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ACM-2* ,

O N2i U89 POR

T0: Medical Use Licensees

FROM: Vandy L. Miller, Chief |Medical, Academic, and ComercialUse Safety Branch

Division of Industrial andMedical Nuclear Safety

Office of Nuclear Material Safetyand Safeguards

SUBJECT: DIAGNOSTIC MISADMINISTRATION REPORT FORM, NRC FORM 473

This is to infom medical use licensees of the development and availability ofNRC Fom 473. Medical use licensees must use this fom to report diagnosticmisadministrations.

When it approved the revision of 10 CFR Part 35, the Consission directed thestaff to develop a form for reporting diagnostic misadministrations. The revisedrule, without an NRC fom number, became effective in April,1987. The Officeof Management cnd Budget has approved the form and the form number was recentlyannounced in the Federal Register. A ccpy of the Federal Register noticeannouncing the fom and a copy of the fom are enclosed for your convenience.

Please note that the use of NRC Fom 473 is required for reporting diagnossicmisadministrations. You may refer to 10 CFR 35.33(c), also enclosed, for thisrequirement.

If you have additional questions concerning the use of NRC Fom 473, pleasecontact Jim Myers at (301)-492-0637.

.

Originsi signed ByVANDY ( MILLER

Vandy L. Miller, ChiefMedical, Academic and Commercial

Use Safety Branch,Division of Industrial and

Medical Nuclear SafetyOffice of Nuclear Material Safety

and Safeguards

Enclosures: -

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1. HRC Form 4732. Federal Register Notice (53 FR 21627)3. 10 CFR 35.33(c)

DISTRIBUTION:IMN5 central File S r/f IMA3 r/f~

JMyers > NMcElroy VMiller

g71gl4088062935 53FR21627 PDR

.. _ _ _ - . . _ _ _ . . _ . _ . . _ _ _ _ . . . . _ _ _ _ . . _ . _ _ _ . _ _ . _ _ _ _ _ _ _ _ - . - _ _ _ _ _ _ _ _ - - - _

AcM4 PDANRC FORM 473

U S. NUCLE Att REGULATORY CO.MMIS$lONtS 8si Ay ae,OMg,

10 0F Pa t 3% 33 31 b3 Ol &O'~ ~'

DIAGNOSTIC MISADMINISTRATION REPORT

INil LICENSE E N AME | iN 21LICE NSE NYUGE R

I l l-l | Il | |-l iIN3) CIT Y IN 45 5 TATE IN6) EVENT DATE IN61 REPORT C ATE

MONTH Dev DEAN MONTH DAY YEAR

l l l I l l I

af.81 CiD THE MISADMINi$ rR A TION INVOLVE AN IN91 NUMBE R OF P A TIE NT5 WHO RECElv E DIN1) T YPE OF Mi$ADMINitTRA flON ISOTOPE OF IODINE A Ul$ADMINisTR AflON UNDER THt$ REPORT4011 WRONG 102) DO5 AGE OlF F E RING

_ R ADIOPHAR M ACE UTICA L - FROM PRE SCRi4ED BY 50%

|(03) WRONG PATIENT 404) WRONG ROUTE s p LYES 1111) NO

IN tol lNTENDE D IN10 Al lN T E N DE D INIII Giv f N

",9$u '105| NO CLINICAL PROCE DUR E IO8) ULTR A$OUND STUDY MILLICORIE S ISOTOPE STUDY$TUDY MILLICURIES ISOTOPE FO MfC3) NUCLE AR ME DICINE M CTSTUDY

_$TUDY 4 Comp 4*ie

_

E _110l NM9 8TUDY

(07) x RAY STUDY (Ill OTHE R -

|N121 PRECIPITATOR

lill RE F ERRING PHYS 6CI AN 1753 AUTHORIZED USER 4761 HOT LA8 TECHNOLOGIST

(77) W ARD NURSE (77| |MAGING TECHNOLOGl5T

(73) WARD CLERs( 178) CLINIC RECEPT 3NIST

(74) NUCLE AR PHARMACY (79) $CHFOULING TECHNCLOGIST~

N AME OF NUCLE AR PHARMACY | CITY |$ TATE 1801 PATIE NT

(81_) OTHE R.

(Nl3) ERROR

HOT LAB REFEMRAL ADMINIS TR A TION OTHER

till Mi$LABEa ED A SYRINGE (IS) SELECTED WRONG vl AL (20) MISUNDER$700D 1301 SE LECTE D WRONG 140) Saeory- WHEN DR AWING DOSAGE R EF ERRING PHY$1Ct AN $ PATIENT

-(12) MabLAEELED A vtAL REQUEST

OR vlAL SHIELD (1615ET DOSE CAtl8RATOR (31} A SWE RE D W AITING(211 REQUESTED WRONG|MPROPE R LY ROOM P AGE INTENDE DSTUDY(13) RECONSTtTUTE D F OR OTHER PATIENT

WR EAGEM MT (17) Mi$RE AD E(22) REQUESTED STUDY (3218 AOUGHT WRQNG

FOR WRONG PATIENT PATIENT TO CLINIC(141 PL ACE D RECONSTITUTE D

vl AL IN WRONG SHIE LD (181 SUN $T000 @ y p,

OR DOS AGE ORDFR CART

(Niel CONTRt8t* TING F ACTORS IN t51 ACTION T AK EN TO PRE VENT RECURRENCE

] IC6) ROVE 5 PE R vi510N680) $TUDE NT TECHNOLOGl37 185) REOutslTION NOT CHECK ED IMPLEMENT NEW PROCE DURES POR

(861 PAYlENT CHARY NOT (C1, vf RIFICAflON OF REQUEST-

011 NEW EMPLOYEE- CHECKED -

(C7| R A DIOPH AR M AC E UTIC A L-

(42) FOREIGN LANGUAGE (C71 NO ACTION

(83) PA flE NT INCOME REN T OR esil NE W PROCEDUR E_ LABEL 6NG AND HANDLING _

1C3) vf RIFIC ATION OF PAflENT IC81 OTHeil- UNCON5ClOUS - - |DE N TIF ICA TION -

(88I HE AvY WORK LOAD

(84) 10 8R ACE LE T NOT CHECK E D IC4) RklNSTRUCT PERSONNE Lg _

(CS) R EPRIM AND PERSONN E L

(Niel EFFECT ON PATIENTS | NONE APPARENT SEE AC$TR ACT

6NI P) C8$ TR ACT Of mee apa, a re9wM. difm A eMieaef sAvera l

ee

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| StGN ATgRE | TELEPHONE |DATERActT10N OFFICER IPmted New6

NUCLE AR REGULATORY COMMi$$lON USE

(N t 81 ( N 191 (N2M RE GION AL LOG IN2tl ACCEf 550N NL M8ER IN278 INITI A LSAS NUMBER

*

.9999 Y E S-

I I III III III I III I< iii} NO

I NRC FORM 473 (6 881

Ac69-1PM'

Federal Register / Vol. 53, No.111/ Thursday, hne 9,1988 / Rules and Regulations*

21627

PART 10'46r-MILM IN THE ne diverting handler shall designate text. A copy of the form wulbe mailed }

1

LOUISVILLE. LEX 1NGTON- the farmer deliveries that shall not be to NRC medical use licensees. '

EVANSYlLh5 MARKETING AREA producer milk.lf the handler fal's toThis amendment is a miace-

!

