RFQ FDA-SOL-75F40126Q00384_.pdf

REQUEST FOR QUOTE

AEMS Think Trends Licenses (Brand Name)

FDA-SOL-75F40126Q00384

DATE POSTED: September 17, 2026

RESPONSE DATE: September 24, 2026, by 1:00PM EST or sooner

CLASSIFICATION CODE: DA10 – IT and Telecom - Business Application/Application Development

Software as A Service

NAICS CODE: 541519 – Other Computer Related Services

SECTION 1 – PRODUCT LIST AND DELIVERY INFORMATION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition

Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation. Proposals are being requested and a written solicitation will not be issued. It is the Government's intent to issue a Firm Fixed Priced Purchase Order in accordance with FAR Part 13.

The solicitation number is FDA-SOL-75F40126Q00384. This solicitation is issued as a Request for Quote (RFQ).

This is an Other Than Full and Open Competition / Brand Name or Equal.

The solicitation document and incorporated provisions and clauses in effect through the Federal Acquisition

Circular 2026-01, effective 13 March 2026. FAR and HHSAR provisions and clauses referenced in this RFQ can be found on the following website: https://www.acquisition.gov/browse/index/far .

The Government is in no way obligated to make an award, nor to pay any costs incurred by the Contractor in preparing and submitting its quote.

1.1 PURPOSE AND BACKGROUND

This Statement of Work (SOW) establishes the requirements for the acquisition and deployment of Think Trends

Software, an Agentic AI technology platform, to support FDA adverse event reporting workflows. Think Trends

Software will be leveraged for its AI-powered Document Processing and Agentic Optical Character Recognition

(OCR) capabilities to streamline adverse event case intake, document extraction, validation, triage, and downstream processing across multiple FDA Centers and Offices, including the Center for Veterinary Medicine (CVM-Drug and CVM-Food), Center for Drug Evaluation and Research (CDER), Center for Biologics (CBER), Center for

Devices and Radiological Health (CDRH), Center for Tobacco Products (CTP), and the Office of Human Foods

Programs (HFP).

Think Trends Software is designed to reduce manual case-processing burden, improve extraction accuracy, accelerate regulatory review workflows, and support Center-specific adverse event reporting requirements through configurable AI agents, human-in-the-loop validation, auditability, and secure deployment within FDA-approved environments.

https://www.acquisition.gov/browse/index/far

1.2 SCOPE OF WORK

The Contractor shall provide Think Trends Software as an Agentic AI and Document Intelligence solution capable of processing structured, semi-structured, and unstructured adverse event documents, including scanned PDFs, handwritten or machine-generated forms, narratives, attachments, medical records, product complaints, lab reports, follow-up submissions, and case correspondence. The solution shall support end-to-end adverse event document processing through the following capabilities:

A. Agentic Document Intake and Classification

Think Trends Software AI agents shall automatically receive, classify, and route adverse event documents by submission type, FDA Center, product category, source, urgency, and case-processing requirements. The intake agent shall identify whether a document relates to drugs, biologics, devices, veterinary products, tobacco products, combination products, or other FDA-regulated products. Key capabilities include:

• Automated ingestion of scanned PDFs, forms, emails, images, attachments, and electronic documents.

• Classification of documents by Center-specific workflow, product type, and reporting pathway.

• Detection of new cases, follow-up cases, duplicate submissions, incomplete submissions, and supporting attachments.

• Intelligent routing to appropriate review queues, case-processing teams, or downstream systems.

B. Agentic OCR and Intelligent Data Extraction

Think Trends Software Agentic OCR shall combine optical character recognition, computer vision, natural language processing, large language models, and rule-based validation agents to extract key adverse event data elements from complex documents. The platform shall extract and structure critical case information, including:

• Reporter, patient, animal, subject, or consumer information.

• Product information, including drug, biologic, device, tobacco, or veterinary product details.

• Adverse event terms, symptoms, outcomes, seriousness, and event narratives.

