Attachment 1 BEST3 IDIQ PWS.docx

The CBER Biologics Effectiveness and Safety (BEST) Initiative #3: Data Sources for Surveillance of Biologics (BEST 3)

Solicitation Number: 75F40124R00002

IDIQ Performance Work Statement (PWS) Revised May 6, 2024

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 and blood 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, 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.

The Center for Biologics Evaluation and Research (CBER) regulates biologics which include vaccines, whole blood and blood components, blood-derived products, tissues and advanced therapeutics. Some examples of blood products include 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 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 disease agents: 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.

CBER also conducts surveillance and epidemiological studies working collaboratively with federal partners such as the Centers for Medicare and Medicaid Services (CMS) and Veterans Health Administration (VA) and other partners. To build an active surveillance system focusing on the requirements and characteristics of biologic products, in September 2017, CBER launched the Biologics Effectiveness and Safety (BEST) Initiative. BEST1 and BEST2 has awarded four contracts to support the new system including two recent five-year Indefinite Deliverables Indefinite Quantities (IDIQ) contracts to Acumen, IQVIA, IBM, and Dovel Technologies.

This solicitation is specifically focused on BEST3 to obtain data sources with the following characteristics. This is a recompete of the BEST 3 multiple award IDIQ requirement awarded to The Lewin Group, IQVIA and CVS Health in 2020. This solicitation is seeking large-scale administrative claims data sources covering health records of tens of millions of individuals living in the United States (US) with full access to their medical records for verification of certain identified health outcomes. The solicitation is also seeking access to large-scale electronic health records (EHR) which provide access to both structured and unstructured data elements of EHR and full medical records of individuals. The solicitation is also seeking linked claims-EHR data sources covering large populations and providing access to full medical records. This contracting activity is part of CBER’s continuing efforts to develop data sources and expand the infrastructure to fulfill its mandated regulatory responsibilities to conduct active post-market risk identification and analysis, and safety and effectiveness evaluation of biologic products. Specifically, we seek access to large sources of patient-level data, especially administrative claims data that includes inpatient, outpatient, and emergency department care settings with the additional requirement to provide access to full medical charts of the patients whose claims data are provided by the data network. The contractors should be the primary source of medical administrative claims data such as an insurer or payer and may have their own team of epidemiologists, subject matter experts, programmers, and others who are experienced in using and interrogating their data sources to conduct safety and effectiveness studies for drugs and biologics in a distributed network system. The contractors will be working with the BEST coordinating center(s) and receive support to participate in a distributed network of data providers.

In response to the COVID-19 global pandemic, the US federal government and public-sector initiated Operation Warp Speed to accelerate the vaccine development process. In December 2020, two vaccines received Emergency Use Authorizations (EUA) and were distributed to the public for use in the adult population and one for adolescents ages 16 – 17 years of age. Since authorization of the first two vaccines other vaccines have been authorized for COVID-19 to address potential, new circulating SARS CoV-2 strains. Additional COVID-19 vaccines have been further authorized for use in children and adolescents ages 6 months to 17 years of age, as well as monovalent boosters and bivalent boosters for adults. Certain COVID-19 vaccines have been approved or licensed for use in adults and children. With most FDA authorized/approved vaccines, there may be limited safety data available for certain outcomes, particularly rare outcomes, in the randomized controlled trials conducted in the pre-market phase of medical products development and evaluation. Soon after the first COVID-19 vaccines were available to the American public, the BEST Initiative has conducted post-market active surveillance of all authorized/approved COVID-19 vaccines in large healthcare databases, including administrative claims, to further evaluate safety profiles and provide timely information to support regulatory decision-making. In addition, BEST has conducted or has been conducting studies for COVID-19 vaccines to evaluate vaccine effectiveness in a real-world setting using real-world data which may be different from the vaccine efficacy evaluation conducted in randomized controlled trials in the pre-licensure phase such as effectiveness in certain sub-populations or virus variants, severity of illness, and others.

