ML25056A092
| ML25056A092 | |
| Person / Time | |
|---|---|
| Issue date: | 03/03/2025 |
| From: | Christian Einberg NRC/NMSS/DMSST/MSEB |
| To: | Jadvar H Advisory Committee on the Medical Uses of Isotopes |
| References | |
| Download: ML25056A092 (1) | |
Text
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MEMORANDUM TO:
Hossein Jadvar, M.D., Ph.D., Chair Advisory Committee on the Medical Uses of Isotopes FROM:
Christian E. Einberg, Branch Chief Medical Safety and Events Assessments Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
SUBJECT:
RESPONSES TO THE ADVISORY COMMITTEE ON THE GUIDANCE FOR THE IMPLEMENTATION OF 10 CFR PART 35 TRAINING AND EXPERIENCE REQUIREMENTS Below are the U.S. Nuclear Regulatory Commissions (NRC) staff responses to the recommendations and comments from the Advisory Committee on the Medical Uses of Isotopes (ACMUI) on the draft guidance for the implementation of 10 CFR Part 35 training and experience requirements. In the ACMUI report, the ACMUI believed that the guidance was well developed and effectively outlined the process to list individuals as authorized users (AUs),
radiation safety officers (RSOs), associate radiation safety officers (ARSOs), authorized nuclear pharmacists (ANPs), and ophthalmic physicists on an NRC license.
The ACMUI provided the following recommendations and comments to the NRC staff on July 3, 2024. The full report from the ACMUI can be found at Agencywide Documents Access and Management System Accession No. ML24185A268.
Recommendations 1.
ACMUI recommendation: Presentation of the required hours (divided into classroom/laboratory and supervised work experience hours) and/or number of cases/supervised clinical casework required to meet regulatory requirements for each training and experience (T&E) element should be presented in tabular format (perhaps as an appendix) as a more accessible resource.
NRC Response: Accepted. Tables that provide the specific number of hours needed for each T&E element for each type of approval sought were developed and posted on the medical uses licensee toolkit. A link to the web-posted tables was added under section 4.3.1.2 on page 16.
CONTACT: Ally L. Marra, NMSS/MSST 301-415-2509 March 3, 2025 Signed by Einberg, Christian on 03/03/25
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2.
ACMUI recommendation: Example T&E case scenarios should be made available that outline common situations; for example:
a.
an interventional radiologist seeking to be listed as an AU for liver microsphere applications, b.
a medical physicist taking on the role of RSO at a new institution, c.
a radiation oncologist 10 years out of training seeking to be listed as an AU for permanent seed implant brachytherapy or radiopharmaceutical therapy, d.
a community radiologist engaged in a solely diagnostic nuclear medicine imaging practice (without dedicated nuclear medicine fellowship or dual 16-month diagnostic radiology - nuclear medicine pathway in residency) and now wants to participate in theranostics.
NRC Response: Partially Accepted. A case scenario and associated Forms 313A for item b was developed and included in the appendix. Other case scenarios commonly submitted as license requests (and associated Forms 313A) for RSO, ANP, AMP, and AUT under the alternate pathway were also developed and included the appendix. A reference to the Appendix was added in Section 4.5.1 of the interim staff guidance (ISG) and to each of the subsections of Section 4.6.
3.
ACMUI recommendation: Section 2.0 Applicability and Use, page 2, add for the medical use of byproduct material after applicants and licensees, and noted that the extensive listing of subtopics of 10 CFR Chapter 1 Part 35 may not be additive.
NRC Response: Accepted.
4.
ACMUI recommendation: Section 4.1.2 Roles and Responsibilities, page 6, under Radiation Safety Committee (RSC), add a statement about how and when 35.1000 technologies are required to have RSC participation.
Response: Accepted. For purposes of clarification, the following statement was added to the RSC paragraph: "Emerging medical technologies under 10 CFR Part 35, Subpart K are not considered in the requirement to establish a Radiation Safety Committee, nor are AUs for emerging medical technologies (EMT) required to be part of the Radiation Safety Committee."
5.
ACMUI Recommendation: Section 4.1.2 Roles and Responsibilities, page 7, under Radiation Safety Officer, add but are not limited to to the statement Typically, these duties and responsibilities include, but are not limited to, the following:
NRC Response: Accepted.
6.
