ML20217Q211

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Forwards Final Rulemaking Package in Response to Petition for Rulemaking (PRM 35-7) Re palladium-103 for Interstitial Treatment of Cancer for Concurrence
ML20217Q211
Person / Time
Issue date: 08/16/1989
From: Beckjord E
NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES)
To: Bernero R, Harold Denton, Parler W
NRC OFFICE OF GOVERNMENTAL & PUBLIC AFFAIRS (GPA), NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS), NRC OFFICE OF THE GENERAL COUNSEL (OGC)
Shared Package
ML20217P754 List:
References
FOIA-98-86, RULE-PRM-35-7 NUDOCS 9804100342
Download: ML20217Q211 (11)
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E NUCLEAR REGULATORY COMMISSION- f WASHINGTON, D. C. 20555 1 l /  !

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MDGANDLM RE: Ibbert M. Bernero, Director, Harold R. Denton, Director, GPA #

William C. Parler, General Counsel Patricia G. Norry, Director, AIM k>

FHCM: Eric S. Beckjord, Director V

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office of Nuclear Regulatory pamaan:h

SUBJECT:

REQUEST CONCIIRRENCE CN FDEL AMEMMENT 'IO 10 CFR 35.400 Please provide your concurrence on the enclosed final rulemaking package in reipcime to a petition for rulenaking (PIM-35-7). 'Ihe following is a summary of this request.

1.

Title:

Palladium-103 for Interstitial Treatment of Canocr.

2. RES Task Isader: Anthony N. Tse, IRA (x23797) .
3. Cbgnizant Individuals:

!@ES: S. Baggett, D.B. Howe. //

GPA: L. Bolling, S. Gagner, h.

OGC: M. RuUnichild. '

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AEM: M. Ter.

4. Requested Acticn: Provide concurrence fo office.
5. Requested Cnipletion Date: Septaber @, 1989.
6.

Background:

A petiticn for rulenaking (PRM-35-7) was submitted by

'Iberagenim CE.ar ration requesting that pa11Mium-103 as a sealed source in seeds be aMM to the list of bradlytherapy sources specified in 10 CFR 35.400. -_ G

/ vi6 AgM f '~54 ished on April 6,198ffor 30-day public

"--.-,4t letter was recieved. The otament i h connent' FR 13892). One ,tu letter, the Naerican College of Radiology, supported the2tWF g petition. #

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'Following ocnsideration of the petition and the otxament letter, the -

request y n~ a,o 4 m p3 4 4e D y l D^ pr~ r W

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PDR FOIA THOMPSON 98-86 PDR i

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Draft Federal Reaister notice for the final amendment was distributed to A the cognizant individuals in }HSS, GPA, OGC, and AIM for connent.

hviate hm. acts were ira.vipucated in the enclosed notice.

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Eric S. Beckjord, Director Office of Nuclear Psqulatory Research i

Enclosures:

Memo to Taylor Encls. to the, Memo A. FR Notj a B. Regult.cory AnalyLis - -

C. Q:enessional letters

/ D. Daily Staff Notes Item -

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NEM~EANIIM RR: James M. Taylor l Acting Executive Director for Operations l

PRM: Eric S. Beckjord, Dirafwc Office of Nuclear Regulatory Researdt SUBJECr: FINAL AMDEMENT 'IO 10 CER 35.400: A[ DING PAIIADIU(-103 1 J

RR INIERST1TIAL 'IREADIENT OF ChN3R (PR6-35-7) l l

Enclosed for your signatu're is a final amanchnent (Enclosure A), to be published in the Federal Reaister, that will amend 10 CFR Part 35, "MMical

, Uma of Byproduct Material." 'Ihis amendment will add palladium-103 as a sealed source in maada to the list of sealed sources that may be used in brachytherapy as specified in 10 CFR 35.400.

BACEGROLED:

1 A petition for rulemaking (PRM-35-7) was m*nnitted by 'Iheragenics Corporation  !

(docketed on E- 2+r 9,1988) requesting that palladium-103 be aMad to l 10 CFR 35.400, "Use of Sources for Bradlytherapy." 'Ihe petitioner stated j that, under the gas-int regulation, users of palladium-103 nust go through the {

nudwrsone prnmaan of amending their licenses before they can use the product  !

l. and that amending 10 CER in the manner suggested would eliminate this '

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A proposed amendment granting the petitioner's request was published forh -

30-day public omenant (54 FR 13892, April 6,1989) . - One tvumant letter was ' l received. 'Iha ocassent letter, mutnaitted by a medical professional i organiza , the petition. <

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j gm1Wrz+MhGirut.of:thEneitinn arwi the.ocannant lat+a3 staff has -

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datannined that the petition should be granted by mMinig nallad um-103 as a,*

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analed source in seeds to 5 35.400.

