RFPATTACHMENT1.pdf

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FDA’S OFFICE OF INFORMATION MANAGEMENT (OIM) CPIC REQUIREMENT

ATTACHMENT 1: TASK ORDER SOW

Food and Drug Administration

Office of Information Management - Capital Planning and Investment Control (CPIC)

Statement of Work

1. Introduction

1.1. Background

1.2. Objectives

1.3. Definitions

2. Constraints

3. Scope

4. Description of Task Areas

4.1. Task 1 - Task Order Management

4.1.1. Management Plan

4.1.2. Task Order Planning Meeting

4.1.3. Execution of Escalation Procedures

4.2. Task 2 – CPIC Management and Operations Support

4.2.1. CPIC Meeting Attendance

5. Deliverables

6. Period of Performance

7. Place of Performance

8. Hours of Operation

9. Government Furnished Information (GFI)

10. Contracting Personnel

11. Other Terms and Conditions

11.1.1. FDA Two-Way-Matching Invoice Clause

11.1.2. Flow Down HHSAR and FAR Clauses

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1. Introduction

1.1. Background

The Office of Information Management (OIM) manages information technology (IT) and other related services including technical oversight of system development processes, policies, and methodologies and management of IT infrastructure to ensure that the Food & Drug Administration (FDA) has a robust IT foundation. OIM works to ensure that foundation enables interoperability across FDA and allows development of enterprise wide systems necessary to meet FDA's mission of promoting and protecting public health in an efficient, effective, productive, and timely manner. In addition, OIM is responsible for overseeing the development, implementation and management of Office of Management and Budget (OMB) and Health and Human Services (HHS) policies, procedures, & processes that comply with legislation, regulations and other applicable laws and guidance as they relate to the Capital Planning and Investment Control (CPIC) process.

CPIC is a decision making process for ensuring that information technology investments integrate strategic planning, budgeting, procurement and the management of IT in support of agency missions and business needs. The CPIC process enables the FDA to address the objective of ensuring investments are well managed, meet the business needs and align to the agency’s mission and to the strategic goals of the organization.

The FDA requires that all IT investments be selected, controlled and evaluated by an IT Investment Review Board (ITIRB) at either the Agency or Center/Office level. The Agency ITIRB / CIO is responsible for reviewing major and crosscutting investments, validating the results of Center / Office level ITIRB activities against Agency goals and priorities, and adjusting the overall Agency IT Portfolio accordingly. Investments not reviewed at the Agency level must be reviewed by the appropriate Center / Office level ITIRB. All ITIRB meetings are conducted at least quarterly to address appropriate "Select-Control-Evaluate" activities. All ITIRB activities and decisions at the Center/ Office level must be formally documented and reported to the CIO on a periodic basis.

Currently, there are five CPIC Managers managing 45 IT investments (See GFI Appendix B a list of IT Investments). There are 8 Majors, 8 Tacticals and 25 Supporting investments, In order for OIM to implement these activities, it is imperative that the CPIC staff members have proper support and guidance in order to effectively manage the FDA IT Portfolio and make informed decisions regarding overall growth and spending.

1.2. Objectives

The OIM expects to achieve the following outcomes, as a direct result of contract performance:

• Improvement and expansion of existing CPIC support and capabilities

• Portfolio support and administration

• CPIC support and administration utilizing project management skills and practices.

• Strategic coordination with the Enterprise Architecture

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• Strategic analysis and planning to help improve FDA’s CPIC processes

1.3. Definitions

ITIM - Information Technology Investment Management (ITIM) requires executive agency participation in real-time transparency of investment projects, to require performance and governance reviews of all cost overruns on Federal information technology investment projects, and for other purposes.

ITIRB - Information Technology (IT) Investment Review Board (ITIRB) implements an investment management process that drives budget formulation and execution for IT investments.

EPLC - Enterprise Performance Life Cycle (EPLC) is a framework to enhance Information Technology (IT) governance through rigorous application of sound investment and project management principles and industry’s best practices (See GFI Appendix F for a Description of EPLC Artifacts).

INTERIM GOVERNANCE BOARD (IGB) – Governance Board responsible for approving and evaluating IT Investment performance measurement baselines, monitoring periodic reporting data, and authorizing and approving Corrective Action Plans and Baseline Change Requests.

