ML24319A040
| ML24319A040 | |
| Person / Time | |
|---|---|
| Issue date: | 11/14/2024 |
| From: | Dafna Silberfeld NRC/NMSS/DMSST |
| To: | Smetherman D American College of Cardiology |
| References | |
| LTR-24-0219 | |
| Download: ML24319A040 (1) | |
Text
Dana Smetherman American College of Radiology 1892 Preston White Dr.
Reston, VA 20191 703-648-8900
Dear Dr. Smetherman:
I am writing in response to your letter dated October 3, 2024 which provided comments on the draft proposed extravasations rulemaking package, which can be found at SECY-24-0067, Proposed Rule: Reporting Nuclear Medicine Injection Extravasations as Medical Events. The SECY paper provides recommendations to the Commission on the next step of the rulemaking process that began when the Commission, in SRM-SECY-22-0043, approved rulemaking to amend the NRCs regulations to include certain nuclear medicine injection extravasations as reportable medical events. The package also includes the Draft Regulatory Guide DG-8062, which is currently with the Commission for review.
During the development of the proposed rule and associated guidance the NRC staff received input from a variety of stakeholders, including patient advocacy groups and members of the public. In addition, the rulemaking docket continues to be updated with the letters we receive from stakeholders at https://www.regulations.gov/docket/NRC-2022-0218, and your letter will be added accordingly. The Commission may use this stakeholder information, in conjunction with the NRC staffs recommendations, in making its determination on the NRCs path forward for the extravasations rulemaking.
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 (ADAMS Accession Number ML24281A163). ADAMS is accessible at https://www.nrc.gov/reading-rm/adams.html. If you have any questions or need additional information, please contact me at Dafna.Silberfled@nrc.gov.
Dafna Silberfeld Deputy Division Director Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Materials Safety and Safeguards November 14, 2024 Signed by Silberfeld, Dafna on 11/14/24
Ltr ML24319A040 OFFICE NMSS/MSST/MSEB NMSS/MSST/MSEB OCIO/DIME NAME KTapp CEinberg DSilberfeld DATE Nov 14, 2024 Nov 14, 2024 Nov 14, 2024