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  1. [, r to the current praction, this dnange will reduos the burden for both niiidical licensees anid $ne NRC staff. 'Ihe level of protection of the public health and a 6e _ - ,

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. the radiation safety and handling instructi l

for palladi 403 are f " J- the, instructions for the

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sources -- - - 2 - listet. in 5 35.400. -

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i 'Ihe staff has determindI that a backfit analysis is not required for this amendment harwma the it does not aanstitute a backfit as defined in 10 CPR 50.109(a) (1) . N

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l A regulatory analysis has been prepared (Encl B). '1he apprtpriate congressional er==nittees will be notified osure c). A - 'fy - it-to the rhaniasion has been prepared (Em1e D). A letter be sent to notify the petitioner of the(gd,7 geh t. Public Affairs A)hasindicated that a public announoanent is not W. % f m m m, Qiul

'Ihe offices of Nuclear Material Safety and Saf , Administration, and Governuental and Public Affairs conaar in this amerriment. 'Ibe Office of $

l General Counsel has to legal objections. l

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T Eric S. Beckjord, Director Office of Nuclear Regulatory Researdt l

Enclosures:

i A. FR notice l B. Regulatory analysis

c. Congressional letters l

D. Daily Staff Notes Item  ;

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l Approved for Publicaticn N_ .

Se Caendasion delegated to the EDO (10 CFR 1.31faj (3)) the authority to develop and prtzuulgate rules as defined in the APA (5 U.S.C.-551 (4)) subject to the limitations in the NRC Manual Chapter 0103, Organizaticm and Functions,

' Office of the Executive Director for Operations, parampgsa 0213, 038, 039, .

and 0310.

Se enclosed final amendment, entitled "Palladitar-103 for Interstitial Treatment of Cancer," amends Part 35 to add pa11adi tua-103 as a sealed source

- e*pt in seeds to the list of sources specified in 5 35.400 for bradiytherapy. mis

Oy rahange use the will termscurosy sealed the replatory wr # c.burden/c se/on[madical o pedeuse d.4licensees m o f M eido plan to pw6/cc l

2 e amendment does not oanstitute a significant question of policy, nor does l . it amend regulaticos contained in 10 CFR Parts 7, 8, or 9 Subpart C concerniIg matters of policy. I, therefore, find that this rule is within the scope of l

t my rulemaking authority and am pE u-iiM to issue it.

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Date James M. Taylor.

Acting Executive Director for Operations '

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Cn Nova **r 30,1988, '1heragenics Corporation subnitted a petition for rulenaking, HM-35-7, which was docketed on nan =har 9,1988. 'Ihe petitioner requested that the NRC amend its regulaticris to add palladium-103 as a sealed source in aaaria for the interstitial treatment of cancer to the list of sealed sources currently permitted in 10 CFR 35.400 for use in bractlytherapy. h petitioner stated that, under current NRC regulations, licensees who are users of palladium-103 must go through the nahamane process of having their licenses amended before using the product and that amending 10 CFR 35.400 in the manner mry==ted would eliminate this me- + process.

In .;upporting the petitin, the p .titioner subnitted several dev,n=nts, including a letter frun the FIR, a safety evaluation report frun the State of Georgia, the package insert, and product literature.

'1he letter from the HR stated that, under Section 510(k) of the Federal Food, Drug, and Q)smetic Act, as amended, marketing the device (palladium-103 as a sealed source in seeds) would be permitted subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act until such p y time as the device has been classified as either a Class I, II, or III device under Secticr1513. p J 1988 (53 FR 554), MR classified radionuclide k l e--

bractlytherapy sources isshe Class II device,. '1his permits 'Iberagenics to atritirme marketing the palbariium-103 aaaria.L- J y an- w ctartia1 &

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==iva1 M b a L . I W h In Mardt 1986, 'Iheragenics, an "Ap.wi:-mit State" licensee of the State of '

Georgia, submitted inforination on the radiation safety prtperties of palladium-103 to Georgia in order to obtain a " Certificate of Registration."

Sudt a certificate is r--wry for 'Iheragenics to manufacture and distribute palladium-103 aaaria to specific licensees. 'Ihe information on these safety rupi=. ties incitxted the design arrt i.u-Loction, prototype testing, conditions of normal use, labeling, external radiation levels, solubility in body fluids, and quality oantrol and assurance. After reviewing the information and determining the Ww'y of the radiation safety supaties of the source, the State of Georgia 4==M a Certificate of Registration to 'Iberagenics on Sqtember 22, 1986. 'Ihis certificate sunnarized the subnitted radiation 2

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1 safety information and specified additional limitations and corditions on the use of the source. 7his certificate was amended in its entirety on June 6, 1988, to include a minor design 12tprovement made by Theragenics.

Following its determination that the radiation safety properties of the source are adarnute, the State of Georgia sent NRC a copy of the certificate ,,

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to include in the Registry of Source ard Device Designs that is maintained by/' ;,i ,

the NRC. The NRC reviewed the certificate for consistency with other p y:

l certificates in the Registry and adekvi palladium-10 .

Registry N F, y' I m

M r4=2 29, 1986, and again in June 1988 to cover Ug da. 12tprovment. #

This action, in effect, granted a premarketing approval of the sealed source ard permitted the use of palladium-103, provided the user's license was amended to include that sealed source.

