Attachment_B_-_BEST_IDIQ_(TO_0001_SOW)_6-21-18.docx

CBER Biologics Effectiveness and Safety (BEST) IDIQ #1

Task Order #0001 SOW:

Queries and Epidemiologic Studies

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, biological products, medical devices, tobacco products, the nation’s food supply, cosmetics, and products that emit radiation. FDA is also responsible for advancing public health through innovation to make medicines, devices, products, and foods more effective, safer, and more affordable.

The Center for Biologics Evaluation and Research (CBER), Office of Biostatistics and Epidemiology (OBE) conducts postmarket safety and effectiveness studies collaboratively in the Sentinel System by working with federal partners such as the Veterans Health Administration, Indian Health Services, and Center for Medicare and Medicaid Services (CMS) and contractors such as Harvard Pilgrim Health Care Institute (HPHC) and IQVIA (previously known as QuintilesIMS). FDA uses these partnerships to help fulfill regulatory and public health responsibilities to conduct surveillance to monitor the safety and effectiveness of biologics such as vaccines, blood and blood products, tissues and advanced therapeutics. These successful collaborations have contributed to FDA regulatory decision-making and resulted in a number of peer-reviewed publications. CBER’s Biologics Effectiveness and Safety (BEST) initiative continues to expand our work beyond current partners (such as CMS and HPHC) to provide data sources, infrastructure, and capabilities with the goal of providing deliverables in a more cost-effective, efficient, and timely manner. BEST is part of the growing and evolving network of CBER postmarket safety and effectiveness analysis system in the Sentinel program. CBER is issuing this Task Order 1 (TO1) as part of its continuing effort to develop new capabilities and build additional capacity for conducting biologics safety surveillance. The proposed FDA work requirement may be conducted under a number of arrangements as indicated in Section 1.1 of the IDIQ Statement of Work (SOW).

1.2 Task Order 1 (TO1): Objectives and Scope

The purpose for TO1 is 1) to develop and enhance the current CBER capabilities with respect to electronic health data sources, infrastructure, methods, and tools and; 2) 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.

Objectives

The objectives of TO1 are:

1. For the Contractor to provide data, resources and support to develop a near real-time surveillance system that can be queried and used to conduct epidemiologic studies.

2. To maintain and expand a network of U.S. health care databases, particularly including electronic health record (EHR) as well as administrative and claims data sources, that can be transformed into a common data model covering millions of U.S. patients.

3. To develop and use automated tools to execute simple and complex queries as well as observational or epidemiologic studies using a distributed network of health care databases.

Scope:

The Contractor shall provide and expand the database sources, tools, and scientific expertise necessary to perform simple and complex queries and complex epidemiologic studies to assess the safety and effectiveness of all biologics.

1. Develop a system to conduct queries and epidemiologic studies

2. Develop a surveillance system with the capability to conduct near real-time surveillance activities for biologics

3. Provide scientific expertise in different disciplines to support conducting surveillance of biologics

4. Estimate incidence rate of serious adverse events (e.g., sepsis, thrombosis, anaphylaxis, etc.) by use of specific biologics, processing of biologics or brands of products, quantity of product received (when relevant), demographic characteristics of patients, and specific sub-populations of interest (e.g., immunocompromised, pregnant women, neonates, children, elderly, and others)

5. Validate the biologic exposures and specific health outcomes of interest in administrative/claims data and EHR by developing a semi-automated method for chart review and validation purposes

6. Develop new methodologies to link administrative/claims, and EHR to each other and additional data sources as part of the development of semi-automated chart review methods

7. Work with other contractors, if requested by FDA, to leverage expanded data, tools, expertise and other infrastructure; to leverage synergies and advance safety and effectiveness surveillance capabilities and capacity.

8. Develop or leverage new methods, approaches and/or technologies for improving capabilities, efficiencies, or cost savings for surveillance of biologics.

