fda information management strategic plan

8/10/2019 FDA Information Management Strategic Plan

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FDA Information Managementand Office of Information

Management

Strategic Plan Version 1.1FY2012 - FY2016

September2012
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/GlobalProductPathway/default.htmhttp://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/GlobalProductPathway/default.htmhttp://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/GlobalProductPathway/default.htmhttp://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/GlobalProductPathway/default.htmhttp://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/GlobalProductPathway/default.htmhttp://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/GlobalProductPathway/default.htmhttp://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/GlobalProductPathway/default.htmhttp://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/GlobalProductPathway/default.htm


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FOREWORD

It is with great excitement that we bring you the first full version of

the FDA Information Management (IM) Strategic Plan. During thetime this document has been under development, we have reachedout to many sources for feedback and are confident that each readerwill feel the document was worth the wait.

In building this plan, careful attention was paid to both the Foodand Drug Administration (FDA) Strategic Prioritiesand the Healthand Human Services (HHS) Strategic Plan. We attempted to mapand align each goal and objective within this document to eachspecific FDA objective, but in the end we decided that approachwas unnecessary. In truth, each of the core goals of this plan

[Infrastructure on Demand, Knowledge Architecture, FinancialOpportunity, Office of Information Management (OIM) WorkforceTransformation] is essential for the successful realization of everycomponent of the FDA mission.

We also strove to keep this document clear for our customers andourselves. While not always simple, the goals and objectives aresimply stated and we are committed to their successful conclusion.It is our intent to publish annual updates and to use this plan asa living document that guides our efforts, without dictating them

to the omission of the essential realtime feedback we will receivealong our journey. We are also developing and utilizing moredetailed internal documents that provide more specificity for ourimplementation processes.

Again, thank you for your support and enthusiasm.

Sincerely,

Eric D. Perakslis, Ph.D.

Chief Information Officer (CIO) and Chief Scientist for InformaticsFood and Drug Administration
http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm227527.htmhttp://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm227527.htmhttp://www.hhs.gov/secretary/about/priorities/priorities.htmlhttp://www.hhs.gov/secretary/about/priorities/priorities.htmlhttp://www.hhs.gov/secretary/about/priorities/priorities.htmlhttp://www.hhs.gov/secretary/about/priorities/priorities.htmlhttp://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm227527.htmhttp://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm227527.htm


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FDAOIMVISION

FDAs technology and knowledge capability is modern, secure,

accessible, costeffective and exceeds customer and partnerexpectations.

FDAOIMMISSION

To provide the information, communication and knowledgeinfrastructure and services that enhance, transform and sustain theability of the FDA to protect and promote the public health.

FDAOIMGuidingPrinciples

InfrastructurethatisAvailableonDemand

InformationastheKeyAsset

Excellence,EfciencyandContinuousImprovement

Collaborations,CoalitionsandTeamwork

InteroperabilityandEnterpriseApproach

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FDAOIMVALUES

1. MissionFirst

We align all our activities with the goals and mission of FDAand we insist that all investments are judged by the valueproduced towards that mission

2.TransparencyandAccountabilityWe require the highest quality of integrity, ethical conduct,fiscal responsibility and openness in operations, processes anddecision making

3.CustomerServiceWe understand and embrace our responsibility to removebarriers to and enhance the productivity of the FDA workforce

4.InnovationandAgilityWe embrace the necessary rate of change within public healthand medical and food product safety, and we will continuouslyevolve our processes and services

5.WorkforceExcellenceWe are committed to the professional competence, continuousimprovement, and the perpetual development of our most

precious resource

2.


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GOALS

1. Provide Technology on Demand via the modernization

of internal infrastructure and the provisioning of externalcapabilities that optimize the productivity of the FDA workforce

2. Develop the Knowledge Architecture and Infrastructurethat enables smooth FDA operations, efficient review processes,riskbased analytics, and secure and seamless collaborationwith public and private partners

3. Create Fiscal Opportunity via the efficient delivery of high

value services that reduce costs and create reinvestmentopportunities

4. Develop a leadership pipeline of highly engaged, qualified andcustomercentric employees that are experts in technologiesand in the business and scientific domains which they serve

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GOAL#1

Provide Technology on Demand via the modernization of internal

infrastructure and the provisioning of external capabilities thatoptimize the productivity of the FDA workforce

DESCRIPTION

At the core, FDAis an informationand process drivenorganization.The realtimeconnectivity andaccess to dataand information isessential for dailyoperations as wellas for the integrityof connectivity tothe public that weserve and the many partners that work with and are dependenton FDA for the execution of their missions. This connectivity andaccess are dependent upon high quality, high availability and high

performing data networks, server and application infrastructure,communication services, many simple and advanced computerapplications, mobile workforce capabilities, and high quality, rapidand responsive service delivery.

This goal is intended to drive the modernization of the entiretechnology infrastructure at FDA as well as to enable the nextgeneration of technologies, business capabilities, mobile servicesand collaborations that will enable FDA to meet its responsibilities toregulate a diverse, global product supply.

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OBJECTIVES

1.1 ModernizeTechnologyInfrastructureandEnableCloud

Computingby2013

FDA IM provides an Agencywide, 21st Century computinginfrastructure that is secure, efficient, effective, scalable,flexible, and reliable; meets the FDA business requirements;and enhances FDAs operational capabilities via internal andexternal infrastructure.

1.2 DeployanAgile,NetCentric,ServiceBasedTechnologyEnvironmentby2014

The FDA systems environments must be flexible, reliable,expandable, predictable, resource conservative, maintainable,standardsbased and cost effective.

1.3 DevelopanddeployacomprehensivesetofWorkforceMobilityandVirtualizationcapabilitiesby2014

Currently more than a third of the FDA workforce is notheadquartersbased or works offsite. In addition, initiativesto streamline the physical footprint of government agencies

have necessitated the development of specific strategies andservices aimed at ensuring the productivity of an increasinglyvirtual workforce.

