ML21222A183
| ML21222A183 | |
| Person / Time | |
|---|---|
| Issue date: | 08/12/2021 |
| From: | Margaret Doane NRC/EDO |
| To: | Ross D US Congress, US HR (House of Representatives), US SEN (Senate) |
| Mary Frances Woods, OEDO | |
| Shared Package | |
| ML21196A256 | List: |
| References | |
| LTR-21-0204 | |
| Download: ML21222A183 (3) | |
Text
August 12, 2021 The Honorable Deborah K. Ross United States House of Representatives Washington, DC 20515
Dear Representative Ross:
On behalf of the U.S. Nuclear Regulatory Commission (NRC), I am responding to your July 12, 2021, letter regarding the NRC staffs evaluation of medical event reporting on extravasations in nuclear medicine procedures. You expressed concerns about potential high levels of radiation that patients may receive through an unintended dose exposure.
The NRCs Medical Radiation Safety Team is evaluating whether and how extravasations should be reported. The staffs technical evaluation will help inform its recommendation to the Commission on a petition for rulemaking that is currently under review, Nuclear Medicine Injection Extravasations as Medical Events, (PRM-35-22; NRC-2020-0141).
The NRC staff has added your letter to the docket for the petition for rulemaking to ensure that your comments become part of the official record.
In addition to the information provided by the petitioner, as part of its evaluation, the NRC staff will be assessing input from the Advisory Committee on the Medical Uses of Isotopes (ACMUI),
the Agreement States, the medical community, members of the public, and current scientific studies.
ACMUI will be holding an online public meeting on September 2, 2021, to discuss the ACMUI Subcommittee on Extravasations and Medical Event Reporting draft report and recommendations on the NRC staffs preliminary evaluation of reporting extravasations as medical events. Both the NRC staffs preliminary evaluation and the ACMUI subcommittees draft report with recommendations were made publicly available on the NRCs website and electronic library (Agencywide Documents Access and Management System (ADAMS)
Accession No. ML21223A085).
Representative Ross 2 The NRC staff expects to provide its recommendation on the petitioners request to conduct rulemaking to the Commission in early summer 2022.
Thank you for taking the time to share your concerns. If you have any questions or need additional information, please feel free to contact me or have your staff contact Eugene Dacus, Director of the Office of Congressional Affairs, at (301) 415-1776.
Sincerely, Roberts, Darrell signing on behalf of Doane, Margaret on 08/12/21 Margaret M. Doane Executive Director for Operations
Representative Ross 3
SUBJECT:
LETTER TO THE HONORABLE DEBORAH K. ROSS FROM M. DOANE, OEDO REGARDING NUCLEAR MEDICINE INJECTION EXTRAVASATIONS AND MEDICAL EVENT REPORTING DATED August 12, 2021 DISTRIBUTION: LTR-21-0204-1 Public JLubinkski, NMSS RLewis, NMSS EDacus, OCA JWeil, OCA KWilliams, NMSS TClark, NMSS KCoyne, NMSS JTappert, NMSS CEinberg, NMSS LDimmick, NMSS PNoto, NMSS SLopas, NMSS KJamerson, NMSS RidsOcaMailCenter Resource RidsOgcMailCenter Resource RidsSecyMailCenter Resource ADAMS Accession Number: ML21196A256 Pkg. *via email OFFICE MSST/MSEB:PM MSST/MSEB REFS/RASB NMSS/REFS NMSS/MSST NAME SLopas CEinberg* CBladey* KCoyne* TClark*
DATE 7/19/2021 7/20/2021 7/20/2021 7/21/2021 7/21/2021 OFFICE NMSS OGC OCA NRC/EDO MDoane NAME RLewis* CSafford JWeil (DRoberts for)
DATE 7/27/2021 8/09/2021 8/09/2021 8/12/2021 OFFICIAL RECORD COPY