3. Section1046.710 amended by make such designa tion, no milk diverted administrative change toan existingrevi Ing peregraph(e) to read as by suchhandler pursuant to this final rulet it merely adds 'he form !tf0U0*8: paragraph shall be producer milk. number for anNRC form to the codified* . * * *

rule. The number had beea omittedi so4u poospiano Signed at Washington. DC, on: June 3,1988. because OMB had not comp 3 tad 11aa * . . . Kenneth A. Gas,. review. Based on this, good caue exists(e)De term "pool plant" shaU not Assistant SecretaryforMarket/ng and to Dnd that me nonce a &procedure provisions of@theapply to b following plants: Inspet/on SerWces.(1) A producer.handlerplantt '

[FR Dec 8913013 Fl!ed s+ast a44 am) Administrative Procedure Act ere(2) Unless determined otherwise by ' ' owen coor whoo.m unnecessary pursuant to the exe aption

the Secretary, a milk piant during any provision found in 5 USC. 553(b)(B).montis to which the millrat such pfaat - Omloes amendsneatIseffoctive. -would be subject to the pricing andpoollas provisions of another ordes" NUCLEAR REGUt.ATOW. pon publication in the Federal:tegister.,

COManSSKng Ad=1=r.s ti, m.se. Issued pursuant to the Act, exceptr

plan)t(i A plant thatqualIKas as a pool 'to CFR Part St. av ronmendeHaippettCategoricalat to paragraph (ay,(b),(c) Exclustom.

Yl d milk exeept porni. a ae a e Wfilled muk,'is disposed of from such in categorical usioni mPlant la thelouisville44xingtoo. Aessecv:Nacleadegulatory.~

uvironmenW impact statanant u art.

.

51.22(c)(3).Thereibre, neithee an. . . .Evansville markstfra aree to other pool Co'n-d ataa- .

plants rad to retallor wholesale outlete Ac1 ease Final rula.I " VI'0""""'' I "'****"*" O * * -

t than in the niarketing area regulated preparedIer Me Analcule. .; - -

pursuant to suds other order during the suesasw:%e Nuclear Regulatoey .current montfeand Commission (NRC)is amendinglas .', p,p,,,,,g g,g,,gga, Act Statemeer

..

x-"-(lly A plant that qualiffes se a pool regulaties for the medicaluse 00 . M BnM amende h.-,. r

-plant pursuant to paragraph (a) of this byproduct material to indicate thelarm coRectiom requirenants that are subisot -section and which also meets the .to be used for reporting diagnostic . to the Papa-a4 RedseolooAct ef t90spooling requirements of another Federaj misadmintatrations.nla action tai (44 USC.350u.tseq) Theseorder on the basis ofroute disposition if intended to inform the publicof the requirements were approved 15e . .the plant la loca ted in the Iouisvilfe developmsat and availsbuity of the Office of Management and Bu get under-lexington Evansville marketing area form that medical licensees must use to . OMB N,umbw 3150-014a -

and this order's C!asa I price applicable meet this reporting requirement.List of Sunfectsinle CFR Part 38 '

at the lant is not less than the Class 1 arrscTivs oats: June er 19ea.-

price at wodd be applicable at the B roduct matertst Dibes, HashhAconesses:A copy of Form NRC 473 faci ties,Ilealthpm8essions,| plant if regulated under the order for theFederal order marketing area in which may be examined at the Commission's Incorporation by. reference, Medical

| the plant has b greatest route Public Document Room at 1717 H Street devices.Nucleas materials,NW., Washington DC. Single copies are Occupational safety and beehh.penalky,isposition: and

,

(3) A plant that quallfleo as a available from James H. Myers, O!!!ce of Radia tion protection. Re;;orting and --

plant pursuar* to paragraph (a) poolNuclear Material Safety and Safeguards, recordkeeping requirementse .of thissection and which also meets the US Nuclear Regulatory Commissforr,

requirements of a fully regula ted plant Wa shington. DC 20555. Telephone: (301) Regulatory Text492-0635.pursaa the p vi na o another . For the reasons set out in the-,

* ''' "" ' E Fon ruwTHen peronesAriou coNTAcTt preambleandunduthe tunherityof thedis bution in such okt markating area jr.mes H. Myers. Office of Nuclear Atomic Energy Act of 1954, as amended,*n rmn w ch the Secntary Materia! Safety and Safeguards, US the Enargy Reo3 Nuclear Regulatory Commission. J as amended, an1anization Act of 1974..5 USC. 553 the NRC le

Itbs ngt n.DC20555. Telephone:(301) p e following amendment to 10ti led I t nmarketing area is greater than routedisposition in such other marketing area sueeutatSNTAnV peront4AT ose ne NRCbut which plant is, nevertheless, fully amended its regulations for the medical PART,35-MEDICAt. USE OF '

regulated under such other Federal use of byproduct material to require BYPRODUCT MATERIAr..

order. licenseea to report certain diagnostia 1.The authority citation for Part 35| 4. Section 1M8.13 is amended by misadministrations to the NRC on a - continues to read as follows:adding a new paragraph (c)(4) to read as special NRC form.nls matter was

discussed in the final rule revising 10 gg 3,,, g,3m ,,follows:-t ,

-

CFRpart 35 (51 FR 3em2; October ilk amended (41 tt.5.C 2:01) eee ase, SPStat.11044aJ Producer mul .i 1986). . .

1242. as amended (42 U.S.C 5841JL* * * * *

Thc NRC staff has developed the $ 35.33, [Amenden,

(c) * * * form, and the Office of Management and 2. In $ 35.33. paragraph (c) is amended(4) Any mftk diverted in excess of theBudget (OMB} ha s approved its use. The by removing footnatst andhylaseseglimits prescribed in paragrsph (c)(3) of NRC is amending its regulations to ''Feene NRC tr3*la p*ase ePfer w 'this section shall not be produc er milk. Insert the form number in the regulatory NRC "In the second sentence.

