LSPPPO Report Signed V2 (Clear Version)

U.S.
DepartmentofHealthand HumanServnces
CentersforDiseaseControlandPrevention(CDC)
Reportto Congresson InternalLaboratoryActivitiesofCDC
andAssociated Funding Levels
[Signed]
ThomasR.Frieden.M.D.,M.P.H.

[Page left blank intentionally]

CDCs laboratory scientists are at the heart ofourworktoprotect

Americaona24/7basis.CDCcouldnotsucceedwithoutthem.Stateand
localpublichealthdepartments,healthcareprofessionals,andmany
othersrelyonourlaboratoryscientistsforspecializedtesting,
consultation,andnewtechnologiestoaddressawideandgrowing
spectrumofhealththreats.CDCisthedefactoreferencelaboratoryfor
theUnitedStatesandfortheentireworld,aninvaluableand
indispensable resource.
ThomasR.Frieden,MD,MPH
Director,CentersforDiseaseControlandPrevention
InSenateReport112-84,whichaccompaniedtheFiscalYear(FY)2012appropriationsbillfor
theU.S.DepartmentsofHealthandHumanServices,Labor,Education,andrelatedagencies,the
SenateCommitteeonAppropriationsstated,
The Committee requests a report to Congress no later than 120 days
after the enactment of this act that details CDCs various internal
laboratory activities and associated funding levels.
TheCentersforDiseaseControlandPrevention(CDC)haspreparedthisreportinresponseto
the committees request. The body of the report is organized into 21 sections that correspond
withthestandardformatoftheCDCbudgetdocumentswithwhichtheCommitteeisfamiliar.
EachsectionaddressesaspecificCDCbudgetactivityanditsassociatedinternallaboratory
activities. The report encompasses the majority of CDCs laboratory activities.Relevant
definitionsanddescriptionsoflaboratoryactivitiesnotaddressedappearintheExplanationand
Definition of CDCs LaboratoryActivitiessectionthatfollows.
Overview of CDC Laboratories
CDCiscommittedtokeepingAmericasafefromthreatstoitshealth,safety,andsecurity,
whetherforeignordomestic.CDCpromoteshealthandqualityoflifedomesticallyandglobally
bypreventingandcontrollingdisease,injury,anddisability.Achievingexcellenceinlaboratory
scienceandindeliveringlaboratoryservicesiskey to fulfilling CDCs mission.
CDCs laboratories are integral elements of itspreventionandcontrolprogramsthataddress
infectiousandchronicdiseases,birthdefectsanddevelopmentaldisabilities,andenvironmental
andoccupationalhealth.Theseprogramscannotsucceedwithouttheactionableinformationand
knowledgegeneratedbyCDCs laboratory scientists, manyofwhomarenationallyor
internationallyrecognizedaspreeminentexpertsintheirfields.
Thanksinparttothelaboratoriesitoperates,CDChasbeenableto
identifyandtakeactiontoaddressnewdiseasethreats(e.g.,theinfluenzastrainthaterupted
intothe2009pandemicinfluenzaA[H1N1]andthenovelvirusthattriggeredsevereacute
respiratorysyndrome[SARS]in2003);
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tracktheemergenceofdrug-resistantinfectionsanddevelopnewwaystocounterthese
threats;
confirmthesourcesoffoodbornediseaseoutbreaks(e.g.,thoseassociatedwithcantaloupes
in2011andeggsin2010),andadviseindustry,theFoodandDrugAdministration(FDA),
andstatesoncorrectiveactions;
serveasWorldHealthOrganization(WHO)CollaboratingCenters(e.g.,forinfluenza,
malaria,tularemia,rotavirus,rabies,poxviruses,andviralhemorrhagicfevers)and
participateinglobalhealthnetworks;
addressprioritiesinhumanimmunodeficiencyvirus(HIV)diagnosis,prevention,and
treatmenttoreduceHIV-relatedillnessanddeathintheUnitedStatesandinternationally;
determineandaddressthecausesofflare-upsofvaccine-preventablediseases(e.g.,thespike
inU.S.measlescasesthatappearedinearly2011after15yearsoflowincidence);
examinesuspicioussubstancestodetermineiftheyposeanythreatsandreportfindingsso
thatappropriateactionstoprotectthepubliccanbetaken(e.g.,the2001anthraxattacks);
testforpotentialhealthdangersstemmingfromtoxicreleases(e.g.,theDeepwaterHorizon
oilspillin2010)andprovidescientificallybasedinformationontheirhealthimplicationsto
thepublicandtodecisionmakers;
collectobjectivedataforuseindesigninginterventionstopreventandcontroldiseaseand
disability(e.g.,throughtheNationalHealthandNutritionExaminationSurvey[NHANES],
theonlyU.S.collectionofbiologicsamplesrelatedtonutritionandhealthona
populationwidebasis);
ensureaccuracyofthetestsstatepublichealthlaboratoriesusetoscreennewbornsinthe
UnitedStatesformedicalconditionsthatcanleadtolifelongdisabilityordeathifnot
detected;and
developanddisseminateauthoritativepublichealthguidelines(e.g.,fortherespiratorsthat
protectmillionsofhealthcareprofessionals,firstresponders,andindustrialworkersfrom
airbornevirusesandpollutants).
CDCs laboratories aredistinctfromthemanycommercial,hospital,andphysician-office
laboratoriesthatperformtestsrelatedtoindividualpatients.CDChastheuniqueabilityto
developandperformhighlysophisticated,cutting-edgetestsimportantformonitoringpopulation
healthandtoserveasthelast-resortreferencelaboratory,abletoconfirmorruleoutanewvirus
orotherpathogens.Someofthisworkisperformedinhigh-containmentlaboratorieswhere
scientistsworkwithespeciallydangerousinfectiousandchemicalagents.CDCisalsouniquely
capableofestablishingdefinitivestandardsforlaboratorytesting,includingtestsusedinboth
publichealthandclinicalsettings.Inaddition,CDCslaboratoryscientistsfocusmultiple,
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complementarydisciplinesonsolvingcomplexpublichealthproblems.Arecentexampleisthe
efforttodevelopandvalidatenewmassspectrometrytestmethodsfordetectinghumanexposure
tobotulinumtoxin a result of collaboration between CDCs EnvironmentalHealth
Laboratory,whichspecializesinassessingchemicalexposures,andFoodborneDisease
Laboratory,whichspecializesinbiologictesting.Thenewtestmethodswillsupportresponsesto
biologicorchemicalterroristattacksandfoodborneillnessoutbreaks,aswellasinvestigationsof
potentiallycontaminatedcosmeticproducts.
CDClaboratoryscientistsworkcloselywiththeirprogrammaticpartnerswithinCDC,including
epidemiologistsandothercolleaguesacrossawidespectrumofdisciplines.Inturn,CDCrelies
ontheworkitslaboratoryscientistsconductacrossmultipledomainsthatarecrucialtothe
agencys priorities and to its vital contribution to national security.Examplesincludethe
following:
Surveillance Testingtotracktrendsindiseasesandotherhealththreats,monitornational
healthstatus,andevaluatetheeffectivenessofvaccines,treatments,infectioncontrol
programs,andotherpublichealthandmedicalstrategies.
Emergency Response Testingforrapididentificationofthecausesofdiseaseoutbreaks
fromnaturalorhuman-madebiologicthreats(BT),chemicalthreats(CT),orradiologic
threats(RT)toensurerationaltreatmentdecisionsaremade.
Standards Setting Establishingtechnicalandscientificstandardsforpublichealthand
clinicallaboratorytests(e.g.,forthemillionsofcholesteroltestsperformedannuallyinour
nations hospitals and clinical laboratories,andforantimicrobialsusceptibilitytesting).
Quality Assurance Developing,promoting,andevaluatingstandardsandguidelinesfor
publichealthandclinicallaboratories,andprovidingtechnicalassistanceandreliable
referencematerialstosupporttestvalidation,qualitycontrol,andproficiencytesting.
New Product Development Applyingresearchfindingstodevelopnewtypesoftests,
newvaccines,andotherproducts,manyofwhicharelicensedtoprivatecompaniesto
manufactureandmakeavailablethroughthecommercialmarketplace.
Health System Support Providingscientific,technical,andfinancialassistancetohelp
stateandlocalpublichealthagencies,healthcareproviders,nonprofitgroups,federal
agencies,andotherpartnersimprovetheirlaboratorypracticesandstrengthentheir
laboratorysystems.
Partnerships
CDCreliesheavilyoncollaborationwithotherfederalagencies,stateandlocalpublichealth
departments,healthcareorganizations,andotherdomesticandinternationalpartnersto
accomplishitsmission.The agencyslaboratoryscientistspartnercloselywithpublichealth
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laboratoryprofessionalsandscientistsinotherU.S.DepartmentofHealthandHumanServices
operatingdivisions,theU.S.DepartmentofHomelandSecurity,theU.S.Departmentof
Defense,theFederalBureauofInvestigation,theU.S.AgencyforInternationalDevelopment
(USAID),andtheU.S.DepartmentofAgriculture(USDA),amongotherfederalagencies;WHO
andministriesofhealthworldwide;andindustryandnongovernmentalorganizations(e.g.,the
AssociationofPublicHealthLaboratories).
Stateandlocalpublichealthlaboratoriesprotecthealthintheirjurisdictionsandpartnerclosely
withCDCascriticalpartsofthenations public health laboratory safety net. Among other
services,stateandlocalpublichealthlaboratoriesperformmanypublichealthreferencetests,
confirmingorrulingoutpatientdiagnoses,advisingprovidersonthesignificanceofpatienttest
results,andsimultaneouslyusingtestresultstomonitorcommunityhealthtrends.Ofspecialnote
arethecriticalrolestheyplayindetectingtheonsetofthreatsatthefrontlineandinproviding
surgecapacity,helpingtomanagethehighnumberoftestsrequiredduringpublichealth
emergencies(e.g.,the2009influenzaAH1N1pandemic).
CDCprovidescriticalsupporttostateandlocalpublichealthlaboratoriesbydesigning,
developing,andtransferringhigh-qualitytestingpracticestothemandbyprovidingtechnical
consultation,training,financialassistance,andhigh-prioritysuppliesnotavailablefromother
sources.Inaddition,CDChassponsoredcreationandoperationofnationalnetworksfordisease
clusterdetectionandinvestigation,rapidcommunication,andtestresultvalidationduring
foodbornediseaseoutbreaks(e.g.,PulseNet)andinresponsetoBTsorCTsorotherpublic
healthemergencies(i.e.,theLaboratoryResponseNetwork[LRN]).PulseNetenablesstateand
localpublichealthagenciestodetectclustersofillnessesinoneormanystatesrapidlyby
comparingDNAfingerprintsofbacteriafromillpatientsthroughtheuseofanonlinepattern
databasemaintainedbyCDC.Thesediseaseclustersoftenrepresentsilentlydeveloping
foodbornediseaseoutbreaksthatcanbecontrolledifdetectedearly.Moreimportantly,PulseNet-
detectedoutbreaksprovideindustryandregulatorstheinformationtheyneedtofixproblemsin
ourfoodsupplythatwouldotherwisegounnoticed.LRNcomprising162laboratories,most
ofwhichcanconfirmthedetectionofBTagentsandasubsetofwhichhaveadditionalcapacity
todoCTtestingexpandsandleveragesthecapacityofthepublichealthlaboratorysystemto
respondtopublichealththreatsandemergencies.Anestimated85%oftheU.S.populationlives
within100milesofanLRNmemberlaboratory,ensuringbroadaccesstotestingduringpublic
healthemergencies.Otherfederalagencies(e.g.,theU.S.DepartmentofDefense,theFederal
BureauofInvestigation,FDA,USDA,theU.S.DepartmentofEnergy,andtheU.S.
EnvironmentalProtectionAgency),collaboratewiththenetworkandcoordinateresponse
activitiesthroughtheIntegratedConsortiumofLaboratoryNetworks.Publichealthlaboratories
inAustralia,Canada,Mexico,andtheUnitedKingdomalsoparticipateinLRN.
University-andindustry-basedscientistsandmembersofscientificandprofessionalassociations
alsoare valuable partners for CDCs laboratory scientists. They bring important viewpoints from
relevantdisciplinesandcontributenewknowledgefromresearchandfront-lineindustryand
clinicalexperience. In turn, CDCs laboratory scientists use multiple channels to disseminate
informationtothesepartnersaboutthenewtests,improvedtestingmethods,andlaboratorybest
practicesCDCdevelops.ThesechannelsincludetheelectronicHealthAlertNetworkand
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LaboratoryOutreachCommunicationSystemandCDCs Morbidity and Mortality Weekly
Report,amongothers.Inaddition,CDCmaintainsandcontinuallyexpandsitsinvaluable
collectionsofuniquebiologicspecimensthatCDCscientistsandcolleaguesinuniversitiesand
othersettingsuseforresearchintothecausesofdiseaseandfordevelopmentofnewmedicaland
publichealthinterventions.
Explanation and Definition of CDCs Laboratory Activities
Forthepurposesofthisreport,internal laboratory activitiesaredefinedaslaboratory-related
activitiesthatCDCemployeesandcontractorsconductedduringFY2011intheUnitedStates,
primarilyatCDCfacilities,andwhichwerefundedbythebudgetactivitiesthatappearinthe
accompanyingtable.ThosefacilitiesarelocatedintheAtlanta,Georgia,metropolitanareaandin
Anchorage,Alaska;Ft.Collins,Colorado;Cincinnati,Ohio;Pittsburgh,Pennsylvania;SanJuan,
PuertoRico;Spokane,Washington;andMorgantown,WestVirginia.
Thisreportaddressestestingandappliedresearchactivities,aswellasselectedscientific,
technical,andlaboratorysupportservices.Ingeneral,supportservicesincludeactivitiessuchas
oversight and implementation of CDCs policy on dual-useresearchofconcern;managementof
CDCs central collection of morethan6millionbiologicspecimensforusebyCDCand
extramuralresearchers;laboratorysecurityandworkersafetyprotectionservices;provisionof
bioinformaticsandinformationtechnologyservices;andprovisionandmaintenanceofphysical
facilities.Theyalsoincludeassistanceincomplyingwithfederalregulatorymandates(e.g.,the
ClinicalLaboratoryImprovementAmendments,diagnosticdeviceregulations,andtheSelect
AgentsandToxinsregulations).TheEmergingInfectiousDiseases,PublicHealthScientific
Services,andPublicHealthPreparednessandResponsesectionsofthisreportinclude
informationregardinglaboratorysupportservicesfundedfromthesethreeappropriations.
ThisreportalsoaddressesdomesticallybasedCDClaboratoryactivitiesthatsupportexternal
partners,includinglaboratoriesoperatedbyministriesofhealthinothercountries.Supportfor
externalpartnersincludesprovisionoflaboratorytechnicalsupportandtraining,program
administration,andcooperativeagreementmanagement.Manyoftheseactivitiesadvance
CDCs globalhealthpriorities.Severalsectionsofthisreport(e.g.,theGlobalHealthsections)
includedescriptionsofdomesticCDClaboratoryactivitiesthatsupportoverseasactivities.
Exclusions
Twotypesoflaboratory-relatedactivitiesthatreceivefundsappropriatedtoCDCdonotappear
inthisreport,explainedasfollows:
Domestic Laboratory-Related Activities Conducted by Grantees Thisreportdoesnot
provideinformationonlaboratory-relatedactivitiesthatstateandlocalpublichealthdepartments
orextramuralresearchersconductwithfundingtheyreceivefromCDCthroughcooperative
agreementsorothermechanisms.However,activitiesthatCDCemployeesandcontractors
conductinsupportofthosegrantees(i.e.,managingcooperativeagreements)arereferenced
whereappropriateandasnotedpreviously.
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Global Laboratory Activities CDCsupportsmultiplelaboratorieslocatedinothercountries
andalsohelpstobuildandoperategloballaboratorynetworks(e.g.,theGlobalPolioLaboratory
Network,whichsupportsworldwidepoliovirussurveillance).Thisreportdoesnotaddressthese
overseasactivitiesorthoseofotherCDCgloballaboratorynetworks.However,where
