RFQ FDA-75F40126Q00115_.pdf
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- Solicitation number
- FDA-75F40126Q00115
About this file
This is a Request for Quote (RFQ) for the renewal of SciNote Electronic Laboratory Notebook (ELN) software licenses issued by the U.S. Food and Drug Administration (FDA).
The FDA seeks to renew SciNote ELN software licenses and support services for the Center for Drug Evaluation and Research (CDER) laboratories located in Silver Spring, Maryland and Saint Louis, Missouri. The solicitation covers a base year (September 29, 2026 – September 28, 2027) with two optional one-year extensions. The requirement includes 270 SciNote software licenses for 12 months, project management and configuration support, technical support, training for up to 270 users, and professional services for post-implementation customization (400 hours). Optional items include additional support services and the ability to increase licenses by up to 150 units. The ELN system must be installed on premises on government-owned servers, support multiple browsers (Chrome, Firefox, Edge), include audit trails, meet ISO 17025 standards, and integrate with ItemAware inventory software, ChemDoodle chemical structure software, and Microsoft Office Online. Contractor must be the Original Equipment Manufacturer or an authorized reseller/servicing agent. The solicitation is issued as Full and Open Competition under FAR Part 13 as a firm-fixed-price purchase order. Responses are due by May 26, 2026, at 1:00 PM EST, with questions due by May 18, 2026. The Government will make award based on lowest price technically acceptable (LPTA) methodology. All quotations must include pricing for each line item, vendor UEI, and proposed warranty terms. Submission of quotes without macros in Microsoft Office documents is mandatory; non-compliant submissions will be rejected without notification or opportunity to correct.
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REQUEST FOR QUOTE
Renewal of SciNote Electronic Laboratory
Notebook (ELN) Software Licenses
FDA-75F40126Q00115
Date Posted: May 11, 2026
Response Date: May 26, 2026, by 1:00 PM EST
Classification Code: DH10 – IT and Telecom – Platform As A Service: Database, Mainframe, Middleware
NAICS Code: 513210 – Software Publishers
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-75F40126Q00115. This solicitation is issued as a Request for Quote (RFQ). This requirement is being solicited as a 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. SUPPLIES OR SERVICES AND PRICE/COST
Base Year: 09/29/2026 – 09/28/2027
Item No Description Qty Unit Unit Price Price
001 SciNote Software Licenses 270 12 Months
Project Management / Configuration and Implementation Support, Local
1 12 Months https://www.acquisition.gov/browse/index/far
Option Year 1: 09/29/2027 – 09/28/2028
Option Year 2: 09/29/2028 – 09/28/2029
Installation Support
Technical Support for 270 Licenses
1 12 Months
004 Training for up to 270 Users 1 12 Months
Professional Services for Post Implementation Customization and Improvements
1 12 Months
Item No Description Qty Unit Unit Price Price
001 SciNote Software Licenses 270 12 Months
Technical Support for 270 Licenses
1 12 Months
003 Training for up to 270 Users 1 12 Months
Professional Services for Post Implementation Customization and Improvements
1 12 Months
Option to Increase SciNote Software Licenses
150 12 Months
Item No Description Qty Unit Unit Price Price
001 SciNote Software Licenses 270 12 Months
Technical Support for 270 Licenses
1 12 Months
003 Training for up to 270 Users 1 12 Months
Professional Services for Post Implementation Customization and Improvements
1 12 Months
2. BACKGROUND
The U. S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) has several laboratories within Office of Pharmaceutical Quality Research (OPQR) and Office of Translational Sciences (OTS) Division of Applied Regulatory Science (DARS) located in Silver Spring, MD and Saint Louis, MO that are world-class regulatory laboratory resources that anticipate and solve regularly challenges. The nature of the work demands quick turn-around on sample analyses.
As the CDER Labs have grown, data and record management has become more critical to the operation of the laboratory. The CDER Labs have been using SciNote Electronic Laboratory Notebook software for last several years to improve laboratory data and record management, enable the move to electronic records and enhance collaboration between divisions within OPQR and between stakeholders within CDER. ELN software makes it easy to capture, reuse, manage, share, and collaborate on results obtained from any analytical system in the laboratory. A paperless alternative to traditional paper notebooks, ELN software saves valuable analysts’ time, shortens the path to results, and expedites better-informed decision-making. It also safeguards intellectual property, maintains record traceability, and supports data integrity and record management requirements.
