Attachment_B_-_BEST_IDIQ_2_(TO_0001_SOW)_june_21_18.docx

CBER Biologics Effectiveness and Safety (BEST) IDIQ #2

Task Order #1 SOW:

Development of New and Innovative Methods for Automated Reporting for CBER-Regulated Biological Products

Statement of Work (SOW) June 21, 2018

Table of Contents

Introduction

1. INTRODUCTION

The U.S. Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, tobacco products, our nation’s food supply, cosmetics and products that emit radiation. As part of its mission, the FDA conducts surveillance and monitoring of the safety and effectiveness of regulated products. CBER plans to award two additional Indefinite Deliverables Indefinite Quantities (IDIQ) contracts in FY2018, as part of the BEST Sentinel initiative to continue its efforts to develop additional active postmarket risk identification and analysis systems. The first Sentinel BEST IDIQ contract will support the availability of expanded data sources, as well as enhanced analytic capabilities and efficiencies with the goal of implementing rapid, intermediate, and complex queries in a cost-effective and efficient manner.

CBER is issuing a second Sentinel BEST IDIQ and the accompanying Task Order 1 (TO1) described here to encourage the development and validation of innovative methods to obtain computable phenotypes from structured and unstructured health records. These methods will potentially include machine learning, artificial intelligence, natural language processing, robotics, and other methods to develop post-market safety and efficacy reports for all CBER-regulated products. Finally, this program will include development and piloting of procedures to automate the development and transmission of electronic case safety reports to the MEDWatch portal of the FDA Adverse Event Reporting System FAERS, or to the Vaccine Adverse Event Reporting System (VAERS) portal.

1. Task Order 1(TO1): Objectives and Scope

Objectives The objectives of this TO1 are:

1. Provide FDA with indirect access to large volumes of United States (US) patient health care data including electronic health records (EHR) and, administrative claims data.

2. Apply innovative computational methods to identify safety and effectiveness phenotypes among users of CBER-regulated products within the US healthcare system.

3. Develop and apply automated or semi-automated patient chart review to validate the accuracy of mined safety and effectiveness phenotypes among patients using CBER-regulated products.

4. Pilot the development and automatic reporting of adverse event (AE) phenotypic information from contract data partners to the MEDWatch FAERS Portal or VAERS portal with validation of the presence and accuracy of the transmitted reports following transmission.

5. Provide FDA with open source or proprietary computer programs or software and related documentation that will support advanced data mining from health records for adverse events and product effectiveness for CBER-regulated products, and subsequently report these data to FDA in an automated manner following reporter validation.

Scope :

The Contractor shall, independently and not as an agent of the Government, provide all necessary resources and personnel to build the new CBER BEST program for the conduct of postmarket safety and effectiveness surveillance, epidemiologic studies and automation for all biologic products. The scope of this program covers all CBER-regulated products and includes the following:

1. The Contractor shall provide the necessary data resources including electronic health records (EHR) and administrative claims data for millions of patients to develop new, innovative methods to mine adverse event information

2. Develop and apply innovative methods to identify and mine safety and effectiveness information from electronic health records (EHR), administrative claims data, and similar electronic healthcare data sources. Innovative methods may include artificial intelligence (AI), natural language processing (NLP), robotics, machine learning, Application Program Interface (API) (e.g. HL7 FHIR), or other methods.

3. Develop capabilities for semi-automated patient chart review and use of these capabilities to conduct validation studies that independently demonstrate the accuracy of computable phenotypes and chart-based diagnostic codes that reflect product safety and effectiveness.

4. Expand the use of innovative methods in two or more additional sources of disparate EHR data to assign computable phenotypes US hospital records or other data sources that are a representative sample of text-based electronic US healthcare data, but independent of the initial contract databases with data structures that are different.

5. Develop and populate adverse event report fields into a standard data table that is compatible with the FDA MEDWatch portal for non-vaccine products or the vaccine VAERS portal for further use in FDA analyses. Conduct pilot studies with de-identified data to electronically establish and transfer information through these adverse event reporting portals.

6. Collaborate with and train FDA staff on the use of tools developed within the contract for documenting exposures to CBER products, mining of patient records for evidence of adverse events and effectiveness, validation of findings using automated processes, and automated AE reporting to FDA by allowing FDA staff access to the tools and de-identified data through a secure portal.

