2023-15130. Reporting Nuclear Medicine Injection Extravasations as Medical Events  

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    AGENCY:

    Nuclear Regulatory Commission.

    ACTION:

    Preliminary proposed rule language; extension of comment period.

    SUMMARY:

    On April 19, 2023, the U.S. Nuclear Regulatory Commission (NRC) solicited feedback on the preliminary proposed rule language and posed specific questions to stakeholders for a rulemaking on the reporting of nuclear medicine injection extravasations as medical events. The public comment period was originally scheduled to close on July 18, 2023. The NRC has decided to extend the public comment period to allow more time for members of the public to develop and submit their comments.

    DATES:

    The due date of comments requested in the document published on April 19, 2023 (88 FR 24130) is extended. Comments should be filed no later than September 1, 2023. Comments received after this date will be considered, if it is practical to do so, but the NRC is able to ensure consideration only for comments received on or before this date.

    ADDRESSES:

    You may submit comments by any of the following methods; however, the NRC encourages electronic comment submission through the Federal rulemaking website:

    Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC–2022–0218. Address questions about NRC dockets to Dawn Forder; telephone: 301–415–3407; email: Dawn.Forder@nrc.gov. For technical questions contact the individuals listed in the FOR FURTHER INFORMATION CONTACT section of this document.

    Email comments to: Rulemaking.Comments@nrc.gov. If you do not receive an automatic email reply confirming receipt, then contact us at 301–415–1677.

    Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at 301–415–1101.

    Mail comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001, ATTN: Rulemakings and Adjudications Staff.

    Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland 20852, between 7:30 a.m. and 4:15 p.m. eastern time, Federal workdays; telephone: 301–415–1677.

    For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the SUPPLEMENTARY INFORMATION section of this document.

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    FOR FURTHER INFORMATION CONTACT:

    Irene Wu, Office of Nuclear Material Safety and Safeguards, telephone: 301–415–1951, email: Irene.Wu@nrc.gov; and Daniel DiMarco, Office of Nuclear Material Safety and Safeguards, telephone: 301–415–3303, email: Daniel.Dimarco@nrc.gov. Both are staff of the U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001.

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    SUPPLEMENTARY INFORMATION:

    I. Obtaining Information and Submitting Comments

    A. Obtaining Information

    Please refer to Docket ID NRC–2022–0218 when contacting the NRC about the availability of information for this action. You may obtain publicly available information related to this action by any of the following methods:

    Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC–2022–0218.

    NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly available documents online in the ADAMS Public Documents collection at https://www.nrc.gov/​reading-rm/​adams.html. To begin the search, select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1–800–397–4209, at 301–415–4737, or by email to PDR.Resource@nrc.gov. The ADAMS accession number for each document referenced (if it is available in ADAMS) is provided the first time that it is mentioned in this document.

    NRC's PDR: The PDR, where you may examine and order copies of publicly available documents, is open by appointment. To make an appointment to visit the PDR, please send an email to PDR.Resource@nrc.gov or call 1–800–397–4209 or 301–415–4737, between 8 a.m. and 4 p.m. eastern time, Monday through Friday, except Federal holidays.

    B. Submitting Comments

    The NRC encourages electronic comment submission through the Federal Rulemaking Website ( https://www.regulations.gov). Please include Docket ID NRC–2022–0218 in your comment submission.

    The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at https://www.regulations.gov as well as enter the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

    If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.

    II. Discussion

    On April 19, 2023, the NRC solicited feedback on the preliminary proposed rule language for a rulemaking on the reporting of nuclear medicine injection extravasations as medical events. To inform this rulemaking, the NRC also posed specific questions to obtain input from stakeholders. The public comment period was originally scheduled to close on July 18, 2023. By email dated July 10, 2023 (ADAMS Accession No. ML23193A202), the Organization of Agreement States Board requested that the NRC extend the comment period by 45 days. The NRC has decided to grant this request and extend the public comment period on this document until September 1, 2023, to allow more time for members of the public to submit their comments.

    The NRC may post materials related to this document, including public Start Printed Page 45825 comments, on the Federal rulemaking website at https://www.regulations.gov under Docket ID NRC–2022–0218. In addition, the Federal rulemaking website allows members of the public to receive alerts when changes or additions occur in a docket folder. To subscribe: (1) navigate to the docket folder (NRC–2022–0218); (2) click the “Subscribe” link; and (3) enter an email address and click on the “Subscribe” link.

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    Dated: July 12, 2023.

    For the Nuclear Regulatory Commission.

    Christopher M. Regan,

    Director, Division of Rulemaking, Environmental, and Financial Support, Office of Nuclear Material Safety and Safeguards.

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    [FR Doc. 2023–15130 Filed 7–17–23; 8:45 am]

    BILLING CODE 7590–01–P

Document Information

Effective Date:
4/19/2023
Published:
07/18/2023
Department:
Nuclear Regulatory Commission
Entry Type:
Proposed Rule
Action:
Preliminary proposed rule language; extension of comment period.
Document Number:
2023-15130
Dates:
The due date of comments requested in the document published on April 19, 2023 (88 FR 24130) is extended. Comments should be filed no later than September 1, 2023. Comments received after this date will be considered, if it is practical to do so, but the NRC is able to ensure consideration only for comments received on or before this date.
Pages:
45824-45825 (2 pages)
Docket Numbers:
NRC-2022-0218
RINs:
3150-AK91: Reporting Nuclear Medicine Injection Extravasations as Medical Events
RIN Links:
https://www.federalregister.gov/regulations/3150-AK91/reporting-nuclear-medicine-injection-extravasations-as-medical-events-
PDF File:
2023-15130.pdf
Supporting Documents:
» Comment Extension Request from OAS Board
» May 24 Extravasation Public Meeting Summary ML23165A284
» May 24 Extravasation Public Meeting Transcript ML23159A193
» Preliminary Proposed Rule Language ML23083B332
» Mary Ajango, Spokesperson, Young Survival Coalition, Patients for Safer Nuclear Medicine Coalition Spokesperson, Letter re: NRC’s decision about extravasations
» Ronald Lattanze, Chief Executive Officer, Lucerno Dynamics, LLC, Letter re: Extravasation, Abnormal Occurrence Reporting, and Information Correction Requests
CFR: (1)
10 CFR 35