The CBER Biologics Effectiveness and Safety (BEST) Initiative: Data, Tools and

Infrastructure for Surveillance of Biologics

IDIQ Statement of Work (SOW)June 21, 2018

Table of Contents1. Introduction............................................................................................................................................1

1.1 Background..................................................................................................................................11.2 Biologics Effectiveness and Safety (BEST) Objectives and Scope.................................................2

2. Tasks Description.....................................................................................................................................42.1 Task 1: Data sources, Tools, Methods, and Related Infrastructure..............................................42.1.1 Data Network...............................................................................................................................42.1.2 Tools............................................................................................................................................52.1.3 Methods Development................................................................................................................52.1.4 Expertise and Experience with Data and Tools............................................................................62.2 Task 2: Queries and Epidemiologic Studies..................................................................................72.2.1 Simple Queries.............................................................................................................................72.2.2 Complex Queries..........................................................................................................................72.2.3 Complex Epidemiologic Studies...................................................................................................72.3 Task 3: Operations and Management..........................................................................................82.3.1 Task Order Management Plan.....................................................................................................92.3.2 Establish Project-Specific Protocols and Procedures.................................................................102.3.3 Organization and Management Procedures..............................................................................102.3.4 Risk Management......................................................................................................................102.4 Task 4: Outreach and Communications.....................................................................................112.4.1 Training......................................................................................................................................112.4.2 Monthly Webinars/Seminars.....................................................................................................112.4.3 Annual Public Workshop............................................................................................................112.4.4 Publications...............................................................................................................................112.4.5 Public Website...........................................................................................................................112.4.6 Secure Portal..............................................................................................................................122.5 Task 5: Transition Services.........................................................................................................122.5.1 Transition-in...............................................................................................................................122.5.2 Transition-out............................................................................................................................132.6 Deliverables...............................................................................................................................132.6.1 Delivery Instructions for Deliverables........................................................................................14

3. Contract Constraints.............................................................................................................................143.1 Security and Privacy...................................................................................................................153.1.1 Baseline Security Requirements................................................................................................15

4. Other Requirements.............................................................................................................................254.1 Key Personnel............................................................................................................................254.2 Government Furnished Information (GFI) / Government Furnished Equipment (GFE).............254.3 Travel.........................................................................................................................................254.4 Administration...........................................................................................................................254.4.1 Period of Performance...............................................................................................................254.4.2 Place of Performance.................................................................................................................264.4.3 Government Points of Contact (POCs).......................................................................................26

5. Labor Category Descriptions

1. INTRODUCTION1.1BACKGROUND The U.S. Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biologic products, medical devices, tobacco products, our nation’s food supply, cosmetics and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines, devices, products, and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health. As part of its mission, the FDA conducts monitoring of the safety of regulated products.

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

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

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

In response to the FDA Amendments Act of 2007 (FDAAA 2007) with the goal to build an active postmarket risk identification and analysis system, the FDA established the Sentinel System and built a national electronic data system for monitoring the safety of FDA-regulated medical products. Sentinel is a distributed database system consisting of numerous data partners who retain operational control over their data; the Sentinel contract (5 years) was awarded to the Harvard Pilgrim Health Care Institute (HPHCI) in FY2015 which set up a coordinating center to manage, receive, and process FDA questions in the form of queries and return summary results back to the FDA. The FDA Center for Biologics Evaluation and Research (CBER) established the Post-licensure Rapid Immunization Safety Monitoring (PRISM) System, within Sentinel, to conduct active postmarket safety studies of vaccine safety and effectiveness. CBER also established the Blood Safety Continuously Active Network (BloodSCAN), within Sentinel, to carry out active postmarket safety evaluation of blood and blood products. In addition to PRISM and BloodSCAN, CBER established Surveillance of Tissues and Advanced Therapies (STAT) to perform active postmarket safety evaluation of tissues, cellular therapies, genetic therapies, and other advanced therapeutics. CBER uses the Sentinel System to conduct some of its epidemiological studies as part of its regulatory responsibilities.

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

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

CBER plans to award two Indefinite Deliverables Indefinite Quantities (IDIQ) contracts in FY2018, as part of its Biologics Effectiveness and Safety (BEST) initiative. CBER is continuing efforts to develop additional active postmarket risk identification and analysis systems by using new data sources, enhanced capabilities and expanded infrastructure with the goal of providing deliverables in a more cost-effective, efficient, and timely manner. This solicitation is specifically focused on the data, tools and infrastructure for the surveillance of biologics.

CBER’s BEST initiative expands our work beyond current partners (such as CMS and HPHCI) to provide data sources; infrastructure; capabilities and deliverables in a more cost-effective, efficient, and timely manner. The BEST Program will become part of the growing and evolving network of CBER postmarket safety and effectiveness analysis systems in the Sentinel Program. This request seeks to identify and develop new methods, approaches, and systems, and may not repeat work currently underway in those programs but is intended to expand CBER OBE’s postmarket safety and effectiveness work in the areas listed above. Provide FDA with access to large sources of patient-centered data, especially clinical data in Electronic Health Record (EHR) format and claims data for inpatient and outpatient settings. Access to medical charts is preferred. The proposed FDA work may be conducted under a number of possible organizational structures and arrangements. The data holder(s) or other organization(s) may have their own team of at least three epidemiologists, subject matter experts, bioinformaticians, at least four programmers and others who are experienced in conducting safety and effectiveness studies for drugs and biologics. Alternatively, the Contractor may work with other organizations, such as a contract research organization or academic partner(s) which has its own team or may assemble its own team of such experts, and may serve as a Coordinating Center to manage the work.

1.2 BIOLOGICS EFFECTIVENESS AND SAFETY (BEST) OBJECTIVES AND SCOPE

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

1.3 OBJECTIVESThe objectives of this contract are:

1. To provide FDA with indirect access to large-scale United States (US) health care data of millions of patients including administrative and claims as well as electronic health records (EHR) data

sources using a distributed data model and network which would require the use of a common data model (CDM).

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

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

1.4SCOPEThe Contractor shall, independently and not as an agent of the Government, provide all necessary resources and personnel to build the new CBER BEST program for the postmarket safety and effectiveness surveillance of all biologic products. The scope of this program is the following:

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

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

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

4. Support for data sources to include the following characteristics and capabilities:a. Building a data network as a distributed database to provide access to health care data

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

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

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

5. Support and tools for FDA to utilize the large distributed data network as follows: a. Scientific experts to design and execute queries and epidemiologic studies. b. Automated tools that can easily and rapidly perform simple and complex queries as well

as execute complex epidemiologic studies in a timely manner. 6. New methods and capabilities developed to link health care data of mothers and their infants so

that FDA can perform assessments for vaccine safety during pregnancy. 7. New methods and capabilities developed to link claims and EHR data. 8. Semi-automated methods and processes developed to validate clinical outcomes and exposures

to replace manual medical chart review. 9. Governance structure developed as well as policies and procedures for the governance of the

program. 10. Collaboration with other vendors and/or partners to form larger data networks and to leverage

and build upon tools previously developed by other contractors for FDA.