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ACI:8-1,

21626ederal Register / Vol. 53, No.111/ Thursday, June 9,1988 / Rules and Regulations. PM|-

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Dated at Rockville. MD. this 27th day of PoA FURTHER INFORedAflott C08efACT preparation of a FederalismMay 196d. Mr. Bdan Yr.nez, FAA. Wichita Aircraft Assessment. *

For the Nuclear Regulatory Coaunissiork . Certification Office. ACE-120W,1801- The FAA has determined that this .,

Airport Road, Room 100, Mid. Continent amendment is not major under section sVictor Selle, Jr. --

acauve D/nhorforOperadow Airport, Wichita, Kansas 07200: of Executive Order 12291. It is f,.

9,1 Doc. se-12es5 Filed 6-4-ee; 8.45 am) telephone (316) 94-4409. Impracticable for the agency to follow - {.sume caos reeket- e suppt.assastrAny twronssATioes This the procedures of Order 12291 with i

amendment revises AD 87-20 02, respect to this rule since the rule must ' g

Amendment 39-5728 (52 FR 35683; be issued immediately to relieve , ,

DEPARTMENT OF TRANSPORTATION September 23,1987) applicable to all unnecessary economic burden hy further iEeech Models 35,35R. A35 B35, C35, modification to the circraft. If this action .

Federed Avletion Administration D35, E35, F35, G35. H35, J35. K35, M35/- is subsequently determined to involve a ,

N35, P35, S35, V35, V35A and V358 significant regulation, a final regulatory [14 CFFI Part 3gairplanes except those modified per evaluation or analysis, as appropriate.-

IOeehas bee. 47-cs-a>Ac; Amst. s&ss441 SupplementalType Certificate (STC)"- . will be prepared and placed in the - ,

SA2149CE (straight tail conversion), AD regulatory docket (otherwise, anAirworthineseDirectives Beech 87-20 02 incorporated the af,rspeed, , evaluation la not required). A copy of it.: i, . ,Models Sal,35R, A4 34 CSS,03Sc ' limitations required by DA 86-21-07 to wh*n filed, may be.obtained by . . r

..

ESS, F4 035, H35, J4 K34, MSE, N4 preclude producing airloads within the contacting the Rules Docket at the -

P38,838 VSS,V35A'and V363 flight envelope that could resultin . location under the caption "a======" c

. Airplaneen structural failure of the V. tail, AD 87-) ~ .at the locatica ide.ntified.'

2

Aesucv1 Federal Aviation.. 20-02 also has provisions for amovin83 Ilst of Subjects lei 14 CFR Part 30 - 3

Administratloc (FAA), DOT; tho a limitations. One provision is.the, Air transportatloa, Aircraft, Aviatien

. - -

installation of the Beech stabihur y- -agg,,,,p w rule..-reinforcement. This installetion requires safe % Safety. .:6 .

,

Isussananvi% amendment revises- the removal or trimming of previous' Adoption of the A===h-*"- -

*.

Airworthiness Directive (AD) 87-20-02, . modifications installed by STCiAmendment 30-472a. applicable to . Subsequent to luuance of AD 87-20 02, Accordingly, pu.rsuat,t to' the authority

. ..-

certain Beech Models 35,35R. A35 B35 Mike Smith Aero, Inc. (MSA) performed delegated to me by the Arfmintatrator,:, .

C38, D38, Ess, F35, G35. H35,135 K35, a atructural test that demonstrated thatthe Federal Aviauon AMstndon: . , ,p,

.

amends i 39.13 of Fart 39 of the FAR as -M35cN35. P35. S35 V35, V35A and V35B the MSA Tall-Safe modification,- . ,

I airplanes' AD 87-20-02 requires ~ - installed per STC SA1649CE for Models - foUowet a, .- >,

incorporation of the altspeed limitations S35 V35.V35A, and V35B airplanee,is-PART$9--(AMENDED}9'/ '. '' d :

*',

required by AD 86-21-o? and also adde. equivalent to the Beech stabilizer- *<~

-*--

, provisions for removing these reinforcement,Rio revision to AD 87 - 1.%e authority citatioa foe Part 39 - t. .

LIlmitations with the incorporetion of 2H2 will permit the use of the Tall Safe . continues to read as follower -,

i ' modifications identified in Beech * . * modification in lieu of the Beech - Authartryt 4e U5C.1354(a}.1421 and 1423i I| . Mandatory Service Bulletin (SB) 2188, . ' stabilizer reinforcements. . - 4e US.C.106(g) (Revloed. Putr. L 97-44e, -

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dited May 1987. A check of the ..T .- Therefon, the FAA is revising AD 87 - January 12,19e3)- and 14 CFR ti.st{. ,accuracy of weight and balance data for 20-02 by allowing the use of the MSA

l all altplanes and of the ruddervator Tall. Safe external angles installed per l'8818 (Am*"d*dl -'

static balance for the Models C35 STC SA1649CE, for Models S35, V35,- 2. By revising and reissuing AD 87-20 .through V358 is also required. ne V35A and V35B airplanes,la lieu of the ' 02, Amendment 39-8728, at follows: 'revision specified hernia will allow - Beech stabilizer reinforcer - *s. In seech: Applies to all Model 38,35R. A35. 84installstion of Mike Smith Aero Inc. addltion, minor editorial cl. 3caticas C35 D35. E35, Fn ",35 M35 D5, K35,'(MSA) Tail-Safe external angles per have been made to the AD.His action- Mn N35. PSL S3A V4 bl.A. and V353 'Supplemental Type Certificate (STC) relieves an unnecewary burden on those Dil artal nut.tes) strplann certificatedSA1640CE in lieu of the Beech atabilizer operators which have installed P'SA in any categor ; <x.-ept to those Mdelsreinforcements for Models S35 V35, Tail-Safe external angles, imposes no S35, #35 Vasa al.d V358 altvwee ;

V35A, and V358 altplanes. nis reviuon additionalburden on any person, and modified per Sapplemental Tye -

Certificate (STC) SA2140CE (straigh. .will relieve operetors of the unnecessary precludes unnecessary modification or ** '

bstden of removing oe trinuning these ahc. don of airplanes equipped with. -

Tall-Safe anglee to accommodste the Tail-Safe external angles MSA STC ;[,7 ***dgd sainaca% unkU .

i I'To sSu theBeech atabiliser reinforcement < ' - SA1M9CE. Therefore, notice and publicfailuru due to ina[nibility for in-flight .taTas: Effective Dotat June 15' 1988 . ptccedure hereon are unnecessary.'