1.4 Providebusinessprocessandworkflowmanagementsolutionsby2015

Business Process Management solutions (including workflowmanagement technology and tracking of performancemetrics) allow efficient use of human resources and optimizeproductivity. These tools also facilitate project management,

maintenance of system inventories, and monitoring andoptimization of system utilization and efficiency.

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MAJORACTIVITIESandTIMING

FY

2012

FY

2013

FY

2014

FY

2015

FY

2016

1.A Maintain a modern robust multitier enterprise computinginfrastructure with virtualization

X X X X X

1.B Maintain modern, highspeed redundant networks andtelecommunications capability

X X X X X

1.C Maintain consistency and reliability through standardizedoperational processes and change management

X X X X X

1.D Provide efficient Information Technology (IT) equipmentupdating, property management, and disposition

X X X X X

1.E Implement servicebased architecture capabilities with useof common components X X X

1.F Implement efficient, agile, and modular approaches tosystems development

X X X X X

1.G Focus on enterprise application development andinteroperability to meet business needs

X X

1.H Provide effective, stable, secure, and robust web capabilitiesand content management

X X X X X

1.I Maintain excellence in implementation and compliancewith governmentwide systems and requirements X X X X X

1.J Provide the virtual office, infrastructure on demand,

collaboration, & high capacity storage

X X X

1.K Provide effective business process, workflow, and project &system management solutions

X X X X X

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KEYPERFORMANCEINDICATORS

Allinfrastructureservicesarecontinuouslymonitoredagainst

published and agreedupon service level agreements

Emailandnetworkconnectivityis100%availablewithservicelevels at or above published service level agreements

Actualdatastoragecostsareatorbelowpublicsectorbenchmarks

80%ofallITsystemshostingrequirementsaremetbystandardinfrastructure service offerings

Engineering

support

is

available

to

all

prioritized

programs/projects

Sustainedrateoftechnologyupgradethatrangesfrom5-15%annually

Infrastructuredesignandstrategyareaidedviaexternaladvice

Applicationperformanceandavailabilitymeetorexceedpublished service levels

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PROGRESSTODATEandSUCCESSSTORIES

DataCenterModernizationtoTier4

OIM successfully completed the data center modernizationand migration project which provided an advanced computinginfrastructure that is secure, scalable, flexible and reliable andable to meet the agencys mission. As a result of this initiative,which includes extensive virtualization, the FDA now has a Tier 4production data center environment with a secure FDA computingenvironment.

A Tier 4 data center is considered the most robust type of datacenter and is inherently less prone to failures due to its fully faulttolerant cooling, power and network links engineered to exceed

99.995%

availability

(less

than

27

minutes

of

downtime

per

year).FDA has formalized the development, test, preproduction, and

production environments. This provides an internal cloud computingenvironment which reduces FDAs costs for environment setup andsupport, and provides agility not previously possible.

ServerandEnvironmentVirtualizationandConsolidation

Additionally, FDA has established consistency and standardizationthrough new operational procedures and processes. Key outcomesachieved which enhance FDA operational efficiency and costsavingsincludean89%serverreductionthroughvirtualizationand

a

reduction

in

the

number

of

Agency

systems

from

397

to

265.

Virtualization allows FDA to run multiple systems on a single highperformance server instead of each system requiring a separateserver. Through virtualization FDA has reduced the physical serverfootprint, which demonstrates savings in power consumptioncosts from a server and data center standpoint and allows FDAto utilize equipment and support resources far more efficiently.Approximately110databaseserverswereconsolidatedinto18servers,foran84%reductionofphysicalequipment.Theoveralldatacenterinfrastructurereliabilityhasincreasedfrom98.3%

to

99.9996%,

meaning

that

unscheduled

server

downtime

has

beenreducedfrom6.6dayspercalendaryeartoapproximately30seconds.Ahigh-performancecomputingenclavehasalsobeenestablished to support the FDAs bioinformatics initiatives. FDAs newdatacentersalreadymeetorexceedall2012and2013ExecutiveOrder and HHS green computing and consolidation goals. Serveruptime has been increased, and OIM is committed to evaluatingcomplete endtoend services to assure maximum customeravailability at all points in utilization processes.

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GOAL#2

Develop the Knowledge Architecture and Infrastructure that enables

smooth FDA operations, efficient review processes, risk-basedanalytics, and secure and seamless collaboration with public andprivate partners

DESCRIPTION

The availability and usability of data is essential to the speedand efficiency of decision making at FDA. Some data must beavailablereal-time24:7andisrequiredtobetranslatablefromdatato information and knowledge almost instantly, as in the casesof imports review and the evaluation of medical adverse events.

Other datadriven processes require deeper contemplation andmultivariate analysis capability, such as the premarket review ofbiopharmaceuticals.

OIM at FDA supports and enables the availability, usability,connectivity, interoperability, security, analysis and visualizationof the vast array of data types and processes that stream into,through and out of FDA on a daily basis. The intent of this goal isto make data available and consumable within and across the FDAand to enable a learning and knowledge network that enables risk

based analytics on a scale that routinely handles global sourcesand volumes of data. This goal is also intended to drive the globaldatasharing, risk analytics, and reliance on third parties that isenvisionedinFDAs2011specialreport,PathwaytoGlobalProductSafety and Quality.

