ATTACHMENT A - IDIQ SENTINEL SOW 8 19 2024.pdf

ATTACHMENT A

Solicitation No.

Sentinel System 3.0 PMO

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ATTACHMENT A: IDIQ STATEMENT OF WORK

Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER)

Office of Surveillance and Epidemiology (OSE)

IDIQ SENTINEL SYSTEM 3.0: PROGRAM MANAGEMENT ORGANIZATION (PMO)

Contents

1. Background and Purpose

1.1 Background

1.2 Purpose

1.3 Sentinel System 3.0 Components

1.3.1 FDA Coordinating Center

1.3.2 Data Hub

1.3.3 Federal Partners

1.3.4 Program Management Organization (PMO)

2. Objectives

3. IDIQ Statement of Work - Sentinel Program Management Services and Operations

Task Area 1: Collaboration Platform

Task Area 2: Sentinel Initiative Website

Task Area 3: Sentinel Source Code Repository

Task Area 4: Medical Code Look-Up Tool

Task Area 5: Operations & Maintenance (O&M) for Collaboration Platform, Website and Source Code Repository

SUB-TASK 1: COLLABORATION PLATFORM – O&M

SUB-TASK 2: SENTINEL INITIATIVE WEBSITE – O&M

SUB-TASK 3: SENTINEL SOURCE CODE REPOSITORY – O&M

Task Area 6: (Optional): DME of the Collaboration Platform, Website and Source Code Repository

SUB-TASK 1: COLLABORATION PLATFORM – DME SERVICES

SUB-TASK 2: SENTINEL INITIATIVE WEBSITE - DME SERVICES

SUB-TASK 3: SENTINEL PUBLIC SOURCE CODE REPOSITORY – DME SERVICES

Task Area 7: Regulatory Operations Support

SUB-TASK 1: COLLABORATION BEST PRACTICES

SUB-TASK 2: MANAGEMENT OF REQUESTS FOR SERVICES

SUB-TASK 3: WORKFLOW MANAGEMENT

SUB-TASK 4: MANAGEMENT OF PROGRAM MEETINGS

SUB-TASK 5: PROJECT MANAGEMENT PLAN

SUB-TASK 6: MANAGEMENT OF OTHER PROGRAM TASKS

Task Area 8: Program Management Plans

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PROGRAM MANAGEMENT PLAN (PMP)

SUB-TASK 1: QUALITY MANAGEMENT PLAN

SUB-TASK 2: RISK MANAGEMENT PLAN

SUB-TASK 3: COMMUNICATION MANAGEMENT PLAN

SUB-TASK 4: STAFFING PLAN

Task Area 9: Transition-In Services

Task Area 10: Transition-Out Service

4. Contract Administration

5. Contract Type / Ceiling Amount

6. Government-Furnished Property, Equipment, Information (GFP/GFE/GFI)

7. HHS Mandated Contractor Training

8. Inspection and Acceptance of Deliverables

9. Deliverables

10. Performance Evaluation Plan (PEP)

11. Vendor Performance Evaluations

12. Key Personnel

13. Contractor Travel

14. Place of Performance

15. Observance of Federal Holidays

16. Period of Performance

17. Provisions and Contract Clauses

DATA RIGHTS CLAUSE .................................................................................................. ERROR! BOOKMARK NOT DEFINED.

COST ACCOUNTING SYSTEM (CAS) (USE APPROPRIATE FAR PART 30 CLAUSE) ....................... ERROR! BOOKMARK NOT DEFINED.

FINANCIAL REPORTING FOR LABOR-HOUR TASK ORDERS .................................................... ERROR! BOOKMARK NOT DEFINED.

INVOICING/PAYMENT INSTRUCTIONS .............................................................................. ERROR! BOOKMARK NOT DEFINED.

18. Advanced Understandings

19. Access to Non-Public Information

20. Attachment List of Applicable Documents

21. Glossary of Abbreviations, Acronyms and Definitions

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1. Background and Purpose

1.1 Background

The Sentinel Initiative was created as the result of a 2007 congressional mandate to strengthen post-market surveillance of medical products. The Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE) director serves as the Sentinel Initiative’s executive sponsor.

The FDA Amendments Act of 2007 (FDAAA) Section 905 required that FDA strengthen its existing post-market safety surveillance for drugs and biological products by directing FDA to create an Active post-market Risk Identification and Analysis (ARIA) System. FDAAA Section 901 required that FDA determine whether ARIA is sufficient to identify or assess a serious risk prior to requiring post-market studies or clinical trials.1,2

In 2008, the Secretary of Health and Human Services (HHS) and FDA’s Commissioner announced the Sentinel Initiative, a long-term effort to create a national electronic system for monitoring FDA-regulated medical product safety in alignment with FDA’s mission to protect the public health. The Sentinel Initiative began with the Mini-Sentinel pilot in 2009. The Mini- Sentinel Pilot was completed in 2014. The Sentinel System is a component under the broader Sentinel Initiative and FDA operationalized the ARIA system as a sub-component within the Sentinel System. Through the Sentinel System, FDA has access to multiple data sources, advanced analytic tools, and scientific subject matter experts to support regulatory science.

In 2016, FDA officially announced the full-scale Sentinel System operations and the formal integration of the ARIA system into the regulatory decision-making process. ARIA fulfills FDAAA’s mandate to modernize safety surveillance by capitalizing on electronic healthcare data and advanced epidemiological methods and expands the FDA's capabilities of post-market surveillance for approved medical products. Now an integrated part of FDA's regulatory review process, FDA can conduct complex, comparative, multi-site studies efficiently using the ARIA system.

