ML20150E439

From kanterella
Jump to navigation Jump to search
Informs Medical Use Licensees of Development & Availability of NRC Form 473.Form Must Be Used to Rept Diagnostic Misadministration
ML20150E439
Person / Time
Issue date: 06/24/1988
From: Miller V
NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:
NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
Shared Package
ML20150E436 List:
References
FRN-53FR21627, RULE-PR-35 AC69-2-2, NUDOCS 8807150140
Download: ML20150E439 (27)
v • d • e


Text

. -.

ACM-2 O N2i U89 POR T0: Medical Use Licensees FROM: Vandy L. Miller, Chief l Medical, Academic, and Comercial Use Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards

SUBJECT:

DIAGNOSTIC MISADMINISTRATION REPORT FORM, NRC FORM 473 This is to infom medical use licensees of the development and availability of NRC Fom 473. Medical use licensees must use this fom to report diagnostic misadministrations.

When it approved the revision of 10 CFR Part 35, the Consission directed the staff to develop a form for reporting diagnostic misadministrations. The revised rule, without an NRC fom number, became effective in April,1987. The Office of Management cnd Budget has approved the form and the form number was recently announced in the Federal Register. A ccpy of the Federal Register notice announcing 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 diagnossic misadministrations. You may refer to 10 CFR 35.33(c), also enclosed, for this requirement.

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

Originsi signed By VANDY ( MILLER Vandy L. Miller, Chief Medical, Academic and Commercial Use Safety Branch, Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards

Enclosures:

1. HRC Form 473
2. 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 g71gl40880629 35 53FR21627 PDR

AcM4 PDA NRC FORM 473

, tS 8si U S. NUCLE Att REGULATORY Ay ae,OMg CO.MMIS 10 0F Pa t 3% 33 31 b3 Ol &O

'~ ~'

DIAGNOSTIC MISADMINISTRATION REPORT INil LICENSE E N AME LICE NSE NYUGE R l iN 21 I l l-l l Il l l-l i IN3) 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 IN1) T YPE OF Mi$ADMINitTRA flON af.81 CiD THE MISADMINi$ rR A TION INVOLVE AN IN91 NUMBE R OF P A TIE NT5 WHO RECElv E D ISOTOPE OF IODINE A Ul$ADMINisTR AflON UNDER THt$ REPORT 4011 WRONG 102) DO5 AGE OlF F E RING

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

p LYES 1111) NO (03) WRONG PATIENT 404) WRONG ROUTE s l IN tol lNTENDE D IN10 Al lN T E N DE D INIII Giv f N 105l NO CLINICAL PROCE DUR E IO8) ULTR A$OUND STUDY MILLICORIE S ISOTOPE ",9$u ' $TUDY MILLICURIES ISOTOPE FO M STUDY fC3) NUCLE AR ME DICINE

$TUDY 4 Comp 4*ie M CTSTUDY E

110l NM9 8TUDY (07) x RAY STUDY (Ill OTHE R -

lN121 PRECIPITATOR lill RE F ERRING PHYS 6CI AN 1753 AUTHORIZED USER 4761 HOT LA8 TECHNOLOGIST (77) W ARD NURSE (77l lMAGING TECHNOLOGl5T (73) WARD CLERs( 178) CLINIC RECEPT 3NIST (74) NUCLE AR PHARMACY (79) $CHFOULING TECHNCLOGIST

~

N AME OF NUCLE AR PHARMACY 1801 PATIE NT l CITY l$ TATE (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 ROOM P AGE INTENDE D lMPROPE R LY STUDY F OR OTHER PATIENT (13) RECONSTtTUTE D 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 ROVE 5 PE R vi510N 680) $TUDE NT TECHNOLOGl37 185) REOutslTION NOT CHECK ED IMPLEMENT NEW PROCE DURES POR

] IC6) 011 NEW EMPLOYEE (861 PAYlENT CHARY NOT (C1, vf RIFICAflON OF REQUEST

- - CHECKED - -

(42) FOREIGN LANGUAGE (C7l R A DIOPH AR M AC E UTIC A L (C71 NO ACTION

_ LABEL 6NG AND HANDLING _

(83) PA flE NT INCOME REN T OR esil NE W PROCEDUR E 1C3) vf RIFIC ATION OF PAflENT IC81 OTHeil

- UNCON5ClOUS - -

lDE N TIF ICA TION -

(88I HE AvY WORK LOAD (84) 10 8R ACE LE T NOT CHECK E D IC4) RklNSTRUCT PERSONNE L g _

(CS) R EPRIM AND PERSONN E L (Niel EFFECT ON PATIENTS l NONE APPARENT SEE AC$TR ACT 6NI P) C8$ TR ACT Of mee apa, a re9wM. difm A eMieaef sAvera l ee l

RActT10N OFFICER IPmted New6 l StGN ATgRE l TELEPHONE lDATE NUCLE AR REGULATORY COMMi$$lON USE (N t 81 ( N 191 (N2M RE GION AL LOG IN2tl ACCEf 550N NL M8ER IN278 INITI A LS AS NUMBER *

.9999 Y E S

< iii} NO I I III III III I III I I NRC FORM 473 (6 881

Ac69-1

'

  • PM Federal Register / Vol. 53, No.111/ Thursday, hne 9,1988 / Rules and Regulations 21627 1

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

LOUISVILLE. LEX 1NGTON- the farmer deliveries that shall not be EVANSYlLh5 MARKETING AREA producer milk.lf the handler fal's to to NRC medical use licensees. '

This amendment is a miace  !