CDER currently has an active SciNote ELN system operating across its labs. The implementation of SciNote began in 2019 with configuration and final rollout to many of its OPQR labs in 2022. CDER expanded its use of SciNote to OTS/DARS in 2023. The goal of this acquisition is to renew the licenses and support for the SciNote ELN.
3. OBJECTIVE
The purpose of this request is to renew SciNote Electronic Laboratory Notebook (ELN) software (licenses and support) for the CDER labs. Brand name equivalent products shall meet all technical requirements and the contractor must provide configuration, professional services, training, and implementation services to transition existing ELN into equivalent ELN. SciNote ELN software is within lifecycle of approved software and satisfies all security and technology requirements from FDA. SciNote ELN software is installed on premises and actively used by CDER labs. Contractor must provide renewal for licenses, support for current on-premises installations, support for current integration with inventory system (ItemAware), ChemDoodle software, and Microsoft Office Online.
Contractor must provide training and professional services.
The Contractor shall provide CDER with consultation and integration assistance including documentation and training deliverables. The required documentation from the contractor will include all executed validation protocols, reports and User Guide/manual for reference.
4. TECHNICAL REQUIREMENTS
4.1 Minimum License and Support Requirements for SciNote ELN
The Contractor shall:
Option to Increase SciNote Software Licenses
150 12 Months
• Provide renewal for 270 licenses.
• Provide SciNote ELN upgrades for on premises installed system at least twice per year.
• Provide Documentation for upgrades.
• Provide Hypercare Priority Support for SciNote ELN installed on premises.
• Provide support for SciNote ELN integration with ItemAware application. See Section 4.3
• Provide support for SciNote ELN integration with ChemDoodle application. See Section 4.3
• Provide support for SciNote ELN integration with Microsoft Office products.
• Provide professional services of 400 hours for additional customizations.
• Provide one in person training session per location and online sessions as needed.
4.2 Minimum Software and License Requirements for ELN
The system shall:
• The ELN should support local (on premises) installation on local virtual servers owned by the Government.
• The ELN should be browser-based and should support Chrome, Firefox, and Edge functionality.
• The ELN should have audit trails (system, records, data, etc.).
• The ELN should meet the standards of ISO 17025.
• The ELN should not have any client-side plugins (Java, etc.).
• The ELN should have support for Single Sign-on.
• The ELN should be able to provide a workflow or system that allows for electronic supervisor review and approval of experiments.
• The ELN should be able to require that all records must have time and date stamp.
• The ELN should be able to create experiments that have versioning.
• The ELN should have basic project management capabilities including the ability to assign tasks to users, assign due dates, monitor the progress of tasks, etc.
• The ELN should have the ability to generate a single report (section of package) from multiple experiments within a project or multiple reports from a single experiment (e.g., a summary report from project by a lead analyst).
• The ELN should have the ability to track, via audit trail, when external reports are generated by the ELN.
• The ELN should include the ability to create project, workflow, and task templates.
• The ELN should provide Forms, fields, and tagging functionality.
• The ELN should have the 508 compliant User Interface (UI).
• The ELN should provide the ability to share experiments (organized by project, user permission to read other’s projects, only comments).
• The ELN should provide analysts/administrators with the ability to leave comments (trackable, history).
• The ELN should be able to preserve dynamic data (hotlink).
• The ELN should have the capability to have automatically populated fields by pulling information from local databases.
• The ELN should have an intuitive graphical user interface which is easy to read, and easy to find options. Using the ELN should not rely significantly on command prompts or nested drop-down menus.
• The ELN should have minimum performance issues/error messages.
• The ELN should have ability to customize fill-in forms.
• The ELN should have the ability to connect units of work (e.g. experiments) into workflows, which should not be limited to linear workflows.
• The ELN should also allow the searching of files inside the system.
• The ELN should have the ability to edit and annotate on files and images inside the program.
• The ELN must have the ability to use the complete Microsoft Office Suite inside of the ELN (online version).
• The ELN must have the ability to use ChemDoodle files and provide preview in User Interface and reports.
• The ELN should have the ability to internally share data.
• The ELN should have customizable accounts/permissions levels that allow for different authoring tools.
• The ELN should support versioning for protocols and for documents must be available through the program.
