ML20217P962
| ML20217P962 | |
| Person / Time | |
|---|---|
| Issue date: | 03/23/1989 |
| From: | Beckjord E NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| To: | Stello V NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| Shared Package | |
| ML20217P754 | List: |
| References | |
| FOIA-98-86, RULE-PRM-35-7 NUDOCS 9804100248 | |
| Download: ML20217P962 (9) | |
Text
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UNITED STATES
,a NUCLEAR REGULATORY COMMISSION a
5 l
WASHINGTON, D. C. 20555 pf VAR 2 31ggg I
MEMORANDUM FOR:
Victor Stello, Jr.
Executive Director for Operations i
FROM:
Eric S. Beckjord, Director Office of Nuclear Regulatory Research
SUBJECT:
PROPOSED AMENDMENT TO 10 CFR 35.400: ADDING PALLADIUM-103 FOR INTERSTITIAL TREATMENT OF CANCER (PRM-35-7)
Enclosed for your signature is a proposed rule (Enclosure A),
to be published in the Federal Register, that would amend 10 CFR Part 35, " Medical Use of Byproduct Material."
This amendment would add palladium-103 as a sealed source in seeds to the list of sealed sources that may be used la brucnytherapy as specified in 10 CFR 35.400.
BACKGROUND:
A petition for rulemaking was submitted by Theragenics Corporation (PRM-35-7, docketed December 9, 1988) requesting that l
palladium-103 be.added to 10 CFR 35.400, "Use of Sources for Brachytherapy."
The petitioner stated that, under the present regulation, users of palladium-103 must go through the cumbersome process of amending their licenses before they can use the product and that amending 10 CFR 35.400 in the manner suggested I
would eliminate this cumbersome process.
Staff review of the petition showed that the addition of palladium-103 to 10 CFR 35.400 would reduce the regulatory burden on medical licensees who plan to use the sealed source.
Thus, as compared to the current practice, the proposed change would reduce the burden for both' medical licensees and the NRC staff.
The level of protection of the public health and safety would be the same because the radiation safety and handling instructions for palladium-103 are similar to the instructions for the j
brachytherapy sources currently listed in Section 35.400.
The L
Proposed rule would grant the petitioner's.~ request by adding palladlum-103 as a sealed source in seeds to the list of approved sources in 10 CFR 35.400.
BACKFIT ANALYSIS:
l The staff has determined that a backfit analysis is not required for this proposed rule because the amendment does not constitute a backfit as defined in 10 CFR 50.109(a)(1).
i 9804100248 980407
{
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l THOMPSON 98-06 PDR s
r 2
.R'2 3 1999 i
. NOTICES:
I A regulatory analysis has been prepared (Enclosure B).
The appropriate Congressional Committees will be notified l
(Enclosure C).
A weekly report to the Commission has been prepared (Enclosure D).
A letter will be sent to notify the petitioner of the proposed rule.
Public Affairs /GPA has l
indicated that a public announcement is not needed.
COORDINATION:
The Offices of Nuclear Material Safety and Safeguards, Administration, and Governmental and Public Affairs concur in this amendment.
The Office of General Counsel has no legal objections, i
Q f
Eric S. Beckjord, Director l
Office of Nuclea'r Regulatory Research
Enclosures:
A.
FRN - proposed rulemaking l
B.
Regulatory analysis C.
Congressional letters D.
Weekly report to Commission i
L l
l l
I
s
^
3-(
a Approved for Publication i
The Commission delegated to the EDO.(10 CFR 1.31(a)(3))-the-l authoritysto develop and promulgate rules as defined in'the APA (5 U.S.C. 551'-(4)) subject ~to the limitations'in the NRC Hanual' Chapter.0103' Organization and Functions, Office-of the Executive-1 l
Director'for Operations, paragraphs 0213', 038, 039, and 0310.
The enclosed proposed rule, entitled "Pallddium-103 for Interstitial. Treatment-of Cancer," would amend-Part 35.to add j
. palladium-103'as a-sealed source in seeds to the list of sources specified in'10 CFRL35.400.for brechytherapy.
This change would f
reduce the regulatory burden on medical use licensees who plan to use the sealed source.
The' proposed' rule does not cons +1tute a significant question of policy, nor does it amend result.tions contained in la CFR Parts L
7,-8, or 9 Subpart C concerning. matters of policy.