: Compliancet As proecribed in the body. contrary to the pub!!c Interest, and goodi tail, and/or adver*buste strength of the V.!, ,

isht characteristicst

.

cf the AD.~ ' cause exists for making this amendment rm! ting from operation outside the ailimit.,

AoniassearGesch Mandatory Service - efrective in less than 30 dayor'

of the center of sravity envelope, accomptish 3-

Bulletin No. 2188, dated May1987; The regulatione set forth in thle- th* followins: *' ' ;

dpplicable to this AD may be obtained ' amendment are promulgated pursuant to (a) Prior to htther !!!sht after the effective !

from Beech Aircraft Corporation, authority in the Federal Aviatico Act of - date of this AD, unleu accomplished per AD'

,

Commercial Service, Department 52, 1958, ae amended (40 U.S.C.1301. et - so-21-on . e

P.O. Box 85 Wichita, KS 67201-0085; sq.), which atstute is constiued to [ M[y 38,35R. A35. 94 C4 Dn-

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telephone 316-681-7279. His - preempt dtate law regulating the same (A) Fabrice end Install on tho instrument .'

,information may be examined at the, subject.Ms. In accordance with ~ panel as near poutble to the airspeed . .

Rules Docket, FAA Ofttce of the Executive Order 12812, trie determined , indicator and in clear view of the pilot the !*

RegicnalCounsel. Room 1558,001 Eset . that such reg'.tlation does not have following placard using to:te:s of 0.101 ch' ,

| 12th Street. Kansas City, Missouri 64108, fcderalism iruplications warranting the minimum height. "Never exceed speed. V ['' >

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M -1*e

P09s

rederal Register / Vol. 51, No. 200 / Thursday, October 16, 1986 / Rules snd Regulations36955

l 35.33 Recess and reports of relative (or guardian), and if not. whymisamrenone, not.The report must not include the(a)When a misadministration patient's name or other inforrestion that

involves any therapy procedure, the could lead toidentification of thelicensee shall notify by telephone the patient.appropriate NRC Regional Office listed

(c)When a misadministrationin Appendix D of part 20 of this chapter, involves a diagnostic procedure, theThelicensee shall also noti thereferring physician of the al ected Radiation Safety Officer shall promptly

patient and the patient or a responsible investigste its cause, make a record forNRC review, and retain the record asdirected in i 35.33(d). The 11 censes shallte ap ician s to i form the

attent or believes, based on medical also notify the referring physician andfudgment, that telling the patent or thethe appro riste NRC Office specified ir.

i 30.6 of a partin writing on Formpatient's responsible relative (orguardian)would be harmful to one or

dministr a y v u ofthe other, respectively.Thesenotifications must be made withIn 24 W 'dal ' d'

medic admini trsti n of s osage[g' tibeb $the five fold different from the intendedphysician, patient, or the pat! ant.a dosage, or administration of byproduct-

responsible relative or guardian cannot rnatorial such tha t 'h t patient is 14ely to 'be reached within 24 hours, the licenne Mceive an orgr greater than 2 rem

shall notify them as soon as practicable. or a whole ood, greater than 500"Illi " d '

The licensee is not re, quired to notify the bibp!.b!a N ''o d lycpatient or the patient s responsiblerelative or gaard!en Without first for amount of r dioactivity

administered, to determine whether aconsulting the referring ph sician:however, the licensee shalf not delay nWs m@ed.medical care for the patient because of (d) Each licensee shall retain a recordthis, of each misadministration for ten years.

(b)Within15 days after aninitial The record must contain the names oftherapy misadministration report to all individuals involved in the eventNRC, tne licensee shall report. in (including the physician, allied healthwriting, to the NRC Regiont,1 Office peraonnel, the patient, and the patient'sinitially telephoned and to the referring referring physician), the patient's socialphysician, and furnish a copy of the security number oridentificationreport : . the patient or the patient's number if one has been assigned, a brieftesponsible relative (or guardian) if description of the event, the effe:t oneither was previously actifled by the the patient, and the action taken,1f sny,

- licensee under paragraph (a)of this to prevent recurrence,section. The written report must include (e) Aside from the reitficationthe licensee's name: the taferring requirement, nothing in this sectionphysician's name: a brief des ription of affects any rights or duties oflicenseesthe event: the effect on the patient: the and physicians in relation to each other.action taken to prevent recun ance: patients, or tr *ponsible relatives (or'

whether the licensee informed the guardians).patient or the patient's responsible

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.___ Te__e. -: re . e<. . _ _ _ _ .,

Norman McElroy( 301 )492-3417. _., . .,

NRC Form 473 Diagnostic Misadministration Report.

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!SUPPORTING STATEMENT

I

FOR

10 CFR PART 35

MEDICAL USE OF BYPRODUCT MATERIAL

AND

NRC FORM 473

DIAGNOSTIC MISADMINISTRATION REPORT

Background

10 CFR Part 35, Medical Use of Byproduct. Material, contains requirements thatapply to Nuclear Regulatory Commission (NRC) licensees who are authorized toadminister byproduct material or its radiation to humans for medical care.

NRC

Form 473 is used by NRC medical licensees to report diagnostic misadminis-trations of radiopharmas -uticals as required by 10 CFR Part 35.

Justification

Part of NRC's function is to license and regulate the use of byproduct mate-rials in order to assure protection of the public health and safety. The NRCrequires licensees to perform certain tasks to ensure fulfillment of theirobligations.

The records required in this part are the least burdensome wayfor licensees to demonstrate compliance. Occasionally, safety matters are ofsuch significance that others need to be aware of information in order toperform their jobs or work in a safe manner. In these cases, reports arerequired.

Need for and Practical Utility of the Information Collection

Sections 35.12 (b) and (c) of 10 CFR Part 35 require that applicants submit acompleted NRC Form 313.

The form elicits an orderly description of the appli-cant's complete radiation safety program. Requests for amendments and licenserenewals may be submitted in let'.er format. Inis report is needed to assureNRC that the applicant is able to protect health and minin3ze danger to life

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3rd property before it can authorize receipt of radioactive material. NRC,

Fona 313 has previously been cleared under OM8 No. 3150-0120, which should be

' referred to for additional supporting information, as well as burden and costdata.

Section 35.13 of 10 CFR Part .35 requires that licensees apply fnr and receive alicense amendment before using material not allowed by the license, beforeadding to or changing key individuals, before receiving more material thanallowed by the license, or before changing t.ie location of use or mailingaddress. The identified trigger events are critical indicators of potentialfor change in the licensee's ability to control radiation dose to workers andthe public, or the NRC's ability to contact the licensee or conduct aninspection.

The information is needed so that the staff can determine whetherthe licensee has the training and experience and facilities and equipmentneeded to assure protection of public health and safety.