9.
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/GlobalProductPathway/default.htmhttp://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/GlobalProductPathway/default.htmhttp://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/GlobalProductPathway/default.htmhttp://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/GlobalProductPathway/default.htmhttp://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/GlobalProductPathway/default.htmhttp://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/GlobalProductPathway/default.htmhttp://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/GlobalProductPathway/default.htmhttp://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/GlobalProductPathway/default.htmhttp://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/GlobalProductPathway/default.htmhttp://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/GlobalProductPathway/default.htmhttp://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/GlobalProductPathway/default.htm


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OBJECTIVES

2.1 EnableSeamlessDataAvailabilityviaEndtoEndand

StandardsBasedMasterDataCapabilityby2015

The FDA must have welldefined processes for thedevelopment, adoption, harmonization, and implementationof data standards to enhance interoperability of informationacquired from multiple sources, to align its systems to HealthIT and other standards, and to interface with industry andother government agencies both at home and abroad.

2.2 EnableEnterpriseDataManagementby2015

Enterprise Data Management provides a coordinated andcomprehensive approach to ensuring data integrity and thatFDAs data and information are accessible and secure.

2.3 EnhancetheEfficacyofFDAProgramsviaIntegrativeInformaticsby2014

The scientific computing technology and data infrastructureenable advanced analytics, integrative analysis, dataaggregation and disambiguation and a wide range of

advanced computational needs, while leveraging agencywidefoundational capabilities made of reusable components.

2.4 EstablishEfficientandEffectiveOperationalGovernanceby2012

FDA and OIM operational and investment strategygovernance provides a businessdriven, businessorientedinvestment management framework integrating criticalorganizational disciplines to successfully improve and ensurecrossagency integration and alignment of IM investments

(see

the

U.S.

General

Accounting

Ofce

(GAO)

-dened

ITInvestment Management Capability Maturity Model).

10.
http://www.gao.gov/new.items/d04394g.pdfhttp://www.gao.gov/new.items/d04394g.pdfhttp://www.gao.gov/new.items/d04394g.pdfhttp://www.gao.gov/new.items/d04394g.pdfhttp://www.gao.gov/new.items/d04394g.pdf


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2.5 DevelopandUtilizeEnterpriseArchitecture(EA)asanEnablingandDrivingForceby2013

FDA IM EA provides a businessdriven framework thatcaptures the current state, the desired end state, anddevelops solutions and transition plans for FDAs businessarchitecture, data architecture, systems architecture,technical architecture, security architecture, and standardsviautilizationoftheGAO-denedIT EA Management MaturityFramework.

2.6 UtilizeRigorousInformationSecurityPracticestoDriveInnovationandCollaborativeDataAccessby2012

FDA IM provides a secure IM environment with multiplelevels of firewall protection, accurate personal identityverification, uptodate intrusion prevention, detection, andresponse systems, and effective user security awareness.These essential principles will be the key enablers oftechnological innovation and worldwide collaboration.

11.
http://www.gao.gov/new.items/d10846g.pdfhttp://www.gao.gov/new.items/d10846g.pdfhttp://www.gao.gov/new.items/d10846g.pdfhttp://www.gao.gov/new.items/d10846g.pdfhttp://www.gao.gov/new.items/d10846g.pdf


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Thereisacollaborativelymanagedmenuofeffectiveanalytical

tools for all primary data types

TheFDASecurityOperationsCentermonitorsandremediatesbillions of intrusion attempts against FDA IT Systems annuallywith no major information security breaches

80%ofsystemsdeliveryisbaseduponpre-designedarchitectural roadmaps

Strategicblendbetweencenter-specicandenterprisesystemsdevelopment is achieved

Risk-basedanalyticsdrive10-15%ofannualchangeininspection prioritization

Dataavailabilityisgreatlyincreasedasmeasuredbyimportsstaff

Knowledgemanagementlayersexistingreaterthan30%ofsoftware applications

At

least

one

new

major

component

of

FDA

strategic

plan

is

dataenabled annually

13.


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PersonalIdentityVerificationImplementation

The Division of Technology assumed a leadership role in the HHSPersonal Identity Verification (PIV) compliance effort [HomelandSecurity Presidential Directive (HSPD) 12]ensuring that FDApersonnel had the ability to use PIV cards to access their computersand FDA facilities. PIV cards are an alternative to users havingmultiple accounts and passwords and are a much safer way tosecure sensitive data and systems.

ProgressonAutomatedRiskManagement

The Division of Technology completed a comprehensive AutomatedRiskManagementplaninsupportofOffice of Management andBudget(OMB)Directive10-15and began the initial phases ofimplementation. AutomatedRiskManagementisamethodologyforrealtime risk management of IT systems and data. Introduction ofAutomatedRiskManagementattheFDAwillgreatlystreamlinetheintroduction of new IT systems and capabilities and will ensure thatproper protections are applied as threats arise and diminish.

RecognitionasanHHSwideInformationSecurityCenterof

Excellence

The FDA was recognized as an HHSwide Information Security Centerof Excellence in acknowledgement of the Division of Technologysleadership in Personal Identity Verification (HSPD12), AutomatedRiskManagement(OMB10-15), and compliance with theFederalInformationSecurityActof2002.

