MANUAL OF POLICIES AND PROCEDURES CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 7600.

POLICY AND PROCEDURES

OFFICE OF PLANNING AND INFORMATICS
CDER Informatics Governance Process

Table of Contents PURPOSE..............................................................................1

BACKGROUND ...................................................................1
POLICY .................................................................................2
RESPONSIBILITIES ...........................................................2
PROCEDURES .....................................................................4
REFERENCES......................................................................6
DEFINITIONS ......................................................................6
SUMMARY OF CHANGES ................................................7
EFFECTIVE DATE..............................................................8
ATTACHMENT 1 Index of Acronyms...............................9
ATTACHMENT 2 PMO Assessment & Decision Tree....10

PURPOSE

This MAPP describes CDERs Informatics Governance policy and procedures. The intent is to align IT investments with overall business priorities, define decision making authority and assign accountability for executing those decisions.

BACKGROUND

In 2003, CDER established the Information Management Advisory Board (IMAB) to review and approve project proposals. However, the IMAB was not connected to the overall planning, decision making, and budgetary processes within CDER. This limited the decision- making authority and involvement of CDER senior management, thereby restricting the IMABs effectiveness in governing informatics activities across the Center in support of long-term strategic goals. CDERs business informatics needs have increased over the years. CDER must enable strategic decision-making for its Information Technology (IT) investments. CDER must also comply with standards, processes and policies defined by the Office of Management and Budget (OMB), Department of Health and Human Services (HHS) and by the Food
Originating Office: Office of Business Informatics
Effective Date: 10/25/11

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and Drug Administration (FDAs) Interim Informatics Governance Board (IIGB). CDER will establish processes for selection, evaluation and control of IT investments consistent with those requirements. Effective October 1, 2011, the IMAB was discontinued and the new CDER governance model was implemented.

POLICY

Under the new CDER IT governance model, each CDER Executive Committee member is considered a Client and is assigned an individual Client Manager from the Office of Business Informatics (OBI), who serves as the single point of contact for all business informatics needs. The Client Manager will conduct quarterly Joint Business Planning (JBP) meetings with the Client to prioritize business informatics needs. The Client Managers collectively make up the CDER Program Management Office (PMO) along with each OBI Service Line Director. The PMO is responsible for reviewing project requests and maintaining the CDER Informatics Action Plan as the sole plan for CDERs key informatics priorities. The Clients collectively make up the CDER Information Technology Investment Review Board (ITIRB). The ITIRB is responsible for resolving priority conflicts and approving the CDER Informatics Action Plan.

RESPONSIBILITIES

CDER Executive Committee Serves as the ITIRB and meets on a quarterly basis to resolve Center-wide priority conflicts and to review and approve the CDER Informatics Action Plan. Director of the Office of Business Informatics Conducts quarterly reviews of the CDER Informatics Action Plan with the CDER Executive Committee. Appoints Client Managers for each CDER Executive Committee member as the single point of accountability. Client Defines the processes within his/her office to identify, assess, and prioritize business informatics needs. Presents business informatics needs to the Client Manager for discussion.

Originating Office: Office of Business Informatics Effective Date: 10/25/11

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Client Manager Works with the Client to understand his/her organizations business informatics needs, and to rank those needs in order of relative priority. Performs Key Element Assessments (KEA) with the Clients on an annual basis to measure Client satisfaction. Program Management Office (PMO) Assesses Client requests and provides the Client Managers with sufficient information to negotiate timing, scope, funding and required business resources. Once the Client agrees, the PMO conducts initial planning and adds the initiative to the CDER Informatics Action Plan for final review and approval through the CDER Executive Committee. Once approved, the PMO will work with the Center IT Liaison to submit the IT Investment Management (ITIM) request and allocate sufficient CDER resources. See Staff Manual Guide 3210.2 IT Investment Management as referenced below. Ensures successful delivery of projects on the approved CDER Informatics Action Plan. If required, escalates issues to the appropriate Client or to the CDER Executive Committee when necessary. PMO Lead Ensures the integrity of the governance process and the operational leadership of the CDER PMO. This includes the management and dissemination of information of the CDER Informatics Action Plan and the quality of PMO services to ensure that best practices are being employed across CDER projects. PMO Coordinator Manages PMO logistics such as schedules, meeting minutes, follow-up, action items and information sharing (collaboration tools and intranet site); and administrative support functions, such as outreach and initial review of project requests with the Center Information Technology Liaison. Center Information Technology Liaison (CITL) Serves as a facilitator in coordinating IT requests between CDER and the Office of Information Management (OIM). Conducts initial review of project requests with the CDER PMO Coordinator.