2. TASKS DESCRIPTIONThe following tasks constitute the performance of work expectations for the BEST program support.

2.1 TASK 1: DATA SOURCES, TOOLS, METHODS, AND RELATED INFRASTRUCTUREThe conduct of postmarket safety and effectiveness surveillance of biologic products and development of new innovative methods under the BEST system shall require the contractor to have access to data sources covering millions of patients; necessary tools for data queries and analyses; and the resources such as technical expertise to support this endeavor.

2.1.1 DATA NETWORK The Contractor shall provide access to a network of large-scale distributed databases that include near real-time (less than 4-month data lag), patient-centered, comprehensive demographic, clinical, and ancillary data from administrative and claims, and EHR data sources that are representative of the US population. This distributed database is expected to grow over the course of the contract with an emphasis on expanding access to EHR data sources and building a large network of EHR data providers. In addition, the contractor shall use a CDM that shall:

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

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

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

Expand and refine data elements regularly and automate data refreshes. Expand the claims and EHR data sources regularly with an emphasis on EHR data.

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

Provide analysis of the patient population, participating institutions, and patient care settings for each database in the network including:o Level of representativeness, which shall include (but not be limited to)

comparisons of size and patient characteristics to the national level data.o Inclusion characteristics, which shall include (but not be limited to) payor

status (if applicable), average length of follow-up, participation in other healthcare systems and healthcare utilization data.

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

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

Provide analysis of prior and current uses of biologic product data, including (but not limited to): post-market safety surveillance, administrative purposes, quality

assessment/improvement and/or benchmarking, academic/industry research. This shall include (but not be limited to):

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

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

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

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

o Presence of demographic data including age (captured in months and days) o Presence of data relevant to medical products, particularly products regulated

by CBER (including ISBT-128 codes and brand names)o Proof of the stability of the data and reproducibility using a test study

o The test study shall be reproduced quarterly to indicate stability of the databases.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Establish a number of data linkages to enrich data sources including: o Patient-level linkages within and between claims and electronic health records such

that individual patients will have both sources of data and can be followed over time despite any change in health insurance or provider.

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

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

Develop automated tools and processes to:o Conduct, augment or assist with medical chart review to validate biologic exposures

and health outcomes in order to augment, assist or replace manual chart review.o Manage and assess quality of data elements in each data source.o Create de-identified patient-level profiles of health care encounters over a defined

period of time.o Characterize the demographic and health characteristics of all patient populations for

each electronic data source in real-time.o Develop appropriate libraries for terminologies and vocabularies defining biologics-

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

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

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

Develop methods and tools to monitor vaccine safety during pandemics (e.g., influenza). Build mobile applications (apps.) for collection of patient-level data to be linked to patient

records in the participating data sources to aid in identification of adverse events after exposure to biologics.

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

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

2.1.4 EXPERTISE AND EXPERIENCE WITH DATA AND TOOLSThe contractor shall provide all the necessary personnel including an interdisciplinary team of scientists and experts such as at least three epidemiologists; subject matter experts on biologic

products; physicians or healthcare experts with expertise in vaccines, tissue, blood and blood products; medical informatics experts; biostatisticians; at least four computer programmers; medical coding specialists; and others who are experienced in conducting safety and effectiveness studies for biologics. The contractor shall provide experienced personnel who are able to:

Describe CDM, coding, completeness, timeliness, and accessibility of databases and tools. Assist in clinically relevant medical diagnostic coding or other criteria to identify

exposures and adverse events of interest. Participate in scientific workgroup meetings to contribute to subject matter and other

technical expertise. Participate in designing, conducting, and interpreting the results of simple and

complex queries and complex epidemiologic studies.

2.2 TASK 2: QUERIES AND EPIDEMIOLOGIC STUDIESThe contractor shall conduct queries and complex epidemiological studies to evaluate the safety and effectiveness of biologic products and to address regulatory issues initiated by the CBER staff. The contractor shall provide the capability and capacity in terms of data sources, tools and methods, scientific expertise and operational management to run queries and observational studies in the form of simple and complex queries as well as complex epidemiologic studies.

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

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

Provide a secure communication portal throughout the query process. Collaborate with FDA in the publication of query results in agreement and compliance

with CBER policies and procedures as referenced in Section 2.4.4 Publications.

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

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

Provide a secure communication portal throughout the query process. Collaborate with FDA in the publication of query results in agreement and compliance

with CBER policies and procedures as referenced in Section 2.4.4 Publications.

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

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

Develop a Level III (or greater) Work Breakdown Structure (WBS) for the study. Develop a protocol for the study that shall include the study population, the

comparator or control group, the study design, and the statistical method to estimate

the measure of association between exposure and outcome while adjusting for confounders.

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

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

Provide a secure communication portal throughout the study process. Publish study protocols and final reports in agreement and compliance with CBER

policies.

To meet the requirements for performing the complex epidemiologic studies, the contractor shall: Establish a coordinating center that manages workflow between various collaborators

and CBER to accommodate the query request process. Collaborate with FDA to establish and meet timelines for providing results for

epidemiologic studies. Timeline dependent on complexity of the study and shall be established in management plan (see Section 2.3).

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

Time and material work plan. Provide a secure portal for communication. Collaborate with FDA in the publication of study results in agreement and compliance

with CBER policies and procedures as referenced in Section 2.4.4 Publications.

2.3 TASK 3: OPERATIONS AND MANAGEMENTThe Contractor’s Program Manager and the Principal Investigator (PI) along with their supporting staff shall provide Program Management (PM) for the BEST program requirements. These PM responsibilities shall include what is necessary to plan, structure, coordinate, schedule, manage, communicate, report, and steward all respective task orders and activities throughout the period of performance.

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

The Contractor shall: Establish a coordinating team or center to manage and coordinate all the operations

of the Contract. Develop a management plan containing written processes and procedures for

collaborating with CBER in study design and analysis. Details of the collaboration will be determined on a task order basis, by mutual decision of all collaborative parties. Collaboration includes sharing summary data findings, interpretation of findings, review of manuscripts, design of protocols, co-authorship of publications, and establishing timelines for providing results for epidemiological studies. The order of participating authors on each publication shall be determined on a case-by-case basis, by mutual decision of all collaborative parties and shall reflect appropriately each author's contribution to the project. Where there is no agreement on the above items, the FDA COR shall provide the final decision.

