SS-75F40126Q00027 FDA BIMO Support Sources Sought.pdf

SOURCES SOUGHT NOTICE

Request # SS-75F40123Q00029

FOR: FDA BIMO Inspections and Compliance Support

DEPT/AGENCY INFORMATION: Department of Health and Human Services U.S. Food and Drug Administration

Requiring Offices: Office of Digital Transformation (ODT)

GENERAL INFORMATION

The U.S. Food and Drug Administration (FDA) is issuing this source sought notice as a means of conducting market research, pursuant to FAR Part 10 Market Research, to identify potential parties from the marketplace capable of providing professional services for FDA Inspections and Compliance Support.

This is a SOURCES SOUGHT ONLY, not a Request for Quote (RFQ) and does not commit the Government to award a contract now or in the future. The purpose of this Sources Sought is to identify SMALL BUSINESSES on GSA MAS Schedule with the capabilities to provide the services stated herein.

Submission of any information in response to this market survey is purely voluntary and the Government assumes no financial responsibility for any costs incurred. Small businesses are encouraged to respond to this notice.

The FDA will use the results of the market research to determine if small business sources capable of satisfying the agency's requirements exist based on its response to the questions contained in this notice.

The FDA does not intend to make a selection decision or award a contract on the basis of responses.

Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the outcome of the FDA's review of the information received. Additionally, the FDA does not intend to hold discussions concerning this Sources Sought with any interested parties. However, FDA reserves the right to contact vendors if additional information is required.

Respondents will not receive individualized feedback on any suggestions. No basis for claims against the United States government shall arise as a result of a response to this request for information or from the United States government's use of such information. Proprietary, classified, confidential, or sensitive information should not be included in your response. The Federal Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). Information obtained because of this notice may be used by the FDA for program planning on a non‐attribution basis.

FDA will not award a contract based on responses nor otherwise pay for the preparation of any information submitted or FDA’s use of such information. Responses to this notice are not offers and cannot be accepted by the Federal Government to form a binding contract.

Eligibility in participating in a future acquisition does not depend upon a response to this notice.

Responses will be reviewed only by FDA personnel and will be held in a confidential manner. Requests for a solicitation will not receive a response.

While the Government anticipates establishing a contract for the FDA BIMO Inspections and Compliance Support which requires contractual support, A SOLICITATION IS NOT CURRENTLY AVAILABLE. The Government is not obligated and will not pay for any information received from potential sources as a result of this Sources Sought.

PURPOSE

The purpose of this sources sought is to broaden FDA’s understanding of the market’s capability to support FDA’s Inspection and Compliance programs to develop, enhance, implement, consolidate, and maintain a broad range of tools and functions. To achieve this purpose, FDA is seeking contractual support for a diverse range of technical, developmental, analytical, data management, and user support activities.

Notice to Small Businesses: The purpose of this Sources Sought Notice is to seek declarations of technical capabilities and various information, data, and materials from qualified small business concerns [including 8A Businesses, Small Disadvantaged Businesses (SDB), Woman‐owned Small Businesses (WOSB), Historically Underutilized Business Zone (HUBZone), Small Businesses, Veteran‐ Owned Small Businesses (VOSB), and Service‐Disabled Veteran‐owned Small Businesses (SDVOSB)].

FDA intends to provide maximum practicable opportunities in its acquisitions to small business, veteran‐owned small business, service‐disabled veteran‐owned small business, HUBZone small business, and small disadvantaged business.

The objectives of this requirement are:

To support the development, consolidation, management, and enhancement of the suite of tools, systems, and services supports the FDA BIMO inspections and compliance portfolio of programs.

BACKGROUND

The Food and Drug Administration (FDA) is responsible for protecting and promoting public health in the United States. Its mission encompasses ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the nation's food supply, cosmetics, and radiation-emitting products. The FDA advances public health by accelerating innovations in medical products and providing accurate, science-based information to the public.

The FDA plays a crucial role in safeguarding public health through its comprehensive inspection and compliance programs. It conducts regular inspections of manufacturing facilities, clinical trial sites, and laboratories to verify compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and other relevant regulations. These inspections help identify potential risks to public health and ensure that companies follow proper procedures in the development, production, and distribution of their products.