They also make formal written recommendations to the business owner and funding authority to discontinue IT Investments with persistent and irreparable performance issues.

PROSIGHT – HHS mandated Portfolio Management Tool (PMT).

TECHSTAT – A face-to-face, evidence-based review of a troubled IT project. Previously, TechStats were managed by OMB, but agencies will now "take the reins," convening sessions internally.

2. Constraints

1. HHS mandates the use of ProSight, the Portfolio Management Tool (PMT), for investment reporting, and Clarity.

3. Scope

The OIM CPIC office requires services to support the execution of capital planning at FDA and to identify, document, follow and support best practices in accordance with HHS and OMB guidance and direction. The Contractor will assist the IT Governance office in leading the development of the IT Capital Planning process and its implementation including communications planning. The objectives described shall serve the full array of capital planning needs from concept to disposition, interaction with enterprise architecture, strategic planning and communication with external entities, as needed.

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4. Description of Task Areas

Task 1: Task Order Management Task 2: CPIC Management and Operations Support

4.1. Task 1 - Task Order Management

The Contractor shall provide the technical and functional support including Quality Assurance, progress/status reporting (see GFI Appendix E for a Monthly Status Report Template), schedule development, integration, risk identification/ handling/ mitigation strategy, and Program Reviews required for the management of this Task Order (TO). The Contractor shall provide the administrative, clerical, documentation, and related functions needed to develop work products and demonstrate completion of activities required under this task. The Contractor shall assign, organize, plan, schedule, control, analyze, and report on all elements of the contract. The PM shall have resources and authority to ensure efficient and timely program execution and shall be the focal point within the contractor's activity for all required program tasks. The PM shall be the primary contact through which communications, work assignments, and technical directions flow between the government and the Contractor. The Contractor shall assign a designated representative to act in the absence of the PM.

Deliverable: (1) Monthly Status Report (MSR)

4.1.1. Management Plan

The contractor shall develop, maintain and deliver a Task Order Management Plan (TOMP). The TOMP will be introduced during a Task Order Planning meeting at the initiation of the task, with the final Management Plan provided after Government review and comment. The TOMP shall include details that address: alerts for issues affecting contract performance, risk and mitigation strategy, major activities to be performed, a work schedule for the major activities, identified due-dates, work products that will be produced, and established milestones for formal deliverables.

Once the TOMP is agreed to by both the Contractor and the FDA COR, changes can only be made after coordination and joint agreement between the Contractor and the FDA COR.

Deliverable: (2) Task Order Management Plan (TOMP)

Performance Standard: Deliverables are clear, concise, technically accurate, well organized, properly referenced, and complete. Requirements and due dates are met or exceeded. Problems that are encountered are minor and resolved in a satisfactory manner. (Excluding Government delays)

4.1.2. Task Order Planning Meeting

The Contractor shall host an initial meeting to introduce the management and the FDA CPIC team within 5 days after contract award. This will be the beginning of a dialogue between the Government and the Contractor to ensure successful execution of the task order. The Contractor

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will take the lead to coordinate the meeting with the Government and meeting specifics will be determined at that time. The Contractor Program Manager and team should be physically present.

The agenda for the meeting should include, at a minimum, the following:

• Introduction of Government and contractor management and team members

• Establishment of common understanding of the contract addressing any outstanding details on contract execution

Deliverable: (3) Meeting Minutes

Performance Standard: Meeting minutes include all required elements identified in the deliverable and will be delivered 48 hours after meeting completion.

4.1.3. Execution of Escalation Procedures

In accordance with the chain of command in OIM, the Contractor shall escalate issues related to any impediment to progress towards any deliverables defined in the SOW. The Contractor shall follow this order of escalation when reporting to FDA personnel:

1. Task Order Contracting Officers Representative (COR)

2. IDIQ COR

4.2. Task 2 – CPIC Management and Operations Support

The Contractor shall support management and operations of the FDA IT investment portfolio, to include providing subject matter consultation and guidance to the FDA’s CPIC team, investment managers and project managers on the performance of FDA’s IT investments Activities performed under this task are designed to accomplish the following objectives:

(1) Ensure the FDA completes OMB and HHS requirements as needed and in a timely manner, specifically:

• Review new baselines and re-baselines to ensure that they meet HHS and OMB guidelines.

