ML20217P946
| ML20217P946 | |
| Person / Time | |
|---|---|
| Issue date: | 02/13/1989 |
| From: | Beckjord E NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| To: | Stello V NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| Shared Package | |
| ML20217P754 | List: |
| References | |
| FOIA-98-86, RULE-PRM-35-7 NUDOCS 9804100243 | |
| Download: ML20217P946 (15) | |
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NUCLE AR REGULATORY COMMISSION W AEHING f DN. D. C. 206%
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MEMORANDUM FOR: Victor Stello, Jr.
EFecutive Director for Operatione FROM: Eric S. Beckjord, Director Office of Nuclear Regulatory Rooonrch
SUBJECT:
PROPOSED AMENDMENT TO 10 CFR 35.400: ADDING
! PALLADIUM-103 FOR INTERSTITIAL TREATMENT OF 1 CANCER (PRM-35-7)
Attached for your signature in a proposed rule (Enclosure A), to be published in the Federal Regiator, that amendo 10 CFR Part 35, "Modical Une of Byproduct Material." This amendment would add palladium-103 an a coaled courcs in neodo to the liet of coaled nources that may be used in brachytherapy an npocified in 10 CFR 35,400.
BACKGROUND:
1 A petition for rulemaking was submitted by Thoragonico Corporation (PRM-35-7, docketed December 9, 1988) roquenting that palladium-103 be added to 10 CFR 35.400, "Une of Sources for Brachytherapy " The petitioner ntated that, under the procent regulation, unorn of palladium-103 must go through the cumbornome l procean of amending their licensen before they can uno tho product and that amending 10 CFR 35.400 would eliminato this cumbornome procese.
Staff review of the petition chowed that the addition of palladium-103 to 10 CFR 35.400 would reduce the regulatory burdon on medical licenseen who plan to use the sealed cource. Thus, ao compared to the current practice, the proposed change would reduce the burden for both medical licenseen and the NRC ataff while providing the same level of protection of the public health and nafety. The proposed rule would grant the petitioner'n requent by adding palladium-103 ao a coaled ocurce in noodn to the list of approved sources in 10 CFR 35.400.
BACKFIT ANALYSIS:
The ntaff han datormined that a backfit analycin io not required i
for this propoced rule becanio the amendment doon not conntitutn l
a backfit an defined in Section 50.109(a)(1),
l NOTICES:
A draft regulatory analynin uan prepared (Enclonurn B) y The approprinto Congrennional Committoon will be n o t. i f i n d
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l (Encionure C). A weekly report to the Commienion wan prepared (Enclocure D). A letter will be sent to notify the petitioner of the proposed rule. Public Affairs /GPA han indicated that a public announcement le not needed.
COORDINATION:
The Officos of Nuclear Material Safoty and Safeguardn, Administration, and Governmental and Public Affairn concur in thin amendment. The Office of General Counsol han no legal objection.
Eric S. Beckjord, Director i Office of Nuclear Regulatory Hononrch Enclonureo:
A. FRH - proposed rulemaking B. Draft regulatory analysis C. Draft congressional letter D. Draft weekly report to Commission
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(Enclosure C)-. A weekly report to the Comminaion was p.epared (Enclosure D). A letter will be sent to notify the petitioner of the proposed rule. Public Affaira/GPA has indicated that a public announcement la not needed.
l COORDINATION:
The Offices of Huclear Material Safety and Safeguards, Administration, and Governmental and Public Affaire concur in this amendment. The Office of General Counsel has no legal objection. ;
Eric S. Deckjord. Director Office of Huclear Regulatory Roncarch
Enclosures:
- A. FRH - proposed rulemaking j l D. Draft regulatory analysis i l C. Draft congressional letter D. Draft weekly report to Comminaion i
DISTRIBUTION (w/o encia.):
Subj-chron-cire, RDD reading file RES: EDeckjord, TSpeia. DMorris, ZRoaztoezy, WLaha, JTelford, ATee(w/encia.)
