css 76F40126Q132810.pdf

Combined Synopsis/Solicitation 76F40126Q132810

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. Offers are being requested, and a separate written solicitation will not be issued. The solicitation number is 76F40126Q132810. This solicitation is issued as a Request for Quote (RFQ). For information regarding this solicitation, please contact Howard Nesmith by e-Mail at howard.nesmith@fda.hhs.gov.

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 www.acquisition.gov/far-overhaul.

The appropriate North American Industry Classification System (NAICS) Code is 334513 - Instruments and Related Products Manufacturing for Measuring, Displaying, and Controlling Industrial Process Variables; with a Small Business Size Standards in number of employees 750.

This requirement is being solicited as unrestricted and made available to Full and Open competition, meaning any qualified vendor regardless of size, status may submit a quote.

Statement of Need/Requirements:

The U.S. Food and Drug Administration (FDA), Human Foods Program (HFP), Office of Laboratory Operations and Applied Science (OLOAS) consisting of the Office of Regulatory Testing and Surveillance (ORTS), Office of Applied Microbiology and Technology (OAMT) and Office of Chemistry and Toxicology (OCT), requires multiple Food Safety Real-Time Polymerase Chain Reaction (PCR) Systems.

The Government intends to issue a single award Firm Fixed Price Indefinite Delivery/Indefinite Quantity (IDIQ) contract with a base and four (4) one-year option years as a result of this solicitation. The IDIQ minimum quantity will be 1 and the maximum quantity will be 50. The quantities below are estimated amounts based on the Government’s anticipated needs.

Schedule of Items (Price quotes shall be FOB destination inclusive of inside delivery, all shipping, handling, delivery, installation, and training charges)

INSTRUMENT SYSTEM

CLIN 0001 - Base Year

Item Description Quantity Unit Price Total Price Food Safety Real-Time Polymerase Chain Reaction (PCR) System 20 $ $ Familiarization Training‐ up to 4 users per lab 11 $ $ Shipping and Handling 20 $ $

TOTAL VALUE $

CLIN 1001 - Option Year 1

Item Description Quantity Unit Price Total Price Food Safety Real-Time Polymerase Chain Reaction (PCR) System 15 $ $ Familiarization Training‐ up to 4 users per lab 11 $ $ mailto:howard.nesmith@fda.hhs.gov http://www.acquisition.gov/

Shipping and Handling 15 $ $

CLIN 2001 - Option Year 2

Food Safety Real-Time Polymerase Chain Reaction (PCR) System 5 $ $ Familiarization Training‐ up to 4 users per lab 5 $ $ Shipping and Handling 5 $ $

CLIN 3001 - Option Year 3

Food Safety Real-Time Polymerase Chain Reaction (PCR) System 5 $ $ Familiarization Training‐ up to 4 users per lab 5 $ $

CLIN 4001 - Option Year 4

Food Safety Real-Time Polymerase Chain Reaction (PCR) System 5 $ $ Familiarization Training‐ up to 4 users per lab 5 $ $

GSA Contract Number: ______________________ (If Applicable)

Background:

The FDA/OAMT & OCT both optimize and validate rapid and highly sensitive microbiological and molecular methods and instrumentation used for recovery, detection, and quantification of enteric bacterial pathogens and their related toxins from foods and cosmetics. The ORTS laboratory network performs scientific testing on products which are regulated by FDA as well as related food processing and farm production environments. To ensure that the testing results are competent and suitable for regulatory purposes, the ORTS laboratories utilize known validated methods including Real-Time PCR protocols according to the reference methods outlined in the FDA Bacteriological Analytical Manual (BAM) for the detection of pathogens, including Salmonella, Shiga-toxin Escherichia coli, Listeria, Hepatitis A/Norovirus and Cyclospora analysis.

Minimum Technical Requirements:

Any catalog number, manufacturer brand name, or proprietary description used in this solicitation is used as descriptive only, not restrictive, and used to indicate type, function, or desired quality.

