lspppo report signed v2 (clear version)

7/27/2019 LSPPPO Report Signed V2 (Clear Version)

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U.S.

Department of

Health

and

Human Servnces

Centers for Disease

ontro

l

and

Prevention (CDC)

Report

to Congress on

Internal

L

aboratory

Activities

of

CDC

and

Associated Funding Levels

igned

Thomas R. Frieden.

M

D., M.P.H.


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CDCs laboratory scientists are at the heart ofourworktoprotectAmericaona24/7basis.CDCcouldnotsucceedwithoutthem.Stateandlocalpublichealthdepartments,healthcareprofessionals,andmanyothersrelyonourlaboratoryscientistsforspecializedtesting,consultation,andnewtechnologiestoaddressawideandgrowingspectrumofhealththreats.CDCisthedefactoreferencelaboratoryfor

theUnitedStatesandfortheentireworld,aninvaluableandindispensable resource.

ThomasR.Frieden,MD,MPHDirector,CentersforDiseaseControlandPrevention

InSenateReport11284,whichaccompaniedtheFiscalYear(FY)2012appropriationsbillfortheU.S.DepartmentsofHealthandHumanServices,Labor,Education,andrelatedagencies,theSenateCommitteeonAppropriationsstated,

The Committee requests a report to Congress no later than 120 daysafter the enactment of this act that details CDCs various internallaboratory activities and associated funding levels.

TheCentersforDiseaseControlandPrevention(CDC)haspreparedthisreportinresponsetothe committees request. The body of the report is organized into 21 sections that correspondwiththestandardformatoftheCDCbudgetdocumentswithwhichtheCommitteeisfamiliar.EachsectionaddressesaspecificCDCbudgetactivityanditsassociatedinternallaboratoryactivities. The report encompasses the majority of CDCs laboratory activities.RelevantdefinitionsanddescriptionsoflaboratoryactivitiesnotaddressedappearintheExplanationandDefinition of CDCs LaboratoryActivitiessectionthatfollows.

Overview of CDC Laboratories

CDCiscommittedtokeepingAmericasafefromthreatstoitshealth,safety,andsecurity,whetherforeignordomestic.CDCpromoteshealthandqualityoflifedomesticallyandgloballybypreventingandcontrollingdisease,injury,anddisability.Achievingexcellenceinlaboratoryscienceandindeliveringlaboratoryservicesiskey to fulfilling CDCs mission.

CDCs laboratories are integral elements of itspreventionandcontrolprogramsthataddressinfectiousandchronicdiseases,birthdefectsanddevelopmentaldisabilities,andenvironmentalandoccupationalhealth.Theseprogramscannotsucceedwithouttheactionableinformationand

knowledgegeneratedbyCDCs laboratory scientists, manyofwhomarenationallyorinternationallyrecognizedaspreeminentexpertsintheirfields.

Thanksinparttothelaboratoriesitoperates,CDChasbeenableto

identifyandtakeactiontoaddressnewdiseasethreats(e.g.,theinfluenzastrainthateruptedintothe2009pandemicinfluenzaA[H1N1]andthenovelvirusthattriggeredsevereacuterespiratorysyndrome[SARS]in2003);

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tracktheemergenceofdrugresistantinfectionsanddevelopnewwaystocounterthesethreats;

confirmthesourcesoffoodbornediseaseoutbreaks(e.g.,thoseassociatedwithcantaloupesin2011andeggsin2010),andadviseindustry,theFoodandDrugAdministration(FDA),

andstatesoncorrectiveactions;

serveasWorldHealthOrganization(WHO)CollaboratingCenters(e.g.,forinfluenza,malaria,tularemia,rotavirus,rabies,poxviruses,andviralhemorrhagicfevers)andparticipateinglobalhealthnetworks;

addressprioritiesinhumanimmunodeficiencyvirus(HIV)diagnosis,prevention,andtreatmenttoreduceHIVrelatedillnessanddeathintheUnitedStatesandinternationally;

determineandaddressthecausesofflareupsofvaccinepreventablediseases(e.g.,thespikeinU.S.measlescasesthatappearedinearly2011after15yearsoflowincidence);

examinesuspicioussubstancestodetermineiftheyposeanythreatsandreportfindingssothatappropriateactionstoprotectthepubliccanbetaken(e.g.,the2001anthraxattacks);

testforpotentialhealthdangersstemmingfromtoxicreleases(e.g.,theDeepwaterHorizonoilspillin2010)andprovidescientificallybasedinformationontheirhealthimplicationstothepublicandtodecisionmakers;

collectobjectivedataforuseindesigninginterventionstopreventandcontroldiseaseanddisability(e.g.,throughtheNationalHealthandNutritionExaminationSurvey[NHANES],theonlyU.S.collectionofbiologicsamplesrelatedtonutritionandhealthona

populationwidebasis);

ensureaccuracyofthetestsstatepublichealthlaboratoriesusetoscreennewbornsintheUnitedStatesformedicalconditionsthatcanleadtolifelongdisabilityordeathifnotdetected;and

developanddisseminateauthoritativepublichealthguidelines(e.g.,fortherespiratorsthatprotectmillionsofhealthcareprofessionals,firstresponders,andindustrialworkersfromairbornevirusesandpollutants).

CDCs laboratories aredistinctfromthemanycommercial,hospital,andphysicianoffice

laboratoriesthatperformtestsrelatedtoindividualpatients.CDChastheuniqueabilitytodevelopandperformhighlysophisticated,cuttingedgetestsimportantformonitoringpopulationhealthandtoserveasthelastresortreferencelaboratory,abletoconfirmorruleoutanewvirusorotherpathogens.Someofthisworkisperformedinhighcontainmentlaboratorieswherescientistsworkwithespeciallydangerousinfectiousandchemicalagents.CDCisalsouniquelycapableofestablishingdefinitivestandardsforlaboratorytesting,includingtestsusedinbothpublichealthandclinicalsettings.Inaddition,CDCslaboratoryscientistsfocusmultiple,

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complementarydisciplinesonsolvingcomplexpublichealthproblems.Arecentexampleistheefforttodevelopandvalidatenewmassspectrometrytestmethodsfordetectinghumanexposuretobotulinumtoxin a result of collaboration between CDCs EnvironmentalHealthLaboratory,whichspecializesinassessingchemicalexposures,andFoodborneDiseaseLaboratory,whichspecializesinbiologictesting.Thenewtestmethodswillsupportresponsesto

biologicorchemicalterroristattacksandfoodborneillnessoutbreaks,aswellasinvestigationsofpotentiallycontaminatedcosmeticproducts.

CDClaboratoryscientistsworkcloselywiththeirprogrammaticpartnerswithinCDC,includingepidemiologistsandothercolleaguesacrossawidespectrumofdisciplines.Inturn,CDCreliesontheworkitslaboratoryscientistsconductacrossmultipledomainsthatarecrucialtotheagencys priorities and to its vital contribution to national security.Examplesincludethefollowing:

Surveillance Testingtotracktrendsindiseasesandotherhealththreats,monitornationalhealthstatus,andevaluatetheeffectivenessofvaccines,treatments,infectioncontrol

programs,andotherpublichealthandmedicalstrategies.

Emergency Response Testingforrapididentificationofthecausesofdiseaseoutbreaksfromnaturalorhumanmadebiologicthreats(BT),chemicalthreats(CT),orradiologicthreats(RT)toensurerationaltreatmentdecisionsaremade.

Standards Setting Establishingtechnicalandscientificstandardsforpublichealthandclinicallaboratorytests(e.g.,forthemillionsofcholesteroltestsperformedannuallyinournations hospitals and clinical laboratories,andforantimicrobialsusceptibilitytesting).

Quality Assurance Developing,promoting,andevaluatingstandardsandguidelinesfor

publichealthandclinicallaboratories,andprovidingtechnicalassistanceandreliablereferencematerialstosupporttestvalidation,qualitycontrol,andproficiencytesting.

New Product Development Applyingresearchfindingstodevelopnewtypesoftests,newvaccines,andotherproducts,manyofwhicharelicensedtoprivatecompaniestomanufactureandmakeavailablethroughthecommercialmarketplace.

Health System Support Providingscientific,technical,andfinancialassistancetohelpstateandlocalpublichealthagencies,healthcareproviders,nonprofitgroups,federalagencies,andotherpartnersimprovetheirlaboratorypracticesandstrengthentheirlaboratorysystems.

Partnerships

CDCreliesheavilyoncollaborationwithotherfederalagencies,stateandlocalpublichealthdepartments,healthcareorganizations,andotherdomesticandinternationalpartnerstoaccomplishitsmission.The agencyslaboratoryscientistspartnercloselywithpublichealth

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laboratoryprofessionalsandscientistsinotherU.S.DepartmentofHealthandHumanServicesoperatingdivisions,theU.S.DepartmentofHomelandSecurity,theU.S.DepartmentofDefense,theFederalBureauofInvestigation,theU.S.AgencyforInternationalDevelopment(USAID),andtheU.S.DepartmentofAgriculture(USDA),amongotherfederalagencies;WHOandministriesofhealthworldwide;andindustryandnongovernmentalorganizations(e.g.,the

AssociationofPublicHealthLaboratories).

StateandlocalpublichealthlaboratoriesprotecthealthintheirjurisdictionsandpartnercloselywithCDCascriticalpartsofthenations public health laboratory safety net. Among otherservices,stateandlocalpublichealthlaboratoriesperformmanypublichealthreferencetests,confirmingorrulingoutpatientdiagnoses,advisingprovidersonthesignificanceofpatienttestresults,andsimultaneouslyusingtestresultstomonitorcommunityhealthtrends.Ofspecialnotearethecriticalrolestheyplayindetectingtheonsetofthreatsatthefrontlineandinprovidingsurgecapacity,helpingtomanagethehighnumberoftestsrequiredduringpublichealthemergencies(e.g.,the2009influenzaAH1N1pandemic).

CDCprovidescriticalsupporttostateandlocalpublichealthlaboratoriesbydesigning,developing,andtransferringhighqualitytestingpracticestothemandbyprovidingtechnicalconsultation,training,financialassistance,andhighprioritysuppliesnotavailablefromothersources.Inaddition,CDChassponsoredcreationandoperationofnationalnetworksfordiseaseclusterdetectionandinvestigation,rapidcommunication,andtestresultvalidationduringfoodbornediseaseoutbreaks(e.g.,PulseNet)andinresponsetoBTsorCTsorotherpublichealthemergencies(i.e.,theLaboratoryResponseNetwork[LRN]).PulseNetenablesstateandlocalpublichealthagenciestodetectclustersofillnessesinoneormanystatesrapidlybycomparingDNAfingerprintsofbacteriafromillpatientsthroughtheuseofanonlinepatterndatabasemaintainedbyCDC.Thesediseaseclustersoftenrepresentsilentlydevelopingfoodbornediseaseoutbreaksthatcanbecontrolledifdetectedearly.Moreimportantly,PulseNet-detectedoutbreaksprovideindustryandregulatorstheinformationtheyneedtofixproblemsinourfoodsupplythatwouldotherwisegounnoticed.LRNcomprising162laboratories,mostofwhichcanconfirmthedetectionofBTagentsandasubsetofwhichhaveadditionalcapacitytodoCTtestingexpandsandleveragesthecapacityofthepublichealthlaboratorysystemtorespondtopublichealththreatsandemergencies.Anestimated85%oftheU.S.populationliveswithin100milesofanLRNmemberlaboratory,ensuringbroadaccesstotestingduringpublichealthemergencies.Otherfederalagencies(e.g.,theU.S.DepartmentofDefense,theFederalBureauofInvestigation,FDA,USDA,theU.S.DepartmentofEnergy,andtheU.S.EnvironmentalProtectionAgency),collaboratewiththenetworkandcoordinateresponseactivitiesthroughtheIntegratedConsortiumofLaboratoryNetworks.PublichealthlaboratoriesinAustralia,Canada,Mexico,andtheUnitedKingdomalsoparticipateinLRN.

