Attachment_1_IDIQ_SOW.pdf

IDIQ STATEMENT OF WORK (SOW) FOR FOOD APPLICATIONS REGULATORY MANAGEMENT

(FARM) & IT INTERFACING SYSTEMS

SOLICTATION #75F40126R00042

1. Description/Specification

1.1. Background

The FDA is responsible for protecting public health by assuring the safety, effectiveness, and security of human and veterinary drugs, biological products, medical devices, cosmetics, the nation's food supply, and other products. The FDA regulates more than $1 trillion of consumer goods, representing about 25% of U.S. consumer expenditures. The Agency's optimal performance delivers significant public health and economic benefits by speeding innovations to market, ensuring access to accurate, science-based information, and coordinating with international organizations to investigate potential health risks, respond to emerging diseases, and address global public health challenges.

The Human Foods Program (HFP) oversees all FDA activities related to food safety and nutrition under the Deputy Commissioner of Human Foods. The HFP's mission is to ensure that food is a source of wellness for all U.S. consumers through science-based approaches to prevent foodborne illness, reduce diet-related chronic disease, and ensure chemicals in food are safe. The FDA's HFP - Office of Food Chemical Safety, Dietary Supplements and Innovation (OFCSDSI) operates multiple integrated IT systems to support its regulatory oversight of food chemicals and dietary supplements, including the Food Applications Regulatory Management (FARM), the Chemical Evaluation and Risk Estimation System (CERES), the Toxicology Reports and Analysis Management (TRAM) system, the Scientific Terminology and Regulatory Information (STARI), and the Warp Intelligent Learning Engine (WILEE). These systems provide robust data access, visualization capabilities, and system integration required to fulfill the office's scientific assessment and regulatory compliance mission.

The FARM system, initiated in 1995, supports premarket and post market safety review of petitions and notifications received from regulated industry. The system currently supports staff across HFP, including OFCSDSI, HFP-OFCSDSI-OPMA, HFP-OFCSDSI-ODSP, HFP-OFCSDSI-OPMAS, HFP-OFCSDSI-Innovative Foods Staff (IFS), Nutrition Center of Excellence (NCE)-Office of Nutrition and Food Labeling (ONFL) and Office of Critical Foods (NCE-OCF). Beyond HFP, FARM also supports the Office of Chief Scientist, Office of Cosmetics and Colors (OCAC), the Center for Veterinary Medicine (CVM)'s Ingredient Safety Team, Division of Animal Feeds, and scientific reviewers in the Center for Drug Evaluation and Research (CDER).

FARM serves as the primary system for HFP reviewers to access and review industry submissions and conduct analysis with regards to chemical, toxicological, and environmental analysis and other issues, regarding specific ingredients, manage correspondence and Electronic Freedom of Information (EFOI) requests, and archive HFP historical files.

For OFCSDFI, the submissions/petitions evaluated include the following:

Food Additive Petitions (FAPs), Color Additive Petitions (CAPs), Generally Recognized as Safe Notices (GRNs), Food Contact Notifications (FCNs), Biotechnology Consultations (BNFs), New Protein Consultations (NPCs), Infant Formula Notifications (IFNs), Notifications for Food Allergens (NFAs), Petitions for Food Allergens (PFAs), Citizen Petitions (CZPs), Cell Culture Consultation (CCC), Cell Culture Ingredients (CCI), and Post-Market food safety assessments.

For the OFCSDSI-Office of Dietary Supplement Programs (ODSP), the submissions/petitions reviewed include the following:

New Dietary Ingredient Notifications (NDIs) and Structure Function Claims (SFCs).

For the Nutrition Center of Excellence - Office Nutrition, Food Labeling and (NCE-ONFL), the submissions/petitions evaluated include the following:

Citizen Petitions (CZPs) and Health Claims (HC).

In addition to providing information technology support to the scientific review of submissions, the FARM System is used to support critical regulatory functions for processing and documenting agency actions pertaining to pre-submission meetings, correspondences and requests for information sent to OFCSDFI, OFCSDFI-ODSP, OFCSDSI-OPMAS, OFCSDSI-OPMA, OFCSDSI-Innovative Foods (IFS), NCE-ONFL and OCS-OCAC such as: Prenotification Consultations, Prepetition Consultations, and Freedom of Information Act (FOIA) responses, Correspondence to OCS-OCAC, and Inquiries/Correspondence for

NCE-ONFL.

The purpose of this ID/IQ is to establish a contracting vehicle for operations and maintenance and IT development services to support the mission of the various program areas. Successful offerors must demonstrate capability to work in a complex, multi-system environment where IT solutions directly support critical regulatory functions. The contractor will be expected to adapt to varying program area needs while maintaining system reliability and supporting FDA's public health mission.

