Attachment 2 CSTAR Task Order 1 SOW.doc

Attachment 2

Task Order 1 – CSTAR Operations and Maintenance (O&M), Steady State, Project Management Support, and Transition Work Activities (Firm Fixed Price) Background

The Center Submission Tracking and Reporting (CSTAR) suite of applications is critical to meeting CDRH's regulatory requirements by helping the Center track, manage, and report on its work. This task identifies Project Management Support, Operations and Maintenance (O&M) / Steady State (SS) Work Activities, and Transition Work Activities to keep the CSTAR suite operating at current levels.

Objective The objective of this task is to obtain resources to support the ongoing operations and maintenance (O&M) of the CSTAR suite of applications. Specific task areas include:

1. Project management (PM) support services necessary to support the execution of the contractor’s approach to the technical activities performed under this contract and to report status to the FDA COTR/Project Manager and CDRH business management.

2. Steady state operations and maintenance (O&M) of the current CSTARS applications. O&M/SS activities include ongoing production, pre-production, test, and development maintenance support; help desk support; data corrections; software upgrades; and minor enhancements.

3. Transition work activities. The contractor shall facilitate the transition in and transition out of development and O&M activities for the CSTAR suite of applications.

Scope

As a task under the CENTER SUBMISSION TRACKING AND REPORTING contract, “CSTAR O&M” is subject to all relevant terms, conditions, requirements and guidance in that contract. Specifically, the following applications shall be covered under this task:

· CTS - Center Tracking System

· CARS - CDRH Ad-Hoc Reporting System

Note: Descriptions and technologies for the CTS and CARS systems are attached as appendices to the CENTER SUBMISSION TRACKING AND REPORTING contract. Please see Appendices A and B for CTS information and Appendices C and D for CARS information.

Description of Work

In conjunction with the CENTER SUBMISSION TRACKING AND REPORTING contract, the contractor shall provide project management, operations and maintenance/steady state, and transition support services according to EPLC and FDA IT standards. These practices also include the use of software development life cycle tools, including JIRA (change requests), Subversion (source code), and Traction (documentation).

Task 1 - Project Management Support (Firm Fixed Price) The contractor shall conduct planning and tracking of the project, through tracking risks, action items, status reports, creating and updating EPLC artifacts, and satisfying any additional government reporting requirements.

1. The contractor shall provide overall Program Management (PM) support throughout the performance period using internal processes consistent with principles outlined in the Project Management Institute’s (PMI) PMBOK® Guide, such as integration management, scope management, budget and schedule management, quality management, risk management, and communications management.

2. The contractor shall provide Project Management (PM), in conjunction with the FDA COTR/Project Manager and CDRH business management, to assist in any clarification of the objectives, scope, deliverables, project schedule, milestones, development, release approach, and roles and responsibilities for IT support of the CSTAR suite of applications.

3. The contractor shall perform the following project management activities: directing and coordinating project staff; maintaining a list of contractor’s staff and respective roles; monitoring planned vs. actual costs and scheduled activities; performing appropriate Quality Assurance (QA) activities; participating in the CSTAR Configuration Control Board (CCB) process; verifying compliance of work products and activities with the FDA regulations, standards, and guidelines; providing technical and project information updates as necessary to support internal and external IT review processes; providing weekly and monthly progress reports; and participating in briefings/meetings as requested.

4. The contractor’s work shall be performed in accordance with EPLC processes and templates. The contractor shall be required to produce all required documentation and artifacts, and perform all activities necessary to complete the phase as identified in FDA’s EPLC framework and as specified by the agreed upon Project Process Agreement (PPA) for a system release. Timelines for FDA review of documentation will be stated in the mutually agreed upon PPA.

5. The contractor shall support Stage Gate Reviews for minor/O&M releases. Appropriate Stage Gate Reviews, as determined by the FDA COTR/Project Manager and CDRH business management, shall be conducted before tasks can proceed to the next phase of the EPLC. Stage Gate Reviews are required to provide for independent review and approval of key elements of the IT project’s development or operation. Stage Gate Reviews consist of an independent confirmation by Critical Partners to the IT governance organization that all documents and contract deliverables are satisfactorily produced and adequately met all exit criteria for the phase to permit advancement to the next phase. The contractor shall be responsible for providing documentation of known issues and plans to mitigate the risks, if any, and facilitate the preparation and execution of the stage gates, as well as be responsible for the delivery of the final stage gate reports.