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

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

Task 1 Description(s) The following tasks constitute the performance of work expectations.

Task 1.1 Data Provision Requirements

The Contractor shall provide U.S. health care data for large numbers of adult and pediatric patients including millions of electronic health records (EHR) and administrative claims data from a variety of healthcare settings and patient populations for use in developing computable phenotypes for adverse events and product effectiveness for CBER-regulated products. The contractor shall provide documentation and methods used to support the availability of the following characteristics and support required for Task 1.1.

· Data shall cover millions of patients per year and support postmarket safety surveillance for rare product-related adverse events for CBER-regulated products. These include vaccines, blood components, blood products (e.g. immunoglobulins, coagulation products) tissues, and advanced therapeutics (e.g. cellular therapies, gene therapies, and others)

· Patient records shall include detailed clinical data, ancillary clinical data, laboratory test results, demographic data, brand names, transfusion data, lot numbers, blood units, dosage and frequency of use for all biologic product exposures.

· For EHR unique product exposure identifiers recognizable by FDA such as ISBT-128 and CODABAR codes, as well as available NDC codes for drugs must be available within the database or otherwise electronically accessible.

· The data made available for program development shall be quality checked using a rigorous, structured approach.

· Describe the completeness (full, partial, etc.), timeliness, and accessibility of data; including estimated times from service delivery to accessibility of data (lag time) and frequency of data refreshes.

· Data must have sufficient detail to allow examination of temporal relationships between product administration and associated adverse events/outcomes.

· Data must permit longitudinal follow-up of patients with product exposures

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

· Describe inclusion characteristics, which shall include payor status (if applicable), criteria for inclusion/exclusion, average length of follow-up, loss to follow-up, participation in other healthcare systems and healthcare utilization data.

· Describe the patient care settings, including number, types, and catchment areas of participating institutions; estimated annual number of patients and/or visits in each setting; ability to longitudinally track patients through different care settings, including content and quality of data available in each setting.

· Data from disparate sources shall be organized for standardized analysis through conversion to a common data model, availability of robotics to permit direct data extraction, or through other means such as API.

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

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

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

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

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

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

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

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

Table 1: Task 1 Deliverables/ Work Products

Task 1.2 Technical report 1.2 - Data Characterization

Characterize large volumes of data provided for use in the contract, including detailed characterization of EHR and claims data for recipients of vaccines, blood and blood products, and tissues and advanced therapeutics according to the characteristics listed above.

Table 1: Task 1 Deliverables/ Work Products

Task 2 Description(s) The following tasks constitute the performance of work expectations.

Task 2: Exposure and Outcome Validation

Contractor shall develop capabilities for automated or semi-automated chart review, and use these capabilities to conduct validation studies demonstrating the accuracy of computable phenotypes that reflect safety and effectiveness data for CBER products. Depending on the context of the analysis, and with the collaboration of CBER staff, the accuracy of mined patient phenotypes can be assessed through objective medical adjudication or using accepted surveillance or case definitions (e.g. ISBT Working Group definitions for Blood Transfusion adverse events). The mean level of accuracy for mined adverse events should exceed 60- 90% for datasets made available within the contract depending on the stage of the contract Task 2.1 Technical Report 2.1

Develop and demonstrate capabilities for rapid and accurate automated or semi-automated chart review for provided databases to rapidly and effectively assess the accuracy of mined data and embedded diagnostic codes. Provide a technical report 2.1 describing approaches, methods, accuracy of mined data and codes, and outcomes of analyses.

Table 2: Task 2 Deliverables/ Work Products

Frequency Delivered to

· Provide technical report 2.1

Task 3 Description(s) The following tasks constitute the performance of work expectations.

Task 3.1 Develop, Implement, and Validate New, Innovative Methods to Address Automated Reporting of Adverse Events for CBER-Regulated products

The Contractor shall provide the expertise to develop new, innovative methods to mine adverse event information and product effectiveness phenotypes associated with the use of CBER-regulated products from EHR and similar electronic healthcare data sources for all CBER-regulated products, except devices. These methods shall include artificial intelligence (AI), natural language processing (NLP), robotics, machine learning, API (e.g. HL7 FHIR), or other methods. The scientific expertise needed for this task includes, (but is not limited to) epidemiology, medicine, informatics, programming, NLP, robotics, machine learning, AI and others. It is critical that proposed personnel include (as staff or consultants) subject matter experts for the CBER products under study to guide the accurate definition exposure and outcome variables.