I, therefore, find that this rule-is within the scope of my rulemaking authority and am proceeding to issue it.
j L
f 1 J42/99
&i Ad Date '
~
~
Victor Ste1lo//r.
Executive Di Metor for Operations i
e L
2 MAR 2 3 gggg NOTICES:
A.4 latory analysis has been prepared (Enclosure B).:
The appropriate Congressional-Committees will be notified (Enclosure C).
A weekly report to the Commission has been prepared (Enclosure D).
A letter will be sent to notify the petitioner of the proposed rule.
Public Affairs /GPA has indicated that-a public announcement is not needed.
COORDINATION:
The Offices of Nuclear Material Safety and Safeguards, Administration, and Governmental and Public Affairs concur in this amendment.
The Office of General Counsel has no legal objections.
9 ORIGINAL SIGNED BY Eric S. Beckjord, Director C ffice of Nuclear Regulatory Research
Enclosures:
A.
FRN -
oposed rulemaking B.
0.mf; gulatory analysis C.
9su6h.,9ngressional letter 6 D.
ace +t U6ekly report to Commission I
, O.
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. /
/'ISTRIBUTION (w/o encle.):
pubj-chron-cire, RDB reading file
/RES:
EBeckjord, TSpeis, _BMorris, ZRosztoczy,
,/
WLahs, JTelford, ATse(w/encle.)
V $ MSS:
RBernero, NMcElroy p3PA.
HDenton, LBolling KC:
WParler, MRothschild VADM:
PNorry, MLesar RE EBeckjord
- See previous conc 3/23/89 i
OFF:k RDB/DRA RDB/DRA DRA/RES DRA/RE R
NAME:
Tee /Telford WLahs*
ZRosztoczy* BMorris*
is DATE:
1
/89 2/}/89 2/jpB9 2/g/89 3
/89
I 2.
In 535.400, paragraph (g) is added to read as fo11 ova:
5 35.400 Use of sources for brachyther.py.
(g) Palladium-103 as a sealed source in seeds for interstitial treatment of cancer.
Dated at Rockville, Maryland, this N
day of
, 1989.
1 I
For the Nuclsar Regulatory Commission.
I
~
Victor Stello, Jr.
Executive Director for Operations QE QLW [EY<_. 6
[E NHSS GPA OGC ADM RBernero HDenton WParler PNorry kjord 2/27/89 2Q89 g /89 2g89
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0FF:
hDB/DRA RD A
[h RES bhR i
NAME: 'Tse/Telford WLahs ZRosztoczy BMorris is DATE:
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/89 2/$/89 2/l3/89 2/15/89 2 g 89 1
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In 535.400, paragraph (g) is adde,d to read as follows:
5 35.400 Use of sources for brachytherapy.
(g) Palladium-103 as a sealed sor.rce in seeds for interstitial
. treatment of cancer.
Dated at Rockville, Maryland, this day of
, 1989, i
For the Ns.clon Regulatory Commission.
l l
L l
Victor Stello, Jr.
Executive' Director for Operations I
l E130 V! tello h /89
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NMSS GPA
- OGC l ADM -
RBernero HDenton
,-WParier PNorry
'kjord 2/
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B/DRA RD A
NAME:
' se/Telford WLabs ZRosztoczy BMorris is g/
/89 2/f/89 2/13/89 2/15/89 2g 89 DATE:
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taget Federal Regist:r / Vct. H. No. 65 / '!hursday. April 6.1989 / Propoord Rules NUCLEAR REQUI.ATORY Regulatory Publications Branch.
In the Raststry of Source and Device COMMISSION Division of Freedom ofInformation and Designs that is maintained by the NRC.
Publications Services. U.S. Nuclear ne NRC reviewed the certificate for 10 CFR Part 35 Regulatory Commission. Washington.
consistency with othe certificates in the DC 20555.
Registry and added palladium.103 to the gg.3, m g ne petitioner enclosed a document Registry on October 29.1986, and again PeRedum.193 forInteratiner from the Food and Drug Administration in June 19ee to cover the design Treatment of Caneer (FDA) of the Department of Health and improvement.nis action. In effect.