Section 35.14 of 10 CFR Part 35 requires that licensees notify the NRC within30 days if a key worker ends his association with the licensee. This promptreport is needed because if the licensee no longer has a complete staff, thecollective training and experience of the remaining staff may no longer besufficient to ensure safety. This report will trigger a check of thelicensee's file to determine whether the remaining key users are qualified toreceive and use material safely.

Section 35.20 requires licensees to have a written program to keep radiationdose as low as reasonably achievable. The program must be written to provideclear statements of authority, responsibility, and internal requirements.

Section 35.21(b)(2) of 10 CFR Part 35 requires that the licensee establish andimplement the written policy and procedures that were submitted as part of theapplication. The policy and procedures are needed so that the staff can reviewthem and make a determination that the applicant can =et the requirements ofthe Atomic Energy Act and the Commission's regulations. The procedures must be

implemented in order to provide for protectior. of the public health and safety.The burden is included in the burden for the application, NRC Form 313, OM8 No.3150-0120.

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Sections 35.22(a)(4) and (5) of 10 CFR Part 35 require that medical institution*

licensees rett.in a copy of Radiation Safety Committee meeting minutes for theduration of the license, and prescribe the information required in the minutes.This record is needed to show continuing managament oversight of the radiationsafety program.

Section 35.23(b) of 10 CFR Part 35 requires that licensees provide a writtenstatement of authority, duties, responsibilities, and radiation safety activi-ties for the Radiation Safety Officer and Radiation Safety Committee. Therecord is needed so that managers and key users know their responsibilities.

The stateident must be retained for the duration of the license.

Section 35.27(a) of 10 CFR Part 35 requires that licensees provide written per-mission to visiting authorized users to work under the license. Section35.27(c) requires licensees to retain a copy of the license that identifies thevisitor as an authorized user. This permission and record are needed to show

that licensee management has permitted this work, and that a regulatory agencyhas reviewed the visitor's training and experience.

Section 35.29(b) of 10 CFR Part 35 requires that mobile nuclear medLine ser-vice licensees keep a letter of permission signed by the management of eachclient. This record is needed to show that client management has permittedthis work.

Section 35.31(b) of 10 CFR Part 35 requires that licensees make a record ofradiation safety program changes. This record is needed to show hat radiationsafety problems were considered before implementing the change, and also pro-vides a record of where within the licensee's facility radioactive ma.terialswere received, used, and stored.

.Section 35.33(a) of 10 CFR Part 35 requires that the licensee notify by tele-phone the appropriate NRC regional office in case of a therapy misadministra-tion within 24 hours after discovering the misadministration. This promptnotit icatioil is necessary because a therapy misadministration may present aclear and present radiation hazard to a member of the public that might bemitigateo by NRC assistance. The licensee is also required to notify the

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referring physician and the responsible relative or guardian of the patient.,

These reports are needed so that those individuals can provide adequate carefor the patient.

Section 35.33(b) of 10 CFR Part 35 requires that a licensee file a writtenreport to NRC within 15 days af ter telephoning ar. initial therapy misadmini-stration report. This report is needed so C.at NRC can determine whether there

might be generic implications in the incident which indicate a need to notifyall licensees. NRC allows the licensee 15 days to submit the report so that itcan review and analyze what has happened and provide NRC with a complete

history of the event. NRC requires submission of the report within 15 days sothat it can promptly notify other licensees if it appears the precipitatingevent might be generic.

Section 35.33(c) of 10 CFR Part 35 requires that the Radiation Safety Officerinvestigate the cause of diagnostic misadministratiors and make a record forNRC review. The licensee must also notify the referring physician and the NRCRegional Office in writing on NRC Form 473 within 15 days. These writtenrecords are needed to determine what kinds of actions precipitate misadminis-trations, and also provide a measure of the licensee's management control ofthe radiation safety program.

Section 35.33(d) of 10 CFR Part 35 requires licensees to retain a record ofeach misadm?nistration for 10 years. The record is needed sc ', hat individual

licensees can determine the causer of misadministrations within their respec-tive facilitie; and take corrective action. This record must be rEleined for10 years because misadministration events are infrequent and, if there is acommon cause fc r them, it will take longer to manifest itself.

Section 35.50?a)(4) of 10 CFR Part 35 requires that licensees make a record ofa geometry dependence test for the dose calibrator. This record is needed toshow t'aat the volume configuration of the radiopharmaceutical does not affectthe ret. ding given by the dose calibrator.

Section 35.50(e) of 10 CFR Part 35 requires that licensees retain a record ofchecks and tests of dose calibrator performance. This record is needed to show

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that the dose calibrator is capable of accurately measuring radiopharmaceutical.

dosages.

.

Section 35.51(a)(3) requires that the licensee note on a survey instrument theapparent exposure rate from a dedicated check source. This information isneeded so the licensee can check the survey instrument for proper operationbefore making measurements. The burden is included in the burden estimate forSection 35.51(d).

Section 35.51(d) of 10 CFR Part 35 requires that licensees retain a record ofsurvey instrument calibrations. This record is needed to show that surveyinstruments were working properly.

Section 35.53(c) of 10 CFR Part 35 requires that licensees retain a record ofeach radiopharmaceutical dosage measurement. This record is needed to showthat licensees are maintaining control of the use of radiopharmaceuticals.

1

Section 35.59(a) of 10 CFR Part 35 requires that licensees mair.tain written-instructions for the safe use of sealed sources and brachytherapy sources.These instructions are needed so that individuals who are handling sources candetermine the specific safety measures appropriate for each kind of sourceused.

Se_ tion 35.59(d) of 10 CFR Part 35 requires that licensees retain a record ofsealed source leak tests. This record is needed to show that the leak test wasdone at the appropriate time, and that the test showed that the source was notleaking.

S;ction 35.59(e)(2) requires that licensees file a report with the NRC withinfive days if leakage of a sealed source is detected. This report is needed so

that NRC can make a determination as to whether other licensees who havesimilar sealed sources should take special precautions. NRC allows thelicensee 5 days to submit the report so that it can review and analyze thesource and the leakage measurement. NRC requires submission of the reportwithin 5 days sc that it can promptly notify cther licensees if it appearsthere may be a generic problem,

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Section 35.59(g) of 10 CFR Part 35 requires that licensees make a record of.

sealed source and brachytherapy source inventory. This inventory is needed toshow that possession of sealed sources did not exceed the amount authorized bythe license. The five year recordkeeping requirement will help to assure con-tinued control over these sources that are only occasionally used.

Section 35.59(i) of 10 CFR Part 31 requires that licensees make a record ofradiation surveys of areas where sealed sources and brachytherapy sources arestored. This record is needed to show that adequate radiation shielding hasbeen provided for such sources, and that dose rates in contiguous areas arewithin allowed levels.

