ML20217Q227

Forwards Final Rulemaking Package in Response to Petition for Rulemaking PRM-35-7 Re 10CFR35.400,palladium-103 for Interstitial Treatment of Cancer for Concurrence

ML20217Q227
Person / Time
Issue date:	08/21/1989
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: ML20217P751 ML20217P836 ML20217P856 ML20217P894 ML20217P946 ML20217P962 ML20217Q166 ML20217Q175 ML20217Q211 ML20217Q227 ML20217Q237 ML20217Q249 ML20217Q261 ML20217Q269 ML20217Q292 ML20217Q304
References
FOIA-98-86, RULE-PRM-35-7 NUDOCS 9804100348
Download: ML20217Q227 (22)

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o UNITED STATES

[d , s f' g NUCLEAR REGULATORY COMMISSION t  ; l \(q#. gp WASHINGTON, D. C. 20555 Q'%]f./

AUG 21 1999 MEMOPANDUM FOR: Robert M. Bernero, Director, NMSS Harold R. Denten, Director, GPA William C. Parler, General Counsel Patricia G. Norry, Director, AD(

FBCH: Eric S. Beckjord, Director Office of Nuclear Regulatory Paaam d SUB7. ECT: RB20EST CINIIRRENCE CN FINAL AMDDENT 'IO 10 CFR 35.400 Please provide your concurrence on the enclosed final rulemaking package in response to a petition for rulemaking (PBM-35-7). '1he followirg is a sumnary of this request.

1. Title. Palladium-103 for Interstitial Treatment of Cancer.

2. RES Task I.eader: Anthony N. Tse, IRA (x23797) .

3. Cbgnizant Individuals:

NMSS: S. Baggett, D.B. Howe.

GPA: L. Bolling, S. Gagner.

OGC: M. Rothschild. -

AIE: M. Ta w .

4. Requested Action: Provide concurrence for your office.

5. Requested Ccmpletion Date: September 8, 1989.

6.

Background:

A petition for rulemaking (PRM-35-7) was subnitted by

'Iheragenics corporatical requesting that palladium-103 as a sealed source in naark be added to the list of brachytherapy sources specified in 10 CFR 35.400.

A proposed amendnent was published on April 6,1989 (54 FR 13892) for a 30-day public u.m mnt period. One conment letter was recieved. 'Ihe ocanment letter, subnitted by the American Cbilege of Radiology, supported the petition.

'Ibe final rulemaking is unchanged, ex pt for editorial inprovements, fran the prrrmai rulemaking in which you have previously concurred.

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9804100348 980407 I PDR FOIA t THOMPSON 98-86 PDR [

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'1he draft Federal Register notice for the final amendment was coordinated with the above named cognizant individuals.

Eric S. Beckjord, D r, Office of Nuclear atory Research

Enclosures:

Memo to Taylor Encls. to the Memo A.-lFR Notice-B. Regulatory Analysis C. Cu ysussional letters D. Daily Staff Notes Item oc (w/encls.):

Cognizant individuals 4

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'Ibe draft Federal Reaister notice for the final amerdment was coordinated with the above named cognizant individuals.

rd Eric S. Beckjord, Director 6 Office of Nuclear Regulatory Research

Enclosures:

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$ $ WASHINGTON, D. C. 20555

\ V[f MDDRREM FDR: Jams M. Taylor Actire Executive Cimctor for Operations FROM: Eric S. Beckjord, Director  !

Office of Nuclear Regulatory Research

SUBJECT:

FDE AMDH2E2R 'IO 10 CFR 35.400: ADDDG PALLADIUM-103 IDR DuuonnAL TREA21E2E OF CANCER (PEM-35-7)

Enclosed for your signature is a final ansduent (Enclosure A), to be published in the Federal Recister, that will amend 10 CFR Part 35, 'hdical Use of Byproduct Material." *Ihis amendment will add palladium-103 as a sealed source in seeds to the list of sealed sources that may be used in brachytherapy as specified in 10 CFR 35.400.

BACI M E D:

A petition for rulemakirq (PRM-35-7) was submitted by 'Iheragenics Corporation (docketed on _ hl 9,1988) requestirg that palladium-103 be added to 10 CFR 35.400, "Use of Sources for Bradlytherapy." 'Ihe petitioner stated that, urder the present regulation, users of palladium-103 must go through the cumberscme process of amending their licenses before they can use the product and that amerdiJg 10 CFR 35.400 in the manner stry3ested would eliminate this cumbersme process.

