Attachment_A_-_BEST_IDIQ_1_SOW_(Req_1196209)_June_21_2018.docx

The CBER Biologics Effectiveness and Safety (BEST) Initiative: Data, Tools and Infrastructure for Surveillance of Biologics

IDIQ Statement of Work (SOW) June 21, 2018

Table of Contents

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, biologic 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: 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 FY2015 which set up a coordinating center to manage, receive, and process FDA questions in the form of queries and return summary results back to the 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 some 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 was 1) to develop a pilot system using electronic health records (EHR) data sources, the Observational Medical Outcomes Partnership (OMOP) Common Data Model, 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 the data, tools and infrastructure for the surveillance of biologics.

CBER’s BEST initiative expands our work beyond current partners (such as CMS and HPHCI) 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 may not repeat work currently underway in those programs but is intended to expand CBER OBE’s postmarket safety and effectiveness work in the areas listed above. 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 is preferred. The proposed FDA work may be conducted under a number of possible organizational structures and arrangements. The data holder(s) or other organization(s) may have their own team of at least three epidemiologists, subject matter experts, bioinformaticians, at least four programmers and others who are experienced in conducting safety and effectiveness studies for drugs and biologics. Alternatively, the Contractor may work with other organizations, such as a contract research organization or academic partner(s) which has its own team or may assemble its own team of such experts, and may serve as a Coordinating Center to manage the work.

1.2 Biologics Effectiveness and Safety (BEST) Objectives and Scope The primary goal of this Contract is to expand and enhance the current CBER capabilities with respect to data sources, infrastructure, methods, and tools and to conduct surveillance and epidemiologic studies that promote OBE’s mission to assure the safety and effectiveness of biologic products including vaccines, blood and blood products, tissues and advanced therapeutics. This contract builds and expands upon activities undertaken as part of previous FDA collaborative studies for biologic product safety and effectiveness such as the Sentinel contract awarded to the HPHCI in 2014 and the contract awarded to IMS Government Solutions, Inc. in 2017.

1.3 Objectives

The objectives of this contract are:

1. To provide FDA with indirect access to large-scale United States (US) health care data of millions of patients including administrative and claims as well as electronic health records (EHR) data sources using a distributed data model and network which would require the use of a common data model (CDM).

2. To build an infrastructure to provide data sources and the capability and capacity to run queries and observational studies on the data sources for CBER-regulated biologic products.

3. To develop semi-automated processes for medical chart review to augment manual review of charts.

1.4 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 biologic products. The scope of this program is the following:

1. Biologic products consist of vaccines, blood and blood products, tissues and advanced therapeutics. There is a need for data sources which provide data for blood, blood products, tissues, advanced therapeutics and vaccines. Incorporation of Information Standard for Blood and Transplant-128 (ISBT-128) and Codabar coding systems (a standard terminology for medical products of human origin) in the data sources and CDM will be useful for this purpose.

2. Support for the CDM to accommodate granular clinical data and some ancillary clinical data such as laboratory test results and blood transfusion data.

3. The available data for analyses is quality checked using a rigorous, structured approach. While access to longitudinal data for at least the past five years is required, the most recent data shall not be older than four months. The minimum data elements (but not limited to) required to be included in the data sources include demographic, granular clinical and ancillary clinical, health care utilization, laboratory test results, blood transfusion, and geographic distribution in all care settings.

4. Support for data sources to include the following characteristics and capabilities:

a. Building a data network as a distributed database to provide access to health care data of a large US population including medical records for millions of patients. The data will include administrative and claims as well as EHR data sources. There will be multiple sources of claims and EHR data with the plan to expand the number of EHR sources rapidly.

b. One of the characteristics of the database will be to provide longitudinal health care data for a large population and at least the last five years.

c. The distributed data network requires the use of a CDM or similar approach. The CDM shall consist of a large library of clinical data elements with the capacity to expand the clinical data library.

5. Support and tools for FDA to utilize the large distributed data network as follows:

a. Scientific experts to design and execute queries and epidemiologic studies.

b. Automated tools that can easily and rapidly perform simple and complex queries as well as execute complex epidemiologic studies in a timely manner.

