ML19332C823

Forwards Regulatory History Documents Re Final Rule 10CFR35, Pd-103 for Interstitial Treatment of Cancer, in Response to Petition for Rulemaking PRM-35-7

ML19332C823
Person / Time
Issue date:	11/22/1989
From:	Tse A NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES)
To:	Huyer D NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
Shared Package
ML19324D741	List: ML19332C823
References
FRN-54FR13892, RULE-PR-35, RULE-PRM-35-7 AD11-2-01, AD11-2-1, NUDOCS 8911290046
Download: ML19332C823 (4)

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1-MDORANDEM FOR:

Darlene Huyer, Chief, NUDOCS/DE 7

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Anthony N. Tse, RDB/DRA/RES SUB.TECT:

REGJIATORY HISTORY DOCLMDf1'S FOR A FINAL AMDDEN1' Copies of the subject hwaants are enclM for the final amendment,.

~" Palladium-103 ' for Insterstitial Treatment of Cancer," which are to be included

-in the NUDCCS. This amendment was prepared in response to a petition for.

rulemaking PRM-35-7. As requested by Michael I.esar of the Regulatory Publications Branch /ADM, the designator "AD11-2" was placed in the upper right-hand corner of each document,' including this transmittal tremorandum.'

Also enclosed for your information is a' copy of the index of the documents-for the-final amendment. Please let me know if you have any questions.

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An ony N. Tse Regulation Developnent Branch DRA/PIS

Enclosures:

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Index 2..

Copies of' documents

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7 8911290046 091122 PDR PR 35 54FR13892 PDR

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p, 100V 2 21989 AD11-2 RH3UIA'IORY HISIORY - INDEX FOR A FINAL AMDDENT

'PALIADILM-103 FOR INTERSITI'IAL 'IREA' DENT OF CANCER" DATE FROM

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07/06/89 ATse Cognizant Draft final rule for individuals u.-.ait 08/21/89 EBeckjord Office Final rule for office Directors concurrence l'

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09/19/89 EBeckjord JTaylor Final rule for approval Undated NA NA Federal Register notice l

Undated NA NA Regulatory Analysis 10/19/89 EBeckjord Ccisp.assional Istters to Oc.'gressional l

Oczanittees Cemnittees 11/03/89 5Bahadur

HCoopal, letter to the petitioner.

'Iheragenics L

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PROPOSED RULE fgyfR/3[(Q) 4 L

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$ 1 Pa11Mium-103 for Interstitial Treatment of Cancer e

N AGI!NCE: Nuclear Nogulatory Nianias, i

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' AcrIQi: Final rule.

Staepm: 'Das Nuclear Regulatory N4==4r=1 (NRC) is amending its regulations governing the medical uses of byproduct material to add !=11Mium-103 as a -

sealed source in seeds to the list of bradiytherapy sources permitted for use in the treatment of anaer. TJhder marrant NRC regulations, usare must have their licenses amended before they use ra11Mium-l')3. 'Ihis amendeant, prtaulgated in response to a petition for r"1==1dng (PEN-35-7), will reduce the regulatory burden cas Wirm1 use licensees idho plan to use the sealed source. An evaluation of the AAlal radiation hazards to hospital personnel and the public showed that there would be minimal risk if the sealed source is used in arwwdance with the samfacturer's radiation safety and' handling instructions.

EITECTIVE DME: (Insert the date of publication)

RR MRIHER INPWMM'ICN 03fDCf: Dr. Anthony N. ' Die, Office of Nuclear Regulatory Panaavi:21, U.S. Nuclear Regulatory n=nimairwi, Washingtal DC 20555, telephone (301)492-3797.

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SUPPLDENING INIGMATION:

Petition for Rulemakirg

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On November 30,1988, 'Jharagonics C pu.. tion mutanitted a petition for rn_1d g, PIM-35-7, Wildt was dodost:ad on nennehar 9,1988.- 'Iha petitionar requested that the NRC amend its regulatims to add =11adium-103 as a saaled source in seeds for the 14d aitial treatment of cancer to the list of sealed j

scuroes cazrrently permitted in 10 cPR 35.400 for uma in bractlyW-.yf. 'Jhs petiticziar stated that, under currunt NRC regulations, licensees who are users of pa11a*=-103 maast go throucf1 the cassbersome process of having their licenses amended before using the product and that amending 10 CFR 35.400 in the mannar suggested would eliminate this amharscuna process.

In supporting the petition, the petitioner sutanitted several rinnwits, includirq a letter from the PDA, a safety evaluation i.pu.t frtan the State of Georgia, the package ineart, and product literature.

'Iha letter frtan the FDA stated that, urrier Section 510(k) of the Federal Food, Drug, arx1 cosmetic Act, as amended, =* Ming the device (,=11= din =-103 as a sealed sauron in seeds) would be permitted subject to the general controls provisions of the Federal Pbod, Drug, and Cosmetic Act until such time as the device has been classified 'as either a Class I, II, or III devica l

l under Mir=1513. class I devices require general ocntrols, that is, l

registration and good marmafacturing rww+4

. Class II devices require perfermance stardaals in addition to general ocritrols, class III devices require price PDA approval of a Pre-Market Approval a,=14rmtion, perftwumice stardards, ard general controls. In Jarmanry 1988 (53 FR 1554), PDA < la-ified radicrariide brachyu-ayf scuroes as class II devices. '!his permits E

'Iheraganics to ocritinue marketing the !=11adium-103 seeds.

