ML18312A413

Slide Presentation for 11/14/2018 Webinar on NRC Staff Evaluation of Training and Experience Requirements for Different Categories of Radiopharmaceuticals

ML18312A413
Person / Time
Issue date:	11/14/2018
From:	Sarah Lopas NRC/NMSS/DMSST/MSEB
To:
Sarah Lopas
References
Download: ML18312A413 (22)

Text

TheNRCStaffEvaluationof TrainingandExperience RequirementsforAdministering DifferentCategoriesof Radiopharmaceuticals WEBINAR November14,2018 MedicalRadiationSafetyTeam MedicalSafetyandEventsAssessmentBranch DivisionofMaterialsSafety,Security,State,andTribalPrograms OfficeofNuclearMaterialSafetyandSafeguards

BridgeLineInformationforWebinar BridgeNumber:8884525182 Passcode:3340287

Agenda 1:00- 1:05p.m.

WelcomeandMeetingInformation 1:05-1:30p.m.

NRCPresentation 1:30- 3:00p.m.

Comments 2

Welcome ChristianEinberg,ChiefoftheMedicalSafetyandEvents AssessmentBranchintheNRCsDivisionofMaterials Safety,Security,State,andTribalPrograms-Officeof NuclearMaterialSafetyandSafeguards 3

PurposeofTodaysWebinar ProvideinformationontheNRCstaffsevaluationof trainingandexperience(T&E)requirementsfor administeringdifferentcategoriesofradiopharmaceuticals forwhichawrittendirectiveisrequiredinaccordancewith Title10oftheCodeofFederalRegulations (10CFR)Part35, MedicalUseofByproductMaterial,SubpartE,Unsealed ByproductMaterial-WrittenDirectiveRequired.

ListentoandacceptcommentsontheT&EFederalRegister docket(NRC20180230).

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MeetingInformation TrainingandExperiencewilloftenbereferredtoasT&E.

AuthorizedUser(s)willoftenbereferredtoasAU(s).

Todaysmeetingisbeingtranscribedbyacourtreporter.

AllcommentsmadetodaywillbecapturedfortheT&E docket(NRC20180230)andforinclusioninourreview.

Ifyouspeakacommenttoday,youdonot needtoagain submitthatsamecommentonRegulations.gov.

Oralandwrittencommentshaveequalweight.

CommentswillbeginaftertheNRCpresentation.

Press*1 onyourphone.

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CurrentT&ERegulations Currentregulationsprovidethreewaysaphysiciancanbe approvedasanauthorizeduser(AU)toadministerunsealed byproductmaterialsorradiopharmaceuticalsrequiringa writtendirective:

Certificationbyamedicalspecialtyboardwhose certificationisrecognizedbytheNRCoranAgreement State.

CompletionofT&E,alsoknownasthealternatepathway:

200hoursclassroomandlabtrainingand500hours supervisedworkexperienceforatotalof700hoursT&E (requirespreceptorattestation).

PreviousidentificationasanAUonanNRCor AgreementStatelicenseorpermit.

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CurrentT&ERegulations,continued TrainingandExperienceRequirementsin10CFR35,SubpartE:

1) 10CFR35.390- Trainingforuseofunsealedbyproduct materialforwhichawrittendirectiveisrequired.

2) 10CFR35.392-Trainingfororaladministrationofsodium iodideI131requiringawrittendirectiveinquantitiesless thanorequalto33millicuries.

3) 10CFR35.394-Trainingfororaladministrationofsodium iodideI131requiringawrittendirectiveinquantities greaterthan33millicuries.

4) 10CFR35.396-Trainingfortheparenteraladministration ofunsealedbyproductmaterialrequiringawritten directive.

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Background-StakeholderConcerns SincerevisionstotheNRCsT&Eregulationsin2002and 2005,stakeholdershaveraisedconcernsthatthe700hour requirement(10CFR35.390)isoverlyburdensomefor physiciansnotboardcertifiedorgrandfathered.

TherequirementcouldcreateashortageofAUs,thus limitingpatientaccesstoradiopharmaceuticals.

In2015and2016,theNRCstaffandtheNRCsAdvisory CommitteeontheMedicalUsesofIsotopes(ACMUI) separatelyreviewedtheT&Erequirementsanddetermined nochangeswereneeded.

TheNRCcontinuestoworkwiththeACMUI ontheT&Eevaluation.

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Background-SRMM170817 InStaffRequirementsMemorandumM170817 (August17,2017;ML17229B284),theCommissiondirected stafftoevaluate:

WhetheritmakessensetoestablishtailoredT&E requirementsfordifferentcategoriesof radiopharmaceuticals; Howthosecategoriesshouldbedetermined; WhattheappropriateT&Erequirementswouldbeforeach category;and Whethertherequirementsshouldbebasedonhours ofT&Eoroncompetency.

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Background-SECY180084 In2018,staffconductedaninitialevaluationofT&Eunder 10CFRPart35,SubpartE,anddocumentedtheirreviewin SECY180084(August28,2018;ML18135A277):

ItmaybefeasibletoestablishtailoredT&Erequirements fordifferentcategoriesofradiopharmaceuticals,andto createlimitedauthorizeduserstatuses.

Thereareviableoptionsforcreatingacompetencybased approachtodemonstratingacceptableT&Eforlimited authorizeduserstatus.

However, thestaffneedstoconductmoreextensive outreachbeforemakingarecommendationtothe Commission.

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TheNRCsT&EEvaluation

• Ifstaffrecommendsrulemaking, theCommissionwillvoteon whetherthestaffshouldproceed withrulemaking.