14.
http://www.dhs.gov/homeland-security-presidential-directive-12http://www.dhs.gov/homeland-security-presidential-directive-12http://www.whitehouse.gov/sites/default/files/omb/assets/memoranda_2010/m10-15.pdfhttp://www.whitehouse.gov/sites/default/files/omb/assets/memoranda_2010/m10-15.pdfhttp://www.whitehouse.gov/sites/default/files/omb/assets/memoranda_2010/m10-15.pdfhttp://www.whitehouse.gov/sites/default/files/omb/assets/memoranda_2010/m10-15.pdfhttp://www.whitehouse.gov/sites/default/files/omb/assets/memoranda_2010/m10-15.pdfhttp://www.whitehouse.gov/sites/default/files/omb/assets/memoranda_2010/m10-15.pdfhttp://www.whitehouse.gov/sites/default/files/omb/assets/memoranda_2010/m10-15.pdfhttp://www.whitehouse.gov/sites/default/files/omb/assets/memoranda_2010/m10-15.pdfhttp://www.whitehouse.gov/sites/default/files/omb/assets/memoranda_2010/m10-15.pdfhttp://www.whitehouse.gov/sites/default/files/omb/assets/memoranda_2010/m10-15.pdfhttp://www.dhs.gov/homeland-security-presidential-directive-12http://www.whitehouse.gov/sites/default/files/omb/assets/memoranda_2010/m10-15.pdfhttp://www.whitehouse.gov/sites/default/files/omb/assets/memoranda_2010/m10-15.pdfhttp://www.whitehouse.gov/sites/default/files/omb/assets/memoranda_2010/m10-15.pdfhttp://csrc.nist.gov/drivers/documents/FISMA-final.pdfhttp://csrc.nist.gov/drivers/documents/FISMA-final.pdfhttp://csrc.nist.gov/drivers/documents/FISMA-final.pdfhttp://csrc.nist.gov/drivers/documents/FISMA-final.pdfhttp://csrc.nist.gov/drivers/documents/FISMA-final.pdfhttp://csrc.nist.gov/drivers/documents/FISMA-final.pdfhttp://csrc.nist.gov/drivers/documents/FISMA-final.pdfhttp://csrc.nist.gov/drivers/documents/FISMA-final.pdfhttp://csrc.nist.gov/drivers/documents/FISMA-final.pdfhttp://csrc.nist.gov/drivers/documents/FISMA-final.pdfhttp://www.whitehouse.gov/sites/default/files/omb/assets/memoranda_2010/m10-15.pdfhttp://www.dhs.gov/homeland-security-presidential-directive-12http://csrc.nist.gov/drivers/documents/FISMA-final.pdfhttp://csrc.nist.gov/drivers/documents/FISMA-final.pdfhttp://www.whitehouse.gov/sites/default/files/omb/assets/memoranda_2010/m10-15.pdfhttp://www.whitehouse.gov/sites/default/files/omb/assets/memoranda_2010/m10-15.pdfhttp://www.dhs.gov/homeland-security-presidential-directive-12http://www.dhs.gov/homeland-security-presidential-directive-12


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ScientificEnclaveDelivery

The Division of Technology delivered the Scientific Enclave

environment to facilitate scientific computing collaboration withinthe FDA, across HHS operating divisions, and with Industry andAcademia while ensuring that the appropriate controls are inplace to protect the sensitive and proprietary data of patients andsponsors. The Scientific Enclave environment is designed for rapidimplementation of collaboration environments where communitiesof scientists can come together to analyze large, integrated data setsand address important questions confronting clinical medicine. Thisaccomplishment has been publically acknowledged by the Secretaryof HHS.

ProgressonEnterpriseArchitecture

EA completed a draft functional model to align with the CIOsPlan,Build,Runparadigm. ItdepictsEAthreadedthroughoutthe paradigm; as a result we are now determining the appropriatestafngneeds. EAisworkingonoptionsfortheArchitecture/EngineeringReviewBoardwhichwillplayapivotalroleinthenewgovernance model being established at the FDA.

IntroductionofSixsigmaProcessImprovement

EA continues to work with one of the CIOs Senior Technical Advisorson process improvement. The first processes work (using six sigmatechniques) is data architecture and management. We have theprocess flows developed, have met internally, and are starting tosocialize the model across the Agency. We are in the preliminarystages of starting the next process which is service architecture.TherearethreeotherGreen-beltprojectsunderwaywithinOIM.

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GOAL#3

Create Fiscal Opportunity via the efficient delivery of high value

services that reduce costs and create reinvestment opportunities

DESCRIPTION

Currently, information technology expenditures and overheadaccountforapproximately12%ofthetotalFDAbudget. Theamount of value realized for this significant investment must becontinuously monitored and optimized. Once the infrastructure hasbeen optimized, by rigorously managing all technology overheadcosts,itisestimatedthat5-15%ofnewcapabilitycanbedeliveredannually without any increase in costs. This can be accomplished

by the strategic reinvestment of a portion of savings realizedthrough cost optimization. Examples of cost savings opportunitiesare in infrastructure standardization, elimination of redundantinfrastructure and computer applications, automation, a strategicbalance of insourcing and outsourcing of resources and capabilitiesand vendor management, with this last opportunity being thelargest opportunity by far.

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OBJECTIVES

3.1 DevelopanimprovedfinancialmodelforIMinvestment

andbudgetingatFDAthatincreasestransparencyandprovidesanactionablydirectunderstandingoftechnologyspendatFDAby2013

Evolve the current and historical allocationbased financialmodels with a more direct set of approaches that enable theunderstanding of fixed, variable and opportunity costs.

3.2 DevelopastrategicvendormanagementstrategyandcapabilityincooperationwiththeFDAcontractingofficeandHHSby2014

Current approaches to IT contract management and strategyare ratelimited by procurement personnel and based uponoutdated technology practices, such as fixedprice approachesfor technology delivery. These contracts can be greatlyoptimized via the application of strategic resources and upto-date procurement strategies to yield the benefits of tens ofmillions of dollars saved annually.

3.3 Developmodelsthattransparentlyconnecttheactualcosts

ofallmajorservicesandtheservicelevelagreementsforthoseservicesby2014

By clarifying the actual cost of IM and mobility costs byservice, customers can make informed choices that increaseproductivity, enable reinvestment and create cost savings.

3.4 Implementeffectiveprogrammanagementmethodologyby2013

By implementing a Program Management Office and HHS

mandated Enterprise Performance Management LifeCycle processes FDA can coordinate systems developmentand maintenance processes across all components of FDAsinformation management activities.