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

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

Representative activities include, but are not limited to: Administering the program; Throughout the period of performance, developing, maintaining, modifying, and updating

plans to include task order (TO) risk management plans, staffing plan, standard operating procedures (SOP), protocols, and others

Identify and create administrative templates for use throughout the period of performance For each TO, preparing a Task Order Management Plan (TOMP) describing the technical

approach, organizational resources and management controls throughout TO execution Preparing and maintaining the Program Management Plan Preparing quarterly progress and financial reports Establishing notification mechanisms for acceptance by the FDA Complying with reporting requirements Following escalation procedures for problems, issues, and recommendations, as

encountered Safeguarding information Managing Contractor staff and providing sub-contractor management, to include the proper

on-boarding and exit procedures are followed when Contractor employees start and leave BPA contract and/or task orders;

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

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

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

Ensuring proper exit criteria are followed when Contractor employees leave projects Providing risk mitigation plans and strategies per section 2.3.4 Conducting and participating in progress meetings, facility meetings, training meetings,

performance meetings, program/project reviews, management briefings, stakeholder presentations, demonstration meetings, transition meetings, COR site visits, and post- requirements meetings as may be required for each individual task order

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

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

2.3.1 TASK ORDER MANAGEMENT PLANAs tasked, for each task order released under this statement of work, the Contractor shall deliver a Task Order (TO) Management Plan. The TO Management Plan (TOMP) shall include a Work Breakdown

Structure (WBS), which shall contain all of the work elements described in the Task Order. The WBS elements shall also illustrate the sequence, timeline, and resources required for each work package.

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

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

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

2.3.2ESTABLISH PROJECT-SPECIFIC PROTOCOLS AND PROCEDURESThe Contractor shall work collaboratively with the FDA to develop and finalize the BEST project protocols and a Management Plan (MP), and update them as needed to reflect the individual task order (ITO) activities. The Contractor shall work with the FDA to identify and meet all required review, approval and standard processes that comply with all relevant institutional, federal, state, and local laws and regulations to conduct the work such as Institutional Review Boards (IRB), data and information technology security such as Federal Information Security Management Act (FISMA), Health Insurance Portability and Accountability Act (HIPAA) and any others identified in the ITO. These procedures (i.e. the MP) shall address at a minimum the following: data collection, handling, sharing, ownership, and security; management and tracking, consensus definitions, transfer, and sharing considerations for data summaries.

Representative activities include, but are not limited to: Developing and implementing secure and robust data use, data quality control, tracking,

management, and storage procedures for data, each analysis and for all analyses. Developing a query intake form or protocol for complex queries and epidemiologic studies.

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

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

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

COR on a monthly basis.

The risk registry shall contain, at a minimum, unless otherwise specified in the ITOs: Issue Number: a sequential numbering of all issues; Severity: assessment of issue severity i.e., likelihood and consequences (High/Medium/Low) Date Found: – date that issue was identified by the Contractor; Duration: number of days that issue has been open; Status: representing issue status as open or closed. The Contractor shall maintain a

complete list of all issues – no issues typically should be deleted from the Contractor’s delivered list;

Title: short description of issue; Updated: date for updated status; Details: narrative description of activities that have been completed to resolve issue; Assigned To: identify Government POC or Contractor that is assigned to resolve the issue; Solution or Workaround: description of the actions and activities taken to resolve or

mitigate issue the issue.

2.4Task 4: Outreach and CommunicationsThe contractor shall ensure ongoing communication and reporting to FDA. This includes the tracking, reporting, and outreach as necessary.

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

2.4.2 MONTHLY WEBINARS/SEMINARSThe contractor in collaboration with the FDA staff shall present study design and planning, interim or final results of newly initiated, ongoing, or completed projects to the FDA staff and other BEST program collaborators on a regular monthly basis in the form of Webinar or in-person seminar at the White Oak campus or other location agreed upon between the contractor and FDA. The schedule of the monthly webinars/seminars will be determined by the FDA and contractor staff. The presentation topics will be determined by the FDA and contractor staff at the first three months of each fiscal year.

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

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

Protocols, final reports, and final work products will be posted to a web-based resource library after clearance by FDA, the prime contractor, and subcontractors. The Parties agree this is a multi-site

program and any publications as a result of studies shall be a multi-site publication coordinated by the prime contractor, subcontractors, FDA/CBER/OBE, and other involved sites. Authorship and other matters relating to publications shall be determined at the task order level. 2.4.5 PUBLIC WEBSITE The contractor may be tasked with creating a public website where materials can be posted and be available to the public as part of an ITO. Materials may include protocols, results of queries or epidemiologic studies, and reports. The public website data security and privacy shall be in compliance with the HHS Information Security and Privacy Policy (IS2P) https://intranet.hhs.gov/it/cybersecurity/policies/index.html). The security and privacy requirements to ensure federally-mandated security and privacy controls and standards shall be met according to FDA/CBER policies.

2.4.6 SECURE PORTAL The contractor shall create and implement a secure data transfer capability to allow secure file sharing and document storage for the contractor, subcontractors, CBER staff, and other collaborators. All the data transfer and document storage related to all queries and complex epidemiological studies, and other activities shall be carried using the secure portal. The Contractor shall obtain and meet all required review, approval and standards processes that comply with all relevant institutional, federal, state, and local laws and regulations to conduct the work such as HHS Information Security Program, Federal Information Security Management Act (FISMA), Health Insurance Portability and Accountability Act (HIPAA), the National Institute of Standards and Technology, and any others identified in the ITO. These procedures (i.e. the MP) shall address at a minimum the following: data collection, handling, sharing, ownership, and security; management and tracking, consensus definitions, transfer, and sharing considerations for data summaries. The secure portal data security and privacy shall be in compliance with the HHS Information Security and Privacy Policy (IS2P). The security and privacy requirements to ensure federally-mandated security and privacy controls and standards shall be met according to FDA/CBER policies.

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

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

Deliver a user-friendly secure portal with graphical interface for conducting day-to-day executive

Communications related to the task. Deliver a user-friendly public website for posting all BEST-related documents.

2.5Task 5: Transition Services Transition activities take place to efficiently transition all activities from the incumbent Contractor to the new IDIQ Contractor. As tasked, the Contractor shall be required to develop transition-out plans and conduct transition activities for task orders issued against this IDIQ vehicle.

