ML20217A664
| ML20217A664 | |
| Person / Time | |
|---|---|
| Issue date: | 04/16/1998 |
| From: | Cool D NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Magnuson D AFFILIATION NOT ASSIGNED |
| Shared Package | |
| ML20217A669 | List: |
| References | |
| NUDOCS 9804220307 | |
| Download: ML20217A664 (1) | |
Text
_..... _..,....
+u-P '"'d M:gnuson, Phsrm.C a
D'
.or, MIdical Inform: tion and Safsty
(~,ter Pharmaceutical 550 California Ave.,
Suite 200 Palo Alto, CA 94306-1440
Dear Dr. Magnuson:
I am responding to your letter dated March 10,1998, in which you requested a technical review of the document entitled " Criteria for Release of lodine-131 Anti-B1 Antibody Patients." The U.S. Nuclear Regulatory Commission (NRC) does not validate or endorse documents such as you have provided on a generic basis. Therefore, we have not conducted the requested technical review of the document.
If NRC licenseer choose to use this document, they would have to demonstrate compliance with the regulations during NRC inspections. NRC inspectors conduct performance-based inspections in this area whereby they wnuld ask the licensee to describe how they demonstrate compliance with the dose limit in 10 CFR 35.75(af, review a sample of instructions provided, and review a sample of records maintained pursuant to 10 CFR 35.75(c). The NRC issued Regulatory Guide 8.39, " Release of Patients Administered Radioactive Materials," (enclosed) to provide guidance to licensees for compliance with 10 CFR 35.75. This guidance provides options for licensees to use to release patients administered radiopharmaceuticals or permanent implants containing radioactive material in accordance with regulatory requirements.
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These options include release of patients based on patient-specific dose calculations.
Individual licensees could propose the methodology you have developed to the NRC for review on a case-by-case basis.
If you have further questions, please contact Dr. Patricia Holahan of my staff at (301) 415-8125.
Sincerely, (orig. signed by)
Donald A. Cool, Director Division of Industrial and Medical Nuclear Safaty
@3p 9804220307 980416 Office of Nuclear Material Safety PDR ORG NOMApg and Safeguards I, - h - f
Enclosure:
As stated AC /)/ cab N C FRF CENER CDPF""
DISTRIBUTION:IMNS-6079 NRC Central File IMNS r/f NMSS r/f PDR: YES.S NO
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