ML23270A956
| ML23270A956 | |
| Person / Time | |
|---|---|
| Issue date: | 09/29/2023 |
| From: | Robert Orlikowski NRC/RGN-III/DRSS/MLB |
| To: | James Heck NRC/RGN-III/DRSS |
| Cender L | |
| References | |
| Download: ML23270A956 (8) | |
Text
September 29, 2023 MEMORANDUM TO: Jared Heck, Acting Director Division of Radiological Safety and Security FROM: Robert J. Orlikowski, Chief Signed by Orlikowski, Robert Materials Licensing Branch on 09/29/23 Division of Radiological Safety and Security
SUBJECT:
FULL MATERIALS LICENSE SIGNATURE AUTHORITY FOR LAURA B. CENDER FOR ALL CATEGORIES OF MATERIALS LICENSES INCLUDING BUT NOT LIMITED TO: BROAD SCOPE USE (ACADEMIC, RESEARCH AND DEVELOPMENT, AND MEDICAL),
RESEARCH AND DEVELOPMENT, VETERINARY AND IN-VITRO-TESTING, NUCLEAR PHARMACIES, RADIONUCLIDE PRODUCTION USING AN ACCELERATOR, SERVICE PROVIDERS, MEDICAL PRODUCT DISTRIBUTION (10 CFR 32.72 AND 32.74), ALL CATEGORIES OF SERVICE PROVIDERS, ALL CATEGORIES OF IRRADIATORS, WASTE DISPOSAL, SOURCE MATERIAL, SPECIAL NUCLEAR MATERIAL, CIVIL DEFENSE, GENERAL LICENSE DISTRIBUTION, AND POSSESSION ONLY LICENSING (PROGRAM CODES 01100, 01110, 03211, 03212, 03610, 03611, 02400, 02410, 01120, 03213, 03612, 02500, 03210, 03220-26, 02511, 03510-21, 03700, 03240, 11200, 11210, 11300, 22110, 22111, 22120, 22130, 22140, 22150, 22151 023300, 03231-36)
Based upon the following information, I recommend that Laura B. Cender be given signature authority for licensing nuclear materials used in all licensed categories managed by the Region III Materials Licensing Branch (including, but not limited to those listed above).
CONTACT: Cassandra F. Frazier MLB/DRSS 630-829-9830
J. Heck 2 Ms. Cender has completed sufficient formal training, individual study activities (ISAs), and on-the-job training activities (OJTs) to demonstrate her mastery of the eleven skills in the three reviewer competency areas described in IMC 1248 Appendix A Materials Health Physics License Reviewer Qualification Journal, and as applicable to any materials licensing action assigned to the Materials Licensing Branch, Division of Radiological Safety and Security.
Ms. Cender joined the Materials Licensing Branch, Division of Radiological Safety and Security, in April 2017 and completed her initial qualification for materials licensing in December 2018. In April 2019 she was assigned signature authority for Category I licensing of fixed gauges, portable gauges, and other measuring and inspection systems. In January 2020 she was assigned signature authority for Category II medical licensing of programs authorizing 10 CFR 35.100, 35.200, and 35.300 materials. In June 2021 she was assigned signature authority for Category III for the remaining limited scope medical licensing covering 10 CFR 35.400, 35.600, and 35.1000, and Category VI industrial radiography, well logging.
In September 2022, Ms. Cender was assigned a Senior License Reviewer mentor (Cassandra F. Frazier) and trained in additional categories, with special emphasis on Category IV research and development, veterinary, and broad-scope institutions (including academic, R&D, and medical), and Category V radiopharmacy, accelerator production, service provider, and medical distribution licenses. She met with her mentor, as needed, to review each of the more than 40 licensing actions that were assigned to her.
Ms. Cender completed new relevant casework includes 34 amendments, 2 new licenses, and 8 license renewals. She has completed a wide variety of licensing action types including modification of materials authorizations; facilities updates including adding new locations and removing locations using decommissioning and close-out survey reviews; and personnel changes (including addition and removal of authorized users and radiation safety officers).
She has also performed licensing site-visits and financial assurance modifications.
Ms. Cender has demonstrated her mastery of the license review process including how to use the U.S. Nuclear Regulatory Commission (NRC) websites specific to materials programs, how to access and use the Sealed Source and Device Registry (SSDR) checklists, the Agencywide Documents Access and Management System (ADAMS) database checklists, Microsoft Word templates for licenses and licensing correspondence, use of Web-Based Licensing for preparation of the NRC 374 Forms, deficiency and transmittal correspondence, decommissioning financial assurance, security for risk-significant radioactive material (10 CFR Part 37), Sensitive Unclassified Non-Safeguards Information (SUNSI) markings, and Web-Based Licensing System functions as they relate to subject program codes.