6. The contractor shall maintain the Project Management Plan (PMP) throughout the period of performance, modifying and updating the plan as necessary. Changes to the plan shall be subject to review and approval by the FDA COTR/Project Manager and CDRH business management. Once approved, the updated PMP shall be enforced for implementation of the tasks. The contractor shall provide an initial plan within 30 days of award. The PMP is a fluid document and shall be modified in accordance EPLC PPA agreements.

7. The contractor shall maintain the Management Plan. At a minimum, the Management Plan shall address the following areas: Risk Management, Requirements Management, Quality Management, Staffing and Project Organization, Earned Value Management (EVM), Performance Metrics, and Technical Metrics. The Contractor Project Manager shall maintain the Management Plan throughout the period of performance, modifying and updating the Plan as necessary. Changes to the Management Plan shall be subject to review and approval by the FDA COTR/Project Manager and CDRH business management. Once approved, the updated Management Plan shall be enforced for implementation of the tasks. The Contractor shall provide an initial plan within 30 days of award. The Management Plan is a fluid document and shall be modified as deemed necessary.

8. The contractor shall deliver a resource utilization report, to be delivered on or before the 3rd calendar day of each month, that shows what percentage of billable hours each member of the contractor’s staff spent on O&M tasks. The O&M tasks shall be identified by each system listed earlier in the Scope section, whereas the DME tasks shall be itemized by DME task order.

9. The contractor shall deliver a Work Breakdown Structure (WBS) for each system release. This WBS will show scope, the schedule for the planned tasks, resources, and percent completion; where applicable the WBS shall be aligned to the EPLC framework. The schedule will be used to track activities and monitor progress, and will be updated as appropriate when changes to the schedule or activities are approved by the FDA COTR/Project Manager and CDRH business management. The contractor shall use Microsoft Project (2003 or later), or other FDA approved project management tool.

· Note: Operations and maintenance (O&M) work activities and costs must be tracked separately from DME tasks.

10. The contractor shall prepare a monthly progress report to be delivered on or before the 20th calendar day of each month. This report shall contain: A narrative review of work accomplished and/or significant events regarding the task order (TO); problems experienced, potential risks, and risk mitigation plan; anticipated progress, deliverables, or milestones due the next reporting period; technical metrics as described in the Management Plan; project schedule status showing planned vs. actual activities; reporting to address limitations of subcontracting clause (52.219-14); and project financial status for this reporting period. The “CDRH Project Tracking” matrix for CDRH business management will also be updated at this time.

11. The contractor shall provide a monthly project dashboard to include the required performance statistics listed for each work activity. Dashboard statistics shall include cumulative, monthly averages for the past year, and monthly averages over the previous year shall be included where appropriate. FDA shall provide a project dashboard template to assist the contractor with providing the required information.

12. The contractor shall conduct CSTAR weekly progress meetings to be held with the FDA COTR/Project Manager and CDRH business management to discuss general status of the projects and any issues as they occur, as well as to gain any FDA management updates and feedback. The status reports shall also include information delineating assignments, accomplishments, potential risks, outstanding issues, and financial status. Finally, the status reports shall include information about planned activities for future reporting period, when appropriate.

13. The contractor shall participate in Project Review Meetings as needed to discuss specific project activities and address any potential problem areas that might arise, or have already arisen. These reviews may be called by the FDA COTR/Project Manager, CDRH business management, or by the contractor on an as needed basis and may include participants from FDA senior management.

14. The contractor shall facilitate the CSTAR Change Control Board (CCB) and any subsequently formed CCBs and meetings. Typically, CCB meetings are held on a recurring monthly basis. The CCB activities include updates on major activities, reviews of Change Control Requests (CCRs) for prioritization, and demonstrations of new features. The CCB agenda and meeting minutes shall be well documented by the contractor.

15. The contractor shall provide the CSTAR CCB each month with an estimate of the unallocated O&M development hours available, which can be prioritized to make minor enhancements to the CSTAR suite of applications.

16. The contractor shall provide the FDA COTR/Project Manager and CDRH business management with the minutes of all status and requirements meetings. The contractor may be required to provide other meeting minutes as directed by the FDA COTR/Project Manager or CDRH business management. These minutes shall include the following:

· Action Items and the assignee

· Summary description of all issues and decisions All agendas shall be delivered at least two (2) working days prior to the meeting unless the meeting is called at the last minute. All meeting minutes shall be made available to the FDA COTR/Project, CDRH business management, and end users within three (3) working days following the meeting.