6. New methods and capabilities developed to link health care data of mothers and their infants so that FDA can perform assessments for vaccine safety during pregnancy.

7. New methods and capabilities developed to link claims and EHR data.

8. Semi-automated methods and processes developed to validate clinical outcomes and exposures to replace manual medical chart review.

9. Governance structure developed as well as policies and procedures for the governance of the program.

10. Collaboration with other vendors and/or partners to form larger data networks and to leverage and build upon tools previously developed by other contractors for FDA.

2. Tasks Description 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 4-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 over the course of the contract 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 that shall:

· Comprise data to support postmarket safety and effectiveness surveillance of vaccines, blood and blood products, and tissues and other therapeutic biologics (e.g. cellular therapies, gene therapies, immunoglobulins, coagulation products).

· Provide clinical data, ancillary clinical data, laboratory test results, demographic data, brand names, transfusion data, lot numbers, blood units, 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 regularly and automate data refreshes.

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

With respect to the data sources the contractor shall provide to FDA, the contractor shall also provide critical information about the type of data sources and the populations represented in these sources. Specifically, the contractor shall:

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

· Level of representativeness, which shall include (but not be limited to) comparisons of size and patient characteristics to the national level data.

· 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.

· 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.

· 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.

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

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

· 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):

· Presence of all necessary source codes including all medical billing and administrative codes and electronic health record data including clinical and blood transfusion data

· Presence of demographic data including age (captured in months and days)

· Presence of data relevant to medical products, particularly products regulated by CBER (including ISBT-128 codes and brand names)

· Proof of the stability of the data and reproducibility using a test study

· 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.

2.1.2 Tools

The Contractor shall develop the tools and methods needed to conduct population-based safety and effectiveness studies of CBER-regulated biologics using a distributed network of databases. Specifically, the contractor shall be able to:

· Identify and use tools and methods to support population-based studies of CBER-regulated biologics.

· Provide tools that are built according to scientific underpinnings including based on methods used in population-based studies; tool which have been validated, and their strengths and limitations are determined.

· Define, characterize, and query cohorts of individuals for descriptive analysis and feasibility assessments.

· Develop a secure portal to allow CBER staff to characterize and query de-identified data using the Contractor’s tools.

· Implement complex epidemiologic studies with observational data including the ability to implement cohort, self-controlled case series (or case-crossover), case-control, historical comparator, and other epidemiologic study designs and the appropriate statistical methods for inferential analyses.

· Analyze data using geographic information, generalized linear models, signal-from-noise detection and other statistical methods.

· Extrapolate both the utilization and patient-level data to national estimates of biologic products utilization and adverse event patterns in the US. The methods for sampling and projection to national estimates shall be valid, reliable, and robust, and the methods shall be fully disclosed.

· Summarize, perform meta-analysis, and visualize results of simple and complex analyses in tabular and graphical formats that shall be easy to understand and follow

· Documentation of data sources while delineating strengths and limitations of data sources

· Detailed tools and methods description to be made available on public website as standalone documents and/or as part of protocols, reports, etc.

2.1.3 Methods Development

The contractor shall develop new and innovative methods in a number of areas to expand and enhance real-time surveillance capabilities of biologics as new technologies emerge and CBER’s surveillance needs grow. Developed methods shall be developed into automated tools to facilitate future analyses whenever possible. The new areas of methods development may include, but are not limited to:

· Establish a number of data linkages to enrich data sources including:

· Patient-level linkages within and between claims and electronic health records such that individual patients will have both sources of data and can be followed over time despite any change in health insurance or provider.

· Linkage between mothers and infants in claims and electronic health records such that the FDA can assess pregnancy and birth outcomes following exposure to biologics.

· Linkage between claims and electronic health records and national, state, and regional vaccine, blood, and tissue registries or banks.

· Develop automated tools and processes to:

· Conduct, augment or assist with medical chart review to validate biologic exposures and health outcomes in order to augment, assist or replace manual chart review.

· Manage and assess quality of data elements in each data source.

· Create de-identified patient-level profiles of health care encounters over a defined period of time.