Table 1. Recent submission data stored in the FARM system (2015 to 2025).

Submission Type 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025

BNF 5 6 6 6 4 5 9 6 2 6

COR 126 98 103 31 18 180 357 427 442 275

FCN 113 122 97 79 82 4 74 67 76 77

EFOIA / FOI 207 205 232 280 235 266 234 264 316 276

GRN 73 64 85 72 86 58 82 49 52 53

GNF 33 35 33 21 37 28 28 24 13

GMT 0 1 0 1 0 0 0 0 1

NDI 0 0 0 2 65 57 56 51 71 85

PETITION 8 5 6 3 6 6 5 7 12 6

PNC 187 174 174 157 131 143 151 157 160 182

NPC 1 0 0 0 0 0 1 0 1 0

IFN 18 30 29 20 44 49 24 23 36

PMR 3 5 3 5 6 3 3 15 9

CZP -OFCSDSI

(CZP) 15 0 0 1 4 0 5 0 4

OCZ-OFCSDSI-

ODSP (OCZ) 0 0 0 0 0 0 0

COR-

OFCSDSI-

ODSP

(CORDS)

167 459 180 272 366 168 58

SFC-OFCSDSI-

ODSP 44 1432 1634 1482 1861 2542 2409

TOR 2 5 6 2 1 0 2

FALCPA 39 72 0 66 2 0 0

GBFP 105 8 72 110 78 100 82

GRAS 6 4 95 110 77 76 67

1.2. Technical Background

Human Foods Program (HFP) has iteratively upgraded the FARM System to its current configuration, an integrated system that supports online submission, content management, search/retrieval, workflows, account management, reporting, forms management, and indexing activities.

Exhibit 1 - FARM Features

FARM supporting software stack is provided in Table 2.

Table 2. Current FARM System technology stack FARM Component / Software FARM Component Software Version

Input/PDF Forms Management Adobe Experience Manager (AEM) 6.5 Application Server Oracle WebLogic 14C (14.1.2.0), Java jdk-21_linux-x64 jdk-21.0.8 Java JDK/JRE Java JDK version 21.0.8 2025-07-15 LTS Java J2EE Jakarta EE 11 Spring Boot 2.7.18 Log4j 2.25.3

Apache PDF Box 2.0.4 Hibernate 5.6.15. Final (FARM Web); 5.6.15. Final (FARM API) Jersey 2.35 Single Sign On (SSO) Oracle SSO 14c DB Storage Oracle RDS 19c (Version 19.18.0.0.0) Search Apache Solr 9.10.1 (Zookeeper 3.9.4) Content Management System Documentum 24.4 Appian/Workflow Appian 25.4 FARM Web Application UI PrimeFaces 11.0.0 Business Object Reports SAP BusinessObjects BI Platform 4.3 Sp4 Patch3 Electronic Submissions MOVEit/file transfer version 14.1 COSM Internet UI Management Angular 17.3.12, JWT 0.7.0, Angular Material 17.3.10, Bootstrap 5.3.8, Prime NG 17.18.15 Apache Kafka 2.13-4.1.0 Kafdrop 4.2.1 Swagger 5.17.14

1.3. Objectives & Scope

The purpose of this IDIQ Statement of Work is to obtain business and information technology support services (ITSS) for on-going operations and maintenance (O&M) and IT system development support using the current and enhanced infrastructure to various HFP IT systems.

As a direct result of contract performance, the FDA aims to achieve the following key outcomes:

• Management of the IT configuration, security requirements, upgrades and programming of software processes associated with the front-end processing of submissions and the back end integrating with the FARM system and other HFP interfacing systems.

• Optimize the FARM system online submission, content management, searching, workflow processes towards Intelligent Business Management (support content creation, review and authorization, categorization, reusability, storage and archiving, and retrieval of data) and reporting needs of HFP.

• Improve data quality, data profiling, governance and data integration between the FARM system data and other FDA data sets to facilitate the search and retrieval and sharing of information

• Improve information reporting capabilities across various data resources to support multiple FDA program areas

The contract encompasses the full range of Information technology services including online submission processing, content management, search management, database administration, customizations and process automation of workflows and reports, performance tuning and monitoring, system administration, help desk support, end-user training, infrastructure configuration, Enterprise Performance LifeCycle (EPLC), and security documentation management, and user account administration for the FARM system and other HFP IT systems.

