Attachment_1_IDIQ_SOW.pdf

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STATEMENT OF WORK

1. INTRODUCTION

The FDA is responsible for protecting the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, biological products, medical devices, the nation’s food supply, and certain other products. In total, the FDA regulates more than $1 trillion of consumer goods, or about 25% of consumer expenditures in the United States.

The FDA’s optimal performance has significant public health and economic benefits. The Agency can speed innovations to market, leading to more affordable medicines and foods. It protects public health, ensuring that people have access to accurate, science‐based information about their medicines and foods. The FDA also coordinates with a number of international organizations to enable global investigations of potential health risks from products, to respond to emerging new diseases, and to help address the challenges faced by public health officials and individuals around the world.

The Center for Food Safety and Applied Nutrition (CFSAN) is one of six product‐oriented centers at the FDA that are charged with advancing a portion of the Agency’s mission. CFSAN assures the safety of most foods and dietary supplements. CFSAN also regulates food additives and food labeling, specifically the "Nutrition Facts" panel typically seen on packaged foods. In addition, it evaluates products that are used in food handling and storage, referred to as "food contact substance”. CFSAN provides services to consumers, domestic and foreign industry, and other outside groups. These services relate to field programs, agency administrative tasks, scientific analysis and support, and policy, planning and handling of critical issues related to food and cosmetic products.

CFSAN uses the mission‐critical Food Applications Regulatory Management (FARM) system to perform its core responsibilities of reviewing pre‐market submissions for substances added to food under the Federal Food, Drug, and Cosmetic (FD&C) Act. The FARM system also supports petitions and notifications submitted under the Food Allergen Labeling and Consumer Protection Act (FALCPA). The FARM system is a repository for over fifty years of regulatory documents that are retrievable for review and taking agency action. FARM is the system available primarily to CFSAN and to reviewers in other centers to access industry submissions and conduct analyses with regards to chemical, toxicological, and environmental analysis and other issues, regarding specific ingredients. Specifically, this system supports CFSAN’s Office of Food Additive Safety (OFAS) and the Office of Nutrition, Labeling and Dietary Supplements (ONLDS) in their review of a wide variety of submissions and petitions submitted by regulated industry to make regulatory safety decisions.

For OFAS, these submissions/petitions include:

Food and Color Additive Petitions (FAPs and CAPs)

Generally Recognized As Safe Notices (GRNS), Food Contact Notifications (FCNs), Biotechnology Consultations (BNFs), New Protein Consultations (NPCs), Infant Formula Notifications (IFN), Food Allergen Labeling and Consumer Protection Act notifications (FALCPA), For ONLDS, these submissions/petitions include:

New Dietary Ingredient 75 Day Notices (NDI), 30 Day Structure Function Label Notices.

In addition to providing information technology support to the scientific review of submissions to OFAS and ONLDS, the FARM system supports critical required functions for OFAS, including:

Citizen Petition responses, Freedom of Information (FOIA) responses and

Correspondence, including with Congress.

2. TECHNICAL BACKGROUND

CFSAN has iteratively upgraded the FARM System to its current configuration – version 5 (FARM V), an integrated system that supports content management, search/retrieval, workflows, reporting, forms management, and scanning activities.

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Exhibit 1 ‐ FARM Features

While FARM system is in full production use at present and requires on‐going Operations & Maintenance, the Agency also anticipates a necessary technology upgrade and a consolidation of FARM workflows and data management (including master data management, content management, search and retrieval, and information reporting).

FDA is currently using the Oracle 10g suite as its base database management system and platform, including the following supporting software but not limited to:

Component Area Technology

Input/PDF Forms Management

Oracle Forms EMC Input Accel 6.5 Adobe Livecycle Forms

DB Storage Oracle DB 10gR2

Search Oracle Text / Portal SQL

Content Management System

Oracle Portal 10.1.4 (embedded

CMS)

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Component Area Technology

Workflow Oracle Workflow (DB 10gR2) Appian BPM 6

Reporting Oracle Reports SAP Business Objects

Single Sign‐on Oracle AS SSO 10g

Portal Oracle Portal 10.1.4

Application Server Oracle 10gAS 10.1.0.2

Note: servers running in the Production environment are planned for high‐availability.

3. FDA DATA CENTERS

FDA has two primary data centers. These data centers are the White Oak Data Center (WODC) and the Contractor Hosted Data Center (CHDC). WODC is used primarily for Development and Test environments. CHDC is used for Pre‐ Production and Production environments. The Contractor may be required to use these four environments in the performance of its support. The Wiley Scientific Data Center (WSDC) is currently in use for hosting some scientific environments. Contractor’s support services may be required there as well.