In 2017, as part of the Sentinel Initiative, the Center for Biologics Evaluation and Research (CBER) developed the Biologics Effectiveness and Safety (BEST) Initiative which focuses on surveillance activities of biological products.3

In 2019, as part of the President’s 2019 budget, FDA created the Medical Data Enterprise to build a modern system that would contain electronic health records’ (EHRs) data from at least 10 million lives.4 Also, in 2019, FDA published the Sentinel Five-Year Strategy, which sought additional expansion of Sentinel’s utility to FDA. To support this expansion, FDA established three centers, via a multiple award indefinite delivery/indefinite quantity (IDIQ) contract to address the goals outlined in the 2019 Sentinel Five-Year Strategy.5 Following is a description of the work performed by each Sentinel System Center:

1 Refer to FDAAA sections 505(o)(3): https://www.govinfo.gov/content/pkg/PLAW-110publ85/html/PLAW-110publ85.htm 2 These studies and clinical trials refer to Post-market Requirements (PMR) and Post-market Commitments (PMC). More information can be found here: https://www.fda.gov/drugs/guidance-compliance-regulatory-information/postmarket-requirements-and-commitments 3More information about the Sentinel Initiative can be found at: https://www.sentinelinitiative.org/about 4 Gottlieb, S. FDA budget matters: a cross-cutting data enterprise for real world evidence. Food and Drug Administration.

https://www.fda.gov/news-events/fda-voices/fda-budget-matters-cross-cutting-data-enterprise-real-world-evidence (2018).

5 U.S. Food and Drug Administration. (2019). Sentinel System Five-Year Strategy 2019-2023.

https://www.fda.gov/media/120333/download

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• The Sentinel Operations Center (SOC) oversees ARIA, conducts core infrastructure development, and maintains the distributed data network.

• The Innovation Center (IC) focuses on meeting the Real-World Evidence (RWE) Medical Data Enterprise requirement by establishing a query-ready distributed data network containing EHRs of at least 10 million lives.

• The Community Building and Outreach Center (CBOC) engages with non-FDA stakeholders, from the clinical research enterprise to health advocacy groups, to broaden and activate a strong community to advance Sentinel’s objectives.

To fulfill a Prescription Drug User Fee VI commitment, FDA conducted an Assessment in Support of the Sentinel System in fiscal year 2022.6,7

1.2 Purpose

FDA is launching the new Sentinel System 3.0 in fiscal year 2025 based on the results of 1) the fiscal year 2022 Assessment in Support of the Sentinel System, 2) FDA’s experience using the Sentinel System, 3) the foundational work conducted by the Sentinel Innovation Center during the 2019 to 2024 contract cycle, 4) the guidance provided by CDER Senior Leadership, and (5) input received through responses to three Requests for Information (RFI) related to the Sentinel System 3.0 recompete (i.e., (1) The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) requests public comments to inform the future organization of the Sentinel System (November 1, 2022, SAM.GOV), (2) Contract Approach for Sentinel 3.0 (December 5, 2023, SAM.GOV), and (3) Request for Information Sentinel System 3.0: Program Management and Business Informatics Support (April 20, 2024, SAM.GOV)

The Sentinel System 3.0 builds on the learnings from prior experience managing the program and preserves core functions required to fulfill the Congressional mandate, to enhance analytic flexibility and access to data, advance regulatory science methods and tools, and address key FDA regulatory needs and priorities.

1.3 Sentinel System 3.0 Components

The Sentinel System 3.0 will include the following components: (1) the FDA Sentinel Coordinating Center (SCC) managed by the Sentinel Core Team (SCT)) in CDER’s OSE, (2) the Sentinel Data Hub (a contract that will provide access to health care data and scientific support services), (3) the Sentinel Program Management Organization (PMO) (a contract that will provide program/project management and business informatics support services), and (4) Federal Partners with which FDA has established interagency agreements to support scientific research (e.g., Centers for Medicare and Medicaid Services (CMS)).

Figure 1 describes the four main components of the Sentinel System 3.0.

6 U.S. Food and Drug Administration. (2017). PDUFA reauthorization performance goals and procedures fiscal years 2018 through 2022. https://www.fda.gov/media/99140/download 7 Assessment in Support of the Sentinel System (2022). https://www.fda.gov/media/161944/download?attachment https://sam.gov/opp/4ca6bfd7de07401d8d818d0bf337f472/view https://sam.gov/opp/e33882c0b5384497a34e39415e75a43e/view https://fda.sharepoint.com/:b:/r/sites/CDER-OSE-IO-RSS-AcquisitionCollaboration-Team/Sentinel/2024%20SENTINEL%203.0/PHASE%20I%20-%20PRE-SOL/1A%20RFP/MKT%20RESCH/SENTINEL%203.0/REQUESTS%20FOR%20INFORMATION%20(3)/RFI%20No.%202%20-%20PRG%20MGMT-BUS%20INF/SAM.pdf?csf=1&web=1&e=3WNxeo

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Figure 1. Sentinel System 3.0 Components

1.3.1 FDA Coordinating Center

The Sentinel Coordinating Center (SCC) is staffed by the FDA Sentinel Core Team (SCT) which is in the Office of Surveillance and Epidemiology (OSE), CDER. The SCT is responsible for providing the scientific, regulatory, strategic, and operational direction to the Sentinel System 3.0. The SCT is led by the Associate Director for Sentinel and is divided in two teams: the Epidemiology Team (EpiT) and the Program Management Team (PMT). The Epidemiology Team provides pharmacoepidemiology subject matter expertise and serves as liaison between the internal FDA Sentinel stakeholders, Federal Partners, and contractors supporting the Sentinel System 3.0. The PMT is responsible for all operational aspects of the day-to-day activities of the Sentinel System 3.0. The PMT ensures projects are completed on time and in accordance with FDA regulations; collaborates with stakeholders to facilitate coordination and project completion; works with stakeholders to identify areas of improvement and develop solutions; and identifies any potential risks to projects or deliverables and develop plans to mitigate them. In addition, the PMT facilitates all internal and external communications while abiding by the established FDA’s guidance and regulations.