Data mining will be based on patient electronic health record (EHR) data to identify and extract known and unexpected adverse events and efficacy measures related to CBER-regulated products, except medical devices. Methods developed should, to the extent possible, identify the temporal sequence to ensure that product exposure proceeds the outcome measure by a known time interval. Initial development will focus on blood components, blood products, and tissues. Administrative claims data, will be a source of supporting information.

Examples of CBER Products and Safety/Efficacy Outcomes to be studied.

Because FDA must be responsive to a changing landscape of products and associated risks (i.e., adverse events, etc.) and benefits (i.e., effectiveness), the BEST system must be flexible and similarly able to respond to safety or effectiveness questions that arise as part of the regulatory review of pre-licensure data or through post market surveillance or studies. Accordingly, it is not possible in advance to identify and determine all the specific products and adverse events or combinations thereof of interest. However, listed below are CBER-regulated biologics and adverse events/effectiveness measures that are likely to require surveillance activities. The provided list is limited and will likely change over time per CBER’s regulatory needs.

Vaccine Products: Influenza vaccines (e.g., inactivated, live, high-dose, etc.); pneumococcal vaccine; meningococcal vaccine; measles mumps rubella vaccine; varicella vaccine; human papilloma virus vaccine; Herpes zoster vaccine; diphtheria, tetanus, pertussis vaccine; and others. The safety and effectiveness of vaccines is likely to be studied on a recurring basis for vaccines that are seasonally re-formulated.

Vaccine adverse events include but are not limited to: Febrile seizure, seizure, Bell’s palsy, Guillain-Barre Syndrome, auto-immune conditions, anaphylaxis, syncope, and others; or outcomes such as confirmed positive influenza test or diagnosis, hospitalization, mortality unexpected events, and others.

Blood Components: Whole blood, Red Blood Cells, Packed Red Blood Cells, Platelets, Plasma, including products that have undergone leukocyte reduction (LR), irradiation, pathogen reduction, solvent-treatment, and others.

Blood Component Adverse Events Include: Transfusion-related Acute Lung Injury (TRALI), Transfusion-associated Circulatory Overload (TACO), Hemolysis, Transfusion-Transmitted viral or parasitic/protozoan infections, sepsis, Transfusion-associated dyspnea (TAD), Allergic reaction (severe), Hypotensive transfusion reaction, Febrile non-hemolytic transfusion reaction (FNHTR), Acute hemolytic transfusion reaction (AHTR), Delayed hemolytic transfusion reaction (DHTR), Delayed serologic transfusion reaction (DSTR), Transfusion-associated graft vs. host disease (TAGVHD), Post-transfusion purpura (PTP), and other adverse events.

Blood Products and analogs include: Albumin, Intravenous Immune Globulin (IGIV), Intramuscular Immune Globulin, Clotting factors such as Factor VII, Factor VIII, Factor IX, anti-hemophilic factors, fibrin sealants, fibrinogen, platelet-rich plasma (PrP) and others

Blood Products and analog outcomes potentially include: thromboembolic events, hemolysis, allergic and anaphylactic reactions, adverse adverse events, lack of efficacy (hyperimmune Ig), and unknown efficacy and other adverse events Tissues include acellular dermal matrix allografts, corneal transplants, allograft heart valves, amniotic membrane transplants, etc.

Tissue adverse events potentially include post-transplant infection, allograft rejection, and other adverse events

Advanced therapy products include: cord blood, cellular therapies (CAR-T cell, Provenge), gene therapies, cultured chondrocytes, keratinocytes, fibroblasts.

Advanced therapy product potential adverse events include: infusion reactions, stroke, unexpected adverse events, and others to be determined.

During the base year, software to define computational phenotypes for the following products and outcomes mined from medical records should be completed with at least 60% accuracy compared to accepted surveillance case definitions. The accuracy of diagnostic codes for these outcomes embedded in the patient chart should also be independently compared with the accepted case definitions. The software shall provide the Government with the capability of being able to search by adverse event.

The Government anticipates up to ten (10) users accessing the database on a weekly basis.