2.5.1TRANSITION-IN As specified in each ITO, the Contractor shall transition-in and assume the responsibility for activities and duties from the prior (incumbent) Contractor in a manner that does not interrupt or negatively impact OAGS’ mission critical operations and activities. The purpose of the Transition-In requirement is to provide an orderly transition from the prior Contractor. For a period as specified by the ITO, the Contractor shall work with the incumbent contractor to affect a smooth transition of work.

Representative activities include, but are not limited to: Developing a Transition-In Plan to ensure full operating accountability and responsibility of

the task orders. Familiarizing the incoming Contractor staff with FDA processes and requirements and work

with the incumbent Contractor as related to transferring tasks and work activities being performed.

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

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

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

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

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

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

Representative deliverables include, but are not limited to: Developing and submitting a Transition-Out Plan and Schedule to the COR Providing the FDA with current versions of all documentation developed (i.e. Standard

Operating Procedures and Manual of Operations) Providing the FDA with a current inventory of all Government-Furnished Equipment (GFE)

and Government Furnished Information (GFI) utilized by the Contractor along with full support in the reconciliation of this inventory

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

2.6. REPRESENTATIVE DELIVERABLES & MEETINGS

Five (5) Year Ordering Period

Item No.

Description of Supplies/Service SOW Section

Quantity Delivery Date

1. Establish and maintain a Coordinating Center (CC)

2.2-2.3 1 Within 8 weeks of award and throughout the Period of Performance

2. Kick Off Meeting N/A 1 Within 2 weeks of award

3. Provide Training Sessions for FDA staff

2.4.1 No more than 6

Throughout the Period of Performance

4. Develop and present monthly webinars on relevant topics related to projects

2.4.2 At least 4

Develop and present within 26 weeks of award and continue monthly throughout the Period of Performance

5. Develop and Implement a program Management Plan

2.3 1 Deliver draft within 4 weeks of award and throughout the Period of Performance

6. Develop and Implement a Risk Management Plan

2.3.4 1 Develop within 4 weeks of award and implement throughout the Period of Performance

7. Assemble Staff Organizational Units

2.3.1 1 Assemble within 8 weeks of award and convene through the Period of Performance

8. Schedule and execute routine meetings

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

Face-to-face: quarterly

2.3.3 1 Develop schedule within 8 weeks of award and convene through the Period of Performance

9. Prepare a Conflict of Interest Plan 3.0 1 Develop within 8 weeks of award and implement throughout the Period of Performance

10. Create and maintain a public website

2.4.5 1 Develop within 16 weeks of award and perform ongoing updates and support throughout the Period of Performance

11. Create and maintain a secure web-based infrastructure for file sharing (portal)

2.4.6 1 Develop within 16 weeks of award and preform ongoing updates and support throughout the Period of Performance

12. Establish web-based resource library

Post all contract deliverables with accompanying instructions in resource library

2.4.4 1 Develop within 16 weeks of award and perform ongoing updates and support throughout the Period of Performance

13. Prepare monthly progress and financial reports

2.3 4 Prepare at the end of each month for the Period of Performance

14. Identify and Create Administrative Templates

2.3 2 Develop 1st draft of templates within 24 week of award and

Identify needed templates Draft templates Finalize templates

final version of templates within 36 weeks of award

15. Prepare a Transition-Out Plan and Schedule

2.5 1 Prepare 4 months prior to the end of Period of Performance

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

2.4.3 1 Schedule the workshop annually within 6 months prior to end of each 12-month Period of Performance

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

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

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

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

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

In addition, the Contractor shall be 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.

3. CONTRACT CONSTRAINTSThe 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.

3.1 SECURITY AND PRIVACY

3.1.1 BASELINE SECURITY REQUIREMENTS1) Applicability . The requirements herein apply whether the entire contract

or order (hereafter “contract”), or portion thereof, includes either or both of the following:

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

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

3) Safeguarding Information and Information Systems. In accordance with the Federal InformationProcessing Standards Publication (FIPS)199, Standards for Security Categorization of Federal Information and Information Systems, the Contractor (and/or any subcontractor) shall:

a. Protect government information and information systems in order to ensure: Confidentiality, which means preserving authorized restrictions on

access and disclosure, based on the security terms found in this contract, including means for protecting personal privacy and

proprietary information; Integrity, which means guarding against improper information

modification or destruction, and ensuring information non-repudiation and authenticity; and

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

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

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

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

4) Information Security Categorization. In accordance with FIPS 199 and National Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II: Appendices to Guide for Mapping Types of Information and Information Systems to Security Categorie s, Appendix C, and based on information provided by the ISSO or other security representative, the risk level for each Security Objective and the Overall Risk Level, which is the highest watermark of the three factors (Confidentiality, Integrity, and Availability) of the information or information system are the following:

Confidentiality: [x] Low [ ] Moderate [ ] HighIntegrity: [x] Low [ ] Moderate [ ] HighAvailability: [x] Low [ ] Moderate [ ] HighOverall Risk Level: [x] Low [ ] Moderate [ ] High

Based on information provided by the Privacy Office, system/data owner, or other privacy representative, it has been determined that this solicitation/contract involves:

[x] No PII [ ] Yes PII

Personally Identifiable Information (PII). Per the OMB Circular A-130, “PII is information that can be used to distinguish or trace an individual's identity, either alone or when combined with other information that is linked or linkable to a specific individual.” Examples of PII include, but are not limited to the

following: Social Security number, date and place of birth, mother’s maiden name, biometric records, etc.

PII Confidentiality Impact Level has been determined to be: [x] Low [ ] Moderate [ ] High

5) Controlled Unclassified Information (CUI). CUI is defined as “information that laws, regulations, or Government-wide policies require to have safeguarding or dissemination controls, excluding classified information.” The Contractor (and/or any subcontractor) must comply with Executive Order 13556, Controlled Unclassified Information, (implemented at 3 CFR, part 2002) when handling CUI. 32 C.F.R. 2002.4(aa). As implemented the term “handling” refers to “…any use of CUI, including but not limited to marking, safeguarding, transporting, disseminating, re- using, and disposing of the information.” 81 Fed. Reg. 63323. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, shall be:

a. marked appropriately;

b. disclosed to authorized personnel on a Need-To-Know basis;

c. protected in accordance with NIST SP 800-53, Security and Privacy Controls for Federal Information Systems and Organizations applicable baseline if handled by a Contractor system operated on behalf of the agency, or NIST SP 800-171, Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations if handled by internal Contractor system; and

d. returned to FDA control, destroyed when no longer needed, or held until otherwise directed. Destruction of information and/or data shall be accomplished in accordance with NIST SP 800-88, Guidelines for Media Sanitization and the FDA IS2P Appendix T: Sanitization of Computer-Related Storage Media.

