ML18298A352

Astro Annual Meeting 2018: Poster, USNRC Evaluation of Training and Experience for Radiopharmaceutical Use

ML18298A352
Person / Time
Issue date:	10/23/2018
From:	Lopas S L NRC/NMSS/DMSST/MSEB
To:
Sarah Lopas
References
Download: ML18298A352 (1)

Text

45907Evaluation of Training and Experience for Radiopharmaceutical UseAmerican Society of Radiation Oncology 2018 Annual MeetingSan Antonio, TX Why We Are Evaluating2.A physician can complete a structured educational program and supervised work experience under an Alternate Pathway. The required 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> breaks down to a minimum of 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training, and 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised work experience.The NRC's training and experience (T&E) requirements for physicians seeking to become an Authorized User are listed in Title 10 of the Code of Federal Regulations (10 CFR) Part 35. Specifically, the T&E requirements in Subpart E of 10 CFR 35 provide three ways that a physician can be authorized to administer unsealed byproduct materials or radiopharmaceuticals requiring a written directive. An attestation may be required to confirm that these requirements are met.1.A physician can be certified by a medical specialty board, whose certification process is recognized by the NRC or an Agreement State.

ReferencesThe NRC is conducting more extensive outreach with the medical community focused on assessing options for tailoring the T&E requirements for medical uses authorized under 10 CFR 35.300.

• Provide feedback: A Federal Register noticewill be published with detailed questions written by NRC staff. The NRC will request feedback on these questions from interested stakeholders.

• Attend NRC public meetings and webinars in November, December, and January.

• Send letters or e-mails to the NRC with your feedback.

• Keep track of the NRC's evaluation at the T&E Web site: www.nrc.gov/materials/miau/med-use-toolkit/training-experience-evaluation.htmlHow You Can Participate3.Aphysician can be authorized if previously identified as an Authorized User (AU) on an NRC or Agreement State license or permit. SRM-M170817:(ADAMS Accession No. ML17229B283)SECY-18-0084:(ADAMS Accession No. ML18135A276)T&E Evaluation Web site:www.nrc.gov/materials/miau/med-use-toolkit/training-experience-evaluation.htmlIs 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> appropriate? How should competency be assessed? Do the current NRC requirements unnecessarily limit patient access to procedures involving radiopharmaceuticals?Should the NRC create tailored T&E requirements for different categories of radiopharmaceuticals?Authorized User Training & ExperienceThe NRC is evaluating: (1) whether it makes sense to establish tailored T&Erequirements 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 appropriateT&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.What should the categories be and how should the requirements be applied?Office of Nuclear Material Safety and SafeguardsDivision of Materials Safety, Security, State, and Tribal ProgramsIf you only have time to participate in one way,please submit a response to the questions posted in the Federal Register notice.