Training and Experience (T&E) Evaluation

On August 17, 2017, the U.S. Nuclear Regulatory Commission (NRC) issued a Staff Requirements Memorandum (SRM) SRM-M170817 approving the final rule revising 10 CFR Part 35 and directing staff to evaluate: (1) Whether it makes sense to establish tailored training and experience (T&E) requirements for different categories of radiopharmaceuticals; (2) How those categories should be determined (such as by risks posed by groups of radionuclides or by delivery method); (3) What the appropriate T&E requirements would be for each category; and (4) Whether those requirements should be based on hours of T&E or focused more on competency. In response to the SRM, the NRC staff documented its initial results, status, and next steps related to this evaluation in SECY-18-0084, "Staff Evaluation of Training and Experience Requirements for Administering Different Categories of Radiopharmaceuticals in Response to SRM-M170817." In SECY-18-0084, the staff concluded that additional outreach with the medical community was needed.

The staff's final SECY paper documenting feedback from the medical community, the Agreement States, and the Advisory Committee on the Medical Uses of Isotopes, and the staff’s evaluation of the T&E requirements, was provided to the Commission for their consideration on January 14, 2020, and is available at SECY-20-0005, "Rulemaking Plan for Training and Experience Requirements for Unsealed Byproduct Material (10 CFR Part 35)." On January 27, 2022, the Commission issued a decision on the staff’s rulemaking plan in SECY-20-0005.  In SRM-SECY-20-0005, the Commission approved Option 1, which maintains the NRC’s current training and experience requirements for use of unsealed byproduct material in 10 CFR Part 35.  Also in this SRM the Commission directed the staff to obtain stakeholder comments on T&E requirements for emerging medical technologies, as part of the approved rulemaking plan for updating 10 CFR Part 35 to establish requirements for rubidium-82 generators and emerging medical technologies (SECY-21-0013). For more information on the staff's evaluation of the T&E requirements, please see the following topics on this page:

• Public Involvement
• Schedule

Public Involvement

On October 29, 2018, the NRC published an initial notice in the Federal Register (83 FR 54380) requesting comments on its evaluation of the T&E requirements for all the medical uses authorized under 10 CFR 35.300, "Use of unsealed byproduct material for which a written directive is required." Publication of the Federal Register notice opened a three-month public comment period that closed on Tuesday, January 29, 2019. Comments submitted to the NRC during the comment period can be viewed on Regulations.gov, the Federal rulemaking Web site. The NRC held four public meetings during this initial comment period.

On May 2, 2019, the NRC published a second Federal Register notice (84 FR 18874) requesting comments on the staff's draft approaches regarding the T&E requirements for radiopharmaceuticals requiring a written directive. The public comment period was originally scheduled to close on June 3, 2019. However, the NRC extended the public comment period to July 3, 2019 in response to several extension requests. Written comments must be submitted via Regulations.gov by the close date of July 3, 2019. The NRC held two public meetings during this second comment period.

Details for all six public meetings, including meeting summaries, transcripts, and slides, are included in the table below.

In addition to obtaining feedback in the form of public comments, the NRC staff has coordinated with the Advisory Committee on the Medical Uses of Isotopes (ACMUI) in an open and transparent manner. The ACMUI meeting minutes, as well as information on how to participate in these meetings, are maintained on the NRC public website to ensure availability to the medical community and the public. Public teleconference summaries and reports of the Training and Experience For All Modalities Subcommittee—a subcommittee of the ACMUI specifically formed to address issues on these topics—are also included in the table below.

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Schedule

The following table summarizes key milestones in the schedule for the NRC staff's evaluation of training and experience, with links to the related documents.