1.3.1. Task Area 1 – Project Management (Firm Fixed Price)

The Contractor shall provide project management oversight the scope, schedule, quality, and cost are properly monitored and controlled throughout the duration of the contract.

Specifically, the Contractor PM shall perform these project management activities described in the following sections:

1.3.1.1. Meetings

The Contractor PM shall participate in the regular status meetings, technical and process improvement meetings. The Contractor PM shall prepare meeting agendas, minutes, issues, risks and action items with clear ownership, deadlines, and completion status to ensure accountability and follow-through.

1.3.1.2. Project Management Plan (PMP)

For the task orders released under this contract, the Contractor shall provide task order level PMP to establish control, management, monitoring and notification mechanisms, ensuring that contracted tasks stay on track and important milestones and performance measures are met. For each task order, the Contractor shall prepare a detailed Management Plan describing the technical approach to be employed for successful project execution. This plan must outline organizational resources that will be allocated to the task, including personnel assignments, and any specialized capabilities needed to fulfill the contract requirements. The Management Plan shall include robust risk management strategies, and other management controls that will be implemented to meet the cost, performance and schedule requirements throughout the entire duration of task order execution. These controls must demonstrate how the Contractor will proactively identify, assess, and mitigate potential risks while maintaining adherence to established budgets, performance standards, and delivery timelines. The plan serves as the foundational document that guides all project activities and ensures accountability at every phase of the work.

The Contractor shall provide monthly status reports on all awarded task orders and their progress to the IDIQ Task Order Contracting Officer Representative (COR). These reports are critical for maintaining transparency and ensuring effective oversight of contract performance throughout the project lifecycle.

Within the first thirty (30) days after the contract award, the Government and the Contractor will collaborate to design and agree upon a standard reporting format that includes consistency and completeness of information to facilitate efficient review and analysis of project status. The agreed-upon reporting format shall include the following information at a minimum:

• Status and progress of tasks, providing clear visibility into completed work and upcoming activities

• Cost and schedule variances, highlighting any deviations from planned budgets and timelines along with explanatory details

• Significant risks to scheduled deliverables and comprehensive plans to mitigate them, ensuring proactive risk management

• Progress against service level metrics, demonstrating adherence to established performance standards and

• Recommendations for changes or additional activities to ensure that the tasks support progress on the overall contract objectives, enabling informed decision-making and timely course corrections when necessary to maintain project success and contract compliance.

In addition to progress reporting, the Contractor shall be proactive in informing the designated government Project Managers and Contracting Officer Representatives of any issues, problems and recommendations that should be addressed in order for the overall effective accomplishment of task order goals. Recommendations for actions that need to be taken by FDA staff, or other Contractors, shall be clearly defined and communicated to the responsible party and the FDA, and have identified dates for completion.

1.3.1.3. Reporting & Documentation

Weekly/Monthly/Annual Progress Reports: The Contractor PM shall submit Weekly, Monthly and Annual Reports and Project Schedule updates

1.3.1.4. EPLC Support & Documentation

The Contractor PM shall follow the FDA Enterprise Performance LiveCycle (EPLC) process and EPLC artifacts/deliverables

1.3.1.5. Release Management

The Contractor PM shall document the underlying software components and follow release management

1.3.2. Task Area 2 – Operations & Maintenance Support (Firm Fixed Price) The Contractor shall perform technical upgrades and refreshes as directed, required and/or mandated by the FDA. The contractor will work with multiple HFP IT systems and interfaces to provide continuous IT solution support on a wide range of operations and maintenance services. For instance, FDA security classifies the FARM as a ‘Mission Critical’ system with a 24/7 operational requirement, excluding planned outages.

Representative activities under this task area may include:

• Provide user production support (such as FARM Helpdesk), user training and responses to Data Calls

• Coordinate, plan, develop, test, and implement all releases (major, minor, and emergency) following FDA EPLC standards with the FDA data center and Cloud environment contractors. Fix defects and perform minor enhancements (less than 200 hours for each enhancement), and incorporate them into releases

• Develop all documentation for EPLC intake processes and save all documents pertaining to the requirements, technical documents, user manuals, online help guides, etc., in the FDA document repository

• Implement infrastructure configuration and increase the scalability of system servers, keep the updated software stack within two versions of the latest release and perform annual operational analysis, by incorporating feedback from users of the IT systems

• Implement mandated security scan, such as Continuity of Operations (COOP) and Information Systems Contingency Plan (ISCP) exercise events that require Contractor support to meet all security requirements.

