ML22306A067

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11-21-22 Letter to Representative Deborah K. Ross, Et Al., from Chair Hanson Regarding the Commissions Current Review of a Petition for Rulemaking on Classifying Radiopharmaceutical Extravasations as Medical Events
ML22306A067
Person / Time
Issue date: 11/21/2022
From: Christopher Hanson
NRC/Chairman
To: Butterfield G, Cline B, Good B, Price D, Ross D, Schakowsky J
US Congress, US HR (House of Representatives), US SEN (Senate)
Shared Package
ML22291A072 List:
References
CORR-22-0109, LTR-22-0298
Download: ML22306A067 (1)


Text

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 November 21, 2022 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 letter dated October 14, 2022, requesting that the Commission immediately make publicly available the staff's evaluation of a petition for rulemaking on classifying radiopharmaceutical extravasations as medical events reportable to the NRC.

In accordance with the NRC's procedures for preparation and review of petitions for rulemaking, the final staff evaluation on classifying radiopharmaceutical extravasations as medical events reportable to the NRC has not yet been publicly released. Those procedures reflect the agency's policy to make petition closure documents publicly available after the Commission has issued a final decision and the petitioner has been informed of that decision.

To ensure full consideration of the impacts of extravasation on patients and the medical community, the NRC staff requested input from an array of stakeholders including the public, medical professional societies, the NRC's Advisory Committee on the Medical Uses of Isotopes (ACMUI), and the Agreement States. As a result, a large body of information used to inform the staff's evaluation is publicly available at www.regulations.gov (Docket ID NRC-2020-0141 ). The docket is continuously updated and contains the petition, additional information submitted by the petitioner throughout the petition review process, public comments received on the petition, and ACMUI deliberations. Furthermore, the Agreement States commented on the draft of the staff's petition evaluation in the fall of 2021; their comments, in addition to public meeting summaries and meeting transcripts, are available on the docket.

I want to assure you that while the Commission is considering this issue, the NRC's current medical use regulations are protective of public health and safety. If you have any questions or need additional information, please contact me, or have your staff contact Eugene Dacus, Director of the Office of Congressional Affairs, at (301) 415-1776.

Sincerely, Christopher T. Hanson

Identical letter sent to:

The Honorable Deborah K. Ross United States House of Representatives Washington, DC 20515 The Honorable Jan Schakowsky United States House of Representatives Washington, DC 20515 The Honorable Ben Cline United States House of Representatives Washington, DC 20515 The Honorable G. K. Butterfield United States House of Representatives Washington, DC 20515 The Honorable David E. Price United States House of Representatives Washington, DC 20515 The Honorable Bob Good United States House of Representatives Washington, DC 20515