4. OBJECTIVES

As a direct result of contract performance, the FDA expects to achieve the following outcomes:

Upgrade FARM platform from Oracle 10g to Oracle 11gR2;

Improve master data management of firms and food master data, resulting in enhanced content management;

Improve data quality, data profiling and data integration between FARM data sets and Scientific Information

Retrieval Exchange Network (SIREN) data sets to facilitate the search and retrieval and sharing of information;

Improve the data governance process;

Optimize FARM content management through the refresh of FARM’s workflow processes towards

Intelligent Business Management (support content creation, review and authorization, categorization, reusability, storage and archiving, and retrieval of data); and finally the reporting needs of CFSAN.

Improve information reporting;

Management of the IT configuration, upgrades and programming of software processes associated with the front end processing of submissions and the back end integrating with FARM workflows.

5. PURPOSE

The purpose of this IDIQ Statement of Work is to obtain business and information technology support services (ITSS) for on‐going O&M support and to extend CFSAN’s FARM capabilities using the established infrastructure.

The contract will allow the Agency to seek the full range of O&M services including database administration, customizations and process automation of workflows; performance tuning and monitoring; system administration;

help desk support and end‐user training; and user account administration for the existing FARM system, applications, web/application services, and databases.

The contract will also allow the Agency the upgrade of its technology platform to Oracle 11gR2; to improve the data quality of existing datasets through master data management; to facilitate the search and retrieval; to optimization FARM submission workflow and content management and improve CFSAN’s reporting needs.

6. CONSTRAINTS

6.1 Technical Standards and Guidelines

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The following current standards and guidelines are subject to change as further guidance becomes available, and must be considered in the execution of this contract:

Health and Human Services (HHS) Enterprise Performance Life Cycle (EPLC) Framework, FDA Project Management Process and Templates, Food and Drug Administration Investment Life Cycle (ILC), IT Infrastructure Library (ITIL).

6.2 FDA Master Approved Technologies List (MAT)

The FDA Master Approved Technology (MAT) List contains a list of approved technologies that include applications (software), infrastructure and peripherals (hardware), and scientific software and devices. The contractor must follow the FDA process to submit a request for approval for new software, if necessary. Approval takes a minimum of two (2) weeks and the contractor is responsible for ensuring the form is submitted in a timely manner.

6.3 Contractor Compliance

The contractor shall adhere to all applicable federal information technology and information management laws, regulations, policies and standards at the government‐wide, HHS, and FDA levels. At the government‐wide level, these include Office of Management and Budget (OMB), National Institute of Standards and Technology (NIST), and General Accounting Office (GAO). These can be primarily found at or through the Federal CIO Council website at:

http://www.cio.gov/ . HHS documents are found at: http://www.hhs.gov/oirm/

6.4 508 Standard Requirements Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, requires that all electronic and information technology (EIT) products and services developed, acquired, maintained, or used under this contract/order must comply with the “Electronic and Information Technology Accessibility Provisions” set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the “Access Board”) in 36 CFR part 1194. Information about Section 508 is available at http://www.section508.gov/. The complete text of Section 508 Final Provisions can be accessed at http://www.access‐ board.gov/sec508/provisions.htm.

6.5 Change Control Procedures

All changes to software and FDA IT infrastructure will follow the FDA established change control procedures. These procedures provide a standardized process that ensures efficient and prompt handling of all changes to the software and FDA IT Infrastructure. They will facilitate the efficient and prompt handling of all changes, and maintain the proper balance between the need for change and the potential negative impact of changes as well as ensure that traceability and accountability are supported.

6.6 Release Management Procedures

All software releases will follow the FDA established release management procedures. The following are high level steps for the software release process for all version upgrades:

Determine if ITIM (IT Standards and the IT Investment Management) approval is required, Register planned deployment dates on MARS (Master Application Release Schedule), Participate in RMAC (Release Management and Coordination), Create VDD (Version Description Document) for deploying to release, Request CHDC Resources for Pre‐Production and Production, Request ICCB (Infrastructure Change Control Board) approval for deployments, Represent RFC(s) (Request For Change) at ICCB meeting, Deliver final “Release Package" to FDA OIM Configuration Management Team, Validate successful deployment to target environment, Evaluate all Change Request and Defect candidates for each release to ensure quality and performance standards.