• Provide maintenance and database support for the FARM system

1.3.3. Task Area 3 – Information Technology System Development (Labor Hour)

The contractor will work on HFP IT systems and interfaces to perform on the development, modernization and enhancements (DME) tasks on a wide range of IT modernization services. The specific IT system development tasks will provide details about the IT systems to be changed or modified to substantively improve their capability or performance. Representative activities under this task area may include:

Perform planning, analyzing and gathering requirements:

o Analyze existing business processes, scenarios, activities, architecture, and information flow o Perform impact analysis scenarios and gap analysis activities to identify inefficiencies, redundancies, obsolescence, and technology gaps

Design and develop IT application system per the requirements o Provide business and technology roadmaps to include blueprints, to-be business processes, information flow and data flow diagram, conceptual, data models, and system architectures that will transform the current state to the designed future state of business processes, web application and systems

Test and Implement IT application system per the requirements into production

1.3.3.1. Create New or Enhance Workflows in Appian Cloud

The FARM System provides information management tools for Agency reviewers and is the key enabler of the electronic document review process and expedites the ingredient safety review process and subsequent safety decision-making effort to maximize productivity. Currently, FARM has 26 workflows:

Collect new requirements, design, develop and implement enhancements to the existing workflows for HFP offices of Pre-Market Additive Safety, Post-Market and Assessment, Dietary Supplement Programs, Nutrition and Food Labeling and the Office of Cosmetics and Colors and other offices.

Collaborate with the agency to implement AI-based Regulatory Review processes such as using FDA Elsa, Modernizing and Accelerating Regulatory Submissions tool (MARS) to embed AI into the workflow

1.3.3.2. Streamline Regulatory Review with AI-Enhanced Workflow Automation

AI-Enhanced Review Automation: Implement AI and LLM tools (e.g., MARS, Elsa) within FARM Appian workflows to automate document processing, data extraction, classification, validation, preliminary assessments, and reporting, freeing scientific reviewers to focus on high-value safety evaluations.

Decision Support & Standardization: Leverage historical data, external scientific databases, and AI recommendations to provide preliminary review synopses, reviewer assignments, standardized language suggestions, and flag inconsistencies against prior agency positions, ensuring regulatory consistency, rigor, and optimized workflow processes across HFP.

Proof of Concept, Metrics, and Documentation: Deliver tested, agentic AI workflows with minimal human intervention; integrate with FDA-approved platforms (Appian, HALO- Databricks, consolidated data lakes) for intelligent routing and predictive analytics;

demonstrate measurable reductions in administrative burden and increased reviewer time on scientific analysis; provide comprehensive system documentation, validation protocols, training materials, user guides, and feedback mechanisms to support adoption and continuous improvement.

1.3.3.3. Centralized Online Submission Module (COSM)

Enhance COSM capabilities, collect, document, and validate technical and functional requirements; optimize system performance; implement monitoring and alerting; and establish standardized submission categorization and validation rules to improve system functionality and user experience.

Support FDA IT consolidation initiatives by planning, designing, and implementing new user management requirements through the integration of COSM's web-facing interface functionalities with FDA's Identity, Confidentiality, Access, and Management (ICAM) public-facing systems and downstream systems, while ensuring the continuity of business operations.

1.3.3.4. Findability Enhancement of Regulatory Submission Data

Enhanced Regulatory Data Access: Upgrade the interface for HFP and associated offices to improve findability and aggregation of regulatory and food safety information from internal and external FDA databases, including Harmonized Analytics Lifecycle Operations (HALO) data bricks. Enable scientists to access historical and current data efficiently for both premarket and post market reviews.

Integration: Implement advanced search capabilities, including Boolean and proximity operators, improved sorting, enhanced metadata, document organization, and duplicate reduction. Integrate FDA AI tools to support intelligent search, document summarization, data extraction, similarity analysis, and regulatory precedent identification, leveraging MARS tool and HALO consolidated data.

FARM Expansion, User Interface, and Training: Expand FARM search to support new submission types, substances, documents, COSM inquiries, and user notifications. Deliver a user-friendly interface with contextual search enhancements, downloadable search results, and integrated short tutorials. Provide comprehensive user guides and training materials to maximize adoption of advanced search and AI-powered features.