· Characterize the demographic and health characteristics of all patient populations for each electronic data source in real-time.

· Develop appropriate libraries for terminologies and vocabularies defining biologics-related exposures, outcomes, and cohorts utilizing current coding systems such as The International Classification of Diseases-Ninth Revision (ICD-9), The International Classification of Diseases-Tenth Revision (ICD-10), different types of procedure codes (Healthcare Common Procedure Coding System (HCPCS), Current Procedural Terminology (CPT)), ISBT-128, Codabar, and others.

· Incorporate national geographic mapping and clustering as a data element for all queries, analyses, and epidemiologic studies at a level of specificity that does not compromise patient privacy or proprietary information.

· Develop methods and tools to monitor emerging infectious diseases (e.g., Zika virus) to ensure safety of blood supply and human tissues products.

· Develop methods and tools to monitor vaccine safety during pandemics (e.g., influenza).

· Build mobile applications (apps.) for collection of patient-level data to be linked to patient records in the participating data sources to aid in identification of adverse events after exposure to biologics.

· Develop new observational study designs and analytic methods optimal for a distributed data network of claims and EHR data sources.

· Develop innovative methods to expand generation of observational data on biologic safety or effectiveness as Real World Data for use as Real World Evidence to support regulatory actions and related activities.

2.1.4 Expertise and Experience with Data and Tools

The contractor shall provide all the necessary personnel including an interdisciplinary team of scientists and experts such as at least three epidemiologists; subject matter experts on biologic products; physicians or healthcare experts with expertise in vaccines, tissue, blood and blood products; medical informatics experts; biostatisticians; at least four computer programmers; medical coding specialists; and others who are experienced in conducting safety and effectiveness studies for biologics. The contractor shall provide experienced personnel who are able to:

· Describe CDM, coding, completeness, timeliness, and accessibility of databases and tools.

· Assist in clinically relevant medical diagnostic coding or other criteria to identify exposures and adverse events of interest.

· Participate in scientific workgroup meetings to contribute to subject matter and other technical expertise.

· Participate in designing, conducting, and interpreting the results of simple and complex queries and complex epidemiologic studies.

2.2 Task 2: Queries and Epidemiologic Studies

The contractor shall conduct queries and complex epidemiological studies to evaluate the safety and effectiveness of biologic products and to address regulatory issues initiated by the CBER staff. The contractor shall provide the capability and capacity in terms of data sources, tools and methods, scientific expertise and operational management to run queries and observational studies in the form of simple and complex queries as well as complex epidemiologic studies.

2.2.1 Simple Queries

The contractor shall utilize the data resources, tools, and scientific expertise to form a workgroup composed of CBER staff and contractor’s relevant scientific experts and admin support staff, if needed, to perform simple queries to:

· Identify exposure to and utilization of biologics, define specific cohorts, identify and classify outcomes, estimate prevalence and incidence rates in a specific or multiple care settings.

· Provide a secure communication portal throughout the query process.

· Collaborate with FDA in the publication of query results in agreement and compliance with CBER policies and procedures as referenced in Section 2.4.4 Publications.

2.2.2 Complex Queries

The contractor shall utilize the data resources, tools, and scientific expertise to form a workgroup composed of CBER staff and contractor’s relevant scientific experts and admin support staff, if needed, to perform complex queries to:

· Evaluate exposure and outcome association for biologics and estimate a measure of association, apply advanced methods to account for confounding and bias.

· Provide a secure communication portal throughout the query process.

· Collaborate with FDA in the publication of query results in agreement and compliance with CBER policies and procedures as referenced in Section 2.4.4 Publications.

2.2.3 Complex Epidemiologic Studies

The contractor shall utilize the data resources, tools, and scientific expertise to form a workgroup composed of CBER staff and contractor’s relevant scientific experts and admin support staff, if needed, to perform complex epidemiological studies to:

· Develop reusable methods and tools to perform post-market safety surveillance of biologics that cannot be addressed by either simple or complex queries.

· Develop a Level III (or greater) Work Breakdown Structure (WBS) for the study.

