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
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; ; UNITED STATES l
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! NUCLEAR REGULATORY COMMISSION 41319
/ WASHINGTON. D.C. 23555 Vol. 54. No.190 l I
""asday, ct ber 12.1989 11/3/89 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, *'
- l Federal Register notice on Pd-103 source. ,,,,,,,,,,,,,,,,,,,,,7,,,; j
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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 I Branch petitioner requeste ' ' hat the NRC l amend its regulations to add palladium- l 103 as a sealed source in seeds for the I 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 HERBERT W. MOWER, Sc. D.
* "EE stNion aAoiaTeoN P+4vsicisT
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In supporting the petition, the i petitioner submitted several documents, l including a letter from the FDA, a safety i Danbury Hospital D The Community Health Cente, evaluation report from the State of Georgia, the package insett, and product i 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 I controls, that is, registration and good manufacturing practices. Class H i devices require performance standart!s l 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). Tecal Arnendment l 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. 16(f).16A.17,49 Stat.163 as amended (16 radiation safety properties of palladium-l 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 THOMPSON 98-86 PDR ; t .l}}