Attachment_A_-_BEST_IDIQ_2_SOW_amendment_2.pdf

The CBER Biologics Effectiveness and Safety (BEST) Sentinel Initiative:

Development of New and Innovative Methods for Automated Reporting for

CBER-Regulated Biological Products

IDIQ Statement of Work (SOW) July 19, 2018

Table of Contents

1. Introduction

1.1 Background

1.2 Biologics Effectiveness and Safety (BEST) Contract Objectives and Scope

1.2.1 Biologics Effectiveness and Safety (BEST) Contract Objectives

1.2.2 Biologics Effectiveness and Safety (BEST) Contract Scope

2. Task Description(s)

2.1 TASK 1: DATA SOURCES, TOOLS, METHODS, AND RELATED INFRASTRUCTURE………..……………………….………….5

2.1.1 Data Network

2.1.2 Develop new, innovative Tools and Methods for Automated Reporting

2.2 TASK 2: OPERATIONS AND MANAGEMENT………………………..…………………………………………………….…………. 7

2.3 TASK 3: TASK ORDER MANAGEMENT PLAN ……….……………………………………………………………….……………...9

2.3.1 Establish Project-Specific Protocols and Procedures

2.3.2 Organization and Management Procedures

2.3.3 Risk Management

2.4. Task 4: Outreach and Communications….…………………………………….……………………………….……….………10

2.5. Task 5: TRANSITION SERVICES

3. Deliverables

4. Contract Constraints

5. Other Requirements ...................................................... ……………………………………………………………………25

5.1 KEY PERSONNEL……………………………………………..……………………………………………………………….………………25

5.2 GOVERNMENT FURNISHED INFORMATION (GFI) / GOVERNMENT FURNISHED EQUIPMENT (GFE)….…………………25

5.3 TRAVEL...............................................................................................................................………………25

5.4 ADMINISTRATIVE..................................................................................................................………………25

5.4.1 Period of Performance……………………………….……………………………………………………………………………25

5.4.2 Place of Performance……………………….……….……………………………………………………………..…..…………25

5.4.3 Government Points of Contact (POCs) ……..…………………………………………………………………..…………25

1. INTRODUCTION

1.1 BACKGROUND

The U.S. Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, tobacco products, our nation’s food supply, cosmetics and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines, devices, products, and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health. As part of its mission, the FDA conducts monitoring of the safety of regulated products.

CBER regulates biologics which include vaccines, whole and blood components, blood products, tissues and advanced therapeutics. Some examples of blood products include all plasma-derived products such as immunoglobulins, coagulation products, fibrinogen concentrate and fibrin sealants. Some of the products in the category of tissues and advanced therapeutics include, but are not limited to: acellular dermal matrix allografts, cornea transplants, allograft heart valves and cardiac conduits, amniotic membrane transplants, cellular therapies, and fertility-related donations such as oocytes and sperms.

Some examples of potential adverse events associated with childhood vaccines include fever, rash, febrile seizure. Some examples of potential adverse events associated with exposure to blood components include: transfusion-related acute lung injury (TRALI), septicemia, sepsis, acute infection following transfusion (AIFT), transfusion-associated circulatory overload (TACO), transfusion-associated graft versus host disease (TA-GvHD), hemolysis, and febrile non-hemolytic transfusion reaction (FNHTR).

Some examples of potential adverse events associated with exposure to blood products, tissues, and advanced therapeutics include: thrombosis (arterial, venous), hemolysis, sepsis, post-transplant infection or disease transmission (all potential transplantation transmitted diseases) such as HIV, HCV, CMV, Chagas, West Nile Virus, Lymphocytic Choriomeningitis Virus (LCMV), Rabies, Tuberculosis, Babesiosis, Zygomycosis, Coccidiodomycosis, multi-drug resistant E. coli, Balamuthia mandrillaris, Microsporidiosis, Zika, allograft removal, inhibitor development, and hypersensitivity reactions.

In response to the FDA Amendments Act of 2007 (FDAAA 2007) with the goal to build an active postmarket risk identification and analysis system, the FDA established the Sentinel system and built a national electronic data system for monitoring the safety of FDA-regulated medical products. Sentinel is a distributed database system consisting of numerous data partners who retain operational control over their data. The Sentinel contract (5 years) was awarded to the Harvard Pilgrim Health Care Institute (HPHCI) in 2014 which set up a coordinating center to manage, receive, and process FDA questions in the form of queries and to return summary results back to FDA. The FDA Center for Biologics Evaluation and Research (CBER) established the Post-Licensure Rapid Immunization Safety Monitoring (PRISM) system, within Sentinel, to conduct active postmarket safety studies of vaccine safety and effectiveness.

CBER also established the Blood Safety Continuously Active Network (BloodSCAN), within Sentinel, to carry out active postmarket safety evaluation of blood and blood products. In addition to PRISM and BloodSCAN, CBER established Surveillance of Tissues and Advanced Therapies (STAT) to perform active postmarket safety evaluation of tissues, cellular therapies, genetic therapies, and other advanced therapeutics. CBER uses the Sentinel System to conduct many of its epidemiological studies as part of its regulatory responsibilities.

