ML20217Q249
| ML20217Q249 | |
| Person / Time | |
|---|---|
| Issue date: | 09/19/1989 |
| From: | Beckjord E NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| To: | Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| Shared Package | |
| ML20217P754 | List: |
| References | |
| FOIA-98-86, RULE-PRM-35-7 NUDOCS 9804100360 | |
| Download: ML20217Q249 (8) | |
Text
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.....# SE? I 91969 MDORANDUM FOR: Jams M. Taylor Actirg Executive Director for Operations FPIM: Eric S. Beckjord, Director Office of Nuclear Rcqulatory Research j
SUBJECT:
FDRL AMD1INDE 'IO 10 CFR 35.400: ADDING PALLADIUM-103 FOR D<nacinnAL TRFEIMDE OF CANCER (PRM-35-7)
Enclosed for your signature is a final amndmnt (Enclosure A), to be i published in the Federal Rmister, that will amnd 10 CFR Part 35, " Medical Use of Byproduct Material." 'Ihis amendment will add palladium-103 as a sealed source in seeds to the list of sealed sources that my be used in brachytherapy as specifiM in 10 CFR 35.400.
BACKGROUND:
I A petition for rulemking (PRM-35-7) was submitted by 'Iheragenics Corporation l (docketed on M*r 9,1988) requestirg that palladium-103 be added to j 10 CFR 35.400, "Use of Sources for Brachytherapy." 'Ihe petitioner stated j that, under the present regulation, users of palladium-103 must go through the ]
cumbersome process of amendiry their 11 nses before they can use the product and that amendity 10 CFR 35.400 in the manner suggested would eliminate this cumberscre process.
A proposed amndnent granting the petitioner's request was published for a 30-day public comment period (54 FR 13892, April 6, 1989). One comment letter was received. 'Ihe ccmaent letter, submitted by a medical professional organization, supported the petition.
'Ibe staff has determined that the petition should be granted by adding palladium-103 as a sealed sourm in s~xts to S 35.400. Cbnpared to the current practice, this change will rMuce the burden for both malical licensees arrl the NRC staff. 'Ibe level of protection of the public health and safety will not decrease hu - the radiation safety and handlirg instructions to be used for palladium-103 are the same as the instructions used currently for the brachytherapy sources listed in 5 35.400.
BACKFIT AIRLYSIS:
'Ihe staff has determined that a backfit analysis is not required for this amendment WMm the airciarazut does not constitute a backfit as defined in 10 CFR 50.109(a) (1) .
f 6-THOMPSON 98-86 PDR j pp/p@/06
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-a SEP1 g1999 NCfrICES:
i A regulatory analysis has been prepared (Enclosure B). 'Ihe appropriate s ytsional oczanittees will be notified (Enclosure C) . A Daily Staff Notes item for the Ninaion has been prepared (Enclosure D). A letter will be sent to notify the petitioner of the final amendment. 'Ibe Office of Govermental and Public Affairs (GPA) has indicated that a public annouimet is not rmadad.
000RDINATI N:
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'Ihe Offices of Nuclear Material Safety and Safeguards, Administration, and Governmental ard Public Affairs concur in this final atie.rdr==it. 'Ihe Office of j the Getnral Counsel has no legal objection.
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k Eric S. Beckjord, pirector Office of 1uc. ear Regulatory F-rth
Enclosures:
A. FR notice l B. Regulatory analysis
! C. Ccaytussional letters D. Daily Staff Notes Item l
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,.c Approved for Publication 1
2e hincion delegated to the EDO (10 Cm 1.31(a)(3)) the authority to develop and prmulgate rules as defined in the APA-(5 U.S.C. 551 (4)) subject to the limitations in the NRC Manual Chapter 0103, Organization and Functions,
' Office of the Executive Director for Operations, Mphs 0213, 038, 039, ard 0310.
Se enclosed final arwaluw4t, entitled " Palladium-103 for Interstitial Treatment of Cancer," amends Part 35 to add palladium-103 as a sealed source in mwk to the list of sources specified in 5 35.400 for brachytherapy. Bis amendment will reduce the regulatory burden on medical use licensees who plan to use the sealed source, but the level of protection of the public health ard safety will not decrease, ,
h e amendment does not constitute a significant question of policy, nor does it amend regulations contained in 10 Cm Parts 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 pr M ing to issue it.
7-Date 4 d n'
%MM M. Tay1 '
ing ve Director for Operations l
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2 lorICES:
A regulatory analysis has been p m pared (Enclosure B). '1he appropriate congmssional ots:rnittees will be notified (Enclosure C). A Daily Staff Notes item for the hMion has been prepared (Enclosure D). A letter will be sent to notify the petitioner of the final sisdi .nt. Public Affairs (GPA) has indicated that a public annour =ent is not m=hi.
COORDINATION:
'Ibe Offices of Nuclear Material Safety and Safeguards, Adminisc. cation, and Governmental ard Public Affairs concur in this final mT&dient. 'Ihe Office of General Counsel has no legal objections.
Eric S. Beckjord, Director Office of Nuclear Regulatory Research
Enclosures:
A. FR notice B. Regulatory analysis C. Congressional letters D. Ihily Staff Notes Item DISTRIBUTION (w/o encls.):
Subj-chron-cire, RDB readiry file EBeckjord, TSpeis, INorris, ZRosztoczy SBahadur, JIblford (w/encls.)