HMSS: RDernero, HMcElroy GPA: HDenton, LBolling OGC: WParler. NRothschild ADM: PHorry, MLenar RRS EBockjord 2/ /09 OFF:
OD/DRA Jn Rb3/DRA b / EC 1fbhi $ RES NAMK: Tne/Tolford WLahn ZRonatoczy BMorrin TSpoln
- DATE: 1/26/89 2/1/09 2/11/09 2/is/09 2/ /89
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Approved for Publication The Commionion delegated to the EDO (10 CFR 1.40(c) and (d)) the authority to develop and promulgete rules an defined in the APA (5 U.S.C. 551 (4)) subject to the limitatione in the NRC Hanual Chapter 0103, Organization and Functionn, Office of the Executive Director for Operations, paragraphe 0213, 038, 039, and 0310.
The enclosed proposed rule, entitled " Palladium-103 for Interstitial Treatment of Cancer " would amend Part 35 to add palladium-103 as a sealed source in seeds to the list of nourcen specified in 10 CFR 35.400 for brachytherapy. This change would reduce the regulatory burden on medical une licensees who plan to une the sealed cource.
The proposed rule does not constitute a significant queotion of policy, nor does it amend regulatione contained in 10 CFR Parta 7, 8, or 9 Subpart C concerning matters of policy. I, thoroforo, find that this rule is within th6 acope of my rulemaking authority and am proceeding to issue it.
Date Victor Stello, Jr.
Executive Director for Operationn
[7509-01]
I NUCLEAR REGULATORY COMMISSION
\
10 CFR Part 35 Palladium-103 for Interstitial Treatmont of Cancer AGENCY: Nuclear Regulatory Commisalon.
i ACTION: Proposed rule.
SUMMARY
- The Nuclear Regulatory Commission (NRC)'in proponing to amend its regulations governing the medical uses of byproduct material. The proposed regulation would add palladium-103 an a sealed source in needs to the list of brachytherapy sourcen permitted for use in treatment of cancer. Under current NRC regulations, usera must have their licenses amended before they may une palladium-103. The proposed rule, developed in renponno to a petition for rulemaking (PRM-35-7), would reduce the regulatory burden on medical une licenseen who plan to une the sealed cource. An evaluation of the potential radiation hazardn to hospital personnel and the public showed that thoro would bo ,
minimal risk if the sealed source la used in accordance with the manufacturer's radiation safety and handling instructionn.
DATE: Comment period expires (30 days from the dato of publication in the Federal Register). Commente received after this date will be considered if it is practical to do no, but aneurance of consideration cannot be given except to commentn received on or before this date.
ADDRESSES: Hall written comments to: Secretary, U.S. Huelcar Regulatory Comminaion, Washington, DC 20555, Attention:
l Docketing and Servico Dranch. Do11ver commentn to Ono Whito )
Flint North, 11555 Rockvillo Pike, Rockv1110, Maryland 20052, betwoon 7:30 n.m. and 4:15 p.m. wookdayn.
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FOR FURTilER INFORMATION CONTACT: Dr. Anthony N. Toe, Offlen of Huclear Regulatory Research, U.S. Nuclear Regulatory Commincion.
Washington, DC 20555, telephone: (301)492-3797.
SUPPLEMENTARY INFORMATION:
Petition for Rulemaking On November 30, 1988 Theragenica Corporation nubmitted a petition for rulemaking, PRM-35-7, which was docketed on December 9, 1988. The petitioner requests that the NRC amend its regulatione to add palladium-103 as a sealed cource in neede for the interotitial treatment of cancer to the lint of cources permitted in 10 CFR 35.400 for use in brachytherapy. A copy of the petition may be obtained from the Regulatory Publications Dranch, Division of Freedom of Information and Publicationn Services, U.S. Nuclear Regulatory Commission, Washington, DC 20555.
The petitioner enclosed a document from the Food and Drug ;.
Administration (FDA) of the Department of Health and Human Services that allows palladium-103 as a sealed source in neede to be marketed. The petitioner stated that, under current NRC regulatione, users of palladium-103 must go through the cumbersome process of having their licenses amended before using the product and that amending 10 CFR 35.400 would elimir. ate thin curbersome process.
In supporting the petition, the petitioner submitted coverni documente, including a letter from the FDA, a cafety evaluation report from the State of Georgia, the package incert, and product literature.