appropriate,itprovidesinformationaboutCDCs domesticallybasedsupportforsuchactivities,
asnotedpreviously.
FY 2011 Funding for CDC Internal Laboratory Activities
TheaccompanyingtableindicatesthatCDCobligated$412,029,029toitsinternallaboratory
activitiesduringFY2011.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.
CertaininternalCDClaboratoryactivitiesaresupportedbyfundsthatotherfederalagencies
transfertoCDC.Suchactivitiesarenotincludedinthisreport,withtheexceptionofthose
supportedbytheU.S.PublicHealthServiceEvaluationFundandthePublicHealthandSocial
ServicesEmergencyFund.Alsoexcludedarelaboratoryactivitiessupportedbyno-yearfunds
appropriatedtoCDCinfiscalyearsbeforeFY2011butobligatedtolaboratoryactivitiesduring
FY2011.
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FY 2011 Funding for CDC Internal Laboratory Activities
Budget Activity Total
Immunization and Respiratcry Diseases
Budget Authority (BA) $ 5,364,537
Public Health and Social Services Emergency Fund* $ 35,777,757
$ 41, 142,294
m Y/AIDS, Viral Hepatitis, STD, and TBPrevention-BA
Domestic m Y/AIDS $ 10,792,414
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
Vectorbome Diseases $ 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
Other (Antimicrobial Resistance and Hantavirus/Special Pathogens) $ 7, 963,416
$ 86,280,394
Clrronic Disease Prevention and Health Promotion - BA $ 6,035,291
Birth Defects, Developmental Disabilities, Disability and Health - BA $ 2,540,629
Environmental Health - BA
Environmental Health Laboratory $ 32,422, 706
Healthy Homes/Childhood Lead Poisoning $ 781,512
$ 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
Public Health Service Evaluation $ 35,896,519
$ 140,963,237
Global Health - BA
Global AIDS Program $ 9,769, 770
Global ImmlU1ization Program $ 4,064,530
Global Disease Detection and Emergency ResJXlllse $ 3,718,221
Parasitic Diseases and 1\1alaria $ 10,256,991
$ 27,809,512
Public Health Preparedness and Response - BA $ 42,168,065
CDC Total $ 412,029,029
BA subtotal $336,602,298
Public Health Service Evaluation subtotal $39,648,974
Public Health and Social Services Fund subtotal $35, 777,757
* To support panderTIlc mfluenza laboratory-related act:JVlues.
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BUDGET ACTIVITY IMMUNIZATION AND RESPIRATORY DISEASES
Nationalvaccineprogramsandpoliciesrelyonafoundationofstrongscience,whichisessential
forvaccinepolicydecisionmakingandforevaluatingvaccinationrecommendationsafterthey
areimplemented.Acomprehensiveimmunizationprogramrequiresnational-levelscientific
expertiseinlaboratorysciencesandservicestomonitorpreventablediseaserates,identify
emergingnewthreats,trackandrespondtooutbreaks,andevaluatevaccineeffectiveness.
CDCeffortshavehelpedreducetheoccurrenceandimpactofmultiplevaccine-preventable
diseases,increasedimmunizationcoveragerates,andimprovedvaccinesafetysurveillanceand
research.Continualchangesininfluenzaandotherrespiratoryvirusesrequirerelentlesstracking
ofemergingstrainstoensurevaccinesareeffectiveaswellasmonitoringincreasingimportation
ofvaccine-preventablediseasesthataffectvulnerablepopulations.
Selected Laboratory Activities in FY 2011
Vaccine-PreventableDiseases
ForeachannualU.S.birthcohortvaccinatedagainst13diseasesinaccordancewiththeschedule
adoptedbyCDC,approximately42,000livesaresaved;20millioncasesofdiseaseare
prevented;$13.6billionindirectcostsaresaved;and$68.9billionindirectplusindirect
(societal) costs are saved. CDCs Immunization Program aims to prevent vaccine-preventable
diseasesbyachievingandmaintaininghighimmunizationrates.Since2009,nationalpolicy
recommendationshavebeeninplaceintheUnitedStatestopreventatotalof17diseasesamong
youngchildren,adolescents,andadults.Thesediseasesincludemeasles,mumps,rubella,
varicellaandherpeszoster,rotavirus,humanpapillomavirus(HPV),influenzaandbacterial
meningitis,whoopingcough(pertussis),diphtheria,andothers.
CDClaboratories
provideddataandanalysisonwhichnationalimmunizationpoliciesarebased;
developednewmoleculardiagnosticassaysformeaslesandmumpsandassistedwiththeir
implementationinstateandlocalpublichealthlaboratoriestodetectandcontroloutbreaks;
providedoutbreakassistanceandperformedtestingtoconfirmvaccine-preventabledisease
occurrence;
diagnosedandanalyzedmeasles,rubella,andcongenitalrubellasyndromecasesinthe
UnitedStates;
assessedvaccineimpactandchangingepidemiologyfornewvaccineprograms(e.g.,
rotavirusandpneumococcalpreventionamongchildrenandmeningococcalvaccineimpact
amongadolescents);
assessedeffectivenessanddurationofvaccineprotectionamongindividualsandacross
populations;
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monitoredchangesinbacteriaandvirusesthatcancausevaccinestobecomelesseffective
andidentifiednewstrainsforuseinvaccinedevelopment;
providedevidence-basedvaccineeffectivenessandprogramimpactresultstodemonstrate
theneedforaboosterdoseofmeningococcalvaccineamongadolescents;
demonstratedimpactofthechildhoodpneumococcalconjugatevaccineintroducedin2010
(theinformationisbeingusedtoformulatenationalpoliciesonpneumococcalvaccineuse
amongadultsaswellaspneumoniaandmeningitistreatmentguidelines);and
supporteddevelopmentandlicensureofnewvaccinesthroughcharacterizationofpathogen
strains(e.g.,meningococcus),developmentofstandardantibodytests(e.g.,pneumococcus
andmeningococcus),andmonitoringtrendsduringvaccinetrials.
Influenza
Influenzaisacontagiousrespiratoryillnesscausedbyinfluenzaviruses.Itcancausemildto
severeillnessanddeath.During19762006,estimatesofflu-associateddeathsintheUnited
Statesrangefromalowof3,000toahighof49,000annually.Certaingroups(e.g.,older
persons,youngchildren,andthosewithcertainhealthconditions)areathigherriskforserious
flu-relatedcomplications. The CDC Influenza Programs laboratory activities support detection,
control,andpreventionofinfluenza.
CDClaboratories
providedyear-rounddomesticsurveillanceforinfluenza;
subtypedandcharacterizednovelinfluenzaviruses;
studiedglobalinfluenzatrendsandviruscharacteristics;
identifiedpotentialcandidateinfluenzavaccinevirusstrainsthroughglobalsurveillance
activities;
usedcutting-edgetechnologiestoengineerinfluenzavaccinecandidatestrains;
providedweeklyelectronicreportsofinfluenzaactivitytohelpdoctors,publichealth
officials,andthegeneralpublicpreventinfluenzas spread;
helpedguidedevelopmentanddeploymentofmedicalcountermeasurestopreventandtreat
personsaffectedbyseasonalandfutureinfluenzapandemics;
servedastheNationalInfluenzaCenterfortheUnitedStatesandasoneoffiveWHO
CollaboratingCentersthatreceivedandtestedthousandsofinfluenzavirussamplesfrom
aroundtheworldtomonitorforemergenceandspreadofnewvariantviruseswithepidemic
andpandemicpotential,includinghighlypathogenicinfluenzaA(H5N1)virusesandother
subtypes(e.g.,H2,H7,andH9)thatcirculateinanimalreservoirpopulationsandposea
pandemicthreat;
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characterizedover11,000influenzavirusesfromdomesticandinternationalsurveillance
partnerlaboratories;
participatedwithotherWHOCollaboratingCentersandNationalInfluenzaCentersinthe
yearlyseasonalvaccinevirusselectionprocessfortheSouthernandNorthernHemispheres;
sequencedandconfirmedmultiplenovelinfluenzaviruses,includingH3N2v,whichwas
confirmedin12casesinfivestatesandhasthepotentialtoemergeasacirculatinghuman
strain;
developedavaccinecandidatestrainforH3N2vinfluenzavirusandstartedworkwith
manufacturerstodevelopavaccine,incaselarge-scaleproductionbecomesnecessary;and
developedandpilotedanewinfluenzariskassessmenttooltoassessthepandemicpotential
ofnovelinfluenzaviruses,whichwillhelpprioritizevirologicandepidemiologicstudiesand
provideinformationonwhichselectionofcandidatenovelinfluenzavirusesforpandemic
vaccinescanbebased.
BUDGET ACTIVITY HIV/AIDS, VIRAL HEPATITIS, STD, AND TB PREVENTION:
DOMESTIC HIV/AIDS
Despitemajoradvancesinpreventionandtreatment,HIVinfectionremainsasubstantialpublic
healthchallenge.CDCestimatesthatapproximately1.2millionpersonsintheUnitedStates
werelivingwithHIVattheendof2008andthatapproximately50,000personsarenewly
infectedeachyear.
CDCs laboratorieshelpadvancegovernmentwideeffortstoreducetheburdenofHIVand
acquiredimmunodeficiencysyndrome(AIDS)intheUnitedStates,asdescribedintheNational
HIV/AIDS Strategy.TheaimsoftheStrategyinclude
reducingnewHIV/AIDSinfections;
increasingaccesstocareandimprovinghealthoutcomesforpersonslivingwithHIV;and
reducingHIV-relatedhealthdisparities.
EarlyidentificationofHIVinfectioncanimproveaccesstolife-savingtreatment,reducefurther
transmission,anddecreasehealthcarecosts.
CDClaboratories
servedasworldwidereferencelaboratoriesfordiagnosisanddrug-resistancetestingfor
HIV/AIDSbyprovidingservicestobothdomesticandinternationalpartners(seetheGlobal
AIDSProgramsectionforadditionalactivities);
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conductedstate-of-the-arttestingtoadvanceHIVprevention,surveillance,andtreatment
(e.g.,testingtosupportearlydiagnosis[facilitatingreferraltocare,aswellascounselingto
helppreventtransmission],evaluatingdiseaseprognosisandresponsetotherapy,and
identifyingdrug-resistantviruses);
helpedstatehealthdepartmentsinvestigatecasesofHIVtransmissionthroughorgan
transplantation;
patentedanovelHIVdrug-resistancetestthatcanidentifyhiddendrug-resistantvirusesin
viralsubpopulationswithinindividualpatients,includingpatientswhorespondto
antiretroviraltherapy(developmentofdrugsthatcantargetthesehiddenvirusesmightlead
toacureforHIV);
developedandevaluatedadditionalnovelstrategiesandmethodsforHIVdetection,
isolation,andsurveillance(e.g.,strategiesforidentifyingHIVinfectionatearlierstagesof
disease,increasingthenumberofpersonswhoknowtheirinfectionstatusandarereferred
forcare,andfacilitatingsimultaneoustestingforinfectionwithHIVandviralhepatitis);
developedrapid,user-friendlyteststhatcanbeusedinthefieldtoidentifyrecentHIV-1
infectionsanddifferentiatebetweenHIV-1andHIV-2viruses;
updatedthenationaldiagnosticalgorithmsforHIVtestingandrevisedHIVscreening
guidelinesfororgandonations;
conductedpreclinicalandclinicalresearchonvaccinesandmethodsforpreventingHIV
transmission;
demonstratedthatthedosageofanoralantiviralmedicationneededtopreventHIVinfection
mightbereducedfromthecurrentlyrecommendeddailydosing;
evaluatedthethreattotheU.S.bloodsupplyposedbyhumanherpesvirustype8(HHV-8)
theetiologicagentofKaposi'ssarcoma,themostcommonAIDS-associatedmalignancy
worldwide and transferred HHV-8diagnostictechnologytointernationallaboratoriesin
AIDS-endemicareasofAfrica(alsodevelopedanHHV-8assayappropriatefororgandonor
screening);and
conductedresearchstudiestodetermineifanassociationexistsbetweenaretrovirus
xenotropicmurineleukemiavirus-relatedvirusandchronicfatiguesyndrome(CFS);no
suchassociationwasidentifiedand,consequently,twopeer-reviewedjournalarticlesfrom
non-CDCinvestigatorswereretracted(seetheEmergingandZoonoticDiseases:Chronic
FatigueSyndromesectionforadditionalactivities).
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VIRAL HEPATITIS
Approximately0.81.4millionpersonsintheUnitedStatesarechronicallyinfectedwith
hepatitisBvirus(HBV)and2.73.9millionareinfectedwithhepatitisCvirus(HCV).Many
personsareunawareoftheirinfection,puttingthematriskforcirrhosisorlivercancerandfor
transmittinginfectiontoothers.
CDCslaboratorieshelpadvanceeffortsacrossthegovernmenttoreducetheU.S.burdenof
chronicviralhepatitisandassociatedcancers,asdescribedintheU.S.DepartmentofHealthand
HumanServices Action Plan for the Prevention, Care and Treatment of Viral Hepatitis.
CDClaboratories
servedasaworldwidereferencelaboratoryfordiagnosisofhepatitisA,B,C,andE;
assistedU.S.statesandcitiesandVeteransAdministrationmedicalcentersininvestigating
23localoutbreaks,includinganoutbreakofHCVinfectionsinanoutpatientclinicin
Georgia,outbreaksofHBVinfectionsinanassistedlivingfacilityandapsychiatriclong-
termcarefacilityinVirginia,andoutbreaksofHCVinfectionstransmittedthrough
transplantedorgansandtissuesinKentucky;
conductedstate-of-thearttestingfordetectionofviralhepatitisantibodiesandantigensand
performedgenomicandproteomicprofilingofhepatitisviruses;
assistedindustryandacademicresearchersaswellashealthcarepartnersbyevaluating
rapidscreeningassaysfordetectionofantibodiestoHCV,
newmethodsfordistinguishingacutefromchronicHCVinfection,
useofmassspectrometrymethodstoimprovedetectionofHCVtransmission,
theefficacyofexistingvaccinesinpreventingHBVinfections,and
candidateHCVstrainsthatmightbeusedtodevelopvaccinesagainstHCV;
conductedappliedresearchonviraltransmissionandpathogenesis,includinganassessment
ofhostgenomicfactorsassociatedwithchronicviralhepatitisinfection;
providedtechnicalassistanceondiseasedetectiontotheU.S.MexicoBorderInfectious
DiseaseSurveillanceprogram;and
conductedsurveillanceforhepatitisEvirusesamonganimalstomonitortheemergenceof
newstrains.
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SEXUALLY TRANSMITTED DISEASES (STDs)
Approximately19millionnewSTDinfectionsoccureachyearintheUnitedStates,
approximatelyhalfofwhichareamongyoungpersons(thoseaged1524years).STDsexacta
tremendouseconomictoll.DirectmedicalcostsassociatedwithSTDsareestimatedtobemore
than$15billionannually.
CDCslaboratoriessupportpublichealtheffortstopreventandreduceSTDsandassociated
medicalcomplications(e.g.,infertilityresultingfrompelvicinflammatorydiseasecausedby
chlamydiaorgonorrhea;adversepregnancyoutcomes,includinginfantdeathsorillnesscaused
byneonatalherpesorcongenitalsyphilis;andcervicalcancercausedbychronicinfectionwith
HPV).
CDClaboratories
servedasworldwidereferencelaboratoriesfordiagnosisofchlamydia,gonorrhea,syphilis,
herpessimplexvirus,Mycoplasma,chancroid,andHPV;
monitoredemergenceofantimicrobialresistance(AR)insexuallytransmittedpathogensand
notifiedthehealthcareandpublichealthcommunities,asneeded(e.g.,aboutemerging
resistancetocephalosporinantibioticsusedtotreatgonorrhea);
providedreferenceservices,diagnosticsupport,andstaffproficiencytrainingtostateand
localhealthlaboratories,privatelaboratories,andFDA;
developedandvalidateddiagnostictests,includingnewmoleculartests,rapidpoint-of-care
tests,andtestsformolecularmarkersofdrugresistance;
providedexpertconsultationtophysiciansandphysiciangroups,includingnationalmedical
andnursingassociations;
updatedthenationallaboratorytestingguidelinesforsyphilis,gonorrhea,andchlamydia(to
bepublishedin2012);and
evaluatedtheimpactoftheHPVvaccinationprogrambyidentifyingHPVtypesincancers,
cervicalprecancers,andcervicalspecimenscollectedaspartofNHANES(seethePublic
HealthScientificServicessectionforamoredetaileddescriptionofNHANES).
13