Universityandindustrybasedscientistsandmembersofscientificandprofessionalassociationsalsoare valuable partners for CDCs laboratory scientists. They bring important viewpoints fromrelevantdisciplinesandcontributenewknowledgefromresearchandfrontlineindustryandclinicalexperience. In turn, CDCs laboratory scientists use multiple channels to disseminateinformationtothesepartnersaboutthenewtests,improvedtestingmethods,andlaboratorybestpracticesCDCdevelops.ThesechannelsincludetheelectronicHealthAlertNetworkand

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LaboratoryOutreachCommunicationSystemandCDCs Morbidity and Mortality WeeklyReport,amongothers.Inaddition,CDCmaintainsandcontinuallyexpandsitsinvaluablecollectionsofuniquebiologicspecimensthatCDCscientistsandcolleaguesinuniversitiesandothersettingsuseforresearchintothecausesofdiseaseandfordevelopmentofnewmedicalandpublichealthinterventions.

Explanation and Definition of CDCsLaboratory Activities

Forthepurposesofthisreport,internal laboratory activitiesaredefinedaslaboratoryrelatedactivitiesthatCDCemployeesandcontractorsconductedduringFY2011intheUnitedStates,primarilyatCDCfacilities,andwhichwerefundedbythebudgetactivitiesthatappearintheaccompanyingtable.ThosefacilitiesarelocatedintheAtlanta,Georgia,metropolitanareaandinAnchorage,Alaska;Ft.Collins,Colorado;Cincinnati,Ohio;Pittsburgh,Pennsylvania;SanJuan,PuertoRico;Spokane,Washington;andMorgantown,WestVirginia.

Thisreportaddressestestingandappliedresearchactivities,aswellasselectedscientific,technical,andlaboratorysupportservices.Ingeneral,supportservicesincludeactivitiessuchasoversight and implementation of CDCs policy on dualuseresearchofconcern;managementofCDCs central collection of morethan6millionbiologicspecimensforusebyCDCandextramuralresearchers;laboratorysecurityandworkersafetyprotectionservices;provisionofbioinformaticsandinformationtechnologyservices;andprovisionandmaintenanceofphysicalfacilities.Theyalsoincludeassistanceincomplyingwithfederalregulatorymandates(e.g.,theClinicalLaboratoryImprovementAmendments,diagnosticdeviceregulations,andtheSelectAgentsandToxinsregulations).TheEmergingInfectiousDiseases,PublicHealthScientificServices,andPublicHealthPreparednessandResponsesectionsofthisreportincludeinformationregardinglaboratorysupportservicesfundedfromthesethreeappropriations.

ThisreportalsoaddressesdomesticallybasedCDClaboratoryactivitiesthatsupportexternal

partners,includinglaboratoriesoperatedbyministriesofhealthinothercountries.Supportforexternalpartnersincludesprovisionoflaboratorytechnicalsupportandtraining,programadministration,andcooperativeagreementmanagement.ManyoftheseactivitiesadvanceCDCs globalhealthpriorities.Severalsectionsofthisreport(e.g.,theGlobalHealthsections)includedescriptionsofdomesticCDClaboratoryactivitiesthatsupportoverseasactivities.

Exclusions

TwotypesoflaboratoryrelatedactivitiesthatreceivefundsappropriatedtoCDCdonotappearinthisreport,explainedasfollows:

Domestic Laboratory-Related Activities Conducted by Grantees

ThisreportdoesnotprovideinformationonlaboratoryrelatedactivitiesthatstateandlocalpublichealthdepartmentsorextramuralresearchersconductwithfundingtheyreceivefromCDCthroughcooperativeagreementsorothermechanisms.However,activitiesthatCDCemployeesandcontractorsconductinsupportofthosegrantees(i.e.,managingcooperativeagreements)arereferencedwhereappropriateandasnotedpreviously.

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Global Laboratory Activities CDCsupportsmultiplelaboratorieslocatedinothercountriesandalsohelpstobuildandoperategloballaboratorynetworks(e.g.,theGlobalPolioLaboratoryNetwork,whichsupportsworldwidepoliovirussurveillance).ThisreportdoesnotaddresstheseoverseasactivitiesorthoseofotherCDCgloballaboratorynetworks.However,whereappropriate,itprovidesinformationaboutCDCs domesticallybasedsupportforsuchactivities,

asnotedpreviously.

FY 2011 Funding for CDC Internal Laboratory Activities

TheaccompanyingtableindicatesthatCDCobligated$412,029,029toitsinternallaboratoryactivitiesduringFY2011.Thesefundsderivedfromthreesources,asfollows:

CDCdirectbudgetauthority($336,602,298total);

theU.S.PublicHealthServiceEvaluationFund($39,648,974total);and

thePublicHealthandSocialServicesEmergencyFund($35,777,757total).

Thetable(nextpage)is organized according to the format of CDCsFY2011operatingplan.

CertaininternalCDClaboratoryactivitiesaresupportedbyfundsthatotherfederalagenciestransfertoCDC.Suchactivitiesarenotincludedinthisreport,withtheexceptionofthosesupportedbytheU.S.PublicHealthServiceEvaluationFundandthePublicHealthandSocialServicesEmergencyFund.AlsoexcludedarelaboratoryactivitiessupportedbynoyearfundsappropriatedtoCDCinfiscalyearsbeforeFY2011butobligatedtolaboratoryactivitiesduringFY2011.

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FY 2011 Funding for CDC Internal Laboratory Activities

udget ctivity

Total

Immunization and Respiratcry Diseases

Budget Authority BA) 5,364,537

Public

Health

and

Social Services

Emergenc

y Fund*

35

,777,757

41,142,294

m Y/AIDS, Viral Hepatitis, STD , and

TBPre

vent ion-BA

Domestic m Y/

AIDS

10,792,4

14

Viral Hepatitis 3,304,900

Sexually

Transmitted

Diseases STDs) 4,154,881

Tuberculosis (TB) 4,888,188

23,140,383

Emerging and Zcxmotic Infectious Diseases - BA

Vectorbom

e

Di

s

ease

s

8,970,182

Lyme Disease

3,669,162

Food Safety 6,979,036

Chronic Fatigue Syndrome 3,362,953

Emerging Infectious Diseases 55,335,645

O

ther

(Antimicrobial Resistance

and

Hantavirus/Special Pathogens) 7,963,416

86,280,394

Clrronic

Dis

ease

Pre

ve

ntion and Health Promotion

- BA

6,035,291

Birth

Defects, D

evelop

mental Disabilities, Disability and Health - BA

2,540,629

Environmental

Health

- BA

Environmental Health Lab

ora

t

ory

32,422,706

Health

y

Homes

/Childhood Lead Poisoning 7

81,512

33

,

204,218

Public Health Scientific Services

Budget

Authority 4,992,551

Public Health Service Evaluation 3,752,455

8,745,006

Occupational Safety and

Health

Budget Authority 105,066,718

Publi

c

Health

Service Evaluation

35

,896,519

14 0,963,237

Global

Health

-

BA

Global AIDS Program 9,769, 770

Global ImmlU1ization Program

4,064,530

Global

Diseas

e

Detection and Emergenc

y ResJXlllse

3,718,221

Parasitic Diseases

and

alaria

10

,256,991

27,809,512

Public Health Preparedness and Response - BA

42,168,065

CDC Total 412 ,029,029

BA subtotal 336602,298

Public

Health

Service Evaluation

subto

tal 39,648,974

Public Health and Social Services m r ~ n Fund subtotal 35, 777,757

To s

upport

panderTIlc mfluenza laboratory-related ac

t

Vlues.

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BUDGET ACTIVITY IMMUNIZATION AND RESPIRATORY DISEASES

Nationalvaccineprogramsandpoliciesrelyonafoundationofstrongscience,whichisessentialforvaccinepolicydecisionmakingandforevaluatingvaccinationrecommendationsaftertheyareimplemented.Acomprehensiveimmunizationprogramrequiresnationallevelscientificexpertiseinlaboratorysciencesandservicestomonitorpreventablediseaserates,identifyemergingnewthreats,trackandrespondtooutbreaks,andevaluatevaccineeffectiveness.

CDCeffortshavehelpedreducetheoccurrenceandimpactofmultiplevaccinepreventablediseases,increasedimmunizationcoveragerates,andimprovedvaccinesafetysurveillanceandresearch.Continualchangesininfluenzaandotherrespiratoryvirusesrequirerelentlesstrackingofemergingstrainstoensurevaccinesareeffectiveaswellasmonitoringincreasingimportationofvaccinepreventablediseasesthataffectvulnerablepopulations.

Selected Laboratory Activities in FY 2011

VaccinePreventableDiseases

ForeachannualU.S.birthcohortvaccinatedagainst13diseasesinaccordancewiththescheduleadoptedbyCDC,approximately42,000livesaresaved;20millioncasesofdiseaseareprevented;$13.6billionindirectcostsaresaved;and$68.9billionindirectplusindirect(societal) costs are saved. CDCs Immunization Program aims to prevent vaccinepreventablediseasesbyachievingandmaintaininghighimmunizationrates.Since2009,nationalpolicyrecommendationshavebeeninplaceintheUnitedStatestopreventatotalof17diseasesamongyoungchildren,adolescents,andadults.Thesediseasesincludemeasles,mumps,rubella,varicellaandherpeszoster,rotavirus,humanpapillomavirus(HPV),influenzaandbacterialmeningitis,whoopingcough(pertussis),diphtheria,andothers.

CDClaboratories

provideddataandanalysisonwhichnationalimmunizationpoliciesarebased;

developednewmoleculardiagnosticassaysformeaslesandmumpsandassistedwiththeirimplementationinstateandlocalpublichealthlaboratoriestodetectandcontroloutbreaks;

providedoutbreakassistanceandperformedtestingtoconfirmvaccinepreventablediseaseoccurrence;

diagnosedandanalyzedmeasles,rubella,andcongenitalrubellasyndromecasesintheUnitedStates;

assessedvaccineimpactandchangingepidemiologyfornewvaccineprograms(e.g.,rotavirusandpneumococcalpreventionamongchildrenandmeningococcalvaccineimpactamongadolescents);

assessedeffectivenessanddurationofvaccineprotectionamongindividualsandacrosspopulations;

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monitoredchangesinbacteriaandvirusesthatcancausevaccinestobecomelesseffectiveandidentifiednewstrainsforuseinvaccinedevelopment;

providedevidencebasedvaccineeffectivenessandprogramimpactresultstodemonstratetheneedforaboosterdoseofmeningococcalvaccineamongadolescents;

demonstratedimpactofthechildhoodpneumococcalconjugatevaccineintroducedin2010(theinformationisbeingusedtoformulatenationalpoliciesonpneumococcalvaccineuseamongadultsaswellaspneumoniaandmeningitistreatmentguidelines);and

supporteddevelopmentandlicensureofnewvaccinesthroughcharacterizationofpathogenstrains(e.g.,meningococcus),developmentofstandardantibodytests(e.g.,pneumococcusandmeningococcus),andmonitoringtrendsduringvaccinetrials.

Influenza

Influenzaisacontagiousrespiratoryillnesscausedbyinfluenzaviruses.Itcancausemildto

severeillnessanddeath.During19762006,estimatesoffluassociateddeathsintheUnitedStatesrangefromalowof3,000toahighof49,000annually.Certaingroups(e.g.,olderpersons,youngchildren,andthosewithcertainhealthconditions)areathigherriskforseriousflurelatedcomplications. The CDC Influenza Programs laboratory activities support detection,control,andpreventionofinfluenza.

