FDA-SSN-75F40125Q00192_RAPID VI_SOW Draft.pdf

U.S. Food and Drug Administration Office of Translational Sciences (OTS)

Center for Drug Evaluation and Research (CDER)

Real-World Application for Innovation and Development

(RAPID)

Version VI

BPA No. _________________

Table of Contents

1. Background

2. Objectives

RAPID Capabilities & Functions

RAPID USE CASES

3. Scope

4. Tasks

4.1.1. Project Management

4.1.2. BPA Program Management

4.1.3. Task Order Management

4.1.4. Personnel Management

4.1.5. Meetings

4.1.6. Reporting

4.1.7. Transition

4.1.8. Research, Prototyping and Deployment

4.1.9. Research and Innovation (Phase 1)

4.1.10. Prototype Development (Phase 2)

4.1.11. Product Deployment (Phase 3)

4.1.12. Maintenance

4.1.12.1. Database Administration

4.1.12.2. Maintenance & Technical Support

1. Background The U.S. Food and Drug Administration is a scientific regulatory agency that employs more than 10,000 scientific, technical, and support staff who are responsible for protecting and promoting the public health in the United States. One of the ways that FDA will advance its broad public health mission is by working to transform administrative systems and infrastructure to support FDA operations.

FDA is responsible for protecting and promoting public health through the regulation and supervision of Food Safety, Tobacco Products, Dietary Supplements, Prescription, and over-the-counter pharmaceutical drugs (medications), Vaccines, Biopharmaceuticals, Blood Transfusion Products, Medical Devices, Electromagnetic Radiation Emitting Devices (ERED), Veterinary Products, and Cosmetics. FDA provides regulatory oversight of the world’s largest and most technologically advanced pharmaceutical, biotechnology, and medical device industries. This includes oversight and regulation of global operations for new product development and expanding chronic use of marketed drugs by millions of U.S. patients. These developments are coupled with a pervasive reliance on electronic data at every stage of the product life cycle. Harnessing the access to, and analysis of, these data provide unprecedented opportunities for greater knowledge, improved efficiency and greater effectiveness. Seizing these opportunities requires highly targeted investments and a focused effort to build, enable, and strategically manage capacity for supporting modern regulatory review of medical products such as the Center for Drug Evaluation and Research (CDER) 21st century regulatory review processes.

CDER scientific reviewers presently use data analytics tools developed under the umbrella of the Real-World Application for Innovation and Development (RAPID) platform. The current RAPID platform leverages cloud platforms (AWS, Azure, Appian), advanced data analytics and other innovative technologies to craft operational solutions for drug and product safety reviews. The CDER mission benefits from optimized approaches and data sources that help improve the efficiency, quality, and cost-effectiveness of tools for FDA users. For example, RAPID provided a suite of analytical tools that helped reviewers evaluate a spectrum of health information sources including spontaneous reports, electronic health records, product labeling, social media, biomedical citations, search logs, clinical trials, epidemiological, chemical and biologic data. RAPID is poised to provide analytical support infrastructure for premarket, post marketing, surveillance, and compliance offices in CDER.

The mission of CDER’s Office of Computational Science (OCS) is to modernize the center’s regulatory review process and enable reviewers to spend less time dealing with complex data and more time applying their expertise to information through the use of integrated tools, services, and training. OCS’ efforts to accomplish this mission involve developing technology and analytics to support regulatory review work. The Real-World Application for Innovation and Development (RAPID) was developed as a means to implement a cloud-based and on-premises environment to develop and continuously improve the applications and databases needed to meet the innovation and analytical needs of FDA users.

The RAPID platform is capable of supporting a variety of cloud and other operations including, supporting individual regulatory research, ingest evaluate and validate new analytic tools and methodologies, support new methods of multi data base curation, characterization and integration for transdisciplinary analysis of complex and big data, and a range of artificial intelligence tools and use cases for FDA needs.

RAPID is a sandbox that promotes the development of innovative analytic tools, supports data science research, and the evaluation of cutting-edge technologies. The RAPID System in its current form uses Artificial Intelligence (AI) and cloud-based compute facilities to develop innovative analytical solutions that support regulatory decision making and scientific analysis.

