Attachment_2_NIMS_TO1_FINAL.pdf

Attachment 2

Nonclinical Information Management System (NIMS)

Task Order 1 – NIMS Systems Operations & Maintenance, Production Support, and Training

Statement of Work

Order Type: Firm Fixed Price

Table of Contents

1. Introduction

2. Objectives/Scope

3. Tasks

3.1 Transition In (FFP) – Optional Task

3.2 Contract Level Project Management (FFP)

3.2.1 Management of Contractor Staff

3.2.2 Project Management Meetings

3.2.3 Monthly Status Report

3.2.4 Monthly Financial Report

3.2.5 Contractor GFE Inventory Report

3.3 Operations and Maintenance (FFP)

3.3.1 NIMS Application Maintenance and Support

3.3.2 NIMS Application Support and Problem Resolution

3.3.3 Change Control Board (CCB) Support

3.3.4 Release Management

3.3.5 Processes and Documentation

3.4 Training (FFP)

3.4.1. Training Support Activities (FFP) – Separately Price Task

3.4.2. Training Clinics (FFP) – Separately Priced Task

4. Deliverables

5. Standard FDA Service Level Agreements

6. Service Support Tiers

7. Place of Performance

8. Period of Performance

9. Government Furnished Property/Government Furnished Information

10. Travel

11. Key Personnel

12. Section 508 Requirements

13. Points of Contact

14. Invoicing Instructions

15. Appendices -- Attachments

1. Introduction Acquiring, storing, managing and presenting nonclinical toxicology and animal model data is a fundamental aspect of accomplishing FDA’s mission. FDA recognizes that access to electronic structured scientific data about regulated products improves science-based, regulatory decision making. Furthermore, it is expected that nonclinical data will be increasingly submitted in electronic standard format as the pharmaceutical and related industries adopt electronic formats and standards for data warehousing and transfer.

FDA recognizes that the study size and variety of formats that will need to be supported for nonclinical data require robust, innovative tools and database systems. It is understood that tools which facilitate better access and analysis for nonclinical toxicology and animal model data review will ultimately lead to safer, more effective and higher quality products in the market. In light of this, FDA purchased, customized, and put into production in 2012, the Nonclinical Information Management System (NIMS). NIMS provides continued nonclinical study data management, analysis, and visualization functionalities for approximately 180 pharmacology and toxicology reviewers. NIMS is comprised of the following COTS PointCross LifeSciences Inc. components: Nonclinical Study Data Repository (NSDR), Study Data Integration and Search System (SDIS), ToxVision++, and XTEND. Enhancements have been made to study activities views, export functions to CDER reviewer templates in MS Word as well as integration of exports with GraphPad’s Prism software. These native capabilities and enhancements significantly broaden CDER reviewers’ ability to quickly and easily conduct safety assessments on nonclinical data that are otherwise not available to reviewers. To continue to support the capabilities of NIMS FDA needs operations and maintenance, user support, training, and project management services to oversee the integration and implementation of the tool(s), training tools and services to better equip the end users This action will address the requirements described in this Statement of Work.

2. Objectives/Scope

• Support/maintain NIMS by providing Steady State Activities described in SOW including software, interface, and configuration updates.

• Create and maintain accurate documentation in accordance with DHHS’s / FDA’s

Enterprise Performance Life Cycle (EPLC) for IT systems for O&M releases, O&M and DME change requests, and other Development activities identified in future DME task orders issued against this contract. More information on the EPLC can be found here:

http://www.hhs.gov/ocio/eplc/

• Participate in EPLC Stage Gate Reviews and document lessons learned.

• Develop, provide and deliver new on-site training, clinics, and on –demand training inclusive of on line training modules this is inclusive of associated materials for training and reviewer resources

• Update existing on-site training, clinics, and on –demand training inclusive of on line training modules and training materials and resources

• Provide technical and customer helpdesk support

• Develop iterative release schedule for minor and major releases informed by NIMS platform upgrades, identified bugs, or Task Orders for development of NIMS enhancements.

