STC-20-066, FRN- Reporting Nuclear Medicine Injection as Medical Events

STC-20-066- FRN- Reporting Nuclear Medicine Injection as Medical Events

ML20266G526
Person / Time
Issue date:	09/15/2020
From:	Office of Nuclear Material Safety and Safeguards
To:
Sarah Lopas, NRC/NMSS
Shared Package
ML20266G512	List: ML20266G516 STC-20-066, FRN- Reporting Nuclear Medicine Injection as Medical Events
References
85FR57148, NRC-2020-0141, PRM-35-22, STC-20-066
Download: ML20266G526 (2)

Text

w 57148 Proposed Rules Federal Register Vol.85,No.179

Tuesday, September 15,2020 Thissection oftheFEDERAL REGISTER confirming

receipt, then contact usat TheNRCcautions younottoinclude contains notices tothepublic oftheproposed301--415-1677.

identifying orcontact information that issuance ofrules.and regulations The

. Mail commentsto:Secretary, U.S. youdonotwanttobepublicly purpose ofthese notices isto give interested Nuclear Regulatory Commission, disclosed inyourcommentsubmission.

persons anopportunity toparticipate inthe Washington,DC20555--0001, ATTN:

.The NRCwill postall comment rule rnaking prior totheadoptionof the final Rulemakings andAdjudications Staff.submissions athttps://

rules.

Foradditional direction onobtaining wwwregulationsgov aswell asenterthe Information andsubmitting comments, commentsubmissions into ADAMS.

NUCLEAR REGULATORY see"Obtaining Information and TheNRCdoes notroutinely edit COMMISSION Submitting Comments" inthe commentsubmissions toremove SUPPLEMENTARY INFORMATION section of identifying orcontactinformation.

10CFRPart35 thisdocument.

Ifyouarerequesting oraggregating FORFURTHER INFORMATION CONTACT:

commentsfromother persons for

[Docket No.PRM-35-22; NRC-2020-0141)

Pamela Noto, OfficeofNuclear Material submission totheNRC,thenyoushould Safety and Safeguards, U.S.Nuclear inform those persons nottoinclude Reporting Nuclear Medicine Injection RegulatoryCommission, Washington, identifying orcontact information that Extravasations asMedicalEvents DC20555-0001; telephone:

301-415-theydonotwanttobepublicly 6795;email:

Pamela.Noto@nrc.gov.

disclosed intheir commentsubmission.

AGENCY:Nuclear Regulatory SUPPLEMENTARY INFORMATION:

Yourrequest should state that theNRC Commission.

does notroutinely edit comment ACTION:

Petition forrulemaking; I.Obtaining Information and submissions toremovesuchinformation notification ofdocketing andrequest for Submitting Comments before making thecomment comment.

A.Obtaining Information submissionsavailable tothepublic or entering thecommentinto ADAMS.

SUMMARY

TheU.S.Nuclear RegulatoryPlease refer toDocket IDNRC-2020-Commission (NRC) hasreceived a

0141whencontacting theNRCabout II.ThePetitioner petition forrulemaking fromRonald K.

theavailability ofinformation for this Thepetition forrulemaking (PRM)

Lattanze onbehalf ofLucerno action.

Youmayobtain publicly-was filed byRonald K.Lattanze, on

Dynamics, LLC,dated May18,2020.

available information related tothis behalf ofLucernoDynamics, LLC.

Thepetitioner requests that theNRC action byanyofthefollowing methods:Ronald K.LattanzeistheChief revise itsregulations torequire

• Federal Rulemaking website:

Goto Executive Officer ofLucerno

Dynamics, reporting ofcertain nuclear medicinehttps://www.regulations.gov andsearchLLC.

Lucerno

Dynamics, LLC,isaNorth injection extravasations asmedical forDocket IDNRC-2020-0141.

Carolina-based company that specializes events.

TheNRCdocketed thepetition e NBC'sAgencywide Documents inthe design and development of onJune 5,2020,andassigned itDocketAccess andManagement System systems thatdetect thepresence of No.PRM-35-22.

TheNRCisexaminino(ADAMS):

Youmayobtain publicly-radiolabeled biomarkers inpatients.

theissues raised inPRM-35-22to available documents online inthe determine whether theyshould be ADAMSPublic Documents collection at m g p,ion e

considered inrulemaking.