A proposed aMJdnent granting the petitioner's request Was published for a 30-day public coment period (54 FR 13892, April 6,1989) . One comment letter was received. 'Ihe ccament letter, suhnitted by a medical professional organization, supported the petition.

'Ihe staff has determined that the petition should be granted by adding palladium-103 as a sealed source in seeds to 5 35.400. Capared to the current practice, this charge will reduce the burden for both medical licensees and the NRC staff. The level of protection of the public health ard safety will not decrease because the radiation safety ard handling 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 MEYSIS:

'Ihe staff has determined that a backfit analysis is not required for this 1

are44.nt because the amerdment does not constitute a backfit as defined in I

10 CFR 50.109(a) (1) .

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2 NctrICES:

A regulatory analysis has been prepared (Enclosure B). The appropriate cumpassional ccmnittees will be notified (Enclosure C) . A Daily Staff Notes iten for the ew,nimion has been prepared (Enclosure D) . A letter will be sent to notify the petitioner of the final amendment. Public Affairs (GPA) has indicated that a public annoursue:iit is not W.

COORDINATION:-

The Offices of Nuclear Material Safety and Safeguards, Administration, and Goveu =d.41 and Public Affairs concur in this final &E-r.ii-nl. The office of General Counsel has no legal objections.

Eric S. Beckjord, Director i Office of Nuclear Regulatory F - rch '

Enclosures:

A. FR notice

. B. Regulatory analysis C. Cciajiessional letters i

. D. Daily Staff Notes Itan I l

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3 Approved for Publication

%e M" ion delegated to the EDO (10 CFR 1.31(a)(3)) the authority to idevelop and prumilgate rules as defined in the APA (5 U.S.C. 551 (4)) st.bject to the limitations in the NRC Manual Chapter 0103, Organization and Functions, Office of the Executive Director for Operations, paragraphs 0213, 038, 039,

'and 0310.

We enclosed final arwAwt, entitled " Palladium-103 for Interstitial Treatment of Can r," anerris Part 35 to add palladium-103 as a sealed source in seeds to the list of sources specified in f 35.400 for bradlytherapy. Bis arw A unt will reduce the regulatory burden cn w im1 use licensees who plan to use the sealed source, but the level of protection of the public health and I safety will not decrease.

Se amendment does not r:anstitute a significant question of policy, nor does it amend regulations contained in 10 CFR 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 prWhxJ to issue it.

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I Date James M. Taylor l Acting Executive Director l for Operations '

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ENCLOSURE A FEDERAL REGISTER NOT..:

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NUCLEAR RB3UIA70RY COMISSICH 10 CFR Part 35 J

RIN No. 3150-AD11  ;

Palladium-103 for Interstitial Treatznent of Cancer j l

AGDJCY: Nuclear Regulatory N 4 = ion.  !

ACITON: Final rule.

SUMMARY

'Ibe Nuclear Regulatory h4= ion (NRC) is amending its regulations governing the .nadimi uses of byproduct matarial to add palladium-103 as a (

sealed source in seeds to the list of brachytherapy sources permitted for use .

in the treatrient of cancer. Under current NRC regulations, users must have their licenses amended before they use palladii v 103. 'Ihis egrrAmt, '

prunulgated in response to a petition for rulemaking (PPM-35-7), will reduce the regulatory buri n on medical use licensees who plan to use the sealed scurce. An evaluation of the potential radiation hazards to hospital personnel and the public showed that there would be minimal risk if the sealed source is used in accordance with the manufacturur's radiation safety and handling instructions.

Inu;nVE EATE: (Insert the date of publication)

FOR IN INIVRMATICN CONIACT: Dr. Antliony N. Tse, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory n=4= ion, Washington DC 20555, telephone (301)492-3797.

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l SUPPLEMENIARY INFOWATION:

Petition for Rulemaking i i

On November 30, 1988, heragenics Corporation subnitted a petition for rulemaking, PRM-35-7, which was docketed on W har 9, 1900. 'Ihe petitioner

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requested that the NRC amend its regulations to add palladium-103 as a b aled source in seeds for the interstitial treatment of cancer to the list of sealed sources currently pennitted in 10 CFR 35.400 for'use in brachytherapy. We' petitioner stated that, under current NRC regulations, licensees who are users I

of palladium-103 must go through the cumberscne process of having their j licenses amended before using the product and that amending 10 CFR 35.400 in the mar.ner suggested would 11minate this cumberscne process.