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In March 1986, 'Ihara-' tics, an " Agreement State" licenses of the State of 1

Gaargia, autanitted information en the radiation safety puy ties of pa11adium-103 to Georgia in order to obtain a " Certificate of Registration."

Such a certificate is r+wy for 'Itsuapanics to manufacture ard distribute palladium-103'aaada to specific li m i.ees. 'Iha information on these safety suru. ties included the design ard w=L.acticri, prototype testirg, conditions of normal use, labeling, external radiation levels, solubility in body fluids, l

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'j ard quality whel ard assurance. After. reviewing the information and determining the Wwy of the radiation safety p.gdes of the source, the State of Georgia i==wl a Certificate of Registration to 'Iharagenics on W h 22, 1986. 'Ihis certificata==narized the sutaitted radiation.

safety information ard specified additional limitations and canditions m the.

J une of the notreco. '1his certificate was amended in its entirety on June 6, 1988, to include a minor design improvement made by '!haragonics.

Pb11cwing its deram%aticut that the radiation safety rwties of the scuros are adequate, the state of Georgin sent NRC a copy of the certificate to inclu3e in the Registry of source and Davios Designs that is maintained by the NRC. 'Ihe NRC reviewed the certificata for consistency with other omrtificates in the Registry and added !=11Mium-103 to the Registry on October 29, 1986, and again in June 1988 to cover the minor design inprovement. 'Ihis action, in effect, granted a presarketing approval of the sealed source and permitted the use of !=11Mium-103, provided the user's l.

license was amended to include that sealed source.

Proposed Amendment and Public W After ocnsidering the petition, the NRC published a pW amendment granting the petition for a 30-day public ocumnant period (54 FR 13892, April 6, 1989). One ocaunent letter was received. '!he oczanent letter, L

sukunitted by a medical professional orgap4*4r=1, sqr n.ised the petition. The r

letter stated that "this would indeed alleviate burdenecana current NRC s

regulations that require users to amend their licenses before using pa11 Miunt-103."

i O nclusion l

'Ihe NRC has detamhed that the acklition of !=11Mium-103 as a sealed L

source in seeds to the list of sealed sources specified in 5 35.400 will not cause additional risk to hospital i==, 61 or the public because the radiation safety and handling instructions to be used for pa11Mium-103 are the same as the instructions used currently for the brachytherapy sources listed in 5 35.400. 'Ihis action will reduce the regulatory burden to the 3

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11Mi a-103 seeds (about 700 potential users) as well.as to the NRC users of P t

staff. Most users will not have to follow the present requiu --it of cutaitting indivichm1 license amendment applications in order to use F11Mium-103 as a sealed source in seeds for the interstitial treatment of i

cancar (if their license permits the use of any bradzytherapy sources specified in 9 35.400). A user idiose license only permits the use of specified bradzytherapy sources will still be required to sutnit a lioones amendment applicaticm. But for anst 1inansees this rule will eliminate the license amendment==1ir= tion proomms and the review and approval process for the NRC. - 'Dals, the NRC is amending 5 35.400 to add 711Miunt-103 as a sealed source in seeds for the interstitial treatment of concer.

Enviunm-udal Tur=rt: Categorical Exclusion y

'Jhe NRC has deFamined that this final amendment is the type of action l

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.. described in 10 CFR 51.22(c) (2). 'Daarefore, neither an envircreantal 4=ar+

l statenent nor an envirermental a====== ant has been prepared far this L

amendmene..

Paperwerk Pdw+1rn Act statement l

'Ihis final amendment does not contain any new or amended informatica l

m11ar+iews requirements subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). hiding requirements were approved by the Office of -

E% t and 95, approval number 3150-0010.

Regulatory Analysis

'Ihe NRC has prepared a regulatory analysis on this amendment. 'Ihe analysis examines the costs and benafits of the alternatives considered by the NRC.

'Iha analysis concludes that the adoption of the amendment will not irua the risk to the public health and safety but will reduce the cost to the wirm_1 use licensees who plan to use y11Mium-103 sealed sources.

Interested pmocrs may examine a copy of the regulatory analysis at the NRC Public W=nt Room, 2120 L Street, NW. (Iower Isvel), Washington, DC.

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Single ocpies of the regulatory analysis may be obtained fran; Dr. Anthony N. Tee (See POR PURIMER INIGMNTICH CEHmCT hooding).

Regulatory Flexibility Certification l

As required by the Regulatory Flexibility Act of 1980, 5 U.S.C. 605(b),

the n=mianim certifies that this amendesnt does not have a significent econcanic iM on a substantial nauber of small entities. This ameruksent adds the use of =11=dhan-103 as a sealed scuros in seeds in 10 CPR 35.400.