In addition to inspections, the FDA's compliance efforts include monitoring adverse event reports, reviewing product quality complaints, and overseeing recalls when necessary. The agency has the authority to take enforcement actions against companies that violate regulations, ranging from issuing warning letters to initiating legal action or imposing fines. The FDA also works collaboratively with industry to promote voluntary compliance through education and guidance. By maintaining a robust inspection and compliance program, the FDA aims to prevent substandard or unsafe products from reaching consumers, protect public health, and maintain public trust in the safety and efficacy of FDA-regulated products.

FDA is embarking on a critical initiative to consolidate its technical infrastructure supporting BIMO inspection and compliance activities across all centers. Currently, each center operates with its own distinct set of technical platforms, support systems, databases, and processes, leading to inefficiencies and inconsistencies. To address these challenges, the FDA aims to consolidate specific components of its inspections and compliance-related activities. This approach involves consolidating workflow processes and workflow applications into a single system, merging databases into one comprehensive repository, and unifying reporting tools into a centralized platform. Additional consolidations will occur for other key components such as site selection tools and data integration processes.

This consolidation effort presents an opportunity for the FDA to significantly improve upon its existing technologies. By consolidating each tool or system, the FDA plans to leverage cutting-edge technologies to introduce seamless automation, artificial intelligence, and agile, modular solutions that provide immediate benefits to Agency staff. This approach aims to enhance efficiency, consistency, and effectiveness of inspection and compliance operations across all centers while maintaining the flexibility to address specific needs. The consolidation will enable more efficient resource allocation, standardize processes, break down data silos, and provide deeper insights through advanced analytics, ultimately supporting data-driven decision-making at all levels of the organization.

INSTRUCTIONS

Responses should not exceed 10 pages in length. A complete response should include answers to all the questions below. Please note that a respondent's failure to provide a complete response to a question will be interpreted to mean that it does not understand the question and does not demonstrate the capability to provide services required. Responses should demonstrate capability, not merely affirm the respondent's capability (i.e. the response must go beyond the statement that, "XYZ company can provide technical support").

Response Due Date/Time: 2:00 PM ET on January 5, 2026

Email to: michelle.dacanay@fda.hhs.gov

Please include the Sources Sought number and Sources Sought Requirement Name in the subject line.

No phone calls will be accepted for this notice.

mailto:michelle.dacanay@fda.hhs.gov

CAPABILITY STATEMENTS

Interested, capable vendors (parties) are invited to submit a capability statement in response to this notice tailored to the information requested, taking into consideration the “Purpose” and “Background” described above along with the draft statement of work provided.

Respondents should include, but are not limited to, addressing their experience and capabilities in the following areas:

1) Contact information:

▪ Company Name

▪ UEI

▪ Mailing Address

▪ Name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives.

▪ Socio Economic Status

▪ Company structure (Corporation, LLC, partnership, joint venture, etc.). Companies also must be registered in the SAM (www.sam.gov) to be considered as potential sources.

▪ GSA contract number(s) with period of performance to include option periods.

▪ Proposed NAICS for this effort

▪ Proposed GSA Schedule for this effort

▪ Provide publicly posted pricing such as price catalogs accordance with FAR Part 10 or a copy of your commercial price catalog as market research.

2) Please respond to the questions below broadly; specificity is not necessary at this time.

a) Does your company have proven experience and capabilities in supporting the technologies and platforms outlined/described in the draft FDA Support SOW? If yes, please complete the table below under item #4.

b) Does your company have experience with Appian tools and systems? If yes, describe your company’s experience in developing or supporting data-driven Appian architectures, specifically highlighting your expertise with Appian tools and systems.

c) Does your company have experience with Appian for long-process large scale workflows?

d) Does your company have the ability to develop and maintain several integrated data systems that can combine information from multiple systems into a single destination? If yes, please provide an example.

e) Does your company also have experience disseminating or sharing information, documents and workflow in a secure, flexible manner for multiple users to multiple systems? If yes, please provide an example.

f) Does your company have proven experience with subject matter expertise and experience supporting an organization conducting similar work including scale and scope of the draft SOW. If yes, please provide an example.

g) Can you describe your company's experience in developing or implementing algorithmic and intelligent systems for risk-based selection of sites, labs, or entities, including any specific methodologies or success metrics used? If yes, please provide an example.

h) How has your company leveraged Artificial Intelligence (AI) in developing applications or capabilities related to inspection and compliance processes? What level of expertise can you demonstrate in integrating AI capabilities for these specific use cases?