Task 3.1 Technical Report 3.1

Data for TRALI, TACO, TACO (alternate definition); bacterial sepsis and immunologic mismatch related to patient exposure to blood components; hemolysis, thromboembolic, and allergic events related to use of IGIV; and bacterial infection related to tissue transplantation are mined with 60% accuracy compared to accepted case definitions. The Contractor shall provide the data for up to 50 adverse events. The Contractor shall work collaboratively with FDA to define the parameters for each report.

Task 3.2 Technical Report 3.2

Provide a detailed Technical Report describing the accuracy of embedded chart diagnostic codes (e.g. ICD-9, ICD-10) and diagnostic codes derived from administrative data (if available) vs accepted case definitions assessed by data mining.

Table 3: Task 3 Deliverables/ Work Products

Task 4 Description(s) Task 4. Electronic Reporting of Adverse Event Case Reports to CBER FAERS

The contractor shall use the data, methods and expertise developed within the contract to build new capabilities for FDA to conduct automated reporting of adverse event data based on data mined from de-identified electronic health records applying machine learning, AI, NLP, API and other approaches, accepted case definitions, other text information and codes. The mined data will in turn be used to populate data tables or fields on FDA adverse event reporting forms (MEDWatch/FAERS portal or vaccine VAERS portal). Reports will then be electronically submitted as pilot reports to the respective portals using existing FDA procedures. The contractor must validate the electronic submission process by ascertaining the presence of accurate automated reports in the appropriate FDA Adverse Event Reporting System (FAERS or VAERS). Contractors shall work with COR and/or other designated project officer to confirm submission of reports.

Task 4.1 Technical Report 4.1

Develop and populate adverse event report fields into a data table that is compatible with MEDWatch report portal content for submission to the FDA FAERS safety databases (VAERS portal for vaccine data) to thoroughly document product exposures and one or more associated adverse events for further use in FDA analyses.

Task 4.2 Technical Report 4.2

Collaborate with FDA staff to develop a contract-specific protocol for pilot studies with de-identified data for blood component recipients to electronically transfer information to the FDA MEDWatch/FAERS adverse event database portal. The Contractor shall generate a written protocol describing the details of the processes used to transfer the information to the FDA MEDWatch/FAERS database. The protocol shall describe the steps required to accomplish the transfer of data. The completed draft protocol shall be delivered by the contractor within 15 business days of finalizing the study(s). Once the protocol is finalized and the terms of the protocol, including the timeline, are mutually agreed upon between the Contractor and FDA, the study shall comply with the agreed upon timeline. The Contractor shall provide a final report describing the study background, objectives, methods, results, conclusions and discussion, strengths, and limitations. The final report shall be submitted no later than 30 days prior to the end of the TO period of performance.

Task 4.3 Technical Report 4.3

Collaborate with FDA staff to develop a contract-specific protocol for pilot studies with de-identified data for vaccine recipients to electronically transfer information to the FDA VAERS adverse event database portal. The Contractor shall generate a written protocol describing the details of the processes used to transfer the information to the FDA VAERS database. The protocol shall describe the steps required to accomplish the transfer of data. The completed draft protocol shall be delivered by the contractor within 15 business days of finalizing the study(s). Once the protocol is finalized and the terms of the protocol, including the timeline, are mutually agreed upon between the Contractor and FDA, the study shall comply with the agreed upon timeline. The Contractor shall provide a final report describing the study background, objectives, methods, results, conclusions and discussion, strengths, and limitations. The final report shall be submitted no later than 30 days prior to the end of the TO period of performance.

Table 4: Task 4 Deliverables/ Work Products

Frequency Delivered to

Task 5 Description(s)

Task 5: Experience and Expertise with Data, Tools, and Studies

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

· 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.

TASK 5.1 TECHNICAL REPORT 5.1

Provide a report describing the Common Data Model (CDM) or related approach, utilization of different coding systems in data sources, completeness, timeliness, and accessibility of databases and tools.

