ML20217P856
| ML20217P856 | |
| Person / Time | |
|---|---|
| Issue date: | 01/23/1989 |
| From: | Steven Baggett NRC |
| To: | Tse A NRC |
| Shared Package | |
| ML20217P754 | List: |
| References | |
| FOIA-98-86 NUDOCS 9804100211 | |
| Download: ML20217P856 (1) | |
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eQ NOTE'TO: Anthony Tse
SUBJECT:
~ DRAFT. PROPOSED RULE: PALLADIUM-103 OR BRACHYTHERAPY Below is my comments.on the proposed rule. My comments deal mainly with page 3 of the. rule and stress two major. point
- to support the rule, 4pthe seeds have been approved for use'since-1986 with minor design improvements /in 1988 and that the' 4
'evaluati,on grants,
.~ w in effect, a presarketing approval.-^
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.,x g m.g.4In th'abaummary section deleted othe words'"phtion't Na'nd", -
,,,m 1.am not sure anyone typically looks atnthe potential u ,4,-
radiation' hazards to patients.
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x M -1lPageq2,hlasti.'paragraphW last'sentenceA;padd4"&aNRC",4 Ag~. .
a good point to mention is its benefit to NRC by"not i amending licenses and reducing the burden on NRC to allow' I for other.more significant activities, such as l inspections.
- Page 3, 3rd and 4th paragraphs, saggest the following l approach, please note the wording is not as critical as j the issues so feel free to noodle. '
In March 1986 Theragenics submitted information on the radiation safety properties of the sources to the State of Georgia. These' safety properties included information on the design and construction, prototype testing, conditions of normal use, labeling, external radiation levels,-
solubility in body fluids, and quality assurance and control. After. review of the information and determining the adequacy,of the radiation safety properties of the source, the State of' Georgia issued a Certificate of Registration to Theragenics in-September 22, 1986. This certificate summarized.the submitted radiation safety information'and" specifies additional limitation and conditions of use of the ,
source. This certificated was amended in its entirety in !
June 6,1988 to include a minor design improvement made~by j Theragenics. . .. ~ .<
w.a.4.+ a ,u c.n.fenew; Following. the State of Georgia's. determination that the. ' lgwp .
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radiation safety properties of the source are adequate to protect health and minimize danger- to' life. of prdportys;hnd f "' .
issuance of a certificate of. Registration.: -The;Stateasent 3 ...
'"NRC a ' copy 'of'the certificate to provide to otheFYsijihl'aYdM*." "
i M authorities and to include,in the Registry of So.grc,e, ^- ;
Device Designs. The NRC reviiwodItheYchrtdfi6stdo whhD%:Is . l
..s w@c%sistonoy)with3other certificat&s Nin+the;Registity WNNb added- Palladium-103 to the Registry in October;29p1986, andr *
< again ii nsJune/1988. to cover .the design changes (fThisMMgyg <,-
action,'in effect, granted a presarketing approval"of'the i source and would permit the:use of the seeds provided'that'
- . the users license is amended.to include,the source.
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JAN 1 S 1989 MEMORANDUM FOR: Donna B H
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- P Lloyd A. Bolling, GPA Mike Lesar, ARM a " FROM: -
SUBJECT:
DRAFT PROPOSED RULE: PALLADIUM-103 FOR BRACHYTHERAPY Enclosed for your review and consent is a draf+, proposed rule in response to PRM-35-7. Please let me know your conments oy 1/24/89.
Because this is a fast-track processing, the proposed rule should reach EDO no later than 3/9/89 (3 months from the docketed date, 12/9/88). After I incorporate your comments, this rulemaking package will be forwarded to your office by the end of January 1989 for office concurrence.
Also, I am enclosing a copy of the petition (w/o enclosures) for your inforraation.
If you have any questions please call me at X23797.
Anthony T e Regulation Development Branch Division of Regulatory Applications Office of Nuclear Regulatory Research
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Enclosures:
- 1. Draft FR Notice ,
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- 2. PRM-35-7 s . .c, ,.9 (_-
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10 CFR Part 35 l Palladium-103 for Interstitial Treatment of Cancer m
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- ' AGENCY
- Nuclear Regulatory Commission
.: - ACTION: Proposed rule l , o1 M
SUMMARY
- The Nuclear Regulatory Commission (NRC) is i
Proposing to amend its regulations governing the medical l
4 l uses of byproduct material. The proposed regulation would l
l add Palladium-103 sealed source as seeds to the list of 4
l [qa .# sources permitted in 10 CFR Part 35 for use in cancer o treatment. Under current NRC regulations, users must have
. #1'p e' l their licenses amended before they may use palladium seeds
? y tt l P in brachytherapy. The proposed rule, developed in response l
to a petition for rulemaking (FRM-35-7), would allow the use i of Palladium-103 seeds by each potential user (about 700 p j si l licensees) without requiring a license amendment.
f [r -
Evaluation of potential radiation hazards to -- -
hospitalpersonnelshowedminimalriskifthesNsareused in accordance with the manufacturer's radiation safety a'nd l~ handling instructions.