17. FDA personnel will be responsible for the earned value management (EVM) of the overall project. The contractor is responsible for providing up-to-date figures on the projects to assist in EVM reporting. For multiple year contracts, FDA will state what reports are required for each year of the contract based on the projects designated tier and when the stated reports are due.

18. In conjunction with the delivery of the Monthly Progress Report the contractor shall deliver a financial report each month due on or before the 20th calendar day of each month.

19. The contractor shall help with the submission of accurate information for data calls to the requestor by the predetermined deadline. Data calls often involve budget requests, security audits, computer or hardware details, application systems such as attributes. Quick turn-around time is often required for data calls. Further, from time to time, the contractor may be required to produce ad hoc status, financial, or technical reports at the request of the Government. Currently, CSTARS experiences approximately four (4) data calls per month.

Task 2 - Operations and Maintenance Support / Steady State (SS) Work Activities (Firm Fixed Price) The contractor shall provide day-to-day operational and maintenance support as well as minor development of change requests approved by the CSTAR Change Control Board (CCB) or deemed mandatory by CDRH business management.

1. It is envisioned that, over this period of performance, that each CSTAR application will undergo at least two O&M/minor releases. A minor release is defined as applied bug fixes and/or new features to improve the existing system in operations and maintenance.

(Past years have included up to four releases.)

2. The contractor’s work shall be performed in accordance with the FDA EPLC processes and templates as applicable. FDA EPLC tasks for the O&M/minor releases of systems are expected to include:

· Managing user administration and access privileges;

· Scheduling and providing training for new hires, changes in assigned responsibilities, disaster recovery, and administrators (Log File Analysis);

· Investigating and reporting security incidents and events;

· Conducting functional system assessments (such as user satisfaction surveys);

· Assisting with the annual architecture and operational analysis as needed;

· Updating and maintaining the plan of actions and milestones;

· Assisting with the annual information security risk assessments;

· Testing contingency and disaster recovery plans;

· Reviewing and remediating vulnerability scan reports;

· Provide information and support for the system re-certification and re-accreditation (as necessary);

· Updating/finalizing FDA EPLC artifacts (per the PPA);

· Working with CDRH and OIM Enterprise Architecture (EA) leads in maintaining the CDRH EA artifacts in the CDRH-directed repositories.

3. The contractor shall work closely with the appropriate FDA IT specialists in maintaining software to provide on-going operations and maintenance support of the CSTAR suite of applications.

4. The contractor shall maintain four separate operating environments for each application within the CSTAR suite: development, test, pre-production, and production.

5. As specified in Section 5 of the CENTER SUBMISSION TRACKING AND REPORTING contract, a hosted data center will provide the pre-production and production regulatory application environments and will host necessary portions of the core IT infrastructure needed for application support (e.g. domains controllers, DNS, firewalls, network cores etc.). The CSTAR contractor is not expected to provide hosting or physical server maintenance support, as the hosted data center contractor will provide these tasks. This environment is also known as the Contractor Hosted Data Center (CHDC). In a similar fashion, the White Oak Data Center (WODC) will provide the development and test environments for the CSTAR suite of applications. Again, the CSTAR contractor is not expected to provide hosting or physical server maintenance support for the development and test environments, as the WODC will provide these tasks.

6. The contractor shall provide pre-production and production control and quality control functions (job submission, checking, and corrections).

7. The contractor shall work with the CHDC and WODC personnel by providing release packages, software updates, application-specific knowledge transfer, and troubleshooting as required.

8. The contractor shall perform patching of software for the system or assist the CHDC or WODC with these tasks.

9. The contractor shall verify the performance of the CSTAR suite of applications after patching, maintenance, or release activities performed by CHDC and WODC personnel. The contractor shall test applicable product versions with all relevant and current updates and patches installed.

10. The contractor shall support the upgrade of servers (i.e., application, database, etc.) as needed.

11. The contractor shall monitor and make recommendations concerning software upgrades. The contractor shall ensure that all software upgrades are compatible with existing software and will perform all necessary testing procedures before moving the software to preproduction and production. Additionally, the contractor shall modify the existing software, and the reporting tools that are used by the software as necessary for compatibility issues that occur with software upgrades.