3. Section1046.710 amended by make such designa tion, no milk diverted administrative change toan existing revi Ing peregraph(e) to read as by suchhandler pursuant to this final rulet it merely adds t'he form  !

f0U0*8: paragraph shall be producer milk.

  • . * *
  • number for anNRC form to the codified i so4u poospiano rule. The number had beea omitted Signed at Washington. DC, on: June 3,1988. because OMB had not comp 3 tad 11a a * . . .

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 &

apply to b following plants: Inspet/on SerWces. procedure provisions of@the (1) A producer.handlerplantt ' Administrative Procedure Act ere

[FR Dec 8913013 Fl!ed s+ast a44 am)

(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 and pon publication in the Federal:tegister.

poollas provisions of another ordes" NUCLEAR REGUt.ATOW.

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 ronmendeHaippettCategorical at to paragraph (ay,(b),(c) Exclustom.

Yl d milk filled muk,'is disposed of from such exeept porni. a ae in categorical a e W usioni m Plant la thelouisville44xingtoo. Aessecv:Nacleadegulatory.~ 51.22(c)(3).Thereibre, neithee an. . . .

Evansville markstfra aree to other pool Co'n-d ataa- .

uvironmenW impact statanant u art.

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 plant pursuant to paragraph (a) of this regulaties for the medicaluse 00 .

byproduct material to indicate thelarm M BnM amende h. r

- coRectiom requirenants that are subisot -

section and which also meets the .to be used for reporting diagnostic . to the Papa-a4 RedseolooAct ef t90s pooling requirements of another Federaj misadmintatrations.nla action tai (44 USC.350u.tseq) These order 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. '

at the lant is not less than the Class 1 List of Sunfectsinle CFR Part 38 price at wodd be applicable at the arrscTivs oats: June er 19ea.

B roduct matertst Dibes, Hashh plant if regulated under the order for the Aconesses:A copy of Form NRC 473 faci ties,Ilealthpm8essions, l may be examined at the Commission's Federal order marketing area in which Incorporation by. reference, Medical l the plant has b greatest route Public Document Room at 1717 H Street devices.Nucleas materials, isposition: and ,

NW., Washington DC. Single copies are Occupational safety and beehh.penalky, available from James H. Myers, O!!!ce of Radia tion protection. Re;;orting and -

(3) A plant that quallfleo as a plant pursuar* to paragraph (a) poolNuclear Material Safety and Safeguards, recordkeeping requirementse of this .

US Nuclear Regulatory Commissforr, section and which also meets the Regulatory Text requirements of a fully regula ted plant Wa shington. DC 20555. Telephone: (301) 492-0635.

, pursaa the p vi na o another .

For the reasons set out in the-

  • "" ' E Fon ruwTHen peronesAriou coNTAcTt preambleandunduthe tunherityof the dis 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 Reo 3 Nuclear Regulatory Commission. J as amended, an1anization Act of 1974..

5 USC. 553 the NRC le ti led I t n Itbs ngt n.DC20555. Telephone:(301) p e following amendment to 10 marketing area is greater than route disposition in such other marketing area sueeutatSNTAnV peront4AT ose ne NRC '

but 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 l 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 t

follows:- ,

discussed in the final rule revising 10 gg 3,,, g,3m ,,

amended (41 tt.5.C 2:01) eee ase, SPStat.

CFRpart 35 (51 FR 3em2; October ilk 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 (4) Any mftk diverted in excess of the 2. In $ 35.33. paragraph (c) is amended limits prescribed in paragrsph (c)(3) of Budget (OMB} ha s approved its use. The by removing footnatst andhylaseseg 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.

ss -

, ACI:8-1 ederal Register / Vol. 53, No.111/ Thursday, June 9,1988 / Rules and Regul 21626 "

^M l Dated at Rockville. MD. this 27th day of PoA FURTHER INFORedAflott C08efACT preparation of a Federalism May 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 .,

Victor Selle, Jr. - -

Airport Road, Room 100, Mid. Continent amendment is not major under section s 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 i Eeech 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 3g evaluation or analysis, as appropriate.-

airplanes except those modified per 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, an AirworthineseDirectives 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 . - -

installation of the Beech stabihur , Air transportatloa, Aircraft, Aviatien y agg,,,,p w rule..-

reinforcement. This installetion requires safe % Safety. .:6 ,

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

  • I Airworthiness Directive (AD) 87-20-02, . modifications installed by STCi . ..