CBER has also conducted a number of epidemiological studies outside of the Sentinel System. CBER’s Office of Biostatistics and Epidemiology (OBE) initiated postmarket safety studies working collaboratively with federal partners such as the Veterans Health Administration, Indian Health Services, and Centers for Medicare and Medicaid Services (CMS).

OBE has conducted numerous epidemiological studies with private sector partners as well. In 2016, CBER funded a study using artificial intelligence, natural language processing, and advanced analytics to more efficiently analyze and review adverse event reports and trends in reports to support and enhance our postmarket safety surveillance work. In September 2017, CBER awarded two separate one-year contracts to IMS Government Solutions, Inc. to launch a pilot initiative, the Biologics Effectiveness and Safety (BEST) program, an expansion of the CBER Sentinel System. The primary goals of these two initial contracts were 1) to access and evaluate administrative claims and EHR data representing millions of patient records using a pilot query system based on the Observational Medical Outcomes Partnership (OMOP) Common Data Model, and Observational Health Data Sciences and Informatics (OHDSI) tools, and related infrastructure; and 2) to develop improved automated adverse events data collection and analysis techniques by using methods such as natural language processing and machine learning to conduct more sophisticated surveillance and automated adverse event reporting for blood and blood-derived products.

CBER plans to award two indefinite Deliverables Indefinite Quantities (IDIQ) contracts in FY2018, as part of its Biologics Effectiveness and Safety (BEST) initiative. CBER is continuing efforts to develop additional active postmarket risk identification and analysis systems by using new data sources, enhanced capabilities and expanded infrastructure with the goal of providing deliverables in a more cost-effective, efficient, and timely manner. This solicitation is specifically focused on new, innovative approaches to conduct automated adverse event reporting for biologic products to include approaches and applications such as machine learning, artificial intelligence, natural language processing and others.

CBER’s BEST initiative expands our work beyond current partners such as Centers for Medicare & Medicaid Services (CMS) and the Harvard Pilgrim Health Care (HPHC) to provide data sources;

infrastructure; capabilities and deliverables in a more cost-effective, efficient, and timely manner. The BEST Program will become part of the growing and evolving network of CBER postmarket safety and effectiveness analysis systems in the Sentinel Program. This request seeks to identify and develop new methods, approaches, and systems, and will augment CBER OBE’s postmarket safety and effectiveness work in the areas listed above. The BEST initiative will provide FDA with access to large sources of patient-centered data, especially clinical data in Electronic Health Record (EHR) format and claims data for inpatient and outpatient settings. Access to medical charts for validation of adverse events independent of FDA is optimal. The proposed FDA work will be conducted under a number of possible organizational structures and arrangements. The data holder(s) or other organization(s) will have their own team of epidemiologists, subject matter experts, at least four bioinformaticians, at least four programmers and others who preferably are experienced in conducting safety and effectiveness studies for drugs and biologics.

1.2 BIOLOGICS EFFECTIVENESS AND SAFETY (BEST) IDIQ OBJECTIVES AND SCOPE

1.2.1 OBJECTIVES

The following represent the expectations and objectives for the BEST program:

1. To provide FDA with indirect access to large-scale United States (US) health care data representing millions of patients from a wide range of healthcare settings including electronic health records (EHR) data sources as well as administrative claims data

2. To develop, validate, and provide FDA with new innovative methods to identify and mine safety and effectiveness information from electronic health records (EHR), claims data, and similar electronic healthcare data sources for all CBER-regulated products.

3. To develop and apply capabilities for automated or semi-automated chart review, and to use these capabilities to conduct validation studies that demonstrate the accuracy of mined safety and effectiveness data for CBER products.

4. Automatically and electronically report adverse event (AE) data to the FDA safety reporting databases with validation of the presence and accuracy of the transmitted reports and clear identification of reports that are sent.

5. Work collaboratively with FDA staff and train FDA staff on the use of tools developed within the contract by allowing FDA staff access to the tools and de-identified data through a secure portal.

6. Provide FDA with a complete collection of programs or software packages and related documentation that FDA can use to implement data mining for adverse events, product effectiveness, and automated AE reporting.

1.2.2 SCOPE

The Contractor shall, independently and not as an agent of the Government, provide all necessary resources and personnel to build the new CBER BEST program for the postmarket safety and effectiveness surveillance of all CBER-regulated biologic products. The scope of this program is the following:

1. Provide FDA with access to large-scale United States (US) health care data representing millions of patients from a wide range of healthcare settings, including administrative claims data as well as electronic health records (EHR).

2. Develop, validate, and provide FDA with new innovative methods to identify computable phenotypes reflecting safety and effectiveness information from US electronic health records (EHR), administrative claims data, or similar electronic healthcare data sources for all CBER-regulated products.

3. Develop capabilities for automated or semi-automated chart review, and to use these capabilities to conduct validation studies that demonstrate the accuracy of computable phenotypes.

