IR 05000351/2023001
| ML18130A693 | |
| Person / Time | |
|---|---|
| Site: | 05000351, 03038705 |
| Issue date: | 05/10/2018 |
| From: | Cook J D NRC Region 4 |
| To: | Harmon J Alaska Cancer Treatment Center |
| References | |
| 602569 | |
| Download: ML18130A693 (2) | |
Text
EMA I L Name: Organization:
Phone: E-mail Address: From: Date: Subject: Pages: Dr. Harmon: UNITED STATES NUCLEAR REGULATORY COMMISSION REGION IV 1600 EAST LAMAR BLVD ARLINGTON, TEXAS 76011-4511 Joseph Harmon, Ph.D., DABR Alaska Cancer Treatment Center 907-276-2803 fharmon@akmed
.co m Jacqueline D. Cook May 10, 2018 License: 50-35123-01 Docket: 030-38705 Control: 602569 Letter dated February 22, 2018 for License Amendment 2 Per your letter dated February 22, 2018, the item on the next page is a deficiency which requires your respons Please respond to this e-mail by Wednesday, May 23, 2018. Our fax number is (817) 200-1263. Please provide a response in a signed and dated letter in pdfformat when responding via ema il. My email address is Jackie.Cook@nrc.go When responding to this e-mai l , please include the l icense, docket, and control numbers located at the top of this page. Thanking you in advance for your cooperation, assistance, and prompt response in this matter. IRA/ Jacqueline D. Cook Senior Health Physicist NON-Puauc O A.3 Se nsitivr-S , . , 0 0 A.7 Sensit ive In t.r r :IJhd Other: * ' ' "-'-=.ij -Date:~ I o l I K J. Harmon, Ph.D. -2-1. Although you are asking to include authorization for 10 GFR 35.100, "Use of unsealed byproduct material for uptake, dilution, and excretion studies for which a written directive is not required" (https://www.nrc.gov/reading-rm/doc-collections/cfr/part035/part035- 0100.html), page 2 of Regulatory Issue Summary (RIS) 2008-31 states that in the case of sentinel lymph node (SLN) procedures, the administered Tc-99m is regulated under 10 GFR 35.200, "Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required." (
collections/
cfr/part035/pa rt035-020 htm I). 2. 3. Please clarify this discrepancy. In order to add a new modality (10 GFR 35.100 and/or 10 GFR 35.200 authorization), please use the licensing guidance in NUREG-1556, Volume 9, Revision 2, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses, (https://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/v9/r2/) specifically Table G.1, Applicability Table and Tables G.2 and G.3, Items 5 and 6 on NRG Form 313: Radioactive Material and Use; Items 7 through 11 on NRG Form 313: Training & Experience, Facilities
& Equipment, Radiation Protection Program, and Waste Disposa Please note that the training and experience (T&E) regulations for 10 GFR 35.200 material authorization can be found in 10 GFR 35.290 (
rm/doc-collections/cfr/part035/part035-0290
.html). It appears that your requested proposed authorized user, Dr. Mary Jo Wright, i s authori z ed for 10 GFR 35.100 material (uptake, dilution, and excretion studies).
Please demonstrate Dr. Wright's T&E for 10 GFR 35.200 material by either submitting a copy of her board certification, an NRG or Agreement State license she is listed on as an authorized user for imaging and localization studies, or follow the alternate pathway outlined in 10 GFR 35.290. In addition, please feel free to utilize NRG Form 313A(AUD)
(https://www.nrc.gov/reading-rm/doc-collections/forms/nrc313a(aud
). pdf) to demonstrate Dr. Wright's T&E.