12. CSTAR applications have an underlying Oracle relational database management system (RDBMS) to hold operational and functional data. The contractor shall provide qualified Oracle staff to perform database administration for the CSTAR databases as needed or required. The contractor shall:

· Work on the smooth operation of the Oracle databases, including parameter configuration, index development and implementation, disk array configuration, and performance tuning;

· Assist with the maintenance of databases in development, test, pre-production, and production environments;

· Perform capacity planning;

· Monitor the execution of Oracle backups and recoveries as required;

· Implement security as per FDA guidelines, policies, and procedures;

· Assist with the administration of Oracle users and their roles;

· Provide tools to proactively monitor system performance and provide alerts for problems that will impact the production environment;

· Provide audit trails in accordance with the CSTAR Security Plan.

13. The contractor shall provide support for the implementation and management of the business intelligence systems that incorporate the Business Objects suite of products. The contractor shall provide qualified Business Objects staff to perform the following tasks:

· Configure, update, and maintain the Business Objects suite of products and its supporting software, or assist the CHDC with these tasks;

· Support the integration of the Single Sign-On system with the production environment;

· Provision and administer the Business Objects user credentials;

· Design, develop, and maintain new Universes and reports as required.

14. The contractor shall collaborate with the network operations centers on day-to-day routine network and application operations. These O&M activities are expected to involve collaboration concerning network design; performance tuning; network component (switches, routers, load balancers, SSL accelerators, etc.) selection, implementation, and security.

15. The contractor shall ensure that all processes are documented properly in an operations manual (also known as a “run book”). The contractor shall maintain and update all CSTAR-related manuals, including server support and Network Control manuals, with the procedures required for operation by FDA's computer control personnel, operators, and system administrators. The contractor shall include procedures for typical systems requirements as well as CSTAR-specific operating instructions as required. Updates to the manuals will be expected with each O&M/minor release. Deployment packages and steps for maintenance releases will be detailed in a Version Description Document (VDD), which has an EPLC template.

16. The contractor shall support, maintain, and renew the security authorization for the applications within the CSTAR suite. This will involve yearly security audits and scans by the FDA IT Security Operations Center and will require a remediation plan for found deficiencies. The contractor shall perform configuration, security and design reviews/audits to ensure software, system, parameter, and configuration are correct.

17. The contractor shall maintain compliance with all FDA required security operational procedures including password controls.

18. The contractor shall work with the FDA IT Risk & Compliance (R&C) Team to ensure configuration changes adhere to FISMA compliance.

19. The contractor shall ensure all requests for changes are logged and given a Change Control Request (CCR) number. Upon approval of the CCR, the contractor shall work closely with the customer/end users to meet their needs.

20. The contractor shall identify and prioritize new tasks versus “fixes” of existing software after consulting with the FDA COTR/Project Manager and CDRH business management. The contractor shall perform corrective maintenance (i.e., bug fixes, data corrections) and develop minor enhancements within scope of the CSTAR CCB.

Note: CCRs from DME and SS tasks may be grouped together in a single software release, but DME CCRs shall be tracked in the appropriate DME task.

21. The contractor shall provide support as requested for troubleshooting and resolution of technical problems. The contractor shall provide on-site support for approximately 1500 CDRH users. On-site support is required Monday-Friday during the hours of 8:00 AM Eastern to 4:30 PM Eastern Time).

22. The contractor shall provide help desk support by collaborating with FDA’s Service Center to address ERIC tickets and issues tracked with CDRH’s issues tracking software tool, JIRA. The monthly average number of help desk support requests is 30. The contractor shall provide the following Help Desk support tasks:

· Enable and disable user accounts;

· Update user accounts;

· Allocate privileges;

· Provide a monthly accounting of help desk user support issues;

· Triage ERIC and JIRA tickets;

· Explain to users how to perform functions of the CSTAR applications;

· Highlight any significant problems;

· Troubleshoot users' problems.

23. The contractor shall perform data corrections required (several times per day) to production databases to address inadvertent user actions as requested by database data entry staff and owners.

24. The contractor shall maintain user documentation for CSTAR Applications: User Manuals, Frequently Asked Questions, and Quick Guides, including adhoc reporting aides such as a physical data model diagram for end-users and corresponding data dictionary to identify and define the tables and fields available in the model for use in reports.

