ML22336A176
| ML22336A176 | |
| Person / Time | |
|---|---|
| Issue date: | 12/07/2022 |
| From: | John Lubinski Office of Nuclear Material Safety and Safeguards |
| To: | Virkar H NRC/OIG/AIGA |
| Shared Package | |
| ML22192A155 | List: |
| References | |
| OEDO-22-00277, OIG-22-A-07 | |
| Download: ML22336A176 (3) | |
Text
December 7, 2022 MEMORANDUM TO: Hruta Virkar Assistant Inspector General for Audits Office of the Inspector General Lewis, Robert signing on behalf FROM: John W. Lubinski, Director of Lubinski, John on 12/07/22 Office of Nuclear Material Safety and Safeguards
SUBJECT:
STATUS OF RECOMMENDATIONS: THE OFFICE OF THE INSPECTOR GENERALS AUDIT OF THE U.S. NUCLEAR REGULATORY COMMISSIONS PROCESS FOR LICENSING EMERGING MEDICAL TECHNOLOGIES (OIG-22-A-07)
Below is the U.S. Nuclear Regulatory Commissions (NRC) status of the recommendation from the Office of the Inspector General (OIG) Audit of U.S. Nuclear Regulatory Commissions Process for Licensing Emerging Medical Technologies (OIG-22-A-07), dated May 9, 2022. This audit report included a recommendation related to the NRCs process for licensing emerging medical technologies (EMTs). The NRC staff responded to this recommendation in a June 8, 2022, memorandum (Agencywide Documents Access and Management System Accession No. ML22139A065), and OIG responded on July 11, 2022 (ML22192A101), that the staffs proposed action would resolve the recommendation. This memorandum provides an update on this recommendation and recommends closure of the recommendation.
Recommendation:
Enhance the efficiency of the emerging medical technology licensing and guidance development processes by compiling a list of emerging medical technology-related guidance and information in a centralized location for NRC staff and Agreement State officials.
Status:
Completed. Staff created a Nuclepedia page with information related to emerging medical technologies. This page has up-to-date information about NRC activities related to EMTs, including a link to the NRCs SharePoint site for Emerging Medical Technologies. This SharePoint site is the repository for EMT-related information including activities of the Standing CONTACT: Celimar Valentin-Rodriguez, NMSS 301-415-7124
H. Virkar 2 Committee for Reviewing Emerging Medical Technologies (current membership and working documents). The site also includes links to current list of EMTs, as well as links to other EMT-related resources including, ACMUI reports related to EMTs, and information about the ongoing rulemaking to establish requirements for rubidium-82 generators and EMTs.
Staff also updated the NRCs public webpage for EMTs, located in the NRCs Medical Toolkit1, including links to manufacturers websites for each technology (when applicable) and the charter and State Agreements procedure for the Standing Committee for Reviewing Emerging Medical Technologies. The links to the guidance documents were reviewed and updated as needed, and more information about the ongoing rulemaking to establish requirements for rubidium-82 generators and EMTs added.
The NRC staff will continue to update these repositories of EMT-related information as needed.
Completion Date: December 2, 2022 Point of
Contact:
Celimar Valentin-Rodriguez 1 The Medical Uses Toolkit does not include proprietary or confidential information shared with the NRC by vendors or by the U.S. Food and Drug Administration under its memorandum of understanding with the NRC. However, the staff has established internal processes to share information with the Agreement States as needed to complete reviews.
ML22336A176 (Response Memo) Package: ML22192A155 OFFICE NMSS/MSST/MSEB NMSS/MSST/MSEB NMSS/MSST/MSEB NMSS/MSST NAME DDimarco CValentin-Rodriguez CEinberg KWilliams (TClark for)
DATE 12/2/22 12/2/22 12/6/22 12/7/22 OFFICE TechEd NMSS NAME TWalker-Web JLubinski (CRichie for) (RLewis for)
DATE 12/7/22 12/7/22