System shall be newly manufactured, latest model, not used, refurbished, or previously used for demonstration.

System Compatibility

• System shall be fully compatible with current validated Applied Biosystems 7500 Fast Real- Time PCR System assays without requiring assay revalidation or modification

• System shall be capable of detecting a minimum of six (6) distinct targets simultaneously within a single reaction

Optical System

• Minimum of 6 decoupled excitation and emission filter channels (96-well format configuration) multi-channel detection

• Filter combinations capability to support at least 21 distinct filter combinations to enable comprehensive multiplexing applications

• Factory calibration for the following fluorescent dyes at minimum: FAM, SYBR Green, VIC, ABY, NED, TAMRA, JUN, ROX, Mustang Purple, and Cy5 Dye Compatibility

• Capable of detecting target quantity differences as low as 1.5-fold in singleplex reactions sensitivity

• Minimum dynamic range of 10 logs (10 orders of magnitude) dynamic range

Thermal Block

• System shall include a sample format of 96-well, 0.1ml reaction block configuration to accommodate standard laboratory throughput requirements

• Sample format options compatible with both 96-well (0.1 mL and 0.2 mL reaction volumes) and 384-well block formats

• 96-Well system shall provide the capability to partition the block into six (6) independent temperature control zones, enabling simultaneous execution of multiple experiments with different thermal protocols

• Shall have an operational temperature range of 4°C to 99.9°C

• Heating/cooling method shall be a peltier-based thermal cycling system

• Maximum temperature variation of ±0.4°C across the block temperature uniformity

• Shall have ramp rate performance of:

o Maximum block ramp rate: ≥6.5°C/second (96-well, 0.2 mL format) o Maximum block ramp rate: ≥9.0°C/second (96-well, 0.1 mL format) o Average sample ramp rate: ≥3.66°C/second

Connectivity and Data Management

• Shall support USB, Wi-Fi, and LAN network connections

• Shall be capable of connecting to manufacturer's cloud platform for remote monitoring, data analysis, and secure data sharing

• Shall have encrypted data transmission and storage capabilities for data security

User Interface Requirements

• Shall have at minimum 8.5-inch interactive touchscreen interface display

• Shall have pre-optimized, simplified protocol templates for standard applications protocol templates

• Shall have interface design suitable for operation by personnel with varying levels of user experience

Instrument Software Regulatory Compliance Features

• Shall have multi-level user access management controls and authentication

• Shall have comprehensive electronic audit trail functionality

• Shall have E-signature capability compliant with 21 CFR Part 11 requirements

• Shall have data integrity features which support FDA data integrity guidelines (ALCOA+ principles)

Performance Requirements

• Throughput run time capable of completing thermal cycling in less than 30 minutes for 96-well 0.2 mL block format using fast chemistry protocols

• Throughput sample capacity configurable for 96-well or 384-well formats as specified

• System shall be designed for continuous uptime laboratory operation with minimal downtime

• Dye calibration interval requirements shall not exceed once every two years under normal operating conditions

• Shall be designed for minimal routine maintenance requirements

System Computer Requirements If procured in PC-attached configuration, the accompanying computer system shall meet or exceed the following:

• Intel Core i5 or equivalent/superior Processor

• 16 GB RAM minimum Memory

• Windows 10 (or current FDA-approved Windows OS version) Operating System

• Adequate storage capacity for data archiving per FDA requirements

Acceptance IQ/OQ/PQ Criteria

• Installation Qualification (IQ) o Proper installation per manufacturer specifications o Confirmation that installation site is suitable per above Instrument Software Regulatory

Compliance Features o All specified hardware components present and functional o Network connectivity operational o Software installation complete with all regulatory compliance features enabled o Electrical safety verification and grounding confirmation o Shall provide documentation confirming (IQ)