• Conduct contract management

3. Tasks

3.1 Transition In (FFP) – Optional Task

It is the responsibility of the new contractor to ensure a smooth transition. The purpose of these tasks is to provide an orderly transition from the previous Contractor by transferring expert knowledge, data, and artifacts that are used to support applications. It is anticipated that the previous contract will overlap with the current contractor for a period of 30 days.

The Contractor shall work toward the Government’s goal of ensuring minimal disruption to services and support for users as soon as possible after the Task Order begins.

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

1. Within two weeks of award the Contractor shall:

Provide weekly transition status to the Contracting Officer’s

Representative (COR).

2. Within two weeks of award the Contractor shall:

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

3. Within 1 month of award, the Contractor shall:

Review documentation and source code which will be provided as

Government Furnished Information (GFI) after award.

Interview incumbent contractors to understand and assess the current operational state.

Shadow incumbent contractors.

3.2 Contract Level Project Management (FFP)

The Contractor shall perform overall contract level Project Management which includes at a minimum the following activities:

Coordinate all required on-boarding and off-boarding activities.

Hold Contract kick-off meeting with CORs to ensure common understanding on project management deliverables, communication methods, and status of all tasks awarded at that time.

Create, review, and maintain Contract documentation Create the required Contract Monthly Reports (including activities performed and planned, risks, financial information, and metrics) Create, manage, and control Integrated Project Schedule Perform Risk Management Perform Scope Management Perform Change Management Perform Issues Management Perform Quality Management Manage deliverables Manage resources Track and report Contract metrics

Contractor Project Manager shall work in conjunction with the FDA Project Managers and other FDA staff and contractor staff. Activities may include project planning, scheduling, project cost management, scope management, change management, issues management, risk management, quality management, problem solving and conflict resolution, and status reporting. As much as practicable, Project Management activities should be coordinated with other Task Order Managers to minimize duplication of efforts.

3.2.1 Management of Contractor Staff

The Contractor shall plan, organize, secure, and manage resources with appropriate knowledge and skills to perform ongoing contract activities.

3.2.2 Project Management Meetings

The Contractor shall schedule, coordinate, facilitate, and participate in meetings in different capacities. During meetings the contractor shall lead discussions, contribute questions and answers, raise issues and concerns, develop and give presentations, and provide other active oral and written communications. The Contractor shall prepare and track meeting agendas, minutes, notes, issues, and action items. The Contractor shall provide the NIMS Project Management with the meeting minutes of all status meetings. The Contractor shall provide other meeting minutes related to this contract as directed by the NIMS Project Manager or their designated representative. Minutes shall be of sufficient detail to accurately document meeting data and location, meeting purpose, items discussed, decisions made, attendees, and action items. Meeting minutes shall be delivered to the requested parties within three business days following the meeting. The Contractor shall participate in monthly status meetings. Ad-hoc meetings may be scheduled as necessary to address specific issues. Virtual meeting technology will be used so that travel to FDA is not required for all meetings.

3.2.3 Monthly Status Report

The Contractor shall submit a monthly report to provide an accurate picture of the current project status using an agreed upon format prior to each monthly project management meeting. The reports shall include, but are not limited to, the following types of information:

Activities and Accomplishments Deliverables Milestones Updated schedule Issues list, Risks Register, and Mitigation Plans Planned Activities for following reporting period Routine Maintenance Activities NIMS Metrics detailed in section 3.3.5 Usage statistics and analysis for the application Usage trends

This monthly status report shall include all active task orders.

3.2.4 Monthly Financial Report

The Contractor shall create and provide a Monthly Financial Report that contains line items for each Task. The Contractor shall abide by a template or format agreed to or supplied by the Contracting Officer (CO) as well as monthly due dates for financial reporting. The detail and format required for this report may be adjusted at any time by the COR.

This monthly financial report shall include all active task orders.

3.2.5 Contractor GFE Inventory Report

The FDA anticipates providing Laptops, PIV cards, network access, and necessary software for the contractor to conduct tasks identified in the SOW off-site. The Contractor shall prepare and provide the COR or their designee an inventory of government furnished equipment (GFE), excluding office supplies. At a minimum, the report shall include the following:

Serial Numbers FDA Property Codes Model Numbers Item Description Person Assigned To

Location

The Contractor shall ensure that the Contractor GFE Inventory is updated when resources are added or removed from the project.