In supporting the petition, the petitioner subnitted several dmmonts, including a letter frcn t;he FDA, a safety evaluation report from the State of Georgia, the package insert, and prcx3uct literature.

'Ihe letter from the FDA stated that, under Section 510(k) of the Federal ,

Food, Drug, and Cosmetic Act, as amended, marketing the device (palladium-103 as a sealed source in seeds) would be permitted subject to the general I controls provisions of the Federal Food, Drug, and Cosnetic Act until such time as the devi has been classified as either a Class I, II, or III device under Section 513. Class I devices require general controls, that is, registration and good manufacturing practices. Class II devices require performance standards in addition to general controls. Class III devices

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require prior FDA approval of a Pre-Market Approval application, performance j standards, and general controls. In January 1988 (53 FR 1554), FDA classified l radionuclide brachytherapy sources as Class II devices. 'Ihis permits  !

'Iheragenics to continue marketing the palladium-103 seeds.

In March 1986, heragenics, an "A7tasiient State" licensee of the State of l

Georgia, subnitted information on the radiation safety pvpe:ules of i palladium-103 to Georgia in order to obtain a " Certificate of Registration."

Such a certificate is mary for 'Iberagenics to manufacture arxi distribute palladium-103 e to specific licensees. 'Ihe information on these safety swLies included the design ard cm:,Lanction, prototype testing, corviitions 1 of normal use, labeling, external radiation levels, solubility in body fluids, i

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determining the adequacy of the radiation safety properties of the source, the h State of Georgia MM a Certificate of Registration to '1heragenics on September 22, 1986. 'Ihis certificate smenarized the subnitted radiation safetyinformationandspecifiedabditionallimitationsandocnditionsonthe j use of the source. 'Ihis certificate idas amended in its entirety on June 6, 1988, to include a minor design improvement made by '!heragonics.

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l Following its detarmination that the radiation safety prtperties of the scuros are m'ia'ymte, the State of Georgia sent NRC a copy of the certificate to include in the Registry of Source and Device Designs that is maintained by i

the NRC. 'Ihe NRC reviewed the certificate for consistency with other i

certificates in the Registry and added palladium-103 to the Registry on OcPr+*" 29, 1986, and again in June 1988 to cover the minor design improvement. 'Ihis action, in effect, granted a prumarketing approval of the l7 sealed sour ard permitted the use of palladium-103, provided the user's license was sir &ded to include that sealed source.

Prgmad Airsdhient and Public Otznent  :

After considering the petition, the NRC published a s q-:=d amendment granting the petition for a 30-day public otanent period (54 FR 13892, .

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April 6, 1989). One otanment letter was received. '1he otunant letter, subnitted by a =*44r al professional organization, sqpported the petition. '1he i letter stated that "this would indeed alleviate burdensame current NRC regulations that require users to amend their licenses before using palladium-103."

Ocnclusion

'Ihe NRC has determined that the addition of palladium-103 as a scaled source in seeds to the list of sealed sources specified in 5 35.400 will not cause additional risk to hospital W .1 or the public because the radiation safety and handling instructims to be used for palladium-103 are the same as the instructims used currently for the brachytherapy sources listed in 5 35.400. 'Ihis action will reduce the regulatory burden to the l- 3

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l users of palladium-103 seeds (about 700 potential users) as well as to the NRC staff. Most users will not have to follow the present requirement of subnitting individual license amendment applications in order to use palladium-103 as a sealed source in seeds for the interstitial treatment of cancer (if their license pennits the use of any brachytherapy sources specified in 5 35.400). A user whose license only permits the use of specified brachytherapy sources will still be required to subnit a license amerdment application. But for most licensees this rule will eliminate the license airs &r_nt application pv we and the ruview ard approval process for the NRC. 'Ihus, the NRC is amending 5 35.400 to add palladium-103 as a sealed source in e for the interstitial treatment of cancer.

Envisumsital Impact: Categorical Exclusion

'Ihe lac has determined that tais fine.1 arendment is the type of action described in 10 CER 51.22(c)(2). 'Iberefore, neither an environmental impact statement nor an envitummital acce==nant has been prepared for this amendment. '

Paperwork Reduction Act Statement

'Ihis final ancasit does not contain any new or amerded information l

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collection requirements subject to the Paperwork Reduction Act of 1980 (44 l U.S.C. 3501 et seq.) . Existing requirements were approved by the Office of Marsg.asit and Badget, approval number 3150-0010.