• The ELN should have basic project management capabilities including the ability to assign tasks to users, assign due dates, monitor the progress of tasks.
• The ELN should have a dashboard where the overview of the work in the platform is visible, including a calendar view.
• The ELN should have the ability to export data in a human-readable form from the platform, including any attachments to the electronic records.
• The ELN should have the ability to have more than one workspace.
• The ELN should have the ability to reference objects and users.
• The ELN should be able to structure organization of the research work into levels that are comparable to ISA tab format (Investigation/Study/Assay) or PISA format (Project/Investigation/Study/Assay).
• The ELN should have capabilities for storing protocols or SOPs in a form other that pdf or a Word document.
• The ELN should have the ability to generate reports in the form of pdf and docx file formats.
• The ELN should support the use of local file storage systems.
• The ELN should have API that can be used by third party vendors.
• The ELN should provide robust inventory system.
4.3 The ELN is integrated with the following third-party applications and must maintain integration for use within the ELN
• ItemAware: software used within OPQR labs to update and track location of inventory items using RFID tags/labels in real time. ELN shall be integrated to allow bidirectional reference and updating of attributes tracked within ItemAware.
• ChemDoodle: FDA’s current chemical structure drawing software. Must support ChemDoodle file format for sharing of data to customers, preview on screen, and in reports.
5. SERVICE AND SUPPORT REQUIREMENTS
The Contractor shall provide the following deliverables: upgrades to SciNote ELN; training documentation; technical documentation; appropriate licenses to meet the requirements stated in Section 4.1.
• The contractor shall provide upgrades and configuration of the existing SciNote ELN system.
• The Contractor shall provide licenses for ELN Users to enable use and support of the deployed ELN. CDER will need 270 licenses.
• The Contractor shall provide training for ELN Users (270 people) to enable use and support of the deployed ELN. The contractor should provide a training plan and support for all users customized for the design of the ELN at CDER Labs.
• The contractor shall provide ongoing technical and functional consultation and support activities to resolve software issues throughout the Period of Performance.
• The Contractor shall provide maintenance and technical support to the SciNote ELN.
“Maintenance” includes software updates for bug fixes and added features. “Technical Support” includes technical and training documentation updates and revisions and answering questions regarding the usage of the ELN.
• The Contractor shall provide ELN helpdesk technical support on Mondays through Fridays between the hours of 8AM to 8PM Eastern Standard time.
• The Contractor shall provide a set of technical and user-facing documentation to be delivered before the deployment of software updates to the CDER system administrator and COR. These documents should include change logs for software updates and instructions for use of newly added or changed features.
• The contractor shall provide professional services for additional customization per request within predetermine limit of number of hours. All customizations must be validated by contractor.
6. TRAINING REQUIREMENTS
As described in Section 5: The Contractor shall provide training for Users to enable use and support of the SciNote ELN. The contractor should provide a training plan and support for all users of the SciNote ELN at CDER. Training can be given both in the form of pre-recorded videos and instructor-led training sessions that will be recorded by CDER. At least one on-site general familiarization training session will be required for each location.
The training plan should cover the following subjects:
• The general use of the SciNote ELN
• Generating reports
• Generating and following workflows and protocols
• Creating projects and updating project status
7. OPTIONS
The Government reserves the right to exercise the following options through unilateral modification. The Government is not obligated to purchase options, however offeror must include options for basis of evaluation.
• Option Years: Contractor shall provide licenses, support and professional services consistent with all requirements stated in Section 4 for two (2) twelve (12) month periods following the base year
• Option to increase SciNote software licenses up to 150 additional licenses
8. DELIVERABLES
8.1 The Contractor shall provide the deliverables listed in Table 1: License and Training Deliverables.
8.2 The Contractor shall also provide the following deliverables:
• Plan for SciNote ELN installation of upgrades of existing instances.
• Monthly invoice & report for services performed according to the Contract including technical support, technical support actions, installation support, and configuration & implementation support. Technical support report should include a list of any support tickets opened with at least 1 sentence describing the issue on the ticket and how it was resolved.
TABLE 1: LICENSE AND TRAINING DELIVERABLES
Description Deliverable Form Quantities Required
Units
SciNote Software Licenses Software Licenses 270 License
Project Management / Configuration and Implementation Support, Local Installation Support *
Upgrade/Installation Plan
Technical Support for 270 Licenses for the whole Period of Performance
Monthly technical support report including date and description of support actions taken, including upgrades/installation
Months of Technical
Support
Training for up to 270 Users Training plan document including topics covered, intended audience, estimated training duration.