3.3 Operations and Maintenance (FFP)

It is expected that the Contractor shall work directly with available FDA IT personnel and third-party vendors to perform the IT functions necessary to further develop, support and implement NIMS and its underlying components (SAS, JAVA, Apache Tomcat) in all environments. The performance of this task may have dependencies upon FDA and other contract personnel that maintain the FDA’s White Oak Data Center where NIMS is hosted. It is further expected that the Contractor shall perform the administrative functions for this tool throughout the period of performance. NIMS Systems Operations and Maintenance Support activities focus on routine operations and maintenance of the application. The Contractor will provide the necessary operational and maintenance support to ensure uptime rates greater than 99% for the NIMS production environment. The production environment uptime rates do not include a typical allowance of 10 hr/month for planned maintenance; if a longer period of application downtime is required (for instance, to upload and index batches of new study data), these would be scheduled over a weekend time period. The Contractor will also ensure that the COR or COR's explicit designee and appropriate OIM points of contact are informed and that approval is obtained prior to execution of the associated maintenance tasks. This additional downtime will not be considered in computing and reporting the targeted system uptime. Maintenance tasks will generally be targeted between 7 PM and 4 AM ET; any exceptions will be approved by the COR, COR's explicit designee and/or OIM as applicable.

The Contractor shall provide all of the NIMS Maintenance and Support activities, which include the following subtasks:

NIMS Application Maintenance and Support including the third-party COTS products that make up NIMS (PopChart, Apache Tomcat, Java, HTML) NIMS Application Problem Resolution NIMS Help Desk Support NIMS Reporting and Other Documentation System Performance Support Technical Refresh Migration (for example - OS upgrades, Java upgrades, Tomcat upgrades).

Release Management Configuration and Change Management Documentation

3.3.1 NIMS Application Maintenance and Support

NIMS application maintenance and support activities focus on routine maintenance activities to ensure that the application is up and running, functioning as expected and problems are addressed in a proactive manner. It also includes routine updates to software versions, interfaces to other systems, and configurations. Support shall include:

Updates to NIMS software versions to keep the system current. It is expected that updates will occur quarterly.

Updates to NIMS interfaces with other systems. Known interfaces to other FDA systems include JANUS and PORTES. It is expected that a one-time integration effort will be required, followed by yearly updates coinciding with major changes to external systems.

Updates to software and hardware configurations.

Patching, re-installation, and upgrades of 3rd party software (PopChart, Apache

Tomcat, Java, HTML), web page updates and general troubleshooting.

For Patch Releases the contractor shall perform application patching impact analyses and modifications prior to implementing into production. The activities include, but are not limited to the following:

o Test patches and upgrades to NIMS service and supporting applications in the Development and Test environments.

o Document and communicate proposed changes to user community at time of patching.

o Update user references or training if proposed changes make those resources obsolete. Promote all accepted changes to the Production environment.

To support maintenance, Contractor shall provide monthly reports pertaining to security as dictated by Authority to Operate (ATO) documentation.

SCHEDULED OUTAGES: Any downtime of the production application must be scheduled at a minimum of two (2) weeks in advance of the work to be performed.

Support requiring production downtime must be performed during off-hours (after 6pm Mon-Thurs (Eastern Time - ET) for emergencies, after 6pm Fri (ET), any time Sat-Sun (ET), any government holidays for minor upgrades/patches) unless application is already down due to application or hardware failure.

UNSCEHDULE OUTAGES: Vendor shall be expected to work on production application immediately after unscheduled outage to bring application back on-line.

The current state of the application is steady and the FDA anticipates no/few application outages.

Included in the scope of this section are any changes/updates/fixes to software code, configurations, interfaces, or any other element of the system which is necessary to ensure continued operation of the NIMS system as intended. All functions and capabilities of the system must be kept operational and functioning as they were designed to. If it is found at any time that existing capabilities are not functioning as expected, those capabilities must be corrected.