CDClaboratories

providedyearrounddomesticsurveillanceforinfluenza;

subtypedandcharacterizednovelinfluenzaviruses;

studiedglobalinfluenzatrendsandviruscharacteristics;

identifiedpotentialcandidateinfluenzavaccinevirusstrainsthroughglobalsurveillanceactivities;

usedcuttingedgetechnologiestoengineerinfluenzavaccinecandidatestrains;

providedweeklyelectronicreportsofinfluenzaactivitytohelpdoctors,publichealthofficials,andthegeneralpublicpreventinfluenzas spread;

helpedguidedevelopmentanddeploymentofmedicalcountermeasurestopreventandtreat

personsaffectedbyseasonalandfutureinfluenzapandemics;

servedastheNationalInfluenzaCenterfortheUnitedStatesandasoneoffiveWHOCollaboratingCentersthatreceivedandtestedthousandsofinfluenzavirussamplesfromaroundtheworldtomonitorforemergenceandspreadofnewvariantviruseswithepidemicandpandemicpotential,includinghighlypathogenicinfluenzaA(H5N1)virusesandothersubtypes(e.g.,H2,H7,andH9)thatcirculateinanimalreservoirpopulationsandposeapandemicthreat;

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characterizedover11,000influenzavirusesfromdomesticandinternationalsurveillancepartnerlaboratories;

participatedwithotherWHOCollaboratingCentersandNationalInfluenzaCentersintheyearlyseasonalvaccinevirusselectionprocessfortheSouthernandNorthernHemispheres;

sequencedandconfirmedmultiplenovelinfluenzaviruses,includingH3N2v,whichwasconfirmedin12casesinfivestatesandhasthepotentialtoemergeasacirculatinghumanstrain;

developedavaccinecandidatestrainforH3N2vinfluenzavirusandstartedworkwithmanufacturerstodevelopavaccine,incaselargescaleproductionbecomesnecessary;and

developedandpilotedanewinfluenzariskassessmenttooltoassessthepandemicpotentialofnovelinfluenzaviruses,whichwillhelpprioritizevirologicandepidemiologicstudiesandprovideinformationonwhichselectionofcandidatenovelinfluenzavirusesforpandemicvaccinescanbebased.

BUDGET ACTIVITY HIV/AIDS, VIRAL HEPATITIS, STD, AND TB PREVENTION:

DOMESTIC HIV/AIDS

Despitemajoradvancesinpreventionandtreatment,HIVinfectionremainsasubstantialpublichealthchallenge.CDCestimatesthatapproximately1.2millionpersonsintheUnitedStateswerelivingwithHIVattheendof2008andthatapproximately50,000personsarenewlyinfectedeachyear.

CDCs laboratorieshelpadvancegovernmentwideeffortstoreducetheburdenofHIVandacquiredimmunodeficiencysyndrome(AIDS)intheUnitedStates,asdescribedintheNationalHIV/AIDS Strategy.TheaimsoftheStrategyinclude

reducingnewHIV/AIDSinfections;

increasingaccesstocareandimprovinghealthoutcomesforpersonslivingwithHIV;and

reducingHIVrelatedhealthdisparities.

EarlyidentificationofHIVinfectioncanimproveaccesstolifesavingtreatment,reducefurthertransmission,anddecreasehealthcarecosts.


CDClaboratories

servedasworldwidereferencelaboratoriesfordiagnosisanddrugresistancetestingforHIV/AIDSbyprovidingservicestobothdomesticandinternationalpartners(seetheGlobalAIDSProgramsectionforadditionalactivities);

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conductedstateofthearttestingtoadvanceHIVprevention,surveillance,andtreatment(e.g.,testingtosupportearlydiagnosis[facilitatingreferraltocare,aswellascounselingtohelppreventtransmission],evaluatingdiseaseprognosisandresponsetotherapy,andidentifyingdrugresistantviruses);

helpedstatehealthdepartmentsinvestigatecasesofHIVtransmissionthroughorgantransplantation;

patentedanovelHIVdrugresistancetestthatcanidentifyhiddendrugresistantvirusesinviralsubpopulationswithinindividualpatients,includingpatientswhorespondtoantiretroviraltherapy(developmentofdrugsthatcantargetthesehiddenvirusesmightleadtoacureforHIV);

developedandevaluatedadditionalnovelstrategiesandmethodsforHIVdetection,isolation,andsurveillance(e.g.,strategiesforidentifyingHIVinfectionatearlierstagesofdisease,increasingthenumberofpersonswhoknowtheirinfectionstatusandarereferredforcare,andfacilitatingsimultaneoustestingforinfectionwithHIVandviralhepatitis);

developedrapid,userfriendlyteststhatcanbeusedinthefieldtoidentifyrecentHIV1infectionsanddifferentiatebetweenHIV1andHIV2viruses;

updatedthenationaldiagnosticalgorithmsforHIVtestingandrevisedHIVscreeningguidelinesfororgandonations;

conductedpreclinicalandclinicalresearchonvaccinesandmethodsforpreventingHIVtransmission;

demonstratedthatthedosageofanoralantiviralmedicationneededtopreventHIVinfection

mightbereducedfromthecurrentlyrecommendeddailydosing;

evaluatedthethreattotheU.S.bloodsupplyposedbyhumanherpesvirustype8(HHV8)theetiologicagentofKaposi'ssarcoma,themostcommonAIDSassociatedmalignancyworldwide and transferred HHV8diagnostictechnologytointernationallaboratoriesinAIDSendemicareasofAfrica(alsodevelopedanHHV8assayappropriatefororgandonorscreening);and

conductedresearchstudiestodetermineifanassociationexistsbetweenaretrovirusxenotropicmurineleukemiavirusrelatedvirusandchronicfatiguesyndrome(CFS);nosuchassociationwasidentifiedand,consequently,twopeerreviewedjournalarticlesfromnonCDCinvestigatorswereretracted(seetheEmergingandZoonoticDiseases:Chronic

FatigueSyndromesectionforadditionalactivities).

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VIRAL HEPATITIS

Approximately0.81.4millionpersonsintheUnitedStatesarechronicallyinfectedwithhepatitisBvirus(HBV)and2.73.9millionareinfectedwithhepatitisCvirus(HCV).Manypersonsareunawareoftheirinfection,puttingthematriskforcirrhosisorlivercancerandfortransmittinginfectiontoothers.

CDCslaboratorieshelpadvanceeffortsacrossthegovernmenttoreducetheU.S.burdenofchronicviralhepatitisandassociatedcancers,asdescribedintheU.S.DepartmentofHealthandHumanServicesAction Plan for the Prevention, Care and Treatment of Viral Hepatitis.


CDClaboratories

servedasaworldwidereferencelaboratoryfordiagnosisofhepatitisA,B,C,andE;

assistedU.S.statesandcitiesandVeteransAdministrationmedicalcentersininvestigating23localoutbreaks,includinganoutbreakofHCVinfectionsinanoutpatientclinicinGeorgia,outbreaksofHBVinfectionsinanassistedlivingfacilityandapsychiatriclongtermcarefacilityinVirginia,andoutbreaksofHCVinfectionstransmittedthroughtransplantedorgansandtissuesinKentucky;

conductedstateofthearttestingfordetectionofviralhepatitisantibodiesandantigensandperformedgenomicandproteomicprofilingofhepatitisviruses;

assistedindustryandacademicresearchersaswellashealthcarepartnersbyevaluating

rapidscreeningassaysfordetectionofantibodiestoHCV,

newmethodsfordistinguishingacutefromchronicHCVinfection,

useofmassspectrometrymethodstoimprovedetectionofHCVtransmission,

theefficacyofexistingvaccinesinpreventingHBVinfections,and

candidateHCVstrainsthatmightbeusedtodevelopvaccinesagainstHCV;

conductedappliedresearchonviraltransmissionandpathogenesis,includinganassessment

ofhostgenomicfactorsassociatedwithchronicviralhepatitisinfection;

providedtechnicalassistanceondiseasedetectiontotheU.S.MexicoBorderInfectiousDiseaseSurveillanceprogram;and

conductedsurveillanceforhepatitisEvirusesamonganimalstomonitortheemergenceofnewstrains.

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SEXUALLY TRANSMITTED DISEASES (STDs)

Approximately19millionnewSTDinfectionsoccureachyearintheUnitedStates,approximatelyhalfofwhichareamongyoungpersons(thoseaged1524years).STDsexactatremendouseconomictoll.DirectmedicalcostsassociatedwithSTDsareestimatedtobemorethan$15billionannually.

CDCslaboratoriessupportpublichealtheffortstopreventandreduceSTDsandassociatedmedicalcomplications(e.g.,infertilityresultingfrompelvicinflammatorydiseasecausedbychlamydiaorgonorrhea;adversepregnancyoutcomes,includinginfantdeathsorillnesscausedbyneonatalherpesorcongenitalsyphilis;andcervicalcancercausedbychronicinfectionwithHPV).


CDClaboratories

servedasworldwidereferencelaboratoriesfordiagnosisofchlamydia,gonorrhea,syphilis,herpessimplexvirus,Mycoplasma,chancroid,andHPV;

monitoredemergenceofantimicrobialresistance(AR)insexuallytransmittedpathogensandnotifiedthehealthcareandpublichealthcommunities,asneeded(e.g.,aboutemergingresistancetocephalosporinantibioticsusedtotreatgonorrhea);

providedreferenceservices,diagnosticsupport,andstaffproficiencytrainingtostateandlocalhealthlaboratories,privatelaboratories,andFDA;

developedandvalidateddiagnostictests,includingnewmoleculartests,rapidpointofcaretests,andtestsformolecularmarkersofdrugresistance;

providedexpertconsultationtophysiciansandphysiciangroups,includingnationalmedicalandnursingassociations;

updatedthenationallaboratorytestingguidelinesforsyphilis,gonorrhea,andchlamydia(tobepublishedin2012);and

evaluatedtheimpactoftheHPVvaccinationprogrambyidentifyingHPVtypesincancers,cervicalprecancers,andcervicalspecimenscollectedaspartofNHANES(seethePublicHealthScientificServicessectionforamoredetaileddescriptionofNHANES).

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TUBERCULOSIS (TB)

One third of the worlds population is infected with TB. During2010,approximately9millionpersonsworldwidebecameillwithTBand1.4milliondied.

AlthoughTBisdecliningintheUnitedStatesapproximately11,000caseswerereportedin2010thediseasecontinuestoaffectdisproportionallyracialandethnicminorities,personsinfectedwithHIV,andpersonswhoareforeignborn,includingthosefromIndia,thePhilippines,Vietnam,andMexico.Moreover,emergenceofmultidrugresistantTB(MDRTB)andextensivelydrugresistantTB(XDRTB)ispresentingnewchallengesfortreatmentandcontrol.PreventionofasinglecaseofMDRTBisestimatedtosavemorethan$250,000.

CDCs laboratoriesfocusonadvancingTBeliminationintheUnitedStatesbyreducingTBamongpopulationsathighriskandreducingTBs globalimpact,includingHIVassociatedTB,MDRTB,andXDRTB.