TUBERCULOSIS (TB)
One third of the worlds population is infected with TB. During2010,approximately9million
personsworldwidebecameillwithTBand1.4milliondied.
AlthoughTBisdecliningintheUnitedStatesapproximately11,000caseswerereportedin
2010thediseasecontinuestoaffectdisproportionallyracialandethnicminorities,persons
infectedwithHIV,andpersonswhoareforeign-born,includingthosefromIndia,the
Philippines,Vietnam,andMexico.Moreover,emergenceofmultidrug-resistantTB(MDRTB)
andextensivelydrug-resistantTB(XDRTB)ispresentingnewchallengesfortreatmentand
control.PreventionofasinglecaseofMDRTBisestimatedtosavemorethan$250,000.
CDCs laboratoriesfocusonadvancingTBeliminationintheUnitedStatesbyreducingTB
amongpopulationsathighriskandreducingTBs globalimpact,includingHIV-associatedTB,
MDRTB,andXDRTB.
CDClaboratories
servedasworldwidereferencelaboratoriesfordiagnosisandresistancetestingforTB;
managedcooperativeagreementsthatprovidedtechnicalandfinancialsupportforTB
diagnosis,surveillance,anddrug-resistancetestingtoall50states,theDistrictofColumbia,
selectcities,andeightU.S.territoriesandfreely-associatedstates;
operatedtheMolecularDetectionofDrugResistanceservice,whichidentifiescasesofMDR
TBandXDRTB;theNationalGenotypingProgram,whichprovidesgeneticbacterial
fingerprintsofTBcasesreportedintheUnitedStates;andtheNationalGenotyping
InformationManagementSystem,whichanalyzeslaboratoryandepidemiologicdatatohelp
identifyTBcasesthatmightbepartofawidespreadormultistateoutbreak;
providedtestevaluationandguidancethatincreaseduseofrapidmoleculartestsbystateand
localpublichealthlaboratories,which
improvedturnaroundtimesforphysicians(i.e.,thetimetakenforaphysiciantoreceivea
laboratoryresult)sothatpatientscanbetreatedmorequickly,and
facilitatedpublichealtheffortstointerruptdiseasetransmissionincommunities;
providedquality-assessmentTBchallengesamplesto40publicandprivatelaboratories
throughtheModelPerformanceEvaluationProgram,whichmonitorsandimprovesdrug-
susceptibilitytesting;
14

providedreferencetestingservicestotheCDCTuberculosisTrialsConsortium,which
includes20clinicalsites,andconducted
appliedresearchondrugresistanceandhumanandbacterialgenetics,and
operationalresearchtodetermineoptimaldiagnosticmethodsandtestingalgorithmsfor
useinhigh-burdenandresource-limitedsettings;
contributedtoWHOguidanceonuseofanewtestfordetectingrifamycin-resistantTB,
whichcanfacilitaterapidisolationandspecializedtreatmentofpatientswithMDRTB;
issuedrecommendationsonuseofanew12-doseregimenforTBpreventivetherapythat
shortensandsimplifiesthecourseoftreatment;
servedasasupranationalreferencelaboratoryintheSTOPTBPartnershipsGlobal
LaboratoryInitiativeTuberculosisNetworkandworkedwithministriesofhealthandWHO
tostrengthenTBlaboratorysystemsoverseas,especiallyincountriesthatcontributetothe
burdenofTBintheUnitedStatesandcountriesthatexperienceoutbreaksofMDRTBor
XDRTB;and
ledaninternationalworkinggroupthatisdevelopingastrategyandorganizationaldesignfor
aninternationalprogramofTBlaboratoryaccreditation.
BUDGET ACTIVITY EMERGING AND ZOONOTIC INFECTIOUS DISEASES:
VECTORBORNE DISEASES
CDCsupportsprogramsforpreventionandcontrolofdiseasesspreadbymosquitoes,ticks,fleas,
andothervectorsintheUnitedStatesandabroad(e.g.,WestNilevirus,dengue/dengue
hemorrhagicfever,andJapaneseencephalitis).Thesediseasescausetensofthousandsof
illnessesintheUnitedStateseachyearandmillionsofcasesinternationally,andtheyrepresent
oneofthemostcriticalemergingthreatstohealthintheUnitedStates.Nohumanvaccinesare
availableforthevastmajorityofthesediseases.
Thesediseasescancauseseriousepidemicsandongoingendemicconditions.Twoexamples
follow:
Since1999,WestNileencephalitishasbeenthemostsignificantarthropodborneviralillness
intheUnitedStates,causinganestimated1.8millioninfectionsandmorethan12,700severe
illnesses.Outbreaksoftenhavebeenseverelocally,costingmillionsofdollarsinvector
controlefforts.
15

Dengue,themostimportantmosquitoborneviraldiseaseintheworld,threatensanestimated
2.5billionpersonsinmorethan100endemiccountries;100millioninfectionsoccur
annually.Theongoingriskfordengueisillustratedbyendemicdiseasetransmissionin
subtropicalareasoftheUnitedStates(e.g.,PuertoRico);sporadicoutbreaksinFlorida,
Texas,andHawaii;andthousandsofilltravelerswhoacquiredengueinotherpartsofthe
world.
CDClaboratories
performedprimaryandconfirmatorydiagnostictestingtodeterminetheetiologyof
suspectedandpreviouslyunknownvectorborne(VB)humaninfections;
evaluatedcommerciallyproducedassaysandadvancedthedevelopmentofnewproductsand
approachesforVBdiagnostics both optimization of existing and next-generationmethods
and development of novel field-deployable,inexpensivebedsideassays;
advanceddevelopmentandevaluationofinnovative,effectivetoolsforbetterprediction,
prevention,andcontrolofVBdiseases;
developed,successfullytested,andcommerciallylicensedinnovativepesticidesderivedfrom
naturalproductsandeffectiveagainstmosquitoes,ticks,andothervectorsthatare
increasinglyresistanttoexistingpesticides(thisworkhasbeencoveredinnationalmediaand
receivedCDCInnovationfunding, an intramural seed grant for ideas that address CDCs
publichealthpriorities);
conducteduniqueinvestigationsontheimmunology,molecularbiology,andgeneticaspects
ofvirusesandtheirhostsandvectors;
provideddiagnosticlaboratorytesting,referencediagnosticservices,andtrainingtolocal,
state,andinternationalhealthlaboratoriesinresponsetooutbreaks,characterizationof
unknownspecimens,andparticipationinfieldstudiesforVBinvestigations;
providedtrainingandproficiencytestingforlaboratorypartnerstoimproverecognition,
response,andconfidenceinVBassayresults;
developedoneofthefirstcandidatevaccineseffectiveagainstallfourspeciesofdengue
virus;
respondedtodengueoutbreaksinmultiplePacificIslandnationsandinEastAfrica;
coordinatedresponsetoyellowfeverinUganda;andrespondedtoadeadlytularemia
outbreakinLouisiana;and
completedvalidationandregulatorystudiesrequiredforFDA510(k)reviewofthefirst
denguemoleculardiagnostictestforuseintheUnitedStates.
16