• Dates, timelines, exposure details, dose, route, duration, lot numbers, manufacturer information, and product identifiers.

• Medical history, concomitant products, lab results, device problem codes, clinical narratives, and follow-up information.

• Center-specific data elements required for CVM-Drugs and CVM-Food, CDRH, CTP, CDER, CBER and HFP.

C. Center-Specific Adverse Event Processing Agents

The Contractor shall configure specialized AI agents within Think Trends Software to support unique regulatory and operational needs across FDA Centers. Each agent shall apply Center-specific data models, validation logic, terminology, business rules, and review workflows. Examples include:

• CVM Agent: Processes veterinary adverse event reports, animal species, breed, weight, product exposure, dosage, outcome, and veterinarian/reporter information.

• CDRH Agent: Processes device-related adverse events, device identifiers, manufacturer information, malfunction details, patient impact, and device problem descriptions.

• CTP Agent: Processes tobacco product adverse experiences, product use patterns, health effects, consumer narratives, and product category information.

• HFP Agent: Processes HFP-specific adverse event reporting requirements and associated workflows.

• CDER Agent: Process drug product adverse experiences, product use patterns, health effects, consumer narratives, and product category information.

• CBER Agent: Processes biologics product adverse experiences, product use patterns, health effects, consumer narratives, and product category information.

D. Case Validation, Quality Control, and Human-in-the-Loop Review

Think Trends Software shall incorporate validation agents to compare extracted data against business rules, required fields, confidence thresholds, terminology standards, and case-processing logic. Records that meet defined thresholds may proceed automatically, while exceptions shall be routed for human review. Key quality-control features include:

• Confidence scoring at field, document, and case levels.

• Source traceability to page, section, table, and line references.

• Automated flagging of missing, inconsistent, conflicting, or low-confidence data.

• Human-in-the-loop review screens for case processors and safety reviewers.

• Reviewer acceptance, correction, override, and approval workflows.

• Full audit trail of AI extraction, human edits, and final approved values.

E. Data Standardization and Regulatory Output Generation

Think Trends Software shall transform extracted adverse event information into structured formats required for case management, analytics, and downstream regulatory processing. The platform shall support configurable mappings to

FDA data standards, Center-specific systems, XML structures, APIs, and reporting formats. Capabilities include:

• Normalization of adverse event terms, product names, dates, identifiers, and narrative fields.

• Mapping to Center-specific safety data models and controlled terminology.

• Generation of structured case records for downstream review and processing.

• API-based integration with FDA systems, case-processing platforms, data lakes, document repositories, and workflow tools.

• Export to XML, JSON, CSV, database tables, or other required formats.

F. Agentic Workflow Automation and Triage

Think Trends Software shall automate repetitive case-processing steps while maintaining reviewer control for regulatory decisions. The system shall support configurable AI agents capable of executing multi-step workflows, requesting missing information, summarizing case narratives, identifying seriousness indicators, detecting duplicates, and prioritizing work queues. Workflow automation shall include:

• Case prioritization based on seriousness, product risk, event severity, due dates, and Center-defined rules.

• Automated summarization of long adverse event narratives and supporting attachments.

• Duplicate and follow-up detection across submissions.

• Exception handling and escalation workflows.

• Generation of reviewer-ready case summaries.

• Dashboard visibility into case volumes, processing status, aging, backlog, error rates, and productivity metrics.

G. AI-Enabled Redaction for FOIA Compliance

ThinkTrends will provide AI-powered redaction capabilities to support FDA's obligations under the Freedom of

Information Act (FOIA). The platform will automatically identify and redact personally identifiable information

(PII), protected health information (PHI), commercially confidential data, law-enforcement-sensitive content, and other exemption-covered materials from adverse event documents prior to public release or response to FOIA requests.

Key capabilities include:

• Automated detection and redaction of PII and PHI, including patient names, addresses, dates of birth, medical record numbers, Social Security numbers, and other personal identifiers.

• Identification and suppression of trade secrets, proprietary formulations, manufacturing processes, and commercially confidential submitter information protected under FOIA Exemption.