Recorded or Instructor-led training session for users
1 Training Plan 1 Attendance
Report
Professional Services for Post Implementation Customization and Improvements
Option to Increase SciNote Software Licenses:
Provide additional licenses with Hypercare training and support
Software Licenses Up to 150 Licenses
License
* “Local Installation Support” Refers to configuring the ELN to work on local, Government-owned servers rather than relying on commercial cloud services, which are not acceptable for this contract.
9. DELIVERY REQUIREMENTS
Software and licensing key, Software and User Manuals or equal to in a digital copy provided on a CD, DVD or digital download. CD, DVD and hard copies of deliverables shall not be required to be returned to the Contractor.
Hard copy deliverables are delivered to the following address:
U.S. Food and Drug Administration Attn: TBD 645 Newstead Ave Saint Louis, MO 63110
U.S. Food and Drug Administration Attn: TBD White Oak Campus 10903 New Hampshire Ave Silver Spring, MD 20993
Schedule: Support and License renewal shall occur on the beginning of the Period of Performance 09/29/2026.
Contractor is responsible for providing technical support during installation of the software by FDA IT personnel.
10. INSPECTION AND ACCEPTANCE CRITERIA
Working media: FDA will load the software and licensing to verify that the platform can execute example project files on local servers.
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. Testing of the system prior to deployment will be conducted. 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 fifteen (15) 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 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.
11. PERIOD OF PERFORMANCE
The anticipated period of performance will consist of the following:
Period of Performance Date
Base Year 09/29/2026 – 09/28/2027
Option Year 1 09/29/2027 – 09/28/2028
Option Year 2 09/29/2028 – 09/28/2029
12. CONTRACT TYPE
This order is a firm-fixed-price order.
13. CONTRACT MANAGEMENT
Contracting Officer (CO):
(To be entered at time of award)
Contracting Specialist (CS):
Terina Hicks terina.hicks@fda.hhs.gov mailto:terina.hicks@fda.hhs.gov
Contracting Officer’s Representative (COR):
(To be entered at time of award)
14. 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.
15. AUTHORIZED RESELLER/SERVICING AGENTS
The Contractor shall be the software Original Equipment Manufacturer (OEM), or an authorized reseller / servicing agent of the software OEM. The Contractor shall notify the Contract Specialist / Contracting Officer immediately if this requirement is registered by a reseller with the OEM. The Contractor shall not void any warranties, usage terms and conditions of the FDA’s term licenses.
16. SPECIAL NOTICE AND AGREEMENT REGARDING SOFTWARE EULA/TOS
Computer software and services are often subject to license agreements, referred to as End User License Agreements (EULA), Terms of Service (TOS), or other similar legal instruments or agreements. Many of these agreements contain indemnification clauses that are inconsistent with Federal law and unenforceable, but which could create a violation of the Anti-Deficiency Act (31 U.S.C. 1341) if agreed to by the Government.
Therefore, by submitting a quotation the Contractor shall agree that the inclusions of any Limitation of Liability, Indemnification, and any clauses that conflict with Federal law or regulation in any EULA or TOS are NULL AND VOID. The Contractor agrees that any EULA/TOS clauses conflicting with Federal law or regulation and are not agreed to by the Government if included with the submission of a quotation. Additionally, by submission of the quotation the Contractor must agree to the inclusion of FAR 52.232-39: Unenforceability of Unauthorized Obligations in any resulting contract or order, if awarded.
17. CONTRACTOR PERFORMANCE EVALUATION(S)
During the life of this order, Contractor performance will be evaluated on an interim and final basis pursuant to FAR Subpart 42.15. The Contractor Performance Assessment Reporting System (CPARS) will be utilized for these reviews. Information on CPARS can be located at http://www.cpars.gov
18. 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 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.
19. IPP INVOICE REQUIREMENTS
(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).
https://www.ipp.gov/vendors
(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.
http://www.cpars.gov/ https://www.ipp.gov/vendors https://www.ipp.gov/ mailto:ipp.noreply@mail.eroc.twai.gov mailto:IPPCustomerSupport@fiscal.treasury.gov
(1) At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.