Accordingly, pu.rsuat,t to' the authority Amendment 30-472a. applicable to . Subsequent to luuance of AD 87-20 02, certain Beech Models 35,35R. A35 B35 Mike Smith Aero, Inc. (MSA) performed delegated to me by the Arfmintatrator,:, .

the Federal Aviauon AMstndon: . , , p C38, D38, Ess, F35, G35. H35,135 K35, a atructural test that demonstrated that M35cN35. P35. S35 V35, V35A and V35B the MSA Tall-Safe modification,- . .

amends i 39.13 of Fart 39 of the FAR as - ,

~ - installed per STC SA1649CE for Models - foUowet , a, .- >

I airplanes' AD 87-20-02 requires incorporation of the altspeed limitations S35 V35.V35A, and V35B airplanee,is- '

required by AD 86-21-o? and also adde. equivalent to the Beech stabilizer- PART$9--(AMENDED}9'/

~

'. d  : *-

, provisions for removing these reinforcement,Rio revision to AD 87 - 1.%e authority citatioa foe Part 39 - t Ilmitations with the incorporetion of 2H2 will permit the use of the Tall Safe . continues to read as follower - . .

L i ' modifications identified in Beech * .

  • modification in lieu of the Beech - Authartryt 4e U5C.1354(a}.1421 and 1423i I l

. Mandatory Service Bulletin (SB) 2188, . ' stabilizer reinforcements. . - 4e US.C.106(g) (Revloed. Putr. L 97-44e, -

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. 84 installstion 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 certificated SA1640CE in lieu of the Beech atabilizer operators which have installed P'SA in any categor ; <x.-ept to those Mdels reinforcements for Models S35 V35, S35, #35 Vasa al.d V358 altvwee Tail-Safe external angles, imposes no -

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

i sainaca% unk I' Beech atabiliser reinforcement < ' - SA1M9CE. Therefore, notice and public To sSu the taTas: Effective Dotat June 15' 1988 . , ptccedure hereon are unnecessary.' failuru due to ina[nibility for in-flight . ,

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

isht characteristics t

~ '

., 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 ,

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

P.O. Box 85 Wichita, KS 67201-0085; telephone 316-681-7279. His -

sq.), which atstute is constiued to preempt dtate law regulating the same

[ M[y 38,35R. A35.' 94 C4 Dn ,

(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 ,

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

['

(

l  ;

c

.__ - - - -- . - - - - - - - - - . - m

e M -1 P09s rederal Register / Vol. 51, No. 200 / Thursday, October 16, 1986 / Rules snd Regulations 36955 l 35.33 Recess and reports of relative (or guardian), and if not. why misamrenone, 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 the licensee shall notify by telephone the patient.

appropriate NRC Regional Office listed in Appendix D of part 20 of this chapter, (c)When a misadministration involves a diagnostic procedure, the Thelicensee shall also noti the Radiation Safety Officer shall promptly referring physician of the al ected investigste its cause, make a record for patient and the patient or a responsible NRC review, and retain the record as te ap ician s to i form the directed in i 35.33(d). The 11 censes shall attent or believes, based on medical also notify the referring physician and fudgment, that telling the patent or thethe appro riste NRC Office specified ir.

patient's responsible relative (or i 30.6 of a partin writing on Form guardian)would be harmful to one or dministr a y v u of the other, respectively.These notifications must be made withIn 24 W medic

'dal '

admini trsti n of s osage d'

[g' tibeb $the -

five fold different from the intended dosage, or administration of byproduct physician, patient, or the pat! ant.a responsible relative or guardian cannot rnatorial such tha t 'h t patient is 14ely to '

be reached within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, 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 patient or the patient s responsible bibp!.b!a N o c d ly relative or gaard!en Without first for amount of r dioactivity administered, to determine whether a consulting 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 record this, of each misadministration for ten years.

(b)Within15 days after aninitial The record must contain the names of therapy misadministration report to all individuals involved in the event NRC, tne licensee shall report. in (including the physician, allied health writing, to the NRC Regiont,1 Office peraonnel, the patient, and the patient's initially telephoned and to the referring referring physician), the patient's social physician, and furnish a copy of the security number oridentification report : . the patient or the patient's number if one has been assigned, a brief tesponsible relative (or guardian) if description of the event, the effe:t on either 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 reitfication the licensee's name: the taferring requirement, nothing in this section physician's name: a brief des ription of affects any rights or duties oflicensees the 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 ,

vh -,-e -g, -. -.,- ,,-.----,,,----n,-->

.c c3 1 Ra-L Ren.uest for OMB Review PDR 7 .

sE . .

.. s ;. + . p3 4 3 e,-; y , em e :-5 '?- be marera. to de re. e..e4 ec ,;.

p. tr *<

. ~ .,

. . ,s, 3 M_'.3 a .4 .' .. * ** t/C %'J O O' If.0 b.;LC'!*rg 1 d!EF!'9I.I to u 1.4 . ' r. s. x p .e CP C6 9 '-W~.C on 3rd Regja:ce y W3..g

,, .. r * . 3 -7 -

('f f 6

  • t 8.sy. f g,. p . , y

'r*

a

. .,. .-' - .'.J: y J CI'. D , CC : L O *4", 4' :< ,320 !

, -;,are v.'

  • ct 4i$5 ~ ( ;" b.- '^'?O3

.~. . . . ... . . . . . . . . . . . . - ..