Inputfrom Medical Stakeholders Review Additional Information Inputfrom AgreementStates InputfromACMUI Information Paper or Rulemaking Plan*

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T&EFederalRegisterNotice TheT&EFederalRegister notice(83FR54380)was publishedonOctober29,2018:

https://www.gpo.gov/fdsys/pkg/FR20181029/pdf/2018 23521.pdf OpenedthecommentperiodfromOctober29,2018 throughJanuary29,2019.

TheFederalRegisternotice(FRN)asksaseriesofspecific questionsontheNRCsT&Erequirements.

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QuestionsintheFRN A.TailoredTraining&ExperienceRequirements 1)ArethecurrentpathwaysforobtainingAUstatusreasonableand accessible,aretheyadequateforprotectingpublichealthandsafety?

2)ShouldtheNRCdevelopanewtailoredT&Epathway?Whatwouldbe theappropriatewaytocategorizeradiopharmaceuticalsfortailoredT&E requirements?

3)ShouldthefundamentalT&ErequiredofphysiciansseekinglimitedAU statusneedtohavethesamefundamentalT&Erequiredofphysicians seekingfullAUstatus?

4)HowshouldtherequirementsforthisfundamentalT&Ebe structuredforaspecificcategoryofradiopharmaceuticals?

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QuestionsintheFRN,continued B.NRCsRecognitionofMedicalSpecialtyBoards TheNRCsproceduresforrecognizingmedicalspecialtyboardsare locatedontheMedicalUsesLicenseeToolkitWebsite:

https://www.nrc.gov/materials/miau/medusetoolkit/certifprocess boards.html.

1)WhatboardsotherthanthosealreadyrecognizedbytheNRC (AmericanBoardofNuclearMedicine,AmericanBoardofRadiology, AmericanOsteopathicBoardofRadiology,CertificationBoardofNuclear Endocrinology)couldbeconsideredforrecognitionformedicaluses under10CFR35.300?

2)ArethecurrentNRCmedicalspecialtyboardrecognition criteriasufficient?Ifnot,whatadditionalcriteriashould theNRCuse?

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QuestionsintheFRN,continued C.PatientAccess 1)IsthereashortageinthenumberofAUsformedicalusesunder 10CFR35.300?Ifso,istheshortageassociatedwiththeuseofaspecific radiopharmaceutical?

2)AretherecertaingeographicareaswithaninadequatenumberofAUs?

3)DocurrentNRCregulationsonAUT&Erequirementsunnecessarily limitpatientaccesstoproceduresinvolvingradiopharmaceuticals?

4)DocurrentNRCregulationsonAUT&Erequirementsunnecessarily limitresearchanddevelopmentinnuclearmedicine?

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QuestionsintheFRN,continued D.OtherSuggestedChangestotheT&ERegulations 1)ShouldtheNRCregulatetheT&Eofphysiciansformedicaluses?

2)ArethererequirementsintheNRCsT&Eregulatoryframeworkfor physiciansthatarenonsafetyrelated?

3)HowcantheNRCtransformitsregulatoryapproachforT&Ewhilestill ensuringthatadequateprotectionismaintainedforworkers,thegeneral public,patients,andhumanresearchsubjects?

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SubmittingWrittenComments SubmitwrittencommentsviaRegulations.govby January29,2019 Gotowww.regulations.gov andsearchNRC20180230 Directcommentsubmissionlink:

https://www.regulations.gov/comment?D=NRC20180230 0001 TheNRCimmediatelyreceivescommentssubmittedto Regulations.gov,butittakesafewweeksforcommentsto bepubliclyposted.

CommentswillalsobepostedtoADAMS.

TheNRCwillconsider,butnotprovide aresponseto,comments.

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AdditionalPublicCommentMeetings Tuesday,December11,2018,1:00p.m.- 4:00p.m.EST InpersonmeetingatNRCheadquartersandwebinar Thursday,January10,2019,1:00p.m.- 4:00p.m.EST InpersonmeetingatNRCheadquartersandwebinar Tuesday,January22,2019,10:00a.m.- 12:00p.m.EST Webinaronly Meetingdetailsandregistrationinformationare availableathttps://www.nrc.gov/pmns/mtg.

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NextSteps DeliverPapertoCommission Fall2019 FinalizeCommissionPaper AugustandSeptember2019 ACMUIT&ESubcommitteePublicTeleconferenceonDraftPaper(TENTATIVE)

August2019 ACMUIandAgreementStatesReviewDraftCommissionPaper May-August2019 DevelopmentofDraftCommissionPaper March-May2019 EvaluationofComments,ReviewAdditionalInformation,ACMUIT&EReport February-March2019 CommentPeriodandPublicMeetings October29,2018-January29,2019 19

ForMoreInformation TheNRCsTrainingandExperienceEvaluationWebsite:

https://www.nrc.gov/materials/miau/meduse toolkit/trainingexperienceevaluation.html TheT&Edocket(NRC20180230)atRegulations.gov:

https://www.regulations.gov/docket?D=NRC20180230 NRCT&Econtacts:

SarahLopas,ProjectManager Sarah.Lopas@nrc.gov and(301)4156360 MaryannAyoade,HealthPhysicist Maryann.Ayoade@nrc.gov and(301)4150862 20

Comments Press*1 onyourphonetoaskaquestionormakea comment.

Yourcommentsarebeingtranscribedbyacourtreporter.

Pleasebeginbyprovidingyourname.

Pleasespeakclearlysothecourtreportercanobtainan accuratetranscript.

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