i) Has your company developed or implemented remote evaluation technologies or methodologies for any customer's processes, and if so, can you describe their key features, effectiveness, and any challenges overcome in their deployment?

j) Does your company have proven experience managing Cloud-based (e.g., Amazon, Google, Microsoft) and on-premises infrastructure to support using Commercial-off-the-Shelf (COTS) and open-source software packages. If yes, please provide an example.

k) Does your company have proven experience with End to End (E2E) Automation Testing Capabilities and Data Security Management and Section 508 experience? If yes, please provide a brief description of your experience for each of these.

l) Does your company have experience in user interface design and UX testing to ensure the usability of the proposed system and ensure user satisfaction? If yes, please provide a brief description and level of expertise.

m) Has your company worked on projects that involved similar stakeholders and supporting multiple concurrent task orders (for example, other government agencies) that’s similar in scope and scale to the draft SOW?

n) Does your company have experience in building tools and systems that perform tasks related to regulatory assessments and inspections? If yes, please provide a brief description and level of expertise.

o) Does your company have experience performing standard, custom, and complex analyses using analytic tools (such as QLIKSense Analytics, Tableau or other relevant tools) and utilize feedback from stakeholders to quickly and efficiently provide revised analyses as needed? If yes, please provide a brief description of this experience.

p) Does your company have experience with developing new services in support of inspections and compliance activities or regulatory enforcement activities within the federal government? This would include understanding inspection and compliance needs, requirements gathering, development, and deployment of a service that is similar in size and complexity to existing services listed in the SOW. If yes, please provide a brief description of your experience.

q) Does your company have experience consolidating complicated legacy data and activity systems into a modern, streamlined platform? If yes, please provide a brief description.

3) Rough Order of Magnitude (ROM) Cost Estimate

As part of this sources sought, respondents are encouraged to submit a Rough Order of Magnitude (ROM) cost estimate based on the scope described in the SOW. The ROM is intended to provide the government with a preliminary, non-binding cost estimate for planning and market research purposes only. No contract award will result from this sources sough, and submission of a ROM does not obligate the respondent or the government in any way.

4) Please provide any comments, feedback, or suggestions you may have on the proposed drafted SOW.

5) Please complete the table based on your experience in performing the task areas and tools and technologies listed in the table on the next page with a yes/no/some.

Task Areas Yes/No/Some Tools & Technologies Yes/No/Some

Project Management Appian

Documentation Development ThinkTrends

IT Architecture Services QLIKSense

System Integration and Engineering Python

Systems/Tools Development Artificial Intelligence

UX testing Machine Learning

Business Analysis Databricks

End to End (E2E) Automation Testing Oracle

Data Management Angular

Data Analytics AWS Cloud Services

Database Administration Java

Outreach and Communication Support JIRA

Operations and Maintenance (O&M)

Support

.Net

Technical Assistance for Existing Tools Postgres

VBA MS Access PowerBI

508 Compliance SharePoint

Data Security Management SQL

ATTACHMENT:

▪ DRAFT Statement of Work

ATTACHMENT – DRAFT SOW

Food and Drug

Administration

Inspections and Compliance BPA Supporting FDA BIMO

DRAFT

Statement of Work (SOW) for FDA Inspections and Compliance Supporting

FDA BIMO Blanket Purchase Agreement

ATTACHMENT – DRAFT SOW

Contents

1 Introduction

1.1 Background

1.2 Purpose and Objectives

2 Scope of Work

2.1 List of Expected Work Areas

1 Introduction

1.1 Background

The Food and Drug Administration (FDA) is responsible for protecting and promoting public health in the United States. Its mission encompasses ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the nation's food supply, cosmetics, and radiation-emitting products. The FDA advances public health by accelerating innovations in medical products and providing accurate, science-based information to the public.

The FDA plays a crucial role in safeguarding public health through its comprehensive inspection and compliance programs. It conducts regular inspections of manufacturing facilities, clinical trial sites, and laboratories to verify compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and other relevant regulations. These inspections help identify potential risks to public health and ensure that companies follow proper procedures in the development, production, and distribution of their products.

In addition to inspections, the FDA's compliance efforts include monitoring adverse event reports, reviewing product quality complaints, and overseeing recalls when necessary. The agency has the authority to take enforcement actions against companies that violate regulations, ranging from issuing warning letters to initiating legal action. The FDA also works collaboratively with industry to promote voluntary compliance through education and guidance. By maintaining a robust inspection and compliance program, the FDA aims to prevent substandard or unsafe products from reaching consumers, protect public health, and maintain public trust in the safety and efficacy of FDA-regulated products.