1.3.3.5. Integration with Interfacing Systems

Enhance the integration of FARM with interfacing FDA IT systems such as EASE, TRAM/CERES, STARI, G-SRS, HFP-DW, and WILEE to enable seamless data exchange and interoperability

Develop and implement integration interfaces to support bi-directional data flow between FARM components and external FDA systems

Establish standardized data exchange protocols and APIs to facilitate real-time communication with interfacing systems

Validate and test system integrations to ensure data accuracy, security, and compliance with FDA IT standards across all connected platforms

1.3.3.6. Development of Other HFP IT Systems

1.3.3.6.1. Perform Planning, Analyzing, and Gathering Requirements

1.3.3.6.2. Design and Develop per the requirements

1.3.3.6.3. Test and Implement per the requirements to release into production

1.3.4. Task Area 4 – Transition-In & Transition-Out (Labor Hour)

1.3.4.1. Transition- In Support (Optional)

The Contractor shall provide Transition-In support in order to provide an orderly transition from the incumbent Contractor to the successor Contractor. The successor Contractor shall work toward the Government’s goal of ensuring minimal disruption to the current system and operational activities.

Working with the incumbent Contractor and the COR, the successor Contractor shall develop a plan to take over ongoing work from the incumbent Contractor as required in the Task Orders released under this IDIQ.

Representative activities may include:

Develop a Transition-In plan, Participate in Transition-In meetings, Conduct and coordinating all on-boarding activities with the Government and obtaining secure badging for team personnel, Ensure staff identified as key personnel are available to work with Subject Matter Experts (SME) from the Government and the incumbent Contractor immediately after IDIQ Task Order awards, Engage in regularly scheduled meetings.

1.3.4.2. Transition-Out Support (Optional)

As tasked, the Contractor shall facilitate the transition of contracted FARM related activities and services to the Federal Government or to a follow-on Contractor at the end of the contract period of performance.

Representative activities under this task area may include:

• Provide the FDA with current versions of all systems and user documentation;

• Provide FDA all licensing and renewal information, asset management records, software documentation, and training materials;

• Provide FDA with a current inventory of all Government-owned assets used by the

Contractor along with full support in the reconciliation of this inventory;

• Provide FDA with current versions of all CONOPS, operational procedures, standard operating procedures, guidelines, performance reports, specifications for hardware and software, and other pertinent information needed to continue the services being performed by the Contractor;

• Provide “shadowing” and other knowledge transfer meetings and opportunities to facilitate the transfer of information, processes, and data needed to continue the services being performed by the Contractor;

• Provide full source code sets (not COTS source code) with configuration management information; and,

• Provide up to date EPLC and program/project management documents.

2. Inspection & Acceptance The FDA Contracting Officers Representative (COR) shall, in accordance with FAR 52.212-4, perform inspection and acceptance of all the services. The FDA COR will inspect and accept the services, documents, and materials provided to ensure they meet the requirements outlined in the contract. The FDA COR will accept goods, reports, and services only if they conform to all terms and conditions to the contract. Specific requirements for inspection and acceptance will be designated at the task order level.

Acceptance shall be communicated within thirty (30) calendar days of receipt in writing.

3. Deliveries or Performance The quoter or applicant shall submit all electronic documents for Microsoft Office suite products without the use of “macros”. When submitting proposals via email, DO NOT include .exe, .mso, or any other executable file types that could potentially trigger email security protections (i.e. email blocks, quarantine). If the offeror or applicant submits documents that contain macros, macro referenced files, and/or executable files, the Government will not be able to view or open such documents and the submission will be considered non-responsive to the solicitation. No additional time will be given to a 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.

Deliverables shall be specified in the task orders issued under this contract. Deliverable products shall be reviewed, validated, and tested as appropriate to ensure that they meet applicable/specified standards, policy, business requirements and quality measures.

Draft versions of the contract level Program Management Plan (PMP) shall be submitted with the Offeror’s proposal. Final versions of the PMP shall be delivered within thirty (30) days of contract award.

When approved by the IDIQ COR, the Contractor shall operate under the PMP.

3.1. Period of Performance

In accordance with FAR 16.504(a)(4)(i), the anticipated period of performance of this IDIQ is sixty (60) months (five (5) years), as follows:

Ordering Period I: Twelve (12) months Ordering Period II: Twelve (12) months Ordering Period III: Twelve (12) months Ordering Period IV: Twelve (12) months Ordering Period V: Twelve (12) months

Individual periods of performance will be identified within each individual task order. Task orders may be issued up to the final day of this IDIQ, and the IDIQ shall remain in force to allow for the completion of all issued task orders (See FAR 52.216-22). The following constraints apply to the period of performance for task orders:

1. Individual task orders may not exceed five (5) years (inclusive of option periods).

2. Individual task orders may perform up to five (5) years (inclusive of options) beyond the expiration of this IDIQ, so long as the IDIQ maximum (inclusive of Ordering Periods I-V) is not exceeded.

In accordance with FAR 52.216-22, any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order.