1.3.2 Data Hub

The Sentinel System 3.0 Data Hub, a multiple award, IDIQ, tiered contract, will allow FDA access to multiple sources of healthcare data and providers of scientific support services to continue supporting FDA’s safety surveillance mission. The Data Hub contractors will work in close collaboration with FDA SCC, and other

6 | P a g e contractors and collaborators within the Sentinel System 3.0 ecosystem. The Data Hub requirements are the subject of a separate procurement. Potential tiers in the Data Hub IDIQ contract shall include the following:

• Tier 1 Commercial Healthcare Insurance Claims: Provide access to large (millions) national commercial health insurance plan claims for services provided and administered by nongovernmental entities. Access to a subset of medical charts to support efficient/cost-effective medical record review process, as needed.

• Tier 2 Commercial Healthcare Insurance Claim Aggregators: Provide access to third-party claims aggregators that collect, and digest adjudicated claims data from multiple sources (private and public payers) and make it ready for analysis. This aggregated data usually includes medical claims, pharmacy claims, and eligibility and provider files.

• Tier 3 Claims-EHR Linked: Provide access to insurance claims data linked to electronic health record (EHR) data to facilitate the evaluation of product safety using data that more clearly and completely captures patients' experiences.

• Tier 4 Scientific Support Services: Provide scientific support services including subject matter expertise and capabilities to conduct pharmacovigilance and pharmacoepidemiology research (e.g., plan and conduct analyses using statistical and epidemiologic data); data science (e.g., expertise in statistical computer languages, data architecture and advanced statistical concepts);

software programming (e.g., expertise in development, testing and analysis using relevant software applications); and methods development to address emerging safety issues and public health emergencies.

• Tier 5 Specialty Healthcare EHRs: Provide access to healthcare data pertaining to special populations (e.g., pediatrics, geriatric) and inpatient healthcare delivery venues (e.g., intensive care unit, pediatric hospital).

• Tier 6 Registries: Provide access to data from product- or disease-based registries.

• Tier 7 CMS – Medicare and Medicaid Data: Provide access and scientific expertise in the use of Medicare and Medicaid data to conduct regulatory and public health safety surveillance research.

The Sentinel System 3.0 will not be limited to the use of a common data model, distributed data partners network, or routine querying tools. Instead, Sentinel System 3.0 will leverage multiple technical approaches.

1.3.3 Federal Partners

The FDA has a longstanding collaboration with other Federal Agencies including the Veterans Administration and CMS through Interagency Agreements (IAAs). FDA scientists routinely work with CMS scientists and its contractor to conduct safety surveillance studies. FDA and CMS are expanding the scope of their collaboration to include analyses conducted as part of the Active Risk Identification and Analysis (ARIA) System, a core element of the Sentinel System.

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1.3.4 Program Management Organization (PMO)

The Sentinel System 3.0 Program Management Organization (PMO) is the subject of this procurement. The PMO contractor will work in close collaboration with the FDA SCC, federal partners, and Data Hub contractors to support all Sentinel System 3.0 regulatory operations and business informatics infrastructure.

The PMO will maintain the program’s overall structure and coordinate program-level plans, schedules, and project management activities. The PMO will provide continuous updates on the program’s status, progress, and performance to SCC leadership. The PMO will also provide tools, templates, and other resources to support program management operations and provide training to project teams, as needed.

The core PMO activities include:

• Sentinel System 3.0 Collaboration Platform: Development, management, and maintenance of a secure collaboration environment, referred to as the “Sentinel Collaboration Platform’, that will allow Sentinel System 3.0 contractors, FDA staff, and Federal Partners to communicate and collaborate in projects and tasks including information and data exchange. The Collaboration Platform will provide access to tools to support Sentinel operations including but not limited to the following: (1) team collaboration tools (e.g., communication and document management tools), (2) workflow management and performance metrics collection and tracking tools, (3) data visualization tools and dashboards (including the ARIA System Dashboard), and (4) medical code sets management tool. The dashboard will also track communication for applicant notification per

MAPP 6701.4

• Sentinel Initiative Website and Public Source Code Repository:

The PMO will be responsible for the operations and maintenance of the public Sentinel Initiative Website (https://www.sentinelinitiative.org/) and Public Source Code Repository (https://dev.sentinelsystem.org/repos?visibility=public).

• Scientific and Regulatory Operations Support: The PMO will support the SCC in managing all scientific and regulatory operations including: (1) the management of all requests for Sentinel System consults and services, workflows, and individual scientific projects, tasks and data calls; (2) collection, tracking, and reporting of program workload and performance metrics; and (3) development and management of standard operating procedures (SOPs) related to the operation of the PMO (4) Facilitate communication between the stakeholders.

Figure 2: Schematic of the Sentinel System 3.0 https://www.fda.gov/media/141216/download https://www.sentinelinitiative.org/ https://dev.sentinelsystem.org/repos?visibility=public

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From this point forward this solicitation will address all references to Sentinel System 3.0 as Sentinel 3.0.