' + M 1. - ., R i, r, . , :. !. ice. All R t;;'.,9 u5 -

^

-: . .- . . n .w _ _ _ . .

2. ne-c o m 6

f U.'S. Nuc' lear Regulatory Commission 3 1 5 0

.___ Te__e. -: re . e<

Norman McElroy

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

NRC Form 473 .

Diagnostic Misadministration Report e c: 2. > e, , w: . ~. s: ; > ~ - <s

.s +. v b, :. &en =

42 un

?

.s.20L(01 _ .. _ <..-

c. c. e , . . . .

3]r,3.,ogy,no,,,,.pe,,,,

. _X , .s 4,

sy t., :v : .e sot.: ces 2 .X ? . s a '-* - ->-'F"' 7 -X 5~' r

  • 8 "*u " o' t'p+n'.e s "ART il -Com;,lete in Far: Cw J the P nuest is fct OMB Review Under Executive Order 12291

?; E .;,. e. e- p.t . *, -yto N

~

- _ _ . . . . .. . .' ..:? e dsi.f M -

6. Vg c o f s a ., v -e a y e er : e vi 'y Type of review requested O J s t f CJ 60.* Iftf f 2f4D P '00 ?'*e if } ~i C;a c3,3

_ .**JC' $m; Fera. g A

1 %, I'!:sse: v

  • m

' _ . . ' +- '

'f, *

, . -g a t' 9 ** ; ;;cJ!

3 ,, [*' *

  • feat y j, ._. ~ g t' " "*' * " 1. A t *%t OCf O*,.0. ; Sal .I _ $' M * *'j o' ' , j ". a' Of & j're t 9 Ef*!*; .'4"**leC e-.

.~e=-- m.m . . . - _ _ .

10. b >- >- .!*. 5.* egi s ' s . 0 *
  • 3 * * * . O R- *t : s'0 ace.N ed *eA.'t P ':5 t*141.*e'i'stre CfA 3 appra.asn eer the Paterno*
  • Resuction Act t

.m ygg .g..

't *

4. . . --

7e ', ** *- 'e5 6'

. -_ ,. f 4 C

  • . . . _ v..;i 3 _- 't J_ NO C e'l f.
  • at'Of' f 0F It t s. at:(y hDi*"'lSt0* $

. .:e g :- ,. - 2. : e , o . a t- m *e; - -

-w i-: e ;m 3, o": s':e% int m e'-a- ' E O 2D; re 3 y n;:Ma: e

..r . f .

  • 3 . e *. 6
  • . *s C ; . $

4 Cate f

g 3 . 9 7 3 . - -> .8 a , , 3 4 -. -g 1

Date

'~

it.so.vs sea u.-.

  • 'O *i j e F Stedare f orm 83 A ,*

?3 :,3

6. . + .  ;> b -* cw - : . . ,T S cre ,3;;,:c g 3 2:9-.,

,- 4%9-1 l POR l

-d-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 that apply to Nuclear Regulatory Commission (NRC) licensees who are authorized to administer 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 NRC requires licensees to perform certain tasks to ensure fulfillment of their obligations.

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

Need for and Practical Utility of the Information Collection Sections 35.12 (b) and (c) of 10 CFR Part 35 require that applicants submit a completed NRC Form 313.

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

..- 4Cfdl-2.

- POR

, 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 cost data.

Section 35.13 of 10 CFR Part .35 requires that licensees apply fnr and receive a license amendment before using material not allowed by the license, before adding to or changing key individuals, before receiving more material than allowed by the license, or before changing t.ie location of use or mailing address. The identified trigger events are critical indicators of potential for change in the licensee's ability to control radiation dose to workers and the public, or the NRC's ability to contact the licensee or conduct an inspection.

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

Section 35.14 of 10 CFR Part 35 requires that licensees notify the NRC within 30 days if a key worker ends his association with the licensee. This prompt report is needed because if the licensee no longer has a complete staff, the collective training and experience of the remaining staff may no longer be sufficient to ensure safety. This report will trigger a check of the licensee's file to determine whether the remaining key users are qualified to receive and use material safely.

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

Section 35.21(b)(2) of 10 CFR Part 35 requires that the licensee establish and implement the written policy and procedures that were submitted as part of the application. The policy and procedures are needed so that the staff can review them and make a determination that the applicant can =et the requirements of the 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.

2

-Y ,

ACM-1 P0/t 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 the duration of the license, and prescribe the information required in the minutes.

This record is needed to show continuing managament oversight of the radiation safety program.

Section 35.23(b) of 10 CFR Part 35 requires that licensees provide a written statement of authority, duties, responsibilities, and radiation safety activi-ties for the Radiation Safety Officer and Radiation Safety Committee. The record 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. Section 35.27(c) requires licensees to retain a copy of the license that identifies the visitor as an authorized user. This permission and record are needed to show that licensee management has permitted this work, and that a regulatory agency has 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 each client. This record is needed to show that client management has permitted this work.

Section 35.31(b) of 10 CFR Part 35 requires that licensees make a record of radiation safety program changes.

