ML21077A315

Shine Medical Technologies, LLC - Letter for Notice of Issuance of Exemption Related to Commercial Grade Dedication

ML21077A315
Person / Time
Site:	SHINE Medical Technologies
Issue date:	05/12/2021
From:	Steven Lynch NRC/NRR/DANU/UNPL
To:	Piefer G SHINE Medical Technologies
Shared Package
DEV000000001	List: ML21077A313 ML21077A315 ML21158A217 ML23283A272 ML23283A273 ML23283A274
References
CPMIF-001, EPID L-2020-LLL-0013
Download: ML21077A315 (4)

Text

May 12, 2021 Dr. Gregory Piefer, Chief Executive Officer SHINE Medical Technologies, LLC 101 E. Milwaukee Street, Suite 600 Janesville, WI 53545

SUBJECT:

SHINE MEDICAL TECHNOLOGIES, LLC - NOTICE OF ISSUANCE OF EXEMPTION FROM CERTAIN REQUIREMENTS OF TITLE 10 OF THE CODE OF FEDERAL REGULATIONS, SECTION 21.3 RELATED TO COMMERCIAL GRADE DEDICATION (EPID NO. L-2020-LLL-0013)

Dear Dr. Piefer:

By letter dated June 2, 2020 (Agencywide Documents Access and Management System Accession No. ML20154K754), SHINE Medical Technologies, LLC (SHINE) requested an exemption from certain requirements of Title 10 of the Code of Federal Regulations (10 CFR)

Section 21.3, Definitions, related to commercial grade dedication of equipment. SHINEs submittal includes the proposed definitions for commercial grade item, basic component, critical characteristics, dedication, and dedicating entity that SHINE would use in lieu of the 10 CFR Section 21.3 definitions that apply to a 10 CFR Part 50, Domestic Licensing of Production and Utilization Facilities, facility other than a nuclear power plant. The U.S. Nuclear Regulatory Commission staff approved the exemption from certain definitions specified in 10 CFR Section 21.3, for SHINE, by letter dated April 30, 2021.

In its exemption request, SHINE stated that upon approval of the 10 CFR 21.3 exemption, SHINE will revise its Quality Assurance Program Description (QAPD) to reflect the commitments made in its exemption request prior to implementing the 10 CFR Part 21, Reporting of Defects and Noncompliance, exemption. Specifically, this QAPD revision will (1) incorporate the definitions of commercial grade item, basic component, critical characteristics, dedicating entity, and dedication applicable to the SHINE facility as authorized by the exemption, and (2) implement a commercial grade item procurement strategy and dedication process, in which SHINE or its approved subcontractor will assume full responsibility as the dedicating entity in cases where SHINE or its approved sub-contractor applies the commercial grade item procurement strategy.

The enclosed Federal Register Notice related to this exemption is being forwarded to the Office of the Federal Register for publication.

G. Piefer If you have any questions, please contact me at (301) 415-1521, or by electronic mail at Steven.Lynch@nrc.gov.

Sincerely, Signed by Lynch, Steven on 05/04/21 Steven T. Lynch, Senior Project Manager Non-Power Production and Utilization Facility Licensing Branch Division of Advanced Reactors and Non-Power Production and Utilization Facilities Office of Nuclear Reactor Regulation Docket No. 50-608 Construction Permit No. CPMIF-001

Enclosure:

As stated cc: See next page

SHINE Medical Technologies, LLC Docket No. 50-608 cc:

Jeff Bartelme Licensing Manager SHINE Medical Technologies, LLC 101 E. Milwaukee Street, Suite 600 Janesville, WI 53545 Nathan Schleifer General Counsel SHINE Medical Technologies, LLC 101 E. Milwaukee Street, Suite 600 Janesville, WI 53545 Christopher Landers Director, Office of Conversion National Nuclear Security Administration, NA 23 U.S. Department of Energy 1000 Independence Ave SW Washington, DC 20585 Mark Paulson Supervisor Radiation Protection Section Wisconsin Department of Health Services P.O. Box 2659 Madison, WI 53701-2659 Mark Freitag City Manager P.O. Box 5005 Janesville, WI 53547-5005 Bill McCoy 1326 Putnam Avenue Janesville, WI 53546 Alfred Lembrich 541 Miller Avenue Janesville, WI 53548 Test, Research and Training Reactor Newsletter Attention: Amber Johnson Dept of Materials Science and Engineering University of Maryland 4418 Stadium Drive College Park, MD 20742-2115

ML21077A315 Ltr PKG ML21080A000 NRR-048 OFFICE NRR/DANU/PM NRR/DANU/LA OGC NRR/DANU/BC NRR/DANU/PM NAME SLynch NParker MYoung JBorromeo SLynch DATE 3/22/2021 3/23/2021 5/11/2021 5/12/2021 5/12/2021