TheNRCis https://www.nrc.gov/reading-rm/

Thepetitioner requests that theNRC requesting public commentonthis adams.html.

Tobegin thesearch, selectamendpart 35oftitle 10of the Codeof petition atthis time.

"Begin Web-based ADAMSSearch."

For Federal Regulations torequire the problems withADAMS,please contact reporting ofcertain nuclear medicine DATES:Submit commentsbyNovembertheNRC'sPublic Document Room(PDR)injection extravasations asmedical 30,2020.Comments received after this reference staff at1-800-397-4209, 301--events.

Extravasation istheinfiltration date willbeconsidered ifitIspractical 415-4737,orbyemail top.dr.resource@

ofinjected fluid intothetissue todoso,buttheNRC1sable toassure nrc.gov.

TheADAMSaccession numbersurrounding aveinorartery.

The consideration onlyforcomments foreachdocument referenced (if itis petition maybefound inADAMSat received onorbefore this date.

available inADAMS) isprovided the Accession No.ML20157A266.

ADDRESSES:

Youmaysubmit comments first timethat itismentioned inthe byanyofthefollowing methods:

SUPPLEMENTARY INFORMATIONsection.

= Federal Rulemaking Website:

Goto Attention:

ThePublic Document Thepetition states

that, in1980,the https://www.regulations.gov andsearchRoom(PDR),

whereyoumayexamine NRCexempted extravasations from forDocket IDNRC-2020-0141.

Addressandorder copies ofpublic documents,medical eventreporting withthe questions about NRCdockets toCarol iscurrently closed.

Youmay submit understanding that extravasations are Gallagher; telephone:

301-415-3463; yourrequest tothePDRvia'email at virtually impossible toavoid.

The email:

Carol.Gallagher@nrc.gov.

For pdr.resource@nrc.gov orcall 1-800-Petition further states

that, since that technical questions contact the 397-4209between 8:00a.m.and4:00 time,ample evidence hasbeen individual listed intheFORFURTHER p.m.(EST),

Mondaythrough Friday, published demonstrating that nuclear INFORMATION CONTACT section ofthis except Federal holidays.

medicine extravasations areavoidable document.

andarecapable ofcausing considerable

• Email commentsto:

B.Submitting Comments harmtopatients.

Referencing literature Rulemaking.Comments@nrc.gov.

Ifyou Please include Docket IDNRC-2020- research andcasestudies, thepetition donotreceive anautomatic email reply0141inyourcommentsubmission.asserts that extravasations canresult in

Federal Register

/Vol.85,No.179/Tuesday, September 15,2020/Proposed Rules 57149 patient tissue doses that exceed existing3.Formedical uselicensees, does FortheNuclear Regulatory Commission.

NRCmedical reporting limits andcan yourfacility currently monitor for Annette L.ViettiCook, harmpatients inmanyways.Inlight of radiopharmaceutical extravasation?

If Secretaryof theCommission.

this

evidence, thepetition requests thatso,whyandhowdoyoumonitor?

Ifnot, [FRDoc.2020-19903 Filed 9-14-20;8:45am) theNRCrevisit the policy establishedin whynot?

BILLING CODE7590-01-P 1980andrequire the reporting of 4.Doyouexpect that monitoring for medical events ofextravasations that extravasation andreviewing theresults result inalocalizeddose equivalent wouldimprove radiopharmaceutical exceeding 50rem(0.5Sv). Thepetition administration techniques atmedical DEPARTMENT OFENERGY asserts that thereportingof certain, uselicensee facilities?

Ifso,how?Ifnot, 10CFRPart431 extravasations asmedical events will whynot?

notonly alert theNRCtoinstances of 5.Doyoubelieve anNRCregulatory

[EERE-2017-BT-STD-0032) serious misuseofbyproduct

material, action requiring'monitoring andreview butalso will incentivize practitioners to ofextravasation wouldimprove patient RIN1904-AE07 improve injection andinfusion quality.

radiological health andsafety?

Ifso, Thepetition states that this isintende"d how? Ifnot,whynot?

