Attachment 2 BEST 3 Task Order 1 SOW.docx

ATTACHMENT 2

CONTRACT NO.

BEST 3 IDIQ TO

ORDER NO.

PAGE OF

1 15

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

Task Order 1 Statement of Work (SOW)

May 30, 2024

Table of Contents

BEST 3 IDIQ

ORDER NO.

Table of Contents

1 Introduction

1.1 Background

Specifically, FDA seeks 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 technical support as needed to participate in a distributed network of data providers. These data providers consist of task order awardees and their subcontractors who provide medical administrative claims data to the FDA for analysis and coordination with the Coordinating Center.

CBER has regulatory responsibility for ensuring the safety and effectiveness of biologic products such as vaccines; advanced therapies including cellular and gene therapies; and blood and blood products. During the recent pandemic and public health emergency certain COVID-19 vaccines were approved or licensed for use in adults and children. With most FDA authorized/approved vaccines, there is usually 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 authorization of the first COVID-19 vaccines, the BEST Initiative conducted post-market active safety 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 vaccine effectiveness studies for COVID-19 vaccines to evaluate vaccine effectiveness in a real-world setting using real-world data. such as effectiveness in certain sub-populations or virus variants, severity of illness, and others. In 2024, as the US continues transition from the pandemic, for the fall season in addition to new COVID-19vaccines, there are two new Respiratory Syncytial Virus (RSV) vaccines as well as influenza vaccine formulations. Beyond vaccine products, there are other CBER-regulated biologic products that BEST will begin to focus on cellular and gene therapies as well as other advanced therapeutics for rare diseases which will raise new challenges and may require descriptive analyses or different approaches than may have been used in prior BEST studies.

1.2 Biologics Effectiveness and Safety (BEST) Initiative Objectives and Scope This Task Order builds and expands upon activities undertaken as part of previous FDA collaborative studies for biologic products safety and effectiveness, such as the BEST Initiative’s previous Task Orders.

The Government estimates the first task order may have a total price range from $6M to $12M among all awardees. The Government has provided the range to facilitate the development of the proposals in RFTOP schedule. It is anticipated that there may be several awardees for this task order, but total amount of all awardees is anticipated not to exceed this range. A proposal outside of those ranges may still be determined to be acceptable, however it may be subject to the availability of funds. Parameters - $6 to $12M range (i.e.: Contractor A $3M, Contractor B $4M, and Contractor C $1M to illustrate the low end of the range.)

Regardless of different task orders written off the IDIQ, any contractor who supplies patient data/information to multiple FDA Centers/Offices cannot double charge the FDA for the same information. Contractors may evenly split the actual patient data/information charges across FDA contract holders. In the event FDA has already paid for the data/information charges and another FDA Center wants that same information; each Center will initiate a chargeback to share overall costs. Contractors may dispute a reduction in charges by demonstrating the patient data/information is unique and is not able to be shared across FDA Centers. Contractors will be audited to ensure compliance.

1.3 Objectives

The primary objective of this Task Order is to obtain and maintain data sources for the CBER BEST Initiative. This task order seeks large-scale 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. Depending on the database to be utilized, 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.

1.4 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. Ability to 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 of biologic products during pregnancy.

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 Contractor shall provide 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. The contractor shall use a Common Data Model (CDM) (for example, Observational Medical Outcomes Partnership (OMOP model), if applicable). The CDM is a data standard, designed to standardize the structure and content of observational data and to enable efficient analyses that can produce reliable evidence for analysis. 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

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

· 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

· 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.

· 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

· 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 own databases. 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 contractor shall 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. The contractor shall 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. The contractor shall 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 contractor shall:

· 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).

· Provide a secure portal for communication and data transfer.

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

· 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. This Task Order requires access to full medical chart of patients whose health care data are available in the databases. The contractor shall have the capability and capacity to 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; the contractor shall 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 (IIS)

Immunization Information Systems (IISs) are vaccine registries which are managed and maintained by 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 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: 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, all respective activities throughout the period of performance.

The contractor shall 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.

The Contractor shall:

· 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 (Refers to the task order awardees, subcontractors, and the BEST1 Coordinating Center). 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.

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 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 (TOMP)

The 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 with the Coordinating Center to promote cohesiveness among activities.

2.2.2 Establish Project-Specific Statement of Work and Procedures The contractor shall work collaboratively with the FDA to develop and finalize the BEST projects statement of work (SOW) at the task order level 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). The FDA policy with regard to federally funded Research in Human Subject have changed with the implementation of the 2018 Revision to the Common Rule. “The FDA will determine if FDA is considered engaged in the research for purposes of 45 CFR part 46 or if an IRB Institutional Review Board Authorization Agreement (IAA) is needed with FDA as the relying institution.” In most BEST studies, IRB approval is not needed since the BEST work is designated as surveillance and not research). FDA and its contractors will adhere to the designation of most studies as surveillance; accordingly, IRB approval is not needed. FDA and its contractors shall adhere to 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, management, and coordination for all analyses.

Representative activities include, but are not limited to:

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

· Developing a query specifications document for queries and protocol 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 contractor shall 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 this task order.

2.2.4 Task Order Financial Reporting Procedures

Refer to the IDIQ SOW for the contractor’s reporting of financial expenditures on a quarterly basis (in Excel) (See Attachment A – an illustration of the reports for Contractor’s Quarterly Report for Financial Expenditures by Project Areas and a Contractor’s Quarterly Report for Financial Expenditures by Individual Projects within a Project Area).

