ML20266G526
| 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: |
| References | |
| 85FR57148, NRC-2020-0141, PRM-35-22, STC-20-066 | |
| Download: ML20266G526 (2) | |
Text
w 57148 Proposed Rules Federal Vol.
Register 85,No.179 Tuesday, September 15,2020 This sectionoftheFEDERAL REGISTER confirming receipt, then contact usat TheNRCcautions younottoinclude contains noticestothepublic oftheproposed 301--415-1677. identifying orcontact information that issuance ofrules.and regulations The . Mail comments to:Secretary, U.S. youdonotwanttobepublicly purpose ofthese notices isto give interested Nuclear Regulatory Commission, disclosed inyour commentsubmission.
persons anopportunity toparticipate inthe Washington, DC20555--0001, ATTN: .The NRC will post all comment rule rnakingpriortothe adoptionof the final Rulemakings and Adjudications Staff.submissions athttps://
rules. Foradditional direction on obtaining wwwregulationsgov aswell asenter the Information andsubmitting comments, commentsubmissions into ADAMS.
NUCLEAR REGULATORY see"Obtaining Information and TheNRCdoes notroutinely edit COMMISSION Submitting Comments" inthe comment submissions toremove SUPPLEMENTARY INFORMATION section of identifying orcontact information.
10CFRPart 35 thisdocument. Ifyouarerequesting oraggregating FORFURTHER INFORMATION CONTACT: comments from other persons for
[Docket No.PRM-35-22; NRC-2020-0141) Pamela Noto, Office of Nuclear Material submission to the N RC, then you should 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- they donotwanttobepublicly 6795;email: Pamela.Noto@nrc.gov. disclosed intheir commentsubmission.
AGENCY: Nuclear Regulatory SUPPLEMENTARY INFORMATION:
Yourrequest should state that the NRC Commission. does notroutinely edit comment ACTION: Petition for rulemaking; I.Obtaining Information and submissions toremove such information notification ofdocketing andrequest for Submitting Comments before making the comment comment. A.Obtaining Information submissions available tothe public or entering thecomment into ADAMS.
SUMMARY
- TheU.S. Nuclear Regulatory Please refer toDocket IDNRC-2020-Commission (NRC) has received a 0141 when contacting the NRCabout II. ThePetitioner petition for rulemaking from Ronald K. the availability of information fort his Thepetition for rulemaking (PRM)
Lattanze onbehalf ofLucerno action. Youmayobtain publicly- was filed byRonald K.Lattanze, on Dynamics, LLC,dated May18,2020. available information related tothis behalf of Lucerno Dynamics, LLC.
Thepetitioner requests that the NRC action byanyofthefollowing methods:Ronald K.Lattanze isthe Chief 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 for Docket IDNRC-2020-0141. Carolina-based company that specializes events. TheNRCdocketed thepetition e NBC's Agencywide Documents inthe design and development of onJune 5,2020, andassigned itDocketAccess andManagement System systems thatdetect the presence of No.PRM-35-22. TheNRCisexaminino "
(ADAMS): Youmayobtain publicly-radiolabeled biomarkers inpatients.
the raised available documents online inthe at m e issues inPRM-35-22 to g p,ion determine whether they should be ADAMSPublic Documents collection .
considered inrulemaking. TheNRCis https://www.nrc.gov/reading-rm/ Thepetitioner requests that the NRC requesting public commentonthis adams.html. Tobegin the search, select amend part 35oftitle 10of the Codeof petition atthis time. "Begin Web-based ADAMSSearch." For Federal Regulations torequire the DATES: Submit commentsbyNovember the problems with ADAMS,please contact reporting ofcertain nuclear medicine 30,2020. Comments received after N this referenceRC's P ublic Document Room (PDR) i njection extravasations as medical staff at1-800-397-4209, 301-- events. Extravasation istheinfiltration date willbeconsidered ifitIspractical 415-4737, orbyemail top.dr.resource@ of injected fluid into the tissue todoso, butthe NRC1sable toassure nrc.gov. The ADAMS accession number surrounding a vein orartery. The consideration only for comments for e ach d ocument referenced (if it is petition may be found inADAMSat received onorbefore this date. available inADAMS) isprovided the Accession No.ML20157A266.
ADDRESSES: Youmaysubmit comments first time that itismentioned inthe byanyofthe following methods: SUPPLEMENTARY * "
INFORMATIONsection.
= Federal Rulemaking Website: Goto Attention: ThePublic Document The petition states that, in1980, the https://www.regulations.gov andsearchRoom(PDR), where youmayexamine NRCexempted extravasations from for Docket IDNRC-2020-0141. Address andorder copies ofpublic documents, medical event reporting with the questions about NRCdockets toCarol iscurrently closed. Youmay submit understanding that extravasations are Gallagher; telephone: 301-415-3463; your request tothe PDRvia'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 397-4209 between 8:00 a.m.and4:00 time, ample evidence hasbeen individual listed inthe FORFURTHER p.m. (EST), Monday through Friday, published demonstrating that nuclear INFORMATION CONTACT section ofthis except Federal holidays. medicine extravasations areavoidable document. andarecapable ofcausing considerable
- Email comments to: B.Submitting Comments harmtopatients. Referencing literature Rulemaking.Comments@nrc.gov. If you Please include Docket IDNRC-2020- research andcase studies, the petition 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 Forthe Nuclear Regulatory Commission.