RES: ATse Reg.I: JPicoone NMSS: D&lowe Reg.II: Gosey GPA: 1Bollirs Reg.III: SFrazier OGC: MRothschild Reg.VI: OCain AIN: Ni m r Reg.V: RIhcanas l
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OFF: R$$/IEA RDB/DRA NAME: ATse JDelford h SBahadur ZRosa6cbzy EHo s DATE: 8/j[/89 !) 8////89 8/lf/89 8////89 8 /89
- OFFICIAL RECORD CDPY s
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2 SEP 1 9 1989 NCTTICES:
A regulatory analysis has been prepared (Erclosure B). 'Ibe apprtpriate wa =sional cx21:nittees will be notified (Enclosure C). A Daily Staff Notes item for the hinaion has been prepared (Enclosure D) . A letter will be sent to notify the petitioner of the final amendment. 'Ihe Office of Governmental and Public Affairs (GPA) has indicated that a public announoennent is not :vwvhi.
COORDINATION:
'Ihe Offices of Nuclear Material Safety and Safeguards, Administration, and Governmental arri Public Affairs concur in this final amendment. 'Ibe Office of the General Counsel has no legal objections.
ORIGInn 3gc m 37 Eric S. Beckjord, Director Office of Nuclear Regulatory Researcti
Enclosures:
A. FR notice B. Regulatory analysis l C. congressional letters i D. Daily Staff Notes Item j
-l DISIRIBUTION (w/o encls.):
Ekabj-chron-cire, RDB reading file 1 Nkjord, TSpeis, IHorris, ZRosztoczy 4 SBahadur, Jrelford (w/encls.) ,
RES: ATse Reg.I: JPiccone '
NES: DEHowe Reg.II: CHosey GPA: IBolling Reg.III: SFrazier j OGC: MRothschild Reg.VI: OCain AIE: M w.ar Reg.V: RHvnam RES N kjord
- See previous conc. /g/89 OPT: RDB/ IRA IRA /RES [RA/RES IEA/RES NAME: ATse* JIblford* SBahadur* ZRosztoczy* INorris* is ,
DATE: 6 8/ /89 8/ /89 8/ /89 8/ /89 / 89 l OFFICIAL REC RD COPY r
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- 2. In 5 35.400, paragraph (g) is added to read as follows:
.5 35.400 Use of sources for brachytherapy.
(g) Palladium-103 as a sealed source in seeds for interstitial treatment of cancer.
DatedatRockville, Maryland,thisk day of O d 6&/A , 1989.
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F5r the Nuclear Regulatory h i m ion. . I
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%MP a d M. Taylor,[
ir*J Executive Director for Operations.
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- See attached conc, memos.
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- RBernero HDenton WParler Biorry lor 9 /lh89. E/ 89 7//l/89 @/ /89 /pey'89 Rj (.
OFF: RDB/[EA gIERA ' k(PES *
%' EES NAME: ATse JTelford Bahadur Bio is 'ord
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i ROUTING A$fD TRANSMITTAL SLIP / 10/5/89 !
/ i i TO: (Name,otnc mbol,toom number, Initisyt Date j bul , yPost) / i
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- 3. cc: (w/o encis.)
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J. Telford I Rinni
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XXy /liil5ti~ File Note and Retum Approval For C'earance Per Conversation ;
As Roquested For ( arrection Prepare Reply
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Circulate For Your information See Me Comment investigate Signature l Coordination Justify REMARKS (Pd-103 BRACHYTHERAPY SOURCE)
SUBJECT:
PUBLICATION OF A FINAL AMENDMENT (PRM-35-7)
Please forward the enclosed finai rule pkg to the FR for publication. Thanks.
Enclosures:
- 1. FRN (signed by the ED0) - 1 original l 5 copies ;
- 2. Congressional ltrs ----- 1 original each (3) 1 copy each 1 conc copy DO NOT use this form as a RECORD of approvals, concurrences, disposals, clearances, and similar actions FROM:(Name,om. symbol, AgencyPost) Room No.-Bldg.
A. Tse - RES Phone No.
f x?3797 son-m .usao me- ms [PTign{gu
, 41 mov.7 m FPun(4 tYFR)10111.296 i f
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ROUT . AND TRANSMITTAL SLIP s
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- TOs (Name,omce nymbol, room number, initlets Dese D1 bulwne. AeoncyPoen / "
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A 1.NMSS: D. B. Howe. S. Baacett. N. McElrov OGC: M. Rothschild 2.GPA: L. Bollino AE00: K. Black 3.RES: 3. Telford. S. Bahadur Reg. I: J. Piccone -
- 4. Reg. II: C. Hosey Reg. Ill: S. Frazier -
- 5. Reg. IV: C. Cain Reg. V: R. T iomas.
Action File Note end Retum Approval For Clearance Per Conversation Ae 6_7 For Correction Propero Repy Circulele ) X::For Your information See Me Comment investleate Signature 2* Justify *
- Coordination -
REMARKS .
Final ruleePd-103 for interstitial treament of cancer Enclosed for your information is a copy of the Federal Register notice - ? the final rule. The effective date is October 12, 1989, the publication date of the notice.
Please call me if you have a'ny questions on this
! notice.
DO NOT use thle form es a RECORD of approvelo, concurrences. disposele, clearances. and enmilar actions FROM:(Name,orp. symbol. Agency . Room No.-- Bldg.
NL/S
...AdTie"-M'ST / -
Phone No.
/ 4Q9 9747 3081 102 e u s GPo. 1988 - 196 g Ogyp C M.7 M Frase(4tIFIt)10111.306
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