7600.8 cder informatics governance process_signed mmk_10.23.11l.pdf

7/28/2019 7600.8 CDER Informatics Governance Process_signed MMK_10.23.11l.pdf

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MANUAL OF POLICIES AND PROCEDURESCENTER FOR DRUG EVALUATION AND RESEARCH MAPP 7600.8

POLICY AND PROCEDURES OFFICE OF PLANNING AND INFORMATICS

CDER Informatics Governance Process Table of Contents

PURPOSE..............................................................................1 BACKGROUND ...................................................................1POLICY.................................................................................2 RESPONSIBILITIES...........................................................2 PROCEDURES.....................................................................4REFERENCES......................................................................6 DEFINITIONS ......................................................................6SUMMARY OF CHANGES ................................................7EFFECTIVE 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 intentis to align IT investments with overall business priorities, define decision makingauthority and assign accountability for executing those decisions.

BACKGROUND

In 2003, CDER established the Information Management Advisory Board (IMAB) toreview and approve project proposals. However, the IMAB was not connected to theoverall planning, decision making, and budgetary processes within CDER. This limited

the decision- making authority and involvement of CDER senior management, therebyrestricting the IMABs effectiveness in governing informatics activities across the Centerin support of long-term strategic goals.

CDERs business informatics needs have increased over the years. CDER must enablestrategic decision-making for its Information Technology (IT) investments. CDER mustalso comply with standards, processes and policies defined by the Office of Managementand Budget (OMB), Department of Health and Human Services (HHS) and by the Food

Originating Office: Office of Business Informatics Effective Date: 10/25/11 Page 1 of 10


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and Drug Administration (FDAs) Interim Informatics Governance Board (IIGB). CDERwill establish processes for selection, evaluation and control of IT investments consistentwith those requirements.

Effective October 1, 2011, the IMAB was discontinued and the new CDER governancemodel was implemented.

POLICY

Under the new CDER IT governance model, each CDER Executive Committee memberis considered a Client and is assigned an individual Client Manager from the Office ofBusiness Informatics (OBI), who serves as the single point of contact for all businessinformatics 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) alongwith each OBI Service Line Director. The PMO is responsible for reviewing projectrequests and maintaining the CDER Informatics Action Plan as the sole plan for CDERskey informatics priorities. The Clients collectively make up the CDER InformationTechnology Investment Review Board (ITIRB). The ITIRB is responsible for resolvingpriority 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-widepriority 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 CDERExecutive Committee.

Appoints Client Managers for each CDER Executive Committee member as thesingle point of accountability.

Client

Defines the processes within his/her office to identify, assess, and prioritizebusiness informatics needs.

Presents business informatics needs to the Client Manager for discussion.

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MANUAL OF POLICIES AND PROCEDURES

CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 7600.8

Client Manager

Works with the Client to understand his/her organizations business informaticsneeds, and to rank those needs in order of relative priority.

Performs Key Element Assessments (KEA) with the Clients on an annual basis tomeasure Client satisfaction.Program Management Office (PMO)

Assesses Client requests and provides the Client Managers with sufficientinformation to negotiate timing, scope, funding and required business resources.Once the Client agrees, the PMO conducts initial planning and adds the initiativeto the CDER Informatics Action Plan for final review and approval through theCDER Executive Committee. Once approved, the PMO will work with theCenter IT Liaison to submit the IT Investment Management (ITIM) request and

allocate sufficient CDER resources. See Staff Manual Guide 3210.2 ITInvestment Managementas referenced below.

Ensures successful delivery of projects on the approved CDER Informatics ActionPlan. If required, escalates issues to the appropriate Client or to the CDERExecutive Committee when necessary.

PMO Lead

Ensures the integrity of the governance process and the operational leadership ofthe CDER PMO. This includes the management and dissemination of information

of the CDER Informatics Action Plan and the quality of PMO services to ensurethat best practices are being employed across CDER projects.

PMO Coordinator

Manages PMO logistics such as schedules, meeting minutes, follow-up, actionitems and information sharing (collaboration tools and intranet site); andadministrative support functions, such as outreach and initial review of projectrequests with the Center Information Technology Liaison.

Center Information Technology Liaison (CITL)

Serves as a facilitator in coordinating IT requests between CDER and the Officeof Information Management (OIM). Conducts initial review of project requestswith the CDER PMO Coordinator.



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CDER Informatics Architect

Reviews IT requests received by the PMO to ensure they fit with the current andfuture architecture master plan.

PROCEDURES

All requests related to the development, purchase, implementation, innovation, oradoption of IT must be submitted to the PMO for review either through Joint BusinessPlanning 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 OBIresources plus funding of more than $25,000. All Requests shall be ranked inorder of relative priority in Joint Business Planning by the Client and will besubmitted to the PMO by the respective Client Manager for further evaluation. Ifneeded, the PMO will assign a Business Analyst to work with the Clientsdesignee to clarify high level requirements.