Human Services that allows tb8 granted e premarketing approval of the aosmev: Nuclear Regulatory marketing of paBadium.103 as a sealed sealed source and permitted the use of Commission, source in seeds b petitioner stated palladium.103 provided that the user's atmost psoposed rule, that, under current NRC
- ations, license was amended toinclude that licensees who are users of ladium-
- gg **""*
eLasanaam %s Nuclear Regulatory 108 most so through the Conunisalon(NRC)is proposing to process of having their bceases Coachselos emend its regulations verning the amended before asi the product and anodicaluses of bypro act matwial&
that amending to CF 35.400 in the W NRC has evaluated the petition 1
proposed regulation would add manner suggested would eliminate tble and supporting information and pilladium-103 as a sealed source la cumbersome process.
Pr* Poses to grant the petition. %e NRC seIds to thelist of brachytherapy In espporting the the has determined that the additica es sources permitted for use in treatraent of PetitJoner su several documents.
palladium-103 as a sealed source in cancer. Under current NRC regulations.
including a letter frorn the FDA. a safety seeds to thelist of sealed sources users must have their licenses amended evelsation report from the State of specified in to CFR 35.400 would not before they easy use paHadium tos.m Georgia, the package inset, and product cause sdditionalrisk to hospital proposed rule, developed in response to litweture.
peonnelor the public because the o p stition for rulemaking (pRM-35-7).
De letter from the FDA stated that, radiation safety and bandling
- wo.dd redece the regulatory burden on under section sic (k) of the Feuere! Food, instructions for palladium-103 are 4
medicaluselicensees who plan to use and Cosmetic Act, as amended, similar to the lastructions for the the sealed source. An evaluation of the eting the device Radian tos as brachytherapy sources currently listed pot:ntial radiation basseds to hospital a sealed sourcela
)would be in 135.m.His acues would value the pe sonnel and the public showed that pumind subject to the controle story burden to the users of thm would be adnimalrisk if the Prootsions of the Fed Food. Drug, dium-tes seeds (about 700 seiled sourceis usedin accordance and Cosmetic Act untilsud thne as the potentialusers)as wellas to the NRC with the manufacturer's radiation safety device has been classiAed as either a staff. Most users would not beve to cad handhng instructions.
Class L R orIH device under section follow the present requirement of
$13.
- eava Comunent period tres Ma a,-
submining bdividualDeense WSF en am-dment a-Dende in wder k he arc less.Casuments receiv fler this date will be considered if it is Qctical to do gf soorgia, submitted information on the able to use peWedlurn-15 as a sea ment State licensee of the state g ""'I U*"
source in seeds fr.be interstitial o
"*'g 7:""tl:r'g-l--a radiation safety properties of pelledium-
,e,mits.t of carmr(if theirIfoonsee.e, a any treatmen
=,ved er 1,e
= io co-te
-*r = *== a ece
.,,,e
Certificate of Registretion." Such a sources specifasd in to CPR 3s.400). A nacaessee: Mail written comsments to:
certincate is necessary forheressalce sur wbme Hoense only permits the use Secretary U.S. Nuclear story to manufacture and distribut*
of specified brachytherapy sources
a=*
Waebhiston, sosas.
paBadium-103 seeds to specific would still be sequired to submit e Att:ntion: Docketing and Service licensees.N informatiorovi these gga,,,,.-l==at application..t Branch. Deliver comunents to One White safety properdaincheded the design redudas k es nude d beena Flint North.11sss Rockville pike, and construction, prototype tesung, samadment applica6ons would reduce Rockvi8e. Maryland 3052. between MSO conditions of normal use, labellhs' lathe expenditure of NRC stafIresources em and 4:1s pm weekdays.
external radiation levels, solubility in reviewlag and grandag er desying *e FOR ruimeen aeroneaaftssa amarracTr brid, f4tde, and quaDtv er=Mr*)I wt repetM hmme amendments.
Dr. Anthony N. Tea. OfBoe of Nuclear assurana. After reviewhg the Regulatory Research. U.S. Nuclear infonastion and h ' t tbe Envireemental kapact:Categodcel Regulatory Commission.Washlagton.
adequacy of the radiaties safety Rxcluelen DC 3o655. telepbone: (301) 4es-47sr.
as of the souros, to State of sumausstraev uromanum Isand a Catasats et
& NRChe dekraired det als proposed regeleden is the type of action f,,
ber.1sesLe sebs,tted,s.o.h neref-e. st.CFR st.22(c)(2).
ab desceibed in se Peelen Ier R=h=-blev
- - -*-menisi O.No mbe, 1
ner em ma..d a.
sadrey taformanes and speciSe
. Impact statement mer an endommental Corporation subadtted a ties for addlesnal thmitatens and one.d dens en seessament has been prepared for Ible rulemaking. PRM-as-7 was dock:ted on t===h== 0, tees N the noe of the soares.His eartiocote
,4::o seguistion.