LYME DISEASE
CDCaddressesthegrowingpublichealththreatintheUnitedStatesposedbyBorrelia
burgdorferi,thepathogenthatistransmittedbyIxodes ticksthatcauseLymedisease(LD).LD
wasthesixthhighestincidentreportablediseaseintheUnitedStatesin2010,with30,158cases
reportedtoCDC.Sincebecomingnationallynotifiablein1991,LDhasbeenincreasingsteadily
intheUnitedStates,bothincasenumbersandingeographicdistribution.
Laboratory activities support CDCs four-partstrategyforLDprevention:(1)strengthenand
refinenationalsurveillance;(2)identifyandvalidateeffectivepreventionmethodsand
approaches;(3)improveearlyandaccuratediagnosisandtreatment;and(4)leverage
collaborativepotentialwithexternalpartnersandstakeholders.
Tocombatthisgrowingpublichealthproblem,CDClaboratoriesworktodevelopnew
preventiontoolsforpersonsandcommunities,betterdiagnosticteststoreducemisdiagnosis,and
newvaccinecandidatestoreplacetheformerLDvaccineforwhichproductionwasdiscontinued
in2002.
Selected Laboratory Activities in FY2011
CDClaboratories
provideddiagnosticandreferenceservicesforLD;
developedacomprehensiveLDserumpanelforvalidationanduseinFDAlicensingofnew
diagnostictests;
distributedreferencereagentstointernallaboratoriesandexternalacademic,clinical,and
pharmaceuticallaboratories;
conductedresearchtotestanovel,food-gradeinsecticide;evaluatedabaitboxwith
antibioticbaitplusatopicalpesticideformitesandtickstargetingrodentreservoirsofLD;
evaluatedanoral,rodent-targetedvaccine;andtestedacommerciallyavailabledoxycycline
creamastick-biteprophylaxis;
discoveredanovelLDvaccinetargetforhumans;
furthereddevelopmentofLDdiagnosticteststhataresimpler,moreobjective,more
sensitive,andaccurateindetectingearlydisease;
identifiedbiomarkersofactiveLDforpotentialuseinnoveldiagnostics;
initiateddevelopmentofnewtickdiagnosticmethodsthatincludedgenetictestsforstudying
vectortickpopulationsandforquicklydetectingandcharacterizingtickbornepathogenic
organisms;
17

managedacooperativeagreementthatfundedtestsandtestingservicesin19statehealth
departmentsinLDendemicandborderlineendemicareas;
initiatedastudyatoneTickNetsitetodefinethefrequencyofsoutherntick-associatedrash
illnessthatmimicsearlyLD;and
launchedanenhancedcommunicationplanandInternet-basedpreventiontoolkitthat
includesinformationregardinglaboratorytestingforLDtoimprovepublicawarenessand
knowledge.
FOOD SAFETY
EveryyearintheUnitedStates,anestimated1in6U.S.residentsexperiencesafoodborne
illness,128,000arehospitalized,and3,000diefromfoodborneillnesses.Theagentsresponsible
fortheseoutbreaksincludebacteriasuchasEscherichia coliO157,Salmonella, Shigella,
Listeria,andCampylobacter;parasitessuchasCryptosporidium,Entamoeba histolytica,
Naegleria fowleri, Angiostrongylus cantonensis,andPlasmodium;andvirusessuchasnorovirus
andhepatitisA.
Foodrecallshelpstopfoodbornediseaseoutbreaks,therebypreventingadditionalillnesses,
hospitalization,anddeaths.PreventingasinglefatalcaseofE. coliO157savesupto$7million
in direct medical costs. The CDC Food Safety Programs laboratory activities support detection,
control,andpreventionoffoodborneillnessoutbreaks.
CDClaboratories
ledandcoordinatedthePulseNetsystemanetworkofpublichealthandfoodregulatory
agencylaboratoriesthatincludes75laboratoriesintheUnitedStatesand82countriesaround
theworld(PulseNetmemberlaboratoriesperformstandardizedmolecularsubtypingor
fingerprintingoffoodbornedisease-causingbacteriaandsubmittheresultstoCDCwherethe
informationisstoredandmadeavailableonlinetootherparticipantsinvolvedinfoodborne
diseaseinvestigations,uponrequest,allowingrapidcomparisonoffingerprintstolinkcases
withinasingleoutbreak);
investigatedoutbreaksoffoodborneillnessandprovidedoutbreakassistancebytesting
suspectedoutbreaksamplesandfacilitatingoutbreakinvestigationsonsite;
ledthepublichealthandfoodsafetysystemsindetecting,investigating,andcontrolling
multistateoutbreaksoffoodborneinfections,including
18

listeriosisoutbreakassociatedwithColoradocantaloupes,whichresultedinthedeadliest
foodbornediseaseoutbreakintheUnitedStatesinapproximately90years;
multidrug-resistantSalmonellaserotypeHeidelbergoutbreakassociatedwithground
turkey;
salmonellosisoutbreaklinkedtopapaya;and
threeE. coliO157outbreakslinkedtoromainelettuce,hazelnuts,andbologna;
playedamajorroleintheinvestigationoftheGermanE. coli O104:H4outbreakby
confirmingU.S.casesandlinkinginternationalcases;
coordinatedtheongoinglaboratoryresponsetothecholeraoutbreakinHaiti,including
testingofhumanandenvironmentalsamplesandthetrainingofHaitiansinlaboratory
methods;
ledandcoordinatedCaliciNetanelectronicnorovirusoutbreaksurveillancenetworkthat
allowsparticipantstocomparefingerprintsfromnorovirusoutbreaks,oftenoccurringon
cruiseships,thathaveacommonsource,allowingforrapidcomparisonoffingerprintsto
linkcaseswithinasingleoutbreak;
improvedcapacityatthestateandlocallevelsinconductingsurveillanceforfoodborne
diseasesandindetecting,investigating,controlling,andreportingoutbreaks;
trainedstateandlocallaboratorypersonneltoassistinfoodborneoutbreakinvestigations;
providedsurgecapacitytestingforstatehealthdepartmentslackingthelaboratorycapacity
crucialforrapidfoodborneoutbreakinvestigationandmonitoring;
providedworldwidereferencelaboratorysupporttoaddressdiagnostictestingforhepatitis
A;
developedandimprovedteststodetectandidentifyfoodbornedisease-causingagents(e.g.,
SalmonellamolecularsubtypingandE. coli genotypingtestmethods);and
provideddataandanalysistoFDAandUSDAonwhichtobasefoodsafetyactionandpolicy
thatledtorecallsofgroundturkey,groundbeef,cantaloupes,importedpapayas,andother
contaminatedfoods.
19


CHRONIC FATIGUE SYNDROME
CFSisestimatedtoaffect14millionU.S.residents.Theillnessislong-lastinganddebilitating,
withanegativeeffectonhealthandqualityoflifesimilartoheartdisease,multiplesclerosis,
cancer,andAIDS.IntheUnitedStates,therelatedannuallossinproductivityisworthan
estimated$9billion,withadditionaldirectmedicalcosts.
CDCsupportsanintramuralmultidisciplinaryprogramthatobtainsandanalyzesbaseline
informationthatwillaiddevelopmentofinterventionsforCFSandwillimprovemeasurementof
clinicaloutcomes.LaboratoryactivitiesaredirectedatimprovingCFSdiagnosisandattempting
toidentifygroupsresponsivetospecifictherapies.Theseactivitiescomplementclinicalresearch
initiativesthatfocusonthecauses,consequences,andtreatmentofCFSandrelateddiseases.
CDClaboratories
maintainedthecollection,processing,andarchivingofserum,plasma,saliva,wholeblood
DNA,andRNAsamplesfromCDCstudiestoformabiorepositorylinkedtoclinicaland
epidemiologicdatafordiscoveryandvalidationofbiomarkersforCFS(materialshave
alreadybeenusedforcollaborativeprojectsinvolvingxenotropicmurineleukemiavirus-
relatedvirus,metagenomicsforunknownpathogens,andforsalivarybiomarkerdiscovery);
conductedmolecularanalyses(e.g.,geneexpressionprofiling)andevaluatedmarkersof
inflammationinbloodsamplesfromcase-controlstudiesofstress-responseasanapproachto
understandingthepathophysiologyofCFSandtoidentifyingCFSsubgroupswithtargetsfor
therapeuticintervention;
analyzedfunctionalmagneticresonanceimagingcase-controldatatoinvestigatethe
hypothesisthatfatigueinCFScorrelateswithalterationsinthebrain;
initiatedstudiestoevaluatehumanherpesvirus-6inCFSandtoidentifybiomarkersof
fatigue;and
continuedeffortstodiscoverpotentialbiomarkersandtheunderlyingpathophysiologyof
CFStovalidatetheimportanceoftheillnessandtoprovideanimpetusfornewtherapeutic
strategies.
EMERGING INFECTIOUS DISEASES
Therangeofpathogenicorganismsandinfectiousdiseasescoveredbythisbudgetactivityis
broadandincludesviral,bacterial,fungal,andparasiticagents.The goals of CDCs emerging
infectiousdiseaseactivitiesaretobuildstateandlocalpublichealthlaboratorycapacity
throughout the United States and to strengthen CDCs core infectious diseaselaboratories.
20

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,includinghealthcare
associatedinfections,whichaloneresultinapproximately100,000deathsandcostin
excessofseveralbilliondollarsannually;
improvingdetectionandcharacterizationofhealthcareassociatedpathogens(e.g.,
Clostridium difficileandmethicillin-resistantStaphylococcus aureus[MRSA]);
detectingnovelandemergingantimicrobialresistanceinhealthcare-associated
bacteria;and
studyingtheimportanceofhealthcareassociateddiseasepathogensinbiofilms(e.g.,
onmedicaldevices);
high-consequencepathogens,includinganthrax,melioidosis,glanders,Ebolaand
Marburghemorrhagicfevers,rabies,monkeypox,smallpox,andbrucellosis,including
usingmoleculartechniquestocharacterizehigh-consequencebacteriainclinical
specimensreferredtoCDCbystateandlocalpublichealthdepartments;
21

servingasWHOCollaboratingCentersforviralhemorrhagicfevers,forpoxviruses,
andforreferenceandresearchonrabies;
servingasaninternationallaboratoryoftheWorldOrganizationforAnimalHealth,
providingdiagnosticreferencetestingforhumanpathogensthatarecarriedby
animals;
identifyingandcharacterizingpotentialmoleculartargetsfortreatingandpreventing
infectionswithhigh-consequenceviruses;
expandingtherangeofdiagnosticcapacitybyimprovingmolecularandserological
assaystohigh-consequenceviruses;and
providingongoingtrainingandmonitoringofpartnernationsonlaboratoryquality
improvement,competency,andstafftraininginaccordwithDefenseThreat
ReductionAgencyguidelinesandgoals.
respiratoryandentericdiseases(e.g.,Legionella,GroupAandBstreptococcus,
mycoplasma,respiratorysyncytialvirus,adenovirus,coronaviruses[SARS],and
rotavirus),including
o servingasaworldwidereferencelaboratoryandtrainingresourcefordiagnostic
testingandantimicrobialsusceptibilitytesting;
o developingnewdiagnostictests,includinganovelassaythatcanbeusedduringan
outbreaktotestsimultaneouslyfor21differentrespiratorypathogens;
o conductingsurveillancestudiestodeterminetheburdenofrespiratorydiseaseinthe
UnitedStates;and
o supportingtheglobalintroductionofnewvaccinesagainstpneumococcalpneumonia
androtavirus(e.g.,byprovidingreferenceservicesformeasuringprotectiveantibody
responsestovaccination);
waterborneandenvironmentalpathogens,including
o identifyingpathogenicfungianddetectingantifungalresistance;
o respondingtodiseaseoutbreaksassociatedwithenvironmentaltransmission(e.g.,
throughdrinkingwater)andusingmolecularsubtypingtomatchpatientand
environmentalisolates;
o developingandimplementingenvironmentalmicrobiologytechniquesfordetecting,
recovering,andinactivatinginfectiouspathogens;and
o providingpublichealthandhospitallaboratorystafftrainingonmoldidentification;
22

meningitisprevention,includingsupportingthedevelopmentandintroductionofanew
meningitisvaccineinAfricancountriesthatexperiencemeningitisepidemicsandleading
developmentofthesecondeditionoftheWHOmanual,Laboratory Methods for
Diagnosis of Meningitis caused by Neisseria meningitidis, Streptococcus pneumoniae,
and Haemophilus influenzae,aglobalresourcefordetection,isolation,and
characterizationofinvasivebacterialvaccine-preventablediseaseagents;
viralhepatitisandSTDs,including
o diagnostictestingforacuteandchronichepatitisBandC;
o establishingapathogendiscoveryprogramtoinvestigatenon-AEviralhepatitis;
o serologictestingforHPV;and
o evaluationoftheimpactofHPVvaccination;
laboratorysupportforfieldinvestigationsofRockyMountainspottedfeverandother
rickettsialdiseases;
providedexpertisetostrengthensurveillanceandappliedresearchprogramstoimprove
detectionandpreventionofnewandemerginginfectiousdiseasethreats,includingsupport
for
developmentofpathogendiscoverytechniquestoidentifynewandemerginglyssaviruses
(thevirusesthatcauserabies);
identificationofsuitabletargetsfordevelopmentofmedicalcountermeasuresforviral
hemorrhagicfevers(i.e.,high-consequenceviruses);
developmentofintegratedecologicandepidemiologicstudiesformonkeypoxandother
orthopoxvirusdiseasesintheUnitedStatesandglobally,andimproveddiagnostic
capabilitiesfororthopoxvirusdiseaseworldwide(thesestudiesfocusonhumandisease,
monkeypoxdiseaseecology,anddiseasetransmissiondynamicsandprovideevidencefor
diseasecontrolefforts,includingtheuseofvaccine);
developedandenhancedcriticalinfrastructureatCDC,including
high-containmentlaboratories(biosafetylevel-3and-4)requiredforworkwithknown
high-consequencepathogens(e.g.,anthrax,melioidosis,glanders,EbolaandMarburg
hemorrhagicfevers,rabies,andbrucellosis),andcriticalintherapididentificationof
newlyemergingpathogensassociatedwithhigh-fatalitydiseaseoutbreaks;
apathologylaboratoryunitthatprovidesstate-of-theartdiagnosticevaluationoftissue
specimenstohelpidentifypreviouslyunrecognizedornewinfectiousdiseases(e.g.,
H1N1pandemicflu,SARS,andhantaviruspulmonarysyndrome);
23