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

2.1 TASK 1: DATA NETWORK REQUIREMENTS

Note: These tasks map to IDIQ SOW Section 2.1.,Task 1: Data sources, Tools, Methods, and Related Infrastructure

The primary goal of this task is to provide FDA access to data sources covering millions of patients in the U.S. and deliver the capability to assess the safety and effectiveness of vaccines, blood and blood products, and tissues and advanced therapies. The Contractor shall provide staffing, support, and infrastructure to use the data to conduct surveillance activities that promote OBE’s mission to assure the safety and effectiveness of FDA-regulated biologics.

The Contractor shall provide:

· Access to a network of large-scale distributed databases transformed into a common data model that include near real-time with a quarterly refresh schedule (less than 4-month data lag), patient-centered, comprehensive demographic, clinical, and ancillary clinical data from administrative and claims, and EHR data sources that are representative of the U.S. population in various care settings and cover vulnerable populations such as children, elderly, pregnant women, immunocompromised patients, and others.

· A common data model that shall

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

· Use a standardized vocabulary to ensure consistency and quality of data across the network of data sources. The standardized vocabulary shall be updated to accommodate gaps in exposure and outcome identification for biologics.

· Provide detailed 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.

The contractor shall provide critical information about the data sources and the populations represented in these sources, within 3 months of task order award. Specifically, the contractor shall:

· Provide a report describing the patient population, participating institutions, and patient care settings for each database in the network, as well as what kinds of coding system each data source uses as the building block for its data including:

· Level of representativeness, which shall include comparisons of size and patient characteristics to the respective catchment area(s) and national level data.

· Inclusion characteristics, which shall include criteria for inclusion/exclusion, average length of follow-up, loss to follow-up, participation in other healthcare systems and healthcare utilization data.

· Patient care settings, which shall include 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, including content and quality of data available in each setting.

· Provide a report describing the use of coding systems in each database ICD9, ICD10, HCPCS, CPT, ISBT-128, and others.

· 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.

Table 1: Task 1 Deliverables/ Work Products

2.2 TASK 2: CONDUCT QUERIES AND EPIDEMIOLOGICAL STUDIES

Note: These tasks map to IDIQ SOW Section 2.2, Task 2: Queries and Epidemiologic Studies

The primary goal of this task is for the Contractor to use data, established methods and tools to conduct analyses such as queries and epidemiologic studies to assess exposures to biologics and related adverse events. The contractor shall provide support infrastructure and all the necessary scientific and administrative personnel to conduct these studies including an interdisciplinary team of scientists and experts such as at least three epidemiologists, subject matter experts on biologic products, physicians with expertise in biologics, medical informaticians, statisticians, at least four computer programmers, medical/billing code specialists, and others who are experienced in conducting safety and effectiveness studies for drugs or biologics. The results of queries and studies shall be provided in tabular and graphical form and sent to FDA using a secure Portal. The epidemiological studies shall also be accompanied by a protocol and a final report.

The Contractor shall:

· Work Collaboratively with FDA to identify projects addressing specific products and adverse events associations for study after the task order is awarded.

· Use the data, tools, and methods to identify trends of biologics utilization over time and assess the epidemiology of biologics, including but not limited to recipients’ demographics, clinical indications, and quantities of the biologic utilization.

2.2.1 SIMPLE QUERIES

The Contractor shall provide the capabilities to use data sources, tools, and methods to conduct up to 50 simple queries to address regulatory questions of interest to FDA. The Contractor shall work collaboratively with FDA to define the query parameters for each simple query. Individual queries shall be completed in no more than 7 business days from the time specifications are confirmed by FDA. The Contractor shall provide the FDA the query output and result report in tabular and graphical format as a deliverable for each simple query.

2.2.2 COMPLEX QUERIES

A complex query is defined as a capability to evaluate exposure and outcome association for biologics and estimate a measure of association, apply advanced methods to account for confounding and bias. The Contractor shall also provide capabilities to use the data sources, tools, and methods to conduct up to 30 moderately complex queries to address regulatory questions of interest to FDA. The Contractor and FDA shall work collaboratively to define the design, data to be used (administrative/claims, EHR), study period, clinical settings, study population, exposures, outcomes, covariates, and analytic approaches.