• Operational Qualification (OQ) o Temperature uniformity within ±0.4°C specification o Ramp rate performance meeting specified values o Optical detection across all specified dye channels o Cloud connectivity and data transfer functionality o 21 CFR Part 11 compliance features operational o Shall demonstrate (OQ)

• Performance Qualification (PQ) o The vendor shall provide validation data demonstrating:

o Sensitivity meeting 1.5-fold detection specification o Dynamic range of 10 logs o Run time performance for fast cycling protocols o Reproducibility across independent temperature zones o Shall provide validation data demonstrating (PQ)

Complete System Shall Include:

• Shall be delivered with all necessary supplies and accessories required for installation and start-up

• One (1) laptop computer if procured in PC-attached configuration meeting above System Computer Requirements

• User manuals and technical documentation

• All necessary consumables for IQ/OQ/PQ testing

• IQ/OQ/PQ protocols and executed documentation

• Training for FDA laboratory personnel (up to 4 users)

• At minimum one-year manufacturer warranty from date of installation

FOB Point Destination:

Shipping, handling, in-side delivery, installation, and training are expected to be completed within 120 days after receipt of contract award. Initial Delivery Order will be in accordance with CLIN 0001 Base Year of which 20 Systems will be delivered as follows:

OpDiv Qty Lab Location ORTS 2 Jefferson, AR ORTS 2 Atlanta, GA ORTS 2 Denver, CO ORTS 2 Irvine, CA ORTS 2 Jamaica, NY ORTS 2 Alameda, CA ORTS 2 Bothell, WA OAMT 1 College Park, MD OAMT 1 Laurel, MD OAMT 1 Bedford Park, IL OAMT 1 Dauphin Island, AL

OCT 2

Undetermined At This Time Potential Locations:

- Laurel MD 20708

- College Park, MD 20740

- Dauphin Island, AL 36528

- Bedford Park, IL 60501

Instrument System FOB Destination & Place of Performance:

U.S. Food and Drug Administration Human Foods Program (HFP) At any of the destinations below:

• Jefferson, AR

• Atlanta, GA

• Denver, CO

• Irvine, CA

• Jamaica, NY

• Alameda, CA

• Bothell, WA

• College Park, MD

• Laurel, MD

• Bedford Park, IL

• Dauphin Island, AL

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 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:

Commercial Item-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 52.212-4, Terms and Conditions - Commercial Products and Commercial Services (DEVIATION) (RFO AUG 2025) applies to this solicitation.

The following addenda apply:

52.203-6 Alt I, Restrictions on Subcontractor Sales to the Government (Jun 2020) Alternate I (Nov 2021) 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) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters

(DEVIATION) (RFO NOV 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_6 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_9

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)

52.219-8, Utilization of Small Business Concerns (DEVIATION) (RFO SEP 2025) 52.219-9, Small Business Subcontracting Plan (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) 52.222-35, Equal Opportunity for Veterans (DEVIATION) (RFO SEP 2025) 52.222-36, Equal Opportunity for Workers with Disabilities (DEVIATION) (RFO SEP 2025) 52.222-37, Employment Reports on Veterans (DEVIATION) (RFO SEP 2025) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act

(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)

52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements (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) 52.225-5, Trade Agreements (Nov 2023) 52.226-8, Encouraging Contractor Policies to Ban Text Messaging While Driving (MAY 2024) 52.229-12, Tax on Certain Foreign Procurements—Notice and Representation (DEVIATION)

(RFO SEP 2025)

52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct 2018) 52.232-36, Payment by Third Party (DEVIATION) (RFO SEP 2025) 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 AUG 2025) 52.244-6, Subcontracts for Commercial Products and Commercial Services (DEVIATION) (RFO

SEP 2025)

52.216-18 Ordering (Aug 2020)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from the effective date of award through the end of the effective period of performance.

