ML23109A056: Difference between revisions
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{{#Wiki_filter:UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 | {{#Wiki_filter:UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 ALL AGREEMENT STATES CONNECTICUT, INDIANA, WEST VIRGINIA NOTIFICATION OF ISSUANCE OF FEDERAL REGISTER NOTICE REQUESTING INFORMATION REGARDING A RULEMAKING ON THE REPORTING OF NUCLEAR MEDICINE INJECTION EXTRAVASATIONS AS MEDICAL EVENTS (STC-23-033) | ||
==Purpose:== | ==Purpose:== | ||
To provide notification that the U.S. Nuclear Regulatory Commission (NRC) has published a Federal Register notice (FRN) that requests feedback to be considered in the development of a proposed rulemaking on the reporting of nuclear medicine injection extravasations as medical events. | To provide notification that the U.S. Nuclear Regulatory Commission (NRC) has published a Federal Register notice (FRN) that requests feedback to be considered in the development of a proposed rulemaking on the reporting of nuclear medicine injection extravasations as medical events. | ||
==Background:== | ==Background:== | ||
| Line 27: | Line 27: | ||
More information on this rulemaking can be found on the NRCs public website at https://www.nrc.gov/materials/miau/med-use-toolkit/reporting-nuclear-medicine-injection-extravasations.html and at https://www.nrc.gov/reading-rm/doc-collections/rulemaking-ruleforum/active/ruledetails.html?id=2180. | More information on this rulemaking can be found on the NRCs public website at https://www.nrc.gov/materials/miau/med-use-toolkit/reporting-nuclear-medicine-injection-extravasations.html and at https://www.nrc.gov/reading-rm/doc-collections/rulemaking-ruleforum/active/ruledetails.html?id=2180. | ||
A public meeting will be held virtually on Wednesday, May 24, 2023, from 1:00 p.m. to 4:00 p.m. | A public meeting will be held virtually on Wednesday, May 24, 2023, from 1:00 p.m. to 4:00 p.m. | ||
Eastern Daylight Time. The NRC will publish a notice with the meeting link and agenda on | Eastern Daylight Time. The NRC will publish a notice with the meeting link and agenda on April 28, 2023 STC-23-033 2 NRCs public meeting website at least 10 calendar days before the meeting. Stakeholders should monitor the NRCs public meeting website ( https://www.nrc.gov/public-involve/public-meetings/) for information about the public meeting. | ||
STC-23-033 | |||
If you have any questions regarding this correspondence, please contact me at Sherrie.Flaherty@nrc.gov, or the individual listed below: | If you have any questions regarding this correspondence, please contact me at Sherrie.Flaherty@nrc.gov, or the individual listed below: | ||
POINT OF CONTACT: Irene Wu | POINT OF CONTACT: Irene Wu EMAIL: Irene.Wu@nrc.gov TELEPHONE: (301) 415-1951 Sherrie Flaherty, Acting Branch Chief State Agreement and Liaison Programs Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards Signed by Flaherty, Sherrie on 04/28/23 | ||
ML23109A056 | ML23109A056 | ||
* via email NMSS/REFS | * via email OFFICE NMSS/REFS NMSS/MSST/MSEB NMSS/REFS/MRPB NMSS/MSST | ||
/MRPB NAME IWu IW CEinberg CE JShepherd CValentin-Rodriguez ACarrera for AC CV DATE Apr 19, 2023 Apr 24, 2023 Apr 20, 2023 Apr 20, 2023 OFFICE NMSS/REFS NMSS/MSST/SLPB* | |||
/MRPB NAME IWu IW SFlaherty SF DATE Apr 24, 2023 Apr 28, 2023}} | |||
Latest revision as of 19:39, 14 November 2024
| ML23109A056 | |
| Person / Time | |
|---|---|
| Issue date: | 04/28/2023 |
| From: | Flaherty S NRC/NMSS/DMSST |
| To: | State of CT, State of IN, State of WV, State, Agreement States |
| References | |
| STC-23-033 | |
| Download: ML23109A056 (3) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 ALL AGREEMENT STATES CONNECTICUT, INDIANA, WEST VIRGINIA NOTIFICATION OF ISSUANCE OF FEDERAL REGISTER NOTICE REQUESTING INFORMATION REGARDING A RULEMAKING ON THE REPORTING OF NUCLEAR MEDICINE INJECTION EXTRAVASATIONS AS MEDICAL EVENTS (STC-23-033)
Purpose:
To provide notification that the U.S. Nuclear Regulatory Commission (NRC) has published a Federal Register notice (FRN) that requests feedback to be considered in the development of a proposed rulemaking on the reporting of nuclear medicine injection extravasations as medical events.