Small Project Request a project that requires minimal OIM or OBI resourcesplus 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 fundingare required and whether a full PMO assessment is necessary. Initial review ofSPR will occur and feedback will be provided with 30 calendar days. This formis available via the My PMO intranet link on the CDER, OPI and OBI Intranethome pages.

Grant Funding Applications Applications that involve informatics needs willbe reviewed by the PMO prior to approval through the corresponding grantfunding approval process. Any major issues or priority conflicts will be escalatedby the PMO to the respective grant approval committee.

MODIFYING EXISTING PROJECTS

Continuous Improvement (CI) Request a new functionality request forexisting IT systems. Each existing IT system will have a designated businessowner and a process for receiving, evaluating and prioritizing new functionalityrequests. The OBI Program Manager and the business owner will be responsiblefor prioritizing these requests. If the request exceeds the original program scope



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or if there is a priority conflict, the OBI Program Manager will escalate CIrequests to the PMO. The PMO may refer CI Requests to Joint Business Planningfor 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 compliancewith FDA OIM standards (e.g., technical and security policies) or highly redundant withother efforts will be denied and sent back to the originator with recommendations of nextsteps.

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 tofurther refine scope, cost and resource estimates. Timelines will be negotiated inJoint Business Planning based on these estimates. Once approved by the CDERExecutive Committee the PMO will work with the CDER IT Liaison to submitthe ITIM request and allocate sufficient CDER resources.

Small Project Requests that meet the assessment criteria will be forwarded to theCDER IT Liaison to begin the ITIM process.

Grant Funding Applications which are subject to the PMO assessment and thatmeet the PMO assessment criteria will be forwarded to the respective grantapproval committee for final decision-making.

Continuous Improvement (CI) Requests will be bundled into scheduledreleases 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 PMOto ensure that the agreed priorities are on track. Major issues will be escalated by the



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Client Managers, first to the Clients and if necessary to the CDER Executive Committeefor resolution. Changes to the CDER Informatics Action Plan will be reviewed andapproved 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 anannual basis to measure Client satisfaction. The Client Satisfaction Survey will consist ofthree 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. OMB, Circular A-130, Revised. Management of Federal Information Resources.2. Clinger Cohen Act, 40 USC 1401 et seq., 1996.3. FDA Staff Manual Guide 2010.3, 1/2004, FDA Data Standards Council.4. FDA Staff Manual Guide 3210.2, 8/2004, IT Investment Management.5. FDA Staff Manual Guide 3210.3, 4/2004, IT Project Management Policy.

6. FDA Staff Manual Guide 3230.2, 6/2004. Enterprise Architecture Policy.7. FDA Staff Manual Guide 3251.1, 1/2007, Responsibility for Information Security

DEFINITIONS

Business Informatics The discipline of combining various aspects of businessmanagement and information technology to ensure that CDER business process needs arerepresented and met during the development of IT products and systems.

Business Owner The person responsible for identifying and prioritizing businessinformatics 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 governanceprocess under the FDA Informatics Governance Board structure. The boardsmembership consists of all members of the CDER Executive Committee.

CDER Informatics Action Plan A list of approved IT projects that includes contactinformation, 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 andOBI 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 ArchitectureTeam.

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: TheCenter Director; Director, Office of Planning and Informatics; Director, Office ofCompliance; Director, Office of Executive Programs; Director, Office of Management;Director, Office of Medical Policy; Director, Office of New Drugs; Director, Office ofPharmaceutical Science; Director, Office of Regulatory Policy; Director, Office ofSurveillance and Epidemiology; Director, Office of Communications; and Director,Office of Translational Sciences.

Client Manager The single point of contact within OBI responsible for representingand managing each Client.

Joint Business Planning The process of Clients assessing and prioritizing theinformatics needs of their offices with their OBI Client Managers.

OBI Program Manager - The OBI staff member assigned to coordinate all effortsrelated to the maintenance and improvement of an existing informatics service orsolution.

OBI Service Line Directors The OBI Directors representing the following OBIComponents:

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.



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EFFECTIVE DATE

This MAPP is effective upon date of publication.



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ATTACHMENT 1 Index of Acronyms

CDER Center for Drug Evaluation and Research

CI Continuous Improvement

CITL Center Information Technology LiaisonEPLC Enterprise Performance Life Cycle

FDA Food and Drug Administration

HHS Health and Human Services

IGB Informatics Governance Board

IMAB Information Management Advisory Board

IT Information Technology

ITIM Information Technology Investment Management

ITIRB Information Technology Investment Review Board

JBP Joint Business Planning

KEA Key Element Assessment

OBI Office of Business InformaticsOIM Office of Information Management

OMB Office of Management and Budget

PMAP Performance Management Appraisal Program

PMO Program Management Office

SPR Small Project Request



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ATTACHMENT 2 PMO Assessment & Decision Tree


7600.8 cder informatics governance process_signed mmk_10.23.11l.pdf

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