Section 35.60(o) of 10 CFR Part 35 requires that licensees label each syringeor syringe radiation shield as to its contents. This label is needed becausereview of misadministr tion reports has indicated that in many cases misadmin-istrations are caused by inadvertent transposition of syringes.

Section 35.61(b) of 10 CFR Part 35 requires that licensees label vial radiationshields with the identity of the radiopharmaceutical contained. NRC review ofseveral misaaministration reports indicates that many misadministrations occurwhen technicians dr4w a dosage from the wrong vial of radioactive material.Labels will help to reduce the chance of this happening.

Sections 35.70(d) and (g) of 10 CFR Part 35 require that the licensee establishaction levels for radiation surveys. The action levels provide the individualwho makes a radiation survey with a record of what levels are expected and whatlevels require investigation. The sections also require that the licenseeimmediately notify the Radiation Safety Officer if excessive levels aredetected during a survey. This report is needed so that the Radiation SafetyOfficer can take appropriate remedial action. The Radiation Safety officer isthe one individual onsite who is qualified to determine what action is neededto ensure worker and public health and safety, and whether that action isneeded immediately o. can be delayed.

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Section 35.70(h) of 10 CFR Part 35 requires that licensees retain a record of'

radiation surveys. The record is needed to show that the required surveys weremade.

Section 35.80(f) of 10 CFR Part 35 requires that mobile nuclear medicineservice licensees make a record of radiation surveys. The record is needed toshow that the required surveys were made.

Section 35.92(b) of 10 CFR Part 35 requires that licensees make a record ofdisposal of waste that was decayed in storage. The record is needed to showthat materials were decayed for the proper length of time and that a propersurvey of each weste container was made.

Section 35.204(c) of 10 CFR Part 35 requires that licensees retain a record ofmolybdenum-99 concentration in radiopharmaceuticals. This record is needed toshow that the concentration measurement was made.

Section 35.205(d) requires that the licensee post a time period of evacuationin areas where aerosols and gases are used. In case of a spill, this providesnotice to workers of how much time air handling equipment needs to reduce theair concentration to permissible limits. The licensee must retain a record ofthe calculations used to determine the evacuation time for the duration of thelicense.

Section 35.310(b) of 10 CFR Part 35 requires that licensees retain a record ofradiation safety instruction given to personnel who care for radiopharma-ceutical therapy patients. This record is needed to snow that the training wasgiven.

Sections 35.315(a)(2) and 35.415(a)(2) require _that the licensee postradiopharmaceutical therapy and brachytherapy patient room doors with a"Radioactive Materials" sign. This provides notice to hospital workers andthe public that there is radioactivity in the room. The section also requires

a :.he licenseo note in tho patient's chart how long visitors t3y stay in thee

patient's room. This is the most convenient way to provide this information to

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nurses, who are usually responsible for enforcing visiting rules, because the.

patient's chart provides all the information concerning the patient.

Section 35.315(a)(4) requires that licensees make a record of dose rates aroundtreatment rooms. This record is needed to show that members of the public arenot exposed to excessive levels of radiation.

Section 35.315(a)(8) of 10 CFR Part 35 requires that licensees make a record ofthe thyroid burden measurement of each individual who helped prepare or admin-ister a therapeutic dosage of iodine-131. This record is needed to show thatworkers were not exposed to excessive levels of iodine-131.

Sections 35.315(b) and 35.415(b) of 10 CFR Part 35 require that the licensee

promptly notify the Radiation Safety Officer if the radiopharmaceutical therapyor brachytherapy patient dies or has a medical emergency. This report isneeded so that the Radiation Safety Officer can take whatever actions arenecessary to prevent a spread of radioactive contamination or loss ofbrachytherapy sources.

The Radiation Safety Officer is the one individual onsite who is qualified todetermine what action is needed to ensure worker and public health and safety,and whether that action is needed immediately or can be delayed.

Section 35.404(b) of 10 CFR Part 35 requires that licensees retain a record ofthe radiation survey of each patient who was treated with temporary implantsources. The record is needed to show that the survey was made.

Section 35.406(b) of 10 CFR Part 35 requires that licensees make a record ofbrachytherapy source use. This record is needed so that, if a brachytherapy

' source is misplaced, the licensee knows where to look for it.

Section 35.406(c) of 10 CFR Part 35 requires that licensees make a record ofradiation surveys of patients af ter implanting sources. This record is neededto show that the survey was made.

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Section 35.406(d) requires that the licensee retain a record of the use of'

brachytherapy sources and special safety surveys. This record is needed toshow that the licensee is providing adequate control for these sources. The

record burden is included in the burden estimate for Sections 35.406(b) and(c).

Section 35.410(a) of 10 CFR Part 35 requires that licensees provide writtenradiation safety instruction for personnel caring for implant therapy patients.This instruction is needed so that these personnel may study and refer to itwhile caring for the patient.

Section 35.410(b) of 10 CFR Part 35 requires that licensees retain a record oftraining for personnel who care for implant patients. This record is needed toshow that the training was given.

Section 35.606 of 10 CFR Part 35 requires that licensees apply for and receivea license amendment before making certain changes in the teletherapy program.This license amendment process is necessary because the licensee might considermaking changes that would cause radiation levels in restricted and unrestrictedareas to exceed permissible levels.

Section 35.610(a) of 10 CFR Part 35 requires that licensees post writteninstructions for individuals who operate teletherapy units. These instructionsare needed to remind workers of proper operating procedures.

Section 35.610(c) of 10 CFR Part 35 requires that licensees make a record oftraining for individuals who operate teletherapy units. This record is neededto show that the training was given.

Section 35.615(d)(4) of 10 CFR Part 35 requires that licensees retain a recordof the teletherapy room radiation monitoring device function check. Thisrecord is needed to show that the check was made.

Section 35.630(c) of 10 CFR Part 35 requires that licensees retain a record ofeach calibration, intercomparison, and comparison of teletherapy dosimetryequipment. These records are needed to show that measurements of radiation

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teletherapy doses were made with instruments capable of making accurate,

measurements.

Section 35.632(g) of 10 CFR Part 35 requires that licensees retain a record ofteletherapy unit calibration. This record is needed to show that the calibra-tions were done and that licensees did not inadvertently misadministerradiation doses to patients.

Section 35.634(c) of 10 CFR Part 35 requires that the qualified teletherapycalibration expert report the results of teletherapy unit spot-checks promptlyto the licensee. This assures the licensee that the results of each spot-checkhave been reviewed by an expert. The licensee must keep a copy of each reportto assure that the review has been made.

Section 35.634(f) of 10 CFR Part 35 requires that licensees retain a record ofspot-checks. This record is needed to show that the required checks were made.