2. Objectives The objective of this IDIQ is to establish a Sentinel Program Management Organization (PMO) to support scientific and regulatory operations activities of the Sentinel 3.0. FDA expects to achieve the following objectives:

1. Development, implementation, operations and maintenance, and the development/modernization/enhancements of a Collaboration Platform to host a secure environment to support Sentinel 3.0 operations.

2. Migration of all relevant content in the current Sentinel System to the Sentinel 3.0 Collaboration Platform.

3. Transition of the content and management of the current Sentinel Initiative Website and Sentinel Public Source Code Repository to the Sentinel 3.0.

4. Program management and regulatory operations support for all Sentinel 3.0 tasks within the new Program Management Organization (PMO) scope of responsibilities, as described in the Performance Work Statement (PWS).

5. Transition-In/Out support services.

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3. IDIQ Statement of Work - Sentinel Program Management Services and Operations The FDA has identified a need for a Program Management Organization to support the scientific and regulatory operations activities of Sentinel 3.0. These services require highly experienced resources to provide support of the representative task areas below:

Table 1: Sentinel 3.0 - IDIQ Representative Task Areas 1-10

Task Area # Task Area Name

Task Area 1 Collaboration Platform

Task Area 2 Sentinel Initiative Website

Task Area 3 Source Code Repository

Task Area 4 Medical Code Sets Management Tool

Task Area 5 O&M for the Collaboration Platform, Website and Source Code Repository

Task Area 6 DME for the Collaboration Platform, Website and Source Code Repository

Task Area 7 Regulatory Operations Support

Task Area 8 Program Management Plans

Task Area 9 Transition-In Services

Task Area 10 Transition-Out Services

FDA expects that through implementation of these task areas that the Sentinel System 3.0 Program Management Organization (PMO) will be well-positioned with the necessary regulatory operations and business informatics operative (i.e., tools, resources, processes) with the establishment of the FDA SCC, the onboarding the Data Hub contractors, and the established federal partner agreements.

All the below sections are divided into the requirements which are the tasks in this IDIQ along with the associated standards, quality assurance, and deliverables which define the minimum task level for the contractor to perform.

Task Area 1: Collaboration Platform As tasked, the Contractor shall develop and implement a collaboration environment (i.e., Collaboration Platform) with a secure access portal to allow team collaborations, data exchange, and communications between FDA, PMO contractors, Federal Partners, and other contractors in the Sentinel 3.0 ecosystem (up to 20 contractor organizations with 5-10 users per contracting organization) at the PMO Contractor’s site.

The development of the Collaboration Platform shall use an agile approach including requirements gathering, development, User Acceptance Testing (UAT), and training.

Representative requirements include but are not limited to:

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The development and implementation of the Collaboration Platform shall include, at a minimum, the following key requirements:

a. Ensure that the Collaboration Platform is fully functional eight (8) months post-award kick-off meeting and no later than July 31, 2025.

b. Provide a secure Collaboration Platform in a cloud-based environment that includes a Collaboration Portal.

c. The Collaboration Portal provides user access to program/project management tools, enable collaboration among multiple parties, account for all activities via workflow, and document management tools to support the day-to-day operations of Sentinel 3.0.

d. Allow sharing of non-public, confidential information including research project deliverables, presentations, recordings, workflow documents (program- and project-related), contract-related documents, and training materials.

e. Allow access to other tools to support regulatory science research (e.g., data visualization tool, medical code sets management tool).

f. Provide user profiles (personas) setup with the appropriate permissions for utilizing tools in the Collaboration Platform such as the following.

i. Project management tools to plan and track work across every team (e.g., JIRA by Atlassian or equivalent)

ii. Repository to store and share documents for program and project related activities, including cross team collaboration and knowledge sharing (e.g., Wiki by Atlassian or equivalent)

iii. Medical Code Sets Management Tool - The Sentinel Code Look-Up Tool is a medical code set management tool customized for use by the FDA Sentinel System (e.g., Medical Code Look-up Tool by Commonwealth Informatics or equivalent)

iv. Source code repository (hosting) tool for private internal FDA access (e.g., BitBucket by Atlassian or equivalent)

g. Provide user profiles (personas) of different Sentinel 3.0 user groups (e.g., PMO contractors, FDA Staff, other contractors) and delineate how to onboard them into the Collaboration Portal with appropriate access.

h. Provide user access to dashboards summarizing workflow activities and up-to-date program performance metrics based on the data collected by the tools.

i. Provide documentation of the Contractor’s methods to ensure robust access control, data encryption, continuous security assessments, and audit trails, to align with Government data management security compliance.

j. Collaborate with the incumbent Contractor to identify, transfer, and archive all relevant Sentinel System’s content and documents in the new Sentinel 3.0 Collaboration Platform within eight (8) months post-award kick-off meeting and no later than July 31, 2025.

k. Provide all relevant Collaboration Platform technical and operational documentation, Standard Operating Procedures (SOP) to include ongoing maintenance and user support five (5) months post-award kick-off meeting.

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l. Coordinate and manage two (2) training webinars to ensure that the FDA SCC and other Collaboration Platform users are familiar with the Collaboration Platform including the operating procedures. Record one of the two training webinars for new users.

m. Provide user training manual, user training slide deck and recorded video of one of the two training webinars.

n. Provide bi-weekly implementation progress status reports to the COR, including any challenges or risks that may impact the implementation milestones. The bi-weekly report shall include status updates, limitations or risks and plan for mitigation and resolution. The reports shall be self-explanatory with links to any associated references.

o. Establish a technical support team to provide day-to-day Collaboration Platform maintenance operations and support.

p. Develop SOPs describing the scope and process for delivering ongoing Collaboration Platform maintenance and user support.

q. Develop a job aid for the day-to-day operations of the Collaboration Platform.

r. Coordinate through the FDA COR with the Office of Digital Transformation (ODT) to understand the requirements to obtain the Authorization to Operate (ATO).