The letter from the FDA stated that, under Section 510 (k),
marketing the device (pn11adium-103 an a nealed nouren in noodn)-
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1 would be permitted subject to the general controla proviolonn of the Federal Food, Drug, and Cosmetic Act until such time as the
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device has been classified under Section 513.
In March 1986, Theragenico submitted information on the radfation safety propertice of palladium-103 to the State of Georgia.
The information on these safety properties included the design and construction, prototype testing, conditions of normal use, labelling, external radiation levels, solubility in body fluido, and quality control and aneurance. After reviewing the information and determining the adequacy of the radiation safety ~
properties of the aource, the State of Georgia innued a Certificate of Registration to Theragonics on September 22, 1986.
Thio certificate summarized the submitted radiation safety information and specified additional limitations and conditions on the use of the cource. This certificate was amended in its entirety on June 6, 1988 to include a minor design improvement made by Theragenice.
Following its determination that the radiation safety properties of the source are adequate, the State of Georgia cent NRC a copy of the certificate to include in the Registry of Source and Device Designs. The NRC reviewed the certificate fer consistency with other certificates in the Registry and added palladium-103 to the Registry on October 29, 1986, and again in June 1988 to cover the design improvement. This action, in effect, granted a premarketing approval of the cealed cource and would permit the une of palladium-103 provided that the user's license was amended to include the sealed cource. .
Conclusion The NRC han examined the petition and supporting information
- nnd proponen to grant the petition. The addition of palladium-103 as a nealed cource in ocedn to the lint of cealed 1
LiDJ) unj
? 0 j sourcen opecified in 10 CFR 35.400 would not cauce additional riek to hospital personnel or the public. This action would reduce the regulatory burden to the users (about 700 licenseen) as well as to the NRC staff. Most usern would not have to submit i individual license amendmente (if their license permits the use of any brachytherapy sources specified in 10 CFR 35.400).
However, come users would still be required to submit license amendmente (if their license only permite the use of specified brachytherapy cources). The NRC staff's efforts to review and approve the license amendments would also be reduced.
Environmental Impact: Categorical Exclusion The NRC han determined that this proposed regulation le the type of action described in 10 CFR 51.22(c)(2)(1). Therefore, neither an environmental impact statement nor an environmental aenessment has been prepared for this proposed regulation.
Paperwork Reduction Act Statement This proposed rule does not contain a new or amended information collection requirement subject to the Paperwork Reduction Act of 1980 (U.S.C. 3501 et seq.). Existing l requirements were approved by the Office of Management and Budget, approval number 3150-0010.
Regulatory Analysis The NBC has prepared a draft regulatory analyais on thia ;
proposed regulation. The analysie examines the costs and benefits of the alternatives considered by the NRC. The draft regulatory analysia is available for inspection in the NRC Public Document Room, 2120 L Street, Lower Level, NW, Washington, DC.
Single copice of the draft-regulatory analycie may be obtained from Dr. Anthony N. Tae (See FOR FURTHER INFORMATION CONTACT l heading).
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5 [7509-01] l The NRC requents public comments on the draft regulatory analyale. Commenta may be submitted to the NRC (See ADDRESSES heading).
Regulatory Flexibility Certification As required by the Regulatory Flexibility Act of 1980, 5 U.S.C. 605(b), the Commiselon certifies that thin rule, if adopted, will not have a eignificant economic impact on a substantial number of emall entities. The proposed rule would add the une of palladium-103 as a sealed'cource in needs in 10 CFR 35.400. This action would reduce the regulatory burden on 3
medical une licensees who plan to une the sealed source.
The NRC has adopted size standards that classify a hoepital as a small entity if its annual grose receipts do not exceed $3.5 million, and a private practice physician an a ema11 entity if the physician's annual groes receipts are $1.0 million or lene.
Although come NRC medical use licensees could be considered
~'emall entitles," the number that would fall into this category deen not constitute a substantial number for purposes of the Regulatory Flexibility Act. However, the proposed rule would have a positive economic impact on about 700 liconeeen.
Backfit Analysis The NRC has determined that a backfit analysin is not required for this proposed regulation because the amendment doen not constitute a backfit as defined in Section 50.109(a)(1).