-Direct Labor-include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category.
-Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other 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, mailto:ERIC@fda.hhs.gov invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.
20. 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.
21. FAR / HHSAR CLAUSES
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) 52.204-18 Commercial and Government Entity Code Maintenance (Aug 2020) 52.204–23 Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab Covered Entities. (Dec 2023) 52.204-25 Prohibition on Contracting For Certain Telecommunications And Video Surveillance
Services or Equipment (Aug 2020) 52.204-27 Prohibition on a ByteDance Covered Application (Jun 2023) 52.212-4 Terms and Conditions—Commercial Products and Commercial Services (Apr 2026)
(Deviation) 52.227-19 Commercial Computer Software License (Dec 2007) 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 52.217-7 Option for Increased Quantity-Separately Priced Line Item (Mar 1989) The Government may require the delivery of the numbered line item, identified in the Schedule as an option item, in the quantity and at the price stated in the Schedule. The Contracting Officer may exercise the option by written notice to the Contractor at any time before the contract expires.
Delivery of added items shall continue at the same rate that like items are called for under the contract, unless the parties otherwise agree.
(End of clause)
FAR 52.217-8 Option to Extend Services (Nov 1999) The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than https://www.acquisition.gov/far/ http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice any time prior to contract expiration.
(End of Clause)
FAR 52.217-9 Option to Extend the Term of the Contract (Mar 2000)
(a) The Government may extend the term of this contract by written notice to the Contractor any time prior to contract expiration.
(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 3 years.
(End of Clause)
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—
(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 22.1803. 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 shall-
(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 shall use E-Verify to initiate verification of employment eligibility of-
(i) All new employees.
(A) Enrolled 90 calendar days or more. The Contractor shall 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 shall 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 shall 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 shall 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 shall 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 shall 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 shall 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)
52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders— Commercial Products and Commercial Services (Mar 2026)
(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:
(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).
(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab Covered Entities (Dec 2023) (Section 1634 of Pub. L. 115-91).
(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Nov 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).
(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).
(5) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Mar 2023) (31 U.S.C. 3903 and 10 U.S.C. 3801).
(6) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).
(7) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and 108- 78 (19 U.S.C. 3805 note)).
(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting
Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:
__ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Jun 2020), with Alternate I (Nov 2021) (41 U.S.C. 4704 and 10 U.S.C. 4655).
__ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Nov 2021) (41 U.S.C. 3509)).
__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)
__ (4) 52.203-17, Contractor Employee Whistleblower Rights (Nov 2023) (41 U.S.C. 4712); this clause does not apply to contracts of DoD, NASA, the Coast Guard, or applicable elements of the intelligence community—see FAR 3.900(a).
_X_ (5) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jun 2020) (Pub. L. 109-282) (31 U.S.C. 6101 note).
__ (6) [Reserved].
__ (7) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).
__ (8) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).
_X_ (9) 52.204-27, Prohibition on a ByteDance Covered Application (Jun 2023) (Section 102 of Division R of Pub. L. 117-328).
__ (10) 52.204-28, Federal Acquisition Supply Chain Security Act Orders—Federal Supply Schedules, Governmentwide Acquisition Contracts, and Multi-Agency Contracts. (Dec 2023) (Pub. L. 115–390, title II).
__ (11) (i) 52.204-30, Federal Acquisition Supply Chain Security Act Orders—Prohibition. (Dec 2023) (Pub. L. 115–390, title II).
__ (ii) Alternate I (Dec 2023) of 52.204-30.
_X_ (12) 52.209-6, Protecting the Government's Interest When Subcontracting With Contractors Debarred, Suspended, Proposed for Debarment, or Voluntarily Excluded. (Jan 2025) (31 U.S.C. 6101 note).