anenvironmentalmicrobiologylaboratoryactivitythatdevelopsandimplements
diagnosticanddisinfectiontechniquestoenhancefoodandwatersafety;
afieldlaboratoryinAlaskawithadiverseportfolioofactivitiesthatsupports
surveillance,studiesinantimicrobialresistance,vaccineevaluations,outbreakresponse,
appliedlaboratoryresearch,andpreparednessactivities;and
abiotechnologycorelaboratorythatperformshigh-throughput,next-generation
sequencingofbacterial,viral,andfungalgenomes;associatedgenomicassembly;and
advancedbioinformaticsforinfectious,andimportantly,outbreakandunknownpathogen
identification;proteomicanalysesofthefunctions,structures,andinteractionsof
proteins,primarilybymassspectrometryandproteinsequencing;chemicalsynthesisof
complexoligonucleotidesandpeptidescriticalformoleculartechnologiesusedbyCDC
laboratoriesandLRN;aswellasevaluatesanddevelopsnew,cutting-edgetechnologies
(thesefunctionsandtheexpertisethatsupportsthemcontinuetoprovidethedataandthe
knowledgeneededbyCDCscientistsandphysiciansrapidly,particularlyduring
emergencies,tokeeptheagencyattheforefrontofpublichealthinanexpandingand
evolvingworld);
providedlaboratoryinfrastructureservicestoallCDCinfectiousdiseaselaboratories,
including
developinganinfectiousdiseaselaboratorydatabaseacomprehensiveandcross-
linkedsourceofinformationregardingCDClaboratoriesforstakeholdersandleadership
andtoaidinmeetinganticipatedFDArequirementsforlaboratory-developedtests;
supportinguniforminformationmanagementsystemsforinfectiousdiseaselaboratories
thatenhancecapacityfortracking,reporting,andanalyzingsamplesreceivedfortesting,
surveillance,andoutbreakinvestigations,aswellasprovidingenterprisecapacityfor
interoperability(i.e.,datasharing)throughtechnologicadvances,sharedresources,and
strategicalignmentwithexternalpartners;
enhancinga quality management system across CDCs infectious diseases laboratories to
strengthenregulatorycomplianceandadherencetoqualitystandardsforthese
laboratories;
supportingcutting-edgepublichealthbioinformaticsthroughanewcentralized
bioinformaticscoreconsistingofhighlyskilledbioinformaticsscientistswhocollaborate
withCDCprogramscientiststofacilitatefasterpathogenidentification,developmentof
betterdiagnostics,andimprovedanalysisoflaboratorydataforepidemiologic
surveillanceandoutbreakinvestigations;
purchasinganddistributinglaboratorysuppliesandpersonalprotectiveequipment;
producing,managing,andshippingbiologicproducts,diagnostickits,cellcultures,and
high-qualityspecializedreagents;
24

providinganimalcareservices(maintainedatmultiplelaboratorysites),withongoing
veterinarycare,guidance,andoversighttoensurethewelfareoflaboratoryanimals
(uniqueservicesthatincludemaintenanceofinsectandtickcoloniesforworkwithVB
pathogens[e.g.,dengueandLD]);
managingspecimens(includingtriage,processing,anddistribution)andmaintaininga
serumbankusedinstudiesofdifferentpathogens;
decontaminatingbiologicwaste,monitoringautoclaves,andmaintaininglaboratorywater
systems;and
providingtheLaboratoryOutreachCommunicationSystemforCDC'sEmergency
OperationsCenterandurgentcommunicationsduringresponseeventstopublichealth
laboratoriesandthe25largestassociationsforlaboratoryprofessionals.
OTHER
ThisbudgetactivityprovidesfundingforactivitiesrelatedtocontrollingandpreventingARand
fordetectingandcontrollingdiseasesforrecognizedandemerginghigh-consequencethreats
knownasspecialpathogens.
AntimicrobialResistance
ARisoneoftheworlds most pressing public health threats and is increasing in scope.
Infectionswithresistantbacteriahavebecomemorecommoninhealthcareandcommunity
settings.Patientsinfectedwithdrug-resistantmicrobesaremorelikelytorequirehospitalization,
remaininthehospitallonger,andhaveapoorprognosis.Ina2008studyofhospital-acquired
antimicrobial-resistantinfections,themedicalcostsattributabletoARrangedfrom$18,588to
$29,069perpatient;hospitalstayswereextendedby6.412.7days;andthemortalityattributable
toARwas6.5%.Usingthemostconservativeestimates,thetotalcostoftheresistantinfections
was$13.35milliondollarsforthe188patientsinthatstudyalone.
Ineffortstoidentify,control,andpreventnewAR,CDClaboratoriessetanultimatestandardfor
laboratorytestingforstatehealthdepartmentsandhospitallaboratories,CDCsurveillanceand
outbreakcontrol,andanalysisofARtransmissionandriskfactors.
CDClaboratories
providedgold-standardtestingservicestostatehealthdepartments,clinicaldiagnostic
laboratories,andacademicresearchersandcollectedandmaintainedarepositoryofAR
isolates;
25

supportedCDCsurveillancesystemsbytestingorganismsofpublichealthimportance,
includingStreptococcus pneumoniae,GroupAandBstreptococcus,Neisseria meningitidis,
MRSA,Haemophilus influenzae,Neisseria gonorrhoeae,Helicobacter pylori,andCandida;
monitoredresistanceratesandinformed,guided,andevaluatedpreventionefforts;
providedoutbreakresponseandtechnicalassistancetostatehealthdepartments(e.g.,
collaboratedwithsevenstatehealthdepartmentsandPuertoRicotostopoutbreaksof
carbapenem-resistantEnterobacteriaceae,andalsoprovidedsusceptibilitytestingforstate
andhospitallaboratories);
testedmorethan5,000samplesofmicrobes,includingSalmonella, Shigella, Campylobacter,
E. coli,andVibrio,todocumenttheemerginggeneticmechanismsofresistanceto
antimicrobialdrugs;
conductedstraintypingandadditionalmolecularcharacterizationofmultipleARpathogens,
includingcarbapenem-resistantEnterobacteriaceae,MRSA,C. difficile,andmultidrug-
resistantAcinetobacterspecies;
detectedemergenceofantibioticresistantN. gonorrhoeaeanddevelopedmolecularassays
fordetectingcephalosporin-resistantN. gonorrhoeaeintheUnitedStates;
usedcultureandmoleculartechniquestodetectandidentifymechanismsofARforall
respiratoryandvaccine-preventablebacterialdiseases,includingS. pneumoniae,N.
meningitidis,andGroupAandBstreptococci;
developednewassaysforsurveillanceofresistanthepatitisCstrainsbypredictingresistance
tocombinedinterferon/ribavirintherapyamongpatientschronicallyinfectedwithhepatitisC
virus;and
detectedtheemergenceofastrainofantibiotic-resistantpneumococcusnotcoveredbythe
PCV7pneumococcalvaccinethatwasrecommendedbytheAdvisoryCommitteeon
ImmunizationPractices(ACIP)in2000(thishelpedguidetheinclusionofthisstraininthe
newpneumococcalvaccine,PCV13,whichwasrecommendedbyACIPin2010).
Hantavirus/SpecialPathogens
Hantaviruspulmonarysyndromeisasevere,sometimesfatal,respiratorydiseaseamonghumans
causedbyinfectionwithahantavirus.CDCprovidescontinuingsurveillanceandepidemiologic
studiesofhantavirusesintheUnitedStatesandglobally.CDCalsoprovidesreagents,technical
advice,responseteams,andepidemiologicinvestigationstoimprovediagnosticandreagent
capabilityforhantavirusesandrelatedhemorrhagicfeverviruses.Throughitslaboratorywork,
CDChasdevelopedmoresensitiveassaysfordetectionofhantavirusesandemerging
hemorrhagicfeverviruses,andforevidenceoftheirinfectionamonghumansandanimalhosts,
thatwillenhancetheabilitytorespondtooutbreaksofthesediseasesdomesticallyandglobally.
26

CDClaboratories
providedlaboratorysupporttoallstatehealthdepartmentsforhantaviruspulmonary
syndromediagnosticsandconsultationsregardingcasemanagementandsurveillance;
providedconsultationsonhantavirussmallanimalreservoirpopulationsinNorthandSouth
America;
conductedbasicresearchtounderstandfurtherthenaturalhistoryandpathogenicityof
hantavirusesforimproveddiagnosticsandvaccinedevelopment;
completedsuccessfulvaccinetrialsofalive-attenuatedRiftValleyfeverrecombinantvirus
foruseamonglivestock;and
discoveredanovelphlebovirusassociatedwithtwoMissouricasesofseverefebrileillness
withthrombocytopenia.
BUDGET ACTIVITY CHRONIC DISEASE PREVENTION AND HEALTH
PROMOTION
ChronicdiseasesaretheleadingcauseofpreventabledeathintheUnitedStates.Preventionand
controlofchronicdiseasesareamongCDCs highest priorities.Annually,U.S.residentssuffer
morethan2millionheartattacksandstrokes.Anestimated443,000personsdieprematurely
fromsmokingorexposuretosecondhandsmoke.Cigarettesmokingaccountsformorethan$96
billionayearinhealthcarerelatedcostsand$97billionayearinlostproductivity.Deficiencies
inmicronutrients(e.g.,iron,iodine,vitaminA,folate,andzinc)affectathirdoftheworld's
population.
CDCs related laboratory activities center on developing and applying accurate, high-quality
methodsto(1)improvedetection,diagnosis,treatment,andpreventionofcardiovasculardisease;
(2)reduceindividualandpopulationexposuretoaddictiveandtoxicsubstancesintobacco
products;and(3)improvenutritionthroughreductionsinmicronutrientdeficiencies.
LipidStandardizationProgramandReferenceLipidTesting
CDClaboratories
developedandmaintainedhighlyaccurateandprecisemethods,includingtwonewmass
spectrometryreferencemethods,tomeasuretotalcholesterol,high-densitylipoprotein(HDL)
cholesterol,low-densitylipoprotein(LDL)cholesterol,andtriglycerides;
27

operatedaninternationallyrecognizedreferencelaboratorytocalibrateandmonitor
accurately,overtime,cholesterolandlipidmeasurementsusedinpatientcare,publichealth,
andresearch;
servedastheonlyU.S.laboratorythatprovidestechnicalassistanceoncholesterolandlipid
assessmentthroughreferencemeasurements,training,andprofessionaleducationactivities;
conductedresearchtoidentifyandbetteraddressproblemswithcurrentcholesterolandlipid
measurements;
providedquality-controlmaterialsto84laboratories,including43research(academic)
laboratories,38commerciallaboratoriesperformingpatient-caretestingandclinicaltrials,
andthreeassaymanufacturerstoensureaccuracyoflipidmeasurementforongoingU.S.and
internationalstudiesofcardiovasculardisease;and
assignedreferencevaluestoproficiencytestingsurveymaterialsusedinassessingthe
performanceofpatientcare,publichealth,andresearchtests(incollaborationwiththe
CollegeofAmericanPathologists).
TobaccoTesting
CDClaboratories
maintainedtheonlyfederallaboratorythatmeasuresaddictiveandtoxicsubstancesin
tobaccoproductsandsmoke,aswellasintheurineandbloodofpersonswhousetobaccoor
areexposedtosecondhandsmoke;
studiedtheeffectsofchemicaladditives,constituents,anddesignonthetoxicityand
addictivenessoftobaccoproducts;
documentedtheimpactthatdifferenttypesofcigarettesandsmokingstyleshaveonexposure
tocarcinogenictobacco-specificnitrosamines(TSNAs)andusedtheselaboratoryfindingsto
shapefutureCDCNHANESsurveys,whichwilltrackcigarettetypesandsmokingbehaviors
tomonitorhowchangesincigarettecompositionaffecthumanexposure(seethePublic
HealthScientificServicessectionforamoredetaileddescriptionofNHANES);
assessed U.S. residents exposure to the harmful chemical constituents oftobaccosmoke,
includingmeasuringahighlyspecificbiomarkerofthemostcarcinogenicTSNA(thefirst
assessmentofexposuretotobaccocarcinogensamongtheU.S.population)andserum
cotinine,amarkerofnicotineandsecondhandsmokeexposure,therebydeterminingthat
nonsmokersexposuretotobaccocarcinogensincreaseswiththeirexposuretosecondhand
smoke;
collaboratedinhealthstudiesexaminingtheassociationofsecondhandsmokeexposurewith
cancer,asthma,suddeninfantdeath,birthdefects,andotherdiseases;
28

demonstratedthatroll-your-owncigarettesdeliverasmuchasormoremainstreamsmokeas
manufactured cigarettes, potentially increasing a smokers exposure to toxic and addictive
chemicals;
collaboratedwithFDAs southeasternregionallaboratorytoestablishstandardmethodsto
measuretobaccoproductconstituentsand to enhance FDA laboratories capability to conduct
testsinsupportofregulatorystandards;and
supportedgloballaboratorycapacitytoanalyzeaddictiveandtoxicsubstancesintobacco
throughshareddevelopmentoftestingmethodsandtestvalidation(incollaborationwiththe
World Health Organizations Tobacco Laboratory Network).
QualityAssuranceandTrainingforMicronutrientTesting
CDClaboratories
improvedlaboratorymeasurementstodetectmicronutrientdeficienciessothatnational
nutritionsurveysindevelopingcountriescanefficientlyandreliablyassessnutritionalstatus;
and
providedfulllaboratorysupport,includingtechnicalassistance,in-countryplanningand
training,externalqualityassessment,andtechnologytransfertoensureaccurateassessment
ofnutritionalstatusinnationalnutritionsurveysintheDemocraticRepublicofCongo,the
DominicanRepublic,Iraq,Kenya,Kyrgyzstan,andMalawi.
BUDGET ACTIVITY BIRTH DEFECTS, DEVELOPMENTAL DISABILITIES,
DISABILITY, AND HEALTH
Birthdefectsandblooddisordersplaceaconsiderableburdenonpersons,families,andsociety.
Approximately1in33babies(orabout130,000annually)isbornwithabirthdefect.Birth
defectsaccountformorethan20%ofinfantdeathsandresultinmorethan$2.6billionannually
inhospitalcosts.NonmalignantblooddisordersaffectmillionsofU.S.residentseachyear.
Directhealthcarecostsforhemophiliaaloneexceed$1billionperyearandmightapproach$3
$4billionifcomplicationsareconsidered.
CDCs internal laboratory activities to address birth defects and blood disorders focus on(1)
preventingandreducingtheadverseconsequencesofbirthdefectsbyconductingstudiesto
identifygeneticfactorsthatcontributetothecausesofthesecomplexdiseasesand(2)preventing
deathanddisabilitybyreducingthecomplicationsassociatedwithblooddisorders.
29