6) Protection of Sensitive Information. For security purposes, information is or may be sensitive because it requires security to protect its confidentiality, integrity, and/or availability. The Contractor (and/or any subcontractor) shall protect all government information that is or may be sensitive in accordance with OMB Memorandum M-06-16, Protection of Sensitive Agency Information by securing it with a FIPS 140-2 validated solution.

Confidentiality and Nondisclosure of Information. Any information provided to the contractor (and/or any subcontractor) by FDA or collected by the contractor on behalf of FDA shall be used only for the purpose of carrying out the provisions of this contract and shall not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract. The Contractor assumes responsibility for protection of the confidentiality of Government records and shall ensure that all work performed by its employees and subcontractors shall be under the supervision of the Contractor. Each Contractor employee or any of its subcontractors to whom any FDA records may be made available or disclosed shall be notified

in writing by the Contractor that information disclosed to such employee or subcontractor can be used only for that purpose and to the extent authorized herein.

The confidentiality, integrity, and availability of such information shall be protected in accordance with HHS and FDA policies. Unauthorized disclosure of information will be subject to the HHS/FDA sanction policies and/or governed by the following laws and regulations:

a. 18 U.S.C. 641 (Criminal Code: Public Money, Property or Records);b. 18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information); andc. 44 U.S.C. Chapter 35, Subchapter I (Paperwork Reduction Act).

7) Internet Protocol Version 6 (IPv6). All procurements using Internet Protocol shall comply with OMB Memorandum M-05-22, Transition Planning for Internet Protocol Version 6 (IPv6).

8) Government Websites. All new and existing public-facing government websites must be securely configured with Hypertext Transfer Protocol Secure (HTTPS) using the most recent version of Transport Layer Security (TLS). In addition, HTTPS shall enable HTTP Strict Transport Security (HSTS) to instruct compliant browsers to assume HTTPS at all times to reduce the number of insecure redirects and protect against attacks that attempt to downgrade connections to plain HTTP. For internal-facing websites, the HTTPS is not required, but it is highly recommended.

9) Contract Documentation. The Contractor shall use FDA-provided templates, policies, forms and other agency documents to comply with contract deliverables as appropriate.

10) Contractor Non-Disclosure Agreement (NDA). Each Contractor (and/or any subcontractor) employee under this contract shall complete the FDA non-disclosure agreement (3398 Form, RFP Attachment D) , as applicable. A copy of each signed and witnessed NDA shall be submitted to the CO and/or COR prior to performing any work under this acquisition.

11) Privacy Threshold Analysis (PTA)/Privacy Impact Assessment (PIA) – The Contractor shall assist the procuring activity representative, program office and the FDA SOP or designee with conducting a PTA for the information system and/or information handled under this contract to determine whether or not a full PIA needs to be completed.

a. If the results of the PTA show that a full PIA is needed, the Contractor shall assist procuring activity representative, program office and the FDA SOP or designee with completing a PIA for the system or information after completion of the PTA and in accordance with HHS and FDA policy and OMB M- 03-22, Guidance for Implementing the Privacy Provisions of the E-Government Act of 2002. The PTA/PIA must be completed and approved prior to active use and/or collection or processing of PII and is a prerequisite to agency issuance of an authorization to operate (ATO).

b. The Contractor shall assist the procuring activity representative, program office

and the FDA SOP or designee in reviewing and updating the PIA at least every three years throughout the Enterprise Performance Life Cycle (EPLC) /information lifecycle, or when determined by the agency that a review is required based on a major change to the system, or when new types of PII are collected that introduces new or increased privacy risks, whichever comes first.

A. POSITION SENSITIVITY DESIGNATIONS

All Contractor (and/or any subcontractor) employees must obtain a background investigation commensurate with their position sensitivity designation that complies with Parts 1400 and 731 of Title 5, Code of Federal Regulations (CFR). The following position sensitivity designation levels apply to this solicitation/contract: [See the FDA Security Article, entitled Contractor Personnel Security Clearance Standards and Residency Requirements for the Position Risk Designation Tier(s) (i.e., 1, 2, and/or 4”) that apply to this award.]

12) Notification. The Contractor (and/or any subcontractor) shall notify the CO and/or COR as soon as it is known that an employee will stop working under this contract.

13) Contractor Responsibilities Upon Physical Completion of the Contract. The contractor (and/or any subcontractors) shall return all government information and IT resources (i.e., government information in non-government-owned systems, media, and backup systems) acquired during the term of this contract to the CO and/or COR. Additionally, the Contractor shall provide a certification that all government information has been properly sanitized and purged from Contractor-owned systems, including backup systems and media used during contract performance, in accordance with HHS and/or FDA policies.

14) The Contractor (and/or any subcontractor) shall coordinate with the COR via email, copying the Contract Specialist, to ensure that the appropriate person performs and documents the actions identified in the FDA eDepart system http://inside.fda.gov:9003/EmployeeResources/NewEmployee/eDepartDepartureSystem/default.htm as soon as it is known that an employee will terminate work under this contract within days of the employee’s exit from the contract. All documentation shall be made available to the CO and/or COR upon request. Contractor shall work with COR to access eDepart system.

B. RECORDS AND MANAGEMENT AND RETENTION

The Contractor (and/or any subcontractor) shall maintain all information in accordance with Executive Order 13556 - Controlled Unclassified Information, National Archives and Records Administration (NARA) records retention policies and schedules and HHS/FDA policies and shall not dispose of any records unless authorized by HHS/FDA.

In the event that a contractor (and/or any subcontractor) accidentally disposes of or destroys a record without proper authorization, it shall be documented and reported as an incident in accordance with HHS/FDA policies.

C. FDA PERSONNEL SECURITY CLEARANCE REQUIREMENTS.

B1. BACKGROUND

The Office of the Assistant Secretary for Management and Budget, Department of Health and Human Services (DHHS), requires that DHHS employees and contractor employees (including subcontractors) who will be working in a DHHS-owned or leased space and/or who will have access to DHHS equipment, and non-public privileged, proprietary, or trade secret information, undergo a background investigation of some type.

Contractor employees who will be in DHHS-owned or lease space for less than thirty (30) days are exempted from the background investigation requirement. These contractor employees must be escorted at all time while in DHHS-owned or leased space.