Bio-Research Monitoring (BIMO)

The Bio-Research Monitoring (BIMO) program is a critical component of the FDA's regulatory oversight. It is designed to ensure the quality and integrity of data submitted to the FDA in support of marketing applications for drugs, biologics, and medical devices, as well as to protect the rights and welfare of human subjects participating in FDA-regulated research. The BIMO program accomplishes these objectives through a comprehensive system of inspections and data audits that cover all aspects of clinical and nonclinical research, from study conduct to data reporting.

BIMO inspections are conducted across various entities involved in the research process, including, but not limited to, clinical investigators, institutional review boards (IRBs), sponsors, contract research organizations (CROs), nonclinical (animal) laboratories, and bioequivalence analytical laboratories.

These inspections verify compliance with FDA regulations and good clinical practices, assess the reliability of submitted data, and evaluate the measures taken to protect human subjects. By maintaining a robust BIMO program, the FDA ensures that the data used to make critical decisions about product approvals are trustworthy and that the rights and safety of research participants are protected throughout the drug development and approval process.

1.2 Purpose and Objectives

The purpose of this Blanket Purchase Agreement (BPA) is to procure comprehensive technical and administrative expertise to support the FDA’s ongoing efforts to modernize and transform IT

ATTACHMENT – DRAFT SOW

systems that support its BIMO regulatory inspection and compliance activities. This initiative aims to consolidate and streamline tools, systems, and applications across all FDA centers, enhancing the agency's ability to effectively regulate and monitor a wide range of products and processes in an increasingly complex public health landscape.

To achieve this purpose, FDA is seeking contractual support for a broad range of analytical, operational, technical, developmental, and administrative activities. This Statement of Work (SOW) outlines the tasks and activities that FDA expects to execute under this contract.

The primary objectives of this contract are to:

• Develop, operate, and maintain a unified suite of support tools and systems that can be utilized across all FDA centers, replacing center-specific solutions with integrated, agency-wide platforms.

• Provide technical support and expertise in integrating data, documents, and workflow processes across all FDA systems, ensuring seamless information flow and enhanced decision-making capabilities throughout the agency.

• Implement and enhance centralized data management solutions that improve data quality, accessibility, and utilization across all FDA programs, supporting more efficient and effective regulatory processes.

• Develop and maintain advanced analytics capabilities, including dashboards, reports, and predictive models, to support data-driven decision-making across all FDA centers and programs.

• Ensure compliance with FDA's security requirements and operational standards while implementing innovative, agency-wide solutions that adapt to evolving regulatory needs.

• Provide resources to develop, utilize, and maintain activities that support internal program objectives across all centers, including program and project administrative support, technical writing and documentation, End-to-End testing support, and SharePoint/Power BI support.

• Continuously improve and optimize FDA systems to enhance user experience, streamline workflows, and increase overall efficiency of operations across all centers.

• Explore, advise, and implement advanced technologies, including Artificial Intelligence (AI), to support FDA programs agency-wide, ensuring consistent and cutting-edge technological adoption across all centers.

Additional objectives may include:

• Establish and integrate standardized components to streamline and harmonize all FDA inspection workflows and internal processes across the organization.

• Develop and implement robust bi-directional data integration capabilities within inspection-based programs and across all relevant FDA data sources to enhance information flow and decision-making.

• Design and deploy advanced data management solutions to optimize data quality, accessibility, and utilization across all inspection programs, facilitating more efficient and effective regulatory processes and outcomes.

Anticipated benefits of this support include:

• Centralization and streamlining of all BIMO workflows and processes, significantly reducing the administrative burden on regulatory staff and allowing them to focus on

ATTACHMENT – DRAFT SOW

critical evaluation and decision-making tasks.

• Enhanced support for evaluation and decision-making on BIMO-related activities, leading to better and stronger regulatory outcomes that ensure the safety and efficacy of FDA regulated products.

• Improved data integration and analytics capabilities, enabling more comprehensive and insightful analyses of clinical trial data and inspection findings.

• Increased efficiency and accuracy in site selection processes, optimizing the allocation of inspection resources and improving the overall effectiveness of the BIMO program.

• Enhanced remote inspection and data comparison capabilities, allowing for more flexible and responsive regulatory oversight, particularly in challenging circumstances such as global health crises.