Not included in the scope of this section are any changes/updates/fixes to software code which would constitute a new function or capability that was not previously included in the system.

3.3.2 NIMS Application Support and Problem Resolution

The NIMS Help Desk operates as the point of contact for problem resolution for users and is the first level of support to identify, diagnose, resolve, and provide status reporting for all problems reported and questions asked by users. The Contractor shall ensure that experienced personnel are available to support users, resolve reported problems in the required timeframe, support data loading, answer questions about the NIMS product and its output, and communicate status to FDA staff. The Contractor shall meet service levels as stated in Service Level Agreements in section 5 for all tiers of requests. The Production Support Management Plan (Version 1.0 - 2013.04.25) attached in Appendix H provides detailed information on the customer support process that the vendor must implement. The vendor shall meet all requirements described in this plan.

Customer support shall involve helping new and advanced users with application-related problems and questions, responding to telephone and email message, monitoring/ tracking/ responding/ closing ERIC tickets via HP Service Manager, and assisting users with specific problems and questions using the tool. Contractor will also provide data curation services to address minor data loading errors that do not require sponsor re-submission or involvement. Contractor shall use a variety of support delivery methods (via phone, in-person, collaboration tool (Adobe Connect), FDA training room, FDA meeting room, etc). It is expected that users will most frequently use the CDER- NIMS Help email address to submit questions and issues, therefore monitoring of that inbox will be a critical activity. Hours of operation shall be five working days per week (Monday through Friday) from 9am-5:30pm (ET). The Contractor shall provide support that is in line with FDA’s existing severity levels and tiered support. See sections 5 and 6 for standard FDA Severity Levels and response time requirements, as well as FDA Tiered Support definitions. Total number of users is expected to be no more than 200.

A Questions Log has been established to document user questions and issues from all sources including clinics and training support activities. The Contractor shall keep this log current by adding all questions/issues and completing all fields in the database. The contractor shall ensure that the solutions in the log are validated and correct for reuse and reference. FDA personnel will use the Questions Log to determine gaps in customer support and training that must be addressed. The Contractor shall work with FDA personnel to help identify gaps, determine solutions, and implement those solutions. In addition, the Contractor shall provide quarterly reports which identify commonly asked questions with an analysis that identifies areas of particular difficulty for users, improvement of previously identified user support issues, and escalation of existing user support issues.

3.3.3 Change Control Board (CCB) Support

The Contractor shall participate in and support Change Control and Configuration Management (CM) for major / minor releases, patches, enhancement activities, and in accordance with FDA standards and processes as defined by EPLC project artifacts.

The purpose of the CCB is to oversee change control activities. The CCB process enables a dialog between the stakeholders and the project team. Stakeholder engagement ensures that issues and risks are identified and resolved, the progress of the project is discussed, and approval to proceed with required changes is obtained in a timely manner. The Contractor shall:

Support the CCB processes to ensure that change requests are managed and documented. Change requests include product defects and enhancements, as well as alterations to project schedule, cost, and scope.

Provide technical information for proposed change requests (e.g. technical feasibility, technical alternatives, level of effort (LOE) required to complete the change).

Use configuration management to manage the changes of configuration items as changes are approved and implemented.

Attend Change Control Board (CCB) meetings (not to exceed more than twice per month).

Analyze and report on the level of effort and impact on the application

The Contractor shall support system release deployment activities to ensure that the correct code is identified for release into the proper environments. The Contractor shall work with the FDA Change Control and Configuration Management (CM) tools to manage NIMS artifacts & configuration items (e.g., software code, system documentation, and project documentation) and processes. Listed below are some examples of the Management Tools that are currently being used:

HP Service Center 6.x/HP Service Manager

JIRA

RequisitePro SubVersion

3.3.4 Release Management

The Contractor shall work with the NIMS Project Manager and other FDA Integrated Project Team members to deploy new software releases. The Contractor shall follow FDA Release Management guidance. The Contractor shall be prepared to provide EPLC documentation, as identified in the Project Process Agreement (PPA) document, for each software release. Tailored PPA’s will be developed by FDA and Contractor for each production release. These activities include, but are not limited to:

