ML20217P836
| ML20217P836 | |
| Person / Time | |
|---|---|
| Issue date: | 01/19/1989 |
| From: | Tse A NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| To: | Steven Baggett, Donna-Beth Howe, Rothschild M 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 9804100206 | |
| Download: ML20217P836 (7) | |
Text
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[, g NUCLEAR REGULATORY COMMISSION D ;j WASHINGTON, D. C. 205b5
\*****/ JAN 1 S 1983 MEMORANDUM FOR:
Marjorie U. Rothschild, OGC Lloyd A. Bolling, GPA Mike Lesar, ARM FRON: Anthony Tse., RDB, DRA, RES
SUBJECT:
DRAFT PROPOSED RULE: PALLADIUM-103 FOR BRACHYTHERAPY Enclosed for your review and coment is a draft proposed rule in response to PRM-35-7. Please let me know your coments by 1/24/89.
Because this is a fast-track processing, the proposed rule should reach EDO no later than 3/9/89 (3 months from the docketed date,12/9/86). After I incorporate your coments, this rulemaking package will be forwarded to your office by the end of January 1989 for office concurrence.
l Also, I am enclosing a copy of the petition (w/o enclosures) for your i information. j If you have any questions please call me at X23797.
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Anthony Tfe Regulation Development Branch Division of Regulatory Applications Office of Nuclear Regulatory Research
Enclosures:
- 1. Draft FR Notice
- 2. PRM-35-7 l !
9804100206 980407 ic PDR FOIA THOMPSON 98-86 PDR I
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NUCLEAR REGULATORY COMMISSION -
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10 CFR Part 35 Palladium-103 for Interstitial Treatment of Cancer AGENCY: Nuclear Regulatory Commission ACTION: Proposed rul,e s
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SUMMARY
- The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations governing the medical ,
uses of byproduct material. The proposed regulation would add Palladium-103 sealed source as seeds to the list of sources permitted in 10 CFR Part 35 for use in cancer treatment. Under current NRC regulations, users must have .
their licenses amended before they may use palladium seeds '
in brachytherapy. The proposed rule, developed in response to a petition for rulemaking (PRM-35-7), would allow the use of Palladium-103 seeds by each potential user (abvut 700 licensees) without requiring a license nmondment.
Evaluation of potential radiation hazards to patient and hospital personnel showed minimal risk if the seeds are used in accordance with the manufacturer's radiation safety and handling Jnstructions.
DATE: Comment period expires (30 days from the date of publication in the Federal Register). Comments received after this date will be considered if it is practical to do so, but assurance of consideration cannot be given except as to comments received on or before this date.
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l ADDRESSES: Mail written comments to: Secretary, U.S.
Nuclear Regulatory Commission, Washington, DC 20555, Attention: Docketing and Service Branch. Deliver comments 1 to One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852, between 7:30 a.m. and 4:15 p.m. weekdays.
FOR FURTHER INFORMATION CONTACT: Dr. Anthony N. Tse, Office ;
of Nuclear Regulatory Research, U.S. Nuclear regulatory Commission, Waehington, DC 20555, telephone: (301)492-3797.
. SUPPLEMENTARY INFORMATION:
Petition for Rulemaking On November 30, 1988, Theragenics Corporation submitted a petition for rulemaking which was docketed PRM-35-7 on December 9, 1988. The petitioner requests that the NRC amend its regulations to add Palladium-103 sealed source as seeds for interstitial treatment of cancer to the list of sources permitted in Section 35.400 of 10 CFR Part 35 for use in brachytherapy. A copy of the petition may be obtained from the Regulatory Publications Branch, Division of Freedom of Information and Publications Services, U.S.
Nuclear Regulatory Commission, Washington, DC 20555.
The petitioner stated that the Palladium-103 sealed source as seeds are permitted to be marketed by the Food and Drug Administration (FDA) of the Department of Health and Human Services. JLxwevet, Qnder the present NRC regulations, users of palladium-103 seeds must go through the cumbersome
- l. process of having their licenses amended before they can use the product. Amending 10 CFR Part 35 as recommended in the s ins au<3 .c e petition woul4 eliminate thre eu;bor .me amendment process for both Thcrage. nice Corporation and the user.
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In supporting the petition, the petitioner submitted >
ceveral documents, including a letter from the FDA, safety _,
evaluation report from the State of Georgia, package insert, and product literature.