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) A delivery order or task order is considered "issued" when—

(1) If sent by mail (includes transmittal by U.S. mail or private delivery service), the Government deposits the order in the mail;

(2) If sent by fax, the Government transmits the order to the Contractor's fax number; or

(3) If sent electronically, the Government either— 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_4 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_219_8 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_219_9 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_19 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_222_35 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_37 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_222_40 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_51 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_222_53 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_5 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_229_12 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_36 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_232_40 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_233_3 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_233_4 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_240_91 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_244_6 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_216_18

(i) Posts a copy of the delivery order or task order to a Government document access system, and notice is sent to the Contractor; or

(ii) Distributes the delivery order or task order via email to the Contractor's email address.

(d) Orders may be issued by methods other than those enumerated in this clause only if authorized in the contract.

52.216-19 Order Limitations (Oct 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than 1 unit, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor-

(1) Any order for a single item in excess of 20 units;

(2) Any order for a combination of items in excess of 50 units; or

(3) A series of orders from the same ordering office within 2 days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within 5 days after issuance, with written notice stating the Contractor’s intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

52.216-22 Indefinite Quantity (Deviation Date) (RFO Deviation) (MAR 2026)

(a) This is an indefinite-quantity contract for the supplies or services specified, and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the Schedule up to and including the quantity designated in the Schedule as the "maximum." The Government shall order at least the quantity of supplies or services designated in the Schedule as the "minimum."

(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(d) Any order issued during the ordering period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order, which may include order options to be exercised after the ordering period of this contract but before the end of the period of performance of the order. The contract shall govern the Contractor's and Government's rights and obligations with respect to that order, including options exercised, to the same extent as if the order were completed during the contract's ordering period; provided, that the Contractor shall not be required to make any deliveries under this contract after the last day of the exercised option+ 364 days.

52.217-6 Option for Increased Quantity (Mar 1989) https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_216_19 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_216_22 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_217_6

The Government may increase the quantity of supplies called for in the Schedule at the unit price specified. The Contracting Officer may exercise the option by written notice to the Contractor anytime before the contract expiration. Delivery of the added items shall continue at the same rate as the like items called for under the contract, unless the parties otherwise agree.

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 anytime before the contract expiration; provided that the Government gives the Contractor a preliminary written notice of its intent to extend anytime before the contract expires. The preliminary notice does not commit the Government to an extension.

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

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 5 years.

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) 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.

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

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 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_217_9 http://www.ipp.gov/ https://www.hhs.gov/web/section-508/index.html 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.

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.

Contract Administration:

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 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;

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

(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.

Contractor Performance Information In accordance with FAR Subpart 42.11, FDA will complete annual (interim) and final contractor performance evaluations. Annual evaluations will be prepared to coincide with the anniversary date of the contract. Additional interim performance evaluations may be prepared at Contracting Officer discretion, as necessary. Final performance evaluations will be completed upon contract expiration.

FDA will utilize the Contractor Performance Assessment Reporting System (CPARS) in order to execute annual and final contractor performance evaluations. CPARS is a secure Internet website located at https://www.cpars.gov/. FDA will register the contractor in CPARS upon receipt of the name and email address of two (2) individuals who will be responsible for serving as the Contractor’s primary and alternate CPARS contracts.

Once FDA registers the contractor in CPARS, the Contractor will receive an automated CPARS email message which contains User IDs and instructions for creating a password.

Once a performance evaluation is issued, the Contractor’s primary and alternate CPARS contact will receive an email instructing them to logon to CPARS in order to review the performance evaluation.

The Contractor has 14 days from the date of performance evaluation issuance in which to review the evaluation. If the Contractor is in agreement with the performance evaluation outcome, the evaluation becomes final. Should the Contractor be in disagreement with the performance evaluation outcome, rebuttal comments must be submitted via the CPARS within 14 days from date the evaluation was issued by the FDA. Any disagreement between the Contracting Officer and the Contractor will be referred to a contracting official one level above the Contracting Officer, whose decision will be final.