• Detection of law-enforcement-sensitive and inter-agency deliberative content subject to FOIA Exemptions.

• Configurable exemption profiles aligned to FDA FOIA policy, Center-specific guidance, and applicable federal regulations.

• Confidence-scored redaction recommendations with source traceability, enabling FOIA reviewers to accept, modify, or override AI-proposed redactions.

• Human-in-the-loop review workflow allowing FOIA analysts to validate, annotate, and finalize redacted documents before release.

• Generation of redacted PDF and document versions with visible redaction markers, exemption codes, and reviewer audit annotations.

• Full audit trail recording every AI-proposed redaction, reviewer decision, exemption code applied, and final release determination.

• Support for bulk redaction processing across large FOIA request batches, including multi-document packages and rolling requests.

• Integration with FDA FOIA tracking systems, document repositories, and case management workflows.

1.3 SALIENT FEATURES OF THINK TRENDS SOFTWARE

Think Trends Software provides the following differentiating capabilities relevant to FDA adverse event reporting modernization:

1. Agentic OCR Beyond Traditional OCR: Think Trends Software does not merely convert images to text. It applies AI agents that read, interpret, validate, cross-check, and structure regulatory information from complex adverse event documents.

2. Center-Agnostic Core with Center-Specific Configuration: The platform provides a common document intelligence foundation while allowing FDA Centers such as CVM, CDRH, CTP, and HFP to configure unique workflows, data models, rules, and outputs.

3. End-to-End Adverse Event Case Automation: Think Trends Software supports intake, classification, extraction, validation, triage, routing, human review, data transformation, and downstream submission/output generation.

4. Human-in-the-Loop Regulatory Control: The system keeps FDA reviewers in control by allowing them to review, correct, approve, or override AI-generated outputs before final case acceptance.

5. Explainability and Source Traceability: Each extracted field can be traced back to the original source document, page, section, and text reference, supporting transparency, auditability, and reviewer confidence.

6. Confidence-Based Processing: Think Trends Software assigns confidence scores to extracted data and automatically routes low-confidence or inconsistent records for human review.

7. Multi-Document and Multi-Format Processing: Think Trends Software shall process scanned PDFs, structured forms, unstructured narratives, tables, handwritten content where feasible, images, attachments, correspondence, and supporting records.

8. Duplicate and Follow-Up Detection: AI agents shall compare incoming submissions against existing records to identify potential duplicates, follow-ups, related cases, and case-history updates.

9. Reviewer-Ready Case Summaries: Think Trends Software shall generate concise adverse event summaries, chronology, product-event relationships, missing-field lists, and review-ready case packages.

10. Secure FDA-Aligned Deployment: Think Trends Software shall be deployable in secure government cloud, FDA-managed, or approved hosting environments with role-based access, audit logs, encryption, and integration with enterprise identity management.

1.4 TECHNICAL REQUIREMENTS

Implementation of Think Trends Software for adverse event document processing is expected to deliver the following outcomes:

• Reduction in manual data entry and repetitive case-processing tasks.

• Faster adverse event intake, triage, and reviewer preparation.

• Improved data quality through AI-assisted validation and standardization.

• Greater consistency across FDA Centers while preserving Center-specific workflows.

• Enhanced traceability, auditability, and regulatory transparency.

• Improved ability to manage high-volume document backlogs and surge workloads.

• Increased reviewer productivity through AI-generated summaries and exception-based review.

• Scalable platform foundation for future FDA adverse event modernization initiatives.