This record is needed to show hat radiation safety problems were considered before implementing the change, and also pro-vides a record of where within the licensee's facility radioactive ma.terials were 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 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after discovering the misadministration. This prompt notit icatioil is necessary because a therapy misadministration may present a clear and present radiation hazard to a member of the public that might be mitigateo by NRC assistance.

The licensee is also required to notify the 3

L--

N(*4~L PDR referring physician and the responsible relative or guardian of the patient.

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

Section 35.33(b) of 10 CFR Part 35 requires that a licensee file a written report 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 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 promptly notify other licensees if it appears the precipitating event might be generic.

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

Section 35.33(d) of 10 CFR Part 35 requires licensees to retain a record of each 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 for 10 years because misadministration events are infrequent and, if there is a common 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 of a geometry dependence test for the dose calibrator. This record is needed to show t'aat the volume configuration of the radiopharmaceutical does not affect the ret. ding given by the dose calibrator.

Section 35.50(e) of 10 CFR Part 35 requires that licensees retain a record of checks and tests of dose calibrator performance. This record is needed to show 4

ACM-a.

POR

. 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 the apparent exposure rate from a dedicated check source. This information is needed so the licensee can check the survey instrument for proper operation before making measurements.

The burden is included in the burden estimate for Section 35.51(d).

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

Section 35.53(c) of 10 CFR Part 35 requires that licensees retain a record of each radiopharmaceutical dosage measurement. This record is needed to show that 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 can determine the specific safety measures appropriate for each kind of source used.

Se_ tion 35.59(d) of 10 CFR Part 35 requires that licensees retain a record of sealed source leak tests. This record is needed to show that the leak test was done at the appropriate time, and that the test showed that the source was not leaking.

S;ction 35.59(e)(2) requires that licensees file a report with the NRC within five 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 have similar sealed sources should take special precautions. NRC allows the licensee 5 days to submit the report so that it can review and analyze the source and the leakage measurement. NRC requires submission of the report within 5 days sc that it can promptly notify cther licensees if it appears there may be a generic problem, 5

3 hC(A-2.

POR

. 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 to show that possession of sealed sources did not exceed the amount authorized by the 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 of radiation surveys of areas where sealed sources and brachytherapy sources are stored. This record is needed to show that adequate radiation shielding has been provided for such sources, and that dose rates in contiguous areas are within allowed levels.

Section 35.60(o) of 10 CFR Part 35 requires that licensees label each syringe or syringe radiation shield as to its contents. This label is needed because review 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 radiation shields with the identity of the radiopharmaceutical contained. NRC review of several misaaministration reports indicates that many misadministrations occur when 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 establish action levels for radiation surveys. The action levels provide the individual who makes a radiation survey with a record of what levels are expected and what levels require investigation. The sections also require that the licensee immediately notify the Radiation Safety Officer if excessive levels are detected during a survey. This report is needed so that the Radiation Safety Officer can take appropriate remedial action. The Radiation Safety officer is the one individual onsite who is qualified to determine what action is needed to ensure worker and public health and safety, and whether that action is needed immediately o. can be delayed.

6

ACM-1 PDA

' 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 were made.

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

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

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

Section 35.205(d) requires that the licensee post a time period of evacuation in areas where aerosols and gases are used. In case of a spill, this provides notice to workers of how much time air handling equipment needs to reduce the air concentration to permissible limits.

The licensee must retain a record of the calculations used to determine the evacuation time for the duration of the license.

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

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

a :.he licenseo note in tho patient's chart how long visitors t3y stay in the patient's room. This is the most convenient way to provide this information to 7

ACWi-1 POR

. 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 around treatment rooms. This record is needed to show that members of the public are not exposed to excessive levels of radiation.

Section 35.315(a)(8) of 10 CFR Part 35 requires that licensees make a record of the thyroid burden measurement of each individual who helped prepare or admin-ister a therapeutic dosage of iodine-131. This record is needed to show that workers 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 therapy or brachytherapy patient dies or has a medical emergency. This report is needed so that the Radiation Safety Officer can take whatever actions are necessary to prevent a spread of radioactive contamination or loss of brachytherapy sources.

The Radiation Safety Officer is the one individual onsite who is qualified to determine 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 of the radiation survey of each patient who was treated with temporary implant sources. 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 of brachytherapy 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 of radiation surveys of patients af ter implanting sources. This record is needed to show that the survey was made.

8

AC.4A-2.

POR 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 to show 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 written radiation safety instruction for personnel caring for implant therapy patients.

This instruction is needed so that these personnel may study and refer to it while caring for the patient.

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

Section 35.606 of 10 CFR Part 35 requires that licensees apply for and receive a license amendment before making certain changes in the teletherapy program.

This license amendment process is necessary because the licensee might consider making changes that would cause radiation levels in restricted and unrestricted areas to exceed permissible levels.

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

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

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

Section 35.630(c) of 10 CFR Part 35 requires that licensees retain a record of each calibration, intercomparison, and comparison of teletherapy dosimetry equipment.

These records are needed to show that measurements of radiation 9

AC481

.. i POR

, 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 of teletherapy unit calibration. This record is needed to show that the calibra-tions were done and that licensees did not inadvertently misadminister radiation doses to patients.