Conduct release implementations, planning, scheduling, and communications Conduct resource planning and scheduling Develop required lifecycle documentation Plan for and implement unscheduled releases due to software defects and other emergency changes Execute production releases Plan for Communications and Training for implemented changes Update required EPLC documentation

3.3.5 Processes and Documentation

The Contractor shall prepare documentation associated with all system lifecycle phases using FDA’s EPLC documentation processes and templates as well as any requested documentation needed for reporting to management. Appendix I – Attachments contains FDA EPLC Project Process Agreement provides guidance as to which artifacts are generally developed, updated, or waived for various release types. The Contractor shall work with the FDA Project Manager to determine precisely which documents need to be updated or developed during the project lifecycle.

The Contractor shall coordinate and participate in all applicable Stage Gate reviews for NIMS application as per EPLC standard processes. The Contractor shall store and track documentation using FDA established tools that are accessible to the NIMS Project Manager. eRoom and SharePoint are the primary tools used to store documentation for team access. Version control shall be used for all artifacts and configuration items. The Contractor shall store and retrieve all NIMS system-related user documents in one central repository for access by NIMS users.

The list of metrics to be tracked may evolve over time at the direction of the NIMS Project Manager. Examples of metrics may include the following:

Defects Metrics o List of defects resolved in each release and cumulative number resolved for the year o Level of effort (planned and actual) for each defect resolved o Planned and actual resolution date for each defect resolved in the month o Average duration of open defects o List of any new defects identified in the month, including system, source

(existing legacy or release in which introduced), and priority System Availability Metrics o System Downtime percentages o System Issue response times o System Issue resolution times

Support Request Metrics/ Issue resolution o Number of support requests created and resolved for the month and cumulative for the year o Reported by complexity o Reported by support request type (e.g. data correction, user support, ad-hoc query/report) o Average number of support requests by type created and resolved per month o Average duration of open support requests o List of all support requests open longer than one month, with status

Customizations/enhancement Metrics o List of enhancements implemented in each release and cumulative number implemented for the year o Level of effort (LOE) (planned and actual hours) for each enhancement implemented o Planned and actual implementation date for each enhancement completed in the month

Contractor shall participate as needed in security assessment and audits required by the Information Systems Security Officer.

Appendices A and I – Attachments contains an overview of the Enterprise Performance Life Cycle and guidance on PPA best practices by release type. A final PPA will be determined by the FDA Project Manager after each task award that would necessitate EPLC documentation change or development.

3.4 Training (FFP)

The Contractor shall support and conduct delivery of training as well as develop updates as needed. A training package has been developed which includes introductory slides, Quick Reference Card, User Guide, and Interactive Training Module outline (see Appendices E, F, and C respectively). It is expected that the Contractor will use the existing training guides as a draft and develop and modify additional training and training guides following assessment. Feedback from training and customer support activities shall be used to identify gaps in existing training and updates shall be made to close those gaps, with input and approval from FDA. The Computational Science Center (CSC) has developed and follows the NIMS Training Plan which defines a training strategy and approach. It also provides activities to aid in the design, development, delivery, and evaluation of training. Elements included in this strategy are training material types, training delivery methods, roles and responsibilities, communications, and logistics. The Contractor shall use the NIMS Training Plan document as guidance while developing training plans (see Appendix G).

3.4.1. Training Support Activities (FFP) – Separately Price Task

• Assess and analyze the effectiveness of the current training, and make updates to correct issues. Information regarding frequently asked questions derived from customer support activities will be used as input to training updates as well. This information shall be included in Application Support and Problem Resolution Quarterly Reports.

• Update NIMS Training plan per CSC program specifications and template.

• Review and refine current training materials and delivery methods based on enhancements to NIMS application (as applicable), releases (as applicable), and to continue to meet the unique needs of FDA reviewers.