25. The contractor shall provide the appropriate training for a release—if it is agreed to per the EPLC PPA. This is separate from training discussed in any DME tasks. The majority of the training is expected to be satisfied with on-line tutorials and/or training documentation. If classroom training is required as determined by CDRH business management, the contractor shall conduct, at a minimum, one round of on-site training for the user groups, as well as provide user support for the troubleshooting issues. Not every release requires training. FDA would estimate approximately one classroom training exercise per year with two to three multiple sessions.

The training options include:

· Demo: The users can participate in a conference style setting, with about 50-60 seats in the room. The users are given handouts to follow along on the computer screen. This session typically last about one to one and a half hour with questions and answers at the end.

· Hands-on Training: The users can participate in a computer lab classroom with about 15-18 seats in the room. Each user is typically seated in front of his/her computer and follows along with the instructor. The users are given a chance to actually performing tasks related to the training.

· One-on-One & Teleconference: The users participate in a specific area of coverage pertaining to their needs. This is done either one-on-one with the instructor at their office or the instructor’s office. The users can also participate in a teleconference with the instructor for the same training.

· Web Audience Training: This training provides the user community with the opportunity to access the training material on-line.

26. The contractor will do an annual assessment of the software it develops and maintains to determine if it is meeting requirements for functionality and O&M and will report the results to the FDA COTR/Project Manager and CDRH business management. This will be done in conjunction with the Evaluate stage of the CPIC lifecycle. In support of the annual assessment, the Contractor will continuously monitor new technology offerings to recommend the most current and best technology to be used that is feasible to implement.

Task 3 - Transition In (Firm Fixed Price) The contractor shall support the transition in and transition out of development and O&M activities for the CSTAR suite of applications. The purpose of the transition is to transfer expert knowledge, data, and artifacts that are used to support applications from the incumbent contractor to the FDA (or its designated contractors) efficiently and orderly.

The contractor shall document and execute a Transition-In plan to meet the following goals.

Within two (2) weeks of award, the contractor shall:

· Initiate a weekly transition status meeting and report to discuss progress with the FDA COTR/Project Manager and CDRH business management.

Within one (1) month of award, the contractor shall:

· Deliver a Transition-In Plan that identifies and sequences the transfer of all key O&M activities from the incumbent contractor. This transition plan must include a staffing plan/model, risks with mitigation strategy, rollback/contingency strategy, schedule, and communication activities.

Within two (2) months of award, the contractor shall:

· Finish reviewing CSTAR documentation and source code, which will be provided as Government Furnished Information (GFI) after award;

· Interview specified CDRH business stakeholders and incumbent contractors to understand and assess the current operational state of the CSTAR suite of applications;

· Shadow incumbent contractors;

· Deliver an O&M Support Plan. This shall include a plan for addressing Operations and Maintenance Manuals (part of EPLC) for CSTAR components.

Task 4 - Transition Out (Optional Task) - Firm Fixed Price The contractor shall document and execute a Transition-Out plan to meet the following goals.

With 90 days left on the contract, the contractor shall:

· Develop a Transition-Out Plan that describes how and when the incumbent will complete and/or transition in-progress development work and update all system documentation (including EPLC artifacts);

· 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.

With 60 days left on the contract, the contractor shall:

· Initiate a weekly transition status meeting and report to discuss progress with the FDA COTR/Project Manager and CDRH business management.

· 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 incoming contractor.

Within 7 days left on the contract, the contractor shall:

· Provide current versions of all system documentation (EPLC artifacts), user documentation, and training materials;

· Provide current versions of operational procedures, standard operating procedures, guidelines, performance reports, specifications for hardware and software, and other pertinent information needed to continue the services;

· Provide full source code sets, including scripts and other mapping files, with configuration management information;

· Provide all licensing and renewal information;

· Prepare to return all Government-furnished equipment.

Service Areas and Service Level Commitment

The following table outlines these service areas and the service level commitment expected by the FDA from the contractor.

Service Areas and Service Level Commitment Service Areas and Service Level Commitment

Fundamentals

· Notify users of outage within 15 minutes or upon notification of outage by means of:

· Email

· Traction

· Web status pages

· Voice mail

· Telephone trees

· Alternate means when electronic systems are not available

Support

Support Response Goals

The contractor, when notified of a high or “show stopper” outage, is required to implement the OIM severity 1 IM ticket and an OIM emergency Request for Change (RFC) and receive approval of the RFC from the OIM Infrastructure CCB. For normal or low urgency levels, the contractor is also required to create an IM ticket, RFC, and attend the weekly Infrastructure CCB meeting for approval of the RFC. CTS and CARS applications are not deemed to be 24/7 applications, so contractor support is performed during a typical eight-hour workday—that is, unless there is an after-hours deployment. The staff who run the CHDC and WODC may be responsible in many cases to implement the contractor’s code or scripts described in the RFC, so response time is dependent on CHDC/WODC resources.