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

Section 35.634(f) of 10 CFR Part 35 requires that licensees retain a record of spot-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 of safety checks for teletherapy facilities. This record is needed to show that the checks were made.

Section 35.641(c) of 10 CFR Part 35 requires that licensees retain a record of radiation measurements after 'nstalling a source in a teletherapy unit. These records provide assurance that the source is properly installed within the teletherapy unit, and that dose rates outside the teletherapy room are within permissible limits.

Section 35.643(a)(3) of 10 CFR Part 35 requires that licensees amend a report made to NRC pursuant to Section 35.645 to include additional survey informatic n if 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-cay submission requirement is contained in Section 35.645.

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

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

10

l. - ..

Acel-2.

pg 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 show that dose rates in restricted and unrestricted areas are within permissible levels. The submission niust be made within 30 days after the completion of the action that initiated the record requirement. The 30-day requirement is imposed because of the especially high dose rates that can be found around teletherapy unics.

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

Reduction of Burden Through Information Technology There are no legal obstacles to reducing the burden associated with this information collection. However, because of the types of information and the infrequency of submission, the applications and reports do not lend themselves readily to the use of automated information technology'for submission.

Effort to Identify Duplication The Federal Information Locator System was searched to determine NRC and other Federal agency duplication. None was found. In general, information required by NRC in applications, reports, or records concerning the transfer, receipt, possession, or use of byproduct material does not duplicate other Federal information collection requirements and is not available from any source other than applicants or licensees. Portions of the needed information might also be contained in other information submittals to hRC or other Federal agencies, i l However, duplication, if any, is slight, and the collection of this information by use of specified forms and other required reports and records is the most effective and least burdensome means of obtaining the information.

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

11

ACW-2.

-s POR 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 of radioactive byproduct material are the same for large and small entities, it is not possible to reduce the burden on small businesses by less frequent or less complete reporting, recordkeeping, or accounting and control procedures.

Consequences of Less Frecuent Collection Required reports are collected and evaluated on a continuing basis as events occur. Applications for new licenses and amendments are submitted only once.

Applications for renewal of licenses are submitted every five years.

Information submitted in previous applications may be referenced without being resubmitted. The schedule for collecting the information is the minimum frequency necessary to assure that licensees will continue to conduct programs in a manner tiiat will assure adequate protection of the public health and safety.

Circumstances Which Justify Variatia from OMB Guidelines Contrary to the OMB Guidelines in 5 CFR 1320.6(f), Section 35.14 requires that licensees notify the NRC within 30 days if a key worker ends his association with the licensee. This prompt report is r.eeded because if the licensee no longer has a complete staff, the collective training and experience of the remaining staff may no longer be sufficient to ensure safety. This report will trigger a check of the licensee's file to determine whether the remaining key users are qualified to receive and use material safely.

Section 35.33(a) requires that the licensee notify by telephone the appropriate NRC regional office in case of a therapy misadministration within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after discovering the misadministration. This prompt notification is necessary because a therapy misadministration may present a clear ar.d present radiation hazard to a member of the public that might be mitigated by NRC assistance.

The licensee is also required to notify the referring physician and the responsible relative or guardian of the patient. These reports are needed so that those individuals can provide adequate care for the patient.

12

SCM-M.

h '. POR Section 35.33(b) requires that a licensee file a written report to NRC within 15 days rafter telephoning an initial therapy misadministration report. This report is needed 50 that NRC can determine whether there might be generic implications 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 promptly notify other licensees if it appears the precipitating event might be generic.

Section 35.33(c) requires that the Radiation Safety Officer investigate the Cduse of diagnostic misadministrations and make a record for NRC review. The licensee must also notify the referring physician and the NRC Regional Office in writing on NRC Fom 473 within 15 days. These written records are needed to determine what kinds of actions precipitate misadministrations, and also provide a measure of the licensee's management control of the radiation safety program.

Section 35.59(e)(2) requires that licensees file a report with the tJRC within five 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 have similar sealed sources should take special precautions. NRC allows the licensee 5 days to submit the report so that it can review and analyze the source and the leakage measurement. NRC requires submission of the report within 5 days so that it can promptly notify other licensees if it appears there may be a generic problem.

Section 35.645 requires that licensees mail a copy of teletherapy source installation records to the NRC. This record is needed to show that. dote rates in 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 of the especially high dose rates that can be found around teletherapy units.

Consultations Outside the Agency l

l 13 t

{

L

^

., s, ALGA-1 PDA Several experts in the use of radioactive material for pnient care were asked tc r.onnent on the technical content, including the information collection requirements, of the proposed regulation. They were representatives of: Food and Drug administration, American Association of Physicists in Medicine, Health Physics Society, Society of Nuclear Medicine, and the American College of Radiology. The comments received were considered in promulgating the final rule. 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 approximately 2500 licensees and applicants. About 2200 of the licensees are hospitals, and ,

about 300 of the licensees are physicians in private practice.