B2. GENERAL

The contractor shall submit the following items to the Contracting Officer, ten (10) calendar days prior to commencement of work under this contract:

a. Certification that all required security form packets and a list of contractor employees names for whom the requisite security information has been provided to Division of Security Operations, Policy and Planning, Personnel Security Staff.

b. "Contractor's Commitment to Protect Non-public Information Agreement" forms signed by each employee named in paragraph a. above.

With the exception of costs associated with fingerprinting Contractor employees outside of the FDA Personnel Security Office, the Government will conduct all required background investigations at no cost to the contractor. The cost of fingerprinting Contractor employees at any location other than the FDA Personnel Security Office will be borne by the Contractor.

Contractor employees shall obtain security badges in order to access to DHHS-owned or leased property without an escort. (See Section 3 for details on the badging process) However, in the event that work must commence before security badges can be issued, contractor employees will be allowed onto DHHS-owned or leased property, but must be escorted at all times.

All Contractor employees who undergo a background investigation are required to log onto the Office of Personnel Management’s (OPM’s) Electronic Questionnaire for Investigation Processing (e-QIP) system to complete the forms necessary to initiate their background investigations. The forms required vary with the position risk levels for the contract.

The position risk levels for this contract are Level 1.

There are two (2) potential position risk levels, which are:

a. Non-Sensitive Positions (Level 1) (SEE CHART A) - Positions which involve the lowest degree of adverse impact on the efficiency of the Agency. The forms set forth by CHART A are required for Non-Sensitive Positions (Level 1). Contractor employees assigned to Level 1 who receive a security badge will be required to provide additional security information for a background investigation as specified in Paragraph 5 below.

b. Public Trust Positions (Levels 5 or 6) (SEE CHART B) - Positions in which the incumbent's actions or inaction could diminish public confidence in the integrity, efficiency, or effectiveness of assigned Government activities, whether or not actual damage occurs. The forms set forth by CHART B are required for Public Trust Positions (Levels 5 or 6). Contractor employees assigned Levels 5 or 6 must receive security badge as well as a background investigation.

In order to access the e-QIP system, Contractor employees must provide the appropriate Personnel Security Specialist with the following information: (a) full name; (b) position title; (c) social security number; (d) date of birth; (e) place of birth; (f) email address; and (g) phone number. The Personnel Security Specialist will use this information to initiate each Contractor employee into the e-QIP system. Once this is done, each Contractor employee will receive an email that contains a web link to access the e-QIP system, as well as instructions and additional forms needed to initiate the suitability background investigation. The Project Officer for the contract will provide the name of the appropriate Personnel Security Specialist to the Contractor.

A Contractor’s failure to comply with the e-QIP processing guidelines will result in that Contractor’s employees being denied access to FDA property until all security processing has been completed.

 B3. BADGING PROCESS

The FDA Project Officer will sponsor Contractor employees on the FDA Form 3391 for the purpose of obtaining an FDA Security Access Card. In order to obtain one, a contractor employee must receive a "favorable" fingerprint return. Fingerprints must be submitted to the Personnel Security Office at least ten (10) days prior to the commencement of work. Fingerprints will be submitted in one of two ways, depending on where the contract will be performed:

a. Contractor employees who will work in the Washington D.C. metro area will, at the direction of the FDA Project Officer or his/her designee, contact the Personnel Security Branch to schedule a fingerprinting appointment, or

b. Contractor employees who will work in a field office will submit fingerprints to:Food and Drug AdministrationFingerprinting and Personnel Security Office10903 New Hampshire Avenue, Building 1, Room 1201Silver Spring, MD 20993

Upon the receipt of a "favorable" fingerprint return, each Contractor employee must present two forms of identification in order to receive his or her badge. One form of identification must be a government-issued photo identification document. Acceptable forms of photo identification are referenced on the FDA Form 3391. Acceptable forms of secondary identification are listed on the back of the I-9 Form. This form can be obtained at http://uscis.gov/graphics/formsfee/forms/files/i-9.pdf.

An individual who receives an unfavorable report may appeal that finding by submitting a written request to the Personnel Security Staff.

B4. BACKGROUND INVESTIGATIONS

The Government shall conduct an additional background investigation for those individuals named to risk Levels 1, 5 and 6 serving under this contract.

Required background investigations may include, but not be limited to:

Review of prior Government/military personnel records;Review of FBI records and fingerprint files;Searches of credit bureaus;Personal interviews; and Written inquiries covering the subject's background.

Background investigations will be conducted by the Office of Personnel Management (OPM).

The Contractor is responsible for ensuring that the integrity of contract performance is maintained pending completion of all appropriate background investigations of contractor employees.

The Contractor shall submit the information required for eQIP access and other requisite forms for the risk level(s) specified. In addition, the contractor shall provide a cover letter which includes: the Contractor's name, the contract number, the name of the Contracting Officer administering the contract, the names of all Contractor employees' for whom a background check is required and those employees’ social security numbers, dates of birth, and former names. This cover letter and all completed forms shall be transmitted, in a separate sealed envelope marked, "TO BE OPENED BY ADDRESSEE ONLY," to:

Food and Drug AdministrationBadging and Credentialing Office10903 New Hampshire Avenue, Building 1, Room 1201Silver Spring, MD 20993

The contractor shall send a separate letter to the Contracting Officer that includes the contract number and employee names.

The contractor shall advise its prospective employees that all standard forms submitted to the FDA will be forwarded to the Office of Personnel Management (OPM) for scheduling background investigations.

Personnel Security Staff will resolve with the contract employee any issues arising out of inaccurate or incomplete forms.

Employees who have been previously granted a Government security clearance shall advise Personnel Security Staff of the details of such clearances to determine if a previous clearance level is suitable for the current FDA position.

At any time, if a contractor employee for whom security forms have been submitted is terminated or otherwise ceases work under the contract, the contractor shall immediately notify Personnel Security Staff, in writing, with copies to the respective FDA Project and Contracting Officers.

The OPM background investigation will take approximately 120 days. The Contracting Officer will notify the Contractor in writing if an employee is denied a clearance. Those individuals who have been cleared by Personnel Security Staff may continue to work under the contract. Those who are not cleared must cease work on the contract immediately.

If a Contractor employee changes job responsibilities under this contract, the contractor shall notify the Contracting Officer, and the Government will make a determination whether an additional security clearance is required.

In the event that a cleared individual is replaced, the contractor shall notify the Contracting Officer and comply with all requirements of this clause, as specified herein, prior to the commencement of work by the replacement individual.

The Contractor shall be responsible for the return of any Government issued security badges to the Project Officer.

B5. NON-PUBLIC DATA PROTECTION

The contractor shall protect the privacy of all information reported by or about contract employees and shall protect against unauthorized disclosure.