Once the specifications are confirmed by FDA, the study shall commence and shall be completed in no more than 17 business days. Results shall be provided by the Contractor in tabular and graphical format accompanied by a report containing a description of the query specifications and results interpretation.

2.2.3 COMPLEX EPIDEMIOLOGIC STUDIES

The Contractor shall provide capabilities to use the data sources, tools, and methods to conduct up to 15 complex epidemiological studies to address regulatory questions of interest to FDA. The Contractor shall generate a written protocol describing the details of the study for the biologic exposure(s) and health outcome(s) of interest. The protocol shall describe the key question(s) of interest, background, study objectives, study design, and analytic methods. These descriptions shall be detailed including information on the validation of exposures, outcomes, and covariate definitions. If the protocol requires medical-chart review, preferably using EHR, the contractor shall provide experts to develop the chart abstraction tool and elements to be evaluated. In addition, the Contractor shall perform all medical record reviews and adjudication of reviews (medical records shall never be shared directly with FDA). The completed draft protocol shall be delivered by the contractor within 15 business days of finalizing the study question(s). Once the protocol is finalized and the terms of the protocol, including the timeline, are mutually agreed upon between the Contractor and FDA, +the study shall comply with the agreed upon timeline. The Contractor shall provide a final report describing the study background, objectives, methods, results, conclusions and discussion, strengths, and limitations. The final report shall be submitted no later than 30 business days after study completion. The Contractor shall obtain and meet all required review, approval and standard processes to conduct studies such as Institutional Review Boards (IRB), Federal Information Security Management Act (FISMA), Health Insurance Portability and Accountability Act (HIPAA), data and information technology security and any others. These procedures shall address at a minimum the following: data collection, ownership, and security, management and tracking, consensus definitions, transfer, and sharing considerations for data summaries.

Components of the queries and studies shall include one or more of the following, but not be limited to the following:

· Assessment of emerging infectious diseases risk that impact recipients of blood, blood products, or human tissues including but not limited to Zika, dengue, babesiosis, and others.

· Assessment of safety and effectiveness of vaccines on a regular basis and for pandemics

· Assessment of emerging technologies that impact safety of the blood and tissue supply including but not limited to pathogen inactivation, advances in testing technologies and others identified by FDA.

Special informational considerations for safety of blood and blood products and tissues and advanced therapeutics include the data source's ability to:

· Identify receipt of specific blood components, blood products, and tissue products as well as dose number and lot information (when relevant).

· Identify the temporal sequence to ensure exposure precedes the adverse event or outcome of interest

Products / Adverse Events pairs to be studied Because FDA must be responsive to a changing landscape of products and associated risks (i.e., adverse events, etc.) and benefits (i.e., effectiveness), the BEST system must be flexible and similarly able to respond to safety or effectiveness questions that arise as part of the regulatory review of pre-licensure data or through postmarket surveillance or studies. Accordingly, it is not possible at this time to identify and determine all the specific products and adverse events of interest to be studied. However, below we list some biologics and adverse events that are likely to require surveillance activities knowing that this list is limited and will change over time according to CBER’s regulatory needs.

As part of its philosophy of product safety throughout the lifecycle, FDA has studied and continues to study a number of biologics and adverse events pairs to ensure products continue to have favorable benefit-risk profiles, and also to potentially identify mitigations to further reduce risks.

Vaccines to potentially study may include: Influenza vaccines (e.g., inactivated, live, high-dose, etc.); pneumococcal vaccine; meningococcal vaccine; measles mumps rubella vaccine; varicella vaccine; human papilloma virus vaccine; Herpes zoster vaccine; diphtheria, tetanus, pertussis vaccine; and others.