1.5 SUPPLIES / SERVICES

THINK TRENDS LICENSES

Reinstatement Period: 12/15/2025 – 09/29/2026

Item No

Description Qty Unit Unit Price Price

0001 Reinstatement Fee - Think Trends Software -

HFP

1 9 Months

Reinstatement Fee - Think Trends Software -

CDRH 1

Reinstatement Fee - Think Trends Software -

CTP

Reinstatement Fee - Think Trends Software – CVM Drugs & CVM Foods

THINK TRENDS LICENSES

Base Period: 09/30/2026 – 09/29/2027

Item No

Description Qty Unit Unit Price Price

0005 Think Trends Software - HFP 1

0006 Think Trends Software - CDRH 1

0007 Think Trends Software - CTP 1 12

Think Trends Software – CVM Drugs & CVM Foods 1

0009 Think Trends Software – CDER, CBER & OCAC 1

1.6 PERIOD OF PERFORMANCE

There will be a Reinstatement Period and one 12-month period of performance for Think Trends Software.

Period of Performance

Reinstatement Period 12/15/2025 – 09/29/2026

Base Year 09/30/2026 – 09/29/2027

1.7 DELIVERY REQUIREMENTS

The Contractor shall deliver all required products, configurations, and documentation in accordance with the schedule established at contract award. Key delivery expectations include:

Platform Configuration: The Contractor shall deliver a fully configured instance of Think Trends Software for each participating FDA Center (HFP, CDRH, CDER, CBER, CTP, CVM-Drugs, and CVM-Food) within a timeframe mutually agreed upon at the post-award kickoff meeting.

Center-Specific Configurations: Extraction templates, business rules, and workflow configurations for each Center shall be delivered and validated prior to production deployment.

Integration Interfaces: API connections and data exchange interfaces with FDA systems shall be delivered and tested in coordination with FDA technical staff.

Documentation: The Contractor shall deliver user guides, system documentation, configuration specifications, and training materials no later than the date of system acceptance.

Training: The Contractor shall conduct user and administrator training sessions prior to or concurrent with production deployment.

All deliverables are subject to FDA review and acceptance. The Government reserves the right to reject deliverables that do not conform to the requirements of this SOW and shall notify the Contractor in writing of any deficiencies within a reasonable review period.

All license keys should be delivered electronically.

1.8 PLACE OF PERFORMANCE

U.S. Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

HFP

CDRH

CDER

CBER

CTP

CVM-Drugs

CVM-Food

1.9 CONTRACT TYPE

This is a Firm-Fixed-Price (FFP) purchase order.

SECTION 2 – CONTRACT ADMINISTRATION

2.1 Contract Management

Contracting Officer (CO):

(To be entered at time if award)

Contract Specialist (CS):

Terina Hicks

Terina.Hicks@fda.hhs.gov

Contracting Officers Representative (COR):

(To be entered at time if award)

2.2 Contracting Officer’s Authority

The Contracting Officer (CO) 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 RFQ; (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. No statement, whether oral or written, by anyone other than the Contracting Officer, shall be interpreted as modifying the terms and conditions of this award. It is the Contractor’s responsibility to contact the CO immediately if there is even the appearance of any technical direction that is or may be outside the scope of the award. The Government will not reimburse the Contractor for any work not authorized by the

Contracting Officer, including work outside the scope of the award.

The Contracting Officer’s Representative (COR) is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the contract 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.

2.3 Interpretations of Modifications

No oral or written statement of any person and no written statement of anyone other than the CO shall modify or otherwise affect the terms and conditions of this contract. Requests for interpretations, modifications or changes mailto:Terina.Hicks@fda.hhs.gov must be made in writing to the CO. The technical point of contact can only respond to technical matters that do not result in a change of scope to this contract.

2.4 IPP Invoice Requirements

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.html

(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 Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov .

(c) 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.

(1) Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov . or phone (866) 973-

3131. 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.

(2) 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.

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

(4) If the Contractors unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting

Officer to explain the circumstances that require the authorization of alternate payment procedures.

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

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

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

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

http://www.ipp.gov/vendors/index.htm https://www.ipp.gov/ mailto:ipp.noreply@mail.eroc.twai.gov mailto:IPPCustomerSupport@fiscal.treasury.gov

- Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirect)-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 FAR52.216-8 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 contractor 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.

(END OF CLAUSE)

2.5 Payment Terms

Payment terms Net 30 days after government acceptance of the supply item/service. Payments shall not be made more frequently than monthly in arrears. Advance payments will not be made.