ACMUI Recommendation: Section 4.1.2 Roles and Responsibilities, page 7, under Radiation Safety Officer, add hyperlink to 10 CFR 35.24.
(https://www.ecfr.gov/current/title-10/chapter-I/part-35/subpart-B/section-35.24)
NRC Response: Accepted.
7.
ACMUI Recommendation: Section 4.1.2 Roles and Responsibilities, page 9, under ARSO, clarify in the third bullet that the appointment of the ARSO as a temporary RSO is maintained by the licensee within the institution rather than a submittal of a license amendment to the regulator. This clarification should include references to the temporary
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RSO requirements in 10 CR 35.24(c) and the notification requirements in 10CFR 35.14(b)(2).
NRC Response: Partially Accepted. The notification requirements, "As required by 10 CFR 35.14(b)(2) and 10 CFR 35.24(c), licensees must notify the NRC within 30 days of a temporary RSOs performing the duties of an RSO" were added to this section and on Page 6, third bullet under RSO. No revisions were made with regard to maintenance of records on site as 10 CFR 35.24 captures the notification requirement.
8.
ACMUI Recommendation: Section 4.3.2.4 Device-Specific Training, page 17, the guidance stated that the training is not required to be specific to the model of the device; this is inconsistent with other guidances that require specific training for new devices and applications. Even though an AU/AMP may be otherwise qualified, they should have training in the use of and emergency procedures for the model of device or byproduct material application for which authorization is sought.
It is later noted that model-specific training may be required under some cases under 10 CFR 35.610, but this would only apply to use of sealed sources in remote afterloader units, teletherapy units and gamma stereotactic radiosurgery (GSR) units, and there are many other byproduct material uses/devices that are not covered under 10 CFR 35.610.
Section 5.1 of the microsphere licensing guidance (ML21089A364) also requires AUs to have training with the specific microsphere product for which the AU is seeking authorization. Clarification of this point in the guidance is recommended.
NRC Response: Partially Accepted. Not all AU training is required to be specific for the type of use and for the specific model of the unit being used. The regulations in 10 CFR 35.610(d) requires a licensee to ensure vendor training, but they do not require training to be under the supervision of an AU like the training required in 10 CFR 35.690.
The regulations in 10 CFR 35.690 require AU training for each type of therapeutic medical unit for which authorization is sought, and also in device operation, safety procedures, and clinical use for the type(s) of use for which authorization is sought. It does not require model-specific training. The training criteria in some of the EMT (10 CFR 35.1000) licensing guidance documents (e.g., the guidance for Y-90 microspheres and GSR units) introduced the criteria for model-and vendor-specific training for physicians, whereby the criteria calls for AU training in the use of each unit. Also, all existing 10 CFR 35.1000 GSR AUs have their approved uses listed on the license limited to the specific units on which they received training. This section of the ISG was revised to clarify and state that the hands-on training with the device applies to AMPs (10 CFR 35.51(c)) and AUs of some of the EMTs.
9.
ACMUI Recommendation: Section 4.3.2.4 Device-Specific Training, page 17; remove the sentence This element must be completed in-person with the device, and provide guidance as to when and what devices/applications require in-person/hands-on training.
NRC Response: Partially Accepted. The sentence cannot be removed because the regulations in 10 CFR 35.51(c) require training to include hands-on device operation, safety procedures, clinical use, and operation of the treatment planning system. Also, some licensing guidance documents specify hands-on training for AUs (e.g., Leksell Gamma-Knife). Instead, "in-person" was revised to "hands-on" for consistency with the regulations. And this section of the ISG was revised to state that the hands-on training
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with the device applies to for AMPs (10 CFR 35.51(c)) and AUs of some of the EMTs.
There are three other uses of in-person in the ISG, but the context in these three cases is an appropriate use of "in-person."
- 10. ACMUI Recommendation: Section 4.5.1 Adding New Authorized Individuals, page 20, word missing, corrected to Guidance on preparing amendment requests and notifications can be found in the NUREG-1556 Volume 9, Revision 3.
NRC Response: Accepted.
Memo ML25056A092 OFFICE NMSS/MSST/SLPB NMSS/MSST/MSEB NMSS/MSST/MSEB NAME CFlannery KTapp CEinberg DATE Feb 25, 2025 Feb 27, 2025 Mar 3, 2025