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NRC RIN: 3150-AI63 Publication ID: Fall 2016 
Title: Medical Use of Byproduct Material--Medical Event Definitions, Training and Experience, and Clarifying Amendments [NRC-2008-0175] 

The final rule would amend the Commission's medical use regulations in part 35. The final rule addresses three ongoing rulemaking projects and several other related topics. First, this rule amends the reporting and notification requirements for a medical event for permanent implant brachytherapy. Second, the rule would amend: 1) The training and experience (T&E) requirement for a written attestation statement for an individual who is certified by a recognized specialty board; requirements for authorized users, medical physicists, Radiation Safety Officers, and nuclear pharmacists; 2) the requirements for measuring molybdenum contamination and reporting of failed technetium and rubidium generators; and 3) allows Associate Radiation Safety Officers to be named on a medical license. Third, the rule makes changes to address a request filed in a petition for rulemaking (PRM-35-20) to exempt certain board-certified individuals from certain T&E requirements (i.e., "grandfather" these individuals) so that they may be identified on a license or permit for materials and uses that they performed on or before October 24, 2005, the expiration date of the former subpart J of part 35 which contained the prior T&E requirements.



Agency: Nuclear Regulatory Commission(NRC)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 10 CFR 35   
Legal Authority: 42 U.S.C. 2201    42 U.S.C. 5841   
Legal Deadline:  None
Action Date FR Cite
NPRM  07/21/2014  79 FR 42410   
NPRM Comment Period End  11/18/2014 
Final Rule  12/00/2016 
Additional Information: The NRC received 69 comment letters containing over a hundred individual comments. The commenters included several medical professional societies including the American Brachytherapy Society, American College of Radiology, Health Physics Society, American Society for Radiation Oncology, American Association of Physicists in Medicine, Council on Radionuclides and Radiopharmaceuticals, the Organization of the Agreement States, the Conference of Radiation Control Program Directors, individual States, practicing physicians, medical physicists, radiation safety officers, nuclear pharmacists, individual members of the public, and a member of the Congress.
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No 
Included in the Regulatory Plan: No 
RIN Information URL: (search for Docket ID NRC-2008-0175)   Public Comment URL: (search for Docket ID NRC-2008-0175)  
RIN Data Printed in the FR: No 
Related RINs: Merged with 3150-AI26 
Agency Contact:
Torre Taylor
Nuclear Regulatory Commission
Office of Nuclear Material Safety and Safeguards,
Washington, DC 20555-0001
Phone:301 415-7900