__ (13) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) (41 U.S.C. 2313).
__ (14) [Reserved].
__ (15) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Oct 2022) (15 U.S.C. 657a).
__ (16) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2022) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).
__ (17) [Reserved] __ (18) (i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2020) (15 U.S.C. 644).
__ (ii) Alternate I (Mar 2020) of 52.219-6.
__ (19) (i) 52.219-7, Notice of Partial Small Business Set-Aside (Nov 2020) (15 U.S.C. 644).
__ (ii) Alternate I (Mar 2020) of 52.219-7.
__ (20) 52.219-8, Utilization of Small Business Concerns (Jan 2025) (15 U.S.C. 637(d)(2) and (3)).
__ (21) (i) 52.219-9, Small Business Subcontracting Plan (Jan 2025) (15 U.S.C. 637(d)(4)).
__ (ii) Alternate I (Nov 2016) of 52.219-9.
__ (iii) Alternate II (Nov 2016) of 52.219-9.
__ (iv) Alternate III (Jun 2020) of 52.219-9.
__ (v) Alternate IV (Jan 2025) of 52.219-9.
__ (22) (i) 52.219-13, Notice of Set-Aside of Orders (Mar 2020) (15 U.S.C. 644(r)).
__ (ii) Alternate I (Mar 2020) of 52.219-13.
__ (23) 52.219-14, Limitations on Subcontracting (Oct 2022) (15 U.S.C. 657s).
__ (24) 52.219-16, Liquidated Damages—Subcontracting Plan (Sep 2021) (15 U.S.C. 637(d)(4)(F)(i)).
__ (25) 52.219-27, Notice of Set-Aside for, or Sole-Source Award to, Service-Disabled Veteran- Owned Small Business (SDVOSB) Concerns Eligible Under the SDVOSB Program (Feb 2024) (15 U.S.C.
657f).
__ (26) (i) 52.219-28, Postaward Small Business Program Rerepresentation (Jan 2025) (15 U.S.C.
632(a)(2)).
__ (ii) Alternate I (Mar 2020) of 52.219-28.
__ (27) 52.219-29, Notice of Set-Aside for, or Sole-Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Oct 2022) (15 U.S.C. 637(m)).
__ (28) 52.219-30, Notice of Set-Aside for, or Sole-Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Oct 2022) (15 U.S.C. 637(m)).
__ (29) 52.219-32, Orders Issued Directly Under Small Business Reserves (Mar 2020) (15 U.S.C.
644(r)).
__ (30) 52.219-33, Nonmanufacturer Rule (Sep 2021) (15 U.S.C. 637(a)(17)).
_X_ (31) 52.222-3, Convict Labor (Jun 2003) (E.O. 11755).
_X_ (32) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Mar 2026) (E.O.
13126).
_X_ (33) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).
_X_ (34) (i) 52.222-26, Equal Opportunity (Sep 2016) (E.O. 11246).
__ (ii) Alternate I (Feb 1999) of 52.222-26.
__ (35) (i) 52.222-35, Equal Opportunity for Veterans (Jun 2020) (38 U.S.C. 4212).
__ (ii) Alternate I (Jul 2014) of 52.222-35.
_X_ (36) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) (29 U.S.C. 793).
__ (ii) Alternate I (Jul 2014) of 52.222-36.
_X_ (37) 52.222-37, Employment Reports on Veterans (Jun 2020) (38 U.S.C. 4212).
_X_ (38) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).
_X_ (39) (i) 52.222-50, Combating Trafficking in Persons (Oct 2025) (22 U.S.C. chapter 78 and E.O.
13627).
__ (ii) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).
__ (40) 52.222-54, Employment Eligibility Verification (Jan 2025) (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial products or commercial services as prescribed in FAR 22.1803.)
__ (41) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA–Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off the-shelf items.)
__ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)
__ (42) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (May 2024) (42 U.S.C. 7671, et seq.).
__ (43) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air
Conditioners (May 2024) (42 U.S.C. 7671, et seq.).
__ (44) 52.223-20, Aerosols (May 2024) (42 U.S.C. 7671, et seq.).
__ (45) 52.223-21, Foams (May 2024) (42 U.S.C. 7671, et seq.).
__ (46) 52.223-23, Sustainable Products and Services (May 2024) (E.O. 14057, 7 U.S.C. 8102, 42 U.S.C. 6962, 42 U.S.C. 8259b, and 42 U.S.C. 7671l).
__ (47) (i) 52.224-3 Privacy Training (Jan 2017) (5 U.S.C. 552 a).
__ (ii) Alternate I (Jan 2017) of 52.224-3.
_X_ (48) (i) 52.225-1, Buy American-Supplies (Oct 2022) (41 U.S.C. chapter 83).
__ (ii) Alternate I (Oct 2022) of 52.225-1.
__ (49) (i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (NOV 2023) (19 U.S.C.
3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, 19 U.S.
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