Ms. Cender has mastered the application of all the NUREG-1556, Consolidated Guidance About Materials Licenses: Program-Specific Guidance, Volumes 1 through 21. Her most recent training has included applying the guidance in Academic and Research and Development (Vol. 7); Licenses of Broad Scope (Vol. 11); Manufacturing & Distribution (Vol.
12); Radiopharmacy (Vol. 13); Administrative Procedures (Vol. 20); and Accelerator-produced materials licensing (Vol 21). She has also reviewed and applied the NUREG-1757 Consolidated Decommissioning Guidance volumes about Decommissioning Process (Vol.1),
and Financial Assurance (Vol. 3). Further, Ms. Cender has also read and applied Title 10 of the Code of Federal Regulations (CFR) Parts 2, 19, 20, 21, 30 through 40, 70 and 71. Ms. Cender has demonstrated a strong sense of safety, responsibility, decision making capability, and casework management.
J. Heck 3 Additionally, Ms. Cender has mastered the use and application of designated NRC tools to calculate and sum ratios, to determine total radioactive material possession limits and appropriately determine whether SUNSI markings are required, or whether 10 CFR Part 37 limits have been triggered. Ms. Cender is extremely experienced with WBL and NSTS and has consistently updated licensees information in the system with the most current data available.
The license documents (NRC Form 374) Ms. Cender generates are accurate, consistent with NRC policy, and rarely require any revisions or edits.
A Training Review Group (TRG) comprised of the Materials Licensing Branch Chief (BC) and two senior materials licensing reviewers was assembled to assess whether Ms. Cender has completed sufficient casework and is competent to be assigned full signature authority for all categories of materials licenses. The TRG has evaluated Ms. Cenders casework and competency and has recommended that Ms. Cender be assigned full signature authority for all categories of materials licenses.
In accordance with the TRGs recommendation and via this memo, Ms. Cender is now assigned Signature Authorities (SAs) for signature authority for all categories of materials licenses.
Enclosures:
- 1. Previous Materials Licensing Qualifications of Laura B. Cender
- 2. Laura B. Cenders Completed Relevant Casework
J. Heck 4 Memorandum to Jared Heck from Robert Orlikowski dated September 29, 2023.
Signed by Heck, Jared Approved: _ on 09/29/23 Date: 9/29/23 Jared Heck, Acting Director Division of Radiological Safety and Security
SUBJECT:
FULL MATERIALS LICENSE SIGNATURE AUTHORITY FOR LAURA B. CENDER FOR ALL CATEGORIES OF MATERIALS LICENSES INCLUDING BUT NOT LIMITED TO: BROAD SCOPE USE (ACADEMIC, RESEARCH AND DEVELOPMENT, AND MEDICAL), RESEARCH AND DEVELOPMENT, VETERINARY AND IN-VITRO-TESTING, NUCLEAR PHARMACIES, RADIONUCLIDE PRODUCTION USING AN ACCELERATOR, SERVICE PROVIDERS, MEDICAL PRODUCT DISTRIBUTION (10 CFR 32.72 AND 32.74), ALL CATEGORIES OF SERVICE PROVIDERS, ALL CATEGORIES OF IRRADIATORS, WASTE DISPOSAL, SOURCE MATERIAL, SPECIAL NUCLEAR MATERIAL, CIVIL DEFENSE, GENERAL LICENSE DISTRIBUTION, AND POSSESSION ONLY LICENSING (PROGRAM CODES 01100, 01110, 03211, 03212, 03610, 03611, 02400, 02410, 01120, 03213, 03612, 02500, 03210, 03220-26, 02511, 03510-21, 03700, 03240, 11200, 11210, 11300, 22110, 22111, 22120, 22130, 22140, 22150, 22151 023300, 03231-36)
DISTRIBUTION:
Jared Heck Kimyata Morgan-Butler Robert Orlikowski Laura Cender ADAMS Accession Number: ML23270A956 OFFICE RIII-DRSS RIII-DRSS RIII-DRSS RIII-DRSS NAME CFrazier BParker ROrlikowski JHeck DATE 9/27/23 9/27/23 9/27/23 9/29/23 OFFICIAL RECORD COPY
J. Heck 5 : Previous Materials Licensing Qualifications of Laura B. Cender Memo ADAMS Qualification Description Date Accession No.