• Improved data management and governance, ensuring the integrity, security, and accessibility of critical BIMO information across the entire product lifecycle.

• Greater adaptability to evolving regulatory requirements and technological advancements, positioning FDA BIMO at the forefront of regulatory science and practice.

By achieving these objectives and realizing these benefits, the FDA will be better equipped to fulfill its mission of protecting public health through effective and efficient bioresearch monitoring, ultimately ensuring the safety, efficacy, and quality of FDA regulated products in the United States.

2 Scope of Work

The FDA requires a comprehensive, integrated information system to support regulatory oversight activities across all its centers. This Statement of Work (SOW) outlines the development, maintenance, and enhancement of a unified platform that will consolidate all centers' BIMO processes and workflows into one or many applications. The contractor shall provide technical expertise, project management, and operational support to ensure the effective functioning, integration, and continuous improvement of this consolidated system architecture. This agency-wide approach aims to promote consistency, efficiency, and seamless information sharing across all FDA centers, leveraging Center’s established tools to create a single, robust solution that meets the diverse needs of the entire organization.

The scope of work encompasses multiple interconnected projects, each addressing specific needs within the BIMO program. The contractor shall employ industry best practices, adhere to FDA security and operational standards, and utilize Agile methodologies where appropriate. Regular communication with FDA stakeholders, participation in relevant meetings, and coordination with other FDA teams will be essential for the success of these projects.

For each project area, the contractor shall provide regular status updates, maintain comprehensive project documentation, and deliver user training as needed. The contractor shall also ensure that all systems are developed and maintained in compliance with FDA's security requirements and operational standards. Throughout the execution of this SOW, the contractor shall demonstrate flexibility, technical expertise, and a deep understanding of FDA BIMO's evolving needs to successfully deliver and maintain these critical information systems.

2.1 List of Expected Work Areas

While the tools, technologies, and systems described in this SOW are currently operational within a specific center, they are expected to expand and adapt to serve all FDA centers if possible. This expansion may involve scaling existing solutions to meet the diverse needs of other centers, ensuring a unified approach to BIMO processes across the agency. It's important to note that this list of tools and systems may not be exhaustive, as the evolving nature of regulatory oversight may necessitate the development of new tools or the integration of emerging technologies. The contractor should be prepared to support both the expansion of current systems and the potential creation of novel solutions to address unforeseen challenges or opportunities that may arise during the consolidation process. This flexible approach will ensure that the FDA remains at the forefront of regulatory science while maintaining a cohesive and efficient BIMO infrastructure across all centers.

Workflow Management

The contractor shall evaluate existing BIMO inspections and compliance workflow systems across FDA centers and identify a primary system that can be maintained and enhanced to serve as the central workflow management tool for regulatory programs across all FDA centers. This evaluation will focus on the potential for consolidation, improvements in workflow management, document handling, data quality, and integration capabilities with other FDA systems.

After thorough assessment, the contractor shall expand the capabilities of the selected system to encompass all BIMO inspection and compliance activities for all FDA centers. This approach aims to consolidate multiple existing tools into a single, comprehensive platform where possible. The work includes operations and maintenance support to ensure the availability, reliability, and security of the consolidated system, and developing standardized workflows for regulatory programs across the entire FDA. The Contractor shall also provide technical and application assistance to users transitioning from legacy systems to the consolidated platform.

Key areas of focus include:

• Ensure compliance with established FDA-wide data, technical, and workflow guidelines, including data harmonization standards and development parameters

• Develop functionality to meet the requirements of BIMO inspection and compliance activities across all centers while creating common components adaptable for general workflow management and other FDA inspection activities including offline capabilities while traveling or at inspections.

• Develop a detailed specification describing the analysis to be performed, pre-conditions and/or data requirements, required inputs, processes to be performed (process flow), and outputs produced.

• Recommend the most appropriate approach and methodology for the new functionality/enhancement based on a review of functional and technical requirements, assumptions, constraints, and other platform/architectural considerations.

• Demonstrate the work accomplished in each development Sprint to business stakeholders/end users as directed by the FDA Project Manager.