List of Subjects in 10 CFR Part 35 Byproduct meterial, Druge, Houlth facilities, Health profcaniona, Incorporation by reference, Medical devicea, Nuclear materiala, Occupational nafety and health, Penalty, Radiation protection, Reporting and recordkeeping requiremento.
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For the reasona set out in the preamblo and under the authority of the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of.1974, as amended and 5 U.S.C 553, the NHC in proponing to adopt the following amendment to 10 CFR Part 35.
- 1. The authority citation for Part 35 continuco to road an follows:
AUTHORITY: Seca. 81, 161, 182, 183, 60 Stat. 935, 940, 953, 954, an amended (42'U.S.C. 2111, 2201, 2232, 2233); noc. 201, 00 Stat. 1242, an amended (42 U.S.C. 5841).
For the purponen of coc. 223, 68 Stat. 958, an amended (42 1 U.S.C. 2273); ll 35.11, 35.13, 35.20(a) and (b), 35.21(a) and l (b), 35.22, 35.23, 35.25, 35.27(a), (c) and (d), 35.31(a), 35.49, j 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(n)-(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), 35.633(a)-(i), 35.636(a) and (b), 35.641(a) and (b), 35.643(a) and (b), 35.645(a) and (b),
35.000, 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 incued under acc.
161b, 68 Stat. 948, ao 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(o), 35.51(d), 35.53(c),
35.59(d) and (o)(2), 35.59(g) and (1), 35.70(g), 35.00(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(j), 35.636(c), 35.641(c), 35.643(c),
i 35.645, and 35.647(c) are innued under noc. 1610, 66 Stat. 950 nn j nmended (42 U.S.C. 2201(o)).
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- 2. In s35.400, paragraph (g) is added to read ao follown:
1 35.400 Une of cources for brachytherapy.
s a a e e (g) Palladium-103 as a sealed source in aceda for interatitial
)
treatment of cancer.
Dated at Rockville, Maryland, this day of I
, 1989.
1 I
For the Nuclear Regulatory Comminaion.
Victor Stello, Jr.
Executive Director for Operations 1
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[7509-01]
- 2. In 535.400, paragraph (g) is added to read ao follows:
I 35.400 Use of cources for brachytherapy.
- s , ,
(g) Palladium-103 as a sealed source in needs for interstitial treatment of cancer.
Dated at Rockville, Maryland, this day of
. 1989.
For the Nucleu Regulatory Commission.
Victor Stello, Jr.
Executive Director for Operations 100 V5tello
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HMSS OPA OGC ADM - SC-RBernero ilDenton WParler PNorry 78 .kjord 0FF:
NAME:
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REGULATORY ANALYSIS 10 CFR PART 35 PALLADIUM-103 FOR INTERSTITIAL TREATMENT OF CANCER
- 1. STATEMENT OF PROBLEM In 10 CFR 35.400, "Use of Sources for Brachytherapy," the }
regulation liste specific radioactive sealed sources that may be used for treatment of cancer in brachytherapy. In December 1988, the NRC received a petition for rulemaking filed by Theragenics Corporation dated November 30, 1988 (docketed PRM-35-7) -to amend 10 CFR 35.400.
The petitioner requested that the NRC amend its regulations '
to add palladium-103 as a scaled source in seede for interstitial treatment of cancer to the list of cources npecified in 10 CFR 35.400. The petitioner stated that,
.nder the present regulation, users of palladium-103 must go through the cumbersome process of amending their licennes before they can use the product and that amending 10 CFR 35.400 would eliminate this cumbersome process.
- 2. OBJECTIVES NBC's objectives are to protect the health and cafety of workers and the public in the licensing of byproduct materiale for medical usee. The State of Georgia performed safety evaluations of the use of palladium-103 and issued a Certificate of Registration. Subsequently, the NRC reviewed the certificate for consistency with other certificates in the Registry of Source and Device Designe and added palladium-103 to the Regietry. This action, in effect, granted a premarketing approval of the source and would permit the une of the source provided that the user's licence was amended to include the source.
- 3. ALTERNATIVES There are only 'wo alternatives: ,
(1) Maintain status quo, i.e., before using palladium-103, a potential user must first apply for and obtain a licence amendment permitting the use; and (2) Amend 10 CFR 35.400 to include palladium-103 an a cealed source in neede for interstitial treatment of cancer.