The CBER BEST Program’s mission and funding is transitioning from a COVID-19 vaccine focus to include more evaluations of the safety and effectiveness of other CBER-regulated biologic products. CBER’s BEST Program has operated for 5 years, and FDA expects cost savings due to contractor operational efficiencies and the return to pre-pandemic surveillance funding levels. The BEST IDIQ represents a broad scope of activities including a rapid Agency response to a future epidemic or pandemic.

1.2 Biologics Effectiveness and Safety (BEST) Initiative Objectives and Scope This contract builds and expands upon activities undertaken as part of previous FDA collaborative studies for biologic products safety and effectiveness and the data needed to conduct it, such as the BEST Initiative’s previous contracts. This solicitation does not seek IT software solutions, IT analytic platforms, open-source healthcare databases, aggregated and linked healthcare data collected from disparate sources, and healthcare data without access to full medical charts. In addition, FDA does not seek access to certain data sources for specific populations where we already have data such as the Centers for Medicare and Medicaid (CMS) data sources for Medicare and Medicaid or any existing FDA reporting systems such as the FDA Adverse Events Reporting System (FAERS) and Vaccine Adverse Events Reporting System (VAERS).

Objectives The primary objective of this solicitation is to obtain and maintain data sources for the CBER BEST Initiative. This solicitation seeks large-scale processed, curated, fit-for-purpose adjudicated administrative claims data sources covering health records of tens of millions of individuals living in the US with full access to their medical records, as well as large-scale electronic health records (EHR) which provide access to both structured and unstructured data elements of EHR and full medical records of individuals, and linked claims-EHR data sources covering large populations and providing access to full medical records. The data sources should also have the capability to link their data to the immunization registries across the country called Immunization Information System (IIS) to supplement their vaccine exposure data with respect to all vaccines particularly COVID-19, seasonal influenza, monkeypox, and others. The data sources will be participating in a distributed network of data providers and work with other data partners, coordinating center(s), and other collaborators.

The data sources shall provide longitudinal health care data for participating patients. The distributed data network may use a common data model (CDM) (potentially OMOP CDM). Access to full medical charts of individuals whose health care data are provided by the administrative claims, or EHR, or linked claims-EHR data sources is required. The data will be refreshed on a monthly (or every two weeks) basis for administrative claims data sources and perhaps more frequently for EHR data sources. The data lag shall not be longer than three months. The IIS linked data will be updated on a monthly (or every two weeks) basis as well.

1.3 Scope

The Contractor shall, independently and not as an agent of the Government, provide all necessary resources and personnel to support the CBER BEST program for the post-market safety and effectiveness surveillance of all biologic products. The scope of this program is the following. The data sources shall provide:

1. Health care data covering exposure to all US biologic products particularly vaccines, blood products, tissues and advanced therapeutics.

2. Processes to provide access to full medical charts of all patients stripped of any individual identifiers for review, abstraction, and adjudication in the context of surveillance activities.

3. Support for the CDM (if utilized) to accommodate granular clinical data and some ancillary clinical data such as laboratory test results and others (if available).

4. The data will be refreshed on a monthly (or every two weeks) basis for administrative claims data sources and more frequently for EHR data sources. The data lag shall not be longer than three months.

5. The available data for analyses are quality checked using a rigorous and 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 three months preferably. The minimum data elements required to be included in the data sources include, but are not limited to, demographic, granular clinical and ancillary clinical, health care utilization, laboratory test results, and geographic distribution in all care settings.

6. Support for data sources to include characteristics and capabilities to build a data network as a distributed database to provide access to health care data of a large US population.

7. Support and tools for FDA to utilize the large database as follows:

a. Computer and informatics experts to design and execute queries and epidemiologic studies and to translate safety and effectiveness questions into a computer programming language to interrogate the database.

8. Capability to link health care data of mothers and their infants so that FDA can assess safety and effectiveness of biologic products during pregnancy and in the newborn.

9. Capability to link health care data to IIS across the country to supplement vaccine exposure data for all vaccines and update the data on a monthly (or every two weeks) basis.

10. Maintenance and improvements to the structure for the governance of the program.

11. Collaboration with other vendors and 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 and Analytic Capabilities

The conduct of postmarket safety and effectiveness of biologic products under the BEST Initiative shall require the contractor to have access to data sources covering millions of patients and providing longitudinal data and to have access to full medical records of participating patients in the data sources.

