ML24151A206
| ML24151A206 | |
| Person / Time | |
|---|---|
| Issue date: | 05/29/2024 |
| From: | Kevin Williams NRC/NMSS/DMSST |
| To: | Mcdermott M Miami Neuroscience Institute |
| Shared Package | |
| ML24122A719 | List: |
| References | |
| LTR-24-0100 | |
| Download: ML24151A206 (1) | |
Text
From:
Kevin Williams To:
MWMCD@baptisthealth.net Cc:
Candace Spore (She); Araceli Billoch Colon; Kellee Jamerson (She/Her); Christian Einberg; Maryann Ayoade
Subject:
Response to GammaKnife E-mail Comment Letter Date:
Wednesday, May 29, 2024 10:08:09 AM Attachments:
image001.png
Dear Dr. McDermott,
My name is Kevin Williams, and I am the Division Director for Materials Safety, Security, State, and Tribal Programs in the office of Nuclear Material Safety and Safeguards at the Nuclear Regulatory Commission.
Thank you for reaching out to the NRC through an email dated Tuesday, April 30, 2024, regarding the current physical presence regulatory requirements for use of Gamma Stereotactic Radiosurgery (GSR) Units (email is in the NRCs Agencywide Documents Access and Management System at Accession No. ML24122A718).
In the email, it was stated that the current NRC physical presence requirements for the use of Gamma Knife seems to be an unnecessary, restrictive, and expensive regulation. In addition, there is a requirement for a Radiation Oncologist to sit outside the treatment room during the treatment and in that time, the Radiation Oncology department will incur considerable expense with having to have a parttime radiation oncologist sit outside the room during patient treatment.
There is an ongoing rulemaking (Rubidium-82 Generators, Emerging Technologies, and Other Medical Use of Byproduct Material (ML23122A356)), part of which proposes to amend the physical presence requirements in 10 CFR 35.615 to require that an AMP and AU be present at initiation of the treatment, and require that an AMP and a physician under the supervision of an AU be present throughout the treatment. Additionally, the AU would need to be physically present at the facility and able to return to the treatment if necessary.The basis for this proposed amendment to the regulations is based on operating experience with 10 CFR Part 35, Subpart H, technologies, as it is evident that equipment performance is reliable if patient set up is done correctly and calibrations are properly performed.
Note that your email to the NRC Chair Hanson will be added as a comment letter to this rulemaking docket for consideration. For the next phase of the rulemaking, the NRC plans to have additional public outreach on the proposed regulatory requirements and accompanying guidance, and we encourage you to participate in this rulemaking process.
We will be sending updates on this, and other NRC activities related to the medical use of byproduct material via our medical list server. You can subscribe to our medical list server at this link https://www.nrc.gov/materials/miau/med-use-toolkit.html#mls.
Also note that there are licensees that may fall outside of NRC jurisdiction and are licensed by an Agreement State. Agreement States, such as California and Florida, are States in which the NRC has discontinued its authority, and the Agreement State assumes authority for licensing certain radioactive materials. Agreement States are required to have their own state regulations that are compatible with NRC regulations and in some cases can have additional requirements from that of the NRC.
If you have any questions or need additional information, including information on the aforementioned rulemaking, please contact me or the NRC rulemaking technical lead Maryann Ayoade at (Maryann.Ayoade@nrc.gov).
Sincerely,
Kevin Williams Director Division of Materials Safety, Security, State, and Tribal Programs Nuclear Material Safety and Safeguards United States Nuclear Regulatory Commission 301-415-3340