FDA’s CPIC team reviewed 14 re-baselines (AKA: Baseline Change Events / BCE’s) in FY 2011.

Examples of events that would generate an investment re-baseline activity would be adding projects / activities, updating activities, adding performance metrics, updating performance metric, deactivating activities, and updating summary of funding.

• Review the IT investment annual budget submission, ensuring that it addresses all FDA IT investments (there are currently 45) and is in accordance with HHS and OMB memos, policies, and guidelines.

Deliverable: (4) Baseline Reviews

(5) IT investment annual budget Reviews

Performance Standard: Deliverables are clear, concise, technically accurate, well organized, properly referenced, and complete. Requirements and due dates are

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(2) Provide the FDA community with insight to budget submission timelines (See GFI Appendix A:

for CPIC Timelines), activities, practices and policies, specifically:

• Interpret and provide guidance on HHS and OMB memos, policies, and guidelines as they apply to the FDA domain. Develop guidance for use by the FDA community in its efforts to manage the cost, schedule, scope, and budget performance of investments. Submit guidance to FDA for review and dissemination.

Deliverable: (6) CPIC Guidance

Performance Standard: Deliverables are clear, concise, technically accurate, well organized, properly referenced, and complete. Requirements and due dates are

(3) Support the FDA CPIC staff with portfolio management and provide guidance as needed, specifically:

• Plan and coordinate communications activities with HHS, subordinate agencies and other organizations in support of the IT Governance Branch as they lead the development of the IT Capital Planning process and its implementation.

• Perform Earned Value Management (EVM) activities such as developing monthly cost and schedule reports. Generate quarterly reports on overall health of Major investments (See GFI Appendix B: Investment List).

• Gather agency budget justifications, and business cases to assist CPIC staff in the development of the budget submissions annual report. Review the budget submissions annual report to ensure it adheres to the A-11 format.

• Develop tools and techniques to assist FDA CPIC Staff with analysis of investments, reviews of Baseline Change Events, Stage Gate Reviews and other strategic work.

• Facilitate meetings, both within OIM, and between OIM and its stakeholders.

• Work with Enterprise Architecture and PMO in integrating key functions and processes within the IT Governance Framework.

• EA-IT Portfolio Coordination

• Perform random audits of investments to ensure compliance with HHS, OMB, and FDA policies in support of Techstat processes.

• Analyze and review submitted Baseline Change Events (BCE) under the direction of the CPIC staff in preparation for approval by FDA’s CPIC team, CIO, the ITIRB’s, and Interim Governance Board (IGB).

• Review established budget submission policies and guidelines set forth by OMB and HHS, and make recommendations as necessary to the CPIC staff to ensure quality and compliance of Exhibit 53s and 300s.

• Draft, update, and edit Standard Operating Procedures (SOP) and submit to FDA for approval. In FY11 the FDA developed 17 SOPs. Please see the attached for a list of SOPs the CPIC office currently follows

• Work with the FDA CPIC Team to reconcile budget formulation and execution processes with OIM Budget and FDA Budget teams

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• Conduct peer reviews of documentation (for example Project Management Plans (PMP), Project Schedules, Boundary Documents) in support of Stage Gate Reviews ,ensuring that projects are in compliance with FDA’s Enterprise Performance Life Cycle (EPLC) framework.

EPLC document review may include up to 50 documents a year.

Deliverables: (7) EVM Reports

(8) Quarterly reports on overall Health of Major Investments

(9) Analysis tools

(10) Audits

(11) Standard Operating Procedures

(12) EPLC Documentation Reviews properly referenced, and complete. Requirements and due dates are

(4) Develop quality reports for executive management in order to inform them on portfolio activities, specifically:

• Develop presentations and reports for stakeholders (i.e. FDA's Interim Governance Board (IGB), COO and CIO's office, etc.).

• Provide weekly reports, bi-weekly reports and monthly reports on high-level key activities to the senior management.

• Provide quarterly briefings on the status of the IT Portfolio and Scorecards (See GFI Appendix D) for the 8 Major investments.