4. Expand the use of innovative methods so as to ultimately support an automated nationwide, representative biological product surveillance system.

5. Develop and populate adverse event report fields into a data table that is compatible with MEDWatch report content for submission to the FDA safety databases (Vaccine Adverse Event

Reporting System (VAERS) for vaccine data, and the FDA Adverse Event Reporting System

(FAERS)).

6. Work collaboratively with FDA staff and provide training on the development and use of tools developed within the contract for documenting exposures to CBER products, mining of patient records for evidence of adverse events and effectiveness, validation of findings using semi-automated processes, and automated AE reporting to FDA.

7. Provide FDA with a complete open source (preferred) collection of programs or software packages and related documentation that FDA can use to implement data mining for adverse events, product effectiveness, and automated AE reporting. Use of proprietary programs or software packages shall be acceptable but should be discussed with FDA in advance and be available to FDA for use.

8. Provide resources and scheduled activities for internal and external communications in support of the contract and FDA’s goal of public transparency.

9. Continue to develop and incorporate more data sources, new technologies, approaches and capabilities into the system.

2. TASK DESCRIPTION(S)

The following tasks constitute the performance of work expectations for the BEST program support.

2.1 TASK 1: DATA SOURCES, TOOLS, METHODS, AND RELATED INFRASTRUCTURE

The conduct of postmarket safety and effectiveness surveillance of biologic products and development of new innovative methods under the BEST system shall require the contractor to have access to data sources covering millions of patients; necessary tools for data queries and analyses; and the resources such as technical expertise to support this endeavor.

2.1.1 DATA NETWORK

The Contractor shall provide access to a network of large-scale distributed databases that include near real-time (less than or equal to a 3-month data lag), patient-centered, comprehensive demographic, clinical, and ancillary data from administrative and claims, and EHR data sources that are representative of the US population. This distributed database is expected to grow every year with an emphasis on expanding access to EHR data sources and building a large network of EHR data providers. In addition, the contractor shall use a CDM (or equivalent method of data standardization) that shall, but is not limited to:

• Comprise data to support postmarket safety and effectiveness surveillance of biologic products.

• Provide clinical data, ancillary clinical data, laboratory test results, demographic data, brand names, transfusion data, lot numbers, blood unit labeling codes, dosage and frequency of use for all biologic products.

• Use ISBT-128 and CODABAR coding systems to define blood and blood component exposures in EHR.

• Expand and refine data elements annually and automate data refreshes.

• Expand the claims and EHR data sources regularly with an emphasis on EHR data.

The contractor shall also be able to provide critical information about the data sources and the populations represented in these sources. Specifically, the contractor shall, but is not limited to:

• Provide the patient population, participating institutions, and patient care settings for each database in the network including:

o Level of representativeness, which shall include but not be limited to comparisons of size and patient characteristics to national- level data.

o Inclusion characteristics, which shall include but not be limited to payor status (if applicable), average length of follow-up, participation in other healthcare systems and healthcare utilization data.

o Patient care settings, which shall include but not be limited to number, types, and catchment areas of participating institutions; estimated annual number of patients and/or visits in each setting; ability to longitudinally track patients through different care settings.

o Use of biologics, which shall include but not be limited to proportion of the total population with clinical/medical data available (i.e., enrolled patients) that receives biologic products on an annual basis.

• Data should be sufficiently granular as to identify brand names, lot#, labeling code

(e.g. ISBT-128 for blood components and tissues), NDC (drugs) or UDI (devices). Data from different sources must be standardized with a high degree of accuracy and validity so as to be ready for common analysis. This approach can be accomplished through the use of a distributed data model and a network of data providers using a common data model (CDM), or through other means.

• Provide prior and current uses of the biologic product data being analyzed, including but not limited to: post-market safety or effectiveness surveillance, administrative purposes, quality assessment/improvement and/or benchmarking, academic/industry research. This shall include but not be limited to:

o Representative examples of publications and/or presentations related to biologic product safety or effectiveness that have been developed using these data.

o Strengths and potential limitations of data source and/or tools for post-market surveillance.

• Develop a data quality assurance plan for each database with respect to all coding systems used in the database such as ICD9, ICD10, HCPCS, CPT, ISBT-128, and others. This plan should include (but not be limited to):

o Presence of all necessary source codes including all medical billing and administrative codes and electronic health record data including clinical and blood transfusion data o Presence of demographic data including age (captured in months and days) o Presence of data relevant to medical products, particularly products regulated by CBER (including ISBT-128 codes and brand names) o Proof of the stability of the data and reproducibility using a test study o The test study shall be reproduced quarterly to indicate stability of the databases.

• Develop a quarterly report to present the results of the data quality assurance plan for each database.

• Develop an action plan to correct any deficiencies or missing data based on the quarterly report results.

