ML22139A065
| ML22139A065 | |
| Person / Time | |
|---|---|
| Issue date: | 06/08/2022 |
| From: | Catherine Haney NRC/EDO/DEDCM |
| To: | Rivera E NRC/OIG/AIGA |
| Valentin-Rodriguez C | |
| Shared Package | |
| ML22136A067 | List: |
| References | |
| OEDO-22-00189, OIG-22-A-07, OIG-2200189 | |
| Download: ML22139A065 (3) | |
Text
June 8, 2022 MEMORANDUM TO: Eric Rivera Acting Assistant Inspector General for Audits Office of the Inspector General Signed by Haney, Cathy FROM: Catherine Haney on 06/08/22 Deputy Executive Director for Materials, Waste, Research, State, Tribal, Compliance, Administration, and Human Capital Programs Office of the Executive Director for Operations
SUBJECT:
STAFF RESPONSE TO THE OFFICE OF THE INSPECTOR GENERALS AUDIT OF THE U.S. NUCLEAR REGULATORY COMMISSIONS PROCESS FOR LICENSING EMERGING MEDICAL TECHNOLOGIES (OIG-22-A-07)
This memorandum responds to your May 9, 2022, memorandum transmitting the subject audit report. We appreciate the Office of the Inspector Generals (OIG) audit of the U.S. Nuclear Regulatory Commissions (NRC) process for licensing emerging medical technologies (EMT) and the OIGs recommendation for enhancement of certain activities within that program.
In the audit report, the OIG makes one recommendation: that the NRC compile a list of EMT-related information and guidance in a centralized location for NRC staff and Agreement State officials. The staff agrees that implementation of the recommendation, as described below, will improve the NRCs process for the licensing of EMTs. The staff intends to implement this recommendation by December 30, 2022. The OIGs recommendation and the staffs response are provided below.
CONTACT: Celimar Valentin-Rodriguez, NMSS/MSST 301-415-7124
E. Rivera 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.
Response and Planned Action Agree: As the OIG notes in the May 9, 2022, report, having a centralized location for EMT-related information will enhance the efficiency of capturing emergency medical technology related guidance. The staff has identified the following strategies to centralize EMT-related information and make it more accessible:
- 1. Enhance the Emerging Medical Technologies website located in the Medical Uses Toolkit within the NRCs public website with applicable EMT-related information1. These resources include guidance, videos on medical use regulations, and documents associated with the Standing Committee for the Review of Emerging Medical Technologies.
- 2. Leverage Nuclepedia to ensure the resources in the Medical Uses Toolkit, as well as other documents that are internally facing, are easily accessible to the NRC staff.
The staff will complete this action by December 30, 2022.
Point of
Contact:
Celimar Valentin-Rodriguez, NMSS/MSST 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.
ML22139A065 (Memo) ML22136A067 (Pkg)
OFFICE NMSS/MSST NMSS/MSST NMSS/MSST OGC NMSS/TechEditor CValentin- PMenefee-NAME CEinberg KWilliams IIrvin Rodriguez Buzdygon DATE 5/19/2022 5/19/2022 5/23/2022 5/24/2022 5/24/2022 OFFICE NMSS/OD DEDM NAME JLubinski CHaney DATE 6/1/2022 6/08/2022