The RAPID platform (which maximizes the use of the FDA Amazon and Azure cloud systems) is a robust IT environment capable of supporting individual regulatory research, evaluation and validation of new analytic tools and methodologies, assessment of new methods of multi-database curation, transdisciplinary analysis of complex, multi-faceted data, and implementation of a range of artificial intelligence tools for numerous FDA needs.

Figure 1: RAPID Platform

2. Objectives Enable the Real-World Application for Innovation and Development (RAPID) Digital AI Platform program to design, develop, deploy prototypes and proof-of-concepts to meet FDA’s mission critical needs. Expand the RAPID platforms capability building upon the lessons learned and functionality provided by RAPID using innovative architecture to support:

• Continue supporting and maintaining the development of existing databases, technologies, and applications in the RAPID Environment. Provide maintenance support for the FDA RAPID environment and deployed applications in the RAPID environment and support the deployment and enhancement of tools and applications into FDA’s production environments. (i.e., On premise, Cloud Platforms).

• Conduct system upgrades for deployed applications to continually improve the ability for the FDA to meet their mission critical real-time data management and analytical capabilities.

• Continue to establish and maintain the exploration/experimentation sandbox that supports innovation and analytics development in support of regulatory review the development of existing databases, technologies, and applications in the RAPID Environment

• The FDA expects accelerated advancements in various AI and Cloud technologies, both software and hardware, over the next 5 years and are seeking support in enabling the RAPID program to be at the forefront of these advancements.

The support includes, but is not limited too:

• Human Centered Design (HCD) which accelerate design into deployment

• Generative AI and AGI

• Data Cataloging and Data Integration solutions

• Rapid design and development of new use cases

• Seamless Multi-Cloud Solutions

• Data Mesh Solutions

• Analytical Tool Development

• Serverless Analytics

• Mission AI

• Real-Time Clinical Trials Frameworks

• Explore data integration solutions

• Software development

• Exploration of AI/ML

• Natural Language Processing (NLP)

• Large Language Models (LLM)

• Analytic tool development.

CURRENT RAPID STATE

The RAPID system was developed originally to provide a bi-directional information transmission pathway for drug safety information and provide to FDA scientists real time data analysis system. The design requirements for RAPID were identified by referencing data and analytic problems which occurred during the drug safety evaluation of peramavir, an unapproved drug publicly released under the Emergency Use Authorization, (section 564 of the Federal Food, Drug, and Cosmetic Act( https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities ), and used as salvage therapy for severely ill patients in during the H1N1 epidemic of 2009-20101 . Since 2013, RAPID was developed to meet CDER requirements of performing drug safety surveillance and analysis during Medical Counter-Measures (MCM) events like the H1N1 epidemic.

The RAPID system has evolved into an AI and Analytics platform for tools supporting innovation and analytics for regulatory review processes. RAPID is FDA CDER’s Innovation As-A-Service (IAAS) Platform, which provides experimentation sandbox’s and a production environment in a multi-cloud environment. RAPID is designed to explore data sets, develop and test new analytics, models, and technologies. RAPID minimizes the barriers to designing analytical solutions by merging data, infrastructure, development support, artificial intelligence, and knowledge management.

RAPID cloud allows safety evaluators and medical officers access to modern technologies to make critical review decisions and enables FDA reviewers and collaborators to address product safety issues and improve patient https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities care. The RAPID Data and Analytics Hub supports innovation efforts in CDER and provides a space or technologists for innovators to prototype and advance new approaches, established RAPID Data Hub w/ Data connections to data sources and managed Platform Service. The space is highly used as a prototyping environment to explore new technologies and generate operational data to help minimize the cost and risk of operationalizing innovative analytics and infrastructure on an enterprise scale for CDER.

FUTURE STATE:

The future of RAPID is in leading the adoption of AI and leading-edge technologies to support FDA use cases across heterogeneous cloud environments.

RAPID needs to continue to adapt to the changing technology landscape and provide the FDA with the next generation of tools, technologies, models, and approaches to ensure the FDA can meet critical mission needs.

While AI technologies are now available to the general public, the development of targeted AI solutions that leverage or use novel techniques or data still require large investments in both compute and data processing.