• Implement and refine document management features that can be utilized agency-wide

• Enhance data validation and quality control measures to ensure consistency across all centers

• Provide a full range of O&M support services for the expanded system, including, but not

ATTACHMENT – DRAFT SOW

limited to: issue identification, tracking, analysis, and resolution; code generation, testing, application customization, configuration, and documentation; change incorporation;

maintenance of tools, custom code, specialized configurations, customizations of scripts, application outputs, and workflows; performance tuning and monitoring; system administration, and user account administration for all FDA centers

• Identify, update, track, and analyze applicable metrics for measuring the success of the unified system, with input from stakeholders/users across all FDA centers

• Evaluate and revise existing documentation on the process and workflow for developing, implementing, and enhancing the system to reflect its agency-wide application. Developing new documentation as needed to support all centers

The contractor shall strive to create a versatile system that utilizes CDER BIMO's specific needs to deliver a standardized solution for BIMO activities across all FDA centers, promoting consistency and efficiency in regulatory oversight throughout the agency.

Data Integrations

The contractor shall evaluate all existing data management solutions in use to identify if one can and enhance the existing centralized data management solution to serve as the primary data hub for inspections and compliance activities across all FDA centers. This evaluation will focus on expanding the system's scope to encompass all regulatory programs beyond its current usage.

The contractor shall enhance and improve all current data integration connections while developing and implementing additional data integrations, both within BIMO tools and systems and with other Agency data systems, to support all centers' needs.

Key responsibilities include:

• Creating and updating a comprehensive data catalog that encompasses BIMO data from all FDA centers

• Supporting and enhancing data connections and integrations across the entire FDA

• Implementing robust data governance practices that align with agency-wide standards

• Facilitating efficient data exchange between various BIMO systems across all centers

• Providing operations and maintenance support for the expanded, agency-wide system

• Developing a roadmap for continuous improvement of current data integrations and expansion to all FDA centers

• Serving as subject matter experts in data transformations, exchanges, and consolidation for BIMO activities across the entire FDA

The contractor shall focus on optimizing the existing BIMO Data Hub's performance, ensuring its scalability to accommodate all FDA centers, and maintaining its pivotal role in the agency-wide BIMO technological ecosystem. This includes staying abreast of emerging data management technologies and best practices to ensure the Data Hub remains at the forefront of FDA BIMO's data integration efforts, promoting consistency and efficiency in BIMO activities across all centers.

Inspection Support Tools

ATTACHMENT – DRAFT SOW

The contractor shall evaluate, maintain, and enhance the existing inspection and compliance tools, with a focus on expanding their capabilities to serve all FDA centers and create a unified, agency-wide suite. This suite will include Site Selection Tools and various other inspection support tools.

The Site Selection Tools (SSTs) are sophisticated data analysis applications that apply algorithmic processing to large datasets from multiple Health and Human Services (HHS) and sponsor-submitted sources to identify, rank, and prioritize high-risk sites for FDA inspection.

These tools process and analyze data from various FDA systems to surface sites that may pose risks to public health, covering programs, such as Clinical Investigator sites (for subject safety and data integrity), Institutional Review Boards (for human subject research oversight), Pharmacovigilance Compliance sites (for post-marketing adverse drug experiences), and Good

Laboratory Practice facilities (for non-clinical study compliance)). By implementing risk-based algorithms that consider factors like compliance history, inherent product risks, and inspection frequency, the SSTs enable FDA to maximize inspection efficiency by focusing limited regulatory resources on the highest-risk entities rather than conducting random inspections.

The Site Selection Tools will be consolidated where possible and enhanced to support multi-center operations across the entire FDA, serving as an integral component of relevant regulatory review processes. The contractor shall approach the development of Site Selection Tools with a forward-thinking mindset, anticipating future needs and technological advancements for all FDA centers. This includes considering the potential for machine learning and AI integration to enhance site selection accuracy and efficiency across the entire agency, promoting consistency in regulatory oversight and decision-making.

In addition to the Site Selection Tools, the contractor shall maintain and enhance a range of inspection support tools. These tools will cover various critical activities, including but not limited to: generating comprehensive background packages with line listings for inspection assignment requests, facilitating remote and on-site inspections (which will require off-line functionality when network connections are limited), processing submission information, and supporting evaluation processes. The contractor shall expand the capabilities of these tools to serve as unified, flexible solutions for all FDA centers, transforming them into agency-wide platforms that support diverse inspection and compliance needs.

The contractor shall approach the development of all these tools with a focus on flexibility, scalability, and standardization, ensuring they can adapt to changing regulatory requirements and inspection processes across all FDA centers. This includes exploring opportunities to incorporate advanced data analytics, machine learning techniques, and mobile-friendly interfaces to enhance the tools' predictive capabilities and decision support features.