3.2. Federal Holidays

Recognized Federal Holidays – The Contractor is not required to provide on-site services on the following days that are Federal Holidays or on any other day designated as a Federal holiday for the Washington, DC area (unless otherwise specified in the Task Orders):

New Year’s Day Martin Luther King’s Birthday President’s Day Memorial Day Independence Day Labor Day Juneteenth National Independence Day Veterans’ Day Columbus Day Christmas Day Thanksgiving Day

Inclement Weather – The Contractor is not required to provide on-site service on days when the Federal Government is closed due to inclement weather. The Contractor is required to follow, as a minimum, other directives issued by the U.S. Office of Personnel Management or other such official for late arrivals due to inclement weather (unless otherwise specified in the Task Orders).

In the event the Federal Government is closed by order of the President of the United States or the U.S.

Office of Personnel Management for any reason, or the agency, the center or the building is closed for administrative or safety reasons, the Contractor will follow directives issued by responsible officials concerning reporting for work.

Each task order will contain instructions on what to do on those days when the Contractor is not permitted to report for work on-site because of a closure as determined above.

3.3. Place of Performance

The primary place of performance will be the FDA facilities within the Washington DC metropolitan area.

Specific locations will be specified in each individual Task Order. Alternate locations may be approved on a Task Order basis.

Due to FDA-wide limited space availability, the Contractor may be expected to perform most contract development activities off-site, at the Contractor’s proposed location. This can be near the Food and Drug Administration HFP, CPK2, 4300 River Road, University Station, College Park, MD, or it can be on/via Contractor’s existing office spaces.

On-site meetings, supports and operations shall be performed at 4300 River Road, College Park, MD 20740 or other local FDA locations. Other contract-related technical works may be performed off-site via Virtual Private Network (VPN) using FDA-issued laptops, personal identity verification (PIV) cards (badges) and appropriate network accounts. The Contractor shall be responsible for providing internet access so Contractor-assigned computers can connect to the FDA network via VPN.

The Contractor may be required to move frequently while working at the various campuses. The Contractor may be required to utilize conference rooms, hoteling space, common areas, libraries, cafeterias, existing offices, or other shared space at the campus. The Contractors will need to be extremely mobile with no expectation of occupying the same work area for an extended period.

Additional requirements may also be specified within each task order.

3.4. Travel

Travel costs within the Washington DC metropolitan area will not be reimbursed. Travel performed for personal convenience or daily travel to and from work at the Contractor’s facility or local Government facility within the Washington DC metro region shall not be reimbursed hereunder. “Local” is defined under this term as the travel destination located within the Washington DC metro region. Travel outside of the Washington DC metropolitan area shall be conducted in strict accordance with the Federal Travel Regulations (FTR) and FAR 31.205-46. Any travel by the Contractor shall be conducted by the direction of the Government and must have written approval by the COR prior to booking and conducting travel.

Costs associated with approved travel shall be reimbursed at actual cost, or by established Government per diems, whichever is less. Travel costs exceeding rates and per diems established under Federal Travel Regulations (FTR) are prohibited from reimbursement without written Contracting Officer approval prior to the associated travel being conducted. Prior to booking or conducting Government-direct travel, the Contractor shall provide a written request for travel to the COR and CO. The Contractor’s request for travel shall be in writing and contain the dates, locations and estimated costs of the travel. The Contractor shall then coordinate specific travel arrangements with the COR and must obtain advance, written COR approval for the travel to be conducted. The Contractor shall, to the maximum extent practicable, minimize overall travel costs by taking advantage of discounted airfare rates and other travel-related expenses available through advance purchase. Prior to changing and/or cancelling any travel that will incur cancellation fees, the Contractor shall notify the COR in writing of the total amount of the fees associated with Government-directed travel changes and/or cancellations. The

Contractor shall consider and purchase reimbursable tickets when it is more beneficial to the Government.

3.5. Other Direct Costs (ODC)

Since ODCs are identified and acquired at the order level, the Contracting Officer is responsible for making a fair and reasonable price determination for all ODCs. To support the price reasonableness of ODCs, the contractor shall obtain quotes for each ODC item in accordance with the FAR procedures for that value of the ODCs included in the quote. The quotes must be submitted to the Government for concurrence of the Program Office and the Contracting Officer. The quotes shall be maintained by the contractor in the contractor’s files and are subject to audit. The contractor may apply indirect costs, as a fixed amount, such as G&A and material handling costs and shall indicate the indirect cost rates applicable to the order. Fee, profit, and overhead may not be applied. All indirect costs must be sufficiently explained. If ODC’s are required in an order in conjunction with services, the ODCs will have its own line item.