Section 35.636(c) of 10 CFR Part 35 requires that licensees retain a record ofsafety checks for teletherapy facilities. This record is needed to show thatthe checks were made.

Section 35.641(c) of 10 CFR Part 35 requires that licensees retain a record ofradiation measurements after 'nstalling a source in a teletherapy unit. These

records provide assurance that the source is properly installed within theteletherapy unit, and that dose rates outside the teletherapy room are withinpermissible limits.

Section 35.643(a)(3) of 10 CFR Part 35 requires that licensees amend a reportmade to NRC pursuant to Section 35.645 to include additional survey informatic nif changes in an installation as approved by NRC were necessary. The

additional information in the report provides assurance to NRC that dose rate,in restricted and unrestricted areas are within permissible limits. The 30-caysubmission requirement is contained in Section 35.645.

Section 35.643(b) of 10 CFR Part 35 requires that licensees request a license;

| amendment if radiation levels in unrestricted areas are above permitted levels.

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This report will trigger an indepth NRC review of safety considerations before.

it allows a licensee to operate the unit. The 30-day submission requirement is

contained in Section 35.645.

Section 35.645 of 10 CFR Part 35 requires that licensees mail a copy of tele-therapy source installation records to the NRC. This record is needed to showthat dose rates in restricted and unrestricted areas are within permissiblelevels. The submission niust be made within 30 days after the completion of theaction that initiated the record requirement. The 30-day requirement isimposed because of the especially high dose rates that can be found aroundteletherapy unics.

Section 35.647(c) of 10 CFR Part 35 requires that licensees keep a record ofteletherapy unit inspection and servicing. This reccrd is needed to show thatthe required w'ork was done.

Reduction of Burden Through Information Technology

There are no legal obstacles to reducing the burden associated with thisinformation collection. However, because of the types of information and theinfrequency of submission, the applications and reports do not lend themselvesreadily to the use of automated information technology'for submission.

Effort to Identify Duplication

The Federal Information Locator System was searched to determine NRC and otherFederal agency duplication. None was found. In general, information requiredby NRC in applications, reports, or records concerning the transfer, receipt,possession, or use of byproduct material does not duplicate other Federalinformation collection requirements and is not available from any source otherthan applicants or licensees. Portions of the needed information might also becontained in other information submittals to hRC or other Federal agencies, i

| However, duplication, if any, is slight, and the collection of this informationby use of specified forms and other required reports and records is the mosteffective and least burdensome means of obtaining the information.

Effort to Use Similar InformationThere is ne similar information available to the NRC.

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Effort to Reduce Small Business Burden.

The majority of licensees who use byproduct material are small businesses.Since the health and safety consequences of improper handling or use ofradioactive byproduct material are the same for large and small entities, it isnot possible to reduce the burden on small businesses by less frequent or lesscomplete reporting, recordkeeping, or accounting and control procedures.

Consequences of Less Frecuent Collection

Required reports are collected and evaluated on a continuing basis as eventsApplications for new licenses and amendments are submitted only once.occur.

Applications for renewal of licenses are submitted every five years.Information submitted in previous applications may be referenced without beingresubmitted. The schedule for collecting the information is the minimum

frequency necessary to assure that licensees will continue to conduct programsin a manner tiiat will assure adequate protection of the public health andsafety.

Circumstances Which Justify Variatia from OMB Guidelines

Contrary to the OMB Guidelines in 5 CFR 1320.6(f), Section 35.14 requires thatlicensees notify the NRC within 30 days if a key worker ends his associationwith the licensee. This prompt report is r.eeded because if the licensee nolonger has a complete staff, the collective training and experience of theremaining staff may no longer be sufficient to ensure safety. This report willtrigger a check of the licensee's file to determine whether the remaining keyusers are qualified to receive and use material safely.

Section 35.33(a) requires that the licensee notify by telephone the appropriateNRC regional office in case of a therapy misadministration within 24 hoursafter discovering the misadministration. This prompt notification is necessarybecause a therapy misadministration may present a clear ar.d present radiationhazard to a member of the public that might be mitigated by NRC assistance.The licensee is also required to notify the referring physician and theresponsible relative or guardian of the patient. These reports are needed sothat those individuals can provide adequate care for the patient.

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PORSection 35.33(b) requires that a licensee file a written report to NRC within15 days rafter telephoning an initial therapy misadministration report. This

report is needed 50 that NRC can determine whether there might be genericimplications in the incident which indicate a need to notify all licensees.NRC allows the licensee 15 days to submit the report so that it can review and

analyze what has happened and provide NRC with a complete history of the event.

NRC requires submission of the report within 15 days so that it can promptlynotify other licensees if it appears the precipitating event might be generic.

Section 35.33(c) requires that the Radiation Safety Officer investigate theCduse of diagnostic misadministrations and make a record for NRC review. The

licensee must also notify the referring physician and the NRC Regional Officein writing on NRC Fom 473 within 15 days. These written records are needed todetermine what kinds of actions precipitate misadministrations, and alsoprovide a measure of the licensee's management control of the radiation safetyprogram.

Section 35.59(e)(2) requires that licensees file a report with the tJRC withinfive days if leakage of a sealed source is detected. This report is needed so

that NRC can make a detemination as to whether other licensees who havesimilar sealed sources should take special precautions. NRC allows thelicensee 5 days to submit the report so that it can review and analyze thesource and the leakage measurement. NRC requires submission of the reportwithin 5 days so that it can promptly notify other licensees if it appearsthere may be a generic problem.

Section 35.645 requires that licensees mail a copy of teletherapy sourceinstallation records to the NRC. This record is needed to show that. dote ratesin restricted and unrestricted areas are within permissible levels. The

submission must be made within 30 days af ter the completion of the action that' initiated the record requirement. The 30-day requirement is imposed because ofthe especially high dose rates that can be found around teletherapy units.

Consultations Outside the Agency

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Several experts in the use of radioactive material for pnient care were asked,

tc r.onnent on the technical content, including the information collectionrequirements, of the proposed regulation. They were representatives of: Food

and Drug administration, American Association of Physicists in Medicine, HealthPhysics Society, Society of Nuclear Medicine, and the American College ofRadiology. The comments received were considered in promulgating the finalrule. There have been no consultations outside the agency since the promul-gation of the revised rule.

Confidentiality None, except for proprietary infonnation.

Sensitive Questions None.

Number and Type of Respondents These requirements will affect approximately2500 licensees and applicants. About 2200 of the licensees are hospitals, and

,

about 300 of the licensees are physicians in private practice.

