July 17, 2019

NRC Describes Acceptable T&E Documentation Preceding Form 313A Update

The U.S. Nuclear Regulatory Commission (NRC) released information advising medical use applicants, licensees and master materials license (MML) permittees about the appropriate forms and procedures that may be used to document their training and education (T&E) until the Office of Management and Budget approves an updated Form 313A series to gather such information.

The following is relevant to the applications and amendment processes for medical use licenses and permits. NRC and MML review this information when approving individuals as radiation safety officers, associate radiation safety officers, authorized users, authorized nuclear pharmacists, authorized medical physicists or ophthalmic physicists:

Submitting training and experience information to comply with the January 14, 2019, revisions to 10 CFR Part 35 (83 FR 33046 published July 16, 2018).

NRC has the Office of Management and Budget (OMB) clearance for the changes in training and experience requirements in the January 14, 2019, revision of 10 CFR Part 35, and those changes are in effect for NRC, NRC Master Materials Licensees (MMLs), and Agreement States that adopted the changes to 10 CFR Part 35 on the effective date of the rule. [Note: Agreement States have 3 years to adopt the changes.] However, the new NRC Form 313A’s that comport with the rule were not included in the OMB rule package. As a consequence, while OMB is currently reviewing the forms, the new forms cannot be used. Also, the old forms do not comport with the new revisions and have been removed for the NRC public web site.

While NRC awaits OMB clearance for the new forms, applicants, licensees, and permittees should follow the instructions on the NRC Medical Uses Licensee Toolkit under Forms, to provide training and experience information to the NRC, MMLs, and Agreement States that adopted the changes to 10 CFR Part 35 on the effective date of the rule. These instructions are from pages 30 through 49 of "Guidance for the Final Rule, "Medical Use of Byproduct Material – Medical Event Definitions, Training and Experiences, and Clarifying Amendments". These instructions comport with the training and experience requirements in 10 CFR Part 35 that went into effect on January 14, 2019. The NRC Medical Uses Licensee Toolkit can be accessed at: https://www.nrc.gov/materials/miau/med-use-toolkit.html.