4. Contract Administration Data

4.1. Contract Type

This is anticipated to be a single-award Indefinite Delivery-Indefinite Quantity (IDIQ) contract. Authorized order types under this contract are: Firm Fixed Price (FFP) and Labor-Hour (LH), or a combination thereof.

4.2. Contract Value

See FAR 52.216-19 for individual task order limitations.

4.2.1. IDIQ Minimum

In accordance with FAR 16.504-1(b) the minimum guarantee for this IDIQ contract $1,000.00, which will be obligated to the IDIQ at the time of IDIQ award or will be obligated to a task order issued concurrently at the time of IDIQ award.

4.2.2. IDIQ Maximum

In accordance with FAR 16.504-1(c), the maximum aggregate dollar value of all task orders awarded over the entire period of performance of all single-award IDIQs combined shall not exceed the IDIQ ceiling amount of $25,000,000.00.

4.3. Government Points of Contact

The following individuals service as the Government points of contact for the IDIQ. Additional and/or different Government points of contact may be identified at the individual task order level. Unless otherwise specified, submit IDIQ deliverables to all Government points of contact listed below.

4.3.1. IDIQ Contracting Officer (CO)

Peter Lee Peter.Lee@fda.hhs.gov 240-402-4287

The Contracting Officer (CO) identified above has responsibility for ensuring the performance of all necessary actions for effective contracting; ensuring compliance with the terms of the contract and mailto:Peter.Lee@fda.hhs.gov safeguarding the interests of the United States in its contractual relationships. The CO is the only individual who has the authority to enter into, administer, or terminate this contract and is the only person authorized to approve changes to any of the requirements under this contract, and notwithstanding any provision contained elsewhere in this contract, this authority remains solely with the CO.

No statement, whether oral or written, by anyone other than the Contracting Officer, shall be interpreted as modifying the terms and conditions of this Task Order. 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 contract. The Government will not reimburse the Contractor for any work not authorized by the CO.

4.3.2. IDIQ Contract Specialist (CS)

Brian Wodzisz Brian.Wodzisz@fda.hhs.gov 301-796-7376

4.3.3. IDIQ Contracting Officers Representative (COR)

To be determined @ time of award

The Contracting Officer may designate other Government personnel (known as the Contracting Officer’s Representative) to act as her authorized representative for contract administration functions which do not involve changes to the scope, price, schedule, or terms and conditions of the contract. The designation will be in writing, signed by the Contracting Officer, and will set forth the authorities and limitations of the representative(s) under the contract. Such designation will not contain authority to sign contractual documents, order contract changes, modify contract terms, or create any commitment or liability on the part of the Government different from that set forth in the contract. The Contractor shall immediately contact the Contracting Officer if there is any question.

4.4. Government Furnished Property/Information

GFP/GFI will be provided at the task order level. In general, the FDA will provide laptops Identity Verification (PIV) cards (badges) and appropriate network accounts. The Government Project Manager shall provide information and access to subject matter experts in both the business and technical areas as necessary. Independently, and not as an agent of the Government, the Contractor shall furnish the necessary services, personnel, materials, equipment, and facilities, not otherwise provided by the Government, as needed to perform this contract. The Contractor is responsible for all costs related to making the property available for use, such as payment of all transportation, installation or rehabilitation costs

4.5. Ordering Procedures

In accordance with FAR 16.504-1, the Government will use the following procedures in issuing orders. In accordance with FAR 52.216-18, all task orders are subject to the terms and conditions of this contract.

In the event of conflict between a task order and this contract, the contract shall control.

4.5.1. Placement of Orders

Individual orders shall be placed under this IDIQ in accordance with the procedures of FAR 16.505 and

FAR 52.216-18.

mailto:Brian.Wodzisz@fda.hhs.gov

In accordance with FAR 16.504-1, this IDIQ is available for use agency-wide and any FDA CO is authorized to issue orders.

A Request for Task Order Proposal (RFTOP) will typically be issued via email to the Contractor's email address.

In accordance with FAR 16.505(a)(2), individual orders will clearly describe all services to be performed or supplies to be delivered so the full cost or price for the performance of the work can be established when the order is placed. Orders shall be within the scope, issued within the period of performance, and be within the maximum value of the contract.

In accordance with FAR 16.505(a)(2), individual orders will clearly describe all services to be performed or supplies to be delivered so the full cost or price for the performance of the work can be established when the order is placed. In accordance with FAR 16.505(a)(7), orders placed under this indefinite-delivery contract will contain the following information:

(i) Date of order.

(ii) Contract number and order number.

