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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.
Selected Laboratory Activities in FY 2011
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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BUDGET ACTIVITY HIV/AIDS, VIRAL HEPATITIS, STD, AND TB PREVENTION:
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.
Selected Laboratory Activities in FY 2011
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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BUDGET ACTIVITY HIV/AIDS, VIRAL HEPATITIS, STD, AND TB PREVENTION:
SEXUALLY TRANSMITTED DISEASES (STDs)
Approximately19millionnewSTDinfectionsoccureachyearintheUnitedStates,approximatelyhalfofwhichareamongyoungpersons(thoseaged1524years).STDsexactatremendouseconomictoll.DirectmedicalcostsassociatedwithSTDsareestimatedtobemorethan$15billionannually.
CDCslaboratoriessupportpublichealtheffortstopreventandreduceSTDsandassociatedmedicalcomplications(e.g.,infertilityresultingfrompelvicinflammatorydiseasecausedbychlamydiaorgonorrhea;adversepregnancyoutcomes,includinginfantdeathsorillnesscausedbyneonatalherpesorcongenitalsyphilis;andcervicalcancercausedbychronicinfectionwithHPV).
Selected Laboratory Activities in FY 2011
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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BUDGET ACTIVITY HIV/AIDS, VIRAL HEPATITIS, STD, AND TB PREVENTION:
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.
Selected Laboratory Activities in FY 2011
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.
Selected Laboratory Activities in FY 2011
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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BUDGET ACTIVITY EMERGING AND ZOONOTIC INFECTIOUS DISEASES:
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.
BUDGET ACTIVITY EMERGING AND ZOONOTIC INFECTIOUS DISEASES:
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.
Selected Laboratory Activities in FY 2011
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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BUDGET ACTIVITY EMERGING AND ZOONOTIC INFECTIOUS DISEASES:
CHRONIC FATIGUE SYNDROME
CFSisestimatedtoaffect14millionU.S.residents.Theillnessislonglastinganddebilitating,withanegativeeffectonhealthandqualityoflifesimilartoheartdisease,multiplesclerosis,cancer,andAIDS.IntheUnitedStates,therelatedannuallossinproductivityisworthanestimated$9billion,withadditionaldirectmedicalcosts.
CDCsupportsanintramuralmultidisciplinaryprogramthatobtainsandanalyzesbaselineinformationthatwillaiddevelopmentofinterventionsforCFSandwillimprovemeasurementofclinicaloutcomes.LaboratoryactivitiesaredirectedatimprovingCFSdiagnosisandattemptingtoidentifygroupsresponsivetospecifictherapies.Theseactivitiescomplementclinicalresearchinitiativesthatfocusonthecauses,consequences,andtreatmentofCFSandrelateddiseases.
Selected Laboratory Activities in FY 2011
CDClaboratories
maintainedthecollection,processing,andarchivingofserum,plasma,saliva,wholebloodDNA,andRNAsamplesfromCDCstudiestoformabiorepositorylinkedtoclinicalandepidemiologicdatafordiscoveryandvalidationofbiomarkersforCFS(materialshavealreadybeenusedforcollaborativeprojectsinvolvingxenotropicmurineleukemiavirusrelatedvirus,metagenomicsforunknownpathogens,andforsalivarybiomarkerdiscovery);
conductedmolecularanalyses(e.g.,geneexpressionprofiling)andevaluatedmarkersofinflammationinbloodsamplesfromcasecontrolstudiesofstressresponseasanapproachtounderstandingthepathophysiologyofCFSandtoidentifyingCFSsubgroupswithtargetsfortherapeuticintervention;
analyzedfunctionalmagneticresonanceimagingcasecontroldatatoinvestigatethehypothesisthatfatigueinCFScorrelateswithalterationsinthebrain;
initiatedstudiestoevaluatehumanherpesvirus6inCFSandtoidentifybiomarkersoffatigue;and
continuedeffortstodiscoverpotentialbiomarkersandtheunderlyingpathophysiologyofCFStovalidatetheimportanceoftheillnessandtoprovideanimpetusfornewtherapeuticstrategies.
BUDGET ACTIVITY EMERGING AND ZOONOTIC INFECTIOUS DISEASES:
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.
Selected Laboratory Activities in FY 2011
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.
Selected Laboratory Activities in FY 2011
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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Selected Laboratory Activities in FY 2011
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.
Selected Laboratory Activities in FY 2011
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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Selected Laboratory Activities in FY 2011
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
Selected Laboratory Activities in FY 2011
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
Selected Laboratory Activities in FY 2011
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.
Selected Laboratory Activities in FY 2011
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.
Selected Laboratory Activities in FY 2011
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.
Selected Laboratory Activities in FY 2011
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.
Selected Laboratory Activities in FY 2011
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