SECTION 3 – INSPECTION & ACCEPTANCE

Inspection and acceptance will be at destination in accordance with FAR clause 52.212-4(a). In accordance with

FAR 52.212-4(a), the Government has the right either to reject or to require correction of nonconforming supplies.

Supplies are nonconforming when they are defective in material or workmanship or are otherwise not in conformity with contract requirements. The Government may reject nonconforming supplies with or without disposition instructions.

The COR will perform inspection and acceptance of all products and services. The performance criteria for these products shall be timely delivery and closure of all activities and deliverables listed above and within the established

Period of Performance.

Inspection and acceptance will occur at the place of delivery. Inspection will include verifying all parts were received and warranties and services are in place. The Government will accept goods and services only if they conform to all terms and conditions of this order. The Government will provide written notification of acceptance or rejection within ten (10) business days of receiving the delivery.

The Government will reject non-conforming products and services. The Contractor shall correct any deficiencies within thirty (30) days of when the Government issues the rejection notice. If the Contractor cannot correct the deficiencies within this time frame, the Contractor shall immediately notify the COR or technical POC of the reason for the delay and provide a proposed corrective action plan within ten (10) business days.

All quoter’s shall be Authorized reseller and/or servicing agent shall identify and/or provide documentation to confirm their claim as an authorized reseller and/or servicing agent.

All Offerors quote shall clearly state license number, product description, quantity, price, and period of performance for each product. The quotation shall include and match license number, product description, quantity, and period of performance. Offerors are advised that should their quotation conflict with or does not clearly reflect the specified product and requirement of this solicitation, their quotation may be deemed as technically unacceptable and may not be considered for award.

Price: Provide a detailed quote for each item/component proposed to the schedule of items. Discounts are highly encouraged.

The offeror or applicant shall submit all electronic documents for Microsoft Office suite products without the use of macros. If the offeror or applicant submits documents that contain macros the Government will not be able to view or open such documents and the submission will be considered non-responsive to the solicitation. No mailto:ERIC@fda.hhs.gov 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 offerors or applicant’s responsibility to ensure all electronic documents are submitted without the use of macros.

SECTION 4 – ORDER OF PRECEDENCE

The Contractor shall follow the terms and conditions of this contract. Should the Contractor include any additional terms and conditions resulting in conflicts between this document and the Contractor’s document, the Order of

Precedence shall be as specified in FAR Clause 52.212-4. The Contractor shall not auto-renew any subscriptions, licenses, maintenances, and services not authorized under this contract. Any auto-renewals are at the risk of the

Contractor, and the Government will not reimburse the Contractor.

In the event of any inconsistencies between any licensing agreement incorporated into this order as an attachment and the FAR and HHSAR Clauses incorporated into this order, the FAR or HHSAR Clauses shall take precedence.

SECTION 5 – GOVERNMENT FURNISHED EQUIPMENT AND INFORMATION

Vendor shall not require access to Government equipment except the ones that are being serviced. No Government laptop, printer or telephone will be needed to do the work except the desktop computers that run the equipment to assess whether the equipment operates normally.

Vendor shall not require access to Sensitive Information, ODT systems or databases or Personally Identifiable

Information. This acquisition is not subject to the Privacy Act. The contractor shall not require any access to sensitive information, no data collected on the instrument will use online data storage, and the system shall not use any cloud services.

