ML19325C974
| ML19325C974 | |
| Person / Time | |
|---|---|
| Issue date: | 09/26/1989 |
| From: | Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | |
| References | |
| FRN-54FR13892, RULE-PR-35 AD11-2-02, AD11-2-2, NUDOCS 8910180242 | |
| Download: ML19325C974 (7) | |
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[7590-01) g PROPOSED RULE NUC2AR REGUIA'ITRY CDeGSSIN
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F Palladitan-103 for Interstitial Treatment of Carcer e
w AGENCY: Nuclear Regulatory nwnissim.
ACTIN: -Final rule.
SLM ORY: _' Die Nuclear Regulatory n=nianim (NRC) is amending its regulations governing the mariinal uses of byproduct material to add P11M4um-103 as a sealed scuros in seeds to the list of brachytMW sources parmitted for use in the treatment of cancar. Under current NRC riegulations, users must have 7
their licenses amended before they use F11Mi an-103. 'Ihis amendment, t
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pranalgated in response to a petition for rM==*4g-(PRM-35-7), will naduce the regulatory burden on medim1 use licensees who plan to use the sealed source. = An evaluatim of the potential radiatico hazards to hospital personnel and the public showed that there would be minilanl rit.'. if the sealed p
source is used in accordance with the raaufacturer's radiation safety and handling instructicais.
s EETECTIVE DNIE: (Insert the date of publication) l FIR FURRIER INFGMATION CCNIACT: Dr. Anthony N. 'Pse, Office of Nuclear D
Regulatory Researdi, U.S. Nuclear Regulatory n===4aaien, Washington DC 20555, telephone (301)492-3797.
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a.I SUPMRG!NINtY INFGNATION:
Petition for Rulenakirg s
On Novunhar 30,1988, 'Iheregenios Corporation sutanitted a petitical for tulenskirg,- PIM-35-7, whicit was docketed on nananhar 9, 1988. 'Iha petitioner i
requested that the NRC amend its regulaticos to add palladium-103 as a sealed i
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source in seeds for the interstitial treatment of cancer to the list of sealed p
sources currently permitted in 10 CPR 35.400 for use in bracitythmayf. 'the petitioner stated that, under current NRC regulations, licensees wim ara users of palladium-103 aust go through the <mhmucme process of having their licenses amended before using the product and that amendinJ 10 CPR 35.400 in the manner sucygested would eliminate this naharscane prooecs.
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In supportirg the petition, the petitioner submitted several h= ants,
' ncludirq a letter from the FDA, a safety evaluation et frtan the State of i
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Georgia, the PW insert, and prochet literature.
'Ihm letter from the MR stated that, urder Secticn 510(k) of the Fo$aral L
Ibod, Drug, and cosmetic Act, as amended,==*+irq the device (na11aMum-103 as a sealed source in seeds) would be permitted subject to the general controls provisions of the Federal Food, Dng, and Cosmetic Act until sucil time as the device has been clarrsified as either a class I, II, or III device q
under Section 513. Class I devices require general u. Luls, that is, registration and good manufacturirq practices. Class II devices require performance standards in addition to general umbuls. Class III devices require prior FDA approval.of a Pre-Market Approval application, performance l-standards, and general umskuls. In January 1988 (53 FR 1554), FDA classified l-radionuclide bractlytherapy sources as Class II devices. 'Diis permits
'Iberagonics to continue marketirg the palladium-103 seeds.
In Martti 1986, 'D:eragenics, an "Ap.hd. State" licensee of the State of Georgia, submitted information on the radiation safety p.gdes of na11aMuur-103 to Georgia in order to obtain a " Certificate of Registration."