Prmmad Amendment and Public Carr7nt 7 After considerity'the petition, the NRC published a proposed amendment granting the petit 5cn for a 30-day public umunuit period (54 FR 13892, April 6, 1989). One u-dit letter was received. The comment letter, submitted by a =viiml professional organization, supported the petition. The i

letter stated that "this would indeed allev. Late burdensme current IT l regulations that require users to amend their licenses before usirg palladium-103." l lC',

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_ Ebllowirg[ consideration of the petition and the ccanent p NRC y (W% ,

y'((cp& , has determined that the additicn of palladium-103 as a sealed sourc to the list of sealed sources specified in 5 35.400 will not cause additicnal risk to or the public ham = M=

u c es uidea tion safety Del c u rreA4D ,

.M ing ons, palladium-103 are r m to the instructionsf for <

the bra &ytherapy sources -- -- T listed in 5 35.400. This action will M I Mvm the regulatory burden.to the users of palladium-103 seeds (about 700 JL potential users) as well as to the NRC staff. Most users will not 9have to  !

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,- follow the roemit requirunent of =*=itting individnal licensq amendment u1Q applications in order h h 9to use palladium-103 as a sealed source in

=aada for the interstitial treatment of cancer (if their license permits the Y '. 3 >

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use of any bradlytherapy sauroasi specified in 5 35.400 . A user whose license only permits the use of specified bradiythafapy sauress will still be required

'to sutatit a license amen &nent application.E  ? . . T- t a 11 " . aw. ef

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-sensidmentak 'Ihus, the NRC is amending 5 35.400 to add pa11adiunt-103 as a , f e.

l sealed in seeds for the interstit.ial treatment of cancer.

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(I 2 2M Enviou->Unl T==Wi~Dategorical Exclusion d [lM { b t [, 4uw0 l ,

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'Ihe NRC has determined that this final amendment is the type of action ~fhr4

  • daar ribed in 10 CFR 51.22(c) (2) . Therefore, neither an envisum=. Lal inpact qQ f statement nor an envitu.-:. ital assessment has been prepared for this as=:= . "- : :a it.

Papenork Reduction Act Statanent l

'Ihis final amendment does not contain any new or amended information collection requirements subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.) . Existing requiremer.cs were approved by the Office of Marwp=nant and M*yat, approval number 3150-0010.

Regulatory Analysis

'Ihe NRC has prepared a regulatory analysis on this amendment. 'Ihe analysis monnines the costs and benefits cf the alternatives considered by the NRC.

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.'Ihm analysis concludes that the adoption of the amen &nent will not increase

%o the risk to the public health and safety but will rartrw the cost to the / i nadirm1 use licensees who plan to use palladiunt-103 sealed sources. ,

Interested persons may examine a copy of the regulatory analysis at the NRC j Public nm= ant Roam, 2120 L Street, NW(Imer Invel) Washirgton, DC. Single .

- copies of the regulatory analysis may be obtained Dr. Anthony N. Tse (See  ;

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  1. 'o UNITED STATES

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'Ihe Hcmorable John B. Breaux, Ominnan

    • vvunnittee on Nuclear Regulaticri Ozenittee on Erwircrament and Public Works United states Senate Washington, DC. 20510

Dear Mr. Chairman:

Enclosed for the infoonnation of the an*wvunnittee is a copy of a notice of rulemaking to be published in the Federal Register. In response to a petition for rulemaking, the NgucRegulatory nweniamiert is amending its regulations to add palladitan-103 as a -w -mm in e7to the list of bractlytherapy  ;

sources specified in 5 35.4 for F- M 'wIterstitial treatment of cancer. i e -

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[ 'Iha amendment wi1[.-- t!= i--y%y c.u_, m. _ '._-1 um. uu: _ % 1 titrdche sealed source. 'Ihe amendment will not cause additional '

risk to hospital personnel or the public h=a the radiation safety and 4 handling instructions for palladium-103 are similar to the instructions for bragherapy acurpos currently listed in Secticri 35.400.

Sincerely, k

Eric S. Beckjord, Director Office of Nuclear Regulatory Daaaa d

Enclosure:

Amenchment to 10 CFR Part 35 oc: Senator Alan K. Simpaan sw+&k ,^"";

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OFFICE OF NUCIEAR RBAJIAIDEN RESEARCH Final Amendstrit signed by EDO On ,1989, the Acting Executive Dirstw for Operations approved a final amendment that amends 10 CFR 35.400, "Use of Sources for Brachytherapy." This amendment, developed in respcrise to a petition for rulanaking (PRM-35-7) sutanitted by 'IN,..f:=dcs C raation, adds palladium-103 as a sealed source in seeds for interstitial treatment of cancer to the list

, of sealed sources specified in 5 35.400. 'Ihe change will zer= tN l

regulatory burden on mariimi use licensees idio plan to use the sealed sourcesj .

'Ihis notice informs the n-imian that, .in accordance with the rulemaking authority delegated to the EDO, the EDO has signed this final amendment and proposes to forward it on _,1989 to the Office of the Federal Register for publication, unless otherwise directed by the n - i - ion. ,

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Enclosure D

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