Enclosure B
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- 4. CONSEQUENCES In terms of the public health and safety, both alternatives would permit the use of palladium-103 an a sealed nource in seeds for brachytherapy, thue, there rould be encentially no difference between the two alternativen.
In termo of coat, alternative 2 would be less burdensome for both the medical une licenseen an 1 the NRC. Alternative 2, if adopted, would eliminate the amendment application proceso for most licenseen who plan to une the sealed uource and the review and approval proceen for the NRC.
- 5. DECISION RAT.IONALE Since Alternative 2 would result in lona burden to the ;
medical use licenaces and the NRC staff while providing the l same level of protection of the public health and safety, the NRC proposes to adopt this alternative. l
- 6. IMPLEMENTATION Implementation involves adding palladium-103 ao a nealed source in needs for interstitial treatment of cancer in 10 i CFR 35.400, j i
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(Identical letters to be sent to other Subcom.mitteco)
The Honorable John B. Breaux, Chairman Subcommittee on Nuclear Regulation Committee on Environment and Public Works
( United States Senate Washington, DC. 20510
Dear Mr. Chairman:
Enclosed ror the information of the subcommittee io a copy of a notice of Proposed Rulemaking to be published in the Federal Register. In response to a petition for rulemaking, the Nucl<ar Regulatory Commission in proposing to amend its regulations to 1 permit the use of palladium-103 an a eealed cource in needo for '
interstitial treatment of cancer.
The proposed rule would reduce the regulatory burden on medical use licenoeen which plan to use the sealed source. l l
The notice will be mailed to medical une licenacon and other )
interested individuale for comment. We expect the medical I community will be very interested in the notice. !
Sincerely, i
Eric S. Deckjord, Director Office of Nuclear regulatory Research
Enclosure:
Federal Reginter notice j i
cc: Senator Alan K. Simpoon I i
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hu:losure C l
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MEMORANDUM FOR: Robert M. Bernero, Director i Office of Nuclear Material Safety and Safeguards Harold R. Denton, Director
['OfficeofGovernmentalandPublicAffairs
{ ,/ William C. Parler, General Counsel Office of the General Counsel
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Patricia G. Norry, Director L Office of Administration FROM: Eric S. Beckjord, Director Office of Nuclear Regulatory Research
SUBJECT:
PROPOSED AMENDMENT TO 10 CFR 35.400: ADDING ;
PALLADIUM-103 FOR INTERSTITIAL TREATMENT OF l CANCER (PRM-35-7) l I
I Please provide office concurrence for the enclosed proposed i rulemaking package in response to a petition for rulemaking !
(PRM-35-7). . This PRM is on fast-track processing; accordingly, I a proposed rulemaking package is due to the EDO on March 9, 1989 (3 months from the docketed date: December 9, 1988).
The following is a summary of this request.
1.
Title:
Palladium-103 for Interstitial Treatment of Cancer.
- 3. Cognizant n iduals:
NHSS: . Baggett, . Howe.
GPA: % Bolling, . Gagner.
OGC:A othschi d.
ADH: .
Lesar. /
- 4. Requested Action: Provide concurrence for your office. l S. Requested Completion Date: February 27, 1989.
- 6.
Background:
A petition for rulemaking (PRM-35-7) requested !
that palladium-103 as a sealed source in seeds be 'added to i the list of brachytherapy sources specified in 10 CFR
- 35.400. ,
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J Staff review of'the petition showed that the addition of palladium-103 to 10 CFR 35.400 would reduce the regulatory burden on medical licensees who plan to use the sealed source. Thus, as compared to the current practice, the proposed change would reduce the burden for both medical licensees and the NRC staff while providing the same level of protection of the public health and safety.
Comments were requested previously on the draft Federal Register notice from the cognizant individuals in HMSS, GPA, OGC, and ADM. Appropriate comments were incorporated.
Originnt signed By Themis P. Speis ric S. Beckjord, Director Office of Nuclear Regulatory Research
Enclosures:
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Memo to Stello Encle. to the Memo A. FR Notice .
B. Regulatory Analysis C. Draft Congressional letter D. Draft Daily Staff Notes Item cc (w/encle.):
Cognizant individuals DISTRIBUTION: (w/encle.) -
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