SECTION 6 – FAR / HHSAR CLAUSES & PROVISIONS

FAR 52.252-2 Clauses Incorporated by Reference (Feb 1998)

This purchase order 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 following

FAR and HHSAR provisions and clauses, incorporated by reference, apply to this acquisition and can be obtained in full text at: https://www.acquisition.gov/far/ and http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

FAR Clauses:

52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017)

52.204-13 System for Award Management - Maintenance (Apr 2026) (Deviation)

52.212-4 Terms and Conditions—Commercial Products and Commercial Services (Apr 2026) (Deviation)

52-232-18 Availability of Funds (Apr 1984)

52.232-39 Unenforceability of Unauthorized Obligations (Jun 2013)

52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Mar 2023)

FAR 52.222-54 Employment Eligibility Verification (Apr 2026) (Deviation)

(a) Definitions. As used in this clause-

Commercially available off-the-shelf (COTS) item—

(1) Means any item of supply that is— https://www.acquisition.gov/far/ http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

(i) A commercial product (as defined in paragraph (1) of the definition of “commercial product” at Federal

Acquisition Regulation (FAR) 2.101);

(ii) Sold in substantial quantities in the commercial marketplace; and

(iii) Offered to the Government, without modification, in the same form in which it is sold in the commercial marketplace; and

(2) Does not include bulk cargo, as defined in 46 U.S.C. 40102(4), such as agricultural products and petroleum products. Per 46 CFR 525.1 (c)(2), "bulk cargo" means cargo that is loaded and carried in bulk onboard ship without mark or count, in a loose unpackaged form, having homogenous characteristics. Bulk cargo loaded into intermodal equipment, except LASH or Seabee barges, is subject to mark and count and, therefore, ceases to be bulk cargo.

Employee assigned to the contract means an employee who was hired after November 6, 1986 (after November

27, 2009 in the Commonwealth of the Northern Mariana Islands), who is directly performing work, in the United

States, under a contract that is required to include the clause prescribed at 22.1802-2. An employee is not considered to be directly performing work under a contract if the employee-

(1) Normally performs support work, such as indirect or overhead functions; and

(2) Does not perform any substantial duties applicable to the contract.

Subcontract means any contract, as defined in 2.101, entered into by a subcontractor to furnish supplies or services for performance of a prime contract or a subcontract. It includes but is not limited to purchase orders, and changes and modifications to purchase orders.

Subcontractor means any supplier, distributor, vendor, or firm that furnishes supplies or services to or for a prime

Contractor or another subcontractor.

United States, as defined in 8 U.S.C. 1101(a)(38), means the 50 States, the District of Columbia, Puerto Rico, Guam, the Commonwealth of the Northern Mariana Islands, and the U.S. Virgin Islands.

(b) Enrollment and verification requirements.(1) If the Contractor is not enrolled as a Federal Contractor in E-

Verify at time of contract award, the Contractor must-

(i) Enroll. Enroll as a Federal Contractor in the E-Verify program within 30 calendar days of contract award;

(ii) Verify all new employees. Within 90 calendar days of enrollment in the E-Verify program, begin to use E-

Verify to initiate verification of employment eligibility of all new hires of the Contractor, who are working in the

United States, whether or not assigned to the contract, within 3 business days after the date of hire (but see paragraph (b)(3) of this section); and

(iii) Verify employees assigned to the contract. For each employee assigned to the contract, initiate verification within 90 calendar days after date of enrollment or within 30 calendar days of the employee’s assignment to the contract, whichever date is later (but see paragraph (b)(4) of this section).

(2) If the Contractor is enrolled as a Federal Contractor in E-Verify at time of contract award, the Contractor must use E-Verify to initiate verification of employment eligibility of-

(i) All new employees.(A) Enrolled 90 calendar days or more. The Contractor must initiate verification of all new hires of the Contractor, who are working in the United States, whether or not assigned to the contract, within 3 business days after the date of hire (but see paragraph (b)(3) of this section); or

(B) Enrolled less than 90 calendar days. Within 90 calendar days after enrollment as a Federal Contractor in E-

Verify, the Contractor must initiate verification of all new hires of the Contractor, who are working in the United

States, whether or not assigned to the contract, within 3 business days after the date of hire (but see paragraph

(b)(3) of this section); or

(ii) Employees assigned to the contract. For each employee assigned to the contract, the Contractor must initiate verification within 90 calendar days after date of contract award or within 30 days after assignment to the contract, whichever date is later (but see paragraph (b)(4) of this section).