This acticm will reduce the regulatory burden on medinal use licensees plaming to use the sealed source by eliminating the reqpirement of submitting a licanos amendment==1imticm. The NRC has Wad size standards that

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classify a hospital as a small entity if its annual gross r-4:*= do not mnaad $3.5 =4114m,' and a private pr=<+4r= physician as a small entity if the physician's annual gross receipts are $1.0 =4114m or less. Althcugh scua NRC medimi use licensees oculd be ccmsidered "small entities," the number that would fall into this

---t+ _-_-f does not ocnstitute a substantial ranuber for purpeens of the Regulatory Maw 4hi14ty Act.

Backfit Analysis l

1he NRC has dstamined that a backfit analysis is not required for this amendment because the action does not ocnstitute a backfit as defined in 10 CFR 50.109(a) (1).

List of subjects-in 10 CFR Part 35 i

Byproduct material, Drugs, Health facilities, Health professions, Ir-imaticm by reference, Madim1 devices, Nelane se mr4=1=, occq:stional e

safety arui health, Penalty, Radiatica WWm, "+ Ling and K - @

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' For the reamans set cut in the pale and under the authority of the Atinir' Energy Act of 1954, as amended, the Energy bum.vanization Act of 1974,

- as amended, and 5 U.S.C 552 and 553, the NRC is adapt 3ng the following amendment to 10 CPR Part 35.

PARP 35 - MEDIchL USE OF BYPRODUCT MMERIAL 1.

. Iha authority citation for Part 35 is zwised to read as fo11cus:-

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AUI1ERITY: Sacs. 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 amarded (42 U.S.C. 5841).

Pbr 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, s

35.27(a),.(c) and (d), 35.31(a), 35.49, 35.50(a)-(d), 3S.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, 35.220,. 35.310(a), 35.315, 35.320, 35.400, 35.404(a), 35.406(a) and (c),

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) and (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, 1

35.970, and 35.971 are issued 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) ard I

. (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),

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 imawl under sec.161o, 68 Stat. 950 as amended (42 U.S.C. 2201(o)).

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2.

In 5 35.400, prop.p (g) is added to read as follows:

i 5 35.400 Use of sources for brachytherapy.

1 (g) Palladium-103 as a sealed saurea in seeds for interstitial treatment

'of cancer.

Dated at Rockville, Maryland, this 2d day of

, 1989.

Pde the Nuclear Regulatory h4=miert.

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RETINItRY ANALYSIS a

10 CPR PARP 35-l PAIZADIIM-103 POR INTERSTITIAL TREA' DENT OF CANCER 1.

STATEMENT OF PROBH M 10 CFR 35.400, "Use of Sources for Bradlytherapy," lists specific ram'=tive sealed sources that may be used for treatment of cancer in bradiytherapy. In December 1988, the NRC received a petition for rulassaking filed by '1heragonics Corporation dated November 30, 1988 (docketed PRM-35-7) to amend 10 CER 35.400.

'1he petitioner requested that the NRC amend its regulations to add palladium-103 as a sealed source in seeds for interstitial treatment of cancer to the list of sources specified in 10 CER 35.400. 'Iha petitioner stated that, under the present regulation, users of palladium-103 nust go through the cumbersome prmana of amendirxj their licenses before they can use the product and that amending 10 CER 35.400 would eliminate this <mhatsane prmana.

2.

OBJECTIVES NRC's objectives are to protect the health and safety of workers and the public in the licensing of byproduct materials for medical uses. 'Iha Food and Drug Administraticri permitted marketing of 'Duragenics' palladium-103 seeds i

under Section 510(k) of the Federal Food, Drug and wlc Act as amended.

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'Ihe State of Georgia, an " Agreement State" whidt lioanoes Theragenics, performed safety evaluations of the use of palladium-103 and issued a Certificate of Registration. Whaarywltly, the NRC reviewed the certificate ij for consistency with other certificates in the Registry of Source and Device l

Designs and added palladium-103 to the Registry. 'Ihis action, in effect, granted a premarketing approval of the source and would permit the use of the source provided the user's license was amended to include the source.

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AUPERNATIVES

'Ihere are only two alternatives:

(1) Maintain the status quo, i.e., a licensee seeking to use palladium-103 nust first apply for arrl obtain a license amendment permitting its use; and (2) Amerd 10 CFR 35.400 to include palladium-103 as a sealed source in maada for interstitial treatment of cancer.

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CONSBRUENCES e

In tenns of the public health and safety, both alternatives would permit the use of palladium-103 as a sealed source in aaada for brachytherapy, thus, there would be essentially no difference between the two alternatives.

In tenns of cost, alternative-2 would be less burdensane for both the medical use licensees and the NRC. Alternative 2 would eliminate the amurdment applicatice W w for most licensees who plan to use the sealed source and the review and approval prma== for the NRC.

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IECISICN RATIGRI.E Since Alternative 2 would result in less burden to the medical use licensees and the NRC staff while providirg the same level of protection of the public health and safety, the NRC is adopting this alternative.

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IMPI2MENIWI' ION l

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'Ibe amendment is effective on the date of publication in the Federal Register.

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