The leading AI companies, such as Google, Microsoft, OpenAI, NVIDIA, spend billions of dollars a year in both computing and collecting data for training their models. To build and develop leading targeted AI solutions that meet FDA use cases, the FDA requires contracting services partners that can work effectively with large, medium, and small organizations to design and develop new solutions that meet FDA requirements. In addition, the skills required to develop and scale novel AI solutions or models require a diverse set of skills and resources, such as Software Engineering, AI model development, Cloud Computing Architecture, DevSecOps, AI Risk Management.

The future of cloud computing at the FDA will most likely be a heterogenous cloud computing environment with multiple Cloud Service Providers (CSP’s) such as Amazon AWS, Microsoft Azure, Google GCP, Salesforce, SnowFlake providing different services to the FDA. Using and deploying solutions, with advanced AI approaches, across heterogenous cloud environments will require the FDA to have contracting services support that understand different CSP environments and how to design, build, and deploy solutions that scale to meet FDA use cases.

RAPID Capabilities & Functions The RAPID platform enables the FDA to meet its mission critical real-time data management requirements during public health events that require the timely access to data and tools, processing, analytics, and remediation that used to take months, weeks, or days must be redefined and reduced to minutes and seconds.

Information must be collected, processed and analyzed when and where needed.

• support and development of the research exploration/experimentation sandbox that supports innovation

• enhance and maintain the project intake and project governance structure for scientific projects in the RAPID space.

• enhance and maintain a searchable system for knowledge management for all projects performed in the RAPID space.

• Enhance, maintain, and manage licenses and applications that supports innovation by FDA scientists and by the Contractor for several analytics packages

• Develop and enhance FDA’s adoption and use of artificial intelligence (AI) and machine learning (ML) in analyzing regulatory review data.

• Maintain the data hub and integration of data in the RAPID environment

• Provide extract, transform, and load (ETL) services for projects supported in RAPID

RAPID CAPABILITIES

The FDA seeks to enhance existing RAPID capabilities by building upon the lessons learned and functionality provided by the RAPID prototype using innovative architecture to support Analytical tool development (including, but not limited to):

Analytic Tool Development.

R-Studio Connect Jupyter Analytics Qlik Sense Tableau Analysis Studio

RAPID USE CASES

Examples RAPID Use Cases include, but are not limited to the following:

Development of an App Support Teams Biopharmaceutics automation tools, which are custom coded tools with the goal of increasing the efficiency and accuracy of dissolution similarity calculations for NDA and ANDA Original Applications, as well as SUPAC submissions.

Designing the operational environment to scale multi cloud/multi-modal AI use cases and create consistent design pattern that can be leverage across the FDA to meet mission needs

Using Large Language Models (LLM) and other python tools to process Establishment Inspection Reports (EIR) to allow users to upload EIRs and save outputs in various formats

Analyzing FDA Adverse Events Reporting Site (FAERS) narratives to extract adverse event data from unstructured text content

Supporting risk optimization thresholds analysis to help characterize and prioritize commodity risks.

Supporting R-Shiny web applications that extracts information from documents for business decision making and returns Utilize Artificial Intelligence methodologies to assist FDA stakeholders and internal scientific team to find and track regulatory information Explore Huggingface proxy servers and GPU clustering as a scalable solution for generative AI in FDA.

Evaluating natural language processing (NLP) tools that improve the efficiency and consistency of writing drug deficiencies.

The creation of new data sources and data architectures to accelerate FDA ability to solve complex regulatory problems Develop, enhance, and provide technical support for novel prototype natural language processing

(NLP)/machine learning and data analytics tools to be capable of extracting safety and efficacy information from unstructured free text from various technical documents and reports, including but not limited to FDA-approved product labels, published scientific literature reports, clinical narratives from spontaneous adverse event reports and deidentified electronic clinical trials data.

Exploring innovative AWS based analytical approaches to evaluate their ability to address CDER analytical needs in line with the current vision for IT architecture

Maintain a transparent RAPID website to make available technical information to users on available services in the RAPID space with additional information regarding project details and their status.

Provide O&M technical support for each tool and application, including troubleshooting to resolve complex problems, identifying, and resolving system errors, supporting software installation and configuration, incorporating patches and updates, computing platforms and environments

3. Scope

The FDA seeks professional and technical support services to support the continuous development and maintenance of the RAPID platform to meet the Government’s requirements to include the following:

• Project Management

• Research and Innovation

• Prototype Development

• Product Deployment

• Maintenance

4. Tasks

The Contractor shall furnish all necessary personnel, materials, services, and facilities necessary to perform the work captured in the Orders awarded under this BPA.