s petiuoner requests that the NRC emend wee amendedinits emairsty en June en fan Rdaslam Act Stahment its regulations to add paBedteam.10e es a tee 8 to bclude a mimar design se:11d source in seeds for the interstitial haprovement made by11ms genica.
nis proposed rule does not contain a trestment of cancer to the het of sealed Fouowtus tia deterudma: ism that the new or amended information collection sources urrently permitted in 10 CFR radiation esfety properties of the source requirement subject to the paperwork as.4ao for we la brachriberapy. A espy m adeq=te,ihm Saw of coensia sent Redacties Act of teen (44 u.itc. seat er of the petioon may be obtahed been ne NRC a copy of the sure8sats to hudade og.). Esisting requirements wm V
'W D
n
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7edesal Basistas Vd. M. No. 45 / Thumday. April 6.11
/ Propo' sed Rales 33333 approved by the Office of unn.g.=.=e List af Subjectsin 3s CFR Part35 DEPARTIRENTOF TRANBPORTATION and Budget, appmval number 2150-0010.
Byprodnet matedal. Dmgs.Walth Federal Atletion Admirdstreson Roydstory Analysis facilities. Heelds professions.
". Medical 14 CFR Part as N NEChas prepared a dreA d
N mated s regulatarl' analysis en this proposed Occupational safety and heelth. Penalty, tDocket les.eD CE 47-AD1 regulatica h analysis saamian the Radiation protection. Reporting and Wrocene$rmsh l
costs and benefits of the alternatives recortBceeping nquirementa.
considered by the)RC.W desA Aeroepene (BAel Pl.c Jetstroom Isodel regulatory analysin is available for for the reasons set out in the 3101 Airpiones inspedian la the NRC Pebbe Damament Pr'""% and under the aoIberity ofIbe AcescatFederal Aviation '
Room. 2120 L Street,lowerinsultanf Atomic Enugy Act of tas4 as essended, g
g FAAj.
the
?n
' woe Asaaf tsps.
Washington. DC. Single copies of the and 5 U.Sc sea,the NRC acssent Notane of propoemd =d===m-g as l
draft reguistory analysis maybe obtained imma Dr. Anthony M.Tse (See I" P'OPouing to adopt du foBowleg (NPR 4 amendammt to to CPR Part 35.
Pon punTMan sosponstAftou cesRaST
,,,,,,,,,, gg, y,gg,,,,p,,,, g, heading).
PARTWAAAENOWj adopt a new Airwasthiness Directise
& NRC requests public commente (AD) applicable to certain Britimb en tb drsft regulatory analysts.
LThe authority citation for Part as is Aerospace (BAe) Jetstrears Model anal Cominents may be subadtted to the NRC, revised to read as loHows:
airplansa.which would g ^ AD 87-07-42. Amendment No.3D-879. AD (See moonesses heading).
Amhoery.sem.et.ist, set.sn a std.
87-07-02 sequires a hie hatitation on tk eas, esa, saa, est. m a=
he (42 Usc att1.
Regulatory &xibility Certificadam autopilot elevator trim cable of 2000 raot. us2. 22:3t sec. set. as Stat. u42. as As required by the Regulatory amended (42 UAC. son).
hours. Subsequent to the issuance of this AD. authercontrol cable failed at L475 Flexibihty Act of 1980. 5 U.S.C. 805(b).
For she purposes af sec. saa. es sant. esa, se bas. Faaare dthis cable can ceanne the Comamission certifice that this rule, if amended (4e U.sc asr3) n sLis.as.ts, adopted, willnot have a signincent asJo is) and M ss21 (e) e..J a 42r. asJs. either a nose up trian hidiostion en the economic isapact on a substmatial 3523.asJNat (c) and(dL ssst(el Ees, flight deck console witneut affecting the j
number of small entities.He proposeg 35Jo (aHd). 3Lat (aHc). asas (a) and (4 elevator trim taba, or an irmsversible n581aHet fellt). la) and (h). naa as.at, nose down trim, which may Joed to rule would add the use of paDadiern-103 353DiaHf).n2135Je (eMe), assa Gight with anaessive conteel force end as a sealed source in seeds in 3D CFR 35.92(a). 35.120. 35Jo0(b). 35.204 (a) and (bL less of airplane control. It is (barefore 35.400. This action would reduce tk 35 205. 35.220. ss;31ote135.315. as.aao. as.aoa necessary to reduce the cable regulatory burden oti medical use 35 404(a). 75.406 le) and {c). 35 41o(a). 35.415.
replecement time to 1000 hours0.0116 days <br />0.278 hours <br />0.00165 weeks <br />3.805e-4 months <br /> io hcensees plarming to use the sealed 35 420. 35.50a 35.520. 35.505. 35A0m 35.810 {a) prevent the development of this unsafe source because most users would not and (b). 3s 915. as sta ss.830 (aj and {bl concliden.