Originating Office: Office of Business Informatics Effective Date: 10/25/11

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CDER Informatics Architect Reviews IT requests received by the PMO to ensure they fit with the current and future architecture master plan.

PROCEDURES

All requests related to the development, purchase, implementation, innovation, or adoption of IT must be submitted to the PMO for review either through Joint Business Planning or by submitting a Small Project Request (SPR) form. There are four types of requests that will be evaluated: REQUESTING NEW PROJECTS Large Project Request a project that requires substantial OIM or OBI resources plus funding of more than $25,000. All Requests shall be ranked in order of relative priority in Joint Business Planning by the Client and will be submitted to the PMO by the respective Client Manager for further evaluation. If needed, the PMO will assign a Business Analyst to work with the Clients designee to clarify high level requirements. Small Project Request a project that requires minimal OIM or OBI resources plus funding of less than $25,000. Small Project Requests will be reviewed by the PMO Coordinator and the CDER IT Liaison to determine if resources or funding are required and whether a full PMO assessment is necessary. Initial review of SPR will occur and feedback will be provided with 30 calendar days. This form is available via the My PMO intranet link on the CDER, OPI and OBI Intranet home pages. Grant Funding Applications Applications that involve informatics needs will be reviewed by the PMO prior to approval through the corresponding grant funding approval process. Any major issues or priority conflicts will be escalated by the PMO to the respective grant approval committee.

MODIFYING EXISTING PROJECTS Continuous Improvement (CI) Request a new functionality request for existing IT systems. Each existing IT system will have a designated business owner and a process for receiving, evaluating and prioritizing new functionality requests. The OBI Program Manager and the business owner will be responsible for prioritizing these requests. If the request exceeds the original program scope
Originating Office: Office of Business Informatics Effective Date: 10/25/11

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or if there is a priority conflict, the OBI Program Manager will escalate CI requests to the PMO. The PMO may refer CI Requests to Joint Business Planning for prioritization. PMO Assessment Criteria The following criteria will be used to assess all project requests: 1. Strategic Fit Has this project request been deemed a strategic fit by the Client? 2. Redundancy Does this request overlap with or duplicate an existing initiative? 3. Technical feasibility and compliance Can this be done and is this in alignment with the Architecture Master Plan and IT Policy and Standards? Requests that are not supportive of CDER's long term strategic goals, not in compliance with FDA OIM standards (e.g., technical and security policies) or highly redundant with other efforts will be denied and sent back to the originator with recommendations of next steps. The following criteria will be used to classify all project requests: 1. Impact How many users are impacted and does this touch other IT systems? 2. Effort How many resources and how much time does this require? 3. Cost What is the total cost to implement and maintain? Large Project Requests that meet the assessment criteria will be added to the CDER Informatics Action Plan. Initial planning will begin for the project to further refine scope, cost and resource estimates. Timelines will be negotiated in Joint Business Planning based on these estimates. Once approved by the CDER Executive Committee the PMO will work with the CDER IT Liaison to submit the ITIM request and allocate sufficient CDER resources. Small Project Requests that meet the assessment criteria will be forwarded to the CDER IT Liaison to begin the ITIM process. Grant Funding Applications which are subject to the PMO assessment and that meet the PMO assessment criteria will be forwarded to the respective grant approval committee for final decision-making. Continuous Improvement (CI) Requests will be bundled into scheduled
releases and added to the CDER Informatics Action Plan.
Monitor and Control The CDER Informatics Action Plan will be reviewed on a weekly basis within the PMO to ensure that the agreed priorities are on track. Major issues will be escalated by the
Originating Office: Office of Business Informatics Effective Date: 10/25/11

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Client Managers, first to the Clients and if necessary to the CDER Executive Committee for resolution. Changes to the CDER Informatics Action Plan will be reviewed and approved by the CDER Executive Committee on a quarterly basis or as needed. Client Managers will perform a Key Element Assessment (KEA) with each Client on an annual basis to measure Client satisfaction. The Client Satisfaction Survey will consist of three key elements: Collaboration between OBI and the Client, Quality of products and services delivered, and Timeliness of the delivery for agreed initiatives.

