ML23313A187
| ML23313A187 | |
| Person / Time | |
|---|---|
| Issue date: | 11/09/2023 |
| From: | Kenneth Erwin NRC/NMSS/DMSST |
| To: | Ajango M Young Survival Coalition |
| References | |
| NRC-2022-0218, 87 FR 80474, LTR-23-0240-1 | |
| Download: ML23313A187 (1) | |
Text
From:
Kenneth Erwin To:
majango@youngsurvival.org Cc:
Celimar Valentin-Rodriguez (She/Her/Hers); Christian Einberg; Jill Shepherd; Andrew Carrera; Irene Wu; Daniel Dimarco; Kevin Williams; Catherine Kanatas; Christine Pineda; Candace Spore (She)
Subject:
Follow-up re: 10/3/2023 extravasation rulemaking letter Date:
Thursday, November 9, 2023 2:26:12 PM
Dear Ms. Ajango,
Thank you for your letter of October 3, 2023, concerning the NRCs rulemaking that would require medical event reporting of extravasations that require medical attention for a suspected radiation injury (letter is in the NRCs Agencywide Documents Access and Management System at Accession No. ML23279A085). We added your letter to the rulemaking docket (NRC-2022-0218).
In your letter, you suggested that the NRC staff develop immediate interim guidance to alert licensees that the NRC rescinds the existing policy that exempts extravasations from medical event reporting and mandate reporting of large extravasations using existing medical event reporting criteria by January 1, 2025. As part of the rulemaking process, the Commission directed the NRC staff to conduct a rulemaking to mandate reporting of certain nuclear medicine extravasations as part of the NRCs medical event reporting regulations. The proposed rule language and implementation guidance will need public review and input, which will be accomplished through the rulemaking process. The next opportunity for you to provide comments as part of the rulemaking process is the proposed rule, which will be issued for a 90-day comment period, following approval by the Commission, currently targeted for Fall 2024. The NRC staff will then prepare a final rule, based on the consideration of all comments received on the proposed rule, to be provided to the Commission for consideration, currently targeted for Winter 2026. We look forward to your continued participation in the process. For more information, please visit the NRCs public website at https://www.nrc.gov/materials/miau/med-use-toolkit/reporting-nuclear-medicine-injectionextravasations.html.
If you have any questions or need additional information, please contact me or the NRC project manager at Irene.Wu@nrc.gov or 301-415-1951.
Thank you!
Kenneth Erwin, Acting Deputy Division Director Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Materials Safety and Safeguards kenneth.erwin@nrc.gov; www.nrc.gov