Regulatory Analysis

'Ibe NRC has prepared a regulatory analysis on this amendnent. 'Ihe analysis ,

examines the costs and benefits of the alternatives considered by the NRC.

'Ihe analysis concludes that the adcption of the amerdment will not increase

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the risk to the public health ard safety but will reduce the o:st to the i

i naMr al use licensees who plan to use palladium-103 sealed sources.

t j Interested persons may examine a copy of the regulatory analysis at the NRC Public Wwaant Rocan, 2120 L Street, NW. (Iower Level), Washington, DC.

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SinJ1e copies of the regulatory analysis may be obtained frcan Dr. Anthony N. Tse - (See FtR PURDER INIUMATION CONDCr baatiitig) .

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

the h4== ion certifies that this amendment does rot have a significant s.udulc in=+ on a substantial number of small entities. Siis amendment adds the use of palladium-103 as a sealed source in aantia in 10 CFR 35.400.

211s action will rMm the recy.11atory burden on medical use licensees l

planning to use the sealed source by eliminating the requi-it of subnitting a license &ir .idi=uit application. Tw NRC has adopted size standards that clasify a hospital as a_small entity if its annual gross receipts do not eyrwai $3.5 million, and a private practice physician as a small entity if the l physiulan's annual gross receipts are $1.C million or less. Although some NRC medical use licensees could be considered "small entities," the number that would fall into this category does rot constitute a substantial number for porposes of the 9 s latory Flexibility Act.

f Backfit Analysis l 'Ihe NRC has determined that a backfit analysis is not required for this l

1 amendment because the action does not constitute a backfit as defined in 10 CFR 50.109(a) (1) .

List of Subjects in 10 CPR Part 35 l l

j- Byproduct material, Drugs, Health facilities, Health professions,

! Iru.u p ration by reference, Medical devices, Nuclear materials, W = tional safety and health, Penalty, Radiation protection, Reporting and recordkeeping requirements.

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For the reasons set out in the preamble and under the authority of the Atcanic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and 5 U.S.C 552 and 553, the NRC is adopting the following l amendment to 10 CFR Part 35.

l-4 PART 35 - MEDICAL USE OF BYPROGXT MATERIAL

1. 'Ihe authority citation for Bart 35 is zwised to read as follows:

AUIH3RITY: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, as l- amended. (42 U.S.C. 2111, 2201, 2232, 2233) ; sec. 201, .88 Stat.1242, as amended (42 U.S.C. 5841) .

~ For the purmaan of sec. 223, 68 Stat. 958, as amended (42 U.S.C. 2273);

l 55 35.11, 35.13, 35.20(a) esd (b), 35.21(a) and (b), 35.22, 35.23, 35.25, c35.27(a), (c) and (d), 35.31(a), 35.49, 35.50(a)-(d), 35.51(a)-(c), 35.53(a) aid (b), 35.59(a)-(c), (e) (1), (g) and (h), 35.60, 35.61, . 35i.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, 35.970, and 35.971 are iamd 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 (e) (2), 35.5)(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 imm d under sec. 161o, 68 Stat. 950 as

7. amended (42 U.S.C. 2201(o)) .

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2. In 5 35.400, paragraph (g) is aMui to read as follcus:

5 35.400 Use of sources for brachytherapy.

.. (g) Palladium-103 as a sealed source in seeds for interstitial treatment of cancer.

Dated at Rockville, Maryland, this day of , 1989.

For the Nuclear Regulatory h 4== ion.

James M. Taylor, Acting Executive C:%r for Operations.

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2. In 5 35.400, paragraph (g) is added to read as follows:

l 5 35.400 Use of sources for brachytherapy.

(g) Palladium-103 as a sealed source in seeds for interstitial treatment of cancer.

Dated at Rockville, Maryland, this day of , 1989.

For the Nuclear Regulatory h 4 = ion.

James M. Taylor, Jcting Executive Director for Operations.

NMSS GPA OGC AIM EDO RBernero HDenton WParler INorry JTaylor

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I ENCLOSURE B REGULATORY ANALYSIS 1

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REGUIA'ICRY ANALYSIS 10 CFR PART 35 PALIADILM-103 FCR INTERSTITIAL 'IREA3 MENT OF CANCER

1. SIXffMENT OF PROBE 2M 10 CFR 35.400,. "Use of Scurons for Bra &ytherapy," lists specific radioactive sealed sources that may be used for treatment of cancer in bradytherapy. In nonenhor 1988, the NRC received a petition for rulemaking filed by 'Iheragenics Corporation dated November 30,1988 (dockstad PIM-35-7) to amend 10 CFR 35.400.