Copies of each performance evaluation and contractor responses, if any, will be retained as part of the official contract file and will be used to support future award decisions. Evaluations will also be stored for a 3-year period in the https://www.cpars.gov/ system.

Contractors may obtain CPARS training material and register for on-line training at https://www.cpars.gov/cparsweb/lc. There is no fee for registration or use of the CPARS.

INVOICE SUBMISSION

No advance payment will be made under the resulting order/contract.

Payment Terms Net 30 Days After Government Acceptance of Supplies/Services.

CONTRACTOR SHALL SUBMIT ALL INVOICES AS FOLLOWS:

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 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-42#FAR_Subpart_42_11 https://www.cpars.gov/ https://www.cpars.gov/ https://www.cpars.gov/cparsweb/lc http://www.ipp.gov/vendors/index.htm the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions - Commercial Items included in commercial items contracts. The IPP website address is:

https://www.ipp.gov c.

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

- 5 business days of the contract award for new contracts or date of modification for existing contracts.

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

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

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

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

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

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

- 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:

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

https://www.ipp.gov/ mailto:IPPCustomerSupport@fiscal.treasury.gov

(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 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.

Solicitation 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. Full text of any provision 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.

FAR Provisions:

mailto:ERIC@fda.hhs.gov 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

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—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) 52.229-11, Tax on Certain Foreign Procurements—Notice and Representation (Jun 2020) 52.240-90, Security Prohibitions and Exclusions Representations and Certifications 52.204-90 Offeror Identification (DEVIATION) (RFO AUG 2025) 52.217-5 Evaluation of Options (DEVIATION) (RFO MAY 2026) Except when it is determined in accordance with FAR 17.202(b) not to be in the Government’s best interests, the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. Evaluation of options will not obligate the Government to exercise the option(s).

52.225-6, Trade Agreements Certificate (Feb 2021)

(a) The offeror certifies that each end product, except those listed in paragraph (b) of this provision, is a U.S.-made or designated country end product, as defined in the clause of this solicitation entitled "Trade Agreements."

(b) The offeror shall list as other end products those supplies that are not U.S.-made or designated country end products.

Other End Products:

Line Item No. Country of Origin

[List as necessary]

(c) The Government will evaluate offers in accordance with the policies and procedures of part 25 of the Federal Acquisition Regulation. For line items covered by the WTO GPA, the Government will evaluate offers of U.S.-made or designated country end products without regard to the restrictions of the Buy American statute. The Government will consider for award only offers of U.S.-made or designated country end products unless the Contracting Officer determines that there are no offers for such products or that the offers for those products are insufficient to fulfill the requirements of this solicitation.

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, https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_203_11 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_229_11 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_240_90 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_217_5 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_225_6 https://www.hhs.gov/web/section-508/index.html information, and documentation meet applicable Section 508 accessibility standards, offerors must submit an appropriate HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibility-checklists/index.html) or an Accessibility Conformance Report (ACR) (based on the Voluntary Product Accessibility Template (VPAT) see https://www.itic.org/policy/accessibility/vpat), in accordance with the completion instructions.

The purpose of the checklists and conformance reports are to assist HHS acquisition and program officials in determining whether proposed ICT supplies, products, platforms, information, and documentation conform to applicable Section 508 accessibility standards. Checklists and ACRs evaluate—in detail—whether the ICT conforms to specific Section 508 accessibility standards and identifies remediation efforts needed to address conformance issues.

(c) If an offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies, products, platforms, information, documentation, or services support delivered do not 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 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.

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 https://www.hhs.gov/web/section-508/accessibility-checklists/index.html https://www.itic.org/policy/accessibility/vpat https://section508.gov/ information corresponding to each minimum technical requirement which demonstrates the capabilities of the offered system.

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).

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

Small Business Subcontracting Plan If the Offeror determines that there will not be subcontracting opportunities, the Offeror shall still submit a subcontracting plan and…