CDClaboratories

servedasworldwidereferencelaboratoriesfordiagnosisandresistancetestingforTB;

managedcooperativeagreementsthatprovidedtechnicalandfinancialsupportforTBdiagnosis,surveillance,anddrugresistancetestingtoall50states,theDistrictofColumbia,selectcities,andeightU.S.territoriesandfreelyassociatedstates;

operatedtheMolecularDetectionofDrugResistanceservice,whichidentifiescasesofMDRTBandXDRTB;theNationalGenotypingProgram,whichprovidesgeneticbacterialfingerprintsofTBcasesreportedintheUnitedStates;andtheNationalGenotypingInformationManagementSystem,whichanalyzeslaboratoryandepidemiologicdatatohelpidentifyTBcasesthatmightbepartofawidespreadormultistateoutbreak;

providedtestevaluationandguidancethatincreaseduseofrapidmoleculartestsbystateandlocalpublichealthlaboratories,which

improvedturnaroundtimesforphysicians(i.e.,thetimetakenforaphysiciantoreceivealaboratoryresult)sothatpatientscanbetreatedmorequickly,and

facilitatedpublichealtheffortstointerruptdiseasetransmissionincommunities;

providedqualityassessmentTBchallengesamplesto40publicandprivatelaboratoriesthroughtheModelPerformanceEvaluationProgram,whichmonitorsandimprovesdrugsusceptibilitytesting;

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providedreferencetestingservicestotheCDCTuberculosisTrialsConsortium,whichincludes20clinicalsites,andconducted

appliedresearchondrugresistanceandhumanandbacterialgenetics,and

operationalresearchtodetermineoptimaldiagnosticmethodsandtestingalgorithmsforuseinhighburdenandresourcelimitedsettings;

contributedtoWHOguidanceonuseofanewtestfordetectingrifamycinresistantTB,whichcanfacilitaterapidisolationandspecializedtreatmentofpatientswithMDRTB;

issuedrecommendationsonuseofanew12doseregimenforTBpreventivetherapythatshortensandsimplifiesthecourseoftreatment;

servedasasupranationalreferencelaboratoryintheSTOPTBPartnershipsGlobalLaboratoryInitiativeTuberculosisNetworkandworkedwithministriesofhealthandWHOtostrengthenTBlaboratorysystemsoverseas,especiallyincountriesthatcontributetothe

burdenofTBintheUnitedStatesandcountriesthatexperienceoutbreaksofMDRTBorXDRTB;and

ledaninternationalworkinggroupthatisdevelopingastrategyandorganizationaldesignforaninternationalprogramofTBlaboratoryaccreditation.

BUDGET ACTIVITY EMERGING AND ZOONOTIC INFECTIOUS DISEASES:

VECTORBORNE DISEASES

CDCsupportsprogramsforpreventionandcontrolofdiseasesspreadbymosquitoes,ticks,fleas,andothervectorsintheUnitedStatesandabroad(e.g.,WestNilevirus,dengue/denguehemorrhagicfever,andJapaneseencephalitis).ThesediseasescausetensofthousandsofillnessesintheUnitedStateseachyearandmillionsofcasesinternationally,andtheyrepresentoneofthemostcriticalemergingthreatstohealthintheUnitedStates.Nohumanvaccinesareavailableforthevastmajorityofthesediseases.

Thesediseasescancauseseriousepidemicsandongoingendemicconditions.Twoexamplesfollow:

Since1999,WestNileencephalitishasbeenthemostsignificantarthropodborneviralillnessintheUnitedStates,causinganestimated1.8millioninfectionsandmorethan12,700severe

illnesses.Outbreaksoftenhavebeenseverelocally,costingmillionsofdollarsinvectorcontrolefforts.

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Dengue,themostimportantmosquitoborneviraldiseaseintheworld,threatensanestimated2.5billionpersonsinmorethan100endemiccountries;100millioninfectionsoccurannually.TheongoingriskfordengueisillustratedbyendemicdiseasetransmissioninsubtropicalareasoftheUnitedStates(e.g.,PuertoRico);sporadicoutbreaksinFlorida,Texas,andHawaii;andthousandsofilltravelerswhoacquiredengueinotherpartsofthe

world.


CDClaboratories

performedprimaryandconfirmatorydiagnostictestingtodeterminetheetiologyofsuspectedandpreviouslyunknownvectorborne(VB)humaninfections;

evaluatedcommerciallyproducedassaysandadvancedthedevelopmentofnewproductsandapproachesforVBdiagnostics both optimization of existing and nextgenerationmethods and development of novel fielddeployable,inexpensivebedsideassays;

advanceddevelopmentandevaluationofinnovative,effectivetoolsforbetterprediction,prevention,andcontrolofVBdiseases;

developed,successfullytested,andcommerciallylicensedinnovativepesticidesderivedfromnaturalproductsandeffectiveagainstmosquitoes,ticks,andothervectorsthatareincreasinglyresistanttoexistingpesticides(thisworkhasbeencoveredinnationalmediaandreceivedCDCInnovationfunding, an intramural seed grant for ideas that address CDCspublichealthpriorities);

conducteduniqueinvestigationsontheimmunology,molecularbiology,andgeneticaspects

ofvirusesandtheirhostsandvectors;

provideddiagnosticlaboratorytesting,referencediagnosticservices,andtrainingtolocal,state,andinternationalhealthlaboratoriesinresponsetooutbreaks,characterizationofunknownspecimens,andparticipationinfieldstudiesforVBinvestigations;

providedtrainingandproficiencytestingforlaboratorypartnerstoimproverecognition,response,andconfidenceinVBassayresults;

developedoneofthefirstcandidatevaccineseffectiveagainstallfourspeciesofdenguevirus;

respondedtodengueoutbreaksinmultiplePacificIslandnationsandinEastAfrica;coordinatedresponsetoyellowfeverinUganda;andrespondedtoadeadlytularemiaoutbreakinLouisiana;and

completedvalidationandregulatorystudiesrequiredforFDA510(k)reviewofthefirstdenguemoleculardiagnostictestforuseintheUnitedStates.

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LYME DISEASE

CDCaddressesthegrowingpublichealththreatintheUnitedStatesposedbyBorreliaburgdorferi,thepathogenthatistransmittedbyIxodes ticksthatcauseLymedisease(LD).LDwasthesixthhighestincidentreportablediseaseintheUnitedStatesin2010,with30,158casesreportedtoCDC.Sincebecomingnationallynotifiablein1991,LDhasbeenincreasingsteadilyintheUnitedStates,bothincasenumbersandingeographicdistribution.

Laboratory activities support CDCs fourpartstrategyforLDprevention:(1)strengthenandrefinenationalsurveillance;(2)identifyandvalidateeffectivepreventionmethodsandapproaches;(3)improveearlyandaccuratediagnosisandtreatment;and(4)leveragecollaborativepotentialwithexternalpartnersandstakeholders.

Tocombatthisgrowingpublichealthproblem,CDClaboratoriesworktodevelopnewpreventiontoolsforpersonsandcommunities,betterdiagnosticteststoreducemisdiagnosis,andnewvaccinecandidatestoreplacetheformerLDvaccineforwhichproductionwasdiscontinued

in2002.

Selected Laboratory Activities in FY2011

CDClaboratories

provideddiagnosticandreferenceservicesforLD;

developedacomprehensiveLDserumpanelforvalidationanduseinFDAlicensingofnewdiagnostictests;

distributedreferencereagentstointernallaboratoriesandexternalacademic,clinical,andpharmaceuticallaboratories;

conductedresearchtotestanovel,foodgradeinsecticide;evaluatedabaitboxwithantibioticbaitplusatopicalpesticideformitesandtickstargetingrodentreservoirsofLD;evaluatedanoral,rodenttargetedvaccine;andtestedacommerciallyavailabledoxycyclinecreamastickbiteprophylaxis;

discoveredanovelLDvaccinetargetforhumans;

furthereddevelopmentofLDdiagnosticteststhataresimpler,moreobjective,moresensitive,andaccurateindetectingearlydisease;

identifiedbiomarkersofactiveLDforpotentialuseinnoveldiagnostics;

initiateddevelopmentofnewtickdiagnosticmethodsthatincludedgenetictestsforstudyingvectortickpopulationsandforquicklydetectingandcharacterizingtickbornepathogenicorganisms;

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managedacooperativeagreementthatfundedtestsandtestingservicesin19statehealthdepartmentsinLDendemicandborderlineendemicareas;

initiatedastudyatoneTickNetsitetodefinethefrequencyofsoutherntickassociatedrashillnessthatmimicsearlyLD;and

launchedanenhancedcommunicationplanandInternetbasedpreventiontoolkitthatincludesinformationregardinglaboratorytestingforLDtoimprovepublicawarenessandknowledge.


FOOD SAFETY

EveryyearintheUnitedStates,anestimated1in6U.S.residentsexperiencesafoodborneillness,128,000arehospitalized,and3,000diefromfoodborneillnesses.Theagentsresponsible

fortheseoutbreaksincludebacteriasuchasEscherichia coliO157,Salmonella, Shigella,Listeria,andCampylobacter;parasitessuchasCryptosporidium,Entamoeba histolytica,Naegleria fowleri, Angiostrongylus cantonensis,andPlasmodium;andvirusessuchasnorovirusandhepatitisA.

Foodrecallshelpstopfoodbornediseaseoutbreaks,therebypreventingadditionalillnesses,hospitalization,anddeaths.PreventingasinglefatalcaseofE. coliO157savesupto$7millionin direct medical costs. The CDC Food Safety Programs laboratory activities support detection,

control,andpreventionoffoodborneillnessoutbreaks.


CDClaboratories

ledandcoordinatedthePulseNetsystemanetworkofpublichealthandfoodregulatoryagencylaboratoriesthatincludes75laboratoriesintheUnitedStatesand82countriesaroundtheworld(PulseNetmemberlaboratoriesperformstandardizedmolecularsubtypingorfingerprintingoffoodbornediseasecausingbacteriaandsubmittheresultstoCDCwheretheinformationisstoredandmadeavailableonlinetootherparticipantsinvolvedinfoodbornediseaseinvestigations,uponrequest,allowingrapidcomparisonoffingerprintstolinkcaseswithinasingleoutbreak);

investigatedoutbreaksoffoodborneillnessandprovidedoutbreakassistancebytesting

suspectedoutbreaksamplesandfacilitatingoutbreakinvestigationsonsite;

ledthepublichealthandfoodsafetysystemsindetecting,investigating,andcontrollingmultistateoutbreaksoffoodborneinfections,including

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listeriosisoutbreakassociatedwithColoradocantaloupes,whichresultedinthedeadliestfoodbornediseaseoutbreakintheUnitedStatesinapproximately90years;

multidrugresistantSalmonellaserotypeHeidelbergoutbreakassociatedwithgroundturkey;

salmonellosisoutbreaklinkedtopapaya;and

threeE. coliO157outbreakslinkedtoromainelettuce,hazelnuts,andbologna;

playedamajorroleintheinvestigationoftheGermanE. coli O104:H4outbreakbyconfirmingU.S.casesandlinkinginternationalcases;

coordinatedtheongoinglaboratoryresponsetothecholeraoutbreakinHaiti,includingtestingofhumanandenvironmentalsamplesandthetrainingofHaitiansinlaboratorymethods;

ledandcoordinatedCaliciNetanelectronicnorovirusoutbreaksurveillancenetworkthatallowsparticipantstocomparefingerprintsfromnorovirusoutbreaks,oftenoccurringoncruiseships,thathaveacommonsource,allowingforrapidcomparisonoffingerprintstolinkcaseswithinasingleoutbreak;

improvedcapacityatthestateandlocallevelsinconductingsurveillanceforfoodbornediseasesandindetecting,investigating,controlling,andreportingoutbreaks;

trainedstateandlocallaboratorypersonneltoassistinfoodborneoutbreakinvestigations;

providedsurgecapacitytestingforstatehealthdepartmentslackingthelaboratorycapacitycrucialforrapidfoodborneoutbreakinvestigationandmonitoring;

providedworldwidereferencelaboratorysupporttoaddressdiagnostictestingforhepatitisA;

developedandimprovedteststodetectandidentifyfoodbornediseasecausingagents(e.g.,SalmonellamolecularsubtypingandE. coli genotypingtestmethods);and

provideddataandanalysistoFDAandUSDAonwhichtobasefoodsafetyactionandpolicythatledtorecallsofgroundturkey,groundbeef,cantaloupes,importedpapayas,andothercontaminatedfoods.