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l DATE: Comment period expires (30 days .trom the date of Publication in the Federal Register). Comments. received,.
. , , . . ..c 1,
. . u ~..aweg m,y., ,,. ;i after this date will be considered if it is practical to do
"*so, but assurance'of consideration cannot be givenTexcept(as7n 4
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+ b't'6'^dbanentis" received'on'or before'this;dit N
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ADDRESSES: Mail written comments to: Sec,re tary , U.S.
Muc. lear Regulatory Commission, Washington, DC 20555, Attention: Docketing and Service Branch. Deliver comments to One White Flint North, 11555 hockville Pike, Rockville, Maryland 20852, between 7:30 a.m. and 4:15 p.m. weekdays.
FOR FURTHER INFORMATION CONTACT: Dr. Anthony N. Tse, Office
'of Nuclear Regulatory Research, U.S. Nuclear regulatory
-Commission, Washington, DC 20555, telephone: (301)492-3797.
. SUPPLEMENTARY INFORMATION:
Petition for Rulemaking y , On November 30, 1988, Theragenics Corporation submitted a petition for rulemaking which was docketed PRM-35-7 on I', v December 9, 1988. The petitioner requests that the NRC
- ,t . amend its regulations to add Palladium-103 sea'.ed source as seeds for interstitial treatment of cancer to ti.e list of sources permitted a Section 35.400 of 10 CFR ?. art 35 for f use in brachytherapy. A copy of the petition may be / ,- .j .'
obtained from th'e Regulatory Publications Branch, Division r of Freedom of Information and Publications Services, U.S. g Nuclear Regulatory Commission, Washington, DC 20555.
The petitioner stated that the Palladium-103 sealed source as seeds are permitted to be marketed by the Food and DrugAdmh.1:'. ration (FDA)oftheDepartbentofHealth'and' I
Human! Services.~ However, under. the. presentiiNRC;;regul.ationsg;p ,
users of palladium-103 seeds must go~~?. through.the cumbersome n
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6;processeof having &.their licenses amendedxbefore nnwwm,ww . .. w na w..na n,-theyicanwuse
- .c e - - s. F AmSAding 10 CFR Part 35 as recommended 'in the 'x,;;s the product. ,
petition would eliminate this cumbersome amendment process-for both Theragenics Corporation and the user # gre c l 1
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In supporting the petition, the petitioner submitted, several-documents, including a letter from the FDA, safety <
evaluation report.from the Stat'e of Georgia, package insert, and' product' literature.
l The letter from the FDA. stated that, under Section 510
.(k)', market of the device (Palladium-103 seeds) would be.
J Permitted subject to the' general controls provisions df the
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- Federal Food, Drug, and Cosmetic Act until such' time as'the
, ' device has been classified'under Section 513.
The safety evaluation report from the State of Georgia's l MRadio1cticalHealthSectionoftheGeorgiaDepartmentof Human-Resources'provided radiatlon safety analyses g concerning the use of Palladium-103 seeds. The State' agency
,') - approved'the use of the sealed source for interstitial /
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4' The evaluation examined various safety 0 -cancer 3reatment. ,
aspects such a prototype testing, conditions for normal / j d, 5
use, labeling, external radiation levela,. quality assurance h d .b l-and control. Additional limitations and conditions of use are also specified in the safety. evaluation report.
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ng the safety evaluation performed by the State of Follo Georgia, the NRC-staff has verified Georgia's evaluation.and .
i determined _that.the. Palladium-103 seeds._present minimalirisk ' l f ' ' for-use-in--brachytherapy-and--that the.s han-fit ant'ud4Eh + " -M,
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l y.isk Therefore, the NRC staff added Palladium-103: seedis tol ~
theRegistryofRadioactiveSealedSour)esandDevices'in' % l l
MO 14 .198d (S. Baggett;of NHSS wily.fillkinf,thM daty))) ,., ,,..
and.would permit the use of the seeds..provided
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w license is , amended Aol. include 1. Palladius 4108P P user .u.w ,u.sm::n.+. coggxp:wqcyg4gQj W)pghkQp:.': tr?A -
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Conclusion f
- .The' NRC has examined the petition and supporting- .
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information and proposes to grant the petition..vThe. w ..m # c;g;,,
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