ML20217Q269
| ML20217Q269 | |
| Person / Time | |
|---|---|
| Issue date: | 11/03/1989 |
| From: | Tse A NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| To: | Mower H DANBURY HOSP., DANBURY, CT |
| Shared Package | |
| ML20217P754 | List: |
| References | |
| FOIA-98-86, RULE-PRM-35-7 NUDOCS 9804100367 | |
| Download: ML20217Q269 (1) | |
Text
{{#Wiki_filter:- ~ _ I s** M% UNITED STATES l 5 NUCLEAR REGULATORY COMMISSION 41319 / WASHINGTON. D.C. 23555 Vol. 54. No.190 l 11/3/89 ""asday, ct ber 12.1989 FOR FURTHER INFORMATION CONTACT: 1
Dear Dr. Mower:
Dr. Anthony N.Tse, Office of Nuclear Regulatory Research, U.S. Nuclear Per your request, enclosed is a copy of the 20sss,"te[pN $'N)46247N, *'
- Federal Register notice on Pd-103 source.
j ,,,,,,,,,,,,,,,,,,,,,7,,,; ) Petition for Rulemaking On November 30,1988, Theragenics Corporation submitted a petition for .A. Tse rulemaking.PRM45-7 which was l Regulation Deyelopment docketed on December 9,1988.%e Branch petitioner requeste ' ' hat the NRC l amend its regulations to add palladium-l 103 as a sealed source in seeds for the interstitial treatment of cancer to the list ) of sealed sources currently permitted in { 10 CFR 35.400 for use in brachytherapy. He petitioner stated that, under current NRC regulations, licensees who are users of palladium-103 must go through the cumbersome process of having their licenses amended before using the product and that amending to CFR "EE HERBERT W. MOWER, Sc. D. " ** P"' stNion aAoiaTeoN P+4vsicisT In supporting the petition, the i petitioner submitted several documents, D The Community Health Cente, including a letter from the FDA, a safety i Danbury Hospital evaluation report from the State of i' Georgia, the package insett, and product literature. Danbury. Connecticut 06810 T* G03i 7s7-7629 The letter from the FDA stated that, under section 510(L) of the Federal Food. Drug, and Cosmetic Act, as amended, l 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 euch time as the device has been classified as either a Class 1. II, or III device under section 513. Class I devices require general controls, that is, registration and good manufacturing practices. Class H i devices require performance standart!s in addition to general controls. Class IU devices require prior FDA approval of a l tu.wn; as rouno m tne catalog or use panamum-sus a ms amenumem. Pre-Market Approval application, Federal Domestic Assistance. prcmulgated in response to a petition for performance standards, and general rulemaking (PRM-35-7), will reduce the controls. In January 1988 (53 FR 1554). l Tecal Arnendment regulatory burden on medical use FDA classified radionuclide Accordingly,7 CFR Part 710 is licensees who plan to use the sealed brachytherapy sources as Class II amended to read as follows: source. An evaluation of the potential devices.This permits Theregenics to radiation hazards to hospital personnel continue marketing the palladium-103 FART 701--{ AMENDED) and the public showed that there would seeds.
- 1. The authority citation for part 701 be minimal risk if the sealed source is In March 1986. Theregenics. an continues to read as follows:
used in accordance with the " Agreement State" licensee of the State manufacturer's radiation aafety and of Georgia, submitted information on the f Authority: Pub. L 7+-76, secs. 5,7-15.16(a), handling instructions. radiation safety properties of palladium-l 16(f).16A.17,49 Stat.163 as amended (16 U.S.C. 590d. 590g-5900. 690p(a). 590q: Pub.l EFFECTIVE DATE: October 12,1989. 103 to Georgia in orde to obtain a 9804100367 980407 ? J PDR FOIA .l l THOMPSON 98-86 PDR ; t}}