ML24218A118
| ML24218A118 | |
| Person / Time | |
|---|---|
| Issue date: | 08/08/2024 |
| From: | John Lubinski NRC/NMSS/DMSST |
| To: | Lattanze R Lucerno Dynamics |
| References | |
| NRC-2020-0141, PRM-35-22 | |
| Download: ML24218A118 (1) | |
Text
.
Ronald K. Lattanze Lucerno Dynamics, LLC 140 Towerview Court Cary, NC 27513 rlattanze@lucernodynamics.com
Dear Mr. Lattanze:
Thank you for your letter dated July 10, 2024, regarding the Information Correction Request (ICR) related to SECY-22-0043, Petition for Rulemaking and Rulemaking Plan on Reporting Nuclear Medicine Injection Extravasations as Medical Events (PRM-35-22; NRC-2020-0141)
(Agencywide Documents Access and Management System Accession No. ML21268A006); the March 2024 NRC Office of the Inspector General (OIG) report (ML24089A252); and the draft proposed rule language discussed during the June 17, 2024, meeting of the Advisory Committee on the Medical Uses of Isotopes (ACMUI).
As stated in my letter dated June 28, 2023 (ML23158A281), the ICR was not accepted because SECY papers are exempt from the NRCs ICR process. In addition, your concerns regarding the SECY-22-0043 and transparency in the rulemaking process have been addressed in my letter and also in Kevin Williamss letter dated April 11, 2023 (ML23048A217).
Referring to the OIGs March 2024 Report, your letter states that the NRC staff have been improperly influenced by the Society of Nuclear Medicine and Molecular Imaging (SNMMI) and the ACMUI. The OIG Report indicated that two members of the ACMUI may have apparent conflicts of interest because of their active participation in the SNMMI, a group which actively opposed PRM-35-22. The NRCs rulemaking effort regarding the reporting of nuclear medicine extravasations is informed by a balanced set of views, well beyond the individuals cited in the special inquiry as having apparent conflicts of interest. The staff's independent evaluation considered input from a variety of stakeholders, including the petitioner, ACMUI, Agreement States, published literature, and the medical community. In this case, the ACMUI unanimously supported the NRC staffs approach to this rulemaking. The OIG investigation highlighted areas where the NRC should strengthen ACMUI training and its internal procedures for screening member conflicts of interest to ensure continued avoidance of current and future conflicts of interest and the appearance of conflicts of interest for ACMUI members, and we are enhancing our procedures to address these concerns (ML24180A124 package).
The NRC staff plans to submit the draft proposed rulemaking package to the Commission in August 2024. If approved by the Commission, the agency will issue the proposed rule, which will begin the agencys notice-and-comment rulemaking process under the Administrative Procedure Act. This provides stakeholders with an opportunity to provide comments on the proposed rule. I encourage you to engage with the rulemaking process through public meetings or the public comment period that are held at that time.
August 8, 2024
R. Lattanze 2
In accordance with 10 CFR 2.390 Public inspections, exemptions, requests for withholding, a copy of this letter will be available electronically for public inspection in the NRC Public Document Room and at ADAMS Accession Number ML24218A118. ADAMS is accessible at https://www.nrc.gov/reading-rm/adams.html.
The NRC appreciates your continued public engagement on this issue and your dedication to patient safety. If you have any questions or need additional information, please contact me at John.Lubinski@nrc.gov.
Sincerely, John Lubinski, Director Office of Nuclear Material Safety and Safeguards Signed by Lubinski, John on 08/08/24
Ltr ML24218A118 OFFICE NMSS/MSST
/MSEB NMSS/MSST/MSEB NMSS/MSST NMSS NAME KTapp CEinberg KWilliams JLubinski DATE Aug 5, 2024 Aug 5, 2024 Aug 8, 2024 Aug 8, 2024