Potential associated serious adverse events or Health Outcomes of Interest to study for vaccines may include but are not limited to: Febrile seizure, seizure, Bell’s palsy, Guillain-Barre Syndrome, auto-immune conditions, anaphylaxis, Syncope, and others; or outcomes such as confirmed positive influenza test or diagnosis, hospitalization, mortality and others.

Blood components to potentially study include: Whole blood, Red Blood Cells, Packed Red Blood Cells, Platelets, Plasma includes additionally process products that have undergone leukocyte reduction (LR), irradiation, pathogen reduced, solvent-treated, and others.

Adverse events or Health Outcomes of Interest to potentially study for blood and blood components include: Transfusion-related Acute Lung Injury (TRALI), Transfusion-associated Circulatory Overload (TACO), Hemolysis, Hemothrombotic Reactions, Acute Respiratory Distress Syndrome (ARDS), Acute Lung Injury (ALI), Thromboembolic Events (TEE), Transfusion-transmitted infections, Sepsis, Septic shock

Tissues and advanced therapies to potentially study include: Albumin, Intravenous Immune Globulin (IVIg), Intramuscular Immune Globulin, Clotting factors such as Factor VII, Factor VIII, Factor IX, anti-hemophilic factors, fibrin sealants, fibrinogen, acellular dermal matrix allografts, corneal transplants, allograft heart valves, amniotic membrane transplants, cellular therapies, gene therapies, and others.

Potential associated serious adverse events or Health Outcomes of Interest to study for tissues and advanced therapies might include but will not be limited to the following: Hemolysis, Acute Respiratory Distress Syndrome (ARDS), Acute Lung Injury (ALI), Thromboembolic Events (TEE), Transfusion-associated dyspnea (TAD), Allergic reaction (severe), Hypotensive transfusion reaction, Febrile non-hemolytic transfusion reaction (FNHTR), Acute hemolytic transfusion reaction (AHTR), Delayed hemolytic transfusion reaction (DHTR),Delayed serologic transfusion reaction (DSTR), Transfusion-associated graft vs. host disease (TAGVHD),Post-transfusion purpura (PTP), or Transfusion-transmitted infection (TTI), Sepsis, Septic shock, Transplantation transmitted infection, Post-transplant infection, Allograft removal

Table 2: Task 2 Deliverables/ Work Products

Study completion to comply with mutually agreed upon timeline.

2.3 TASK 3: METHODS, INFRASTRUCTURE, AND LINKAGE TOOLS REQUIREMENTS

Note: These tasks map to IDIQ SOW Section 2.1.,Task 1: Data sources, Tools, Methods, and Related Infrastructure. The goal of this task is to establish a number of data linkages to enrich data sources.

2.3.1 LINKAGE OF ELECTRONIC HEALTH RECORDS TO ADMINISTRATIVE CLAIMS DATABASES

Patient-level linkages within and between claims and EHR such that individual patients will have both sources of data and can be followed for several years despite any changes in their health insurance or provider. New methods and capabilities shall be developed to link claims and EHR data within 1 year of the task order award date. This linkage would serve two purposes:

· The EHR data would serve as the standard measure for exposures and outcomes and be used for validation of exposures and outcomes identified in claims data.

· The linkage of two data systems would provide more granular clinical and ancillary clinical data and longer follow-up data for the population whose claims and administrative data are available to FDA.

2.3.2 LINKAGE OF MOTHERS TO BABIES

Linkages between mothers and infants in claims and EHR such that the FDA can assess pregnancy and birth outcomes following exposure to biologics:

· New methods and capabilities shall be developed to link health care data of mothers and their infants within 1 year of the task order award date so that FDA can perform assessments for biologics safety and effectiveness during pregnancy.

· The capability to link the mother-infant data to state birth registries shall be developed as well within 1 year of the task order award date.

Table 3: Task 3 Deliverables/ Work Products

2.4 TASK 4: EXPERIENCE AND EXPERTISE WITH DATA, TOOLS, AND STUDIES

Note: These tasks map to IDIQ SOW Section 2.1., Task 1: Data sources, Tools, Methods, and Related Infrastructure

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; medical officers with expertise in vaccines, tissue, blood and blood products; medical informaticians; biostatisticians; at least four computer programmers; medical/billing code specialists, and others who are experienced in conducting postmarket safety and effectiveness studies for drugs or biologics.