The KEA rating scale will be as follows:

10 Very Good, 8 Good, 6 Fair, 4 Poor, 2 Very Poor.
The Client Managers, as part of their Performance Management Appraisal Plan (PMAP),
will be responsible for maintaining, and improving Client satisfaction.

REFERENCES

1. 2. 3. 4. 5. 6. 7.

OMB, Circular A-130, Revised. Management of Federal Information Resources. Clinger Cohen Act, 40 USC 1401 et seq., 1996. FDA Staff Manual Guide 2010.3, 1/2004, FDA Data Standards Council. FDA Staff Manual Guide 3210.2, 8/2004, IT Investment Management. FDA Staff Manual Guide 3210.3, 4/2004, IT Project Management Policy. FDA Staff Manual Guide 3230.2, 6/2004. Enterprise Architecture Policy. FDA Staff Manual Guide 3251.1, 1/2007, Responsibility for Information Security

DEFINITIONS

Business Informatics The discipline of combining various aspects of business management and information technology to ensure that CDER business process needs are represented and met during the development of IT products and systems. Business Owner The person responsible for identifying and prioritizing business informatics opportunities for an existing IT system and working closely with the OBI program manager to plan and execute continuous improvement activities. CDER ITIRB CDERs Information Technology Investment Review Board governance process under the FDA Informatics Governance Board structure. The boards membership consists of all members of the CDER Executive Committee. CDER Informatics Action Plan A list of approved IT projects that includes contact information, project description, objectives, measures, status and schedules. The CDER
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Informatics Action Plan is available via the My PMO intranet link on the CDER, OPI and OBI Intranet home pages. CDER Informatics Architect The person who owns the overall business informatics architecture across CDER and works closely with the FDA OIM Enterprise Architecture Team. CDER Program Management Office A matrixed staff consisting of the OBI Director, Client Managers, OBI Service Line Directors, a PMO Lead and Coordinator. Client Each of the following members of the CDER Executive Committee: The Center Director; Director, Office of Planning and Informatics; Director, Office of Compliance; Director, Office of Executive Programs; Director, Office of Management; Director, Office of Medical Policy; Director, Office of New Drugs; Director, Office of Pharmaceutical Science; Director, Office of Regulatory Policy; Director, Office of Surveillance and Epidemiology; Director, Office of Communications; and Director, Office of Translational Sciences. Client Manager The single point of contact within OBI responsible for representing and managing each Client. Joint Business Planning The process of Clients assessing and prioritizing the informatics needs of their offices with their OBI Client Managers. OBI Program Manager - The OBI staff member assigned to coordinate all efforts related to the maintenance and improvement of an existing informatics service or solution. OBI Service Line Directors The OBI Directors representing the following OBI Components: Drug Quality and Compliance Services and Solutions Regulatory Review and Drug Safety Services and Solutions Business Management Services and Solutions Data Management Services and Solutions Innovation Management and Architecture Services and Solutions

SUMMARY OF CHANGES

N/A. This is an initial issuance.

Originating Office: Office of Business Informatics Effective Date: 10/25/11

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EFFECTIVE DATE

This MAPP is effective upon date of publication.

Originating Office: Office of Business Informatics Effective Date: 10/25/11

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ATTACHMENT 1 Index of Acronyms

CDER CI CITL EPLC FDA HHS IGB IMAB IT ITIM ITIRB JBP KEA OBI OIM OMB PMAP PMO SPR

Center for Drug Evaluation and Research Continuous Improvement Center Information Technology Liaison Enterprise Performance Life Cycle Food and Drug Administration Health and Human Services Informatics Governance Board Information Management Advisory Board Information Technology Information Technology Investment Management Information Technology Investment Review Board Joint Business Planning Key Element Assessment Office of Business Informatics Office of Information Management Office of Management and Budget Performance Management Appraisal Program Program Management Office Small Project Request

Originating Office: Office of Business Informatics Effective Date: 10/25/11

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ATTACHMENT 2 PMO Assessment & Decision Tree

Originating Office: Office of Business Informatics Effective Date: 10/25/11

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