2.1.1 Data Sources

The representative tasks objectives include:

· 2.1.1.1. Providing access to large-scale database(s) that includes near real-time (less than 3-month data lag), patient-level, comprehensive demographic, clinical, and ancillary data from administrative claims, EHR, and linked claims-EHR data sources that are representative of the US population with access to complete patient medical chart information. respect to the data sources, provide information about the type of data sources and the populations represented in these sources.

· 2.1.1.2. Utilizing a Common Data Model (CDM) (for example, Observational Medical Outcomes Partnership (OMOP model), if applicable). The databases shall have the following characteristics.

· Data to support surveillance of all biologic products

· Clinical and ancillary data, laboratory test results, demographics, and other related data elements

· Data with mother-infant linkage

· Linkage to IIS data sources across the country to supplement data for all vaccines

· Storage capacity for different versions of databases

· Monthly or every two weeks data refresh of data sources and the IIS data

· 2.1.1.3. With respect to the data sources, provide information about the type of data sources and the populations represented in these sources.

· 2.1.1.4. Provide demographics of the patient population, type and geographic distribution of participating institutions, types of care settings, average length of follow-up for patients, number of current and historical enrollees in participating health plans.

· 2.1.1.5. Develop a data quality assessment plan for each database with respect to all coding systems used in the database such as the International Classification of Diseases (ICD) codes ICD9, ICD10, ICD11, the Healthcare Common Procedure Coding System (HCPCS) codes, Current Procedural Terminology (CPT) codes, and other coding systems used in administrative claims and EHR data sources.

· 2.1.1.6. Develop a quarterly report to present the results of the data quality assessment plan for each database and develop an action plan to correct any deficiencies or missing data based on the quarterly report results.

· 2.1.1.7. Work with the coordinating center(s) to set up, implement, and report the data quality assessment plans.

2.1.2 Analytic Capabilities

In collaboration with coordinating center(s), the contractor shall develop analytic capabilities to conduct simple and complex data queries and studies to interrogate the databases pertaining to the contractor’s in-house databases that have been previously used to conduct similar analyses. The queries can range from simple cohort identification or frequency distribution of events to complex assessment of association between exposures and outcomes adjusting for confounding.

The representative tasks objectives include:

· 2.1.2.1. Provide the necessary personnel such as epidemiologists, experts on their own databases, computer programmers, and project managers to maintain, update, and interrogate the databases, and run queries and studies in a distributed data network environment pertaining to the contractor’s own databases.

· 2.1.2.2. Participate in conducting simple and complex queries and epidemiologic studies to evaluate the safety and effectiveness of biologic products to address regulatory issues initiated by the CBER staff.

· 2.1.2.3 Provide the capability and capacity in terms of data sources, scientific expertise, medical chart procurement, and operational management to run queries and studies.

The deliverables shall include access to data, data quality assessment plan and reports, participation in designing and implementing studies and preparing results. Deliverables must not exceed the agreed upon timeline between the contractor and the CBER staff.

To meet the requirements for performing queries and studies, the representative tasks include:

· 2.1.2.4. Collaborate with FDA to establish and meet timelines to prepare query and study results. Timelines will be dependent on complexity of the query or study and shall be established in the management plan and agreed upon by the contractor, CBER staff, and coordinating center(s).

· 2.1.2.5. Provide a secure portal for communication and data transfer.

· 2.1.2.6. Collaborate with FDA in the publication of study results in agreement and compliance with CBER policies and procedures.

· 2.1.2.7. Recruit the personnel in the relevant labor categories with the relevant scientific expertise to participate in the contract work performance.

Queries and studies are divided into four categories:

1. Feasibility assessments which include but are not limited to frequency distribution of medical exposures or events or outcome(s) within a specified study population and timeframe.

2. Descriptive epidemiologic studies which are defined as a study that summarizes patterns of exposure or outcomes in terms of time, place and populations. Descriptive studies shall include but are not limited to frequency distribution of medical exposures or outcome(s) within a specified study population and time period of events in relation to each other.

3. Inferential epidemiologic studies which include studies with efforts in operationalizing complex study designs, analytic methods, or infrastructure.