The letter from the FDA stated that, under Section 510
-(k), market of the device (Palladium-103 seeds) would be permitted subject to the general controls provisions of the Federal _ Food, Drug, and Cosmetic Act until such time as the device has been classified under Section 513.
The safety evaluation report from the State of Georgia's Radiological Health Section of the Georgia Department of Human Recources provided radiatior safety analyses
-concerning the use of Palladium-103 seeds. The State agency approved the use of the sealed source for interstitial cancer treatment. The evaluation examined various safety
, aspects such as prototype testing, conditions for normal use, labeling, external radiation levels, quality assurance and control. Additional limitat' ns and conditions of use are also specified in the safete - luation report. l I
Following the safety.evaluat;0u yerformed by the State of l Georgia, the NRC staff has verified Georgia's evaluation and I determined that the Palladium-103 seeds present minimal risk for use in brachytherapy and that the benefit outweigh the risk. Therefore, the NRC staff added Palladium-103 seeds to l the Registry of Radioactive Sealed Sources and Devices in
, 198__ (S. Baggett of HMSS will fill in the date) ;
and would permit the use of the seeds provided that the user's license is amended to include Palladium-103.
Conclusion ,
. The NRC has examined the petition and supporting i
information and proposes to grant the petition,. The 3
N addition of Palladium-103 sealed source as seeds to the list of sealed sources specified in Section 35.400 of 10 CFR Part 35 would not cause additional risk to patients and hospital personnel, but it would reduce burdens to the users as well e, %
as NRC staff; users (potentially abo.ut 700) would,sn ot have e wm sonma - e omem. ,cpen to submit license amendments to the NRCgand The NRC staff , ,. t ,, , e .u .J,.
uc? d .ct-have-te evaluate,and approve the 4 amendmentg.
seckon $44b0.
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Environmental Impact: Categorical Exclusion The NRC has determined that this proposed regulation is the type of action described in 10 CFR 51.22(c)(2)(i).
Therefore, neither an environmental impact statement nor an environmental assessment has been orepared for this proposed regulation.
Paperwork Reduction Act Statement This proposed rule does not contain a new or amended information collection requirement subject to the P,iperwork Reduction Act of 1980 (U.S.C. 3501 et seq.). Existing requirements were appenved by the Office of Management and Budget approval number 3160-0010.
Regulatory analysis The NRC has prepared a draft regulatory analysis on this I
proposed regulation. The analysis examines the costs and benefits of the alternatives considered by the NRC. The draft analysis is available for inspection in the NRC Public Document-Room, 2120 L Street, Lower Level, Washington, DC.
I Single copies of the analysis may be obtained from Dr. Anthony N. Tse (See FOR FURTHER INFORMATION CONTACT heading).
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-The NRC' requests public-comments'on the draft regulatory analysis. . Comments on the draft analysis may be' submitted
~ to the NRC (See: ADDRESSES heading) .
Regulatory: Flexibility Certification l As required by the'3egulatory Flexibility'Act'of 1980, 5 L <U.S.C. 605(b), the Commission certifies thatLthis rule, if adopted, will not have a.significant economic impact on a
. substantial number of small entities. The proposed rule.
Ly _ would permit the use of Palladiur-103 sealed source as reeds without requiring each user.to submitt-a license amendment.
.The NRC has adopted size standards that: classify a' hospital as a.smal' entity if its annual gr,ss recairts.do not: exceed
$3.5 million, and a private..prac'tice physician as a small entity if the physician's annual gross receipts are $1.0 l million'or less. Although some NRC medical licensees /could
- l. Lbe. considered "small entities," the number that would' fall
.into this. category does not constitute a' substantial number for purposes of the Regulatory flexibility Act.
I-The purpose of the proposed regulation is to add Palladium-103 sealed source as seeds to a list of otSer radioactive sources specified in Section?35.400.of *.0 CFR Part 35 for brachytnerapy. This would benefit potential F . users.of Palladium-103 seeds that they may use the seeds j without'the burden of submitting a: license amendment:to the !
NRC.for-approval.
.Backfit Analysis l
The NRC.has determined that a backfit an'alysis is not l
. required for this proposed regulation-because these amendments do not apply to 30 CFR Part 50 licensees. l
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