I how to follow the present vequirement 35ms2 (eHfl. 5884 (eHel sss3s to) and (b).
Desm DDmment$ med h Mceived on of submitting e Icense amendment 35 641 (e) and (b). asses (e) and (bl. asses !s)
- nd M assan assia maan zase.ssses, oMm May 22.m application in order to use paBadunn-asasa. assa samat.susa samea ssm.
Aconsames:BAe Mandatory Alert 103 as a sealed source in aseds far the es.em, and stars are issued ander see.1 stb.
Service Bulletin }etstream 22-A-laterditial treMe*"I af 8**C8'Iif the es Stat. Dea, as amended (42 UEC. ass (bik
}AaB1023. Rev 2. dated January 8,1989, gcense permi a ge use gasF and il as.64.2L2tthi asJa(b). asJs(bl. %2r applicable to this AD may be obtained brachytherspy soumes specirsed ta to
- 9) and kl.nas(4 asas kHdl.maan g g % p, g % gg CFR 3L400).
35.sola), aL5 tid). 3&ss(c). 25Ae (d) and (e)(21 Product Support Civil AircraftDivisiori, He NRC has adopted size standards 3sso is) and OL as>B(sl. uso(t), ss.az(b1 hes W
3 c 51 35J1 5
) 40s that classify a hosf al as a small antity g
79888 if its annaal gross receipts do not exceed 35225(d)l4). 35 83 Ole). 35 632(g). 35.634(f).
Bdtish Aerospace.Inc Ubrarian Bax
$3.3 million, and a pdwate practice 35.83e(c). 35 041(c). 35 643(c). 35.t,45. and 17414. Dulles International Airport.
P ysician,as a small annry ithe 35 eme) are 6eseed under sec. tes o, as stat; Wa shington. DC. 20041: Telephone pos) h P ysitne a annualgross receipts are $1 eso es emanded (42 Usc 2mito1).
435-4100. This information also may be h
mi"* 2 m !<..$. N *,.1..,ome NRC eu,2;;. m,;,. n u,,,2c;;;1 gag medical use licensees could be
- 2. L 31400 paragraph (g)is added n address below. Send comments on the considered *small entities." the number sead as follows:
proposalin triplicate to the Federal Aviation Administration. Central is estimated to be a very smaD l Ss.400 tDee of sources for percentage of Ibe total number of breeerytherapy.
Region.Officeof the AssistaatChief Counsel. Attention: Rules Docket No.
licensees and does not constitute a 89-CE 07-AR ham 1554, m Ead 12th anal member for purposee eMw (g) Palladium.203 as a sealed source Street. Kansas City. Missouri e4tos.
Regulatory Flexibihty Act.However, the in seeds for interstatial treatment of propoeed rn e would have a positive Commente may be 1::spected at this ca c,,'
er onomic impact on about 70D licensees.
location between 4 a.m. and 4 pn Detad at Beckville,b4eryland.this 2sth day Monday through Friday, holidays tW of haanh tag.
excepted.'
F'r ew welm Regoleimy Onnmnsion ron pusmenn atsoet costracr.
The NRC has determined that a bac ki. analysis is not required for this VictotSt'Uo.I'-
Ms. Ted Eb!ha. Aircraft Certification proposed segelstion becewee the Executire Directorfor Clperudoms.
Othe AEU-100. Europe. Africa,sind
, amendment does not constitute a backfit {FR Dec. es-atte Filed 4-s-se, a es ami Middle EastOffice FAA.clo Amt'rican
, Embessy.B-1000 Brussels.Belgiunu es der:nert in 30 CFR 50.201(a)(1).
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Enclosed for your.use'is opy of 'the draft Regulatory '
Analysis associated with he proposed rule giublj?? *..
shed-on April 6, 1989.(54 FR 13892).
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