The contractor shall provide a roster of personnel and corresponding expertise and curriculum vitae.

The contractor shall provide experienced personnel who are able to:

· Provide a report describing the Common Data Model (CDM) or related approach, utilization of different coding systems in data sources, 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 designing, conducting, and interpreting the results of simple and complex queries and complex epidemiologic studies.

The contractor shall provide the following information with respect to its scientific experts:

· Time and project involvement of scientific experts

· Curriculum vitae from scientific experts that describe:

· Their experience and expertise

· Their experience and knowledge in working with the data sources, tools, and observational/epidemiologic studies

· Each scientific expert’s current and prior relationships (financial or otherwise) with this and other potential data sources

Table 4: Task 4 Deliverables/ Work Products

2.5 TASK 5: OPERATIONS AND MANAGEMENT

Note: These tasks map to IDIQ 2.3 Section, TASK 3: Operations and Management

The Contractor’s Project Manager, the Principal Investigator (PI), and their administrative support staff shall provide Program Management (PM) as specified in Section 2.3 of the Master Contract SOW and Task Order-level Project Management services to assemble and build the components of the BEST system that can be used by CBER to conduct surveillance-based safety and effectiveness studies for biologics and associations with specific adverse events as part of a national biovigilance system. Briefly, the TO1 requires that the Contractor shall provide access to data sources with millions of patient EHRs; the infrastructure, staffing, and relevant expertise. Moreover, the Contractor 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.

2.5.1 MANAGEMENT PLAN

The Contractor shall deliver a Management Plan as specified in the Master Contract SOW Section 2.3.1. including standard operating procedures and a master plan of procedures.

2.5.2 QUARTERLY PROGRESS REPORTS (QPRs)

The Contractor shall provide task order management to ensure that tasks stay on track and milestones, performance measures, deliverables, and work products are met. The Contractor shall deliver a quarterly progress report (QPR) to the COR and CO on the 1st day of each quarter of the Federal Government fiscal year. At a minimum, the QPR shall contain the following information:

· The previous quarter’s progress

· Deviance from previous quarter’s planned progress (either positive or negative)

· The current quarter’s planned progress

· Status of deliverables

· Issues and recommendations

· Performance and Cost Report (P&CR): the P&CR shall include all recurring and non-recurring costs, cumulative cost, total labor hours, and cumulative labor hours for each task area for the previous month

· Program risks, risk mitigation plans, risk mitigation actions taken and resolution of risks.

Lastly, the Contractor shall ensure that all deliverables are sent in electronic format (i.e. Microsoft Office or Adobe PDF) for the COR’s inspection/acceptance.

2.5.3 KICK-OFF MEETING

The Contractor shall lead a kick-off meeting at FDA White Oak Campus with the COR and Government staff within 10-calendar days of task order award. The purpose of the kickoff meeting is to introduce the contractor staff to the Government and discuss the contractor’s approach to meeting the requirements of the SOW.

2.5.4 ANNUAL IN-PERSON MEETING

The Contractor shall schedule and conduct an annual in-person meeting with FDA personnel at the FDA White Oak Campus in Silver Spring, MD to discuss Contractor’s performance under the task order; and provide a presentation of recently completed or in progress individual task order collaborative studies.

