ML22145A560
| ML22145A560 | |
| Person / Time | |
|---|---|
| Issue date: | 07/25/2022 |
| From: | Kevin Williams Office of Nuclear Material Safety and Safeguards |
| To: | Segall G American Board of Nuclear Medicine |
| J. Fisher, NMSS/MSST | |
| References | |
| Download: ML22145A560 (3) | |
Text
July 25, 2022 American Board of Nuclear Medicine ATTN: George Segall, MD Executive Director 1030 Highlands Plaza Drive, Suite 511E St. Louis, MO 63110
SUBJECT:
AMERICAN BOARD OF NUCLEAR MEDICINE, COMPLETION OF THE REVIEW FOR CONTINUED RECOGNITION BY THE U.S. NUCLEAR REGULATORY COMMISSION
Dear Dr. George Segall:
Thank you for responding to the U.S. Nuclear Regulatory Commissions (NRC) letter dated March 15, 2022 (Agencywide Documents Access Management System (ADAMS)1 Accession No. ML22069A712), which requested confirmation that American Board of Nuclear Medicine (ABNM) continues to satisfy the NRC recognition criteria for specialty board certification processes in Title 10 of the Code of Federal Regulations (10 CFR) Part 352, Medical Use of Byproduct Material. The NRC staff reviewed your response letter dated April 14, 2022 (ML22105A576) and the letter dated May 25, 2022 (ML22151A323) in which you clarified the training and experience requirements.
The NRC staff performed a review of each NRC-recognized specialty board per the Office of Nuclear Material Safety and Safeguards (NMSS) Office Procedure MSST-70-3, Procedures for Recognizing, Monitoring, and Terminating the Certification Process of Specialty Boards, Section 3.11, Monitoring Continued Satisfaction of Recognition Requirements (ML20351A389). As part of the review, the NRC staff evaluated ABNMs publicly available website at http://www.abnm.org, as well as any provided documentation for changes that could affect the recognition of the boards certification process. Based on your response letters, the supporting documentation provided, and the NRCs subsequent review, the NRC staff determined that the Nuclear Medicine specialty area continues to satisfy the board recognition criteria in 10 CFR 35.190, Training for uptake, dilution, and excretion studies, 10 CFR 35.290, Training for imaging and localization studies, and 10 CFR 35.390, Training for use of unsealed byproduct material for which a written directive is required.
In addition, thank you for providing the four new certificates for ABNM Nuclear Medicine; effective from 1) October 28, 2005, to October 11, 2007, 2) October 12, 2017, to October 6, 2011, 3) October 7, 2011, to October 4, 2012, and 4) October 5, 2012, to present. The NRC 1 Records are available electronically for public inspection in the NRC Public Document Room or in the NRCs ADAMS, accessible from the NRC website at http://www.nrc.gov/reading-rm/adams.html.
2 The 10 CFR Part 35 index is available for review at:
https://www.govinfo.gov/app/collection/cfr/2021/title10/chapterI/part35.
G. Segall staff added the certificates to the NRC public website titled Specialty Board(s) Certification Recognized by NRC Under 10 CFR Part 35, available at https://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html. The NRC public website is used by NRC license reviewers, as well as license reviewers in Agreement States, to verify that the certificates submitted by licensees are valid. Please ensure that ABNM shares any future changes to certificates with the NRC with the date that the revised certificates became or will become effective.
In 2019, the NRC revised its medical use regulations, including training and experience requirements. A history of the rulemaking, pertinent guidance document references, and a summary of major changes are available in a 2018 presentation titled Final Rule - Medical Use Regulations in 10 CFR 30, 32, and 35 (ML19085A550).3 The NRC staff determined that ABNM is in compliance, but we encourage you to review these changes if you have not done so already.
This letter further confirms that as the Executive Director of the ABNM, you are the designee for all official correspondence with the NRC. If this changes in the future, please contact the NRC with the individual responsible for this role.
Please notify the NRC, via letter, if the board changes the boards name, certification processes, or certification documents because these changes could affect the recognition of certification process under the NRC requirements. In addition, please notify the NRC 6 months in advance of any plans for ABNM to become inactive or disband the Nuclear Medicine certification program.
For further information or for questions, please contact Maryann Ayoade at (301) 415-0862 or via email at Maryann.Ayoade@nrc.gov or Jennifer Fisher at (301) 415-1456 or via email at Jennifer.Fisher@nrc.gov.
Clark, Theresa signing on behalf of Williams, Kevin on 07/25/22 Kevin Williams, Director Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards 3 Additional information can be found in the July 16, 2018, section of the NRC website titled Background Information for Medical Licensees, available at https://www.nrc.gov/materials/miau/med-use-toolkit/background-info-med-license.html#july162018.
ML22145A560 OFFICE NMSS/MSST NMSS/MSST NMSS/MSST NMSS/MSST NMSS/MSST T Clark for:
NAME J Fisher M Ayoade C Valentin-Rodriguez C Einberg K Williams DATE 07/14/2022 07/20/2022 07/21/2022 07/21/2022 07/25/2022