ML19011A463
| ML19011A463 | |
| Person / Time | |
|---|---|
| Issue date: | 01/11/2019 |
| From: | Sarah Lopas NRC/NMSS/DMSST/MSEB |
| To: | |
| Sarah Lopas | |
| References | |
| Download: ML19011A463 (1) | |
Text
45907 Evaluation of Training and Experience for Radiopharmaceutical Use Society of Nuclear Medicine and Molecular Imaging 2019 Mid-Winter Meeting Palm Springs, CA Why We Are Evaluating
- 2. 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 NRCs 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.
References The 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.
- A Federal Register notice (83 FR 45380) was published on October 29, 2018 opening a three-month comment period on the NRCs T&E evaluation.
- Submit written comments by January 29, 2019 by going to www.Regulations.gov and searching for docket NRC-2018-0230.
- Participate in the NRCs January 22 webinar to discuss the T&E evaluation and provide oral comments on the T&E docket.
- Keep track of the NRCs evaluation at the T&E Web site:
www.nrc.gov/materials/miau/med-use-toolkit/training-experience-evaluation.html How You Can Participate
- 3. A physician 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 Federal Register Notice:
(83 FR 54380; October 29, 2018)
Is 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 & Experience The NRC is evaluating:
(1) whether it makes sense to establish tailored 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.
What should the categories be and how should the requirements be applied?
Office of Nuclear Material Safety and Safeguards Division of Materials Safety, Security, State, and Tribal Programs The NRCs T&E requirements describe the minimum training for physicians to safely use radioactive materials protecting themselves, coworkers, patients, the public, and the environment.
The NRC issues licenses to medical facilities and not specifically to individual physicians (physicians are listed as AUs on a license).
The NRC does not license physicians.
Protecting Health and Safety