Table 1: Task 1 Deliverables/ Work Products

2.1.2 DEVELOP NEW, INNOVATIVE TOOLS AND METHODS FOR AUTOMATED REPORTING

The Contractor shall develop new, innovative methods to conduct automated reporting of adverse event information associated with CBER-regulated products. Contractor shall deliver the new tools, data and capabilities developed for FDA that will fully automate reporting of adverse event data, mined from records such as electronic health records using accepted case definitions, other text information, and codes. The tools will in turn be used to populate data tables or fields on FDA adverse event reporting forms, and automatically submit them to the FDA FAERS database in MedWatch format, or for vaccines, submit them to the VAERS database using the VAERS reporting format. Contractor shall determine accuracy of mined AEs which should be >90% for most AEs related to CBER-regulated products, and validate the electronic transfer process by ascertaining delivery to the FDA Adverse Event Reporting System (FAERS).

The Contractor shall, but is not limited to:

• Work collaboratively with FDA to identify, develop and build tool, methods, capabilities and capacities to conduct automated adverse event reporting for CBER-regulated products using EHR and similar electronic data

• Use the data, methods and expertise to build new capabilities for FDA to conduct automated reporting of adverse event data, mined from records applying machine learning, AI, NLP and other approaches to electronic health records using accepted case definitions, other text information and codes.

• Identify generally accepted case definitions for adverse events related to CBER-regulated products from sources such as the International Society of Blood Transfusion (ISBT), Brighton Collaboration, published peer-reviewed literature and other reliable sources for use in identifying key elements for data mining and matching of key case definition terms to the EHR records including non-structured text portions of the record or to build EHR phenotype cohorts.

Task Deliverable Due Date Quantity / Frequency Delivered To

Task 1.1 Develop a data quality assurance plan for each database with respect to all coding systems used in the database such as

ICD9, ICD10, HCPCS, CPT, ISBT-

128, and others.

Plan due NLT 2 weeks after task order award date

Once COR

Task 1.1 Develop a quarterly report to present the results of the data quality assurance plan for each database. Develop an action plan to correct any deficiencies or missing data based on the quarterly report results.

1st report due within 90 days of task order award date

Quarterly COR

• Provide a tool for mapping of medical coding for products, product transfusions or administrations, diagnoses, procedures, etc. across coding systems such as International Classification of Diseases, Tenth Revision, (ICD-10), ICD-9, Medical Dictionary for Regulatory Activities (MedDRA), ISBT-128, CODABAR and others.

• Use mined data to populate fields in a data table used in further studies, and to populate fields compatible with the FDA MedWatch adverse event reporting form or VAERS reporting form, and automatically submit to the FDA FAERS or VAERS system using established protocols.

• Validate the ability of developed methods to accurately identify and mine >90% of the specific adverse events related to CBER-regulated products during the performance period.

• Validate delivery of AE reports generated from patient data via MedWatch -compatible tables and demonstrate retrieval of reports from FAERS.

Safety information will include both known and unexpected adverse events. Innovative methods shall include artificial intelligence (AI), natural language processing (NLP), robotics, or other methods.

Effectiveness information includes health outcomes of interest. The contractor shall assemble the scientific experts and expertise needed for this task includes but is not limited to epidemiology, medicine, informatics (at least four informaticists), programming (at least four programmers), NLP, robotics, machine learning, AI and others. Proposed personnel must also include subject matter experts for the CBER products under study.

2.2 TASK 2: OPERATIONS AND MANAGEMENT

The Contractor’s Program Manager and the Principal Investigator (PI) along with their supporting staff shall provide Program Management (PM) for the BEST program requirements. These PM responsibilities shall include what is necessary to plan, structure, coordinate, schedule, manage, communicate, report, and steward all respective task orders and activities throughout the period of performance.

As specified in individual task orders (ITO), the Contractor shall ensure effective operations between its Coordinating Center, Data source(s) / partner(s), scientific experts, and work collaboratively with the FDA to ensure delivery of coordination activities such as meetings, telecons, and reports; and identify projects, develop protocols, review deliverables such as protocols, interim analyses and results, interim reports, and final reports.

The Contractor shall, but is not limited to:

• Establish a coordinating team or center to manage and coordinate all the operations of the Contract.

• Develop a management plan containing written processes and procedures for collaborating with CBER in study design and analysis. Details of the collaboration will be determined on a task order basis, by mutual decision of all collaborative parties.

Collaboration includes sharing summary data findings, interpretation of findings, review of manuscripts, design of protocols, and co-authorship of publications. The order of participating authors on each publication shall be determined on a case-by-case basis, by mutual decision of all collaborative parties and shall reflect appropriately each author's contribution to the project. Where there is no agreement on the above items, the FDA COR shall provide the final decision.

• The Management Plan shall contain a written processes and procedures for addressing Conflicts of Interest for Contractor staff, Investigators and collaborators.

Additionally, the Contractor shall provide both program-level management services and task order-level project management services to establish control, management, monitoring, and notification mechanisms for the program requirements. Moreover, the Contactor shall work with the Government Contracting Officer (CO), Contracting Officer’s Representative (COR), and subject matter experts (SMEs) to ensure that tasks stay on track and important milestones are met.