· Develop a protocol for the study that shall include the study population, the comparator or control group, the study design, and the statistical method to estimate the measure of association between exposure and outcome while adjusting for confounders.

· The deliverables shall include a study protocol, all data analysis results, and a comprehensive final report which consists of the following sections: introduction, background, methods, results, conclusions, and discussion.

· Deliverables must not exceed the agreed upon timeline between the contractor and the CBER staff.

· Provide a secure communication portal throughout the study process.

· Publish study protocols and final reports in agreement and compliance with CBER policies.

To meet the requirements for performing the complex epidemiologic studies, the contractor shall:

· Establish a coordinating center that manages workflow between various collaborators and CBER to accommodate the query request process.

· Collaborate with FDA to establish and meet timelines for providing results for epidemiologic studies. Timeline dependent on complexity of the study and shall be established in management plan (see Section 2.3).

· Provide documentation of the vocabulary (and codes and coding systems if applicable) utilized for cohort, exposure and outcome identification, applied tools and methods, and any other information related to the query, e.g. care settings, data partners.

· Time and material work plan.

· Provide a secure portal for communication.

· Collaborate with FDA in the publication of study results in agreement and compliance with CBER policies and procedures as referenced in Section 2.4.4 Publications.

2.3 Task 3: 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 the individual task order (ITO), the Contractor shall ensure smooth 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:

· 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, co-authorship of publications, and establishing timelines for providing results for epidemiological studies. 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.

· Generate a document providing information as to which key personnel will be used on each project and the percentage of time and staff member effort and contribution to the program on a per-task order basis.

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

· Identify and create administrative templates for use throughout the period of performance

· 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 quarterly 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 BPA contract and/or task orders;

· Coordinating tasks and working collaboratively with FDA CBER staff to carry out the work of the contract per section 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 2.3.4

· 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 may be 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

· Provide training to FDA staff in small and large groups on data sources, study approaches or methods and tools employed and developed as part of the specific Task Orders and tasks. The specific type of training shall be determined based on the tools and methods developed and may include development of training manuals and slides, conduct of training sessions, and preparation of other similar activities.

2.3.1 Task Order Management Plan

As tasked, for each task order released under this statement of work, 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, 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.

2.3.2 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 as needed to reflect the individual task order (ITO) activities. The Contractor shall work with the FDA to identify 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;

2.3.3 Organization and Management Procedures

The contractor shall schedule and facilitate (to include notes, minutes, action items) meetings with FDA personnel to ensure smooth operations. These meetings shall include administrative and budgetary telecons every two weeks, monthly telecons for executives/leaders of the contract and FDA, as well as weekly scientific workgroup meetings for specific task orders.

2.3.4 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 on a monthly basis.

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.

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 Monthly 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 monthly 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 of the monthly webinars/seminars will be determined by the FDA and contractor staff. The presentation topics will be determined by the FDA and contractor staff at the first three months of each fiscal year.

2.4.3 Annual Public Workshop

The contractor shall organize and conduct up to one annual public workshop to present work related to the development of infrastructure, tools, methods, projects or tasks completed previously and the work plan that will be completed in the future. FDA in collaboration with the contractor shall determine the date, agenda, and participants in this workshop.

2.4.4 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.

2.4.5 Public Website

The contractor may be tasked with creating a public website where materials can be posted and be available to the public as part of an ITO. Materials may 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.

2.4.6 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 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. 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 executive

· 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.

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 a smooth 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

2.6. Representative Deliverables & Meetings

Five (5) Year Ordering Period

· Telecons: monthly executive/leadership, bi-weekly administrative, and weekly scientific workgroup

· Face-to-face: quarterly

· Post all contract deliverables with accompanying instructions in resource library

· Identify needed templates

· Draft templates

· Finalize templates

2.6.1 Delivery Instructions for Deliverables

Unless otherwise specified, all deliverables, reports or copies of reports shall be delivered to the COR via email. The monthly progress and financial reports shall also be submitted to the Contracting Officer and/or Contract Specialist assigned to the contract. Requirements for inspection and acceptance are as follows:

· The COR or the POC 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…