CDClaboratories
servedasthecentrallaboratoryfortheNationalBirthDefectsPreventionStudy(NBDPS),
thelargestpopulation-basedcase-controlstudyintheUnitedStatesthatcollectsgenetic
samplesandinformationregardingenvironmentalexposures;incollaborationwitheight
grantees,
testedthequalityofmorethan5,500biologicspecimenscollectedatNBDPSsites;
developed,validated,andperformedgenetictestsforresearchstudiesonselectedbirth
defects;
investigatedandappliedoptimalmethodsforDNAcollection,processing,andquality
assessmentandprovidedguidanceonthelong-termstorageofbiologicspecimens;
providedquality-assurancematerialsandtechnicalassistancetoensurethatcollaborating
NBDPSlaboratoriesperformhighlyaccuratemeasurements;
performedpilotprojectstoevaluatenewtechnologiesforthecollection,processing,
genotyping,andstorageofbiologicspecimens;and
evaluatedcollectionmethodsandprovidedguidancetoincreasetheeffectivenessof
NBDPSsampleuse;
monitoredforinfectiousagentsintheU.S.bloodsupplytopreventthetransmissionof
infectiousdiseasestopersonsundergoingtreatmentforbleedingdisordersandthalassemia
(theonlylaboratoryintheworldthatconductssuchactiveinfectiousdiseasesurveillance);
monitoredandadaptednewtechnologiesforsurveillanceofbloodproducts;
performedgeneticandotherrelatedresearchoncoagulationinhibitor(antibody)formation,a
seriouscomplicationamonghemophiliapatients;
compiledandmaintainedanationaldatabaseofgeneticinformationtohelpproviders
diagnoseandpreventdiseasecomplicationsassociatedwithhemophiliaandcoagulation
inhibitors;
maintainedthelargestcollectionintheworldofDNAsamplesfrompersonsofAfrican
descentintheUnitedStateswhohavehadavenousthrombosisevent(acriticalresourcefor
definingriskfactorsamongthispopulation);and
performedABOBloodGrouptypetestingduringthe2011Haiticholeraoutbreaktoassess
theseverityofdisease.
30

BUDGET ACTIVITY ENVIRONMENTAL HEALTH
Public health action to protect the nations health includes promoting a healthy environment and
preventingprematuredeath,avoidableillness,anddisabilitycausedbynoninfectious,
nonoccupational,environmental,andrelatedfactors.CDCs EnvironmentalHealthLaboratory
providesuniquelaboratorysciencetoimprovedetection,diagnosis,treatment,andpreventionof
(1)diseasesthatresultfromexposuretoenvironmentalchemicals,(2)treatablecongenital
disordersamongnewborns,and(3)nutrition-relateddiseasesandselectedotherdiseases
requiringadvancedlaboratorymeasurementforaccuratediagnosis.
Environmental Health Laboratory
BiomonitoringofChemicalExposures
IntheUnitedStatesandinternationally,personscomeintocontactwiththousandsofchemical
substancesintheenvironment,bothnaturallyoccurringandmanufactured.TheEnvironmental
HealthLaboratoryconductsbiomonitoringthedirectmeasurementofenvironmental
chemicals,ortheirproducts,inhumanbloodandurinetoassesspopulationandindividual
exposuretoenvironmentalchemicals.
CDClaboratories
conducted the nations only comprehensive assessment of U.S. residents exposuretomore
than300chemicalsintheenvironmentthroughbiomonitoringofpersonswhoparticipatein
theongoingNHANESsurvey(seethePublicHealthScientificServicessectionforamore
detaileddescriptionofNHANES);
updatedtheFourth National Report on Human Exposure to Environmental Chemicalsto
includenewbiomonitoringresultsfor66environmentalchemicals,includingcotinine,
bisphenol-A,phthalates,triclosan,andperfluorchemicals;
providedlaboratorymeasurementsfor50studiesthatexaminedtheexposureofvulnerable
groupstoenvironmentalchemicalsorinvestigatedassociationsbetweenexposuresand
adversehealtheffects;
served as the worlds soleorprimarysourceforhigh-qualitylaboratorytestsinhumanblood
orurineforbisphenol-A,transfattyacids,speciatedarsenic,uranium,speciatedmercury,
volatileorganiccompounds,phthalates,triclosan,selectedradionuclides(e.g.,polonium-210,
cesium-134,cesium-137,andiodine-131),andothersubstances;
31

developed,evaluated,andappliedinnovativelaboratorymethodsto
improveresponsetopublichealthemergencies,includingemergenciesthatinvolve
diseaseanddeathfromunknowncauses;and
measureandanalyzepriorityenvironmentalchemicals;
providedtechnicalsupport,training,qualityassurance,andtechnologytransfertostateand
locallaboratoriesduringinvestigationsofknownandpotentiallyunsafechemicalexposures;
and
demonstratedtheimpactofvoluntarydiscontinuationoftheuseofperfluorooctanesulfonic
acid(PFOS)bydocumentingasubstantialreductioninhumanexposuretoPFOSafterthe
endofproductionin2002.
NewbornScreening
Eachyear,morethan4millionnewbornsnearlyeverynewbornintheUnitedStatesare
screenedforsuchdisordersascongenitalhypothyroidismandsicklecelldisease.These
conditionsoftencanbetreatedtopreventseriouscomplicationsifdetectedearlyinlife.State
publichealthlaboratorieswhichtest98%ofU.S.infantsforbirthdefectseveryyearrely
onCDCtoensuretheaccuracyoftestingandtodevelopmethodsfordetectingcongenital
disordersthatarenotapparentatbirth.
CDClaboratories
operated the nations only quality-assuranceprogramtoensuretheaccuracyofnewborn
screeningteststodetecttreatablediseasesthatcausemalformation,mentalretardation,and
death;
providednewbornscreeningquality-assurancematerials,proficiencytesting,andtechnical
assistancetomorethan500laboratoriesinall50U.S.statesandin67countries;
developednewmethodstodetectnewborndiseases;and
conductedlaboratorystudiesthatsupportedtheadditionofseverecombined
immunodeficiency (SCID), better known as Bubble Boy Disease, to the U.S.Department
of Health and Human Services Secretarys Recommended Uniform Newborn Screening
Panelthefirstnewconditionaddedtotheoriginalpanelof29conditions(SCIDaffectsan
estimated1in100,000to1in40,000newbornsandleadstodeathduringinfancyifnot
treatedearly).
32

Nutrition-RelatedandSelectedOtherChronicDiseases
Preventionandtreatmentofnutrition-relatedandselectedotherchronicdiseasesrequireaccurate
laboratorymeasurementtodetectanddiagnosediseaseandtoassesstheeffectivenesspublic
healthinterventions.
CDClaboratories
conducted the nations only comprehensive assessment of the nutritional status of the U.S.
populationbymeasuringmorethan50nutritionalindicatorsamongpersonswhoparticipate
inNHANES(seethePublicHealthScientificServicessectionforamoredetaileddescription
ofNHANES);
developednewandimprovedmethodsformeasuringnutritionalanddietarybioactive
compounds,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 lead
throughbiomonitoringofpersonswhoparticipateintheNHANESsurvey,determinedthe
prevalenceofpersons(includingchildrenaged1yearandolder)withleadexposureshigher
thantoxicitylevels,andreportedelevatedexposurestoensureeffectivetreatmentand
exposureinterventions(seethePublicHealthScientificServicessectionforamoredetailed
descriptionofNHANES);
providedlaboratorymeasurementsfor11 studies (including the National Childrens Study)
thatexaminedtheexposureofvulnerablegroupstolead;
providedbloodleadqualityassurancetonearly70U.S.laboratoriesthroughCDCs Lead
andMulti-ElementProficiencyProgram;
providedportablebloodleadinstruments,qualityassurance,training,andlaboratory
assistancetotheinvestigationofanoutbreakofleadpoisoningintwominingvillagesin
Nigeria,whereCDCstaffusedtheportableleadinstrumenttoidentifyexposedchildren
rapidlyonsite,enablinglife-savingmedicaltreatment.
33

BUDGET ACTIVITY PUBLIC HEALTH SCIENTIFIC SERVICES
Thisbudgetactivityprovides funding for activities related to support services for CDCs
laboratories 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.
TheseessentialsupportservicesextendfromcoordinationofnationalCDClaboratoryinitiatives
toassistanceincomplyingwithmultiplefederalregulatorymandates.Theyalsoinclude
technicaltraining,laboratoryworkersafety,andavailabilityofsuitableequipmentandfacilities,
amongotherservices.
CDClaboratory-supportservices
assessedimplicationsforthe agencyslaboratoriesifstateandlocalpublichealthlaboratories
themajorityofwhichoperateunderintensefiscalandotherpressurescontinuetolose
capacitytoconductcriticallyimportanttests(thisledtocreationofthenewLaboratory
EfficienciesInitiativetohelpthemmaintaintestingcapacityandachievelong-term
sustainabilitythroughtheadoptionofalternativehigh-efficiencymanagementpractices);
providedconsultationtoCDClaboratorydirectorsregardingcompliancewithfederal
regulatoryrequirementsrelatedtodiseaseagentsthathavepotentialtoposeseverethreatsto
human,animal,andplanthealthandtoanimalandplantproducts;
coordinatedformulationandimplementationofauniform,agencywidepolicytoassistCDC
laboratoriesincomplyingwiththefederalSelectAgentsandToxinsregulations(the
regulationsareavailableathttp://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=/
ecfrbrowse/Title42/42cfr73_main_02.tpl);
enhanced management of CDCs central collectionofmorethan6millionbiologic
specimensanddeliveredmorethan700,000specimenstoCDCandextramuralscientistsfor
researchintothecausesandpreventionofdisease;
trainedmorethan450CDCscientistsindual-useresearchawarenessandpolicies(basedon
recommendationsoftheNationalScienceAdvisoryBoardforBiosecurity)topreventrelease
ofresearchfindingsthatcanbemisusedintentionallytoposeabiologicorchemicalthreatto
publichealthornationalsecurity;
providedadvancedtrainingthroughtheNationalLaboratoryTrainingNetworktostateand
localpublichealthlaboratoryprofessionals,preparingthemtorespondtobiologicand
chemicalterrorism,infectiousdiseaseoutbreaks,disasters,andotherpublichealththreatsand
emergencies;
34

providedtraininginsafehandlingpracticesandinspecializedmicrobiologytestingforBT
agents;
managed CDCs technology transfer program to facilitate commercialization of inventions
generatedbyCDClaboratoryscientistsandotherresearchers;
licensed51inventionsbyCDClaboratoryscientistsforproductionandsalebyprivate-sector
firmsandmaintainedanadditional1,116patentsbasedonCDCinventionsconsistentwith
U.S.PatentandTrademarkOfficerequirements;
managed CDCs cooperative agreement with the Association of Public Health Laboratories
toassistCDCsscientistsinconductingresearch,developinginformaticsapplications,
deliveringtraining,andimplementingotherhigh-priorityprojectswithextramuralpartners;
and
supportedagencywideplanstoreviewandcomplywithFDAregulatoryrequirementsforin
vitrodiagnosticdevices.
TheNationalHealthandNutritionExaminationSurvey
DatafromNHANEShavebeenthecornerstonefornationalhealthandnutritionpolicyand
surveillanceactivitiesthesurveysaretheonlycollectionofbiologicsamplesrelatedto
nutritionandhealthonapopulationwidebasisintheUnitedStates.Eachyear,tensofthousands
ofspecimensfromNHANESparticipantsareprocessedandshippedtomultipleCDCprograms
forlaboratoryanalysisofnutritionalbiochemistries,environmentalexposures,infectious
diseases,andotherhealthindicators.Approximately250differenttypesoflaboratorytestsare
performed.ThoseCDCprogramsprovidefundingforthelaboratoryteststheyneed,withthe
followingexception,whichissupportedbythePublicHealthScientificServicesfundingline.
CDClaboratories
received,processed,andtestedmorethan4,500bloodsamplesforacompletebloodcount,a
paneloftestsusedtoscreenforsuchdisordersasanemia,presenceofinfection,andother
diseases.
BUDGET ACTIVITY OCCUPATIONAL SAFETY AND HEALTH
Workerstypicallyspendaquarteroftheirlivesanduptohalfoftheirwakinghoursatwork,
makingtheworkplaceakeylocationforhealthproblems.During2010,employersintheprivate
sectorreportedapproximately2.9millionnonfatalwork-relatedinjuriesandapproximately
200,000casesofoccupationalillness.Onaverage,14workersintheUnitedStatesdieeachday
fromaninjurysustainedatwork(approximately4,500workersduring2010),andanother134
diefromwork-relateddisease.Thetotalestimateddirectandindirectcostsforwork-related
35