Such a certificate is r====ary for 'Iheragenics to manufacture ard distribute
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palladium-103 seeds to specific licensees. 'Ihe information en these safety properties included the design and ua=Luction, prototype testirg, conditions of normal use, labeling, external radiation levels, solubility in body fluids, 1
'N, and quality cu h ul and assurance. After reviewing the information and Mamining the adequacy of the radiation safety rgdes of the source, the State of Georgia 4mmwi a Certificate of Registration to '1heragenios on September 22, 1986. '1his certificate ensnarized the sukunitted radiation safety information and specified additional limitations and carditions on the use of the source. 'Ihis certificate was amended in its entirety on June 6, 1988, to include a minor design improvement made by 'Iheragenios.
j Following its determination that the radiation safety rgcies of the source are adequate, the State of Georgia sent NRC a copy of the certificate to include in the Registry of Sauros and Devios Designs that is maintained by the NRC. Iha NRC reviewed the certificate for consistercy with other certificates in the Registry and attriari m11arilum-103 to the Registry on C6 4 +E 29, 1986, and again in June 1988 to cover the minor design improvement. This action, in effect, granted a premarketing approval of the.
I sealed source and permitted the use of n=11ari4um-103, provided the user's license was amended to include that sealed source.
Fc,-:;=1 Amendment and Public Omnant i.
After nonsidering the petition, the NRC published a gu
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granting the petition fcir a 30-day public omaant period (54 ER 13892,
' April 6, 1989). One emnant letter was received. 'Ihe <mnant letter, sulanitted by a medical professional organization, supported the petition. 'Ihe letter stated that "this would indeed alleviate burdenecane current NRC regulations that require users to amend their licenses before usirxJ pa11 adium-103. "
I conclusion
'Ihe NRC has &amined that the additicm of palladium-103 as a sealed source in maark to the list of sealed sources specified in 9 35.400 will not cause additional risk to hospital personnel or the public because the radiation safety and handling instructions to be used for palladium-103 are the same as the instructions used currently for the brachytherapy sources listed in S 35.400. 'Ihis action will reduce the regulatory burden to the 3
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I users of palladitun-103 seeds (about 700 potential users) as well as to the NRC -
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staff. Most users will not have to follow the present requirement of subnitting individual license amendment applications in or&r to use j
palladium-103 as a sealed source in seeds for the interstitial treatment of cancer (if their license permits the use of any brachytherapy sources specified in E 35.400). A user whose license only permits the use of specified brachytherapy sources will still be required to sutanit a license amendment application.. Rat for most licensees this rule will eliminate the license amendment application prooses and the review and apptwal proomas for the NRC.- 'Jhus, the NRC is amending 5 35.400 to add r=11dum-103 as a sealed source in seeds for the interstitial treatment of cancer.
Envim===dal T==rt: Chtegorical Exclusion
'Jhs NRC has determined that this final amendment is the type of action
. described in 10 CFR 51.22(c)(2). 'Jherefore, neither an enviu.-=dal inpact
- statement nor an envim_Aal assessment has been prepared for this amendment.
Peperwor'x Reduction Act Statsunent 1his final amendment does not contain any new or amended information l
collecticut requi _4s subject to the Peparwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). Existing requirements were approved by the Office of Management arri Dudget, apptwal runnhar 3150-0010.
Regulatory Analysis
'Ihe NRC has prepared a regulatory analysis on this amendment. 'Ihe analysis examines the costs and benefits of the alternatives considered by the NRC.
'Jhe analysis concludes that the adoption of the amendment will not increase the risk to the public health and safety but will reduce the cost to the Mm1 use licensees who plan to use palladium-103 sealed sources.
Interested persons may examine a copy of the regulatory analysis at the NRC Public W=arrt Rocan, 2120 L Street, NW. (Iower Ievel), Washirgton, DC.
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- Dr. Ant:heny N. Tee (See POR PURDG!R INFOR9LTICN ONDCP bandirig).
Regulatory Flavihility Certificatica As required by the Regulator) Flavihi14ty Act of 1980, 5 U.S.C. 605(b),
the n==Immion certifies that this amendment does not have a significant 1
actncanic 4W an a substantial raaber of small entities. B is amendment
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adds the use.of =11=di an-103 as a sealed source 'in aseds in 10 CFR 35.400.
t mis motice will redaos the regulatory burden an==dir=1 use licensees plarming to use the sealed source by eliminating the requirement of substitting a-license amendment =pr= tion. Se NIC has Wad size standards that classify a hospital.as a amall entity if its annual gross receipts do not L
awmad $3.5 =4114m, and a private prar+4r= physician as a amm11 entity if the physittinn's amaal groes receipts are $1.0 millim or less. Although eene NRC medir=1 use licensees could be considered "sumat2. enti*.ies," the rumber that wauld fall into this category does not ocnstitute a substantial raaber for purposes of the Regulatory Flavihi14ty Act.
i Backfit Analysis.
