ML20162A174

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Letter to Ronald K. Lattanze on Behalf of Lucerno Dynamics, LLC Petition That the NRC Revise Its Regulations in 10 CFR Part 35, Medical Use of Byproduct Material (PRM-35-22)
ML20162A174
Person / Time
Issue date: 09/03/2020
From: Annette Vietti-Cook
NRC/SECY
To: Lattanze R
Lucerno Dynamics
Shepherd J
Shared Package
ML20160A182 List:
References
NRC-2020-0141, PRM-35-22
Download: ML20162A174 (2)


Text

September 3, 2020 Ronald K. Lattanze Chief Executive Officer Lucerno Dynamics, LLC 140 Towerview Court Cary, NC 27513

Dear Mr. Lattanze:

This letter is in reference to the petition for rulemaking (PRM) that you submitted on behalf of Lucerno Dynamics, LLC, to the U.S. Nuclear Regulatory Commission (NRC) on May 18, 2020 (NRCs Agencywide Documents Access and Management System (ADAMS)

Accession No. ML20157A266). As stated in the NRCs June 9, 2020, letter (ADAMS Accession No. ML20160A183), the NRC docketed this petition under Section 2.803 of Title 10 of the Code of Federal Regulations (10 CFR), Petition for Rulemaking-NRC Action.

In the petition, you request that the NRC revise its regulations in 10 CFR Part 35, Medical Use of Byproduct Material, to require reporting of nuclear medicine injection extravasations that exceed 0.5 Sievert (50 rem) dose equivalent to tissue as medical events. Your petition has been assigned Docket Number PRM-35-22. Please reference this docket number on any correspondence you may have concerning the petition.

The enclosed notice announcing the docketing of the petition will be published in the Federal Register. The NRC is requesting public comment on your petition. As the staff reviews your petition, it may be necessary to request additional information.

You can monitor the docket for your petition on the Federal rulemaking Web site, https://www.regulations.gov, by searching for Docket ID NRC-2020-0141. The Federal rulemaking Web site allows you to receive alerts when changes or additions occur in a docket folder. To subscribe: (1) navigate to the docket folder NRC-2020-0141; (2) click the Email Alert link; and (3) enter your e-mail address and select how frequently you would like to receive e-mails (daily, weekly, or monthly). The NRC tracks all petition actions on its Web site at https://www.nrc.gov/reading-rm/doc-collections/rulemaking-ruleforum/petitions-by-year.html and https://www.nrc.gov/reading-rm/doc-collections/rulemaking-ruleforum/active/PetitionIndex.html.

R. Lattanze 3 You may direct any questions you have concerning the petition process or the status of your petition to Cindy Bladey at 301-415-3280 (e-mail: Cindy.Bladey@nrc.gov) or to Helen Chang at 301-415-3228 (e-mail: Helen.Chang@nrc.gov).

Sincerely, Annette L. Digitally signed by Annette L. Vietti-Cook Vietti-Cook Date: 2020.09.03 09:58:43 -04'00' Annette L. Vietti-Cook Secretary of the Commission

Enclosure:

Notice of docketing of petition