Representative activities include, but are not limited to:

• Administering the program;

• Throughout the period of performance, developing, maintaining, modifying, and updating plans to include task order (TO) risk management plans, staffing plan, standard operating procedures (SOP), protocols, and others

• For each TO, preparing a Task Order Management Plan (TOMP) describing the technical approach, organizational resources and management controls throughout TO execution

• Preparing and maintaining the program Management Plan

• Preparing monthly progress and financial reports

• Establishing notification mechanisms for acceptance by the FDA

• Complying with reporting requirements

• Following escalation procedures for problems, issues, and recommendations, as encountered

• Safeguarding information

• Managing Contractor staff and providing sub-contractor management, to include the proper on-boarding and exit procedures are followed when Contractor employees start and leave IDIQ contract and/or task orders;

• Coordinating tasks and working collaboratively with FDA CBER staff to carry out the work of the contract per sections to 2.1 to 2.5

• Attending quarterly face-to-face meetings with FDA CBER staff at the FDA White Oak Campus

• Reporting, communicating, presenting, and publishing of all BEST project findings shall be done in coordination with and concurrence of the CBER staff and the FDA COR

• Ensuring proper exit criteria are followed when Contractor employees leave projects

• Providing risk mitigation plans and strategies per section 2.3.3.

• Conducting and participating in progress meetings, facility meetings, training meetings, performance meetings, program/project reviews, management briefings, stakeholder presentations, demonstration meetings, transition meetings, COR site visits, and post-requirements meetings as required for each individual task order

• Responding to ad-hoc data calls to refine or confirm project findings or address FDA questions or concerns concerning project findings

2.3 TASK 3: TASK ORDER MANAGEMENT PLAN

As tasked, for each task order released under this IDIQ, the Contractor shall deliver a Task Order (TO) Management Plan. The TO Management Plan (TOMP) shall include a Work Breakdown Structure (WBS), which shall contain all of the work elements described in the Task Order. The WBS elements shall also illustrate the sequence, timeline, personnel, and resources required for each work package.

Additionally, the TOMP shall include a schedule that details activities; dependencies and timeframes for meeting FDA objectives and deliverables; and an organizational chart identifying relationships, authorities, and responsibilities. The TOMP shall include a description of the management controls that the Contractor shall employ to meet the performance, cost, and schedule requirements; and other areas the Contractor deems relevant and important to the management of the Task Order. The Contractor shall ensure that activities are coordinated across task orders, if applicable, to promote cohesiveness among contracted activities.

The TOMP shall address all the action items from any Kickoff Meetings and other follow-on meetings, as appropriate. The Contactor shall update the TOMP when re-planning any activities. Changes to the TOMP are subject to approval of the COR.

The contractor shall devise a plan for the governance of the program that will include governance structure, relationships and responsibilities, policies and procedures that will be followed by all the parties involved in terms of governing the program.

2.3.1 ESTABLISH PROJECT-SPECIFIC PROTOCOLS AND PROCEDURES

The Contractor shall work collaboratively with the FDA to develop and finalize the BEST project protocols and a Management Plan (MP), and update them to reflect the individual task order (ITO) activities. The Contractor shall obtain and meet all required review, approval and standard processes that comply with all relevant institutional, federal, state, and local laws and regulations to conduct the work such as Institutional Review Boards (IRB), data and information technology security such as Federal Information Security Management Act (FISMA), Health Insurance Portability and Accountability Act (HIPAA) and any others identified in the ITO. These procedures (i.e. the MP) shall address at a minimum the following: data collection, handling, sharing, ownership, and security; management and tracking, consensus definitions, transfer, and sharing considerations for data summaries.

Representative activities include, but are not limited to:

• Developing and implementing secure and robust data use, data quality control, tracking, management, and storage procedures for data, each analysis and for all analyses.

• Developing a query intake form or protocol for complex queries and epidemiologic studies.

Each document shall provide the stated regulatory question to be addressed; indicate data to be used, including years; protocols shall include a draft feasibility analysis and power calculations for sample size, estimated number of patients and patient records, cohorts to be studied including control and treatment populations; methods used and rationale;

2.3.2 ORGANIZATION AND MANAGEMENT PROCEDURES

The contractor shall schedule, document, and facilitate meetings between FDA personnel to ensure effective operations. These meetings shall include administrative and budgetary telecons every two weeks, monthly telecons for executives/leaders of the contract and FDA, taking minutes, as well as weekly scientific workgroup meetings for specific projects.

2.3.3 RISK MANAGEMENT

The Contractor shall identify and report for resolution to the Government any issues that prevent the Contractor from performing the work in any Task Order that the Contractor is unable to resolve independently. For each Task Order, the Contractor shall document and report the risks and opportunities within a risk registry. The Contractor shall maintain the risk registry and provide it to the COR.