Throughout the development process, the contractor will ensure that these enhanced tools function within the broader inspections and compliance ecosystem, integrating with the centralized data hub and other relevant systems across all FDA centers. This integration will promote consistency in regulatory oversight and efficiency throughout the agency. The contractor will align enhancements with the goal of consolidating multiple existing tools into a single, comprehensive platform where possible, while maintaining the availability, reliability, and security of the system.

• Maintain and update tool functionalities to meet evolving program needs across all FDA

ATTACHMENT – DRAFT SOW

centers.

• Implement significant improvements in data ingestion, processing, and export processes, focusing on automation, standardization, and optimization across centers.

• Enhance usability, interface design, and data visualization to improve user experience and efficiency for all FDA personnel.

• Provide comprehensive operations and maintenance support for the consolidated, agency-wide platform.

• Ensure seamless integration with other inspections and compliance systems and data sources across all centers.

• Develop scalable solutions to accommodate the potential expansion of tool usage throughout the FDA, including optimizing performance for handling large datasets and complex comparisons.

• Implement advanced analytics capabilities, including machine learning algorithms, to support data-driven decision-making, enhance anomaly detection, and pattern recognition across all centers.

• Conduct regular performance assessments and optimizations to ensure consistent functionality across the agency.

• Apply appropriate programming languages and data manipulation techniques to support agency-wide requirements.

• Implement robust error handling, data validation mechanisms, and data security measures to ensure consistency, accuracy, and protection of sensitive information across the entire agency.

• Develop customizable reporting features and user-friendly interfaces for intuitive data exploration and selection, accommodating diverse stakeholder needs and center-specific requirements.

• Enhance remote inspection capabilities to adapt to evolving regulatory environments across the entire agency.

• Develop new features as required by agency-wide inspections and compliance programs needs, including advanced analytics and risk assessment tools applicable to all centers.

• Provide comprehensive documentation, user training materials, and support, including the development of user guides and online resources applicable to all FDA personnel.

• Ensure all tools and systems comply with agency-wide standards and support the diverse inspection types and data needs of all centers.

BIMO Database and Analytics

The contractor shall support the development, maintenance, and expansion of a comprehensive, agency-wide central repository for all FDA BIMO inspection and compliance data. This effort will involve transforming existing center-specific databases into a unified system that serves all FDA centers.

This centralized database will store data from various upstream sources across all FDA centers, supporting agency-wide reporting, dashboards, and in-depth data analysis. The contractor shall ensure that the database is scalable, secure, and capable of handling the diverse data needs of all FDA centers involved in inspection and compliance activities.

In conjunction with the centralized database, the contractor shall develop and maintain advanced analytics capabilities for inspection and compliance programs across all FDA centers. This will involve

ATTACHMENT – DRAFT SOW

expanding the recently implemented analytics platform to become the sole source of FDA-wide dashboards, reports, and analytic capabilities, serving all centers.

The contractor shall focus on integrating these data and analytics systems with other inspection and compliance tools, ensuring a seamless flow of information throughout the agency. This integration will support more efficient decision-making, improve resource allocation, and enhance the overall effectiveness of FDA's inspection and compliance efforts.

The contractor shall provide comprehensive services to enable FDA personnel to easily modify and manage data for both database and analytics purposes. This includes developing user-friendly interfaces and tools for data entry, modification, and preparation; implementing data validation rules and audit trails; creating a self-service platform with role-based access controls and guided workflows; and offering ongoing training and support. The contractor will ensure data integrity, traceability, and quality throughout all modification processes, while empowering FDA staff with the necessary skills and resources to effectively manage and transform data for their analytical needs. This holistic approach will enhance the FDA's data management capabilities, streaml ine analytics processes, and ensure data modifications meet organizational requirements and best practices.

Throughout this process, the contractor shall prioritize data standardization, system interoperability, and user accessibility to ensure that all FDA centers can effectively utilize these tools for their specific needs while maintaining consistency in agency-wide reporting and analysis.

• Continue development through multiple phases, expanding from legacy system reports to comprehensive inspections and compliance workflow information across all FDA centers.

• Address data reconciliation challenges between historical and current data capture methods from various centers, including planning, executing, and completing data migration of historical information into the new modernized environment.