Table 5: Task 5 Deliverables/ Work Products

Frequency Delivered to

Task 5.1

Task 6 Description(s)

Task 6: Operations and Management

The Contractor’s Program Manager, the Principal Investigator (PI), and their administrative support staff shall provide Program Management (PM) as specified in Section 2.3 of the master contract SOW and Task Order-level Project Management services to assemble and build the components of the BEST system that can be used by CBER to mine healthcare data for adverse events as part of a national biovigilance system. TO1 requires that the Contractor shall provide access to data sources with millions of patient EHRs or claims data and provide the infrastructure, staffing, and relevant expertise to conduct the program. Moreover, the Contractor shall work with the Government Contracting Officer (CO), Contracting Officer’s Representative (COR), and subject matter experts (SMEs) to ensure that tasks stay on track and important milestones are met. The contractor will also schedule and run all contract-related meetings. In general, the contractor will prepare and distribute review materials in advance of the meeting; draft, vet, and distribute minutes and action items to meeting participants; track and maintain a central repository of minutes and action items and associated materials relating to all meetings/calls

Task 6.1 Organize and Lead Kick-Off Meeting

Following the contract award, the Contractor shall conduct a kickoff meeting at the FDA White Oak Campus, Bldg 71 for all participating FDA and Contractor staff. The kick-off meeting shall be conducted to introduce the Contractor team, discuss roles, responsibilities, other relevant issues as well as the contractor’s approach to meeting the requirements of the SOW.

Task 6.2 Establish Task Order Workgroup

The Contractor shall work collaboratively with FDA staff and the COR and shall establish joint project workgroups.

Task 6.3 Organize and Lead Task Order ADMINISTRATIVE Meetings

The Contractor shall organize and lead monthly meetings with the COR and Government administrative staff beginning the second contract month. The purpose of the administrative meeting is to review administrative aspects of the program to ensure that the program runs smoothly and effectively.

Task 6.4 Organize and Lead Task Order Leadership Meetings

The Contractor shall organize and lead monthly meetings with the COR and Government leadership staff beginning the second contract month. The purpose of the leadership meeting is to review program progress at a high level.

Task 6.5 Task Order Management plan The Contractor shall deliver a Task Order Management Plan (TOMP) as specified in the IDIQ Contract SOW. Additionally, the TOMP shall include a schedule that details activities, dependencies and timeframes for meeting FDA objectives and deliverables; an organizational chart identifying relationships, authorities, and responsibilities; a description of the management controls that the Contractor shall employ to meet the performance, cost, and schedule requirements. The TOMP shall include any other areas the Contractor deems relevant and important to the management of the Task Order. The Contractor shall ensure that activities are coordinated 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.

Task 6.6 Monthly Progress Reports

The Contractor shall provide task order management to ensure that tasks stay on track and milestones, performance measures, deliverables, and work products are met. The Contractor shall deliver a monthly progress report to the COR and CO on the 5th day of each month following the reporting month. At a minimum, the MPR shall contain the following information:

1. The previous month’s progress

1. Deviance from previous month’s planned progress (either positive or negative)

1. The next month’s planned progress

1. Status of deliverables

1. Issues and recommendations

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

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

Task 6.7 Task Order Workgroup Meetings and Deliverables

The contractor shall schedule and provide administrative support for task order scientific workgroup meetings. In performing this task, the Contractor shall:

1. Prepare and distribute agendas to include conference call-in information

1. Prepare and distribute review materials in advance of the meeting

1. Take and distribute minutes and action items to meeting participants

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

1. Prepare a Draft Technical Report for FDA review and comment and a Final Technical Report consisting of a description of work performed and results obtained for the entire contract period of performance in sufficient detail to describe comprehensively the results achieved. The Final Technical Report shall incorporate FDA comments and input.

1. Prepare abstracts, presentations, reports, and manuscripts derived from analyses under the task order for publication and public and non-public presentations.

Task 6.8 Annual In-Person Meeting

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

Task 6.9 Draft Final Technical Report

Prepare a Draft Technical Report for FDA review and comment consisting of a description of work performed and results obtained for the entire contract period of performance in sufficient detail to describe comprehensively the results achieved. The draft final report is due thirty days prior to the end of the Task Order Project Period of Performance.

Task 6.10 Final Technical Report

The Final Technical Report shall incorporate FDA comments and input to the draft and is due prior to the end of the Task Order Project Period of Performance.

Table 6: Task 6 Deliverables/ Work Products

Frequency Delivered to

COR

6.7

Task Workgroup

6.8

Task 7 Description(s)

Task 7: Communications and Outreach

The Contractor shall participate in communication and outreach activities as indicated in the Master Contract SOW. These include training session for FDA staff; a secure web portal for internal sharing of program information; hosting of a website for sharing BEST contract progress with the public; drafting, presenting, and publishing scientific reports.

