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.

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

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.

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 17, 2020	SECY-20-0005, "Rulemaking Plan for Training and Experience Requirements for Unsealed Byproduct Material (10 CFR Part 35)"
Staff Requirements Memorandum issued	January 27, 2022	Staff Requirements – SECY-20-0005 – Rulemaking Plan for Training and Experience Requirements for Unsealed Byproduct Material (10 CFR Part 35)