• Deliver open house clinics on-site during which reviewers can ask questions about their specific needs and / or concerns with the application. The number of clinics would not likely exceed one per month, and the number of participants per day would not likely exceed twenty.

• Develop and deliver additional webinars, on-site training sessions, 1:1 training sessions, and clinics. In total, these additional training activities would likely be necessary up to twice per month.

• Develop and update on demand training inclusive of web-based training and materials within the NIMS application.

• A database to store frequently asked user questions will be provided by FDA.

Contractor shall keep this database up to date with information from training and help desk activities. Contractor shall provide an Application Support and Problem Resolution Quarterly Report summarizing current status of the frequently asked questions database and recommending updates to training and customer support.

• Develop and deliver additional training materials (i.e. user guides and reference guides) that may be required for more advanced users.

• Update existing or develop new training materials and training delivery to reflect changes that occur from new releases, development and enhancements. This includes developments that result from Task Order 2.

• Collect onsite attendance from each class, scanning and saving to FDA storage and reporting back to project team

• Ensure training material is published and available to users. Location for material will be determined by the COR, and necessary access will be provided.

• Print and provide hard copies of class materials to participants; including but not limited to Training Slides, Manuals, Quick References

• Schedule training class times, dates and locations based on the needs and availability of the project team and end users

• Document and communicate any changes needed in delivery or presentation of classes based on feedback from users, trainer identification, trending questions, help ticket frequency, and any other sources as they come along.

• Update the training material and delivery of training based on changes approved by FDA project team. Updates can be expected to coincide with quarterly Application and Problem Resolution reports.

• Updating and publishing training materials, adapting to changes in business processes.

• Update the Question Log with issues that become apparent during training activities, and work with FDA to correct training methods and materials to address those issues.

PLEASE NOTE: For success of onsite training sessions the FDA anticipates that the contractor will provide a professional instructor skilled in NIMS Hardware / software / functionality

3.4.2. Training Clinics (FFP) – Separately Priced Task

The Contractor will develop and deliver twelve 3-hour training clinics on-site over the course of the year. The topics of the clinic will be drawn from questions contained in the frequently asked questions database described above with the option to address walk-in issues. The FDA will provide facilities and NIMS access. It is expected that the personnel conducting the clinic will be available for 4 hours for each session (3 hours for the clinic, 30 min to set up, 30 min afterward to address additional questions). It is expected that no more than 20 users will participate in a clinic. Clinics are expected to begin within 3 months of contract award.

4. Deliverables Table 1: Deliverables

Ref Description of Deliverable Frequency Delivery Date Deliver To

3.1 Transition Plan Once Within 2 weeks of award COR and NIMS Project Team

3.2 Kickoff meeting

presentation

2 Meetings 1st meeting within 2 weeks upon contract award.

COR and NIMS Project Team

3.2 Integrated Project Schedule Once Within 1 month of

award

COR and NIMS Project Team

3.3.5 EPLC Documentation and

Updates

Ongoing Determined by final PPA COR

3.2.2 Meeting Minutes Maximum of 1

monthly status meeting.

Ad-hoc meetings as necessary

3 Business Days following the meeting.

COR and NIMS Project Management Team

3.2.3 Monthly Status Report 1 Per Month No later than the 15th of each month for the previous month

COR

3.2.4 Monthly Project Financial

Reports

1 Per Month No later than the 15th of each month for the previous month

COR

3.2.5 GFE Inventory Report 1 initial report and

as changes occur

Initial Report due within 75 days upon award.

Updated Reports – As Needed

COR

3.3.2 Application Support and

Problem Resolution Quarterly Reports

Quarterly COR

3.4.1 Training attendance list After each in-person

training event

Within 1 week of training event

COR

3.4.1 Updated Training Plan Once Within 6 weeks of award COR and NIMS Project Team

3.4.1 Updated training materials Schedule dependent Schedule dependent COR and NIMS Project Team

5. Standard FDA Service Level Agreements The table below entitled “Computer Support Service Level Agreement” describes issues, severity levels, expected response times, and expected resolution times.