(iii) For supplies and services, line item number, subline item number (if applicable), description, quantity, and unit price or estimated cost and fee (as applicable). The corresponding line item number and subline item number from the base contract shall also be included.

(iv) Delivery or performance schedule.

(v) Place of delivery or performance (including consignee).

(vi) Any packaging, packing, and shipping instructions.

(vii) Accounting and appropriation data.

(viii) Method of payment and payment office, if not specified in the contract (see 32.1110(e)).

(ix) North American Industry Classification System code (see 19.102(b)(3)). Any work that the

Contractor undertakes prior to receiving a fully executed task order that has been signed by the CO (or the Contractor has received prior authorization to proceed from the CO) shall be at the Contractor’s risk.

4.5.2. Pricing of Orders

Proposals submitted in response to a RFTOP must use labor rates equal to or less than the established IDIQ Ordering Period labor rates listed in the IDIQ Price Schedule based on the date the work is actually performed. If a task order’s performance period crosses into new IDIQ Ordering Period rates, the Contractor may propose the next applicable IDIQ Ordering Period rates for that portion of the performance period. The Contractor may propose lower rates in response to a RFTOP. RFTOPs may include option periods in accordance with FAR clause 52.217-9.

The Contractor shall comply with FAR 52.212-4, Contract Terms and Conditions—Commercial Products and Commercial Services, with regard to fixed-prices for individual deliverables and FFP task orders. The total amount specified in FFP deliverables and task orders shall be fixed for the period of performance and shall not be subject to adjustment; except, as a result of a direct action or inaction by the Government, which delays the Contractor from completing the task within the time specified in the order.

The Contractor shall comply with FAR 52.212-4, Contract Terms and Conditions—Commercial Products and Commercial Services—Alternate I, with regard to the ceiling price for individual labor categories and LH task orders. LH task orders will include a ceiling price. If a task order’s stated period of performance must be extended as a result of Government delay, the Contractor may request that the most current labor rates be used to price the work effort during the extended period for LH task orders.

The Contractor’s pricing schedules for labor categories shall contain fully burdened hourly labor rates, including all wages, indirect costs, fringe benefits, overhead, general and administrative, and profit.

Hourly rates apply to services at both Government and non-Government sites. By mutual agreement of the parties, additional labor categories may be added to this IDIQ contract to support the tasks of this contract.

4.6. Invoicing

The Contractor shall include the payment address, if it is different from that shown for the Contractor.

Specific invoicing instructions may be provided in each individual task order. Unless otherwise specified, the FDA invoicing procedures shall be in accordance with HHSAR 352.232-71, Electronic Submission of Payment Requests, and as follows:

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

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

Department of Treasury’s Invoice Processing Platform System (IPP).

http://www.ipp.gov/vendors/index.htm

(b) Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with 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) -----

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

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

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

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

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

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

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

http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/22.1803

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

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

- Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other

Indirects)- show rate, base and total amount;

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

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

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

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

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

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

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

- invoice number, amount, & date submitted

- corresponding payment amount & date received

- total amount of all payments received to date under the subject contract or order

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

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

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

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

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

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

(End Of Clause)

4.7. Availability of Funds

The Government’s obligation for performance of this contract is contingent upon the availability of appropriated funds from which payment for contract purposes can be made. No legal liability on the part of the Government for any payment may arise for performance under this contract until funds are made available to the Contracting Officer for performance and until the Contractor receives notice of availability, to be confirmed in writing by the Contracting Officer.

5. Special Contract Requirements Additional and/or specific special contract requirements

5.1. Section 508 Requirements

Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) requires Federal agencies to purchase information and communication technologies (ICT) that meet specific accessibility standards. This law helps to ensure that federal employees with disabilities have access to, and use of, the information and data they need to do their jobs. Furthermore, this law ensures that members of the public with disabilities have the ability to access government information and services.

There are three regulations addressing the requirements detailed in Section 508. The Section 508 technical and functional standards are codified at 36 CFR Part 1194 and may be accessed through the Access Board’s Web site at http://www.access-board.gov. The second regulation issued to implement Section 508 is the Federal Acquisition Regulation (FAR). FAR Part 39.2 requires that agency acquisitions of information and communication technology (ICT) comply with the Access Board’s standards. The entire FAR is found at Chapter 1 of the Code of Federal Register (CFR) Title 48, located at http://www.acquisition.gov. The FAR rule implementing Section 508 can be found at http://www.section508.gov. The third applicable regulation is the HHS Acquisition Regulation (HHSAR).

Regardless of format, all Web content or communications materials produced for publication on or delivery via HHS Web sites - including text, audio or video - must conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information…