6.7 Compatibility With Existing FDA Enterprise Architecture

Development activities of this contract must follow and be compatible with existing FDA Enterprise Architecture standards. These standards range from the standard Oracle RDBMS, Microsoft SQL Server, to the SOA‐based environment that span across the Web/Presentation, Application, and Data layers currently existing in the FDA.

These FDA Enterprise Architecture standards will be provided to the contractor once the work has commenced.

http://www.cio.gov/ http://www.hhs.gov/oirm/ http://www.section508.gov/ http://www.access-board.gov/sec508/provisions.htm http://www.access-board.gov/sec508/provisions.htm

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6.8 IT Security

This section ensures the system be compliant with Federal and agency security requirements, and support all security related activities including the certification and accreditation process. Project compliance includes:

HHS Information Security and Privacy Program http://www.hhs.gov/ocio/securityprivacy/index.html

FISMA http://www.whitehouse.gov/sites/default/files/omb/memoranda/m03‐19.pdf NIST SP800‐53: http://csrc.nist.gov/publications/nistpubs/800‐53‐Rev3/sp800‐53‐rev3‐ final_updated‐errata_05‐01‐2010.pdf FDA Security Authorization process, which closely resembles NIST SP800‐37:

http://csrc.nist.gov/publications/nistpubs/800‐37‐rev1/sp800‐37‐rev1‐final.pdf

6.9 Data Standards and Guidelines

FDA intends to fully utilize and comply with existing internal & external data standards where applicable, for its data.

For example:

Use HL7 Structured Product Labeling (SPL) standards for Product data, Use Regulated Product Submission Release (RPS) standard, Use existing standard terminologies/vocabularies such as Dun & Bradstreet (e.g., DUNS); ISO (e.g., 3166‐1 Alpha‐3 Country Code, ISO IDMP); FDA (e.g., UNII, NDC); commercial databases such as MedDRA, Herbs of Commerce (HoC), Personal Care Products Council (PCPC) Cosmetic Ingredient Dictionary; internal CFSAN vocabularies and CAERS verbatim terms; Substance Registration System (SRS) etc.

As appropriate, use the common data exchange format (e.g., XML) in exchanging data among IT component(s).

Additionally, as regulations and standards are implemented to facilitate higher volume of data and better data quality from electronic submissions, FDA will exploit the feasibility of automating and consuming (i.e. acquire, validate, transform, transport, etc.) much of the data directly from input sources, thereby increasing the efficiency and quality of the overall master data environment.

6.10 Data Rights

The FAR Clause 52.227‐14 (Alternate II, IV, and V) governs the parties’ rights in data created in the performance of this contract

7. SCOPE

The scope includes business and information technology support services (ITSS) to provide on‐going O&M support and to extend CFSAN’s FARM capabilities using the established infrastructure.

8. DESCRIPTION OF TASK AREAS

The Contractor shall provide technical support throughout all phases of FDA’s Enterprise Performance Life Cycle (EPLC). Information Technology support includes knowledge transfer in a wide range of activities including: concept development, project initiation, planning, preparing and overseeing project schedules, maintaining spreadsheets to track cost expenditures, etc., (i.e. interacting with various points‐of‐contact (POCs) for specific tasks regarding progress, issues and concerns); preparing reports and briefings to FDA, senior management in support of project goals; developing and reviewing requirements and monitoring their implementation in FDA, to ensure that business needs are met; providing business and technical expertise to assist in planning and managing FDA projects; providing technical writing capabilities in support of technical and management project decision‐making; and monitoring program status and relating any trends as they become known.

The Contractor shall furnish all necessary services, qualified personnel, material, development tools and methodologies, not otherwise provided and subject to approval by the FDA, as needed to perform business informatics and IT support services.

8.1 Transition‐In Support

The Contractor shall provide Transition‐In support in order to provide an orderly transition from the incumbent Contractor to the successor Contractor. The successor Contractor shall work toward the Government’s goal of ensuring minimal disruption to the current system and operational activities.

Working with the incumbent Contractor and the COR, the successor Contractor shall develop a plan to take over on‐ going work from the incumbent Contractor as required in the Task Orders released under this IDIQ.

