ML19036A752
| ML19036A752 | |
| Person / Time | |
|---|---|
| Issue date: | 02/25/2019 |
| From: | Patricia Holahan Office of Nuclear Material Safety and Safeguards |
| To: | Sioshansi P Advanced Radiation Therapy |
| Bladey C | |
| Shared Package | |
| ML19036A749 | List: |
| References | |
| Download: ML19036A752 (2) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 Dr. Piran Sioshansi, Ph.D., President and CEO, on Behalf of Advanced Radiation Therapy, LLC One Industrial Way, Unit 6 Tyngsboro, MA 01879
Dear Dr. Sioshansi:
I am responding to your correspondence to the U.S. Nuclear Regulatory Commission (NRC) on December 10, 2018,1 in which you propose regulatory changes for a new brachytherapy procedure, which would no longer require the presence of the physician authorized user for all patient therapy and follow-up visits.
The NRC has reviewed your request and has concluded that the information you provided does not meet the Commissions criteria for a petition for rulemaking under Title 10 of the Code of Federal Regulations (10 CFR) 2.802(c). Specifically, your petition does not: (1) cite, enclose, or reference publicly available technical, scientific, or other data or information to support your assertion of the identified problems or issues, as required by 10 CFR 2.802(c)(1)(iv); or (2) cite, enclose, or reference any other publicly available data or information to support your proposed solution, as required by 10 CFR 2.802(c)(1)(vii). In addition, as required by 10 CFR 2.802(c)(1)(ii), a petition for rulemaking submitted by an organization must provide additional identifying information (as applicable) including the petitioner's organizational or corporate status, the petitioner's State of incorporation, the petitioner's registered agent, etc.
For the reasons discussed above, your December 10, 2018, submission does not satisfy the requirements of 10 CFR 2.802(c) and, therefore, cannot be docketed as a petition by the NRC, as provided for in 10 CFR 2.803(b). If you wish the NRC to consider your request that the agency amend its regulations, you must supplement your correspondence of December 10, 2018.
If you have any questions, please contact Cindy Bladey, Chief, Regulatory Analysis and Rulemaking Support Branch, Division of Rulemaking, Office of Nuclear Material Safety and Safeguards, by phone at 301-415-3280 (toll-free at 1-800-368-5642), or by e-mail at Cindy.Bladey@nrc.gov.
Sincerely,
/RA/
Patricia K. Holahan, Director Division of Rulemaking, Office of Nuclear Material Safety and Safeguards 1 Available in the NRCs Agencywide Documents Access and Management System (ADAMS) under Accession No. ML19036A750.
February 25, 2019
ML19036A749 (package)
- concurrence by e-mail OFFICE NMSS/DRM/RASB/RT NMSS/DRM/RASB OGC NMSS/DRM/MRPB NAME J. Shepherd-Vladimir C. Bladey*
I. Irvin V. Cox DATE 2/14/19*
2/22/19 2/14/19*
2/14/19*
OFFICE D:NMSS/DRM NAME P. Holahan DATE 2/25/19