- De NRC has determined that a backfit analysis is not required for this W har=ma the action does not ocmstituta a backfit as defined in 10 CER 50.109 (a) (1).
Lis,t of Subjects in 10 CER Part 35 L
Byproduct material, Drugs, Health facilities, Health professions, Irmru.wi.icn by reference, Medical devices, Nuclear materials, Occupational safety and health, Penalty, Radiation protection, Ep.u.t.irg arri recor*i 's i
requit _ d.s.
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a Fdr the raamans set out in the preamble ard under the authority of the J
. Atamic Energy Act 'of 1954, as amended,1 the Energy Reorganization Act c'f 1974, I
as amarded, 'arx15 U.S.C 552 arti 553, the NRC is adapting the followirq
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amendment to 10.CFR Part 35.
PARP 35 - MEDICAL USE OF BYPR000CT MATERIAL F
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'Ihe authority citation for Part 35 is zwised to read as follows:
AURERITY: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, as' amended- (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, - 88 Stat.1242, as amended (42 U.S.C. 5841).
For the purposes of sec. 223, 68 Stat. 958, as amended- (42 U.S.C. 2273);
- 55 35.11,- 35.13, 35.20(a) and (b), 35.21(a) and (b), 35.22, 35.23, 35.25,
-35.27(a), (c) and' (d), 35.31(a), 35.49, 35.50(a)-(d), 35.51(a)-(c), 35.53(a) and (b), 35.59(a)-(c), (e)(1), (g) and (h), 35.60, 35.61, 35.70(a)-(f), 35.75,
-35.80(a)-(e),; 35.90, 35.92(a), 35.120, 35.200(b), 35.204(a) and (b), 35.205,
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35.220,' 35.310(a), 35.315,' 35.320, 35.400, 35.404(a), 35.406(a) and (c),
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35.410(a), 35.415, 35.420, 35.500, 35.520, 35.605, 35.606, 35.610(a) and (b),
35.615, 35.620, 35.630(a) and _ (b), 35.632(a)-(f), 35.634(a)-(e), 35.636(a) and (b), 35.641(a) ard (b), 35.643(a) and (b), 35.645(a) and- (b), 35.900, 35.910, 35.920,' 35.930, 35'932, 35.934, 35.940, 35.941, 35.950, 35.960, 35.961,
- 35.970,- arci 35.971' are i=M under sec.161b, 68 Stat. 948, as amended (42
' U.S.C. 2201(b)); and 55 35.14, 35.21(b), 35.22(b), 35.23(b), 35.27(a) and (c),
35.29(b), 35.33(a)-(d), 35.36(b)', 35.50(e), 35.51(d), - 35.53(c), 35.59(d) and l:
(e)(2), 35.59(g) and (i), 35.70(g), 35.80(f), 35.92(b), 35.204(c), 35.310(b),
35.315(b), 35.404(b), 35.406(b) and (d), 35.410(b), 35.415(b), 35.610(c),
p 35.615(d) (4), 35.630(c), 35.632(g), 35.634(f), 35.636(c), 35.641(c),
35.643(c), '35.645, and 35.647(c) are 1-M under sec.161o, 68 Stat. 950 as amended (42 U.S.C. 2201(c)).
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In 5 35.400,. pa.wy. '(g) - is added to read as follows:
-i 35.400 Use of sources for bractytherapy.
m-(g) Palladium-103 as a sealed sauroa in seeds for interstitial treatment 1
of cancer.
- ay of
, 1989.
Dated at Rockville, Maryland, this 2d d
For the Nuclear Regulatory Omnission.
P LES M.Tayld J
Acting Dancutive Dirdw. for Operations.
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