diseasesandinjuriesareapproximately$250billion.CDCmaintainsuniquelaboratorycapacity
forconductingmultidisciplinaryoccupationalsafetyandhealthresearchandprovidesglobal
leadershipinareasofevidence-basedinformationtopreventwork-relatedillness,injury,
disability,anddeath.
AssessmentofMiningHealthandSafetyHazardsandDisasterPrevention
CDClaboratories
conductedfull-scaleexperimentsbeforetestinginterventionsatworkingminesites;
developedanewaward-winningLEDcaplamptopreventinjuriesbyenhancingthe
illuminationofundergroundminesandassociatedhazards,includingunevenandcluttered
surfaces,areasofunstablerock,andotherobstaclesintegraltominingoperations;
improvedunderstandingofmineexplosions,designedexplosionandfiresuppression
strategies,anddevelopedapproachesforminimizingorpreventingmassiverockfailuresby
usingtheuniquecapabilitiesoftheLakeLynnLaboratoryandtheMineRoofSimulator;
simulatedundergroundcoalminingconditionsatactiveproductionzonesandconducted
researchthataddresseshealthhazards(e.g.,coaldust);
identifiedinadequatecoalminedustingstandards,whichledtheU.S.DepartmentofLaborto
issueanEmergencyTemporaryStandardforallcoalminestopreventcoaldustexplosions;
and
conductedresearchonhearinglosspreventionformineworkersusinglarge-scalemining
equipment.
ImprovedPersonalProtectiveEquipmentandTechnologies
CDClaboratories
conductedresearchtoadvancetechnologytoimproveprotection,comfort,fit,andtheuseof
personalprotectiveequipmentandtoexamineexposurestoinhalation,dermal,andother
occupationalhazards;
conductedfirefighterturnoutgearinvestigationsandresearchinpersonalprotective
equipmentanthropometricsandaerosols/filtrationbyusingcapabilitiesthatexistinonlya
fewlaboratoriesintheworld(e.g.,humanmetabolicresponsesimulationandchemical
protectiveclothingpenetration);
administeredtherespiratorcertificationprogramtoensurealevelofstandardfilterefficiency
forallrespiratorsusedinU.S.workplacesbyusingtheonlyfull-sizerespiratortesting
facilityintheUnitedStates;and
36

improvedthequalityandquantityofrespiratoryprotectionforworkersthrough588certified
respiratordecisions(including356newapprovals)and248completerespiratoraudit
activities.
IndustrialHygiene
CDClaboratories
developedandevaluatedmethodsusedworldwidetosampleandanalyzecontaminantsin
workplaceairandinthebloodandurineofworkerswhoareexposedoccupationally;
designedandtestedaerosolsamplingequipmentprototypestoevaluateexposuretoultrafine
andnanoparticlesinfieldstudies;
identified,evaluated,developed,andimplementedtechnologytopreventworkerexposureto
workplacehealthhazards;and
developedaportable,free-standingairborneisolationsystemcapableofproducingairborne
infectionisolationinharshenvironments.
AppliedToxicology
CDClaboratories
useddiverselaboratorydisciplines(e.g.,exposuregenerationandassessment,pulmonary
toxicology,cardiovasculartoxicology,andneurotoxicology)toanswercriticalquestions
aboutworkplacehazardsandhowtheyaffectworkersonabiologicandphysiologicallevel;
conductedaerosolgenerationandanimalinhalationexposureresearchforwork-related
hazards(e.g.,multiwalledcarbonnanotubes,carbonnanofibers,weldingfumes,andartificial
flavorings);
conductedresearchbyusinganimalmodelsandpublishedaseriesofreportsonthehealth
effectsoftheoildispersantusedintheDeepwaterHorizonemergencyresponse;
usedabiosafetylevel-3adaptablelaboratorywithsimulatedpatientexaminationroom
completewithacoughingandbreathingmannequintomonitorhealthcare workers potential
aerosolexposuretoaninfectedpatient;and
demonstratedaerosolizedtransmissionofinfluenzavirusinlaboratorystudiesandhospital
settingsandcharacterizedviralparticlesizeandquantityincoughsfrominfluenzapatients.
SafetyEngineering
CDClaboratories
developedengineeringcontrolsandsafeworkpracticestopreventwork-relateddeathsand
injuries;
37

researchedhumanbehavior,physicalresponses,anddecision-makingskillsundersimulated
conditionsofworkatelevatedheightsbyusinguniquevirtualrealitycapacity;
researchedinteractiveeffectsofbiomechanics,physiologicalload,andpsychologicalstress
onworkers;and
registeredandquantifiedhumanbodysizeandshapeofvariousoccupationalgroupsforuse
indevelopingimprovedequipmentdesigns(e.g.,developedanddisseminateda
comprehensivedatabaseoftruckdriveranthropometricstomajortruckmanufacturerswho
areusingthedatatoimprovetruckcabdesignforincreasedsafety).
BUDGET ACTIVITY GLOBAL HEALTH: GLOBAL AIDS PROGRAM
ThirtyyearssincetheonsetoftheHIV/AIDSepidemic,technicaladvancesandimproved
knowledgeofdiseaseepidemiologyhaveledtoinvestmentsinpreventionandtreatmentthatare
helpingtoreducenewinfections,savelives,andachieveanAIDS-freegeneration.
U.S.-basedCDClaboratoriesprovidetechnicalassistanceandexpertconsultationtoadvancethe
U.S.GlobalHealthInitiativeandthePresidents Emergency Plan for AIDS Relief (PEPFAR) by
improvingdiseasepreventionandtreatmentandcareforpersonslivingwithHIV/AIDS.
CDClaboratories
servedasworldwidereferencelaboratoriesfordiagnosisanddrug-resistancetestingfor
HIV/AIDS,providingservicestobothdomesticandinternationalpartners(seetheDomestic
HIV/AIDSsectionforadditionalactivities);
providedlaboratorysupporttoaddresspublichealthprioritiesinHIVdiagnosis,prevention,
care,andtreatment,aswellasincross-cuttingareas(e.g.,HIV/TBco-infection,health
systemsstrengthening,publichealthtraining,andlaboratorybiosafetyandbiosecurity);
helpeddevelopingcountrieslaboratoriesimplementimprovedmethodsfordiagnosisofHIV
andAIDS-relatedopportunisticinfections,includingco-infectionwithTB;forHIVandTB
drug-resistancetesting;formeasurementofbloodCD4
+
levelsandHIVviralloadsto
monitordiseaseprogressionandtreatmenteffectiveness;andforHIVincidencetestingto
monitortheeffectofdiseasepreventionandcontrolefforts;
assistedministriesofhealthin45countriesindevelopingnationallaboratorystrategicplans
thatstrengthenthelaboratorycomponentofnationalhealthsystems(e.g.,byimplementing
qualitylaboratoryservicesandsystems,strengtheninglaboratorybiosafetyandbiosecurity,
anddevelopingnationallaboratorynetworksthatoptimizetheuseoflocalresources);
38

providedsupportforhands-ontrainingto865laboratoryprofessionalsin283laboratoriesin
22countriestoimproveaccreditationpreparedness,andhelpedtoestablishtheAfrican
SocietyforLaboratoryMedicine,whichwilladministeraregionallaboratoryaccreditation
program;
strengthenedHIV/AIDSpreventionandcontrolprogramsby
providingsupportfortraininganddiagnosticassistancetodevelopingcountrypublic
healthlaboratoriesthatcollectivelytested9.8millionpregnantwomenforHIV,leading
topreventionofmother-to-childtransmissionandallowinganestimated200,000infants
tobebornHIV-free;
providingtestingpanelsto120laboratoriesin40PEPFARcountriestofacilitatetraining
indrug-resistancetestingbyusingthelow-costdriedbloodspotassaydevelopedatCDC;
and
evaluatingthequalityofHIVrapidtestsconsideredforinclusionintheUSAIDwaiver
list,whichauthorizeslocalprocurementofgoodsandservicesunderPEPFAR(useof
theserapidtestsallowspromptreferralforcareandtreatment);and
conductedoperationalresearchto
evaluatefielduseofrapidpoint-of-caretestsinresource-limitedsettings(e.g.,to
acceleratetheentryintocareofHIV-positivepregnantwomen);
implementwidespreaduseofmoleculartestsforearlydiagnosisofHIVamonginfants
(e.g.,toallowearlydeterminationoftheHIVstatusofinfantsborntoHIV-positive
mothers);and
scaleupcollectionandanalysisoflaboratorydataformeasuringtheimpactofHIV
preventionefforts,facilitatingfastertranslationofresearchfindingsintolocalpractice.
BUDGET ACTIVITY GLOBAL HEALTH: GLOBAL IMMUNIZATION PROGRAM
Vaccinationagainstseriousinfectiousdiseases(e.g.,polioandmeasles)isoneofthemost
effectiveofallglobalpublichealthinterventions.Globally,casesofpoliohavedecreasedby
over99%since1988.PoliovaccinationintheUnitedStateshasyieldedneteconomicbenefits
thatexceed$180billion,notcountingtheintangiblebenefitsassociatedwitheliminating
endemicpoliointheUnitedStates.Globally,measlesdeathsdeclinedby78%during2000
2008,althoughthediseasecontinuestoaffectmorethan20millionpersonseachyear.Measles
vaccinationisoneofthemostcost-effectivehealthinterventionsavailabletodayforpreventing
deaths.
However,muchremainstobedone.U.S.-basedCDClaboratoriesarehelpingtoadvancethe
GlobalPolioEradicationInitiativebyprovidingcriticaldiagnosticservicesandgenomic
sequencingofpoliovirusestotracklocalandglobaltransmissionpathwaysandhelpguide
39

diseasecontroleffortsinmultiplecountries.TheCDCPolioLaboratoryservesasaWHOglobal
specializedlaboratory,ahigh-levelfacilitythatprovidestechnicalandprogrammaticassistance
totheGlobalPolioLaboratoryNetwork.CDCalsoishelpingtoadvancetheGlobalMeasles
Initiative,whichaimstoacceleratethereductionofmeaslesdeathsworldwide.Moreover,
increaseduseofacombinedmeaslesandrubellavaccineisalsoreducingbirthdefectscausedby
congenitalrubellasyndrome.TheCDCmeaslesandrubellalaboratoriesareWHOglobal
specializedlaboratorieswithintheWHOMeaslesandRubellaLaboratoryNetwork.
Inaddition,CDC laboratories support global efforts to prevent childrens deaths from other
vaccine-preventablediseasesbyincreasingaccesstovaccinesinlow-resourcecountriesandby
helpingtostrengthensurveillancecapacity.
CDClaboratories
servedasworldwidereferencelaboratoriesandasregionalreferencelaboratoriesforthe
PanAmericanHealthOrganizationfordiagnosisofpolio,measles,andrubella,aswellas
forothervaccine-preventablediseases(i.e.,infectionswithStreptococcus pneumoniae,
Haemophilus influenzatypeb,Neisseria meningitidis,andpertussis);
providedproficiencytesting,technicalassistance,andtrainingandconsultationregarding
bestpracticestoexpandandenhancetheWHOGlobalPolioLaboratoryNetwork(145
laboratories)andtheWHOGlobalMeaslesandRubellaLaboratoryNetwork(700
laboratories);
developed,evaluated,anddeployedstate-of-thearttestsfordiagnosis,genotyping,and
subtypingofpolio,measles,andrubella;thesetestssupportoutbreakinvestigationsand
disease-trackingandguidepolioandmeaslespreventionstrategies;
usedglobalgenotypingdatatotrackandcontainover200domesticcasesofmeasles;
conductedappliedresearchtodevelop,evaluate,andimplementnewpreventionapproaches
(includingvaccines)andtreatments(includingantiviraldrugs)(e.g.,theCDCPolio
Laboratoryhasevaluatednewinactivatedpoliovaccines,oralpoliovaccines,andnovel
vaccinedeliverytechnologies);
developedandvalidateddiseasesurveillancetools,including
aglobalmeaslesDNAsequencedatabase,developedincollaborationwithWHO,that
providescriticalinformationforcontrollingmeaslesathomeandabroad;and
amoleculardiagnosticassayforpoliovirusthatwillhelpguidedecision-makingand
outbreakresponseincountrieswherepoliohasnotyetbeeneliminated.
providedsupportforhands-onlaboratorytrainingandassistance,includingdevelopingand
publishinglaboratoryguidelines,fortheWHOInvasiveBacterial/Vaccine-Preventable
DiseasesSurveillanceNetworkoflaboratoriesinsixWHOregions;and
40

providedsupportforhands-onlaboratorytrainingandsentinelsiteassistancetoministriesof
healthinthreecentralAfricancountries(Cameroon,CentralAfricanRepublic,andthe
DemocraticRepublicofCongo)forlaboratory-basedsurveillanceofvaccine-preventable
diseasesaspartoftheProjetdeRenforcementdelaSurveillanceenAfriqueCentraleproject.
BUDGET ACTIVITY GLOBAL HEALTH: GLOBAL DISEASE DETECTION AND
EMERGENCY RESPONSE
CDCs U.S.-basedinfectiousdiseaselaboratoriessupporttheoverseaslaboratoryoperationsof
theCDCGlobalDiseaseDetection(GDD)regionalcenterswhosegoalistostrengthenglobal
healthsecuritybyensuring(1)promptidentificationandreportingofnewthreatsand(2)rapid
responsetopublichealththreats,includingpublichealthemergenciesofinternationalconcern
reportedtoWHOundertheInternationalHealthRegulations(IHR).
TheGDDRegionalCenterslocatedinChina,Egypt,Guatemala,India,Kenya,Thailand,and
SouthAfricaworkcloselywithU.S.-basedCDClaboratoriesandwiththeGDDOperations
CenterinAtlanta.
TheU.S.-basedCDCinfectiousdiseaselaboratoriesprovidedguidance,technicalsupport,and
managementservicestoGDDregionalcentersthat
servedasregionalresourcesfor
technicalassistance,training,andrapidcoordinationofdiagnostictestingduringpublic
healthemergencies;and
strategicplanningforIHRimplementation;
detectedsevenpathogensthatwerenewtotheworld,newtotheirgeographicregion,orfor
whichtestingcapacitynowexists(e.g.,aBartonella vinsoniisubspecies,Streptococcus
difficilis,metapneumovirus,andaCrimean-Congohemorrhagicfevervariant);
workedwithministriesofhealthinChina,Guatemala,Kenya,andThailandtostrengthen
nationalpublichealthlaboratorysystemsthatoptimizetheuseoflocalresources;
workedwiththeministriesofhealthofChinaandThailandtoadvanceIHRimplementation
bydevelopingandcustomizinglaboratorysystemassessmenttoolsforIHRcomplianceand
conductingassessmentsin29laboratoriesinGuangdongProvince,China,and13regional
medicalcentersandclinicallaboratoriesinThailand;
advanceddevelopmentoftheWHOLaboratoryQualityManagementSystemanddistributed
thesystemhandbook,whichisbasedontrainingsessionsandmodulesprovidedbyCDCand
WHOinmorethan25countries;and
41