4.1.1. Project Management

The Contractor shall perform project management activities for efforts awarded as part of a task order.

The Contractor shall manage cost, schedule, and quality daily. All program and project management activities for the BPA and Task Orders shall be performed throughout the period of performance. Not all the below project management tasks will apply equally to each individual Task Order. The specific project management tasks will be annotated in awarded Task Orders.

4.1.2. BPA Program Management

The Contractor shall provide overarching management of all task orders awarded with this BPA.

This includes developing, maintaining, and updating a Program Management Plan (PMP) for all BPA activities. These representative activities include but are not limited to:

• Directing and coordinating Contractor project staff

• Executing application developments and enhancements

• Developing required plans

• Managing software changes including version control of production and development code sources

• Managing user documentation

• Planning transition in/transition out activities.

4.1.3. Task Order Management

The Contractor shall provide specific management of each task order awarded with this BPA.

This includes planning and organizing work to deliver required results, provide appropriate resources with the required skillsets and ability to complete the work within agreed upon timeframes, and provide guidance and leadership to those resources. It also requires the development and updating of a Task Order Management Plan (TOMP) for each task order. The TOMP should address the following areas:

• Requirements Management. This includes the inclusion of the technical approach.

• Change Control. This includes the management of software and hardware versions.

• Risk Management. This includes identification of expected issues in completing tasks.

• Schedule Management. This includes the use of a detailed work breakdown structure.

• Cost Management. This includes close monitoring of planned and actual expenditures.

• Quality Management. This includes managing planned deliverables and documentation.

• Performance Metrics. This includes the use of agile software development metrics.

• Communications. This requires the development of a strategy to engage all stakeholders.

• Resource Management. This includes subcontractors, staffing, staff training and retention.

4.1.4. Personnel Management

The Contractor shall coordinate all required on-boarding and off-boarding activities. The Contractor is also expected to submit new or replacement personnel resumes to the COR for them to verify that the new personnel meet the requirements of the proposed Labor Category and Statement of Work (SOW) before the candidate starts the FDA on-boarding process. The Contractor shall also provide the COR a minimum of 30 days’ notice prior to a change to a designated Key personnel resource due to reassignment.

4.1.5. Meetings

The Contractor shall support routine project management and status meetings. The Contractor shall participate in meetings to include leading discussions, contributing questions and answers, raising issues and concerns, developing and giving presentations, and other active oral and written communications. The Contractor shall prepare and track meeting agendas, minutes, notes, issues, and action items for all meetings held with SMEs and FDA designated staff in support of the project and any planned deliverable. Meeting minutes shall be required for all project meetings, and shall include participant information, summary of the meeting discussion, action items, issues, and decisions made during meetings.

In addition to the routine project meetings, the Contractor shall schedule and facilitate a kickoff meeting within 5 days after BPA award. The Contractor shall develop a Kickoff Meeting Summary to document key decisions, actions, milestones, issues, and concerns that were discussed and agreed upon during the Kickoff Meeting.

4.1.6. Reporting

The Contractor shall immediately and proactively inform the COR, Project Manager(s) and/or designee of all issues, problems, and recommendations that should be addressed for the overall effective accomplishment of Task Order goals. Upon COR’s approval, recommendations for actions that need to be taken by FDA staff, or other Contractors, shall be clearly defined and be reviewed by the COR for approval. The Contractor shall communicate each approved action to the responsible party and FDA, and each approved action shall identify completion dates. In addition to the informal and ongoing reporting, the Contractor shall also provide weekly and monthly status reports.

Weekly Status Reports The Contractor shall plan to participate in a weekly status call with the COR and other FDA staff, as needed. These calls shall be used as a mechanism for discussing and managing administrative and project issues that surface prior to the call. The Contractor shall provide a written summary of the teleconference on the third working day following the weekly government-scheduled meeting.

Monthly Status Reports The Contractor shall submit to the COR a monthly progress report covering all requirements and tasks specified in all Task Orders. Within the first 30 days after BPA award, the Contractor shall propose a reporting format, subject to Government approval.

