ML23075A186

From kanterella
Jump to navigation Jump to search
LTR-23-0009-1 Email to Mary Ajango Letter of 1/9/2023 to the Commission Regarding Extravasations Rulemaking
ML23075A186
Person / Time
Issue date: 03/16/2023
From: Theresa Clark
Office of Nuclear Material Safety and Safeguards
To: Ajango M
- No Known Affiliation
References
NRC-2022-0218, 87 FR 80474
Download: ML23075A186 (1)


Text

From: Theresa Clark (She)

To: majango@youngsurvival.org Cc: Celimar Valentin-Rodriguez (She/Her/Hers); Christian Einberg; Jill Shepherd; Andrew Carrera; Irene Wu; Daniel Dimarco; Kevin Williams; Tara Inverso (She); Christine Pineda; Candace Spore (She/Her/Hers)

Subject:

follow-up re: 1/9/23 extravasations letter Date: Thursday, March 16, 2023 10:20:56 AM Attachments: image001.png

Dear Ms. Ajango,

Thank you for your letter of January 9, 2023, concerning Commission direction to the NRC staff to proceed with a 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. ML23011A041).

As you noted in your letter, the Commission recently approved staffs recommendation to consider a petition in the rulemaking process (87 FR 80474). The NRC staff has initiated rulemaking activities in accordance with the Commissions direction in the staff requirements memorandum for SECY-22-0043. We will add your letter to the rulemaking docket (NRC-2022-0218).

In your letter, you suggested that the NRC staff develop interim staff guidance to help reduce the reliance on patient reporting. We are developing guidance that we expect to address the points you raised. The draft guidance will need public review and input, which will be accomplished through the rulemaking process.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 an upcoming request for information that will be published in the Federal Register in April 2023. The request will seek comments on preliminary rule text and other considerations. In addition, we expect to hold a public meeting in May 2023. 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-injection-extravasations.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!

Theresa Valentine Clark (she/her/hers) MSST Vision:

Deputy Director Active partnership and Division of Materials Safety, Security, trustworthy leadership for...

State, and Tribal Programs safety and security, Office of Nuclear Material Safety and Safeguards engaged people, U.S. Nuclear Regulatory Commission reliable relationships, and Theresa.Clark@nrc.gov l Teams Chat l 301-415-4140 smart regulatory solutions Visit me! T-5B87 on the 1st M/Tu/Th and 2nd W/Th