ML18275A420
| ML18275A420 | |
| Person / Time | |
|---|---|
| Issue date: | 10/15/2018 |
| From: | Dan Collins NRC/NMSS/DMSST |
| To: | |
| Ayoade Maryann | |
| References | |
| Download: ML18275A420 (3) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 October 15, 2018 ALL NRC MEDICAL USE, COMMERCIAL NUCLEAR PHARMACY, AND MASTER MATERIALS LICENSE LICENSEES NOTIFICATION OF PUBLIC MEETINGS ON THE FINAL 10 CFR PARTS 30, 32, AND 35 RULE
Purpose:
To inform the U.S. Nuclear Regulatory Commission (NRC) licensees, Master Materials License Licensees (MMLs), and MML Permittees that the NRC staff plans to have public meetings on the final Title 10 of the Code of Federal Regulations (CFR )
Parts 30, 32, and 35 rule, Medical use of Byproduct Material-Medical Event Definitions, Training and Experience, and clarifying Amendments, effective January 14, 2019. These public meetings are scheduled for November 8, December 4, and December 6, 2018.
Background:
The NRC published revisions to the regulations in 10 CFR Parts 30, 32, and 35 for drug manufacturers, commercial nuclear pharmacies, and medical use licensees on July 16, 2018, in the Federal Register (83 FR 33046). The final rule can be found in the NRC Medical Uses Licensee Toolkit (Toolkit) (https://www.nrc.gov/materials/miau/med-use-toolkit.html) under Regulations or in the Federal Register (https://www.gpo.gov/fdsys/pkg/FR-2018 16/pdf/2018-14852.pdf). The accompanying final guidance is also available in the Toolkit under Guidance.
Discussion: The NRC is conducting these public meetings to provide information on the changes to the regulations. The final rule includes changes in the following eleven broad categories:
Generators Diagnostic medical uses Associate Radiation Safety Officer and 10 CFR 35.300 Radiopharmaceuticals Ophthalmic Physicist Emerging Technologies Sealed Source and Device Registry Notification Vendor Training Manual Brachytherapy Gamma Knife Source Exchange Training and Experience The public meetings on The final 10 CFR Parts 30, 32, and 35 rule, will be conducted via the webinar and the presentation slides from the meetings will be available on the Toolkit under Guidance. The meetings are scheduled for November 8, December 4, and December 6, 2018, from 10:00 a.m. - 3:00 p.m. (Eastern Time). Participants must register in advance of the webinar at the following link: https://attendee.gotowebinar.com/rt/1752824238652822018.
If you have any questions regarding this correspondence, please contact me at 301-415-3340 or the individuals named below:
POINT OF CONTACT: Donna-Beth Howe Maryann Ayoade E-MAIL: Donna-Beth.Howe@nrc.gov Maryann.Ayoade@nrc.gov TELEPHONE: (301) 415-5441 or (301) 415-0862
/RA/
Daniel S. Collins, Director Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguard
ALL NRC MEDICAL USE, COMMERCIAL NUCLEAR PHARMACY, AND MASTER MATERIALS LICENSE LICENSEES DATED OCTOBER 15, 2018 ML18275A420 OFFICE NMSS/MSEB NMSS/MSEB NMSS/MSEB NMSS/MSST NAME MAyoade LDimmick DBollock DSCollins DATE 10/5/18 10/5/18 10/2/18 10/15/18 OFFICIAL RECORD COPY