Ihe 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 CFR 35.400. 'Ihe petitioner stated that, under the present regulation, users of y=11= Hum-103 nist go through the cumberscane prma== of amending their licenses before they can use the product

' and that amending 10 CFR 35.400 would e iminate this cumbersome prma==.

l 2. OILTECTIVES NRC's objectives are to protect the health and safety of workers and the public in the licensing of byproduct materials for medical uses. 'the State of Georgia, an " Agreement State" Whi& licenses 'Jheragonics, performed safety _

evaluations of the use of palladium-103 and issued a' Certificate of ,

Registration. 9*==T=ntly, the NRC reviewed the certificate for consistency with other certificates in the Registry of Source and Device Designs and added palladium-103 to the Registry. 'Ihis action, in effect, granted a premarketinJ-approval of the source and would permit the use of the source provided the user's license was amended to include.the source.

3. ALTERNATIVES

'Jhere are only. two alternatives:

(1) Maintain the status quo, i.e., a licensee seeking to use palladium-103

nust first apply for and obtain a license amendment permittinJ its use; i- .ard

(. (2) Amand 10 CFR 35.400 to include palladium-103 as a sealed source in seeds for interstitial trentznant of cancer.- j

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4. CENSEQUDiCES -

1 In terms of the public health and safety, both alternatives would permit the I use of palladium-103 as a sealed source in seeds for bra &ytherapy, thus, I there would be essentially no difference between the two alternatives. l l

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In tems of cost, alternative 2 would be . .A 'urt$ensane for both the medical use licensees and the NRC. Alternative 2 would eliminate the &ruerdient application prma== for most licensees who plan to use the sealed source ard the review and approval pr m for the NRC.

5. DECISICH RATIORIE since Alternative 2 would result in less burtlen to the dim 1 use licensees and the NRC staff while providing the same level of protection of the p.lblic

health and safety, the NRC is adopting this alternative.

6. IMPIDENIATION l 'Ihe amendment is effective on the date of publicatica in the Federal l Dagister.

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ENCLOSURI C i CONGRESSIONAL LETTERS

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. pea caz 4 vq% UNITED STATES E ;j ,, ' ,g NUCLEAR REGULATORY COMMISSION l

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@, a l WASHINGTON. D. C. 20555

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Identical letters will be sent to other Committees.

The Honorable.7ahn B. Breaux, Chairman l Stt h ittee en Nuclear Regulation

' ccmimittee on Dwitw.w.t and Public Works United States Senate l

Washington, DC. 20510

Dear Mr. Chairman:

Enclosed for the information of the sih ittee is a copy of a notice of rulemaking to be published in the Federal Reaister. In response to a petition

for rulemakirg, the Nuclear Regulatory hi== ion is amending its reentlations to add palladitme-103 to the list of brachytherapy sources specified in 5 35.400 as a sealed source in da for interstitial treatment of cancer.

The arr& digit will not increase the risk to the public health and safety but will reduce the regulatory burden to the malical use licensees who plan to use palladium-103 sealed sources.

Sincerely, Eric S. Beckjord, Director office of Nuclear Regulatory Research l

D elosure:

Amendment to 10 CFR Part 35 oc: Senator Alan K, Sirpson I

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ENCLOSURE D DAILY STAFF NOTES ITEM i

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l OTJLY SIAFF NCTIES OFFICE OF NUCI. EAR REGUIA'IORY RESEARCH Final Amendemnt signed by EDO On _ , 1989, the Acting Executive Director for Operations approved a final ann

• ment that amends 10 CER 35.400, "Use of Sour s for Brachytherapy." 'niis ag=rds ad., developed in rW=e to a petition for rulemaking (PRM-35-7) sutunitted by '1heragenics Corporation, adds palladium-103 as a sealed source in aasda for interstitial treatment of cancer to the list of sealed sources specified in 5 35.400. 'Ihe change will rwh the regulatory burden on Wiml use licensees who plan to use the sealea sour &s, but will not increase the risk to the public health and safety.

'Ihis notice informs the h4== ion that, in accordance with the rulemaPdng authority delegated to the EDO, the EDO has signed this final Ere.rdie.nt and proposes to forward it on , 1989 to the Office of the Federal Register for publication, unless otrerwise directed by the hi" ion.

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