Representative standards include but are not limited to:

a. Be completed, approved by the COR, and operational eight (8) months post-award kick-off meeting but no later than July 31, 2025.

b. Transfer or migration of the relevant and accessible current Sentinel System content to the new

Sentinel 3.0 secure Collaboration Platform within eight (8) months post-award kick-off meeting and no later than July 31, 2025.

c. Collaboration Platform SOPs five (5) months post-award kick-off meeting.

d. Comply with FDA records management requirements

(https://www.fda.gov/media/81394/download).

e. Provide access up to 200 concurrent users and have the capacity to expand, as needed.

f. Provide Multi-Factor Authentication (MFA) access to the Collaboration Platform in compliance with FDA cybersecurity requirements. Select the appropriate system e-Authentication assurance levels (EAL) in accordance with the requirements described in the National Institute of Standards and Technology (NIST) for user identification and authentication in compliance with methods used by U.S. Department of Health and Human Services (HHS) systems.

(https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-63-3.pdf.

g. Provide classification in accordance with Federal Information Processing Standards (FIPS) 199 – Standards for Security Categorization of Federal Information and Information Systems (https://csrc.nist.gov/pubs/fips/199/final).

h. Comply with the Federal Information Security Management Act (FISMA), Federal Risk and Authorization Management Program (FedRAMP), and Section 508 of the Rehabilitation Act (IT Accessibility Laws and Policies - Section508.gov) compliant.

i. Comply with the FDA security requirements to obtain an Authority to Operate (ATO) certification.

j. Obtain Authority to Operate (ATO) certification.

k. Documentation that all User Acceptance Testing was successfully completed.

https://www.fda.gov/media/81394/download https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-63-3.pdf https://csrc.nist.gov/pubs/fips/199/final

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l. Inventory documentation that all content and documents targeted for transfer from the incumbent Contractor’s environment to the Collaboration Platform and supporting documentation of the complete transfer of all documents.

m. Documentation that all technical, functional, and operational features of the Collaboration Platform have been inspected and accepted by the COR.

Representative quality assurance tasks include but are not limited to:

For the Sentinel 3.0 Collaboration Platform Quality Assurance Task, the Contractor shall ensure that the Program Management Support Plans outlined in Task Area 8 (and all Sub-Tasks) align with the Requirements and Standards for the Sentinel 3.0 Collaboration Platform services.

Representative deliverables include but are not limited to:

Task Area Deliverable

Description Deliverable

Schedule Task Area 1:

Collaboration Platform - Development and Implementation of the Collaboration Platform

• Fully operational Collaboration Platform, with all relevant documentation, including documentation of ATO, Standard Operating Procedures (SOP), security assessment documentation, user training manual, training slide deck and 2 user training webinars that shall be also recorded (at least one) and accessible on demand to all users.

Eight (8) months after contract award and not later than July 31, 2025

• Communicate Task Area 1 status via bi-weekly meetings and PMO Monthly Report

Bi-weekly/Monthly

• Draft Collaboration Platform SOPs Five (5) months post-award kick-off meeting

• Final Collaboration Platform SOPs 20 business days after the Contractor receives FDA’s comments on the draft SOPs

Task Area 2: Sentinel Initiative Website The Sentinel Initiative Website (https://www.sentinelinitiative.org/) is a communication tool to inform industry and the public about the work performed under the Sentinel Initiative. This website is one of the primary vehicles used to meet transparency mandates associated with FDA policy objectives and user fee commitments. The Sentinel Initiative Website has a vast amount of information that promotes scientific collaborations.

Representative requirements include but are not limited to:

As tasked, the transition of the Sentinel Initiative Website shall include, at a minimum, the following key requirements:

https://www.sentinelinitiative.org/

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a. Ensure that the Sentinel Initiative Website is functional within eight (8) months post-award kick-off meeting and no later than July 31, 2025.

b. Functional verification of the website after domain transfer. Ensure that the Sentinel Initiative Website is operational and accessible by the public.

c. Provide bi-weekly Sentinel Initiative Website transition progress status reports to the COR, including any challenges or risks that may impact the implementation milestones.

d. Enable interactive online features and analytics, when requested by FDA, using JavaScript, HTML5, Qlik Sense or other relevant software (Reference: (https://www.fda.gov/drugs/questions-and-answersFAERS Public Dashboard).

e. Establish a Technical Support Team to provide operations and maintenance support, and post content as directed by the FDA SCC as follows:

i. Post content to include, but not be limited to, analytic packages, study results, regulatory determinations, database statistics, promulgation of publications, and other scientific materials, and training resources, links to recordings of trainings, upcoming events, graphics, webinars, and seminars, and other program documents and activity contents on the Sentinel website and YouTube channel provided by FDA, the PMO contractor and other contractors within the Sentinel 3.0 ecosystem, and other systems within the Sentinel Initiative (e.g., Biologics Effectiveness and Safety (BEST) system).

ii. Provide technical support in coordinating time sensitive website posting for associated documents during applicant notification, advisory committees, and public conferences.