CHARTS A & B ARE APPENDED TO THIS CLAUSE

For clarification purposes and to facilitate the flow of all required security forms, the following matrix is provided:

CHART A

Mandatory for all on-site contract employees

NON-SENSITIVE

POSITIONS - LEVEL 1       

 FORM NAME

OBTAINFROM WHEN REQUIRED SUBMIT

TO DATE REQUIRED

FDA Form 3391 - FDA Security Card Access Request

Project Officer. Sponsorship must be

provided by FDA Project Officer.

All positions on DHHS property or leased space

Food and Drug AdministrationAttn: Badging and Credentialing Office

10903 New Hampshire AvenueBuilding 1, Room 1201

Silver Spring, MD 20993**Form must be submitted by Security Rep.

Form must be received prior to

making fingerprint appointment.

Contractor’s Commitment to Protect Non-Public Information (NPI)

Agreement formContracting Officer

All positions with access to non-public privileged,

proprietary, or trade secret information

Contracting Officer for retentionin contract file

Ten (10) calendar days prior to

commencement of work

Listing of all contractor employee names, social security #s, gender,

dates of birth, former names, and a completed Fair Credit Reporting

Act Release

Contractor generatedAll positions, including intermittent, per diem or

temporary

*Food and Drug AdministrationAttn: Badging and Credentialing Office

10903 New Hampshire AvenueBuilding 1, Room 1201

Silver Spring, MD 20993(301) 796-4592

Ten (10) calendar days prior to

commencement of work

SF 85 - Questionnaire for Non-Sensitive Positions

Online via OPM’s e-QIP system

Non-Sensitive Positions - Level 1 Clearance

*Submit to OPM online via the e-QIP system

Ten (10) calendar days upon request of

the Contracting Officer

FD 258 - Fingerprint Chart (2 Charts Required)

Fingerprinting services availableby appointment only.Call (301) 827-9527

Contracting Officer Non-Sensitive Positions - Level 1 Clearance

*Food and Drug AdministrationFingerprinting & Personnel Security Office

10903 New Hampshire AvenueBuilding 1, Room 1201

Silver Spring, MD 20993(301) 796-4607

Ten (10) calendar days prior to

commencement of work

 

*In addition to the submission of these forms, the contractor shall provide a cover letter that includes: contractor’s name, contract number, contractor employees’ names, and name of Contracting Officer. 

*Upon favorable fingerprint return, contractor will be notified to respond to the badging office for their building pass.

CHART B

*Food and Drug AdministrationBadging and Credentialing Office

8:00 a.m. – 11:00 a.m. and 1:00 p.m. – 3:00 p.m.10903 New Hampshire Avenue

Building 1, Room 1201Silver Spring, MD 20993

No appointment necessary(301) 796-4592

Public Trust Positions - Levels 5

or 6       

 

FORM NAME

OBTAINFROM WHEN REQUIRED SUBMIT

TO DATE REQUIRED

SF 85P - Questionnaire for Public Trust Positions

 

Online via OPM’s e-QIP system

 

Public Trust Positions - Level 5 or 6 Clearance *Submit to OPM online via the e-QIP system

Ten (10) calendar days prior to

commencementof work

FD 258 - Fingerprint Chart (2 Charts Required)

Fingerprinting services availableby appointment only.Call (301) 827-9527

Contracting Officer Public Trust Positions - Level 5 or 6 Clearance

*Food and Drug AdministrationFingerprinting & Personnel Security Office

10903 New Hampshire AvenueBuilding 1, Room 1201

Silver Spring, MD 20993 

(301) 796-4607

Ten (10) calendar days prior to

commencement of work

FDA Form 3391 - FDA Security Card Access Request

Project Officer. Sponsorship must be

provided by FDA Project Officer.

All positions on DHHS property or leased space

Food and Drug AdministrationAttn: Badging and Credentialing Office

10903 New Hampshire AvenueBuilding 1, Room 1201

Silver Spring, MD 20993 

**Form must be submitted by Security Rep. 

Form must be received prior to making fingerprinting appointment.

Contractor’s Commitment to Protect Non-Public Information (NPI)

Agreement formContracting Officer

All positions with access to non-public privileged,

proprietary, or trade secret information

Contracting Officer for retention

in contract file

Ten (10) calendar days prior to

commencement of work

Listing of all contractor employee names, social security #s, gender,

dates of birth, former names, and a completed Fair Credit Reporting Act

Release

Contractor generatedAll positions, including intermittent, per diem or

temporary

*Food and Drug AdministrationAttn: Badging and Credentialing Office

10903 New Hampshire AvenueBuilding 1, Room 1201

Silver Spring, MD 20993 (301) 796-4592

Ten (10) calendar days prior to

commencement of work

*Upon favorable fingerprint return, contractor will be notified to respond to the badging office for their building pass.

*Food and Drug AdministrationBadging and Credentialing Office

8:00 a.m. – 11:00 a.m. and 1:00 p.m. – 3:00 p.m.10903 New Hampshire Avenue

Building 1, Room 1201Silver Spring, MD 20993

No appointment necessary (301) 796-4592 

*In addition to the submission of these forms, the contractor shall provide a cover letter that includes: contractor’s name, contract number, contractor employees’ names, and name of Contracting Officer.

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.

Key Personnel at the IDIQ-Level are: Principal Investigator Program Manager Physician Epidemiologist

Key Personnel may be assigned at the ITO level also.

4.2 GOVERNMENT-FURNISHED-INFORMATION(GFI)/GOVERNMENT FURNISHED EQUIPMENT (GFE)

The FDA does not intend to provide the Contractor with any Government Furnished Information (GFI) or Government Furnished Equipment during the period of performance of this contract. The FDA will specify any GFI and GFE requirements in future individual task orders (ITOs).

4.3 TRAVEL

Performance under this IDIQ may require contractor employees to travel. If travel within the continental United States (CONUS), is required, the contractor is responsible for making all needed arrangements for its employees.

The Government will not reimburse the contractor for local travel costs incurred within the Washington DC (50-mile radius). All travel shall be in accordance with rules set forth for temporary duty travel in FAR 31.205-46 and the Federal Travel Regulation (http://www.gsa.gov/portal/content/102886). Travel and Per Diem authorized reimbursed under this contract shall not exceed the Government approved rates in effect (https://www.gsa.gov/portal/content/104877).

The contractor shall submit all travel requests to the COR and the Contract Officer for review and approval at least 10-calendar days in advance.

4.4 ADMINISTRATION

4.4.1PERIOD OF PERFORMANCE

The period of performance for this IDIQ vehicle will have a five (5) year ordering period. Individual task orders awarded under this IDIQ contract shall be for periods of varying duration, but are anticipated to range from 12- to 60-months.

