 Combating Trafficking in Persons (DEVIATION) (RFO SEP 2025) 52.222-90 Addressing DEI Discrimination by Federal Contractors (DEVIATION) (RFO APR 2026) 52.223-23 Sustainable Products and Services (DEVIATION) (RFO SEP 2025) 52.225-1 Buy American – Supplies (DEVIATION) (RFO SEP 2025) 52.226-8 Encouraging Contractor Policies to Ban Text Messaging While Driving (MAY 2024) 52.232-33 Payment by Electronic Funds Transfer-System for Award Management (Oct 2018) 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Mar 2023) 52.233-3 Protest after Award (DEVIATION) (RFO SEP 2025) 52.233-4 Applicable Law for Breach of Contract Claim (Oct 2004) 52.240-91 Security Prohibitions and Exclusions (DEVIATION) (RFO SEP 2025) https://www.acquisition.gov/far-overhaul https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_203_17 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_203_19 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_204_13 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_209_6 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_209_10 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_219_6 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_222_3 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_222_36 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_222_50 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_222_90 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_223_23 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_225_1 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_226_8 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_232_33 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_232_40 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_233_3 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_233_4 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_240_91

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

SEP 2025)

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

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

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

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

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

(END OF CLAUSE)

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

[(DEVIATION)]

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

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

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

https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_244_6 https://www.hhs.gov/web/section-508/index.html https://www.hhs.gov/web/section-508/accessibility-checklists/index.html https://www.itic.org/policy/accessibility/vpat

(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)]

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

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

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

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

(3) Performing technical evaluation as required;

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

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

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

Name: TBD Email:

Phone:

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

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

(2) Modify or extend the period of performance;

(3) change the delivery schedule;

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

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

The contact information for the Contracting Officer is:

https://www.hhs.gov/web/section-508/accessibility-checklists/index.html https://www.hhs.gov/web/section-508/accessibility-checklists/index.html

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

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

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

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

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

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

(c)-

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

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

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

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

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

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

mailto:timothy.walbert@fda.hhs.gov http://www.ipp.gov/vendors/index.htm

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

RFQ Provisions:

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

FAR Provisions:

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

(DEVIATION) (RFO AUG 2025)

52.222-18 Certification Regarding Knowledge of Child Labor for Listed End Products (Feb 2021) 52.225-2 Buy American Certificate (Oct 2022) 52.240-90 Security Prohibitions and Exclusions Representations and Certifications 52.204-90 Offeror Identification (DEVIATION) (RFO AUG 2025)

HHSAR Provisions:

352.239-78 Information and [Communication] Technology Accessibility Notice (Feb 2024) [(Deviation)]

(a) Any offeror responding to this solicitation must comply with established HHS Information and Communication Technology (ICT) accessibility standards. Information about Section 508 is available at https://www.hhs.gov/web/section-508/index.html.

(b) The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239-79 Information and Communication Technology Accessibility. In order to facilitate the Government’s determination whether proposed ICT supplies, products, platforms, information, and documentation meet applicable Section 508 accessibility standards, offerors must submit an appropriate HHS Section 508 Accessibility Conformance Checklist (see https://www.acquisition.gov/far-overhaul https://www.acquisition.gov/far-overhaul https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_203_18 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_204_7 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_222_18 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_225_2 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_240_90 https://www.hhs.gov/web/section-508/index.html https://www.hhs.gov/web/section-508/accessibility-checklists/index.html) or an Accessibility Conformance Report (ACR) (based on the Voluntary Product Accessibility Template (VPAT) see https://www.itic.org/policy/accessibility/vpat), in accordance with the completion instructions. The purpose of the checklists and conformance reports are to assist HHS acquisition and program officials in determining whether proposed ICT supplies, products, platforms, information, and documentation conform to applicable Section 508 accessibility standards. Checklists and ACRs evaluate—in detail— whether the ICT conforms to specific Section 508 accessibility standards and identifies remediation efforts needed to address conformance issues.

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

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

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

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

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

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

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

(End of provision)

The Quoter shall submit a written Accessibility Conformance Report (ACR) for each item not in compliance with 508 standards identified in clause 352.239-74, describing how the item(s) will fully address the accessibility requirements outlined in the solicitation; and a description of the evaluation methods the offeror will use to validate for conformance to the Revised 508 Standards. The ACR should be based on the Voluntary Product Accessibility Template Version 2.5 (MS Word) provided by the Industry Technology Industry Council (ITIC).

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

https://www.hhs.gov/web/section-508/accessibility-checklists/index.html https://www.itic.org/policy/accessibility/vpat https://section508.gov/ http://508.hhs.gov/ http://www.itic.org/policy/accessibility

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

The provision at FAR 52.212-1 Instructions to Offerors - Commercial Products and Commercial Services (DEVIATION)(RFO Aug 2025) applies to this solicitation. The following addenda apply:

Technical Acceptability. Offerors shall provide sufficient technical information necessary for the government to conclusively determine that the offered service/equipment/product meets all the technical requirements herein, to include descriptive material, literature, brochures and other information corresponding to each minimum technical requirement which demonstrates the capabilities of the offered system.

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

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

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

Buy American Act and Executive Order 14005.

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

Line Item No. Country of Origin

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

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

http://www.sam.gov/

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

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

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

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

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

The following evaluation factors apply:

(i) Technical Acceptability

(ii) Price

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

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

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

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

These issues may include technical, price or other issues.

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

NOTICE

- System updates may lag policy updates. The System for Award Management (SAM) may continue to require entities to complete representations based on provisions that are not included in this solicitation. Contracting officers will rely on representations from offers based on provisions in the solicitation. Entities are not required to, nor are they able to, update their entity registration to remove these representations in SAM.

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

Offerors are responsible for submitting, by e-mail ONLY, quotes and supporting documents to Tim Walbert, timothy.walbert@fda.hhs.gov NLT 2:00 pm CDT on July 31, 2026.

mailto:timothy.walbert@fda.hhs.gov