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CHRONIC FATIGUE SYNDROME

CFSisestimatedtoaffect14millionU.S.residents.Theillnessislonglastinganddebilitating,withanegativeeffectonhealthandqualityoflifesimilartoheartdisease,multiplesclerosis,cancer,andAIDS.IntheUnitedStates,therelatedannuallossinproductivityisworthanestimated$9billion,withadditionaldirectmedicalcosts.

CDCsupportsanintramuralmultidisciplinaryprogramthatobtainsandanalyzesbaselineinformationthatwillaiddevelopmentofinterventionsforCFSandwillimprovemeasurementofclinicaloutcomes.LaboratoryactivitiesaredirectedatimprovingCFSdiagnosisandattemptingtoidentifygroupsresponsivetospecifictherapies.Theseactivitiescomplementclinicalresearchinitiativesthatfocusonthecauses,consequences,andtreatmentofCFSandrelateddiseases.


CDClaboratories

maintainedthecollection,processing,andarchivingofserum,plasma,saliva,wholebloodDNA,andRNAsamplesfromCDCstudiestoformabiorepositorylinkedtoclinicalandepidemiologicdatafordiscoveryandvalidationofbiomarkersforCFS(materialshavealreadybeenusedforcollaborativeprojectsinvolvingxenotropicmurineleukemiavirusrelatedvirus,metagenomicsforunknownpathogens,andforsalivarybiomarkerdiscovery);

conductedmolecularanalyses(e.g.,geneexpressionprofiling)andevaluatedmarkersofinflammationinbloodsamplesfromcasecontrolstudiesofstressresponseasanapproachtounderstandingthepathophysiologyofCFSandtoidentifyingCFSsubgroupswithtargetsfortherapeuticintervention;

analyzedfunctionalmagneticresonanceimagingcasecontroldatatoinvestigatethehypothesisthatfatigueinCFScorrelateswithalterationsinthebrain;

initiatedstudiestoevaluatehumanherpesvirus6inCFSandtoidentifybiomarkersoffatigue;and

continuedeffortstodiscoverpotentialbiomarkersandtheunderlyingpathophysiologyofCFStovalidatetheimportanceoftheillnessandtoprovideanimpetusfornewtherapeuticstrategies.


EMERGING INFECTIOUS DISEASES

Therangeofpathogenicorganismsandinfectiousdiseasescoveredbythisbudgetactivityisbroadandincludesviral,bacterial,fungal,andparasiticagents.The goals of CDCs emerginginfectiousdiseaseactivitiesaretobuildstateandlocalpublichealthlaboratorycapacitythroughout the United States and to strengthen CDCs core infectious diseaselaboratories.

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Inadditiontotheseactivities,theEmergingInfectiousDiseasesfundinglinealsoprovidescross-cuttinglaboratoryservicesessentialtotheoperationofallCDCinfectiousdiseaseslaboratories.Theselaboratorieshavemanyfunctions,includingbutnotlimitedto

referenceanddiagnostictesting,technicalassistance,consultation,andtrainingforstate,local,tribal,andotherpartnersworldwide;

testinginsupportofnumeroussurveillanceprograms;

testinginsupportofoutbreakresponseinvestigations;

identificationandcharacterizationofnovel,unusualoratypicalpathogens;

development,evaluation,anddeploymentofdiagnostictestsandreagents;

supportforvaccineevaluationtrials;and

provisionofproficiencytestingprogramsforotherlaboratories.


CDClaboratories

providedworldwidereferencelaboratorysupporttoaddress

healthcareassociatedinfections,including

investigatingandrespondingtoemerginginfections,adverseevents,anddisease

outbreaksassociatedwithhealthcaredeliveryinallsettings,includinghealthcareassociatedinfections,whichaloneresultinapproximately100,000deathsandcostinexcessofseveralbilliondollarsannually;

improvingdetectionandcharacterizationofhealthcareassociatedpathogens(e.g.,Clostridium difficileandmethicillinresistantStaphylococcus aureus[MRSA]);

detectingnovelandemergingantimicrobialresistanceinhealthcareassociatedbacteria;and

studyingtheimportanceofhealthcareassociateddiseasepathogensinbiofilms(e.g.,

onmedicaldevices);

highconsequencepathogens,includinganthrax,melioidosis,glanders,Ebolaand

Marburghemorrhagicfevers,rabies,monkeypox,smallpox,andbrucellosis,including

usingmoleculartechniquestocharacterizehighconsequencebacteriainclinicalspecimensreferredtoCDCbystateandlocalpublichealthdepartments;

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servingasWHOCollaboratingCentersforviralhemorrhagicfevers,forpoxviruses,andforreferenceandresearchonrabies;

servingasaninternationallaboratoryoftheWorldOrganizationforAnimalHealth,providingdiagnosticreferencetestingforhumanpathogensthatarecarriedby

animals;

identifyingandcharacterizingpotentialmoleculartargetsfortreatingandpreventinginfectionswithhighconsequenceviruses;

expandingtherangeofdiagnosticcapacitybyimprovingmolecularandserologicalassaystohighconsequenceviruses;and

providingongoingtrainingandmonitoringofpartnernationsonlaboratoryqualityimprovement,competency,andstafftraininginaccordwithDefenseThreatReductionAgencyguidelinesandgoals.

respiratoryandentericdiseases(e.g.,Legionella,GroupAandBstreptococcus,mycoplasma,respiratorysyncytialvirus,adenovirus,coronaviruses[SARS],androtavirus),including

o servingasaworldwidereferencelaboratoryandtrainingresourcefordiagnostictestingandantimicrobialsusceptibilitytesting;

o developingnewdiagnostictests,includinganovelassaythatcanbeusedduringanoutbreaktotestsimultaneouslyfor21differentrespiratorypathogens;

o conductingsurveillancestudiestodeterminetheburdenofrespiratorydiseaseinthe

UnitedStates;and

o supportingtheglobalintroductionofnewvaccinesagainstpneumococcalpneumoniaandrotavirus(e.g.,byprovidingreferenceservicesformeasuringprotectiveantibodyresponsestovaccination);

waterborneandenvironmentalpathogens,including

o identifyingpathogenicfungianddetectingantifungalresistance;

o respondingtodiseaseoutbreaksassociatedwithenvironmentaltransmission(e.g.,throughdrinkingwater)andusingmolecularsubtypingtomatchpatientand

environmentalisolates;

o developingandimplementingenvironmentalmicrobiologytechniquesfordetecting,recovering,andinactivatinginfectiouspathogens;and

o providingpublichealthandhospitallaboratorystafftrainingonmoldidentification;

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meningitisprevention,includingsupportingthedevelopmentandintroductionofanewmeningitisvaccineinAfricancountriesthatexperiencemeningitisepidemicsandleadingdevelopmentofthesecondeditionoftheWHOmanual,Laboratory Methods forDiagnosis of Meningitis caused by Neisseria meningitidis, Streptococcus pneumoniae,and Haemophilus influenzae,aglobalresourcefordetection,isolation,and

characterizationofinvasivebacterialvaccinepreventablediseaseagents;

viralhepatitisandSTDs,including

o diagnostictestingforacuteandchronichepatitisBandC;

o establishingapathogendiscoveryprogramtoinvestigatenonAEviralhepatitis;

o serologictestingforHPV;and

o evaluationoftheimpactofHPVvaccination;

laboratorysupportforfieldinvestigationsofRockyMountainspottedfeverandotherrickettsialdiseases;

providedexpertisetostrengthensurveillanceandappliedresearchprogramstoimprovedetectionandpreventionofnewandemerginginfectiousdiseasethreats,includingsupportfor

developmentofpathogendiscoverytechniquestoidentifynewandemerginglyssaviruses(thevirusesthatcauserabies);

identificationofsuitabletargetsfordevelopmentofmedicalcountermeasuresforviral

hemorrhagicfevers(i.e.,highconsequenceviruses);

developmentofintegratedecologicandepidemiologicstudiesformonkeypoxandotherorthopoxvirusdiseasesintheUnitedStatesandglobally,andimproveddiagnosticcapabilitiesfororthopoxvirusdiseaseworldwide(thesestudiesfocusonhumandisease,monkeypoxdiseaseecology,anddiseasetransmissiondynamicsandprovideevidencefordiseasecontrolefforts,includingtheuseofvaccine);

developedandenhancedcriticalinfrastructureatCDC,including

highcontainmentlaboratories(biosafetylevel3and4)requiredforworkwithknownhighconsequencepathogens(e.g.,anthrax,melioidosis,glanders,EbolaandMarburg

hemorrhagicfevers,rabies,andbrucellosis),andcriticalintherapididentificationofnewlyemergingpathogensassociatedwithhighfatalitydiseaseoutbreaks;

apathologylaboratoryunitthatprovidesstateoftheartdiagnosticevaluationoftissuespecimenstohelpidentifypreviouslyunrecognizedornewinfectiousdiseases(e.g.,H1N1pandemicflu,SARS,andhantaviruspulmonarysyndrome);

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anenvironmentalmicrobiologylaboratoryactivitythatdevelopsandimplementsdiagnosticanddisinfectiontechniquestoenhancefoodandwatersafety;

afieldlaboratoryinAlaskawithadiverseportfolioofactivitiesthatsupportssurveillance,studiesinantimicrobialresistance,vaccineevaluations,outbreakresponse,appliedlaboratoryresearch,andpreparednessactivities;and

abiotechnologycorelaboratorythatperformshighthroughput,nextgenerationsequencingofbacterial,viral,andfungalgenomes;associatedgenomicassembly;andadvancedbioinformaticsforinfectious,andimportantly,outbreakandunknownpathogenidentification;proteomicanalysesofthefunctions,structures,andinteractionsofproteins,primarilybymassspectrometryandproteinsequencing;chemicalsynthesisofcomplexoligonucleotidesandpeptidescriticalformoleculartechnologiesusedbyCDClaboratoriesandLRN;aswellasevaluatesanddevelopsnew,cuttingedgetechnologies(thesefunctionsandtheexpertisethatsupportsthemcontinuetoprovidethedataandtheknowledgeneededbyCDCscientistsandphysiciansrapidly,particularlyduringemergencies,tokeeptheagencyattheforefrontofpublichealthinanexpandingand

evolvingworld);

providedlaboratoryinfrastructureservicestoallCDCinfectiousdiseaselaboratories,including

developinganinfectiousdiseaselaboratorydatabaseacomprehensiveandcross-linkedsourceofinformationregardingCDClaboratoriesforstakeholdersandleadershipandtoaidinmeetinganticipatedFDArequirementsforlaboratorydevelopedtests;

supportinguniforminformationmanagementsystemsforinfectiousdiseaselaboratoriesthatenhancecapacityfortracking,reporting,andanalyzingsamplesreceivedfortesting,

surveillance,andoutbreakinvestigations,aswellasprovidingenterprisecapacityforinteroperability(i.e.,datasharing)throughtechnologicadvances,sharedresources,andstrategicalignmentwithexternalpartners;

enhancinga quality management system across CDCs infectious diseases laboratories tostrengthenregulatorycomplianceandadherencetoqualitystandardsfortheselaboratories;

supportingcuttingedgepublichealthbioinformaticsthroughanewcentralizedbioinformaticscoreconsistingofhighlyskilledbioinformaticsscientistswhocollaboratewithCDCprogramscientiststofacilitatefasterpathogenidentification,developmentof

betterdiagnostics,andimprovedanalysisoflaboratorydataforepidemiologicsurveillanceandoutbreakinvestigations;

purchasinganddistributinglaboratorysuppliesandpersonalprotectiveequipment;

producing,managing,andshippingbiologicproducts,diagnostickits,cellcultures,andhighqualityspecializedreagents;

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providinganimalcareservices(maintainedatmultiplelaboratorysites),withongoingveterinarycare,guidance,andoversighttoensurethewelfareoflaboratoryanimals(uniqueservicesthatincludemaintenanceofinsectandtickcoloniesforworkwithVBpathogens[e.g.,dengueandLD]);

managingspecimens(includingtriage,processing,anddistribution)andmaintainingaserumbankusedinstudiesofdifferentpathogens;

decontaminatingbiologicwaste,monitoringautoclaves,andmaintaininglaboratorywatersystems;and

providingtheLaboratoryOutreachCommunicationSystemforCDC'sEmergencyOperationsCenterandurgentcommunicationsduringresponseeventstopublichealthlaboratoriesandthe25largestassociationsforlaboratoryprofessionals.