4.4.2PLACE OF PERFORMANCEThe 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.

4.4.3GOVERNMENT POINTS OF CONTACT (POCS)Contract Officer Representative (COR):

To be identified at award

5. LABOR CATEGORY DESCRIPTIONS

PRINCIPAL INVESTIGATOR: Maintains project oversight and oversees the successful completion of project reports, objectives, and goals. Responsibilities include formulation of project strategy, survey design, data analysis, quality control assurance, and stakeholder briefings. The PI directly supervises the Program Manager, oversees the fiscal management and evaluation of the project, and develops technical strategies. The PI contributes technical expertise and develops multifaceted procedural solutions. The PI develops technical approach and solutions, leads research studies, and validates research methodologies. This position is responsible for all reports and interactions with the Federal agency. The Principal Investigator has at least a Ph.D. and 10 years of experience.

CO-PRINCIPLE INVESTIGATOR: A person with sufficient experience, education and knowledge to be responsible for the design and implementation of a research project; this person works with the Federal agency to determine approach, constructs study design and provides content expertise; identifies types of resources required to successfully meet the project objectives, responsible for overall success of project and liaison with Federal agency. Meet with client to clarify research question, design work plan, assign duties, review results, participate in writing materials/ reports. The Co-Principal Investigator has at least a Ph.D. or MD and 10 years of experience.

CO-INVESTIGATOR II: Maintains project oversight and oversees the successful completion of project reports, objectives, and goals. Responsibilities include formulation of project strategy, survey design and data analysis approaches, quality control assurance, and stakeholder briefings. The Co-Investigator II shall work with the Project Manager overseeing the fiscal management and evaluation of the project, and develops training strategies. The Co-Investigator II may provide technical expertise and develop multifaceted procedural solutions. This position is responsible for all reports and interactions with the funding agency. The Co-Investigator II has at least a Ph.D. or MD and 10 years of experience.

CO-INVESTIGATOR I: The Co-Investigator I manages a portfolio of highly technical projects and implements activities that analyze, communicate, and use policy-relevant data and information on demographic, population, and health topics. He/she possesses strong technical skills in research design, data analysis, program evaluation, and communication of research findings as well as expertise in presentation and interpretation of data. The Co-Investigator I assists in developing projects, managing and extending relationships with existing key clients, and serves as a primary contact point with some clients. The Co-Investigator I manages technical staff and teams who assist him/her in implementing project activities. The Co-Investigator has at least a Ph.D. and 5 years of experience.

SENIOR STATISTICIAN: Design, manage and conduct complex statistical projects involving multiple and simultaneous tasks, able to develop work plans and budgets, technical expertise in multiple statistical methods, and able to present complex statistical results to wide variety of audiences. Extensive knowledge of statistical software packages. The Senior Statistician has at least a Ph.D. and 10 years of experience.

EPIDEMIOLOGIST: Substantial experience designing and managing epidemiologic studies and staff. Primary functions include the application of epidemiologic methods to the assessment of health and morbidity/mortality in defined populations. Experience and training in the design, development and/or analysis of large health-related databases. Must be adept in the use of statistical analysis software such as SAS or SPSS. Must be a self-starter, with a demonstrated ability to develop collaborative working relationships and the flexibility to manage multiple, time-critical tasks. Skilled in data analysis, writing and utilizing statistical analysis software code. Possess strong spoken and written communications skills. Skilled in MS Word/Excel/Access/Power Point. The Epidemiologist has at least a Ph.D. or MD and 10 years of experience.

RESEARCH ANALYST/PROGRAMMER II: Ability to conduct project tasks with minimal supervision, general knowledge of research techniques, conduct programming projects with minimal supervision, write reports, and devise data input strategies. Education: Bachelors of Science or Master’s Degree in related field with 10 years of experience.

RESEARCH ANALYST/PROGRAMMER I: Ability to conduct project tasks with minimal supervision, general knowledge of research techniques, conduct programming projects with minimal supervision, write reports, and devise data input strategies. Education: Bachelors of Science or Master’s Degree in related field with 5 years of experience.

PROJECT MANAGER: Defines project objectives and strategic direction. Is responsible for providing leadership and vision to project teams and serves as a key facilitator between multiple teams to achieve objectives of complex efforts. Responsible for project planning, project financials, and staff direction and oversight for multiple projects. Performs day-to -day management of contract. Provides technical guidance to the project team in performance of work and review quality of all work products. Primary contact with client’s technical representative. Education: Bachelors of Science or Master’s Degree in related field with 10 years of experience.

RESEARCH ASSISTANT: Works as part of a research team to gather, organize, input and finalize data from research and evaluation activities. Assists in the development of data collection approaches to facilitate the compilation of research statistics, budget figures and other project related information. Assembles materials for training and presentations. Assists in preparing project deliverables and reports/papers for publication in technical journals for presentation to agency sponsor or for use in further applied or theoretical research activities. Education: Bachelors of Science or Master’s Degree in related field with 5 years of experience.

PHYSICIAN: Licensed physician with patient care experience, experience in analyzing medical delivery systems, and applying computer technology to clinical and/or analytical activities. Responsibilities include interpreting medical terminology and symptoms to assist in database integrity, determining the implications of diagnoses in terms of clinical pathways and resource consumption in order to prepare medical algorithms, assessing practice variations to model medical practices, consulting with medical specialty societies to determine standards of care to improve medical algorithms, and

otherwise advising the staff on medical informatics. MD or DO degree from a school certified by the AAMC, completed a residency program recognized by the ACGME, and licensed to practice medicine. It is desirable that the Physician be board certified. Also, should be experienced in computer application in medical practice and research. The Physician has an MD and least 10 years of experience.

MEDICAL INFORMATICIST: Reviews and analyzes available data to generate the most complete and accurate reference possible and to expand annotation associated with that information. Uses specialized databases, bioinformatics software, and literature reviews to curate highly annotated records for modeling. Reviews and updates database records. Corresponds with collaborators regarding missing or inaccurate information. Interacts with client's scientific staff to resolve questions regarding missing or inaccurate information. Uses manual and electronic methods to ensure quality control. Works independently in assigned work and reviews work for completeness and compliance with guidelines. Assists in problem resolutions and recommends enhancements to analytical, processing and statistical software. Tests software improvements to bioinformatics tools. Hands-on laboratory experience in bioinformatics research, analysis, design, development, testing, implementation of databases and/or software. Provides Management and supervisory experience from inception of task. The Medical Informaticist has at least a Masters and 1 year of experience.