Material shall be reviewed and cleared by the FDA SCC and other FDA personnel (as needed) unless other arrangements are made before publicly posting.

iii. Track, analyze and report on the clearance and posting of final reports, presentations, publications, analytic results, and other documents online.

iv. Develop Standard Operating Procedures (SOP) for the management of the Sentinel Initiative Website.

e. Collaborate with the incumbent Contractor to:

i. Support the transfer of Sentinel Initiative Website domain from the current registrar to FDA.

ii. Transfer the management of the Sentinel Initiative Website from the incumbent Contractor to the PMO Contractor to ensure continuity of services.

iii. Obtain from the incumbent Contractor the Sentinel Initiative Website inventory and performance metrics (i.e., traffic, ranking, indexable URL).

iv. Include all relevant information and data available in the Sentinel Initiative Website currently managed by the incumbent contractor.

f. Provide a Sentinel Initiative Website Data Management and Performance Assessment Plan to routinely assess the website’s performance including monitoring of website traffic to provide statistics on the location of end-users, page hits for each subpage and other descriptive data to provide, but not limited to the following:

i. Organic traffic: How many visitors enter the site via search engines? What’s the distribution of this traffic across the different pages?

ii. Organic rank: Which pages rank for your target keywords and in which search engine results page (SERP) position?

https://www.fda.gov/drugs/questions-and-answersFAERS%20Public%20Dashboard https://www.fda.gov/drugs/questions-and-answersFAERS%20Public%20Dashboard

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iii. Pages crawled: The number of pages search engines crawl when going through the site.

iv. Indexable URLs: How many URLs get indexed?

v. Site structure: How many clicks does it take to reach the most remote page on the site? Are there any orphan pages that have no internal links pointing to them?

vi. Site speed: How quickly do pages load and become interactive?

g. Coordinate and manage the content of the Sentinel Initiative Website in collaboration with the FDA Sentinel Coordinating Center.

h. Ensure the content of the website is accurate and updated and that the documents accessed via the Sentinel Initiative Website are archived in compliance with FDA Records Management Policy.

a. Be completed, approved by the COR, and operational by July 31, 2025.

b. Provide a secure version of HTTP that uses encryption to protect data sent between a web browser and a website.

c. Provide intuitive and effective search functions, the ability to broadcast or push new information to subscribers, and enable viewers to download and review presentations, results, and other information.

d. Secure the Sentinel Initiative Website using a secure HTTP Secure Socket Layer (SSL) or Transport Layer Security (TLS) version of HTTP that uses encryption to protect data exchanges.

e. Environments include pre-production, production, and back-up environments.

f. Web-content Management System is customizable, scalable, and adapts to future challenges (e.g., Drupal or equivalent).

g. Host the Sentinel Initiative Website in a Federal Information Security Management Act (FISMA) compliant environment and be routinely updated to meet FDA's requirements.

h. Environment is compliant with Section 508 of the Rehabilitation Act (IT Accessibility Laws and

Policies - Section508.gov).

i. Within six (6) months post-award kick-off meeting, provide the SOPs describing the process for developing, reviewing, clearing, posting, refreshing, and archiving website content.

j. The Contractor shall include a section in the Program Management Organization (PMO) Monthly

Report summarizing website content changes implemented since the last monthly report.

For the Sentinel Initiative Website Quality Assurance Task, the Contractor shall ensure that the Program Management Support Plans outlined in Task Area 8 (and all Sub-Tasks) align with the Requirements and Standards for Sentinel Initiative Website services.

https://www.section508.gov/

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Description

Deliverable Schedule

Task Area 2:

Sentinel Initiative Website - Implementation of the Migrated Sentinel Initiative Website

• Fully operational Sentinel Initiative Website, with all relevant documentation, features, and functionality

• Sentinel Initiative Website domain transferred for all environment from the current registrar to

FDA.

Approximately Eight

(8) months after contract award and No Later Than:

July 31, 2025

• Communicate Task Area 2 status via meeting and progress report.

• Acton items within the bi-weekly report will be addressed according to noted timeline and deviations from a timeline will be recorded with a rationale and plan of action.

Bi-weekly

• Draft Sentinel Initiative Website Standard Operating Procedures (SOP)

Six (6) months post-award kick-off meeting

• Final Sentinel Initiative Website Standard Operating Procedures (SOP)

20 business days after the Contractor receives FDA’s comments on the draft SOPs.

Task Area 3: Sentinel Source Code Repository The Sentinel System Source Code Repository contains a broad range of tools of interest to developers and other scientists interested in data analysis including Sentinel analytic tools, quality assurance tools, data format required for use of any Sentinel tool, and Medicare Claims synthetic public use files in Sentinel Common Data Model format. The Source Code Repository has a secure private area and a public area. The private area contains items that are only accessible to Sentinel Collaboration Platform users whereas the public area is available via the Sentinel Initiative Website. Some of the items are common for both private and public viewing.

Representative requirements include but are not limited to:

As tasked, the development and implementation of the Source Code Repository shall include, at a minimum, the following key requirements:

a. Ensure that the Sentinel Source Code Repository is functional no later than July 31, 2025.

b. Ensure that the migrated Sentinel Public Source Code Repository is operational and accessible by the public via the Sentinel Initiative Website. (This link to access the Sentinel Source Code Repository from the Sentinel Initiative Website is here:

https://www.sentinelinitiative.org/methods-data-tools)

c. Ensure that the migrated Sentinel Private Source Code Repository is operational and accessible via the Collaboration Portal with appropriate permission

d. Data verification: This is tested on initial migration load and then again on final migration load.