Representative activities may include:

http://www.hhs.gov/ocio/securityprivacy/index.html http://www.whitehouse.gov/sites/default/files/omb/memoranda/m03-19.pdf http://csrc.nist.gov/publications/nistpubs/800-53-Rev3/sp800-53-rev3-final_updated-errata_05-01-2010.pdf http://csrc.nist.gov/publications/nistpubs/800-53-Rev3/sp800-53-rev3-final_updated-errata_05-01-2010.pdf http://csrc.nist.gov/publications/nistpubs/800-37-rev1/sp800-37-rev1-final.pdf

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Develop a Transition‐In plan, Participate in Transition‐In meetings, Conduct and coordinating all on‐boarding activities with the Government and obtaining secure badging for team personnel, Ensure staff identified as key personnel are available to work with Subject Matter Experts (SME) from the

Government and the incumbent Contractor immediately after IDIQ Task Order awards, Engage in regularly scheduled meetings.

8.2 Project Management Plan (PMP)

For the task orders released under this contract, the Contractor shall provide task order level PMP to establish control, management, monitoring and notification mechanisms, ensuring that contracted tasks stay on track and important milestones and performance measures are met. For each task order, the Contractor shall prepare a Management Plan describing the technical approach, organizational resources, risk management and other management controls to be employed to meet the cost, performance and schedule requirements throughout the task order execution.

The Contractor shall provide monthly status reports on all awarded task orders and their progress to the IDIQ Task Order Contracting Officer Representative (COR). Within the first thirty (30) days after contract award, the Government and the Contractor will design and agree upon a standard reporting format that includes the following information at a minimum:

Status and progress of tasks, Cost and schedule variances, Significant risks to scheduled deliverables and plans to mitigate them, Progress against service level metrics and

Recommendations for changes or additional activities to ensure that the tasks support progress on the overall contract objectives.

In addition to progress reporting, the Contractor shall be proactive in informing the designated government Project Managers and Contracting Officer Representatives of any issues, problems and recommendations that should be addressed in order for the overall effective accomplishment of task order goals. Recommendations for actions that need to be taken by FDA staff, or other Contractors, shall be clearly defined and communicated to the responsible party and the FDA, and have identified dates for completion.

8.3 Documentation Management

For tasks areas governed by the FDA EPLC, the Contractor shall ensure that all system documentation be completed as required by the specific task order.

8.4 Task Area ‐ Operations and Maintenance Support

Operations and Maintenance activities focus on the maintenance of existing FARM capabilities to ensure the functionality, reliability, availability, performance, stability, sustainability and security of the tools, systems, and environments that are used in support of the FARM operations including computing software, configurations, integrated services and interfaces, customizations, and components. As tasked, the Contractor shall provide support services including but not limited to issue identification, tracking, analysis, and resolution; code generation, testing, and documentation; custom code, specialized configurations, customizations and process automation such as scripts, templates, and workflows.

Representative activities under this task area may include:

Provide production support for FARM system. Provide configuration management and version control on production, test, and development environments;

Provide production support for Business Objects reporting;

Provide technical support for test, development, training, and production environments at FDA;

Provide system backup and archiving support to include, but not limited to: assistance with creating and testing scripts; testing and restoration of data from backups; and, documentation of procedures;

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Perform operational work such as COTS software upgrades and patches, application modifications, application and database trouble‐shooting, and application release enhancements.

Help desk activities such as triage, including evaluation and assignment, troubleshooting, resolution and tracking tickets and issues, and responding to end users within timelines established by the COR/Project Managers. Resolve critical defects and/or high priority change requests; provide weekly (or as requested) status reports, on all help desk issues to COR/Project Managers, using the FDA standard issue tracking system and reporting tool.

Provide performance monitoring and tuning requirements for FARM and SIREN data repositories;

8.5 Task Area ‐ Technology Upgrade

The Contractor shall support, evaluate and document recommended improvements to upgrade the technology stack (see Section 0 2. TECHNICAL BACKGROUND) and produce best practice documentation for technology upgrade.

Representative activities under this task area may include:

Recommend and support implementation of a governance structure for managing the upgrade;

Provide support services to ensure upgrades to operating systems, databases, and interfacing systems;

Provide support services for any change within the data centers and necessary technology impacted by the Oracle technology upgrade. Support services include but are not limited to planning, obtaining work approval, and testing;

Develop, test, and implement maintenance and releases to correct any defects related to the upgrade;

Maintain and update system documentation as needed;

Collaborate with OIM Division of Infrastructure and other FDA units to maintain fully functioning training environment capable of supporting the training to FARM users;

Support user training activities, including maintaining and updating all training and practice environments following patches and releases;

Engage with business process and system owners and other stakeholders at least monthly or if required on a frequent basis to proactively identify change requests or issues with downstream business users. Identify impact and facilitate change requests and new enhancements.