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10R,Estimate of'Comoliance Burden,

Reporting Requirements

Licensee Total AnnualNo. of Licencee Staff Hours Licensee Burden

Sectio ~n Responses Annually Per Submittal (Hours)

35.12(b) See OMB Clearance No. 3150-0120,

35.12(c) See OMB Clearance No. 3150-012035.13 1800 3 540035.14 500 0.5 250

35.27(a)(1) 2500 0.5 125035.27(a)(2) 2500 0.5 125035.33(a) 5 1 5

35.33(b) 5 10 50

35.33(c) See NRC Form 473 (below), OMB Clearance No. 3150-0140 |35.59(e) 1 2 2

35.60(b) 2200 7.5 1425035.61(b) 400 0. 5 200

35.70(d) 26400 0.02 52835.70(g) 26400 0.02 528

35.315(b) 1 0.1 1

35.315(a)(2) 8400 0.2 1680

35.410(a) 4800 0.5 2400

35.415(b) 1 0.1 1

35.415(a)(2) 4800 0.2 96035.606 40 1 40

35.610(a) 100 0.5 50

35.634(c) 4800 0.1 480

35.643(c) 1 2 2

35.643(d) 1 2 2

35.645' 100 0.5 50

Total 85755 29379NRC Form 473 500 1 500

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Recordkeeping Require 2ents.

TotalNo. of Record-Record- Annual Hours keeping RecordSection keepers per Recordkeeper Hours Detention Period

35.20 see 35.12 (b) and license duration(c)*

35.21(b)(2) see.35.12 (b) and license duration(c)*

35.22(a)(4)and (a)(5) 2200 2 4400 license duration

35.23(b) see 35.12(b) and license duration(c)*

35.27(c) see 35.27(a)* 3 years after lastuse

:-35.29(b) 50 1 50 duration of service35.31(b) 1200 1 1200 license duration35.33(c) 500 2 1000 10 years35.33(d) see 35.33 (b) and 10 years

(c)*35.50(b)(4) see 35.50(e)(4) eqpt. duration35.50(e)(1) 1900 5 9500 3 years35.50(e)(2) 1900 0. 2 380 3 years35.50(e)(3) 1900 2 3800 3 years35.50(e)(4) 380 1 380 eqpt, duration35.51(d) 2500 0. 2 500 3 years

and (a)(3)35.53(c) 2200 75 165000 3 years35.59(a) 2500 0.1 250 eqpt. duration35.59(d) 2500 2 5000 3 years

'35.59(g) 2200 2 4400 5 years35.59(i) 2200 2 4400 3 years35.70(h) 2200 65 143000 3 years35.80(f) 50 100 5006 3 years

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90A.,Recordkeeping Requirements (Continued)

.

Total'

No. of Record-Record- Annual Hours keeping RecordSection keepers per Recordkeeper Hours Detention Period

35.92(b) '2200 6 13200 3 years35.204(c) 1900 5 9500 3 years33.205(d) 400 0.1 40 3 years35.310(b) 700 1 700 3 years35.315(a)(4) 700 1 700 3 years35.315(a)(8) 700 2 1400 until disposal auth'd35.404(b) 400 1 400 3 years35.406(b) 400 2 800 3 years35.406(c) 400 1 400 3 years35.406(d) included in 35.406(b) and (c)35.410(b) 400 1 400 3 years35.610(c) 400 0.1 40 3 years35.615(d)(4) 400 5 2000 3 years35.630(c) 200 1 200 eqpt duration35.632(g) 400 16 6400 license duration35.634(c) 400 1 400 3 years35.634(f) 400 12 4800 3 years

,

35.636(c) 100 1 100 3 years35.641(c) 100 8 800 license duration35.647(c) 100 0.1 10 license duration

Total Recordkeepers: 2,500Total Recordkeeping Burden: 390,550 hours

TOTAL BURDEN, 10 CFR PART 35: 419,929 hours

TOTAL BURDEN, NRC FORM 473: 500 hours '

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*These documents are prepared as a written report and must be retained by thelicensee for. reference. The time spent making the record is included in thenoted reporting section.

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POR-Estimated Cost to Public to Respond

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Section-

Annual Cost to Respond

35.12(b) See OMB Clearance No. 3150-012035.12(c) See OMB Clearance No. 3150-012035.13

324,00035.14

15,00035.20 included in 35.12(b) and (c)35.21(b)(2) included in 35.12(b) and (c)35.22(a)(4) and 264,000

(a)(5)35.23(b) included in 3'i.12(b) and (c)35.27(a)(1) 75,00035.27(a)(2) 75,00035.27(c) included in 35.27(a)35.29(b) 3,00035.31(b) 72,00035.33(a) 30035.33(b) 3,00035.33(c) 60,00035.33(d) included in 35.33(b) and (c)

,

35.50(b)(4) included in 35.50(e)(4)35.50(e)(1) 570,00035.50(e)(2) 22,80035.50(e)(3) 228,00035.50(e)(4) 22,80035.51(d) & (a)(3) 30,00035.53(c) 9,900,00035.59(a) 15,00035.59(d) 300,000

_,

'35.59(e) 120 !

35.59(p) 264,000

,35.59(i) 264,00035.60(b) 855,000

18

- _ _ _ _ _ _ ___ ____

g.- >..

SectionAnnual Cost to Respond.

35.61(b)12,000

35.70(d)31,680

35.70(g)31,680

35.70(h)8,580,000

35.80(f)300,000

35.92(b)792,000

35.204(c)570,000

35.205(d)2,400

35.310(b)42,000

35.315(a)(2)100,800

35.315(a)(4)42,000

35.315(a)(8) 84,00035.315(b)

6035.404(b)

24,00035.406(b)

48,00035.406(c)

24,00035.406(d) included in 35.406(b) and (c)

-35.410(a)144,000

35.410(b)24,000-

35.415(a)(2),

57,60035.415(b)

6035.606

2,40035.610(a) 3,00035.610(c)

2,40035.615(d)(4) 120,00035.630(c)

12,00035.632(g)

384,00035.634(c) 52,80035.634(f) 288,00035.636(c) 6,00035.641(c) 48,00035.643(c)

120

,

19

:e -

MWl1..

P0A... ..Section

Annual Cost to_ Respond'

35.643(d)120

35.645 ,

3,00035.647(c)

600Total

$25,195,740

NRC form 473$30,000

Source of Burden and Cost Data ano Method of Estimatina and Cost

The estimates are based on submittals to NRC in past years. Cost to licenseesand applicants is calculated at a rate of $60.00 per hour. This figureincludes both salaries and overhead.

Estimate of Cost to the Federal Government

Application review activities are attributable to and reported under NRC Fcrm313, OMB Clearance No. 3150-0120.

Annual Cost of NRC staff review for activities other than application review.(Professional eff' ort is 640 m urs @ $60.00 (hr)). = $38,400

.

20

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