14

\(

R M-1 10R,

, Estimate of'Comoliance Burden Reporting Requirements Licensee Total Annual No. 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. 3150-0120 35.13 1800 3 5400 35.14 500 0.5 250 35.27(a)(1) 2500 0.5 1250 35.27(a)(2) 2500 0.5 1250 35.33(a) 5 1 5 35.33(b) 5 10 50 35.33(c) See NRC Form 473 (below), OMB Clearance No. 3150-0140 l

35.59(e) 1 2 2 35.60(b) 2200 7.5 14250 35.61(b) 400 0. 5 200 35.70(d) 26400 0.02 528 35.70(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 0.2 960 35.606 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 29379 NRC Form 473 500 1 500 l

I 15

S ., 3 Ac691 pg Recordkeeping Require 2ents Total No. of Record-Record- Annual Hours keeping Section keepers Record 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 last use

-35.29(b) 50 1 50 duration of service 35.31(b) 1200 1 1200 license duration 35.33(c) 500 2 1000 10 years 35.33(d) see 35.33 (b) and 10 years (c)*

35.50(b)(4) see 35.50(e)(4) eqpt. duration 35.50(e)(1) 1900 5 9500 3 years 35.50(e)(2) 1900 0. 2 380 3 years 35.50(e)(3) 1900 2 3800 3 years 35.50(e)(4) 380 1 380 eqpt, duration 35.51(d) 2500 0. 2 500 3 years and (a)(3) 35.53(c) 2200 75 165000 3 years 35.59(a) 2500 0.1 250 eqpt. duration 35.59(d) 2500 2 5000 3 years

'35.59(g) 2200 2 4400 5 years 35.59(i) 2200 2 4400 3 years 35.70(h) 2200 65 143000 3 years 35.80(f) 50 100 5006 3 years 16

e ,

kJA-1 90A.

,Recordkeeping Requirements (Continued)

Total No. of Record-Record- Annual Hours keeping Record Section keepers per Recordkeeper Hours Detention Period 35.92(b) '2200 6 13200 3 years 35.204(c) 1900 5 9500 3 years 33.205(d) 400 0.1 40 3 years 35.310(b) 700 1 700 3 years 35.315(a)(4) 700 1 700 3 years 35.315(a)(8) 700 2 1400 until disposal auth'd 35.404(b) 400 1 400 3 years 35.406(b) 400 2 800 3 years 35.406(c) 400 1 400 3 years 35.406(d) included in 35.406(b) and (c) 35.410(b) 400 1 400 3 years 35.610(c) 400 0.1 40 3 years 35.615(d)(4) 400 5 2000 3 years 35.630(c) 200 1 200 eqpt duration 35.632(g) 400 16 6400 license duration 35.634(c) 400 1 400 3 years ,

35.634(f) 400 12 4800 3 years 35.636(c) 100 1 100 3 years 35.641(c) 100 8 800 license duration 35.647(c) 100 0.1 10 license duration Total Recordkeepers: 2,500 Total Recordkeeping Burden: 390,550 hours0.00637 days <br />0.153 hours <br />9.093915e-4 weeks <br />2.09275e-4 months <br /> TOTAL BURDEN, 10 CFR PART 35: 419,929 hours0.0108 days <br />0.258 hours <br />0.00154 weeks <br />3.534845e-4 months <br /> TOTAL BURDEN, NRC FORM 473: 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> l

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

17

. ,,. ke-2.-

POR-Estimated Cost to Public to Respond Section Annual Cost to Respond 35.12(b) See OMB Clearance No. 3150-0120 35.12(c) See OMB Clearance No. 3150-0120 35.13 324,000 35.14 15,000 35.20 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) 75,000 35.27(a)(2) 75,000 35.27(c) included in 35.27(a) 35.29(b) 3,000 35.31(b) 72,000 35.33(a) 300 35.33(b) 3,000 35.33(c) 60,000 35.33(d) included in 35.33(b) and (c) 35.50(b)(4) included in 35.50(e)(4) 35.50(e)(1) 570,000 35.50(e)(2) 22,800 35.50(e)(3) 228,000 35.50(e)(4) 22,800 35.51(d) & (a)(3) 30,000 35.53(c) 9,900,000 35.59(a) 15,000 35.59(d) 300,000 _,

'35.59(e) 120  !

35.59(p) 264,000 35.59(i) 264,000 35.60(b) 855,000 18

g Section

. Annual 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) 84,000 35.315(b) 60 35.404(b) 24,000 35.406(b) 48,000 35.406(c) 24,000 35.406(d) included in 35.406(b) and (c)

-35.410(a) 144,000 35.410(b)

, 24,000-35.415(a)(2) 57,600 35.415(b) 60 35.606 2,400 35.610(a) 3,000 35.610(c) 2,400 35.615(d)(4) 120,000 35.630(c) 12,000 35.632(g) 384,000 35.634(c) 52,800 35.634(f) 288,000 35.636(c) 6,000 35.641(c) 48,000 35.643(c) 120 19

e -

MWl1

... .. P0A Section Annual Cost to_ Respond 35.643(d) 120 35.645 ,

3,000 35.647(c) 600 Total

$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 licensees and applicants is calculated at a rate of $60.00 per hour. This figure includes both salaries and overhead.