BUDGET ACTIVITY EMERGING AND ZOONOTIC INFECTIOUS DISEASES:OTHER

ThisbudgetactivityprovidesfundingforactivitiesrelatedtocontrollingandpreventingARandfordetectingandcontrollingdiseasesforrecognizedandemerginghighconsequencethreatsknownasspecialpathogens.

AntimicrobialResistance

ARisoneoftheworlds most pressing public health threats and is increasing in scope.Infectionswithresistantbacteriahavebecomemorecommoninhealthcareandcommunity

settings.Patientsinfectedwithdrug-resistantmicrobesaremorelikelytorequirehospitalization,remaininthehospitallonger,andhaveapoorprognosis.Ina2008studyofhospitalacquiredantimicrobialresistantinfections,themedicalcostsattributabletoARrangedfrom$18,588to$29,069perpatient;hospitalstayswereextendedby6.412.7days;andthemortalityattributabletoARwas6.5%.Usingthemostconservativeestimates,thetotalcostoftheresistantinfectionswas$13.35milliondollarsforthe188patientsinthatstudyalone.

Ineffortstoidentify,control,andpreventnewAR,CDClaboratoriessetanultimatestandardforlaboratorytestingforstatehealthdepartmentsandhospitallaboratories,CDCsurveillanceandoutbreakcontrol,andanalysisofARtransmissionandriskfactors.


CDClaboratories

providedgoldstandardtestingservicestostatehealthdepartments,clinicaldiagnosticlaboratories,andacademicresearchersandcollectedandmaintainedarepositoryofARisolates;

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supportedCDCsurveillancesystemsbytestingorganismsofpublichealthimportance,includingStreptococcus pneumoniae,GroupAandBstreptococcus,Neisseria meningitidis,MRSA,Haemophilus influenzae,Neisseria gonorrhoeae,Helicobacter pylori,andCandida;

monitoredresistanceratesandinformed,guided,andevaluatedpreventionefforts;

providedoutbreakresponseandtechnicalassistancetostatehealthdepartments(e.g.,collaboratedwithsevenstatehealthdepartmentsandPuertoRicotostopoutbreaksofcarbapenemresistantEnterobacteriaceae,andalsoprovidedsusceptibilitytestingforstateandhospitallaboratories);

testedmorethan5,000samplesofmicrobes,includingSalmonella, Shigella, Campylobacter,E. coli,andVibrio,todocumenttheemerginggeneticmechanismsofresistancetoantimicrobialdrugs;

conductedstraintypingandadditionalmolecularcharacterizationofmultipleARpathogens,includingcarbapenemresistantEnterobacteriaceae,MRSA,C. difficile,andmultidrug-

resistantAcinetobacterspecies;

detectedemergenceofantibioticresistantN. gonorrhoeaeanddevelopedmolecularassaysfordetectingcephalosporinresistantN. gonorrhoeaeintheUnitedStates;

usedcultureandmoleculartechniquestodetectandidentifymechanismsofARforallrespiratoryandvaccinepreventablebacterialdiseases,includingS. pneumoniae,N.meningitidis,andGroupAandBstreptococci;

developednewassaysforsurveillanceofresistanthepatitisCstrainsbypredictingresistancetocombinedinterferon/ribavirintherapyamongpatientschronicallyinfectedwithhepatitisCvirus;and

detectedtheemergenceofastrainofantibioticresistantpneumococcusnotcoveredbythePCV7pneumococcalvaccinethatwasrecommendedbytheAdvisoryCommitteeonImmunizationPractices(ACIP)in2000(thishelpedguidetheinclusionofthisstraininthenewpneumococcalvaccine,PCV13,whichwasrecommendedbyACIPin2010).

Hantavirus/SpecialPathogens

Hantaviruspulmonarysyndromeisasevere,sometimesfatal,respiratorydiseaseamonghumanscausedbyinfectionwithahantavirus.CDCprovidescontinuingsurveillanceandepidemiologicstudiesofhantavirusesintheUnitedStatesandglobally.CDCalsoprovidesreagents,technicaladvice,responseteams,andepidemiologicinvestigationstoimprovediagnosticandreagentcapabilityforhantavirusesandrelatedhemorrhagicfeverviruses.Throughitslaboratorywork,CDChasdevelopedmoresensitiveassaysfordetectionofhantavirusesandemerginghemorrhagicfeverviruses,andforevidenceoftheirinfectionamonghumansandanimalhosts,thatwillenhancetheabilitytorespondtooutbreaksofthesediseasesdomesticallyandglobally.

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CDClaboratories

providedlaboratorysupporttoallstatehealthdepartmentsforhantaviruspulmonarysyndromediagnosticsandconsultationsregardingcasemanagementandsurveillance;

providedconsultationsonhantavirussmallanimalreservoirpopulationsinNorthandSouthAmerica;

conductedbasicresearchtounderstandfurtherthenaturalhistoryandpathogenicityofhantavirusesforimproveddiagnosticsandvaccinedevelopment;

completedsuccessfulvaccinetrialsofaliveattenuatedRiftValleyfeverrecombinantvirusforuseamonglivestock;and

discoveredanovelphlebovirusassociatedwithtwoMissouricasesofseverefebrileillness

withthrombocytopenia.

BUDGET ACTIVITY CHRONIC DISEASE PREVENTION AND HEALTH

PROMOTION

ChronicdiseasesaretheleadingcauseofpreventabledeathintheUnitedStates.PreventionandcontrolofchronicdiseasesareamongCDCs highest priorities.Annually,U.S.residentssuffermorethan2millionheartattacksandstrokes.Anestimated443,000personsdieprematurelyfromsmokingorexposuretosecondhandsmoke.Cigarettesmokingaccountsformorethan$96billionayearinhealthcarerelatedcostsand$97billionayearinlostproductivity.Deficienciesinmicronutrients(e.g.,iron,iodine,vitaminA,folate,andzinc)affectathirdoftheworld'spopulation.

CDCs related laboratory activities center on developing and applying accurate, highqualitymethodsto(1)improvedetection,diagnosis,treatment,andpreventionofcardiovasculardisease;(2)reduceindividualandpopulationexposuretoaddictiveandtoxicsubstancesintobaccoproducts;and(3)improvenutritionthroughreductionsinmicronutrientdeficiencies.


LipidStandardizationProgramandReferenceLipidTesting

CDClaboratories

developedandmaintainedhighlyaccurateandprecisemethods,includingtwonewmassspectrometryreferencemethods,tomeasuretotalcholesterol,highdensitylipoprotein(HDL)cholesterol,lowdensitylipoprotein(LDL)cholesterol,andtriglycerides;

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operatedaninternationallyrecognizedreferencelaboratorytocalibrateandmonitoraccurately,overtime,cholesterolandlipidmeasurementsusedinpatientcare,publichealth,andresearch;

servedastheonlyU.S.laboratorythatprovidestechnicalassistanceoncholesterolandlipidassessmentthroughreferencemeasurements,training,andprofessionaleducationactivities;

conductedresearchtoidentifyandbetteraddressproblemswithcurrentcholesterolandlipidmeasurements;

providedqualitycontrolmaterialsto84laboratories,including43research(academic)laboratories,38commerciallaboratoriesperformingpatientcaretestingandclinicaltrials,andthreeassaymanufacturerstoensureaccuracyoflipidmeasurementforongoingU.S.andinternationalstudiesofcardiovasculardisease;and

assignedreferencevaluestoproficiencytestingsurveymaterialsusedinassessingtheperformanceofpatientcare,publichealth,andresearchtests(incollaborationwiththe

CollegeofAmericanPathologists).

TobaccoTesting

CDClaboratories

maintainedtheonlyfederallaboratorythatmeasuresaddictiveandtoxicsubstancesintobaccoproductsandsmoke,aswellasintheurineandbloodofpersonswhousetobaccoorareexposedtosecondhandsmoke;

studiedtheeffectsofchemicaladditives,constituents,anddesignonthetoxicityandaddictivenessoftobaccoproducts;

documentedtheimpactthatdifferenttypesofcigarettesandsmokingstyleshaveonexposuretocarcinogenictobaccospecificnitrosamines(TSNAs)andusedtheselaboratoryfindingstoshapefutureCDCNHANESsurveys,whichwilltrackcigarettetypesandsmokingbehaviorstomonitorhowchangesincigarettecompositionaffecthumanexposure(seethePublicHealthScientificServicessectionforamoredetaileddescriptionofNHANES);

assessed U.S. residents exposure to the harmful chemical constituents oftobaccosmoke,includingmeasuringahighlyspecificbiomarkerofthemostcarcinogenicTSNA(thefirstassessmentofexposuretotobaccocarcinogensamongtheU.S.population)andserumcotinine,amarkerofnicotineandsecondhandsmokeexposure,therebydeterminingthat

nonsmokersexposuretotobaccocarcinogensincreaseswiththeirexposuretosecondhandsmoke;

collaboratedinhealthstudiesexaminingtheassociationofsecondhandsmokeexposurewithcancer,asthma,suddeninfantdeath,birthdefects,andotherdiseases;

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demonstratedthatrollyourowncigarettesdeliverasmuchasormoremainstreamsmokeasmanufactured cigarettes, potentially increasing a smokers exposure to toxic and addictivechemicals;

collaboratedwithFDAs southeasternregionallaboratorytoestablishstandardmethodstomeasuretobaccoproductconstituentsand to enhance FDA laboratories capability to conducttestsinsupportofregulatorystandards;and

supportedgloballaboratorycapacitytoanalyzeaddictiveandtoxicsubstancesintobaccothroughshareddevelopmentoftestingmethodsandtestvalidation(incollaborationwiththeWorld Health Organizations Tobacco Laboratory Network).

QualityAssuranceandTrainingforMicronutrientTesting

CDClaboratories

improvedlaboratorymeasurementstodetectmicronutrientdeficienciessothatnational

nutritionsurveysindevelopingcountriescanefficientlyandreliablyassessnutritionalstatus;and

providedfulllaboratorysupport,includingtechnicalassistance,incountryplanningandtraining,externalqualityassessment,andtechnologytransfertoensureaccurateassessmentofnutritionalstatusinnationalnutritionsurveysintheDemocraticRepublicofCongo,theDominicanRepublic,Iraq,Kenya,Kyrgyzstan,andMalawi.

BUDGET ACTIVITY BIRTH DEFECTS, DEVELOPMENTAL DISABILITIES,

DISABILITY, AND HEALTH

Birthdefectsandblooddisordersplaceaconsiderableburdenonpersons,families,andsociety.Approximately1in33babies(orabout130,000annually)isbornwithabirthdefect.Birthdefectsaccountformorethan20%ofinfantdeathsandresultinmorethan$2.6billionannuallyinhospitalcosts.NonmalignantblooddisordersaffectmillionsofU.S.residentseachyear.Directhealthcarecostsforhemophiliaaloneexceed$1billionperyearandmightapproach$3$4billionifcomplicationsareconsidered.

CDCs internal laboratory activities to address birth defects and blood disorders focus on(1)preventingandreducingtheadverseconsequencesofbirthdefectsbyconductingstudiestoidentifygeneticfactorsthatcontributetothecausesofthesecomplexdiseasesand(2)preventing

deathanddisabilitybyreducingthecomplicationsassociatedwithblooddisorders.

