ML22178A133
| ML22178A133 | |
| Person / Time | |
|---|---|
| Issue date: | 06/30/2022 |
| From: | Kevin Williams NRC/NMSS/DMSST |
| To: | Gardner D - No Known Affiliation |
| S. Lopas, NMSS/MSST/MSEB | |
| References | |
| Download: ML22178A133 (3) | |
Text
D. Garner UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 Drew Garner 4705 Village Green Drive Roswell, GA 30075 Via email to randrewgarner@bellsouth.net
Dear Mr. Garner:
I am responding to the emails dated May 16, May 19, and May 23, 2022, with respect to medical event reporting of extravsastions and a request for the Advisory Committee on the Medical Use of Isotopes (ACMUI) to respond to comments from July 2021, submitted in advance of the ACMUI public meeting on extravasations in September 2021. In the July 2021 comments, a response was requested from the ACMUI related to the committees past evaluations of reporting extravasations as medical events, and the radiological impacts of nuclear medicine extravasations. In the subsequent emails from May 2022, the staff was asked why the ACMUI did not respond to the comments or provide answers to the questions.
The ACMUI is a federal advisory committee that reports to me, the Director of the Division of Materials Safety, Security, State, and Tribal Programs in the Office of Nuclear Material Safety and Safeguards. The operations of the ACMUI are governed by the Federal Advisory Committee Act of 1972 (5 U.S.C. app). As a result, the NRC provides the public with an opportunity to submit written comments to the ACMUI for the committee members consideration prior to the committees public meeting on a given topic. As part of the ACMUIs review of extravasations, they did review your comments to inform their review. This is consistent with Federal Advisory Committee Act requirements. Additionally, at the discretion of the ACMUI chair or another committee member who leads the ACMUI public meeting, members of the public are given an opportunity to provide oral comments during the ACMUI public meetings. However, the NRCs bylaws and procedures do not require ACMUI members to respond to public comments.
As Ms. Lopas noted in her email dated May 17, 2022, your comments and questions were provided to the ACMUI for the members review prior to the extravasation public meeting and were appended to the published meeting transcript (see page 79 of the transcript, which is available in ADAMS at Accession No. ML21286A807), and the meeting transcript was placed on the docket as supporting material related to the petition for rulemaking on reporting nuclear medicine injection extravasations as medical events (PRM-35-22).
June 29, 2022
D. Garner The Commission recently received the staffs recommendations on reporting certain extravasations as medical events and for resolving the PRM-35-22. The Commission will consider all the information placed on the petition docket during its evaluation of the staffs recommendations. If you have any further questions or concerns, please feel free to contact me by email at Kevin.Williams@nrc.gov, or by phone at 301-415-3340.
Sincerely, Kevin Williams, Director Division of Materials Safety, Security, State and Tribal Programs Office of Nuclear Material Safety and Safeguards Signed by Williams, Kevin on 06/29/22
ML22178A133 OFFICE NMSS/MSST NMSS/MSST NMSS/MSST NMSS/MSST NAME SLopas CValentin-Rodriguez CEinberg KWilliams DATE 06/21/22 06/22/22 06/23/22 06/29/22