ML20217B904

Discusses Petition for Rulemaking PRM-35-7 Filed by Theragenics Corp.Petition Requests Commission to Amend Regulations Re Medical Use of Byproduct Matls 10CFR35.400 to Add Pd-103 as Sealed Source for Treatment of Cancer

ML20217B904
Person / Time
Issue date:	01/09/1989
From:	Beckjord E NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES)
To:	Mcdonald W NRC OFFICE OF ADMINISTRATION & RESOURCES MANAGEMENT (ARM)
Shared Package
ML20217B758	List: ML20217B753 ML20217B810 ML20217B833 ML20217B866 ML20217B872 ML20217B904
References
FOIA-98-86, RULE-PRM-35-7 NUDOCS 9804230154
Download: ML20217B904 (1)

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C MEMORANDUM FOR: William G. Mcdonald, Director, Office of Administration i; _

and Resources Management k (W). ;

Eric S. Beckjord, Director, Office of Nuclear Regulatory FROM:

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SUBJECT:

PETITION FOR RULEMAKING (PRM FILED BY THERAGENICS

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CORPORATION t

c' We have reviewed the subject petition and determined that this petition does 6

qualify for special fast-track processing.

The petition requests that the Commission amend its regulations concerning the medical use of byproduct material, 10 CFR 35.400, to add Palladium-103 as a sealed source in seeds for interstitial treatment of cancer to the list of sources approved for use in brachytherapy. The petitioner requests this amendment so that each potential user of the sealed source would not have to obtain a license amendment permitting use of the scaled source.

The changes advocated in the petition are of a nonpolicy nature and would not substantially modify existing regulations. Furthermore, the changes advocated in the petition are a minor safety or environmental issue, are clearly meritorious, and would increase NRC staff efficiency by reducing the number of applications for individual license amendment. Hence, this petition does qualify for special handling as a fast-track petition according to Section 11.7(c) of the NRC Regulations Handbook, NUREG/BR-0053 Ac:ordingly, the draft Federal Register notice will not be required.

This petition will be assigned to Dr. Anthony H. Tse of the Regulation Development Branch.

Eric S. Beckjord, Director Office of Nuclear Regulatory Research Distribution: [PETITIONFORRULEPRM357]

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