Estimate of Cost to the Federal Government Application review activities are attributable to and reported under NRC Fcrm 313, 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

412 25 n 4

'* v.. & u 4 6,, w 6 A f C m v COwuds7f g' 7, i I . 4.e,~9 J e 68

. . DIAGNOSTIC MISADMINISTRATION REPORT d'loh0.

e (411 LtCt 9516 Naul PDR l 5 %i' L'C t %[t %vwa t a l

\

t%3) Caf f ~

'Na' 8?a f t liHliI IHI

'45. Est%fpart I i%s mEPom? ca rt l

l

%80 % I 4 Cat *4am WO%Im C4y ,ean~ l etoft tvPE 08 ursaoustiff matiO4 t f 1 I fI i l i'*810iD acess iist m a f #0as inivo6 vt ase a

soisan0*G #

E Or 180f0P3 fOss00

=a wise,8 i%si %5we:a os ea tit %f s n=0 e t Ctiv s o a wisaowigstimatio% v%cta f ues REpont l

_ m&D,0P am.actut, eat _ ,C3s m0 .DO, at SAG.C 80 niv..# # E m.igo

  1. 03l vemo4G Pa tit 47 sosi mmono m0utt e lrggelvis l l s t tis mo 14 I01 #478 40E 0 ineioAs imit wo8 0 4%i ti G$w t%

106140 Clah8 CAL Pm0Ct 0 Vat

+081hvCLlan ut0sciht

_ soti uttmalouko tivo v WILUCVait s #607081 ,"

'"'07 sfvov W'Lucumit s l iS070Pt CM,4 0ujC al sTv0,

_ $ f WO V ices =ee*e tosi ct lfVOY

[Ik h t0W 607) E ma y $fV07 liol4 M tfuCY itH0fwam switi PetCiPetafon in ts alp t a missQ PurS6CI A8s

[% ) 4 f Jelf s/l 's =/54 I I?sa MOT LA8 ftCH40LOGit?

!?2twan0 NUmst _

I73) wAmo CL8mt 17P1 suAQisso itch 880LCIGilf (fti CuestC mtCtrf>0 mitt

~ (7aa avvCLLAR PotamenACY MAME Op muCLEAm PnameiaC= fIDI SCHEDuu8:0 ?ECM8*0LOGi87 lCif v ltfAfi ggge pAfiggt isil Ofut a 10013 3m804 se31 LAs atFtmeAL a0Ms8e stim a f1080 TTHE m Iltl WilLASELt0 A gimiaoG4

- tiliitticf to semoseG eat

] e20i u msumotaff000 (12 'sitLAttLLO A VI AL Om vsAL SaltLO Urut4 Omassing OxaG4 a r t aniqG PntstCI A41 ] 13cettLECft08rm0**G m:00887 PafitMT ]ia08 M H68 8 ussiafan (2H A E8780wnowo

  • 0 1936 mEComesfifutt0 It?! Wisst a0 cost '3" '00u ,a'o t"q'fg'% 0 wnosso alAG8Mt Elf CALiamaf 0m 804 Ofwsm pafstNT tit) Wisuae 0Emsf000 m

_ (22) #t0V887t0 $7V0v (321smovom?wa0NO tial PLACIO atCoselfifvf to m ata0Pua n u aCluf oCA L ?Om **08vG ParisNT vian. im woopeo guetLO 04 Do8AGI omot e ,,,.,,

Patetse f 70 CLihtC a

es3i $448Cf to w8sosee semanat enou co$Act Cant thias C047me90fikQ f AC70pt sieign aCfiose 7asles % PatvEset stCummtWCE ecol 87'90441fICMNOL0cest Le6l at0visitions soof CMICEto auPLIWear? Nim Pm0Clovat8 P0m ove aega vis.om

- 1818 htw tutt07tt

  • 88 Pati 84 f CMAmt 40f IC14 venisiCAT Os,0s atoutsf

] #Csi gyg is2t 80mt6Cas LANGuAGg C HE Ca t 0 -

- IC21 m a 080Pu a m W Ac t utsC A L e836 PAfstest inCOMantNT Om ,

LA te Li8eG a40 mAmottae4 Nf 6 40 aCfiON

- UNCONSClous -

<suttwPm0Clount iCs, vinificatio= 0* Pa titt?

(Cal 0 tut e leal Mtavv no#EL0a0 ict wfis tCA fioso -

444) 50 8mactLaf 407 CatCato

_ 7,,, stai m ei8vstavCT Pt mSONNE L IC51 a t Pas u ah 0 Pim Som% 3 L thill 898tCT 0% pa tit =fs lmostAPeantief sa t assimact m i n a .: rm AC f ,,,.i.4,, m - .,,,,. ama, .a .,

t f,ll0 Nea ' $6) Y. / ftC 4 V'

[4.. . . . . . . 7

$ln A M

  • I* 'Q ' ' ' ' '

i etVCLEaR RIOULATORY COhe8if1886086 USE taisi imits i=Joi ntG+oaiat LOG imin ACitssic= wwwassi AS NvW6fm i%ni ime fia ts 19001 til HU8*O h l h

Retrieved from "https://kanterella.com/w/index.php?title=ML20150E439&oldid=2970946"