The risk registry shall contain, at a minimum, unless otherwise specified in the ITOs:

• Issue Number: a sequential numbering of all issues;

• Severity: assessment of issue severity i.e., likelihood and consequences (High/Medium/Low)

• Date Found: – date that issue was identified by the Contractor;

• Duration: number of days that issue has been open;

• Status: representing issue status as open or closed. The Contractor shall maintain a complete list of all issues – no issues typically should be deleted from the Contractor’s delivered list;

• Title: short description of issue;

• Updated: date for updated status;

• Details: narrative description of activities that have been completed to resolve issue;

• Assigned To: identify Government POC or Contractor that is assigned to resolve the issue;

• Solution or Workaround: description of the actions and activities taken to resolve or mitigate issue the issue.

2.4 TASK 4: OUTREACH AND COMMUNICATIONS

The contractor shall ensure ongoing communication and reporting to FDA. This includes the tracking, reporting, and outreach as necessary to be further detailed in individual task orders.

2.4.1 TRAINING

The contractor shall provide the FDA staff with both small and large group training sessions on the use of data sources, tools, methods, and processes. The training sessions will occur over multiple days at FDA both at the start of the contract and whenever FDA determines they are needed throughout the duration of the contract. These trainings target new users of the system as well as more advanced users separately. There will be no more than six training sessions per year.

2.4.2 QUARTERLY WEBINARS/SEMINARS

The contractor in collaboration with the FDA staff shall present study design and planning, interim or final results of newly initiated, ongoing, or completed projects to the FDA staff and other BEST program collaborators on a regular quarterly basis in the form of Webinar or in-person seminar at the White Oak campus or other location agreed upon between the contractor and FDA. The schedule and presentation topics of the monthly webinars/seminars will be specified in the follow-on ITO. Annual Public Workshop

As tasked per ITO, the contractor shall assist with planning, scheduling, and conducting a public workshop to present work related to the development of infrastructure, tools, methods, projects or tasks completed in the past year and the work plan that will be completed in the following year.

2.4.3 PUBLICATIONS

The contractor shall provide drafts of protocols, reports, presentation materials (e.g., presentation slides and posters), and manuscripts. In addition, the contractor shall share summary data findings and interpretation of findings in the context of the data and tools used. Details of the collaboration will be determined on a task order basis.

Protocols, final reports, and final work products will be posted to a web-based resource library after clearance by FDA, the prime contractor, and subcontractors. The Parties agree this is a multi-site program and any publications as a result of studies shall be a multi-site publication coordinated by the prime contractor, subcontractors, FDA/CBER/OBE, and other involved sites. Authorship and other matters relating to publications shall be determined at the task order level.

2.4.4 PUBLIC WEBSITE

The contractor shall be tasked with creating a public website where materials can be posted and be available to the public as part of an ITO. Materials shall include protocols, results of queries or epidemiologic studies, and reports. The public website data security and privacy shall be in compliance with the HHS Information Security and Privacy Policy (IS2P) https://intranet.hhs.gov/it/cybersecurity/policies/index.html). The security and privacy requirements to ensure federally-mandated security and privacy controls and standards shall be met according to FDA/CBER policies.

Protocols and final reports of projects will be posted to the public website after clearance by FDA.

Ongoing projects and interim work products shall not be publicly shared and released. Final work products will be posted to the public website.

2.4.5 SECURE PORTAL

The contractor shall create and implement a secure data transfer capability to allow secure file sharing and document storage for the contractor, subcontractors, CBER staff, and other collaborators. All the data transfer and document storage related to all queries and complex epidemiological studies, and other activities shall be carried using the secure portal. The Contractor shall obtain and meet all required review, approval and standards processes that comply with all relevant institutional, federal, state, and local laws and regulations to conduct the work such as HHS Information Security Program, Federal Information Security Management Act (FISMA), Health Insurance Portability and Accountability Act (HIPAA), the National Institute of Standards and Technology, and any others identified in the ITO.

These procedures (i.e. the MOP) shall address at a minimum the following: data collection, handling, sharing, ownership, and security; management and tracking, consensus definitions, transfer, and sharing considerations for data summaries. The secure portal data security and privacy shall be in compliance with the HHS Information Security and Privacy Policy (IS2P). The security and privacy requirements to ensure federally-mandated security and privacy controls and standards shall be met according to FDA/CBER policies.

Representative deliverables for this task include, but are not limited to:

• Deliver well-written and formatted briefings, protocols, reports, presentation materials, and manuscripts

• Deliver a user-friendly secure portal with graphical interface for conducting day-to-day communications related to the task.

• Deliver a user-friendly public website for posting all BEST-related documents.

2.5 TASK 5: TRANSITION SERVICES

Transition activities take place to efficiently transition all activities from the incumbent Contractor to the new IDIQ Contractor. As tasked, the Contractor shall be required to develop transition-out plans and conduct transition activities for task orders issued against this IDIQ vehicle.

https://intranet.hhs.gov/it/cybersecurity/policies/index.html

2.5.1 TRANSITION-IN

As specified in each ITO, the Contractor shall transition-in and assume the responsibility for activities and duties from the prior (incumbent) Contractor in a manner that does not interrupt or negatively impact OAGS’ mission critical operations and activities. The purpose of the Transition-In requirement is to provide an orderly transition from the prior Contractor. For a period as specified by the ITO, the Contractor shall work with the incumbent contractor to affect an efficient transition of work.