(3) If the Contractor is an institution of higher education (as defined at 20 U.S.C. 1001(a)); a State or local government or the government of a Federally recognized Indian tribe; or a surety performing under a takeover agreement entered into with a Federal agency pursuant to a performance bond, the Contractor may choose to verify only employees assigned to the contract, whether existing employees or new hires. The Contractor must follow the applicable verification requirements at (b)(1) or (b)(2) respectively, except that any requirement for verification of new employees applies only to new employees assigned to the contract.

(4) Option to verify employment eligibility of all employees. The Contractor may elect to verify all existing employees hired after November 6, 1986 (after November 27, 2009, in the Commonwealth of the Northern

Mariana Islands), rather than just those employees assigned to the contract. The Contractor must initiate verification for each existing employee working in the United States who was hired after November 6, 1986 (after

November 27, 2009, in the Commonwealth of the Northern Mariana Islands), within 180 calendar days of-

(i) Enrollment in the E-Verify program; or

(ii) Notification to E-Verify Operations of the Contractor’s decision to exercise this option, using the contact information provided in the E-Verify program Memorandum of Understanding (MOU).

(5) The Contractor must comply, for the period of performance of this contract, with the requirements of the E-

Verify program MOU.

(i) The Department of Homeland Security (DHS) or the Social Security Administration (SSA) may terminate the

Contractor’s MOU and deny access to the E-Verify system in accordance with the terms of the MOU. In such case, the Contractor will be referred to a suspending and debarring official.

(ii) During the period between termination of the MOU and a decision by the suspending and debarring official whether to suspend or debar, the Contractor is excused from its obligations under paragraph (b) of this clause. If the Contractor is not suspended, debarred, or subject to a voluntary exclusion, then the Contractor must reenroll in E-Verify.

(c) Web site. Information on registration for and use of the E-Verify program can be obtained via the Internet at the Department of Homeland Security Web site: https://www.e-Verify.gov.

(d) Individuals previously verified. The Contractor is not required by this clause to perform additional employment verification using E-Verify for any employee-

(1) Whose employment eligibility was previously verified by the Contractor through the E-Verify program;

(2) Who has been granted and holds an active U.S. Government security clearance for access to confidential, secret, or top secret information in accordance with the National Industrial Security Program Operating Manual;

or

(3) Who has undergone a completed background investigation and been issued credentials pursuant to Homeland

Security Presidential Directive (HSPD)-12, Policy for a Common Identification Standard for Federal Employees and Contractors.

(e) Subcontracts. The Contractor must include the requirements of this clause, including this paragraph (e)

(appropriately modified for identification of the parties), in each subcontract that-

(1) Is for—(i) Services (except for commercial services that are part of the purchase of a COTS item (or an item that would be a COTS item, but for minor modifications), performed by the COTS provider, and are normally provided for that COTS item); or

(ii) Construction;

(2) Has a value of more than $3,500; and

(3) Includes work performed in the United States.

(End of clause)

This contract incorporates one or more HHSAR clauses by reference, with the same force and effect as if they were given in full text. The full text of the HHSAR clauses may be accessed electronically at this address:

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

HHSAR Clauses:

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

352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (DEC 2015)

HHSAR 352.203-70 Anti-Lobbying (JUN 2026) (Deviation)

Pursuant to the HHS annual appropriations acts, except for normal and recognized executive-legislative relationships, the Contractor must not use any HHS contract funds for:

(a) Publicity or propaganda purposes;

(b) The preparation, distribution, or use of any kit, pamphlet, booklet, publication, electronic communication, radio, television, or video presentation designed to support or defeat the enactment of legislation before the

Congress or any State or local legislature or legislative body, except in presentation to the Congress or any state or local legislature itself; or designed to support or defeat any proposed or pending regulation, administrative action, or order issued by the executive branch of any state or local government, except in presentation to the executive branch of any state or local government itself; or

(c) Payment of salary or expenses of the Contractor, or any agent acting for the Contractor, related to any activity designed to influence the enactment of legislation, appropriations, regulation, administrative action, or Executive order proposed or pending before the Congress or any state government, state legislature or local legislature or legislative body, other than for normal and recognized executive-legislative relationships or participation by an agency or officer of a state, local, or tribal government in policymaking and administrative processes within the executive branch of that government.

