ML20009C051
| ML20009C051 | |
| Person / Time | |
|---|---|
| Issue date: | 01/15/2020 |
| From: | Christian Einberg, Christian Einberg NRC/NMSS/DMSST/MSEB |
| To: | Mary Muessle, David Pelton, James Trapp NRC Region 1, NRC/RGN-III, NRC Region 4 |
| Howe D | |
| Shared Package | |
| ML20009C048 | List: |
| References | |
| Download: ML20009C051 (3) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 January 15, 2020 MEMORANDUM TO:
James M. Trapp, Director Division of Nuclear Materials Safety Region I David L. Pelton, Director Division of Nuclear Materials Safety Region III Mary C. Muessle, Director Division of Nuclear Materials Safety Region IV FROM:
Christian E. Einberg, Chief
/RA/
Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State and Tribal Programs Office of Nuclear Material Safety and Safeguards
SUBJECT:
PUBLICATION OF REVISION 1, NORTHSTAR MEDICAL RADIOISOTOPES LLC, RADIOGENIX' MOLYBDENUM-99/
TECHNETIUM-99M GENERATOR SYSTEM LICENSING GUIDANCE FOR MEDICAL USE LICENSEES, MEDICAL USE PERMITTEES AND COMMERCIAL NUCLEAR PHARMACIES On February 2018, the U.S. Food and Drug Administration approved the NorthStar Medical Radioisotopes, LLC, RadioGenix' Molybdenum-99/Technetium-99m Generator System (hereafter the RadioGenix' System), and the U.S. Nuclear Regulatory Commission (NRC) published the licensing guidance for the RadioGenix' System models 1.0a and 1.1. The guidance document provided applicants with one acceptable means of satisfying the requirements for a license for the use of the RadioGenix' System models 1.0a and 1.1.
Subsequently, NorthStar Medical Radioisotopes, LLC, developed the RadioGenix' System Model 1.2 which contains hardware, software and firmware changes that require additional training, operational changes and safety procedures. As a result, a working group consisting, of NRC and Agreement State staff developed revision 1 of the licensing guidance.
CONTACT: Donna-Beth Howe, NMSS/MSST 301-415-5441
J. Trapp, et al.
2 Enclosed is revision 1 of the RadioGenix' System licensing guidance. The major changes to the guidance are: 1) the inclusion of the model designations when applying for a license but not listing the model number on the license; 2) use of the Safety Evaluation Report (SER) to include information on new models, including a table in the SER describing the specific model number with its required training and experience and the appropriate version of the licensing guidance for that model; 3) revision of the training and experience section of the licensing guidance to clarify the type of training needed to use and operate both the current and future models;
- 4) adding new optional programs that the applicant can apply for and receive authorization for without future amendments; 5) restructuring of the guidance to move the optional programs (e.g., Sections 7.4 and 7.5 in the original guidance) into Sections 7 and 8 of the commitment sections of the guidance; 6) adding new license conditions; and 7) clarifying when the authorizations are listed on the license and when the commitments are included in the tie down conditions of the license.
The guidance continues to include standard language and formatting developed by the NRCs Medical Radiation Safety Team for all emerging technology licensing guidance documents (e.g, cover page; table of contents; document revision date; page numbers; example license language for radionuclide, form, possession limits, and purpose of use).
The guidance document will be posted on NRCs public Web site at:
https://www.nrc.gov/materials/miau/med-use-toolkit/emerg-licensed-med-tech.html. The SER can be accessed through the NRCs Sealed Source and Device Registry home page at:
(https://scp.nrc.gov/ssdr.html). If you have any questions, please contact me at 301-415-5422, or Donna-Beth Howe of my staff at (301) 415-5441 or donna-beth.howe@nrc.gov.
Enclosure:
Revision 1, NorthStar Medical Radioisotopes LLC, Radiogenix' Molybdenum-99/
Technetium-99m Generator System
ML20009C048 (Pkg)
- via email OFFICE MSST MSST OGC NLO*
NAME DBHowe CEinberg A Gindelman DATE 11/21/2019 1/15/2020 11/21/2019