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FY

2012

FY

2013

FY

2014

FY

2015

FY

2016

3.A Establish integrated portfolio management, CapitalPlanning and Investment Control (CPIC), and projectexecution and cost accounting

X X X X

3.B Provide effective support for IMrelated acquisitionsthrough FDA contracting services and modernizeprocurement strategies

X X X X

3.C Maintain excellence and transparency in fiduciaryaccountability and resource management and IMprocurement services

X X X X

3.D Implement standardized IM program managementoversight, ensuring evaluation of projects at critical stagesin their development

X X X


Measurablycloseralignmentbetweenactualspendandbudget

forecasts available transparently throughout the fiscal year

Signicantdecreaseinunplannedspendinginfourthquarter

Continuouscostoptimizationonallmajorservices

20%overalldecreaseinspendonmajorprojectsviavendormanagement

10%decreaseinannualsupportofcommercialsoftwarelicensing

Sustainedrateoftechnologyupgradethatrangesfrom5-15%annually

Annualdecreaseincostofdatastorage

18.


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Establishment of the FDA OIM Program Management Office(PMO)

The FDA OIM PMO is the organizational component established bythe CIO that defines and maintains the standards of IM program andproject management processes within FDA. The PMO strategicallyaddresses areas for process improvement and fills critical gaps inprogram coordination, collaboration, and program and projectmanagement across all FDA information management activities. ThePMO strives to standardize and introduce repeatable processes andprovide documentation, guidance, processes and metrics in order toachieve successful IM projects that are delivered in scope, on timeand within budget constraints.

FieldOfficeInfrastructureRefresh

The FDA has is currently completing its field IT infrastructuremodernizationsupporting220FDAeldlocationsincludingOfceofRegulatoryAffairs,CenterforDrugEvaluationandResearchandCenter for Food Safety and Applied Nutrition facilities. This effortincludes network connectivity and monitoring for all field locations,implementation of VoiceOverIP phone integration for medium-tolarge sites, a streamlined enterprisestandard security patch

distribution system, standardized file and print sharing for all fieldlocations, and laboratory instrument backups for 13 field locations.

The number of file and print servers has been reduced throughthiseffortfrom110priortothiseffortto27today. Consolidation,virtualization and standardization have greatly reduced capitalequipment and operations and maintenance costs for field ITinfrastructure,achievingaReturnonInvestment(ROI)ofninemonthswithrecurringannualsavingsof$2.65M.

LeaseBuyoutofContractorHostedData

Center(CHDC)Equipment

Purchase of leased equipment in the FDAs primary production datacenter in Ashburn, Virginia achieved a large savings and will greatlysimplify the data center support contract recompete process, asbothdatacentersarenowGovernmentFurnishedEquipment(GFE)ratherthanamixofleaseandGFE. Overallnetsavingsof$9.1Mwasachieved.

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SuccessStory:ProjectandPortfolioManagementToolImplementation

A central electronic tool capable of harnessing project and portfoliomanagement information in a single central repository wasimplementedbyOIMin2010,withreportingcapabilitiestomineinformation that can be accomplished by anyone with access andprivileges to these data. This tool is used to centrally manage andcommunicate project, contract, and investment data under the FDAITPortfolio. Approximately$0.4Minsavingshasbeenrealizedtodate.

SuccessStory:ContractManagementSupport

OIM continually reviews IT contracts to look for cost savingopportunities while maintaining or increasing benefits to FDAprograms. A key area identified for improvement was InteragencyAgreements(IAGs). IAGscanoftensavebothtimeandmoney,but since we are paying another agency to perform contractmanagement this is an area we review periodically to reevaluatecostefciency. WedeterminedthatbringingtwoofourIAGsin house would provide cost savings and more effective vendorrelationships. By partnering with the Office of Acquisitions andGrantServices(OAGS),themajorityofOracleandMicrosoftservices

are

now

handled

internally

by

FDA,

saving

over

$0.4M

in

the

rst

year, with an expected savings of over $2M over the next five years.

SuccessStory:StandardITProjectSupportTools

We have reduced costs around tools that support applicationdevelopment(CongurationManagement,Test,Requirements,Issue tracking) by centralizing and standardizing the tools we andour contractors must use. The project teams now have a betterknowledge base around these tools, and we can provide expertise toproject teams that need support. We reduced total number of tools

from

20

to

14,

saving

$0.25M

per

year

in

license

and

support

costs,as well as additional cost avoidance through standardization.

20.


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GOAL#4

Develop a leadership pipeline of highly engaged, qualified and

customer-centric employees that are experts in technologies and inthe business and scientific domains which they serve

DESCRIPTION

While the FDA information technology budget representsapproximately12%ofthetotalFDAbudget,thefederalOIMstaffaccountsforlessthan4%oftheFDAworkforce. Evenwhentheaverage amount of supplemental contractors is added, the total OIMworkforceislessthan7%. Astheseresourcesarepreciousandcanbe ratelimiting, it is essential that FDA OIM staff be intentionally

developed, carefully enhanced when growth is possible, andmanaged diligently. This is especially true given the rapid rate ofchange of technology, analytics and IT service models. The staffmust be engaged, lean, active learners, agile and efficient if FDA is tomeet its essential mission.

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OBJECTIVES

4.1 OIMstaffmustbetransformedintoaproactive

transformationalentitythatenhancesrelationshipbuildingamongitsstakeholderswhileimprovingtheintegrationofbusiness,strategy,performance,andtechnologyby2014.

Information Management is an essential driving andoperational force for the mission of the agency and as thatmission evolves technologically, scientifically and legislatively,so must the OIM staff. The FDA and OIM leadership arecommitted to an intensive approach to modernizing the OIMworkforce.

4.2 OIMisresultsdriven,providingvaluetoitsstakeholdersthroughproactive,innovative,andstrategicthinking,customerservice,performancemanagement,andgovernanceofIMbusinesssolutionsby2013

As important as Information Management is to the FDAmission, the OIM staff does not generally, participate directlyin the regulatory work of the Agency, e.g., pre and postmarket evaluation of drugs and devices, inspections, etc. OIMexists to serve the FDA employees that do perform the core

mission functions at FDA and it is this service that is the solebasis of OIM progress.