2.5.5 Scientific Workgroup Meetings and Deliverables

The Contractor shall assemble a task order scientific workgroup for every query and epidemiologic study consisting of data, clinical, epidemiologic, biostatistical, and medical coding experts. The Contractor shall schedule and provide administrative support for task order scientific workgroup meetings. In performing this task, the Contractor shall:

· Prepare and distribute agendas and conference call-in information no later than 2 business days prior to the meeting

· Prepare and distribute review materials in advance of the meeting no later than 2 business days prior to the meeting

· Record and distribute minutes and action items to meeting participants no later than 3 business days after the meeting

· Track and maintain a central repository of minutes and action items and associated materials relating to all meetings/calls

· Prepare abstracts and presentations for meetings and conferences no later 10 business days prior to submission or presentation

· Prepare reports and manuscripts derived from analyses under the task order for publication and public and non-public presentations no later than 21 business days prior to the agreed date

2.5.6 Administrative Requirements

The Contractor shall ensure smooth operations between its Coordinating Center, Data holders/partners, and work collaboratively with FDA to ensure delivery of activities such as kick-off meetings, telecons, quarterly reports, and in-person meetings; and completion of queries, query reports, protocols, interim analyses, interim reports and final reports.

The Contractor shall:

· Schedule and run bi-weekly administrative meetings to manage task order operations.

· Schedule and run quarterly executive/leadership meetings for strategic planning.

· Generate a Key Personnel Document providing information as to which key personnel (see Section 3.1 for key personnel) will be used on each project and identifying the percentage of time and staff member effort and contribution to the program on a per-project basis no later than 1 month after the award date.

Table 5: Task 5 Meetings

Table 6: Task 5 Deliverables/ Work Products

2.6 TASK 6: COMMUNICATIONS AND OUTREACH

Note: These tasks map to IDIQ 2.4 Section 2.4, Task 4: Outreach and Communications

2.6.1 Training

The Contractor shall participate in communication and outreach activities as indicated in the Master Contract SOW Section 2.4. The contractor shall provide FDA staff with both small and large group training sessions on use of the data sources, tools, methods, and processes by allowing CBER staff access to the tools and de-identified data through a secure portal. The training sessions shall accommodate new users of the system and advanced users separately. The training sessions will occur over multiple days at FDA both at the start of the task order and whenever FDA determines they are needed throughout the duration of the task order. Training to FDA staff shall include topics such as data sources, study approaches, methods, and tools employed and developed as part of the specific tasks. The specific type of training shall be determined based on the type of data sources and tools and methods developed and shall include development of training manuals and slides, conduct of training sessions, and preparation of other similar activities. There will occur no more than 6 training sessions during the period of performance of this task order. The contractor shall also perform monthly webinar/seminars to report to the FDA and other BEST collaborators on the scientific aspects of ongoing or planned projects such as introducing a new project’s study design, reporting on a query, interim results of a query or study and of final results of a project or study or query during the period of performance of this task order.

2.6.2 Public Website and Secure Portal

The contractor shall create a public website where materials can be posted and be available to the public. 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. The public website shall be developed within 16 weeks of the task order award date.

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. The secure portal will be developed within 16 weeks after task order award date. 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 standard 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 contract and/or TO documents. 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.

Table 7: Task 6 Deliverables/Work Products

2.7 TASK 7: Transition Services

Note: These tasks map to IDIQ Section 2.5, Task 5: Transition Services

Transition planning shall detail activities and practices to ensure minimal disruption to services, and shall extend to both Transition-in (arrival of new contractor) and transition-out (departure of new contractor at end of performance).

2.7.1 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.

Work activities include:

· 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

Table 8: Task 7 Deliverables/Work Products

3. Task Order Administration

3.1 Key Personnel

Per HHSAR 352.237-75, the key personnel specified in this TO are considered to be essential to work performance. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer.

Key Personnel for this Task Order are:

· Principal Investigator

· Project Manager

· Physician

· Epidemiologist

3.2 Period of PERFORMANCE

Task Order Performance Period: 12-month period of performance.

09/17/2018 – 09/16/2019

3.3 PLACE OF PERFORMANCE

The Contractor shall perform specified duties at its own site. Swing space may be provided occasionally to staff members who may need to visit the FDA headquarters for certain meetings and activities.

3.4 GOVERNMENT POINTS OF CONTACT (POCS)

Task Order Contracting Officer’s Representative (COR):

· To be completed at time of award.

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