ML18130A693
| ML18130A693 | |
| Person / Time | |
|---|---|
| Site: | 03038705 |
| Issue date: | 05/10/2018 |
| From: | Jackie Cook NRC Region 4 |
| To: | Harmon J Alaska Cancer Treatment Center |
| References | |
| 602569 | |
| Download: ML18130A693 (2) | |
See also: IR 05000351/2023001
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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.com
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 response. 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 email. My email address is Jackie.Cook@nrc.gov. When responding to
this e-mail, please include the license, 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
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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." (https://www.nrc.gov/reading-rm/doc-
collections/ cfr/part035/pa rt035-0200. 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
Disposal.
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 (https://www.nrc.gov/reading-
rm/doc-collections/cfr/part035/part035-0290.html).
It appears that your requested proposed authorized user, Dr. Mary Jo Wright, is
authorized 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.