4.3 TheFDAandOIMinformationmanagementteammusthavestrongvisionaryleadershipthatsustainsthetrainingandresourcesneededtosupporttheAgencyMission,andthatestablishesacultureoflearning,excellence,transparency,andaccountabilityby2012

OIM leadership must be strong, collaborative, rigorous,engaged and transparent in the performance of their duties

and in the management of all OIM staff.

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FY

2012

FY

2013

FY

2014

FY

2015

FY

2016

4.A Implement strategic workforce planning and an IM humancapital management plan, with tactical plans for managingthe IM workload

X X X X

4.B Implement individual training, skill development, andprofessional development and career managementprograms for IM staff

X X X X X

4.C Implement active recruitment, hiring, and retentionprocesses that are built upon a skills inventory, needsassessment, and gap analysis

X X X X

4.D Provide continuous interactive support and communicationfor FDA information systems users and stakeholders X X X X

4.E Provide efficient Helpdesk, technical support, and othercustomer support & training services X X X X X

4.F Maintain a culture of excellence, learning, and continualbusiness process improvement, including strategicplanning, continuous program evaluation, and qualitymanagement systems

X X X

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80%ofallVIPandseniorsupportstaffareMicrosoftCertied

75%ofallOracleDatabaseAdministrators(DBAs)areCertied

OIMtechnologystaffskillsetdistributionmeetsorexceedsproportions recommended by external benchmarks

AllOIMemployeeshaveatleastonesignicanttechnologyorcustomer service domain goal in their PerformanceManagement Appraisal Program (PMAP) critical elements

AllOIMpeoplemanagershaveonesignicantPMAPgoalon

staff development

OIMself-fundsanannualstafftrainingplanthatensuresatleast onehalf of staff are upgrading at least one critical skill orcapability

PerformanannualskillsassessmentacrossOIMwithinputfrom across FDA

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CIORoleExpansionandRecruitment

Inlate2011,theFDAleadershipdevelopedanexpandedroledefinition that added to the Chief Information Officer a secondtitle of Chief Scientist Informatics. This expansion allowed therecruitment of a senior IT and scientific leader that would not onlyfocus on technology but that also had the medical, scientific andanalytic knowledge to truly drive the FDA mission forward.

OIMOrganizationalStabilization

AsofSeptember2011,fouroutofsevenOIMseniorleadershiproleswere occupied by employees with acting status. Several of the roleshad gone without permanent leaders for more than 3 years. As ofJune2012,threeofthefourroleshavebeenlledwithpermanentleaders, including the CIO and Deputy CIO, and there is an offerextended on the fourth.

OIMStaffTrainingFundedandOngoingviaReductionofConsultingFees

Duringthescalyears2010-2011,theOIMtrainingbudgethadbeen

eliminated

as

cost

savings.

In

early

FY

2012,

this

budget

was

re-established via the elimination of consulting fees. The result is thatactive training programs are ongoing in all FDA OIM divisions.

ProjectManagementTraining

The FDA Project Management (PM)Certification Program over the pastfive years has clearly demonstratedthat leadership is action, notposition. The goal of the PMCertification Program is to educateproject managers in the discipline ofgood project management as defined by the Project ManagementInstitute and Project Management Body of Knowledge. During thesepastveyearstherehavebeenapproximately238governmentand Commissioned Corps FDA (OIM and nonOIM) employees whohave graduated from the program achieving a Masters Certificate inProject Management. An additional 42 staff graduated this past July.

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DRIVERS&FRAMEWORKfortheSTRATEGICPLAN

FDA and OIM are responsible for providing the IM infrastructure

and services to support FDAs mission to advance the health of thepublic. It is required to do this according to the following laws anddirectives, which govern the federal government IM line of business:

FederalRecordsActof1950&NationalArchivesandRecordsAdministrationActof1984provides framework for recordsmanagementinfederalAgencies;NARAguidesinappraisingrecords, regulating and approving disposition, operatingFederalRecordsCenters,andpreservingpermanentrecords

PrivacyActof1974balance between government rights to

maintain information on individuals and individual rights tohave privacy protected collection limitation, disclosure,secondary usage, record correction, security

CompetitioninContractingActof1984requires, with limitedexceptions, that contracting officers promote and provide forfull and open competition in soliciting offers and awardingfederal government contracts

ComputerSecurityActof1987establishes minimum

acceptable security practices for federal systems; requirescreation of computer security plans and training of systemusers or owners where the systems house sensitive information

GovernmentPerformanceandResultsActof1993requiresagencies to engage in project management tasks such assetting goals, measuring results, and reporting their progress;agencies must produce strategic plans, performance plans, andconduct gap analysis of projects

PaperworkReductionActof1980,amended1995federal

agency policies, principles, standards, and guidelines onprivacy, confidentiality, security, disclosure, and informationsharing; requires OMB approval for information collected fromthe public; no persons required to respond without OMBcontrol number

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http://www2.ed.gov/policy/gen/leg/fra.htmlhttp://www.archives.gov/about/laws/http://www.archives.gov/about/laws/http://www.it.ojp.gov/default.aspx?area=privacy&page=1279#contentTophttp://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t41t42+120+1++()%20%20AND%20((41)%20ADJ%20USC):CITE%20AND%20(USC%20w/10%20(253)):CITEhttp://www.nist.gov/cfo/legislation/Public%20Law%20100-235.pdfhttp://georgewbush-whitehouse.archives.gov/omb/mgmt-gpra/gplaw2m.htmlhttp://www.archives.gov/federal-register/laws/paperwork-reduction/http://www.archives.gov/federal-register/laws/paperwork-reduction/http://georgewbush-whitehouse.archives.gov/omb/mgmt-gpra/gplaw2m.htmlhttp://www.nist.gov/cfo/legislation/Public%20Law%20100-235.pdfhttp://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t41t42+120+1++()%20%20AND%20((41)%20ADJ%20USC):CITE%20AND%20(USC%20w/10%20(253)):CITEhttp://www.it.ojp.gov/default.aspx?area=privacy&page=1279#contentTophttp://www.archives.gov/about/laws/http://www.archives.gov/about/laws/http://www2.ed.gov/policy/gen/leg/fra.html