Deliverables: (13) Presentations and Reports for Stakeholders

(14) Weekly, bi-weekly, and monthly reports on high-level key activities

(15) IT Portfolio/Scorecard Quarterly Briefings properly referenced, and complete. Requirements and due dates are

5) Support of data call requests:

The Contractor shall respond to data call requests in all of the areas listed above. Data Call requests may come from the CIO, IGB, HHS, and Investment Managers and various government sources. Examples of data call requests are requests for information to be entered into ProSight that requires Investment Manager input such as changes to data fields. The Contractors may also be asked to export Exhibit 300s / 53’s to Excel to answer specific data calls.

Deliverable: (16) Data call information

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Performance Standard: Data submitted is in the required format and is complete and technically accurate. Data submission dates are met or exceeded. Problems that are encountered are minor and resolved in a satisfactory manner.

(Excluding Government delays)

(6) Support of TechStat requests:

The Contractor shall gather information for TechStat requests. The IGB requested 4 TechStats be conducted in FY2012.

Deliverable: (17) Techstat information

Performance Standard: Data submitted is in the required format and is complete and technically accurate. Data submission dates are met or exceeded. Problems that are encountered are minor and resolved in a satisfactory manner.

(Excluding Government delays)

4.2.1. CPIC Meeting Attendance

FDA’s CPIC staff is responsible for attending meetings and gathering information related to FDA’s IT investments. The contractor shall assist CPIC staff in gathering information by attending the CPIC related meetings identified below. The primary goal of meeting attendance is to obtain knowledge on FDA’s IT investment goals. The following meetings are recurring:

1. Weekly Department of Health and Human Services CPIC Meeting: CPIC meets with HHS and other operating divisions to discuss direction for various CPIC activities

2. Weekly FDA CPIC Office Meeting: Team status meeting

3. FDA Monthly Governance Working Group Meetings: CPIC obtains IGB updates

4. FDA Monthly IT Portfolio Managers Meeting: CPIC hosted cross-center status meeting

Deliverable: (18) Meeting Minutes

Performance Standard: Meeting minutes will include all required elements identified in the deliverable and will be delivered 48 hours after meeting completion.

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5. Deliverables

Deliverables and the schedule for delivery are captured below:

Task# Del #

Deliverable Title Format Due Date Frequency and Remarks

4.1 1 Monthly Status Report

MS Word; IAW Monthly Status Report Template

30 days after Contract Start

Monthly

4.1.1 2 Task Order Management Plan

MS Word Draft due with proposal submission. Final due at the Planning Meeting

Updated as necessary

4.1.2 3 Task Order Planning Meeting Minutes

Contractor- Determined Format

48 hours after Planning Meeting

One time

4.2 4 Baseline Reviews TBD IAW Agreed-upon schedule

As directed

5 IT investment annual budget submission Review

TBD 15 days before final report is due

Annual

4.2 6 CPIC Guidance TBD 15 days after new memos, policies, and guidelines are issued

As directed

4.2 7 EVM Reports TBD IAW Agreed-upon schedule

IAW Agreed-upon schedule

4.2 8 Reports on overall Health of Major Investments

TBD 90 days after contract start

Quarterly

4.2 9 Analysis tools TBD IAW Agreed-upon schedule

As directed

4.2 10 Audits TBD IAW Agreed-upon schedule

As directed

4.2 11 SOPs MS Word 15 days after change is reported

As directed

4.2 12 EPLC MS Word IAW Agreed-upon As directed

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6. Period of Performance

The Period of Performance for this task order will be twelve months base period.

7. Place of Performance

Support of the general program will be performed at the following location:

1350 Piccard Drive, Suite 370 Rockville, MD 20850

Meetings and work sessions may be conducted at FDA offices in Rockville, Maryland, White Oak, Maryland or other locations in the DC metropolitan area as required. Additional work can be performed at contractor locations or other approved remote locations per discretion of the COR.

8. Hours of Operation

The contractor shall maintain continuous service between 8:00 a.m. and 5:00 p.m. Eastern Time, Monday through Friday, excluding Federal holidays and building closures. During these times, the Contractor program manager, or designee, must be available (on-site or by cell phone and e-mail) to address FDA CPIC related concerns. Due to the nature of work of the OIM CPIC task the contractor may need to work after hours and on weekends in order to meet stringent OMB mandated deadlines as the and if the building(s) is/are accessible.