Representative activities include, but are not limited to:

• Developing a Transition-In Plan to ensure full operating accountability and responsibility of the task orders.

• Familiarizing the incoming Contractor staff with FDA processes and requirements and work with the incumbent Contractor as related to transferring tasks and work activities being performed.

• Coordinating with assigned COR to obtain access to the required data, Government furnished equipment (GFE), systems / applications, and required training.

• Participating in Transition-in meetings and other technical exchange meetings and opportunities to facilitate the transfer of information, processes, and data needed to continue the services being performed by the incumbent Contractor.

• Certifying that employees working on the contract have completed their review and understand Integrated Services requirements, documentation, processes, and technical environments prior to the completion of the Transition-in activities.

• Verifying to the COR that all of the Transition-in documents are available.

2.5.2 TRANSITION-OUT

The Contractor shall facilitate the transition-out of contracted activities and services to the Federal Government or, to a follow-on Contractor by the end of the contract period of performance.

The Contractor shall provide support for transition-out activities. During this period, the Contractor shall ensure no degradation in support provided under the task order. Between the turnover date designated by the COR and the end of the contract period of performance, the outgoing Contractor shall ensure all task order activities are closed out and provide sustainment support to complete the transition.

Representative deliverables include, but are not limited to:

• Developing and submitting a Transition-Out Plan and Schedule to the COR

• Providing the FDA with current versions of all documentation developed (i.e. Standard

Operating Procedures and Manual of Operations)

• Providing the FDA with a current inventory of all Government-Furnished Equipment (GFE) and Government Furnished Information (GFI) utilized by the Contractor along with full support in the reconciliation of this inventory

• Providing the follow-on contractor with the ability to “shadow” and participate in technical exchange meetings and opportunities to facilitate the transfer of information, processes, and data needed to continue the services being performed by the Contractor

3. REPRESENTATIVE DELIVERABLES & MEETINGS

Five (5) year ordering period

Item No.

Description of Supplies/Service SOW Section

Quantity Delivery Date

1 Establish and maintain a Coordinating Center (CC) - SOW Section 2.2

2.2

1 Within 4 weeks of award and throughout the Period of Performance

2 Kick Off Meeting N/A 1 Within 2 weeks of award 3 Training Sessions for FDA staff

2.4.1 3 large and 3 small training sessions per year

Provide at 2 month intervals

4 Quarterly webinars on relevant topics

2.4.2 4 per year

Quarterly throughout the Period of Performance

5 Management Plan

2.2 1 Within 4 weeks of award updated throughout the Period of Performance

6 Risk Management Plan 2.2 1 Within 4 weeks of award and updated throughout the Period

7 Executive Committee Meeting

2.3.2 12 Monthly throughout the Period

8 Administrative and Budgetary telecon meetings

2.3.2 26 Every 2 weeks throughout the Period of Performance

9 Quarterly face-to-face meetings at FDA

2.2 4 Quarterly meetings throughout the Period of Performance

10 Workgroup meetings 2.3.2 24 Two per month throughout the Period of Performance

11 Create and maintain a public website

• Develop workplan and implement specification for launching and maintain the website

2.4.5 1 Within 12 weeks of award and perform ongoing updates and support throughout the Period of Performance

12 Create and maintain a secure web-based infrastructure for file sharing

• Develop workplan, implement specification and launch

2.4.6 1 Within 12 weeks of award and preform ongoing updates and support throughout the Period of Performance

13 Establish web-based resource library

• Develop workplan, implement specifications, and launch

• Post all contract deliverables with accompanying

2.3 1 Develop within 12 weeks of award and preform ongoing updates and support throughout the Period of Performance instructions in resource library

14 Complete and submit yearly FISMA audits to FDA

2.3.1 1 Submit annually at end of contract year

15 Prepare monthly progress and financial reports

2.2 4 Submitted by the 10th of each month prior to submission of any invoice for that same period.

16 Prepare a Transition-Out Plan and Schedule

2.5.1 1 Prepare 4 months prior to the end of Period of Performance

17 Schedule and conduct a public workshop to present work completed in the past year

2.4.3 1 Annually Prior to end of each 12-month Period of Performance

3.1 DELIVERY INSTRUCTIONS FOR DELIVERABLES

Unless otherwise specified, all deliverables, reports or copies of reports shall be delivered to the COR and Project Officer via email. Requirements for inspection and acceptance are as follows:

• The COR and Project Officer designated in each TO, will inspect and accept the services provided to ensure they meet the requirements detailed in the relevant IDIQ task order.

• The Government will accept products and services only if they conform to all terms and conditions of the contract statement of work and each TO.

• The Government will provide written notification of acceptance or rejection within ten (10) calendar days of receiving the service.