8.6 Task Area ‐ Concept Development / Business Analysis

The Contractor shall support, evaluate and document recommended improvements to existing processes and produce best practice documentation for Master Data Management (MDM) process enhancements and support tools.

Representative activities under this task area may include:

Provide technical guidance related to master data management strategy, business analysis, system architecture and infrastructure framework to support, evaluate, improve and transform existing programs and processes;

Perform impact analysis scenarios and gap analysis activities; ensuring standardization and consistency across data base management systems;

Perform impact analysis scenarios and gap analysis activities to identify inefficiencies, redundancies, obsolescence, and technology support gaps;

Analyze existing business processes, scenarios, activities, architecture, and information flow;

Provide future state of business processes, systems, applications and databases applying best practices that includes the list of business processes to be improved;

Provide business and technology roadmaps to include blueprints, to‐be business processes, information flow and data flow diagram, conceptual, data models, and system architectures that will transform the current state to the designed future state of business processes and systems;

Establish performance goals and metrics for the future MDM solution;

Assessment and documentation of potential alternatives that could support the major objectives of the Master Data Management effort;

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Provide business and technology roadmaps to align each center’s MDM solution with the enterprise FDA MDM vision.

8.7 Task Area ‐ Data Quality Management

The Contractor shall provide services to support, evaluate and document recommended improvements to the existing FARM and SIREN datasets processes, search and retrieval and sharing of information and produce improved best practice documentation for data quality management, process enhancements and associated tools. Representative tasks may include work described in the following sections:

8.7.1 Master Data Management Governance

The Contractor shall support, evaluate and document recommended improvements to existing Master Data Management governance processes and produce best practice documentation for Master Data Management governance enhancements.

Representative activities under this task area may include:

Recommend and support implementation of a governance structure for managing the master data management (MDM) of FARM and SIREN data sets to improve data quality, data profiling and data integration between these data sets, to facilitate the search and retrieval (content tagging using metadata and enterprise taxonomy);

Develop a master data management operational plan that will address key concepts such as data governance framework, communication management, change management, issues and resolution management, data quality, training etc., required to establish centralized operational data management services;

Implement and help establish MDM Governance board that ensures successful interplay between technology, people and processes and that enables proactive approach to address issues and disconnects;

Facilitate MDM governance board meetings, agenda, and discussions to help manage and resolve master data issues;

Engage with business process and system owners, and other stakeholders on at least monthly or if required on a more frequent basis to proactively identify change requests or issues with downstream business users. Identify impact and facilitate change requests and new enhancements;

Provide data governance support for existing data governance structure.

8.7.2 Content Management Governance

The Contractor shall support, evaluate and document recommended improvements to existing Content Management governance processes and produce best practice documentation for Content Management enhancements.

Representative activities under this task area may include:

Recommend and support implementation of a governance structure for optimizing the content management of FARM (from content creation, review and authorization, categorization, reusability, storage and archiving, to data retrieval);

Develop a Content Management operational plan that will address key concepts such as metadata management, communication management, change management, version control, issues and resolution management, data quality, training etc., required to establish centralized operational content management services;

Implement and help establish Content Management governance board that ensures successful interplay between technology, people and processes and that enables proactive approach to address issues and disconnects;

Facilitate Content Management governance board meetings, agenda, and discussions to help manage and resolve content management issues;

Engage with business process and system owners, and other stakeholders on at least monthly or if required on a more frequent basis to proactively identify change requests or issues with downstream business users. Identify impact and facilitate change requests and new enhancements;

Provide content management governance support for existing content management structures.

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8.8 Task Area ‐ Full Life Cycle Development

The Contractor shall work closely with the CFSAN to perform a wide range of engineering services necessary to assist the FDA in conducting the design modernization and enhancement of the FARM system. This work may include tasks such as working closely with CFSAN to facilitate, validate and document requirements; research and analysis activities; system analysis and design activities; customization, configuration and integration activities; and system testing activities.

8.8.1 System Engineering

Representative activities under this task area may include:

Requirements Management – Documenting, vetting and refining business requirements into technical requirements, Research & Analysis ‐ Researching, evaluating and providing guidance on the technologies (features), configuration and customizations that are necessary to achieve CFSAN’s goals, Development of concept‐of‐operations or similar preliminary design documentation to support early planning and the acquisition process including evaluation of COTS vendor solutions for feasibility and risk, Develop prototypes or proofs‐of‐concept to better define new requirements, develop accurate estimates for future acquisitions, and provide input into management decisions.