Additional testing may be required if immediate migration load is done.

https://www.sentinelinitiative.org/methods-data-tools

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e. Bi-weekly progress status reports to the COR on Sentinel Public and Private Repository migration, including any challenges or risks that may impact the implementation milestones.

f. Provide a Technical and Scientific Support Team to provide operations and maintenance support, and post content on the site as directed by the FDA SCC.

g. Develop Standard Operating Procedures (SOP) for the management of the Source Code Repository.

h. Collaborate with the incumbent Contractor to:

i. Transfer the management of the Sentinel Source Code Repository (both private and public) to the successor Contractor to ensure continuity of services.

ii. Migrate its contents to a separate server managed and maintained by the successor Contractor at its site.

iii. Obtain from the incumbent Contractor the Sentinel Source Code Repository inventory and performance metrics (i.e., traffic, ranking, indexable URL).

iv. Provide features similar to or better than those of the Sentinel Public Repository currently managed by the incumbent contractor.

v. Include all relevant information and data available in the Sentinel Public Repository currently managed by the incumbent contractor.

i. Provide a Sentinel Source Code Repository Data Management and Performance Assessment Plan to routinely assess the website’s performance including monitoring of traffic to provide statistics on the location of end-users, page hits for each subpage and other descriptive data to provide, but not limited to the following:

i. Organic traffic: How many visitors enter the site via search engines? What’s the distribution of this traffic across the different pages?

ii. Organic rank: Which pages rank for your target keywords and in which search engine results page (SERP) position?

iii. Pages crawled: The number of pages search engines crawl when going through the site.

iv. Indexable URLs: How many URLs get indexed?

v. Site structure: How many clicks does it take to reach the most remote page on the site? Are there any orphan pages that have no internal links pointing to them?

vi. Site speed: How quickly do pages load and become interactive?

a. The full implementation of the migrated Sentinel Public and Private Source Code Repository shall be no later than July 31, 2025.

b. Provide a secure version of HTTP that uses encryption to protect data sent between a web browser and the Sentinel Source Code Repository.

c. Secure the Source Code Repository using a secure HTTPs Secure Socket Layer (SSL) or Transport Layer Security (TLS) version of HTTPs that uses encryption to protect data exchanges.

d. Environments to include pre-production, production, and back-up environments.

e. Host the Sentinel Source Code Repository in a Federal Information Security Management Act

(FISMA) compliant environment and be routinely updated to meet FDA's requirements.

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f. Environment is compliant with Section 508 of the Rehabilitation Act (IT Accessibility Laws and Policies - Section508.gov).

g. Both private and public Source Code Repository is compliant with the FDA Records Management Policy

For the Sentinel Source Code Repository Transition Quality Assurance Task, the Contractor shall ensure that the Program Management Support Plans outlined in Task Area 8 (and all Sub-Tasks) align with the Requirements and Standards for Sentinel Source Code Repository services.

Description

Deliverable Schedule

Task Area 3:

Sentinel Source Code Repository - Ensure Full Operability of Sentinel Source Code Repository

• Fully operational Sentinel Source Code Repository with private and public access, with all relevant documentation, features, and functionality

Approximately Eight

(8) months after contract award and No Later Than:

July 31, 2025

• Communicate Task Area 3 status via meeting and progress report

Bi-weekly

Task Area 4: Medical Code Look-Up Tool The Sentinel Medical Look Up Tool has been an important component of the Sentinel System. This tool facilitates the development and management of medical code sets allowing scientists to search for medical diagnosis, procedures, drug products, and other terminologies employed in pharmacoepidemiology studies.

As tasked, the transition for the Medical Code Look-up Tool shall include, at a minimum, the following key requirements:

Representative requirements include but are not limited to:

a. Purchase access to the Sentinel Medical Code Look-Up tool currently used by the incumbent Contractor from CommonWealth Informatics or an equivalent tool.

b. Provide access to the Medical Code Look-Up tool to all FDA relevant staff (e.g., FDA SCT, epidemiologists in OSE) and the Sentinel 3.0 Data Hub Tier contractors that provide scientific support services via the Sentinel 3.0 Collaboration Portal.

c. Ensure that the Medical Code Look Up Tool provides access to all code sets currently available through the Sentinel Medical Code Look Up Tool such as International Classification of Diseases, Tenth Revision (ICD-10), ICD-9, Medical Dictionary for Regulatory Activities (MedDRA), and others.

https://www.section508.gov/

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d. As identified, coordinate enhancements as well as functionality improvements of the tool with SCC and the vendor.

e. Ensure that the Medical Look Up Tool is operational and accessible to all relevant FDA staff and Data Hub contractors in the Tier providing scientific support services.

f. The Contractor shall provide bi-weekly progress status reports to the COR on the setup of Medical Code Look Up Tool, including any challenges or risks that may impact the implementation milestones.

a. The full implementation of a Medical Code Look Up tool shall be completed no later than July 31, 2025.

b. Ensure that the Medical Code Lookup tool is operational, and the user interface table can be queried for the creation of sets of clinical codes via the Collaboration Portal.

For the Medical Code Look Up Tool Transition Quality Assurance Task, the Contractor shall ensure that the Program Management Support Plans outlined in Task Area 8 (and all Sub-Tasks) align with the Requirements and Standards for Medical Code Look Up Tool Transition services.