NRCmedical reporting limits andcan your facility currently monitor for Annette L.ViettiCook, harmpatients inmanyways. Inlight of radiopharmaceutical extravasation? If Secretaryof the Commission.
this evidence, thepetition requests thatso,whyandhowdoyoumonitor? Ifnot, [FR Doc.2020-19903 Filed 9-14-20;8:45 am) theNRCrevisit the policy established in whynot? BILLING CODE7590-01-P 1980andrequire the reporting of 4.Doyouexpect that monitoring for medical events of extravasations that extravasation andreviewing the results result ina localizeddose equivalent would improve radiopharmaceutical exceeding 50rem (0.5Sv). The petition administration techniques atmedical DEPARTMENT OFENERGY asserts that thereportingof certain, uselicensee facilities? If how?If so, not, 10CFRPart 431 extravasations asmedical events will whynot?
notonly alert the NRCtoinstances of 5.Do youbelieve anNRCregulatory serious misuse ofbyproduct material, action requiring'monitoring andreview [EERE-2017-BT-STD-0032) but also will incentivize practitioners to ofextravasation would improve patient RIN1904-AE07 improve injection andinfusion quality. radiological health andsafety? Ifso, Thepetition states that this isintende"d how? If not,whynot? Energy Conservation Program: Energy toensure that diagnostic and Conservation Standards for therapeutic .
nuclear med1c1ne . . . Medical patientsRepo rtingCriteria Event Classificationand EvaPorativel Y Cooled Commercial areprotected from avoidable irradiation Package Air Conditioners andWater andgiven access tovital information to Currently, the NRCexcludes Cooled Commercial Package Air understand whenandhowmedical extravasation of radiopharmaceuticals Conditioners their from its medical eventreporting events impact care.
regulations.Medical eventsmaynot Oh he 8y hm a V.Request for Public Comment necessarily result in harm tothe patient, Renewable Energy, Department of TheNRC's Medical UsePolicy butthey c'an indicate a potential Energy.
Notice ofproposed Statement (65 FR47654) states,^in part, problem in a medical facility's use of ACTION:
that the NRCwill notintrude into radioactive materialsor in determination andrequest for comment.
medical judgments affecting patients, a dministration as directed by the except asnecessary toprovide for the physician. Because licensees are not
SUMMARY
- TheEnergy Policy and ConservationAct(EPCA),
radiation ofworkers andthe required to report to the a s safety extravasations amended, prescribes energy general public. Italso states that the NRC, extravasation events arenot NRCwill, whenjustified by the risk to documented inthe NRC's Nuclear conservation standards ior various patients, regulate theradiation safety of Material Events Database (NMED), consumer products and certam patients primarily toassure theuse'of which contains records ofevents commercial andIndustrial equipment, including evaporatively-cooled radionuclid^es isinaccordance with the .involving nuclear material reported to commerc1al package air conditioners physician ,
s directions. Considering the NRC these policy objectives andhowthey 1. Are^there any benefits, not related and water-cooled air commercial (referred toas package mayrelate to radiopharmaceutical to medical techniques, to monitoring conditioners commercial extravasations, the NRCisrequestingandreporting certain extravasations as evaporatively-cooled umtary air conditioners ('ECUACs) public comment on the following medical events? What would bethe specific questions. burden associated with m onitoring for and water-cooled commercial unita,ry andreporting certain extravasations as alrcondit1oners ( WCUACs' ) m th1s Infection Quality Monitoring medical events? document). EPCA also requires the U.S.
TheNRCencourages licensees touse 2.If the NRCweretorequire 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 the administration that the whatreporting criteria should beused result insignificant additional physician intended. TheNRCrequirestoprovide the NRCdata that canbe conservation ofenergy, be certain quality assurance procedures- used toidentify problems, monitor technologically feasible, andbe such ascalibrating instruments used to trends, andensure that the licensee economically justified. Inthis notice of measure patient dosages andrecording takes corrective action(s)? proposed determination ("NOPD"), DOE dosages administered-but there are 3.If the NRCrequires reporting of hastentatively determined thatthe other procedures that the NRCdoes not extravasations that meetmedical event standards for small (cooling capacity require that could berelevant to reporting criteria, should a distinction less than 135,000 Btu/h), large (cooling extravasation. TheNRCisseeking bemadebetween reporting capacity greater than orequal to135,000 information on useofquality assuranceextravasations ofdiagnostic and andless than 240,000 Btu/h), andvery tools andtechnologies for therapeutic radiopharmaceuticals? Ifso, large (cooling capacity greater than or radiopharmaceutical injection quality why? If n ot, why not? equal to 240,000 a nd less than 760,000 monitorin andextravasation. VL Conclusion Btu/h) ECUACs andWCUACs donot 1.How "equently does need t obe amended, and DOE requests radiopharmaceutical extravasation TheNRChas determined that the commenton this proposed occur? petition meetsthe sufficiency determination andthe associated 2.Do youknowofany extravasations requirements for docketing at@ 2.803 analyses andresults.
that have resulted inha~rm topatients? TheNRCwill examine the issues raisedDATES:
Ifsoandwithout including information inPRM-35-22 andanycomments Meeting: DOEwill hold a webinar on that could lead tothe identification of received onthis document todetermine Thursday, October 1,2020, from10:00 the individual, describe the whether these issues should be a.m. to3:00 p.m. Seesection V,"Public circumstances, typeofeffect harm, and considered inrulemaking Participation," for webinar registration the impacts. Dated: September 3,2020. information, participant instructions,