ML22349A565
| ML22349A565 | |
| Person / Time | |
|---|---|
| Issue date: | 12/22/2022 |
| From: | Brooke Clark NRC/SECY |
| To: | Lattanze R Lucerno Dynamics |
| Bladey, Cindy 301-415-3280 | |
| References | |
| NRC-2020-0141, PRM-35-22 | |
| Download: ML22349A565 (2) | |
Text
December 22, 2022 Ronald K. Lattanze Chief Executive Officer Lucerno Dynamics, LLC 140 Towerview Court Cary, NC 27513
Dear Ronald K. Lattanze:
This letter is in response to the petition for rulemaking (PRM) that you submitted to the U.S.
Nuclear Regulatory Commission (NRC) on behalf of Lucerno Dynamics, LLC, on May 18, 2020 (Agencywide Documents Access and Management System Accession No. ML20157A266). In the PRM, Lucerno Dynamics, LLC, requests that the NRC amend its regulations in Part 35, Medical Use of Byproduct Material, of Title 10 of the Code of Federal Regulations (10 CFR) to require reporting of certain nuclear medicine injection extravasations as medical events. The NRC docketed the PRM on June 5, 2020, under Docket ID No. PRM-35-22.
The NRC published a notice of docketing and request for comment in the Federal Register on September 15, 2020 (85 FR 57148). The comment period closed on November 30, 2020, and the NRC received 488 public comment submissions on the petition.
The NRC has reviewed the PRM and the public comments. For the reasons provided in the enclosed notice, the NRC will evaluate within the rulemaking process medical event reporting of extravasations that require medical attention for suspected radiation injury.
Public comments and supporting materials related to this petition can be found at https://www.regulations.gov by searching on the petition Docket ID NRC-2020-0141. The NRC tracks the status of all PRMs on its websites at https://www.nrc.gov/reading-rm/doc-collections/rulemaking-ruleforum/petitions-by-year.html and https://www.nrc.gov/about-nrc/regulatory/rulemaking/rules-petitions.html.
The docket for this petition is closed. You may direct any questions regarding this matter to Andrew Carrera at 301-415-1078 or by e-mail to Andrew.Carrera@nrc.gov.
Sincerely, Brooke P. Digitally signed by Brooke P. Clark Clark Date: 2022.12.22 15:33:59
-05'00' Brooke P. Clark Secretary of the Commission
Enclosure:
Federal Register notice