8.8.2 System Development

Task Orders may encompass the complete range of system development lifecycle support services necessary to develop new systems and/or enhance existing capabilities. Tasks may encompass the complete lifecycle of activities required for database, application and tool development including, but not limited to requirements elicitation, analysis and validation; system design; code generation; testing; deployment; and documentation. As tasked, the Contractor shall also develop, support and evolve designs, customizations and process automation such as interfaces, templates, scripts, workflows, and interfaces to permit the FDA Center staff access to perform enterprise search and retrieval of master data and conduct data entry and reconciliation. Deliverable products, specified within each individual Task Order , shall be validated and tested to ensure that they meet applicable/specified standards, policy, business requirements and quality measures.

Representative activities under this task area may include:

Improvement of existing FARM workflows, development, deployment of workflow using approved workflow tools;

Re‐design and consolidate the FARM and SIREN data repositories, user interface, data validation/transforming service components, and data access/supply service components for the consuming systems;

Re‐design of the FARM search tool, user interface, and the generation of associated documentation and training to users;

Re‐design the search capabilities to support multiple and complex search techniques; configure indices to improve search performance; manage and format search output; support automatic indexing based on user defined specifications; filtering based on FARM fields; include in‐house and external thesauri into

FARM;

Installation, configuration, and documentation of new tools, if necessary;

Conduct MDM and Content Management data quality testing to ensure adherence to data standards and work with IT teams to resolve issues;

Collaborate with IT to support testing, training and post‐implementation support for functionality developed to improve, and enhance existing business processes. Update and maintain relevant documentation such as SOPs, other process documents, training material etc. accordingly;

Conduct unit, system, and integration testing of the applications, tools, automated workflows and interfaces;

Support user acceptance and performance/stress testing;

Development of test specifications (i.e. test strategy, test plans, test scenarios, test cases, procedures/scripts, etc.) and document test results of all categories of testing.

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8.8.3 Security support

The Contractor shall provide input into security planning, including the assessment of security risks, preparing responses to security related data calls (e.g. Privacy Act responses) and supporting Certification and Accreditation activities.

8.9 Task Area ‐ Training Support

As tasked, the Contractor shall plan, develop and deliver training. As tasked, the Contractor shall develop and execute a training strategy that will provide the CFSAN reviewer community with the skills necessary to effectively utilize the enhanced FARM system. Training programs (courses, material, etc.) will be evaluated, tracked, and measured for effectiveness in meeting business goals and objectives.

Representative activities under this task area may include:

Perform training assessments, evaluations and analyses, Develop a training plan, Develop training material, Provide on‐demand training, Update training material to stay in line with updates made to the FARM upgrade, Develop and implement web‐based training.

8.10 Task Area ‐ Transition‐Out Support

As tasked, the Contractor shall facilitate the transition of contracted FARM related activities and services to the Federal Government or to a follow‐on Contractor at the end of the contract period of performance.

Representative activities under this task area may include:

Provide the FDA with current versions of all system and user documentation;

Provide FDA all licensing and renewal information, asset management records, software documentation, and training materials;

Provide FDA with a current inventory of all Government‐owned assets used by the Contractor along with full support in the reconciliation of this inventory;

Provide FDA with current versions of all CONOPS, operational procedures, standard operating procedures, guidelines, performance reports, specifications for hardware and software, and other pertinent information needed to continue the services being performed by the Contractor;

Provide “shadowing” and other knowledge transfer meetings and opportunities to facilitate the transfer of information, processes, and data needed to continue the services being performed by the Contractor;

Provide full source code sets (not COTS source code) with configuration management information; and, Provide up‐to‐date‐EPLC and program/project management documents.

9. DELIVERABLES

Deliverables shall be specified in the task orders released under this contract. Deliverable products shall be reviewed, validated and tested as appropriate to ensure that they meet applicable/specified standards, policy, business requirements and quality measures.

Draft versions of the contract level Program Management Plan (PMP) shall be submitted with the Offeror’s proposal.

Final versions of the PMP shall be delivered within 30 days of contract award. When approved by the IDIQ COR, the Contractor shall operate under the PMP.

10. PERSONNEL

The Contractor shall ensure that all Contractor support personnel are adequately trained, possess the credentials specified in the appropriate labor categories, and are otherwise fully qualified to provide the high level of support required by this SOW prior to being assigned to task orders awarded.