ML19016A330
| ML19016A330 | |
| Person / Time | |
|---|---|
| Issue date: | 02/07/2019 |
| From: | Office of Nuclear Material Safety and Safeguards |
| To: | |
| Shared Package | |
| ml19016a042 | List: |
| References | |
| Download: ML19016A330 (3) | |
Text
ML19016A330 Instructions for submitting training and experience information for authorized user for uses under 10 CFR 35.100, 35.200, and 35.500 NRC Medical Use Applicants, Licensees, and Master Materials Permittees This instruction describes the training and experience information that applicants, licensees and Master Material License (MML) permittees should submit for each authorized user (AU) for uses under 10 CFR 35.100, 35.200, and 35.500 in Item 7, Individual(s) Responsible for Radiation Safety Program and Their Training and Experience of NRC Form 313, Application for a Materials License. These instructions are effective until the Office of Management and Budget (OMB) approves the revisions to the NRC Form 313 A series.
Usually, applicants, licensees, and permittees use the NRC Form 313 A series to provide training and experience information. However, OMB has not yet approved the revisions to the revised NRC Form 313 A series that comports with the final rule, Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments, 83 FR 33046 (July 16, 2018). Therefore, these forms should not be used by medical use applicants, licensees, or permittees in submissions to either the NRC or an MML. The current NRC Form 313 A series of forms should also not be used because they do not comport with the final rule.
Applicants, licensees, and permittees should follow the instructions provided below to provide training and experience information to the NRC and MMLs. These instructions are from pages 30 through 49 of Guidance for the Final Rule Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments, which is available at https://www.nrc.gov/docs/ML1817/ML18176A377.pdf. These instructions comport with the training and experience requirements in 10 CFR Part 35 that went into effect on January 14, 2019.
Authorized User for 10 CFR 35.100, 35.200 and 35.500 Medical Uses:
Provide the following:
Name of the proposed AU and uses requested; AND Medical, podiatry, or dental license number and issuing entity; AND For an individual previously identified as an AU on an NRC or Agreement State license or permit:
Previous license number (if issued by the NRC) or a copy of the license (if issued by an Agreement State) or a copy of a permit issued by an NRC master materials licensee, a permit issued by an NRC or Agreement State broad-scope licensee, or a permit issued by an NRC Master Materials License broad-scope permittee on which the physician, dentist, or podiatrist was specifically named as an AU for the uses requested; AND For an AU requesting a medical use not currently authorized on a license or permit, a description of the additional training and experience is needed to demonstrate the AU is
2 also qualified for the new medical uses requested (e.g., training and experience needed to meet the requirements in 10 CFR 35.290(b)). A preceptor attestation may also be required. (For example, a preceptor attestation is needed for all individuals seeking authorization through the alternate training and experience pathway.)
AND If applicable, description of recent related continuing education and experience as required by 10 CFR 35.59.
For an individual qualifying under 10 CFR 35.57(b)(3):
Documentation that the physician, dentist, or podiatrist used only accelerator-produced radioactive materials, discrete sources of Ra-226, or both, for medical uses performed at a Government agency or Federally recognized Indian Tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC; AND Documentation that the physician, dentist, or podiatrist used these materials for the same medical uses requested; AND For an AU requesting a medical use for which he or she is not currently authorized on a license or permit, a description of the additional training and experience to demonstrate the AU is also qualified for the new medical uses requested (e.g., training and experience needed to meet the requirements in 10 CFR 35.290(b)). A preceptor attestation may also be required. (For example, a preceptor attestation is needed for all individuals seeking authorization through the alternate training and experience pathway).
AND If applicable, description of recent related continuing education and experience as required by 10 CFR 35.59.
For an individual who was certified before October 24, 2005, by a board listed in 10 CFR 35.57(b)(2):
Copy of certification issued before October 24, 2005, by a specialty board whose certification is listed in 10 CFR 35.57(b)(2);
AND Documentation demonstrating that the individual was using the requested materials and uses on or before October 24, 2005; AND If applicable, description of recent related continuing education and experience as required by 10 CFR 35.59.
3 For an individual qualifying under 10 CFR Part 35, Subparts D and G, who is board-certified:
A copy of the certification(s) by a specialty board(s) whose certification process has been recognized1 by the NRC under 10 CFR Part 35, Subpart D or G, as applicable to the use requested; AND For a physician with a board certification recognized under 10 CFR 35.390 for medical uses described in 10 CFR 35.200, a description of the supervised work experience eluting generator systems required in 10 CFR 35.290(c)(1)(ii)(G) demonstrating that the proposed AU is also qualified for imaging and localization medical uses; AND If applicable, a description of recent related continuing education and experience as required by 10 CFR 35.59.
For an individual qualifying under 10 CFR Part 35, Subparts D and G, who is not board-certified:
A description of the training and experience identified in 10 CFR Part 35, Subparts D and G demonstrating that the proposed AU is qualified by training and experience for the use(s) requested; AND A written attestation, signed by a preceptor physician AU2 or if applicable the residency program director,3 that the above training and experience have been satisfactorily completed and the individual is able to independently fulfill the radiation safety-related duties as an AU for the requested medical uses; AND If applicable, a description of recent related continuing education and experience as required by 10 CFR 35.59.
1 The names of board certifications that have been recognized by the NRC or an Agreement State are posted on the NRCs Web site http://www.nrc.gov/materials/miau/med-use-toolkit.html.
2 Document that the preceptor physician AU meets the criteria to sign the attestation.
3 Document that the criteria for the residency program director to sign the attestation are met.