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CDClaboratories

servedasthecentrallaboratoryfortheNationalBirthDefectsPreventionStudy(NBDPS),

thelargestpopulationbasedcasecontrolstudyintheUnitedStatesthatcollectsgeneticsamplesandinformationregardingenvironmentalexposures;incollaborationwitheightgrantees,

testedthequalityofmorethan5,500biologicspecimenscollectedatNBDPSsites;

developed,validated,andperformedgenetictestsforresearchstudiesonselectedbirthdefects;

investigatedandappliedoptimalmethodsforDNAcollection,processing,andqualityassessmentandprovidedguidanceonthelongtermstorageofbiologicspecimens;

providedqualityassurancematerialsandtechnicalassistancetoensurethatcollaboratingNBDPSlaboratoriesperformhighlyaccuratemeasurements;

performedpilotprojectstoevaluatenewtechnologiesforthecollection,processing,genotyping,andstorageofbiologicspecimens;and

evaluatedcollectionmethodsandprovidedguidancetoincreasetheeffectivenessofNBDPSsampleuse;

monitoredforinfectiousagentsintheU.S.bloodsupplytopreventthetransmissionofinfectiousdiseasestopersonsundergoingtreatmentforbleedingdisordersandthalassemia(theonlylaboratoryintheworldthatconductssuchactiveinfectiousdiseasesurveillance);

monitoredandadaptednewtechnologiesforsurveillanceofbloodproducts;

performedgeneticandotherrelatedresearchoncoagulationinhibitor(antibody)formation,aseriouscomplicationamonghemophiliapatients;

compiledandmaintainedanationaldatabaseofgeneticinformationtohelpprovidersdiagnoseandpreventdiseasecomplicationsassociatedwithhemophiliaandcoagulationinhibitors;

maintainedthelargestcollectionintheworldofDNAsamplesfrompersonsofAfrican

descentintheUnitedStateswhohavehadavenousthrombosisevent(acriticalresourcefordefiningriskfactorsamongthispopulation);and

performedABOBloodGrouptypetestingduringthe2011Haiticholeraoutbreaktoassesstheseverityofdisease.

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BUDGET ACTIVITY ENVIRONMENTAL HEALTH

Public health action to protect the nations health includes promoting a healthy environment andpreventingprematuredeath,avoidableillness,anddisabilitycausedbynoninfectious,nonoccupational,environmental,andrelatedfactors.CDCs EnvironmentalHealthLaboratoryprovidesuniquelaboratorysciencetoimprovedetection,diagnosis,treatment,andpreventionof(1)diseasesthatresultfromexposuretoenvironmentalchemicals,(2)treatablecongenitaldisordersamongnewborns,and(3)nutritionrelateddiseasesandselectedotherdiseasesrequiringadvancedlaboratorymeasurementforaccuratediagnosis.

Environmental Health Laboratory


BiomonitoringofChemicalExposures

IntheUnitedStatesandinternationally,personscomeintocontactwiththousandsofchemical

substancesintheenvironment,bothnaturallyoccurringandmanufactured.TheEnvironmentalHealthLaboratoryconductsbiomonitoringthedirectmeasurementofenvironmentalchemicals,ortheirproducts,inhumanbloodandurinetoassesspopulationandindividualexposuretoenvironmentalchemicals.

CDClaboratories

conducted the nations only comprehensive assessment of U.S. residents exposuretomorethan300chemicalsintheenvironmentthroughbiomonitoringofpersonswhoparticipateintheongoingNHANESsurvey(seethePublicHealthScientificServicessectionforamoredetaileddescriptionofNHANES);

updatedtheFourth National Report on Human Exposure to Environmental Chemicalstoincludenewbiomonitoringresultsfor66environmentalchemicals,includingcotinine,bisphenolA,phthalates,triclosan,andperfluorchemicals;

providedlaboratorymeasurementsfor50studiesthatexaminedtheexposureofvulnerablegroupstoenvironmentalchemicalsorinvestigatedassociationsbetweenexposuresandadversehealtheffects;

served as the worlds soleorprimarysourceforhighqualitylaboratorytestsinhumanbloodorurineforbisphenolA,transfattyacids,speciatedarsenic,uranium,speciatedmercury,volatileorganiccompounds,phthalates,triclosan,selectedradionuclides(e.g.,polonium210,

cesium134,cesium137,andiodine131),andothersubstances;

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developed,evaluated,andappliedinnovativelaboratorymethodsto

improveresponsetopublichealthemergencies,includingemergenciesthatinvolvediseaseanddeathfromunknowncauses;and

measureandanalyzepriorityenvironmentalchemicals;

providedtechnicalsupport,training,qualityassurance,andtechnologytransfertostateandlocallaboratoriesduringinvestigationsofknownandpotentiallyunsafechemicalexposures;and

demonstratedtheimpactofvoluntarydiscontinuationoftheuseofperfluorooctanesulfonicacid(PFOS)bydocumentingasubstantialreductioninhumanexposuretoPFOSaftertheendofproductionin2002.

NewbornScreening

Eachyear,morethan4millionnewbornsnearlyeverynewbornintheUnitedStatesarescreenedforsuchdisordersascongenitalhypothyroidismandsicklecelldisease.Theseconditionsoftencanbetreatedtopreventseriouscomplicationsifdetectedearlyinlife.Statepublichealthlaboratorieswhichtest98%ofU.S.infantsforbirthdefectseveryyearrelyonCDCtoensuretheaccuracyoftestingandtodevelopmethodsfordetectingcongenitaldisordersthatarenotapparentatbirth.

CDClaboratories

operated the nations only qualityassuranceprogramtoensuretheaccuracyofnewbornscreeningteststodetecttreatablediseasesthatcausemalformation,mentalretardation,anddeath;

providednewbornscreeningqualityassurancematerials,proficiencytesting,andtechnicalassistancetomorethan500laboratoriesinall50U.S.statesandin67countries;

developednewmethodstodetectnewborndiseases;and

conductedlaboratorystudiesthatsupportedtheadditionofseverecombinedimmunodeficiency (SCID), better known as Bubble Boy Disease, to the U.S.Departmentof Health and Human Services Secretarys Recommended Uniform Newborn ScreeningPanelthefirstnewconditionaddedtotheoriginalpanelof29conditions(SCIDaffectsanestimated1in100,000to1in40,000newbornsandleadstodeathduringinfancyifnot

treatedearly).

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NutritionRelatedandSelectedOtherChronicDiseases

Preventionandtreatmentofnutritionrelatedandselectedotherchronicdiseasesrequireaccuratelaboratorymeasurementtodetectanddiagnosediseaseandtoassesstheeffectivenesspublichealthinterventions.

CDClaboratories

conducted the nations only comprehensive assessment of the nutritional status of the U.S.populationbymeasuringmorethan50nutritionalindicatorsamongpersonswhoparticipateinNHANES(seethePublicHealthScientificServicessectionforamoredetaileddescriptionofNHANES);

developednewandimprovedmethodsformeasuringnutritionalanddietarybioactivecompounds,includingamethodtomonitorvitaminDbloodlevelsamongpopulations;and

standardizedandimprovedtheaccuracyofclinicalmeasurementsforcholesterol,related

lipids,testosterone,estradiol,andselectedotherdiagnostictestsforchronicdiseases.

Healthy Homes/Childhood Lead Poisoning


CDClaboratories

conducted the nations only comprehensive assessment of U.S. residents exposure to leadthroughbiomonitoringofpersonswhoparticipateintheNHANESsurvey,determinedthe

prevalenceofpersons(includingchildrenaged1yearandolder)withleadexposureshigherthantoxicitylevels,andreportedelevatedexposurestoensureeffectivetreatmentandexposureinterventions(seethePublicHealthScientificServicessectionforamoredetaileddescriptionofNHANES);

providedlaboratorymeasurementsfor11 studies (including the National Childrens Study)thatexaminedtheexposureofvulnerablegroupstolead;

providedbloodleadqualityassurancetonearly70U.S.laboratoriesthroughCDCs LeadandMultiElementProficiencyProgram;

providedportablebloodleadinstruments,qualityassurance,training,andlaboratoryassistancetotheinvestigationofanoutbreakofleadpoisoningintwominingvillagesin

Nigeria,whereCDCstaffusedtheportableleadinstrumenttoidentifyexposedchildren

rapidlyonsite,enablinglifesavingmedicaltreatment.

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BUDGET ACTIVITY PUBLIC HEALTH SCIENTIFIC SERVICES

Thisbudgetactivityprovides funding for activities related to support services for CDCslaboratories and for selected laboratory testing as part of CDCs unique NHANESsurvey.

LaboratorySupportServices

The success of CDCs laboratory scientists and laboratories depends on their access to a

spectrumofscientific,technical,policy,andotherservicesprovidedbymultipleCDCoffices.TheseessentialsupportservicesextendfromcoordinationofnationalCDClaboratoryinitiativestoassistanceincomplyingwithmultiplefederalregulatorymandates.Theyalsoincludetechnicaltraining,laboratoryworkersafety,andavailabilityofsuitableequipmentandfacilities,amongotherservices.


CDClaboratorysupportservices

assessedimplicationsforthe agencyslaboratoriesifstateandlocalpublichealthlaboratoriesthemajorityofwhichoperateunderintensefiscalandotherpressurescontinuetolosecapacitytoconductcriticallyimportanttests(thisledtocreationofthenewLaboratoryEfficienciesInitiativetohelpthemmaintaintestingcapacityandachievelongtermsustainabilitythroughtheadoptionofalternativehighefficiencymanagementpractices);

providedconsultationtoCDClaboratorydirectorsregardingcompliancewithfederalregulatoryrequirementsrelatedtodiseaseagentsthathavepotentialtoposeseverethreatstohuman,animal,andplanthealthandtoanimalandplantproducts;

coordinatedformulationandimplementationofauniform,agencywidepolicytoassistCDClaboratoriesincomplyingwiththefederalSelectAgentsandToxinsregulations(theregulationsareavailableathttp://ecfr.gpoaccess.gov/cgi/t/text/textidx?c=ecfr&tpl=/ecfrbrowse/Title42/42cfr73_main_02.tpl);

enhanced management of CDCs central collectionofmorethan6millionbiologicspecimensanddeliveredmorethan700,000specimenstoCDCandextramuralscientistsforresearchintothecausesandpreventionofdisease;

trainedmorethan450CDCscientistsindualuseresearchawarenessandpolicies(basedonrecommendationsoftheNationalScienceAdvisoryBoardforBiosecurity)topreventreleaseofresearchfindingsthatcanbemisusedintentionallytoposeabiologicorchemicalthreatto

publichealthornationalsecurity;

providedadvancedtrainingthroughtheNationalLaboratoryTrainingNetworktostateandlocalpublichealthlaboratoryprofessionals,preparingthemtorespondtobiologicandchemicalterrorism,infectiousdiseaseoutbreaks,disasters,andotherpublichealththreatsandemergencies;

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providedtraininginsafehandlingpracticesandinspecializedmicrobiologytestingforBTagents;

managed CDCs technology transfer program to facilitate commercialization of inventionsgeneratedbyCDClaboratoryscientistsandotherresearchers;

licensed51inventionsbyCDClaboratoryscientistsforproductionandsalebyprivatesectorfirmsandmaintainedanadditional1,116patentsbasedonCDCinventionsconsistentwithU.S.PatentandTrademarkOfficerequirements;

managed CDCs cooperative agreement with the Association of Public Health LaboratoriestoassistCDCsscientistsinconductingresearch,developinginformaticsapplications,deliveringtraining,andimplementingotherhighpriorityprojectswithextramuralpartners;and

supportedagencywideplanstoreviewandcomplywithFDAregulatoryrequirementsforinvitrodiagnosticdevices.