*DS = Desk-side support; EC = Executive Care; FS = Field Support

Table 2: Computer Support Service Level Agreement

Level Impact Response

Time

Resolution

Time

Severity 1 Global failure; Work halted or a potential halt of work for multiple customers on a floor, building or entire

Center

Examples: Multiple customers in building cannot log onto Local Area Network (LAN) or cannot access email

DS: 15 min

EC: 15 min

FS: 30 min

DS: 3 hrs

EC: 3 hrs

FS: 4 hrs

Severity 2 Single complete failure; Work halted for single customer

Examples: Individual customer cannot access LAN;

customer’s computer will not boot

DS: 1 hr

EC: 1 hr

FS: 1 hr

DS: 6 hrs

EC: 6 hrs

FS: 6 hrs

Severity 3 Single problem for a customer; customer still able to work

Examples: Customer's spell check will not run

DS: 4 hrs

EC: 2 hrs

FS: 2 hrs

DS: 2 days

EC: 1 day

FS: 1 day

Severity 4 Service requests & procedural questions

Examples: Relocate PC; install additional Random

Access Memory (RAM); install software upgrade

DS: 1 day

EC: 4 hrs

FS: 1 day

DS: 3 days

EC: 2 days

FS: 2 days

6. Service Support Tiers The table below defines levels of support provided to application users.

Table 3: Service Support Tiers

Tier Level Definition

Tier 0 Tier 0 refers to a collection of web resources that will permit the customer to attempt to solve a problem based on published knowledge. Tier 0 also empowers the customer to describe a non-urgent problem and submit a work ticket through the ERIC website.

Tier 1 Tier 1 refers to the services provided by [xxxx] when the customer calls [xxx], the customer is directed to an IT specialist who will attempt to solve the customer’s issue by phone or by remote assistance.

Tier 2 Tier 2 refers to support provided when an issue cannot be resolved through Tier 0

& Tier 1 and is escalated to [xxx]. The issue may require one of the following:

• On-site support by a trained technician / SME

• Experienced technical expertise

• Expertise in the technology causing the problem.

7. Place of Performance The place of performance is at the Contractor’s facility. The Contractor shall be responsible for providing internet access to ensure staff can connect to the FDA network via VPN. The Contractor will be required to occasionally attend meetings on-site and provide on-site support at 10903 New Hampshire Ave, Silver Spring, MD 20993. For the occasions that on-site support is required, the FDA will provide a temporary work location that can accommodate 1-2 people.

8. Period of Performance The period of performance will be 12 months from award.

9. Government Furnished Property/Government Furnished Information

Upon receipt of FDA badges, the FDA will provide personal computers and any essential accessories along with FDA network access to staff under this Contract. FDA will provide the Development, Test, Pre-production, Production and any other server based environment necessary to accomplish the stated work. Government Furnished Information will be accessible through the FDA network and paper copies, as needed. The following will be provided to the Contractor upon arrival and obtaining badging access to the FDA network:

• Access to document repositories and file shares

• System related artifacts

• Production system documentation

• Access to FDA tools

• System software and code

• Other relevant information

Additionally, the FDA will provide contractors access to facilities to conduct training clinics.

10. Travel Local travel may be required to attend training or meetings in the DC Metro area. Local travel will not be reimbursed.

11. Key Personnel The FDA considers individual(s) that possess the following skills critical to the success of this task order; therefore will be deemed key personnel:

Possesses the knowledge, skills, and abilities to effectively manage the work required in this task order;

Possesses the knowledge, skills, and abilities to effectively manage and develop the NIMS training program.

12. Section 508 Requirements NIMS is required to be in compliance with 508 standards. Any changes to the system must meet those standards. See https://www.section508.gov/index.cfm?fuseAction=stds for details).

13. Points of Contact To be filled in upon award.

14. Invoicing Instructions To be filled in upon award.

15. Appendices -- Attachments Appendix C – Interactive Training Module Outline Appendix D – Introduction to NIMS Appendix E – NIMS Reference Card Appendix F – NIMS User Guide Appendix G – NIMS Training Plan Appendix H – Production Support Management Plan Appendix I – PPA Best Practices by Release Type