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5CodeofFederalRegulations(CFR)1320OMBs final rule oncontrolling paperwork burden

InformationTechnologyManagementReformActof1996(ClingerCohenAct)comprehensive approach forexecutive agencies to improve the acquisition and managementof their information resources information resource planning;capital planning and investment control process linked tobudget formulation and execution; develop, maintain, andfacilitate implementation of toplevel enterprise architecture

FreedomofInformationActof1996agencies shall makeavailable for public inspection and copying a generalindex of records and copies of all records, with certain

exceptions to protect proprietary and privacy information

HealthInsurancePortabilityandAccountabilityActof1996to simplify administration of health insurance;to combat waste, fraud, and abuse; to create nationalstandards to protect medical records; requires adoption ofnational standards for electronic health care transactionsand national identifiers for providers, health plans, andemployers; establishes standards for privacy and securityof health information, as well as standards for electronic datainterchange of health information

GovernmentPaperworkEliminationActof1998 requires that, when practicable, Federal agencies use electronicforms, electronic filing, and electronic signatures to conductofficial business with the public; focuses on recordsmanagement issues; guidance to agencies on securinginformation in interconnected electronic networks;significantly increased security for government systems

PresidentialDecisionDirective63Critical Infrastructure

Protection

(1998)

established

Information

and

Communications as a critical infrastructure segment

27.
http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?tpl=/ecfrbrowse/Title05/5cfr1320_main_02.tplhttp://www.cio.gov/Documents/it_management_reform_act_feb_1996.htmlhttp://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htmhttps://www.cms.gov/Regulations-and-Guidance/HIPAA-Administrative-Simplification/HIPAAGenInfo/downloads/HIPAALaw.pdfhttps://www.cms.gov/Regulations-and-Guidance/HIPAA-Administrative-Simplification/HIPAAGenInfo/downloads/HIPAALaw.pdfhttp://www.whitehouse.gov/omb/fedreg_gpea2http://www.fas.org/irp/offdocs/pdd/pdd-63.htmhttp://www.fas.org/irp/offdocs/pdd/pdd-63.htmhttp://www.whitehouse.gov/omb/fedreg_gpea2https://www.cms.gov/Regulations-and-Guidance/HIPAA-Administrative-Simplification/HIPAAGenInfo/downloads/HIPAALaw.pdfhttps://www.cms.gov/Regulations-and-Guidance/HIPAA-Administrative-Simplification/HIPAAGenInfo/downloads/HIPAALaw.pdfhttp://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htmhttp://www.cio.gov/Documents/it_management_reform_act_feb_1996.htmlhttp://ecfr.gpoaccess.gov/cgi/t/text/text-idx?tpl=/ecfrbrowse/Title05/5cfr1320_main_02.tpl


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OMBCircularA11,part7CapitalAssetManagement(2003) federal budget process and capital asset managementprocesses,Exhibit300,EnterpriseArchitecture

OMBCircularA76Performance of Commercial Activities(2003)requirescompetitionforneededcommercialservices

HomelandSecurityPresidentialDirective7(HSPD7,2003)identify and prioritize critical infrastructure and to protectthem from terrorist attacks

HomelandSecurityPresidentialDirective12(HSPD12,2004)amandatory,Government-widestandardforsecureandreliable forms of identification issued by the Federal

Government

to

its

employees

and

contractors

FederalAcquisitionRegulation(FAR,2005)detailedcontracting requirements

OMBM0805&M0932Trusted Internet Connections(2007,2009)optimizingoffederalindividualexternalinternetconnections

OMBCircularA127FinancialManagementSystems(2009) policies for financial management systems; requires FSIOCertified Commercial (COTS) Systems

OMBCircularA16CoordinationofGeographicInformationandRelatedSpatialDataActivities(2010)coordinationanduse of geospatial data

OMBDirectiveM1015ReportingInstructionsfortheFederal Information Security Management Act and AgencyPrivacyManagement(2010)

TeleworkEnhancementActof2010 Mandates that federalagencies establish policy under which eligible employees maybe authorized to telework

ExecutiveOrder13589PromotingEfcientSpending(2011)

DIGITALGOVERNMENT:Buildinga21stCenturyPlatformtoBetterServetheAmericanPeopleInformationCentric,SharedPlatform,Customer-Centric,SecurityandPrivacy(2012)