TheNationalHealthandNutritionExaminationSurvey

DatafromNHANEShavebeenthecornerstonefornationalhealthandnutritionpolicyandsurveillanceactivitiesthesurveysaretheonlycollectionofbiologicsamplesrelatedtonutritionandhealthonapopulationwidebasisintheUnitedStates.Eachyear,tensofthousandsofspecimensfromNHANESparticipantsareprocessedandshippedtomultipleCDCprogramsforlaboratoryanalysisofnutritionalbiochemistries,environmentalexposures,infectiousdiseases,andotherhealthindicators.Approximately250differenttypesoflaboratorytestsareperformed.ThoseCDCprogramsprovidefundingforthelaboratoryteststheyneed,withthefollowingexception,whichissupportedbythePublicHealthScientificServicesfundingline.


CDClaboratories

received,processed,andtestedmorethan4,500bloodsamplesforacompletebloodcount,apaneloftestsusedtoscreenforsuchdisordersasanemia,presenceofinfection,andotherdiseases.

BUDGET ACTIVITY OCCUPATIONAL SAFETY AND HEALTH

Workerstypicallyspendaquarteroftheirlivesanduptohalfoftheirwakinghoursatwork,makingtheworkplaceakeylocationforhealthproblems.During2010,employersintheprivatesectorreportedapproximately2.9millionnonfatalworkrelatedinjuriesandapproximately200,000casesofoccupationalillness.Onaverage,14workersintheUnitedStatesdieeachdayfromaninjurysustainedatwork(approximately4,500workersduring2010),andanother134diefromworkrelateddisease.Thetotalestimateddirectandindirectcostsforworkrelated

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diseasesandinjuriesareapproximately$250billion.CDCmaintainsuniquelaboratorycapacityforconductingmultidisciplinaryoccupationalsafetyandhealthresearchandprovidesgloballeadershipinareasofevidencebasedinformationtopreventworkrelatedillness,injury,disability,anddeath.


AssessmentofMiningHealthandSafetyHazardsandDisasterPrevention

CDClaboratories

conductedfullscaleexperimentsbeforetestinginterventionsatworkingminesites;

developedanewawardwinningLEDcaplamptopreventinjuriesbyenhancingtheilluminationofundergroundminesandassociatedhazards,includingunevenandclutteredsurfaces,areasofunstablerock,andotherobstaclesintegraltominingoperations;

improvedunderstandingofmineexplosions,designedexplosionandfiresuppressionstrategies,anddevelopedapproachesforminimizingorpreventingmassiverockfailuresbyusingtheuniquecapabilitiesoftheLakeLynnLaboratoryandtheMineRoofSimulator;

simulatedundergroundcoalminingconditionsatactiveproductionzonesandconductedresearchthataddresseshealthhazards(e.g.,coaldust);

identifiedinadequatecoalminedustingstandards,whichledtheU.S.DepartmentofLabortoissueanEmergencyTemporaryStandardforallcoalminestopreventcoaldustexplosions;and

conductedresearchonhearinglosspreventionformineworkersusinglargescalemining

equipment.

ImprovedPersonalProtectiveEquipmentandTechnologies

CDClaboratories

conductedresearchtoadvancetechnologytoimproveprotection,comfort,fit,andtheuseofpersonalprotectiveequipmentandtoexamineexposurestoinhalation,dermal,andotheroccupationalhazards;

conductedfirefighterturnoutgearinvestigationsandresearchinpersonalprotective

equipmentanthropometricsandaerosols/filtrationbyusingcapabilitiesthatexistinonlyafewlaboratoriesintheworld(e.g.,humanmetabolicresponsesimulationandchemicalprotectiveclothingpenetration);

administeredtherespiratorcertificationprogramtoensurealevelofstandardfilterefficiencyforallrespiratorsusedinU.S.workplacesbyusingtheonlyfullsizerespiratortestingfacilityintheUnitedStates;and

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improvedthequalityandquantityofrespiratoryprotectionforworkersthrough588certifiedrespiratordecisions(including356newapprovals)and248completerespiratorauditactivities.

IndustrialHygiene

CDClaboratories

developedandevaluatedmethodsusedworldwidetosampleandanalyzecontaminantsinworkplaceairandinthebloodandurineofworkerswhoareexposedoccupationally;

designedandtestedaerosolsamplingequipmentprototypestoevaluateexposuretoultrafineandnanoparticlesinfieldstudies;

identified,evaluated,developed,andimplementedtechnologytopreventworkerexposuretoworkplacehealthhazards;and

developedaportable,freestandingairborneisolationsystemcapableofproducingairborneinfectionisolationinharshenvironments.

AppliedToxicology

CDClaboratories

useddiverselaboratorydisciplines(e.g.,exposuregenerationandassessment,pulmonarytoxicology,cardiovasculartoxicology,andneurotoxicology)toanswercriticalquestionsaboutworkplacehazardsandhowtheyaffectworkersonabiologicandphysiologicallevel;

conductedaerosolgenerationandanimalinhalationexposureresearchforworkrelated

hazards(e.g.,multiwalledcarbonnanotubes,carbonnanofibers,weldingfumes,andartificialflavorings);

conductedresearchbyusinganimalmodelsandpublishedaseriesofreportsonthehealtheffectsoftheoildispersantusedintheDeepwaterHorizonemergencyresponse;

usedabiosafetylevel3adaptablelaboratorywithsimulatedpatientexaminationroomcompletewithacoughingandbreathingmannequintomonitorhealthcare workers potentialaerosolexposuretoaninfectedpatient;and

demonstratedaerosolizedtransmissionofinfluenzavirusinlaboratorystudiesandhospital

settingsandcharacterizedviralparticlesizeandquantityincoughsfrominfluenzapatients.

SafetyEngineering

CDClaboratories

developedengineeringcontrolsandsafeworkpracticestopreventworkrelateddeathsandinjuries;

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researchedhumanbehavior,physicalresponses,anddecisionmakingskillsundersimulatedconditionsofworkatelevatedheightsbyusinguniquevirtualrealitycapacity;

researchedinteractiveeffectsofbiomechanics,physiologicalload,andpsychologicalstressonworkers;and

registeredandquantifiedhumanbodysizeandshapeofvariousoccupationalgroupsforuseindevelopingimprovedequipmentdesigns(e.g.,developedanddisseminatedacomprehensivedatabaseoftruckdriveranthropometricstomajortruckmanufacturerswhoareusingthedatatoimprovetruckcabdesignforincreasedsafety).

BUDGET ACTIVITY GLOBAL HEALTH: GLOBAL AIDS PROGRAM

ThirtyyearssincetheonsetoftheHIV/AIDSepidemic,technicaladvancesandimprovedknowledgeofdiseaseepidemiologyhaveledtoinvestmentsinpreventionandtreatmentthatare

helpingtoreducenewinfections,savelives,andachieveanAIDSfreegeneration.

U.S.basedCDClaboratoriesprovidetechnicalassistanceandexpertconsultationtoadvancetheU.S.GlobalHealthInitiativeandthePresidents Emergency Plan for AIDS Relief (PEPFAR) byimprovingdiseasepreventionandtreatmentandcareforpersonslivingwithHIV/AIDS.


CDClaboratories

servedasworldwidereferencelaboratoriesfordiagnosisanddrugresistancetestingforHIV/AIDS,providingservicestobothdomesticandinternationalpartners(seetheDomesticHIV/AIDSsectionforadditionalactivities);

providedlaboratorysupporttoaddresspublichealthprioritiesinHIVdiagnosis,prevention,care,andtreatment,aswellasincrosscuttingareas(e.g.,HIV/TBcoinfection,healthsystemsstrengthening,publichealthtraining,andlaboratorybiosafetyandbiosecurity);

helpeddevelopingcountrieslaboratoriesimplementimprovedmethodsfordiagnosisofHIVandAIDSrelatedopportunisticinfections,includingcoinfectionwithTB;forHIVandTBdrugresistancetesting;formeasurementofbloodCD4+levelsandHIVviralloadstomonitordiseaseprogressionandtreatmenteffectiveness;andforHIVincidencetestingtomonitortheeffectofdiseasepreventionandcontrolefforts;

assistedministriesofhealthin45countriesindevelopingnationallaboratorystrategicplansthatstrengthenthelaboratorycomponentofnationalhealthsystems(e.g.,byimplementingqualitylaboratoryservicesandsystems,strengtheninglaboratorybiosafetyandbiosecurity,anddevelopingnationallaboratorynetworksthatoptimizetheuseoflocalresources);

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providedsupportforhandsontrainingto865laboratoryprofessionalsin283laboratoriesin22countriestoimproveaccreditationpreparedness,andhelpedtoestablishtheAfricanSocietyforLaboratoryMedicine,whichwilladministeraregionallaboratoryaccreditationprogram;

strengthenedHIV/AIDSpreventionandcontrolprogramsby

providingsupportfortraininganddiagnosticassistancetodevelopingcountrypublichealthlaboratoriesthatcollectivelytested9.8millionpregnantwomenforHIV,leadingtopreventionofmothertochildtransmissionandallowinganestimated200,000infantstobebornHIVfree;

providingtestingpanelsto120laboratoriesin40PEPFARcountriestofacilitatetrainingindrugresistancetestingbyusingthelowcostdriedbloodspotassaydevelopedatCDC;and

evaluatingthequalityofHIVrapidtestsconsideredforinclusionintheUSAIDwaiver

list,whichauthorizeslocalprocurementofgoodsandservicesunderPEPFAR(useoftheserapidtestsallowspromptreferralforcareandtreatment);and

conductedoperationalresearchto

evaluatefielduseofrapidpointofcaretestsinresourcelimitedsettings(e.g.,toacceleratetheentryintocareofHIVpositivepregnantwomen);

implementwidespreaduseofmoleculartestsforearlydiagnosisofHIVamonginfants(e.g.,toallowearlydeterminationoftheHIVstatusofinfantsborntoHIVpositivemothers);and

scaleupcollectionandanalysisoflaboratorydataformeasuringtheimpactofHIVpreventionefforts,facilitatingfastertranslationofresearchfindingsintolocalpractice.

BUDGET ACTIVITY GLOBAL HEALTH: GLOBAL IMMUNIZATION PROGRAM

Vaccinationagainstseriousinfectiousdiseases(e.g.,polioandmeasles)isoneofthemosteffectiveofallglobalpublichealthinterventions.Globally,casesofpoliohavedecreasedbyover99%since1988.PoliovaccinationintheUnitedStateshasyieldedneteconomicbenefitsthatexceed$180billion,notcountingtheintangiblebenefitsassociatedwitheliminating

endemicpoliointheUnitedStates.Globally,measlesdeathsdeclinedby78%during20002008,althoughthediseasecontinuestoaffectmorethan20millionpersonseachyear.Measlesvaccinationisoneofthemostcosteffectivehealthinterventionsavailabletodayforpreventingdeaths.

However,muchremainstobedone.U.S.basedCDClaboratoriesarehelpingtoadvancetheGlobalPolioEradicationInitiativebyprovidingcriticaldiagnosticservicesandgenomicsequencingofpoliovirusestotracklocalandglobaltransmissionpathwaysandhelpguide

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diseasecontroleffortsinmultiplecountries.TheCDCPolioLaboratoryservesasaWHOglobalspecializedlaboratory,ahighlevelfacilitythatprovidestechnicalandprogrammaticassistancetotheGlobalPolioLaboratoryNetwork.CDCalsoishelpingtoadvancetheGlobalMeaslesInitiative,whichaimstoacceleratethereductionofmeaslesdeathsworldwide.Moreover,increaseduseofacombinedmeaslesandrubellavaccineisalsoreducingbirthdefectscausedby

congenitalrubellasyndrome.TheCDCmeaslesandrubellalaboratoriesareWHOglobalspecializedlaboratorieswithintheWHOMeaslesandRubellaLaboratoryNetwork.

Inaddition,CDC laboratories support global efforts to prevent childrens deaths from othervaccinepreventablediseasesbyincreasingaccess

lspppo report signed v2 (clear version)

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