2.2.5 Risk Management

The risk management plan shall follow the criteria set in the IDIQ SOW.

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 this task order, 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. 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 maintain 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 analysis.

2.4 Task 4: Transition Services

Refer to the IDIQ SOW for transition services.

2.5. Task Order Deliverables & Meetings

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

· Post all contract deliverables with accompanying instructions in resource library

Request Type (Budgeted Number for Commercial Databases)

Feasibility Assessment (50)

Descriptive Epidemiologic Study (35)

Inferential Epidemiologic Study (6)

Infrastructure and Methods Study (4)

Methodology for Categorization and Counting of Requests Below describes guiding principles for categorizing and counting BEST requests; requests are evaluated on a case-by-case basis. Each contract year, BEST prepares a predetermined number of queries per category that they expect to use throughout the contract year. The numbers of queries are shared with each character and counted accordingly throughout the course of the contract. In the event the number of queries in a particular category has expired, i.e., will be exceeded, one or more queries from a lesser category and/or category with excess remaining counts may be converted for use in the deficient query count category.

Categorization of Requests

Feasibility Assessments

· Intended to provide information on the viability of future analysis of a study question in a specified population by providing summary information such as frequency of medical exposures or outcomes or conducting analyses to assess statistical power.

Descriptive Epidemiologic Studies

· Development of documented study specifications is required ahead of study initiation.

· Provides descriptive summaries of populations and outcomes without methods employed to establish causal relationships, e.g., will typically not involve fitting of models (covariate adjustment) or hypothesis testing.

· May report incidence rates, rate ratios, odds ratios, or other statistics.

Inferential Epidemiologic Studies

· Development of a formal protocol is required ahead of study initiation.

· Involves application and operationalizing of study designs and statistical methods to test hypotheses, potentially with the aim of establishing causal relationships between exposures and outcomes.

Methodologic Studies

· Develop new methods in epidemiology, biostatistics, or bioinformatics.

· Integrate qualitative and quantitative techniques, and new technology, to derive study designs, analytical approaches, or techniques as complex regulatory questions emerge.

Counting of Requests

· A study begins at the time that the request is made by FDA and specifications, including scope (outcomes, exposures, population) are finalized and ends once the data partner has delivered results that pass QA checks by the BEST Coordination Center and FDA and satisfy the request.

· If a data partner needs to run a code package for a specific study multiple times to obtain usable or reliable results, this will still only count as a single study.

· If multiple outcomes or exposures of interest are indicated in the finalized scope of the initial request, then performing an assessment with the same methodology for each of these outcomes will generally not be considered separate feasibility assessments; however, if at a later point in time additional outcomes, exposures or populations are requested, this may be considered a new feasibility request.

· Generally, requests to obtain results using an updated data cut will not be considered a new study request unless there is some corresponding change in methodology.

· For inferential epidemiologic studies, if the study specifications or protocol document indicates that the analysis will be run multiple times, has the potential to be updated with an updated data cut, may involve re-evaluation of outcomes of interest, or other pre-specification of an ongoing nature, then each of run by a data partner to satisfy these conditions will still be considered under the original descriptive or inferential study.

· For descriptive epidemiologic studies, the analysis will be counted as a new analysis for each specified run of the analysis (e.g., for a descriptive study involving quarterly monitoring, this will be counted as four distinct descriptive analyses).

2.5.1 Delivery Instructions for Deliverables

Refer to the IDIQ SOW for instructions for deliverables.

3. Contract Constraints

1. Refer to the IDIQ SOW for contract constraints.

3.1 Security and Privacy

Refer to the IDIQ SOW for Security and Privacy requirements.

4. Other Requirements

4.1. Key Personnel

Per HHSAR 352.237-75, the key personnel specified in this IDIQ contract are considered to be essential to work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced), the Contractor shall notify the Contracting Officer. The Contractor shall submit a comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this Contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer.

Identify one (1) Key Personnel at the Task Order Level for the following:

· Principal Investigator

· Project Manager(s)

· Epidemiologist(s)

· Research Analyst/Programmer(s)

4.2. Government Furnished Information (GFI)/ Government Furnished Equipment (GFE) The FDA intends to provide the Contractor with Government Furnished Information (GFI) that results from the collection of data from the data partners and collaboration of data among the task order awardees and the BEST1 Coordination Center. FDA can provide the Contractor with Government Furnished Equipment (GFE) as needed.

4.3. Travel

Refer to the IDIQ SOW for travel procedures if they are required during this task order.

4.4. Administrative

4.4.1 Task Order Period of Performance

The Task Order’s period of performance is for Base (12 months). The FDA may revise the requirements as FDA’s mission evolves due to funding and public health initiatives.

Base: 09/30/2024 – 09/29/2025

4.4.2 Place of Performance

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

4.4.3 Government Points of Contact (POCs)

Contract Officer Representative (COR):

· To be identified at award

5. Labor Category Descriptions

Please refer to the IDIQ SOW for the labor category descriptions:

6. Attachment A

Refer to the IDIQ SOW for detailed information on the Contractor’s Quarterly Report for Financial Expenditures by Project Areas and the Contractor’s Quarterly Report for Financial Expenditures by Individual Projects within a Project Area.

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