disseminatedtwodiagnosticteststolaboratoriesinGDDhostcountries,includingareal-time
diagnosticplatformforuseinidentifyingcausesofunexplainedrespiratorydisease
outbreaks.
BUDGET ACTIVITY GLOBAL HEALTH: PARASITIC DISEASES AND MALARIA
Parasiticinfectionsareresponsibleforamajordiseaseburdenthroughouttheworld.Malaria
affects250300millionpersonsannually,resultinginapproximately700,000deaths,primarily
amongchildren.Approximately1,500casesofmalariaarediagnosedeachyearintheUnited
States,primarilyfromreturningtravelersandimmigrants.Otherparasiticdiseasessometimes
calledneglectedtropicaldiseases affectmorethan1billionpersons,includingcertain
diseasesthatareendemictotheUnitedStates(e.g.,neurocysticercosis,toxocariasis,and
toxoplasmosis).
TheU.S.-basedCDCinfectiousdiseaselaboratoriesfocusonadvancingtheU.S.GlobalHealth
Initiative, the Presidents MalariaInitiative,andtheNeglectedTropicalDiseasesInitiativeand
onimprovingdiagnosisandcontrolofparasiticdiseasesintheUnitedStates.
CDClaboratories
servedasaworldwidereferencecenterfor
diagnosisofmalaria,neglectedtropicaldiseases,andotherparasiticdiseases;and
evaluationofcommerciallyavailablerapiddiagnostictestsformalaria;
providedassistance,training,andconsultationtostateandlocalpublichealthdepartmentsin
diagnosing,investigating,preventing,andcontrollingparasiticdiseases;and
providedfirst-lineandreferencediagnostictestingservicesforphysicians,hospitals,clinical
laboratories,andgovernmentpartners;
conductedover15,000diagnostictests,includingmicroscopicevaluationforover100
medicallyimportantparasites,immunodiagnostictestingfor14diseases,andmolecular
detectionforover20agents;
operatedanInternet-basedtelediagnosticserviceforparasiticdiseases;
developedmolecularassaysforuseinmalariacasemanagementandsurveillance,aswellas
newmethodsfordiagnosisofotherparasiticdiseases,includingfilariasis,cyclosporiasis,
strongyloidiasis,andinfectionswithfree-livingamoebas;
42

improvedneglectedtropicaldiseasediagnosesthroughvalidationoflaboratorytests,
includingrapidtestsandassaystodetectmultiplediseasesfromasingledropofblood;
providedtrainingandconsultationtodomesticandglobalpartnersonsurveillancefordrug
resistance(e.g.,CDCofferedtrainingtoinvestigatorsinendemiccountriesregardinguseof
molecularmarkerstodetectandtrackdrug-resistantparasites);
provided technical support to ministries of health and WHO thus helping to strengthen
malaria prevention and control programs by providing a resident advisor to assistwith
implementingthe Presidents Malaria Initiative in 15 African countries;and
conductedappliedresearchonantimalarialdrugsandondrugresistancemechanismsin
parasiteandvectorpopulations.
BUDGET ACTIVITY PUBLIC HEALTH PREPAREDNESS AND RESPONSE
CDCs laboratories are critically important to Americas national security. CDChelpsthenation
prepareforandrespondtourgentpublichealththreatsbyprovidingstrategicdirection,support,
andcoordinationforemergencypreparednessandresponseactivitiesacrosstheagency,aswell
aswithlocal,state,tribal,national,territorial,andinternationalpublichealthpartners.
CDCalsoworkswithotherfederalagenciesandintelligenceauthoritiestoensurethatauthorities
areapprisedofallnovelthreats(engineeredandnatural)andretainsworld-classexpertisein
detecting,preventing,andcontrollingBT,CT,andRTagents.
Tomeetthesegoals,CDCsupportsLRN,anintegratednetworkofstateandlocalpublichealth,
federal,military,andinternationallaboratoriesthatoperates24/7torespondtoBTandCTand
otherpublichealththreatsandemergencies.LRNprotectsthehealthandsecurityofU.S.citizens
andarmedforces,providingessentialinformationonhumanandanimalexposurestoenable
healthofficialstoreactappropriatelytothreats,includingdeploymentofmedical
countermeasures.LRNidentifiesthethreatagents,whohasbeenexposedandhowseverely,and
thegeographicalextentofexposuretofacilitatereactiveandpreemptiveactions.CDCalso
promoteslaboratorybiosafetyandbiosecuritybyadministeringtheHHSSelectAgentProgram
(42CFRPart73,availableathttp://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=/
ecfrbrowse/Title42/42cfr73_main_02.tpl),whichregulatesthroughouttheUnitedStatesthe
possession,use,andtransferofBTandtoxinsthatcanposeaseverethreattopublichealthand
safety.Intheabsenceofthesecriticalprograms,theuse,movement,andpresenceoftheseBT
threatagentswouldbeunmonitoredandcouldallowtheirintentionaluseasabiologicweaponto
goundetected.
Selected Laboratory Activities in FY2011
CDClaboratories
strengthenedthebiologiccomponentofLRNby
43

developingreagentsandassaysforBTandemergingthreats,includingamass
spectrometrymethodfordetectinganthraxlethalfactor(acomponentofanthraxtoxin)
thatdetectsdisease24hoursbeforesymptoms;methodstoquantifyclinicallyrelevant
levelsofbotulinumneurotoxinsinserumandfeces;methodstodeterminebotulinum
toxinsubtypesAandB(usedtoidentifyapreviouslyunknownsubtype);arapidpoint-
of-caretestforplagueandotherBTagents;
providingconsultationandconfirmatorytestingfortheU.S.DepartmentofHomeland
SecurityBioWatchprogram,whichdetectsenvironmentallydispersedBTagents,
includingthebacteriumthatcausesanthrax;
ensuringsafeandsecureworkingconditionswithinbiosafetylevel-4containment
facilitiesforscientistsworkingwithhigh-consequencepathogensandVBagents;
enhancingpreparednesstorespondtooutbreaksofhigh-consequencepathogensthrough
testdevelopmentanddemonstrationofefficacyforprophylaxisorpostexposure
treatments,includingvarioustherapeuticinterventionsfortreatmentoforthopoxvirus
infections(e.g.,attributabletovaccine-relatedadverseeventsortosmallpox);
providinginstructiontomorethan3,000sentinellaboratorypersonnelfromlocalpublic
health,hospitalandclinicallaboratoriesinRule-Out-and-Referprotocolsandin
laboratorysafetyandsecurityprotocols,includingsafehandling,packaging,andshipping
ofpotentiallydangerousspecimens;
conductingintensive,hands-ontrainingsfor28LRNreferencelaboratoriesinrapid
detectionandidentificationofBTagents;
ensuringlaboratoryperformanceandtimelyresponsetoabiologicterrorismincidentby
conductingBTresponseteamexercises,developinganddistributingquality-control
materials,providingquality-assuranceandperformancetestingtolaboratories,and
coordinatingwithfederalpartnersthroughtheIntegratedConsortiumofLaboratory
Networks;and
processing1,530individualtestresultsreportedby143laboratories(outof162LRN
laboratories)participatingintheLRNBTproficiencytestingprogramandcertifyingthat
LRNBTlaboratoriesarequalifiedtomeasurebiologicthreatagentsduringapublic
healthresponse.
strengthenedthechemicalcomponentofLRNby
maintaininground-the-clocklaboratoryresponsecapability,expandingsurgecapacity,
andupgradingtheRapidToxicScreenthatcanevaluateupto150CTagentswithin24
36hours;
44

ensuringlaboratoryperformanceandtimelyresponsetoachemicalterrorismincidentby
conductingCTresponseteamexercises,developinganddistributingquality-control
materials,providingquality-assuranceandperformancetestingtolaboratories,and
coordinatingwithfederalpartnersthroughtheIntegratedConsortiumofLaboratory
Networks;
processing11,500individualtestresultsreportedby46statepublichealthlaboratories
participatingintheLRNproficiencytestingprogramandcertifyingthatLRNlaboratories
arequalifiedtomeasureCTagentsduringapublichealthresponse;
developednewanalyticmethodsfortheurineradionuclidescreen,therebystrengthening
CDClaboratorycapacitytoassessradiologicexposureofpersonsduringRTevents,
includingexposurestolow-gradenuclearbombs,industrialunintentionalincidents,
thermonucleardevices,andradionuclidesthatcannotbedetectedbyGeigercountersorby
clinicalassessment(e.g.,exposurestouranium-235,strontium,plutonium-238,andradium);
investigatedandidentifiedlowlevelsofradiationexposureamongU.S.residentsworkingin
JapanafterreleaseofradiationfromtheFukushimaDaiichiNuclearPowerPlantbyusingthe
urineradionuclidescreen;
executedregulatoryandstatutoryresponsibilitiesfortheHHSSelectAgentProgram(42
CFRPart73,availableathttp://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=/
ecfrbrowse/Title42/42cfr73_main_02.tpl),theCDCImportPermitProgram(42CFRPart
71.54,availableathttp://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=d53e3b1
b73bd80865fb0a044f8be8c1d&rgn=div8&view=text&node=42:1.0.1.6.59.6.19.4&idno=42),
theForeignQuarantineRegulations,theBioterrorismResponseActof2002,andthe
PATRIOTAct.CDCregulatesmorethan325entitiesthatuse,possess,ortransferSelect
AgentswithintheUnitedStatesandprocessesmorethan1,500importpermitsperyearto
preventbioterrorismeventswithintheUnitedStates(e.g.,theanthraxattacksofOctober
2001).
improvedanalysisandmessagingofBT,CT,andRTdataby
assistingstatesinimplementinglaboratoryinformationmanagementsystemsthat
increasethespeedandaccuracyofdatatransfer;
disseminatingcustomizedsoftwarethatpromotesuseofcommondefinitionsofBT
eventsbyallLRNlaboratories;and
developingacommunicationschannelforaddressingdelaysanddifficultiesin
disseminatingtestinformation(e.g.,results,testspecifics,andspecimentypes)withinthe
publichealthcommunity;
45

supportedacross-cuttingprogramthatprovidesinfrastructure,diagnostic,reference,
research,reagentproduction,andsurveillanceprogramstoCDClaboratories;theunique
servicesprovidedareessentialtothedailyoperationsofthelaboratoriesandinclude
veterinaryandanimalhusbandry,centralizedspecimenmanagement,andsupporttoCDC
scientistsingenomics,proteomics,bioinformatics,chemicalsynthesis,andotherscientific
disciplines;
confirmedexposuresamongAlaskaresidentstosaxitoxin,aneurotoxinlocatedinshellfish
exposedtotoxicalgalblooms;
helpedidentifythesourceofthe2011choleraoutbreakinHaitibyusingnext-generation
wholegenomesequencingdata;
producedbiologicproducts,reagents,kits,andcellculturestoprovideimmediatereadiness
tomeettheneedsofCDClaboratories,ongoinginfluenzasurveillanceprojects,andLRN
(e.g.,testkitsforanthraxandbotulismdetection,aswellasinfluenzaserotyping);and
managedamemorandumofunderstandingestablishedwiththeOfficeofIn-VitroDiagnostic
DeviceEvaluationandSafetyatFDAforthe1-yearassignmentofaCDCscientisttoFDAto
learnaboutregulatory510(k)requirementsforlaboratory-developedtestsandin vitro
diagnostics,andtoassistCDClaboratoriesinmeetingtheserequirements.
46

List of Abbreviations Used in This Report

ACIP AdvisoryCommitteeonImmunizationPractices
AIDS acquiredimmunodeficiencysyndrome
AR antimicrobialresistance
BA budgetauthority
BT biologicthreat
CDC CentersforDiseaseControlandPrevention
CFS chronicfatiguesyndrome
CT chemicalthreat
FDA FoodandDrugAdministration
FY FiscalYear
GDD GlobalDiseaseDetection
HBV hepatitisBvirus
HCV hepatitisCvirus
HDL high-densitylipoprotein
HHV-8 humanherpesvirustype8
HIV humanimmunodeficiencyvirus
HPV humanpapillomavirus
IHR InternationalHealthRegulations
LD Lymedisease
LDL low-densitylipoprotein
LRN LaboratoryResponseNetwork
MDRTB multidrug-resistanttuberculosis
MRSA methicillin-resistantStaphylococcus aureus
NBDPS NationalBirthDefectsPreventionStudy
NHANES NationalHealthandNutritionExaminationSurvey
PEPFAR Presidents Emergency Plan for AIDS Relief
PFOS perfluorooctanesulfonicacid
RT radiologicthreat
SARS severeacuterespiratorysyndrome
SCID severecombinedimmunodeficiency
STD sexuallytransmitteddisease
TB tuberculosis
TSNAs tobacco-specificnitrosamines
USAID U.S.AgencyforInternationalDevelopment
USDA U.S.DepartmentofAgriculture
VB vectorborne
WHO WorldHealthOrganization
XDRTB extensivelydrug-resistanttuberculosis
47

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BUDGET ACTIVITY EMERGING AND ZOONOTIC INFECTIOUS DISEASES:

List of Abbreviations Used in This Report

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