• Develop and implement new reports, dashboards, and analytic areas with information from current tools used by all FDA centers, including Site Selection information and other FDA system data.

• Provide subject matter expertise for ongoing development and optimization of the agency-wide analytics platform.

• Implement innovative and creative solutions for evolving analytical requirements across all FDA centers, including advanced data visualization techniques, interactive dashboards, predictive analytics, and forecasting capabilities.

• Ensure seamless data integration between the analytics platform and the expanded, agency-wide centralized database.

• Develop custom analytical models to support decision-making processes across all FDA centers.

• Support comprehensive training for end-users from all centers on new tools and systems.

• Implement robust data governance practices, security measures, and validation processes that comply with agency-wide standards.

• Continuously evaluate and incorporate emerging technologies and methodologies to benefit all FDA centers in data analytics and database management.

• Expand the centralized database's capacity and scope to encompass all FDA inspections and

ATTACHMENT – DRAFT SOW

compliance data from every center, ensuring the architecture meets FDA-wide requirements while optimizing efficiency.

• Develop and maintain comprehensive data dictionaries and metadata repositories that standardize terminology across all FDA centers.

• Optimize database and analytics platform performance for high-volume data processing, complex queries, and efficient data collection, storage, and dissemination across all centers.

• Conduct comprehensive data review, analysis, and cleanup activities as needed to ensure data integrity and consistency across all centers.

• Provide regular database administration, performance tuning, and optimization for the agency-wide system.

Other Program Support Areas

In addition to the specific tools and systems mentioned previously, this BPA encompasses critical support for various program-wide and multi-project activities essential to the success of inspection and compliance activities across all FDA centers. These areas of support include:

• Artificial Intelligence (AI) Expertise: The contractor will provide Subject Matter Experts (SMEs) in AI to recommend improvements to current AI usage across all FDA centers. Additionally, these experts will explore and develop AI technologies for future implementation, ensuring all centers remain at the forefront of technological advancements in regulatory science.

• End-to-End (E2E) Testing Support: Both automated regression testing and new E2E testing for new developments are required for all FDA centers. The contractor is expected to employ industry best practices when developing test cases and offer recommendations for testing improvements, encompassing both technological solutions and process enhancements that can be standardized across the agency.

• Data Architecture Expertise: Data Architecture SMEs will offer recommendations on improving the overall data architecture of BIMO inspection and compliance systems across all FDA centers. They will be capable of assisting project teams in enhancing or modifying their current architecture and supporting the overall program in Agency-wide architecture discussions to promote standardization.

• Project Management Support: The contractor will provide comprehensive support encompassing project management, business analysis, and interface expertise across all FDA centers. This support includes organizing and improving document processes, facilitating meetings, implementing best project management practices, conducting business analysis to optimize processes and systems, and providing interface expertise to ensure seamless integration and user-friendly designs. The contractor will also assist in change management, develop project artifacts, create visual representations of processes and data flows, conduct stakeholder engagements, and provide regular status updates to FDA leadership. This holistic approach aims to enhance the FDA's project management capabilities, streamline business processes, and ensure that systems and interfaces effectively meet the needs of all stakeholders throughout the organization.

• Legacy System Support: The contractor will continue to operate and maintain legacy systems across all FDA centers until the completion of the FDA-wide inspections and compliance information technology ecosystem. The contractor will then assist in the decommissioning process for all legacy tools. This includes systems like the MS Access database called Complis used by CDER. No future work outside of regular operations and maintenance is expected for these legacy systems.

• Training: The contractor will develop and execute end user trainings for all inspection and compliance tools and systems covered in this BPA across all FDA centers. This includes, but is not limited to, developing user guides, walkthroughs, demos, presentation materials, training accounts, and all other activities needed for a training session that can be standardized and used agency-wide.

• SharePoint and Power BI Support: This encompasses operations and maintenance of existing platforms, potential SharePoint integrations, and creation of new tools aimed at improving user efficiency and experience across all FDA centers. The contractor will be responsible for enhancing and optimizing these collaborative and analytical platforms to meet evolving program needs agency-wide.

These support areas are designed to enhance efficiency, transparency, and overall quality across all FDA inspection and compliance activities. By providing expertise in these crucial domains, the contractor will play a vital role in maintaining and advancing the technological infrastructure and operational effectiveness of inspection and compliance activities throughout the FDA, ultimately contributing to the agency's mission of protecting public health through effective and consistent regulatory oversight across all centers.