Task Area & Sub- Task Area

Deliverable Description

Deliverable Schedule

Task Area 4:

Medical Code Look- Up Tool

Ensure Full Operability of the Medical Code Look Up Tool

• Fully operational Sentinel Public Repository, with all relevant documentation, features, and functionality available via the Collaboration Portal

Approximately Eight

(8) months after contract award and No Later Than:

July 31, 2025

• Communicate Task Area 3 status via meeting and progress report

Bi-weekly

Task Area 5: Operations & Maintenance (O&M) for Collaboration Platform, Website and Source Code Repository

As tasked, the Contractor shall ensure the continuous and efficient operations of the Collaboration Platform, the Sentinel Initiative Website, and the Source Code Repository and shall include, at a minimum, the following key requirements:

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SUB-TASK 1: COLLABORATION PLATFORM – O&M

a. Ensure the continuous and efficient operations of the Collaboration Platform by providing operations and maintenance services, user access maintenance including but not limited to services management, staff supervision (including sub-contractors), hardware, software licenses and updates, tool licenses, and other infrastructure maintenance requirements.

b. Develop and implement Operations and Maintenance SOPs to support continuity of operations of the Collaboration Platform five (5) months post-award kick-off meeting.

c. Provide monthly status reports including Collaboration Platform performance metrics and usage.

SUB-TASK 2: SENTINEL INITIATIVE WEBSITE – O&M

a. Ensure the continuous and efficient operations of the Sentinel Initiative Website by ensuring all the links are working, regularly updating content, and fixing any broken links, backing up the site regularly and monitoring the website's performance.

b. Develop and implement O&M SOPs to support continuity of operations of the Sentinel Initiative Website five (5) months post-award kick-off meeting.

c. Provide monthly status reports including Sentinel Initiative Website performance metrics and usage.

SUB-TASK 3: SENTINEL SOURCE CODE REPOSITORY – O&M

a. Ensure the continuous and efficient operations of both the Sentinel Public and Private Source Code Repositories by ensuring all the links are working, regularly updating content, and fixing any broken links, backing up the site regularly and monitoring the website's performance.

b. Develop and implement O&M SOPs to support continuity of operations of the Sentinel Public Repository five (5) months post-award kick-off meeting.

c. Provide monthly status reports including Sentinel Source Code Repository performance metrics and usage.

a. Clear and concise O&M SOPs for the Collaboration Platform, Sentinel Initiative Website and

Sentinel Public Source Code Repository five (5) months post-award kick-off meeting

b. Performance metrics of the Collaboration Platform, Sentinel Initiative Website and Sentinel

Public Source Code Repository.

For the O&M Quality Assurance Task for the Collaboration Platform, Sentinel Initiative Website and Sentinel Public Source Code Repository, the Contractor shall ensure that the Program Management Support Plans outlined in Task Area 8 (and all Sub-Tasks) align with the Requirements and Standards for O&M services.

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Task Area

Sub-Task Area Deliverable

Deliverable Schedule

Task Area 5:

O&M for Collaboration Platform, Website and Public Repository

Sub-Task Area 1:

Collaboration Platform O&M

• Draft O&M SOPs Five (5) months post-award kick-off meeting

• Final O&M SOPs 20 business days after the Contractor receives FDA’s comments on the draft SOPs

• Monthly performance metrics report

Monthly

Sub-Task Area 2:

Sentinel Initiative O&M

• Draft O&M SOPs Five (5) months post-award kick-off meeting

• Final O&M SOPs 20 business days after the Contractor receives FDA’s comments on the draft SOPs

• Monthly performance metrics report

Monthly

Sub-Task Area 3:

Sentinel Public Repository O&M

• Draft O&M SOPs Five (5) months post-award kick-off meeting

• Final O&M SOPs 20 business days after the Contractor receives FDA’s comments on the draft SOPs

• Monthly performance metrics report

Monthly

Task Area 6: (Optional): DME of the Collaboration Platform, Website and Source Code Repository

As tasked, the Contractor shall provide development, modernization, and enhancement (DME) services to enhance the operations of the Collaboration Platform, the Sentinel Initiative Website, and the Source Code Repository, as required by FDA.

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SUB-TASK 1: COLLABORATION PLATFORM – DME SERVICES

The Contractor shall expand the operations and services provided by the Collaboration Platform including the expansion of the number of users and available tools.

Provide bi-weekly status reports of Collaboration Platform DME projects.

SUB-TASK 2: SENTINEL INITIATIVE WEBSITE - DME SERVICES

The Contractor shall expand the content and services provided by through the Sentinel Initiative Website including the software updates, improved website design and expanded content.

Provide bi-weekly status reports of Sentinel Initiative Website DME projects.

SUB-TASK 3: SENTINEL PUBLIC SOURCE CODE REPOSITORY – DME SERVICES

The Contractor shall expand the content and services provided through the Sentinel Public Source Code Repository including the software updates, improved website design and expanded content.

Provide bi-weekly status reports of Sentinel Public Source Code Repository DME projects.

Clear and concise responses to requests for task order proposals to obtain DME services for the Collaboration Platform, Sentinel Initiative Website and Sentinel Public Source Code Repository.

For the DME services Quality Assurance Task, the Contractor shall ensure that the Program Management Support Plans outlined in Task Area 8 (and all Sub-Tasks) align with the Requirements and Standards for the DME services.

Task Area Sub-Task Area Deliverable Description

Deliverable Schedule

Task Area 6:

DME

Collaboration Platform, Sentinel Initiative Website and Sentinel Source Code Repository

Sub-Task 1:

Collaboration Platform DME

• Response to request for task order proposals

Per RFTOP Terms

• Bi-weekly DME status reports Bi-weekly

Sub-Task 2:

Sentinel Initiative

DME

• Response to request for task order proposals

Per RFTOP Terms

• Bi-weekly DME status reports Bi-weekly Sub-Task 3:

Sentinel Source Code Repository

DME

• Response to request for task order proposals

Per RFTOP Terms

• Bi-weekly DME status reports Bi-weekly

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Task Area 7: Regulatory Operations Support As tasked, the Contractor shall provide written processes and procedures for the end-to-end services to support all regulatory operations activities in the Sentinel 3.0…