Energy Conservation Program:

Energy Conservation Standards for toensure that diagnostic and Medical EventClassificationand Evaorativel Cooled Commercial P

Y therapeutic nuclear med1c1ne patientsR epo ingCriteria rt areprotected fromavoidable irradiation Package AirConditioners andWater andgiven access tovital information to Currently, theNRCexcludes CooledCommercial Package Air understand whenandhowmedical extravasation ofradiopharmaceuticals Conditioners eventsimpact their care.

fromits medical eventreporting Oh he yhm a

8 regulations.Medical eventsmaynot V.Request forPublic Comment necessarily result inharm tothepatient, Renewable

Energy, Department of TheNRC'sMedical UsePolicy buttheyc'an indicate apotential Energy.

Statement (65 FR47654) states,^in part, problem inamedical facility's useof ACTION:Notice ofproposed that theNRCwill notintrude into radioactive materialsor in determination andrequest forcomment.

medical judgments affecting patients,administration asdirected by the except asnecessary toprovide forthe physician.

Because licensees are not

SUMMARY

TheEnergy Policy and radiation safety ofworkers andthe required toreport extravasations tothe ConservationAct(EPCA),

as general public.

Italso states that the NRC,extravasation eventsare not amended,prescribes energy

NRCwill, whenjustified bytherisk to documented intheNRC's Nuclear conservation standards iorvarious

patients, regulate theradiation safety of Material Events Database (NMED),

consumer products andcertam patients primarily toassuretheuse'of whichcontains records ofevents commercial andIndustrial equipment, radionuclid^es isinaccordance withthe.involving nuclear material reported to including evaporatively-cooled th NRC commerc1al package airconditioners physician sdirections.

Considering e

these policy objectives andhowthey 1.Are^there anybenefits, notrelatedand water-cooled commercial package mayrelate toradiopharmaceutical tomedical techniques, tomonitoringairconditioners (referred toas extravasations, theNRCisrequestingandreporting certain extravasations as evaporatively-cooled commercial public commentonthefollowing medical events?

Whatwouldbethe umtaryair conditioners

('

ECUACs) specific questions.

burden associated withmonitoring for andwater-cooled commercial unita,ry andreporting certain extravasations as alrcondit1oners ( WCUACs' )m th1s Infection Quality Monitoring medical events?

document).

EPCA also requires theU.S.

TheNRCencourages licensees touse 2.IftheNRCweretorequire that Department ofEnergy

("DOE") to quality assurance tools andavailablelicensees report certain extravasations periodically determine whether more technology toensure that thelicenseeasmedical events(recorded inNMED), stringent, amended standards would delivers theadministration that the whatreporting criteria should beused result insignificant additional physician intended.

TheNRCrequirestoprovide theNRCdata that canbe conservation

ofenergy, be certain quality assurance procedures-usedtoidentify

problems, monitor technologically

feasible, andbe suchascalibrating instruments used to

trends, andensurethatthelicensee economically justified.

Inthis notice of measurepatient dosages andrecordingtakes corrective action(s)?

proposed determination

("NOPD"),DOE dosages administered-but there are 3.IftheNRCrequires reporting of hastentatively determined that the other procedures that theNRCdoes not extravasations that meetmedical event standards forsmall (cooling capacity require that could berelevant to reporting

criteria, should adistinction less than135,000Btu/h),

large (cooling extravasation.

TheNRCisseeking bemadebetween reporting capacity greater than orequal to135,000 information onuseofquality assuranceextravasations ofdiagnostic and andless than 240,000Btu/h),

andvery tools andtechnologies for therapeutic radiopharmaceuticals?

Ifso, large (cooling capacity greater thanor radiopharmaceutical injection qualitywhy?Ifnot,whynot?

equal to240,000andless than760,000 Btu/h)

ECUACsandWCUACsdonot monitorin andextravasation.

VLConclusion 1.How "equently does needtobeamended,andDOErequests radiopharmaceutical extravasation TheNRChasdetermined that the commentonthis proposed occur?

petition meetsthesufficiency determination andtheassociated 2.Doyouknowofanyextravasations requirements fordocketing at@2.803 analyses andresults.

that haveresulted inha~rm topatients?

TheNRCwill examine theissues raisedDATES:

Ifsoandwithout including information inPRM-35-22andanycomments Meeting:

DOEwill holdawebinar on that could lead totheidentification of received onthis document todetermine

Thursday, October 1,2020,from10:00 theindividual, describe the whether these issues should be a.m.to3:00p.m.Seesection V,"Public circumstances, typeofeffect harm,and considered inrulemaking Participation,"

forwebinar registration theimpacts.

Dated:

September 3,2020.

information, participant instructions,