29.
http://www.whitehouse.gov/sites/default/files/omb/assets/omb/circulars/a11/current_year/a_11_2003.pdfhttp://www.whitehouse.gov/sites/default/files/omb/assets/omb/circulars/a076/a76_incl_tech_correction.pdfhttp://www.dhs.gov/xabout/laws/gc_1214597989952.shtmhttp://www.dhs.gov/xabout/laws/gc_1217616624097.shtmhttps://www.acquisition.gov/far/http://www.whitehouse.gov/sites/default/files/omb/assets/omb/memoranda/fy2008/m08-05.pdfhttp://www.whitehouse.gov/sites/default/files/omb/assets/memoranda_fy2009/m09-32.pdfhttp://www.whitehouse.gov/sites/default/files/omb/assets/agencyinformation_circulars_pdf/a127_attachment.pdfhttp://www.whitehouse.gov/sites/default/files/omb/memoranda/2011/m11-03.pdfhttp://www.whitehouse.gov/sites/default/files/omb/assets/memoranda_2010/m10-15.pdfhttp://www.gpo.gov/fdsys/pkg/BILLS-111hr1722enr/pdf/BILLS-111hr1722enr.pdfhttp://www.gpo.gov/fdsys/pkg/FR-2011-11-15/pdf/2011-29683.pdfhttp://www.whitehouse.gov/sites/default/files/omb/egov/digital-government/digital-government.htmlhttp://www.whitehouse.gov/sites/default/files/omb/egov/digital-government/digital-government.htmlhttp://www.whitehouse.gov/sites/default/files/omb/egov/digital-government/digital-government.htmlhttp://www.whitehouse.gov/sites/default/files/omb/egov/digital-government/digital-government.htmlhttp://www.gpo.gov/fdsys/pkg/FR-2011-11-15/pdf/2011-29683.pdfhttp://www.gpo.gov/fdsys/pkg/BILLS-111hr1722enr/pdf/BILLS-111hr1722enr.pdfhttp://www.whitehouse.gov/sites/default/files/omb/assets/memoranda_2010/m10-15.pdfhttp://www.whitehouse.gov/sites/default/files/omb/memoranda/2011/m11-03.pdfhttp://www.whitehouse.gov/sites/default/files/omb/assets/agencyinformation_circulars_pdf/a127_attachment.pdfhttp://www.whitehouse.gov/sites/default/files/omb/assets/memoranda_fy2009/m09-32.pdfhttp://www.whitehouse.gov/sites/default/files/omb/assets/omb/memoranda/fy2008/m08-05.pdfhttps://www.acquisition.gov/far/http://www.dhs.gov/xabout/laws/gc_1217616624097.shtmhttp://www.dhs.gov/xabout/laws/gc_1214597989952.shtmhttp://www.whitehouse.gov/sites/default/files/omb/assets/omb/circulars/a076/a76_incl_tech_correction.pdfhttp://www.whitehouse.gov/sites/default/files/omb/assets/omb/circulars/a11/current_year/a_11_2003.pdf


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NISTSecurityGuidancesNational Institute of Standards andTechnology mandates for IT security matters

FederalCIOStrategicPlanand25PointReform ImplementationPlan

HHSStrategicPlanandSecretarysPriorities

HHSCIOStrategicPlanandPolicy/Directives

OfficeoftheNationalCoordinatorforHealthITDirectionsrelatingtoElectronicHealthRecord(EHR)Standards,Federal Health Architecture, Nationwide Health InformationNetwork, EHRMeaningfulUse,etc.

PCASTReportonHealthInformationTechnology(2010)

PCASTReportonDesigningaDigitalFuture(2010)

TopicswithCIOresponsibility/oversight(GAO04823,GAO11-634,OMBm1129)

FDA Information Management, generally through OIM, is responsibletoGuideBusinessNeedswithinRegulationsandMandatesOIMassists the FDA Programs in implementation of their business needsin a way that is acceptable within the boundaries defined by Laws,Regulations,Standards,andothermandates.

Comments or suggestions, please contact either the FDA CIO [email protected],MD,[email protected].

30.
http://csrc.nist.gov/publications/PubsByLR.htmlhttp://ocio.os.doc.gov/s/groups/public/@doc/@os/@ocio/@oitpp/documents/content/prod01_002082.pdfhttps://cio.gov/wp-content/uploads/2012/09/25-Point-Implementation-Plan-to-Reform-Federal-IT.pdfhttps://cio.gov/wp-content/uploads/2012/09/25-Point-Implementation-Plan-to-Reform-Federal-IT.pdfhttp://www.hhs.gov/secretary/about/priorities/priorities.htmlhttp://www.hhs.gov/secretary/about/priorities/priorities.htmlhttp://www.hhs.gov/ocio/ea/documents/hhs_irm_strategic_plan_2007_2012.pdfhttp://www.hhs.gov/ocio/policy/index.htmlhttp://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov__regulations_and_guidance/1496http://www.whitehouse.gov/sites/default/files/microsites/ostp/pcast-health-it-report.pdfhttp://www.whitehouse.gov/sites/default/files/microsites/ostp/pcast-nitrd-report-2010.pdfhttp://www.gao.gov/new.items/d04823.pdfhttp://www.gao.gov/new.items/d11634.pdfhttp://www.gao.gov/new.items/d11634.pdfhttp://m.whitehouse.gov/sites/default/files/omb/memoranda/2011/m11-29.pdfmailto:[email protected]:[email protected]:[email protected]:[email protected]://m.whitehouse.gov/sites/default/files/omb/memoranda/2011/m11-29.pdfhttp://www.gao.gov/new.items/d11634.pdfhttp://www.gao.gov/new.items/d11634.pdfhttp://www.gao.gov/new.items/d04823.pdfhttp://www.whitehouse.gov/sites/default/files/microsites/ostp/pcast-nitrd-report-2010.pdfhttp://www.whitehouse.gov/sites/default/files/microsites/ostp/pcast-health-it-report.pdfhttp://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov__regulations_and_guidance/1496http://www.hhs.gov/ocio/policy/index.htmlhttp://www.hhs.gov/ocio/ea/documents/hhs_irm_strategic_plan_2007_2012.pdfhttp://www.hhs.gov/secretary/about/priorities/priorities.htmlhttp://www.hhs.gov/secretary/about/priorities/priorities.htmlhttps://cio.gov/wp-content/uploads/2012/09/25-Point-Implementation-Plan-to-Reform-Federal-IT.pdfhttps://cio.gov/wp-content/uploads/2012/09/25-Point-Implementation-Plan-to-Reform-Federal-IT.pdfhttp://ocio.os.doc.gov/s/groups/public/@doc/@os/@ocio/@oitpp/documents/content/prod01_002082.pdfhttp://csrc.nist.gov/publications/PubsByLR.html


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