4. Infrastructure or methods development studies which are defined as activities that expand the data infrastructure or develop new epidemiologic or biostatistics or informatics methods to be applied to the inferential studies.

2.1.3 Medical Records

Some complex queries and epidemiologic studies may include a medical chart review component.

The representative tasks objectives include:

· 2.1.3.1 Contractor requires access to full medical chart of patients whose health care data are available in the databases.

· 2.1.3.2 Obtain patients’ medical charts for certain queries and studies in a timely manner, to abstract the relevant data, and in some cases have clinicians adjudicate relevant exposures, outcomes, and covariates; in other cases, the data provider will obtain the medical charts, remove all personal identifiers, and transfer them to the coordinating center(s) so that the chart review process will be conducted by the coordinating center and its experts. FDA will not have access to the medical charts;

· 2.1.3.3 Provide the chart review results to FDA as part of query or study results in a de-identified and aggregate format.

2.1.4 Immunization Information Systems

Immunization Information Systems (IISs) are vaccine registries which are managed and maintained by the local and state level public health authorities. They are confidential, population-based, computerized databases that record all immunization doses administered in their respective local and state jurisdictions. Health care databases capture a large proportion of vaccine exposures, but they miss a proportion depending on where the vaccine exposure occurs. As a result, health care databases should set up legal agreements with IIS across the country to link their data to the IIS to supplement the vaccine exposure data of their enrollees for all vaccines. This linkage is necessary for FDA to be able to conduct safety and effectiveness studies of vaccines.

The representative tasks objectives include:

· 2.1.4.1. The linked data should be updated on a monthly (or every two weeks if feasible). FDA will not have access to the IIS data or the linked data.

2.2 Task 2: Business Operations and Management

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

2.2.1 Business Operations

The representative tasks objectives include:

· 2.2.1.1. Ensure efficient operations between data sources, FDA staff, and coordinating center(s) to safeguard optimal delivery of activities such as CDM ETL (Extraction, Transformation, and Load Process), data transfer, meetings, telecons, and study results.

· 2.2.1.2. Develop a management plan containing written processes and procedures for collaborating with CBER and the coordinating center(s) to provide health care data, obtain and review medical charts, and participate in running queries and studies. Details of the collaboration will be determined on a task order basis, by mutual decision of all collaborating parties. Collaboration includes sharing computer codes, design of queries and studies, preparing protocols, summary and aggregate data, interpretation of findings, review of manuscripts, and co-authorship of publications.

· 2.2.1.3. 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 administrative 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)

· Preparing and maintaining the Program Management Plan

· Preparing quarterly financial expenditure reports for each query and study

· Preparing and submitting monthly progress reports and invoices

· 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 CBER staff, coordinating center(s), and other collaborators to carry out the work of the contract per Sections 2.1 to 2.4

· Attending regular workgroup meetings, administrative meetings, and quarterly meetings virtually or in-person if necessary

· 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 2.2.4

· 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 different aspects of projects

2.2.1 Task Order Management Plan

The representative tasks objectives include:

· 2.2.1.1. For each task order released under this performance work statement, 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.

· 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.

2.2.2 Establish Project-Specific Performance Work Statements and Procedures

The representative tasks objectives include:

· 2.2.2.1. Collaborating with the FDA to develop and finalize the BEST projects performance work statements (PWS) at the task order level and a Management Plan (MP) and update them as needed to reflect the individual task order (ITO) activities.

· 2.2.2.2. 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) (if needed although in case of most studies IRB approval is not needed since the BEST work is designated as surveillance and not research), 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. Moreover, the contractor shall develop and implement secure and robust data use, data quality control, tracking, and management for all analyses.

· 2.2.2.3. Developing, implementing, and maintaining secure and robust data use, data quality control, tracking, management, and secure storage procedures for confidential, private data, each analysis and for all analyses.

· 2.2.2.4. Developing a specifications document for queries and a protocol for 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, and other components for a full study protocol.

Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all electronic and information technology (EIT) supplies and services developed, acquired, or maintained under this contract or order must comply with the “Architectural and Transportation Barriers Compliance Board Electronic and Information Technology (EIT) Accessibility Standards” set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the “Access Board”) in 36 CFR part 1194. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of Section 508 Final Provisions can be accessed at https://www.access-board.gov/ict/ and https://www.hhs.gov/web/governance/digital-strategy/it-policy-archive/hhs-policy-section-508-compliance-accessibility-information-communications-technology.html.

2.2.3 Organization and Management Procedures

The representative tasks objectives include:

· 2.2.3.1. Schedule and facilitate (to include notes, minutes, action items) meetings with FDA personnel to ensure efficient 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.

2.2.4 Financial Reporting Procedures on Funded Task Orders

The representative tasks objectives include:

· The contractor shall provide financial expenditures on a quarterly basis (in Excel) for all task orders (See Attachment A) to meet FDA audit and internal reporting requirements. Enhancements to the financial expenditures report may occur throughout the contract’s period of performance and reporting improvements may be proposed by the Contractor. All project codes and naming conventions are issued by the Coordination Center to ensure reporting accuracy across all Data Partners.

Financial Reporting Expenditures

· Financial Expenditures by Project Areas – Use a universal tracking code by all contractors

· Administrative Activities

· Data Management/Infrastructure

· Immunization Information Systems (IIS), if applicable

· Project/Studies

· Publication Costs (journal charges, if applicable)

· Travel

· Other Direct Costs (ODCs)

· Financial Expenditures by Individual projects within a Project Area – Tracking code or code listed in the Project Name

· CODE - Name of Project

· Labor categories used, Total Number of hours and Total project cost

· Study type: feasibility assessment, descriptive epidemiologic study, Inferential epidemiologic study, and Infrastructure or methods development study

· Categories would include # Jurisdictions:

· IIS data being used in BEST analyses

· Data received and approved for inclusion in analyses

· Data reviewed but not approved for use in studies

· Agreements in place

· State declined

· Indicate if all vaccines included or only a subset (i.e., COVID-19, Mpox, etc.)

· Study related to State IIS data (If applicable)

· Data Network Activities

2.2.5 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.

· Cost associated with the Risk Solution or Workaround

2.3 Task 3: Communications and Outreach

The contractor shall ensure ongoing communication and reporting to FDA. This includes the tracking, reporting, and outreach as necessary.

2.3.1 Annual in-Person Meeting

The contractor shall participate in the annual meeting to discuss work related to the ongoing task orders, projects or tasks completed previously and the work plan that will be completed in the future. This meeting may be virtual or in-person depending on the situation with respect to any ongoing public health emergency.

2.3.2 Annual Public Workshop

The contractor shall participate in an annual public workshop and assist CBER to organize the workshop. The purpose of the workshop will be to present the results from the BEST Initiative activities to the public and the scientific and regulatory community.

2.3.3 Publications

The contractor shall participate in developing drafts of protocols, reports, presentation materials (e.g., presentation slides and posters), and manuscripts.

Protocols, final reports, and final work products will be posted to a web-based resource library (BEST website) 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/OBPV, and other involved parties. Authorship and other matters relating to publications shall be determined at the task order level. Manuscripts will be also prepared for submission to public pre-print servers as well as peer-reviewed journals. Presentations will be made to the public and in scientific meetings and conferences nationally or internationally or within FDA and other government agencies.

2.3.4 Secure Portal

The contractor shall create and utilize 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 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, Section 508 compliant, 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. Furthermore, the contractor shall deliver a user-friendly secure portal with graphical interface for conducting day-to-day executive.

2.4 Task 4: 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.

2.4.1 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.

2.4.2 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

2.5. Representative Deliverables & Meetings

Five (5) Year Ordering Period

· Telecons: monthly executive/ leadership, monthly administrative meetings (as needed), and weekly scientific workgroup

· Post all contract deliverables with accompanying instructions in resource library

2.5.1 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 performance work statement 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.

PERFORMANCE REQUIREMENTS SUMMARY

Performance requirements will vary by task and will be defined in the specific task orders

Work Requirement

3. 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 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 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 may 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 CO. 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.

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

0. 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.

1. 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.

0. 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:

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

0. 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;

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

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

1. 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.

1. 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.

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

0. Information Security…