• The Government will reject non-conforming products and services. The Contractor shall correct any deficiencies within thirty (30) calendar days of when the Government issues the rejection notice. If the Contractor cannot correct the deficiencies within this time frame, the Contractor shall immediately notify the COR of the reason for the delay and provide a proposed corrective action plan within ten (10) calendar days.

In addition, the Contractor shall be proactive in informing the designated CBER COR of any issues, problems and recommendations that shall be addressed for the overall effective accomplishment of contract goals and deliverables. Recommendations for actions that need to be taken by FDA staff, or other Contractors shall be clearly defined and communicated (via email) to the responsible party and the FDA, and have identified dates for completion.

4. CONTRACT CONSTRAINTS

The following constraints are applicable to this contract:

1. The Contractor shall ensure that all appropriate administrative and regulatory approvals are obtained. These include but are not limited to those that address human subject considerations;

and clearances including applicable Institutional Review Boards (IRBs), and Office of Management and Budget (OMB) which will be detailed during the ITO process.

2. Interim data used in technical progress reports and other reports developed for the purpose of study monitoring and shall not be released publicly. Premature release of such data could result in interpretations that prove to be unreliable or invalid once the study is completed and the full context for the data is known and lead the public and medical practitioners to pursue inappropriate measures.

3. The Contractor shall be responsible for knowledge of and compliance with all applicable federal information technology and information management laws, regulations, policies and standards at the government-wide, HHS and FDA levels.

i. The computer programs, data management systems, databases, and other resources used or developed through this contract shall comply with data standards and procedures established by DHHS and FDA (per http://www.fda.gov/ForIndustry/DataStandards/default.htm).

4. The Contractor shall not use confidential or otherwise privileged information shared by FDA with contractors to solicit or in any way encourage industry funding/financial sponsorship of research projects to be performed by the contractor. In the event that a third party, such as a drug sponsor, independently requests that the contractor conduct research on a safety issue the contractor shall conduct such research only if both of the following conditions are satisfied: (1) the contractor shall not divulge confidential and privileged information previously shared by the FDA; and (2) the contractor shall recuse itself from all subsequent conversations with FDA about the safety of the involved biologic product(s). In conjunction with the above, the contractor shall provide a Conflict of Interest Plan as outlined in FDA Clause 1337 Conflict of interest (see FDA 1337, Conflict of Interest).

5. The Contractor shall work collaboratively with FDA CBER during the task order proposal request;

projects will be mutually agreed upon by both parties, and final approval is required by the FDA COR. Communications, presentations, and publications require internal FDA clearance of up to 30 days. Generally, the FDA COR will offer final decision on products and FDA CO approval will be needed on any modifications to the contract or ITOs.

4.1 SECURITY AND PRIVACY

4.1.1 BASELINE SECURITY REQUIREMENTS

1) Applicability. The requirements herein apply whether the entire contract or order (hereafter “contract”), or portion thereof, includes either or both of the following:

2) Access (Physical or Logical) to Government Information: A Contractor (and/or any subcontractor) employee will have or will be given the ability to have, routine physical (entry) or logical (electronic) access to government information.

a. Operate a Federal System Containing Information: A Contractor (and/or any subcontractor) will operate a federal system and information technology containing data that supports the HHS mission. In addition to the Federal Acquisition Regulation (FAR) Subpart 2.1 definition of “information technology” (IT), the term as used in this section includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources.

3) Safeguarding Information and Information Systems. In accordance with the Federal

Information Processing Standards Publication (FIPS)199, Standards for Security Categorization of Federal Information and Information Systems, the Contractor (and/or any subcontractor) shall:

http://www.fda.gov/ForIndustry/DataStandards/default.htm

a. Protect government information and information systems in order to ensure:

• Confidentiality, which means preserving authorized restrictions on access and disclosure, based on the security terms found in this contract, including means for protecting personal privacy and proprietary information;

• Integrity, which means guarding against improper information modification or destruction, and ensuring information non-repudiation and authenticity; and

• Availability, which means ensuring timely and reliable access to and use of information.

b. Provide security for any Contractor systems, and information contained therein, connected to an FDA network or operated by the Contractor on behalf of FDA regardless of location. In addition, if new or unanticipated threats or hazards are discovered by either the agency or contractor, or if existing safeguards have ceased to function, the discoverer shall immediately, within one (1) hour or less, bring the situation to the attention of the other party. This includes notifying the FDA Systems Management Center (SMC) within one (1) hour of discovery/detection in the event of an information security incident.

c. Adopt and implement the policies, procedures, controls, and standards required by the

HHS/FDA Information Security Program to ensure the confidentiality, integrity, and availability of government information and government information systems for which the Contractor is responsible under this contract or to which the Contractor may otherwise have access under this contract. Obtain the FDA Information Security Program security requirements, outlined in the FDA Information Security and Privacy Policy (IS2P), by contacting the CO/COR or emailing your ISSO.

d. Comply with the Privacy Act requirements and tailor FAR clauses as needed.

4) Information Security Categorization. In accordance with FIPS 199 and National Institute of

Standards and Technology (NIST) Special…