(d) The prohibitions in paragraphs (a), (b), and (c) of this clause include any activity to advocate or promote any proposed, pending, or future federal, state, or local tax increase, or any proposed, pending, or future requirement for, or restriction on, any legal consumer product, including its sale or marketing, including, but not limited to, the advocacy or promotion of gun control. (End of clause)

HHSAR 352.224-71 Confidential Information (FEB 2024) (Deviation)

(a) Definition. As used in this clause—

Confidential information means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.

(b) Identification of information. Specific confidential information or categories of information that the

Government will furnish to the Contractor, or that the Contractor is expected to generate, is identified in this contract.

(c) Disclosure. The Contractor shall not disclose confidential information or records until written notice is provided to the Contracting Officer at least 45 days in advance of the Contractor's intent to release findings of studies or research, to which an agency response may be appropriate to protect the public interest or that of the agency. The Contractor shall not disseminate or publish such information without the written consent of the

Contracting Officer.

(d) Government furnished or provided information: For information provided by or on behalf of the government—

(1) The publication or dissemination of the following types of information are restricted under this contract: All data and analysis of FDA food supply chain activities within the system.

(2) The reason(s) for restricting the types of information identified in subparagraph (d)(1) is/are: Manufacturer data is commercial confidential data. Retail sales data is subject to review and clearance through each retail sales data company. All other data and analyses are for government use only, the analyses are pre-decisional intended to inform govt policy decisions and are not subject to FOIA or public release.

(e) The Contractor shall consult with the Contracting Officer when there is uncertainty with regard to the confidentiality of, or a property interest in, information under this contract prior to the release, disclosure, dissemination, or publication of such information. (End of clause)

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

(a) Definitions. As used in this clause –

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

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

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

(d) Submission of alternate payment procedures authorization. If alternate payment procedures are authorized, the

Contractor must include a copy of the Contracting Officer's written authorization with each payment request. (End of clause)

352.237-75 Key Personnel (DEC 2015)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the

Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties. (End of clause)

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

(a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce

Investment Act of 1998, all information and communication technology (ICT) supplies, products, platforms, information, documentation, and services support developed, acquired, maintained or delivered under this contract or order must comply with the Revised 508 Standards, which are located at 36 C.F.R. 1194.1 and Appendices A, B, and C, and are available at https://www.access-board.gov/ict/ . Information about Section 508 is available at https://www.hhs.gov/web/section-508/index.html .

(b) Additional Section 508 accessibility standards applicable to this contract or order may be identified in the specification, statement of work, or performance work statement. If it is determined by the Government that ICT supplies, products, platforms, information, documentation, and services support provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies, products, platforms, 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/accessibilitychecklists/index.html) or an

Accessibility Conformance Report (ACR) (based on the Voluntary Product Accessibility Template (VPAT) see https://www.itic.org/policy/accessibility/vpat), 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 http://www.ipp.gov/ https://www.access-board.gov/ict/ https://www.hhs.gov/web/section-508/index.html https://www.hhs.gov/web/section-508/accessibilitychecklists/index.html https://www.itic.org/policy/accessibility/vpat support provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(d) If this is an Indefinite-Delivery type contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests that include ICT supplies, products, platforms, information, documentation, or services support will define the specifications and accessibility standards for the order. In those cases, the

Contractor shall be required to provide a completed HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibility-checklists/index.html) or an ACR (based on the VPAT see https://www.itic.org/policy/accessibility/vpat), and any other additional information necessary to assist the

Government in determining that the ICT supplies, products, platforms, information, documentation, or services support conform to Section 508 accessibility standards. If it is determined by the Government that ICT supplies and services provided by the Contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

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

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

This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text.