The table below outlines the response goals for different levels of urgency.

Time (between 8:00 AM ET and 4:30 PM ET) Resolution Goal

Urgent

(“Show Stopper”) Major application outage or defect causing the client not to be able to perform critical business processes.

Significant business or user impact.

Within 15 minutes or upon notification

Less than three hours (or by mutually agreed deadline)

Major impact on business operations or a user’s ability to perform work.

business days or by required deadline

Does not significantly interfere with business operations.

Within 1 business week

As negotiated between client and contractor manager

Does not significantly interfere with business operations.

Within 1 business week

As negotiated

Information

Requests (data calls)

Assumptions

1. The contractor will ensure that minor CCB-requested changes do not duplicate, negate, or otherwise interfere with the development work under separate DME task orders.

2. Any O&M/minor system release will adhere to FDA EPLC standards.

3. The contractor will not make interface changes to non-CDRH systems.

4. OIM-mandated software upgrades (e.g., Oracle, Internet Explorer) will be handled through task order.

Key Personnel

Key Personnel and their qualifications for this SOW include:

· Project Manager - In addition to any qualifications required by this labor category under the contract, the Project Manager must have the following qualifications:

· Certified Project Management Professional (Project Management Institute PMP)

· Knowledge/experience with Earned Value Management (EVM)

· Knowledge/experience with Microsoft Project

· Senior Systems Architect - In addition to any qualifications required by this labor category under the contract, the Senior Systems Architect must have the following qualifications:

· Knowledge/experience developing web services

· Experience in developing applications/services in a service oriented architecture (SOA)

· Senior Application Engineer - In addition to any qualifications required by this labor category under the contract, the Senior Application Engineer must have the following qualifications:

· Knowledge/experience developing Business Objects reports and services

· Experience in developing applications/services in a database environment using end-user metadata for analyses and implementation

· Senior Computer Systems Analyst - In addition to any qualifications required by this labor category under the contract, the Senior Computer Systems Analyst must have the following qualifications:

· Knowledge/experience of business analysis standards and methodologies

· Experience in analyzing and modeling business processes

· Senior Information Engineer - In addition to any qualifications required by this labor category under the contract, the Senior Information Engineer must have the following qualifications:

· Knowledge/experience of business process improvement and practices

· Experience in developing and applying organization-wide information models for an integrated environment of shared software and database systems.

Government Furnished Information/Government Furnished Equipment

FDA will provide laptops, tokens (fobs), and any essential accessories along with FDA network access along with FDA network access to all members under this task order. FDA will provide the development, test, pre-production, production and any other server based environment necessary to accomplish the stated work.

Deliverables

All deliverables shall be delivered to the point of contact(s) listed in the table using the agreed upon templates which meet the needs of FDA. The templates shall be reviewed and modified as necessary within 30 days of the beginning of the period of performance.

The FDA COTR/Project Manager, CDRH business management, and contractor can adjust the set of deliverables or templates when mutually agreed upon in writing. The contractor shall provide written justification for deviating from agreed-upon deliverable dates.

Business Management

Business Management

Business Management

Business Management

Business Management

Contracting Officer

Business Management

Business Management

Business Management

Minutes – 3 working days following the meeting

COTR/PM

Business Management

Business Management

Business Management

Business Management

Business Management

Business Management

Business Management

Business Management

Business Management

Business Management

Business Management

Business Management

Business Management

Business Management

Business Management

Business Management

Place of Performance The contractor will be required to interact with FDA staff in multiple locations throughout the Washington, DC metropolitan area. All CDRH business staff is located at FDA’s White Oak campus in Silver Spring, MD. FDA’s Office of Information Management (OIM) staff is located at facilities in the Rockville, MD area. As of now, the Government expects that space for contractor staff will be available at an FDA site, but space has become more of a premium recently. Therefore, the contractor shall be prepared to work offsite at its own facility, at any point, during this period of performance.

Projected Schedule

CDRH anticipates that the period of performance for this task order will be one (1) year from contract award, with four one-year options.