United States Nuclear Regulatory Commission - Protecting People and the Environment

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, will be provided to the Commission for their consideration in late December, and will be publicly available in January 2020. For more information, please see the following topics on this page:

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.

The following links to non-NRC servers and websites are provided solely as a reference for the convenience of users. NRC cannot guarantee the authenticity of documents or the validity of information obtained at these non-NRC websites. See our Site Disclaimer for more information.

Public Meeting Date and Time Participation Information Related Documents
November 14, 2018 Webinar Meeting Summary
Meeting Transcript
Public Meeting Notice
November 14 Slide Presentation

December 11, 2018 Webinar and In-Person Meeting Meeting Summary
Meeting Transcript
December 11 Slide Presentation
Public Meeting Notice
January 10, 2019 Webinar and In-Person Meeting Meeting Summary
Meeting Transcript
January 10 Slide Presentation
Public Meeting Notice
January 22, 2019 Webinar Meeting Summary
Meeting Transcript
January 22 Slide Presentation
Public Meeting Notice
February 26, 2019 ACMUI Public Teleconference on the T&E Subcommittee Report Training and Experience (T&E) for All Modalities
Subcommittee - Final Report

Meeting Summary
Meeting Transcript
May 14, 2019 Webinar and In-Person Meeting Meeting Slides
Meeting Summary
Meeting Transcript
Draft Approaches Federal Register Notice
Public Meeting Notice
May 23, 2019 Webinar Meeting Slides
Meeting Summary
Meeting Transcript
Draft Approaches Federal Register Notice
Public Meeting Notice
October 18, 2019 ACMUI Public Teleconference on the NRC staff's draft T&E Commission Paper Training and Experience (T&E) for All Modalities Subcommittee - Final Report on Staff’s Draft T&E SECY
Meeting Summary
Meeting Transcript

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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.

The following links to non-NRC servers and websites are provided solely as a reference for the convenience of users. NRC cannot guarantee the authenticity of documents or the validity of information obtained at these non-NRC websites. See our Site Disclaimer for more information.

Key Milestones Date Related Documents
Staff Requirements Memorandum (SRM) SRM-M170817 published August 17, 2017 SRM-M170817
Information paper SECY-18-0084 published August 28, 2018 SECY-18-0084
Attend the American Society for Radiation Oncology (ASTRO) 2018 Annual Meeting October 21 – 24, 2018 Meeting Poster

Meeting Handout
Federal Register notice published and three-month comment period begins October 29, 2018 83 FR 54380
Webinar November 14, 2018 Meeting Summary
Webinar and Public Meeting in the Commission Hearing Room at NRC Headquarters December 11, 2018 Meeting Summary
Webinar and Public Meeting in the Three White Flint Building at NRC Headquarters January 10, 2019 Meeting Summary
Attend the Society for Nuclear Medicine and Molecular Imaging (SNMMI) 2019 Mid-Winter Meeting January 17 – 19, 2019 Meeting Poster
Meeting Handout
Webinar January 22, 2019 Meeting Summary
Federal Register notice comment period closes January 29, 2019 83 FR 54380
Docket NRC-2018-0230
Public Teleconference on the ACMUI T&E Subcommittee Report February 26, 2019 Training and Experience (T&E) for All Modalities Subcommittee – Final Report
Meeting Summary
Meeting Transcript
Federal Register notice published on staff's draft approaches and 30-day comment period begins May 2, 2019 84 FR 18874
Docket NRC-2018-0230
Webinar and Public Meeting in the Commission Hearing Room at NRC Headquarters May 14, 2019 Meeting Summary
Webinar May 23, 2019 Meeting Summary
Federal Register notice on staff's draft approaches comment period closes July 3, 2019 Docket NRC-2018-0230
Public Teleconference on the ACMUI T&E Subcommittee’s Comments on the NRC Staff's Draft T&E Commission Paper October 18, 2019 Training and Experience (T&E) for All Modalities Subcommittee - Final Report on Staff’s Draft T&E SECY
Meeting Summary
Commission paper publicly released January 2020  

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Page Last Reviewed/Updated Thursday, December 05, 2019