Documentation Review schedule

4.2 13 Presentations / Reports to Stakeholders

TBD IAW Agreed-upon schedule

As directed

4.2 14 Weekly, Bi-weekly, Monthly Reports

MS Word 2 days after the end of the period

Weekly, Bi-weekly, Monthly as appropriate

4.2 15 IT Portfolio/ Scorecard Quarterly Briefings

Power point IAW Agreed-upon schedule

Quarterly (4 times per year)

4.2 16 Data Call Response TBD IAW Agreed-upon schedule

As requested

4.2 17 TechStat Information

TBD IAW Agreed-upon schedule

As requested

4.2.1 18 Meeting Minutes Contractor- Determined Format

48 hours after meeting completion

Dependent upon frequency of meeting

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After hours/weekend work will be limited to a maximum of 8 hours per month, except in the event of an emergency situation, in which case the contractor is expected to work as many hours as are required to resolve the crisis. FDA estimates no more than 120 hours of after-hours/weekend work will be required per year.

9. Government Furnished Information (GFI)

• GFI Appendix A: Standard Federal Budget CPIC Timeline

• GFI Appendix B: List of 45 Investments

• GFI Appendix C: CPIC Standard Operating Procedures List

• GFI Appendix E: Monthly Status Report Template

• GFI Appendix D: Scorecard Template

• GFI Appendix E: Sample Monthly Status Report

• GFI Appendix F: EPLC Artifact Descriptions

10. Contracting Personnel

Contracting Officer/Contract Specialist

Name: Jody O'Kash Address: 5630 Fishers Lane, RM 1086 Telephone: 301-827-5094 Email: jody.o'kash@fda.hhs.gov

Task Order Contracting Officer’s Representative:

The Task Order COR shall serve as the Contractor’s first point of contact for any technical questions and is responsible for: (1) monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and compliance with all substantive project objectives; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; (5) assisting in the resolution of technical problems encountered during performance; and (6) providing technical direction; and, (7) reviewing of invoices/vouchers.

The Task Order COR does not have authority to act as agent of the Government under this contract.

Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

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The Government may unilaterally change its Task Order COR designation.

TBD at time of award

Contractor Key Personnel for Labor Hour Task No. 3:

1) CPIC Program Manager

2) CPIC Senior Analyst

3) CPIC Mid-Level Analyst

11. Other Terms and Conditions

11.1.1. FDA Two-Way-Matching Invoice Clause

A. The Contractor shall submit all invoices to all addresses in the manner specified below:

One hard copy version and one PDF version to the Contracting Officer (see contact box 5 of SF 347)

One PDF version to the COR – clearly marked “Courtesy Copy Only” to the COR (see contact information in Section 6 of the Task Order Award Document / SF 347)

Invoices submitted under this contract must comply with the requirements set forth in FAR clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer – Central Contractor Registration) and or other applicable FAR clauses contained in this contract, and must contain the following:

(i) Name and address of the Contractor; (ii) Invoice date and number; (iii) Task Order Modification Number, contract number, and line item numbers and;

(iv) Description of tasks and subtasks, name of employee that performed task/subtask, how many hours the employee worked on task, identify whether the employee was a prime or subcontractor, the unit price for the services delivered; (v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading; (vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent; (viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract. (x) Electronic funds transfer (EFT) banking information. (xi)DUNS number.

(xii) Attach Monthly status report to the invoice

C. Electronic invoices shall be in PDF format, legible, and must not contain any ink changes.

D. Direct questions regarding payment to the FDA Payment Office at:

Office of Financial Services Food and Drug Administration Attn: Vendor Payments 10903 New Hampshire Avenue

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Bldg 32, Rm 2162, Mail Hub 2145 Silver Spring MD 20993-0002 Email: fdavendorpaymentsteam@fda.gov

11.1.2. Flow Down HHSAR and FAR Clauses

352.242-70 KEY PERSONNEL (January 2006)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the contractor or Government.

(End of clause)

52.217-8 Option to Extend Services. (Nov 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days.

(End of clause) mailto:fdavendorpaymentsteam@fda.gov