Task 7.1 Training

The contractor shall provide FDA staff with both small and large group training sessions on use of the data sources, tools, methods, and processes. The training sessions shall accommodate new users of the system and advanced users separately. The training sessions will occur over multiple days at FDA both at the start of the contract and whenever FDA determines they are needed throughout the duration of the contract. Training to FDA staff shall include topics such as data sources, study approaches, methods and tools employed and developed as part of the specific tasks. The specific type of training shall be determined based on the tools and methods developed and shall include development of training manuals and slides, conduct of training sessions, and preparation of other similar activities. The contractor shall also perform monthly webinar/seminars to report to the FDA and other BEST collaborators on the scientific aspects of ongoing or planned projects such as introducing a new project’s study design, reporting on a query, interim results of a query or study, and of final results of a project or study or query.

Task 7.2 Secure Portal for Exchange of program information

The contractor shall create and implement a secure data transfer capability to allow secure file sharing and document storage for the contractor, subcontractors, CBER staff, and other collaborators. The secure portal will be developed within two months after contract award. All the data transfer and document storage related to all queries and complex epidemiological studies, and other activities shall be maintained 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), and the National Institute of Standards and Technology. These procedures (i.e. the MOP) shall address at a minimum the following: data collection, handling, sharing, ownership, and security; management and tracking, consensus definitions, transfer, and sharing considerations for data summaries. The secure portal data security and privacy shall follow 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 per FDA/CBER policies.

Task 7.3 Public Website

The contractor will create a public website where materials can be posted and be available to the public as part of an ITO. Materials shall include protocols, results of queries or epidemiologic studies, and reports. The public website data security and privacy shall follow 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 per FDA/CBER policies. The public website shall be developed within 2 months of task order award.

Task 7.4 Prepare abstracts and reports

Scientific communications will be prepared based on work conducted under the task order and presented via abstracts and reports in public and non-public venues. The contractor shall:

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

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

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

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

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

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

Task 7.5 Prepare presentations and manuscripts

Scientific communications will be prepared via presentations and manuscripts for public and non-public venues. The contractor shall:

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

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

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

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

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

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

Task 7.6 Technical report

Before the end of TO1, prepare a report containing overall recommendations and approaches to creating a national capability for data mining of text-based patient records for adverse events and efficacy data related to CBER-regulated products.

Task 7.7 Transition-In

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 CBER’s mission critical operations and activities. The purpose of the Transition-In requirement is to provide an orderly transition from the prior Contractor. Within 15 days of the task order award, the Contractor shall work with the incumbent contractor to affect a smooth transition of work.

Work activities include:

· Developing a Transition-In Plan to ensure full operating accountability and responsibility of the task orders.

· Familiarizing the incoming Contractor staff with FDA processes and requirements and work with the incumbent Contractor as related to transferring tasks and work activities being performed.

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

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

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

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

Table 7: Task 7 Deliverables/ Work Products

Delivery Instructions for Deliverables

Unless otherwise specified, all deliverables, reports or copies of reports shall be delivered to the COR and Project Officer via email. Requirements for inspection and acceptance are as follows:

· The COR and Project Officer 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.

8. Task Order Administration

8.1 Key Personnel

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

Key Personnel at the Task Order-Level are:

· Principal Investigator

· Project Manager

8.2 Travel

The Government does not intend travel costs (local and non-local) to be incurred during the term of this contract. If deemed necessary and appropriate, the Contractor shall identify and forecast travel requests per each ITO. However, non-local travel (outside of the Washington DC Metro area) is not anticipated at this time. If local or non-local travel is deemed necessary, it must be approved in writing by the ITO CS, CO, and COR in advance (at least 10 calendar days). The travel to be reimbursed shall not exceed the travel ceilings specified in the Federal Travel Regulations and award.

Federal Travel Regulation: http://www.gsa.gov/portal/content/104790

8.3 PERIOD OF PERFORMANCE

Task Order Performance Period: 12-month period of performance

8.4 PLACE OF PERFORMANCE

The Contractor shall perform specified duties at its own site.

8.5 GOVERNMENT POINTS OF CONTACT (POCS)

Task Order Contracting Officer’s Representative (COR):

· To be completed at time of award.

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