Project Closure Reports The Contractor shall prepare and submit a comprehensive Project Closure Report to capture work performed/completed during the Task Order period of performance.

4.1.7. Transition

The Contractor shall transition work from the incumbent Contractor upon BPA award and at the conclusion of the contract shall facilitate transitioning either to the government or a successor contractor.

Transition-In The Contractor shall transition work from the incumbent Contractor. Once the work is fully transitioned and the incumbent Contractor period of performance has ended, the Awardee shall assume full responsibility for all activities, documentation, tasks and deliverables.

Transition-Out If transitioning services to the government or a new contractor becomes necessary, the Contractor shall facilitate efficient transfer of information, expert knowledge, data and artifacts.

It is the Government’s intention to perform closeout procedures on an individual Task Order basis as well as for the BPA. The Contractor shall perform the necessary internal functions to support the transition process in a timely manner.

4.1.8. Research, Prototyping and Deployment

Projects for system upgrades/enhancements may be tasked in developmental phases (e.g. being initiated as a technology assessment effort but migrating to technology design and implementation) if prototypes are deemed promising by the Government. A technology can enter at any of the 3 phases, detailed below. There will be a deliberate FDA decision in graduating an effort from one phase to the next. The expectation is that these graduations will likely be conducted in separate task orders. For example, the Contractor may be tasked to design a product based on a working prototype and to provide a report/results paper detailing the successes and failures. Then FDA will analyze the viability, breadth of user need, benefits, cost and any other factors to determine whether the product should be deployed. The developmental phases are detailed below and in Figure 1:

• Research and Innovation – Enabling scientific discovery and commercial research through the exploration of emerging technologies that could be implemented in FDA’s RAPID environment.

• Prototype Development – Develop prototypes and proof of concepts to inform the feasibility of scaling up a capability to meet the needs of a broad set of users.

• Product Deployment – Supporting the deployment and enhancement of tools and applications into FDA’s production environments (on premise, cloud platforms) for prototype testing and operational enterprise use.

Project tasking may include one or more developmental phases and Task Orders may include one or more projects. It is anticipated that skillsets for each developmental phase may be different for each Task Order and potentially for efforts within a Task Order.

Figure 2 Development Phases

4.1.9. Research and Innovation (Phase 1)

The Contractor may be tasked to actively assess the commercial, government and academia technology space and identify opportunities for the FDA to utilize technological advances to advance FDA use cases.

The Contractor may also be tasked to develop a white paper capturing expected benefits from pursuing a prototype or proof of concept.

4.1.10. Prototype Development (Phase 2)

The Contractor may be tasked with developing prototypes and proof of concepts that can be hosted within FDAs Experimentation Sandbox and implemented in FDA’s Deployment environment. The Contractor shall assist FDA technical experts with prototype development and limited user interface testing of potential products and applications that address FDA’s regulatory science and review needs.

As directed in the individual task order, the Contractor shall conduct the necessary experimentation to inform FDA leadership of the technology readiness and usability of the proposed application for full-scale implementation. The Contractor shall employ the right technical experts to inform and assist in these activities. The results from this activity shall be documented in a detailed development plan.

4.1.11. Product Deployment (Phase 3)

The Contractor may be tasked to assist FDA technical experts within the design, development and testing to deploy tools into FDA’s RAPID Deployment environment. As directed in the individual task order, the Contractor shall provide the appropriate expertise to develop an implementation plan that captures the various activities across multiple stakeholders required to field the requested capability.

The results from this activity shall be documented in a detailed implementation plan.

4.1.12. Maintenance

4.1.12.1. Database Administration

The Contractor may be tasked to work with OIMT (Office of Information Management and Technology) and other FDA IT departments, including cloud providers, WODC (White Oak Data Center) and ADC (Ashburn Data Center) to ensure servers and applications are synchronized, upgraded and RFC (Request for Change) tickets are created.

4.1.12.2. Maintenance & Technical Support

The Contractor may be tasked to provide technical support for each tool & application listed in the individual task order, including but not limited to troubleshooting to resolve complex problems, identifying and resolving system errors, supporting software installation and configuration, incorporating patches and updates, and managing computing platforms and environments.