Background:
On May 18, 2020, the NRC received a petition for rulemaking requesting that the NRC amend 10 CFR Part 35, Medical Use of Byproduct Material, to require medical event reporting of radiopharmaceutical extravasations that lead to an irradiation resulting in a localized dose equivalent exceeding 50 rem (0.5 Sieverts). The NRC reviewed the petitioners request and conducted an independent evaluation, considering input from the Advisory Committee on the Medical Uses of Isotopes, Agreement States, external stakeholders, and available published literature on extravasations. On May 9, 2022, the NRC staff issued a rulemaking plan in SECY-22-0043, Petition for Rulemaking and Rulemaking Plan on Reporting Nuclear Medicine Injection Extravasations as Medical Events, that presented options for amending Part 35 and recommended including certain nuclear medicine injection extravasations as reportable medical events. On December 12, 2022, the Commission approved the staffs recommendation in the staff requirements memorandum (SRM) for SECY-22-0043.
Discussion: The NRC issued an FRN (88 FR 24130) on April 19, 2023, which is available at:
https://www.regulations.gov/document/NRC-2022-0218-0004. This FRN can also be accessed on https://www.regulations.gov by searching for Docket ID No. NRC-2022-0218. The notice announces a 90-day public comment period on information related to the NRCs rulemaking to require the reporting of certain nuclear medicine injection extravasations as medical events. The FRN contains questions that the NRC is seeking feedback on in the following areas: definitions, procedures, and healthcare inequities. The FRN also announces the availability of preliminary proposed rule language. The preliminary rule language is available at www.nrc.gov/docs/ML2308/ML23083B332.pdf.
More information on this rulemaking can be found on the NRCs public website at https://www.nrc.gov/materials/miau/med-use-toolkit/reporting-nuclear-medicine-injection-extravasations.html and at https://www.nrc.gov/reading-rm/doc-collections/rulemaking-ruleforum/active/ruledetails.html?id=2180.
A public meeting will be held virtually on Wednesday, May 24, 2023, from 1:00 p.m. to 4:00 p.m.
Eastern Daylight Time. The NRC will publish a notice with the meeting link and agenda on April 28, 2023 STC-23-033 2 NRCs public meeting website at least 10 calendar days before the meeting. Stakeholders should monitor the NRCs public meeting website ( https://www.nrc.gov/public-involve/public-meetings/) for information about the public meeting.
If you have any questions regarding this correspondence, please contact me at Sherrie.Flaherty@nrc.gov, or the individual listed below:
POINT OF CONTACT: Irene Wu EMAIL: Irene.Wu@nrc.gov TELEPHONE: (301) 415-1951 Sherrie Flaherty, Acting Branch Chief State Agreement and Liaison Programs Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards Signed by Flaherty, Sherrie on 04/28/23
- via email OFFICE NMSS/REFS NMSS/MSST/MSEB NMSS/REFS/MRPB NMSS/MSST
/MRPB NAME IWu IW CEinberg CE JShepherd CValentin-Rodriguez ACarrera for AC CV DATE Apr 19, 2023 Apr 24, 2023 Apr 20, 2023 Apr 20, 2023 OFFICE NMSS/REFS NMSS/MSST/SLPB*
/MRPB NAME IWu IW SFlaherty SF DATE Apr 24, 2023 Apr 28, 2023