12/18/18 ML18355A678 Completion of all formal training and individual study activities (ISAs) outlined in Appendix A to IMC 1248 and Initial Qualification as a materials health physics license reviewer 04/23/19 ML19114A511 Signature Authority (SA) for licensing of materials used in fixed gauges, portable gauges, gas chromatography devices, and x-ray fluorescence analyzers (Program Codes (PCs) 03120-21/04414- 17*, and 03122-23) 01/17/20 ML20021A299 SA for licensing of materials for medical use, as described in 10 CFR 35.100 (in-part), 35.200, 35.300, 35.500, and 31.11 (PCs 02120-21/04810-13*, 02200-01/04814-17*, and 02220/04820/04821*)
06/10/21 ML21161A333 SA for licensing of materials for medical use as described in 10 CFR 35.400, 35.600, and 35.1000 and for Industrial Radiography and Well Logging (PCs 02120, 02200, 02210, 02230, 02231, 02240, 02300, AND 02310)
- Note that only PCs associated with 0-5 locations of use are listed in SA memos. PCs associated with 6 locations of use or more are included in this enclosure for reference.
J. Heck 6 : Relevant Completed Casework Licenses of Broad Scope Licensee Control Type Description No.
Beaumont Health System 633926 Amend Request to name new RSO on the license Charles River Laboratories 632279 Amend Request to add multiple sealed sources to the license Curium US LLC 631733 Amend Major amendment requesting conversion from limited to broad scope.
Mercy Hospital St. Louis 632241 Renewal Full renewal, medical and service provider license.
Purdue University 634147 Amend Amendment requesting relaxation of release criteria for feline veterinary patients treated with I-131 Purdue University 633326 Amend Request to authorize Cs-131 manual brachytherapy seeds for veterinary use.
Washington University 634183 Amend Addition of new cyclotron into previously unused cyclotron vault. Reviewed updated commitments associated with the addition of the new unit. Shielding and ventilation evaluated under CN 634184 Saint Louis University 634303 Amend Request to authorize 10 CFR 35.400 uses of Cs-131 (Gamma Tiles)
Michigan State University 635924 Amend Major facility changes - expansion of uses (FA processed under 635490)
The Curators of the University of Missouri 634904 Renewal Type A broadscope license renewal.
The Regents of the University of Michigan 635555 Amend Amendment request to authorize dispersible source material (DU and natural uranium salts) in quantities exceeding 10 mCi. 10 CFR 40.36 requires FA above this threshold which the licensee believed was covered by their existing Part 30 FA. OGC consulted, confirming additional FA is required. Issued amendment limits licensee to less than 10 mCi.
Accelerator Production / Cyclotron Licensee Control Type Description No.
BAMF Health 633719 Amend Addition of new isotopes, and licensee name change.
Charles River Laboratories 632187 Amend Request to name a new AU on the license.
Karmanos Cancer Center 631446 Renewal Full program renewal and addition of new AU's.
NukeMed Inc. dba SpectronRX 632717 New New license for dual-unit cyclotron facility.
PETNET Solutions 631947 Renewal Full program renewal and addition of new AU's.
Washington University in St. Louis 634184 Amend Addition of a new cyclotron to an unused vault.
Coordinated with Amendment to BS License No. 24-00167-11 to authorize possession and use of material produced from this vault.
Sofie Co. dba SOFIE 633916 Amend Addition of new cyclotron operator.
BAMF Health, Inc. 635642 Amend Facility changes associated with addition of Medtrace system - rad safety changes made to facility medical license.
J. Heck 7 Nuclear Pharmacy and Medical Distribution (32.72/32.74)
Licensee Control Type Description No.
BAMF Health, Inc. 633718 Amend Addition of Ge/Ga generators, request to name an ANP, and authorize use of Cu-64 and Zr-89.
Jubilant DraxImage, Inc. 633975 Renewal Full renewal and addition of Ge/Ga generators.
CardioNavix, LLC 633315 New New license authorizing handling, transportation and shipping of Sr-Rb generators to licensed medical clients.
CPI Pharmacy Holdings LLC 632236 Amend Remove ANPs Cardinal Health 414, LLC 634881 Amend Addition of RadioGenix System and new RadioGenix AU's Sofie Co. dba SOFIE 633916 Amend Change of RSO and addition of new ANP's including one ANP through 35.55 pathway BAMF Health 635187 Amend Request to amend Ge/Ga generator authorization to no longer be manufacturer/model specific.
Curium US LLC 631688 Renewal License renewal and RSO change for Curium's medical distribution license.
Cardinal Health 414, LLC 636111 Amend Addition of Ge/Ga generators, request to name an ANP, and authorize use of Cu-64 and Zr-89.
BAMF Health, Inc. 635644 Amend Facility changes associated with addition of Medtrace system - rad safety changes made to facility medical license.
Research and Development Licensee Control Type Description No.
Butler University 628443 Amend Request to move license temporarily into standby pending addition of a new AU Charles River Laboratories 629350 Amend Addition of a calibration source Charles River Laboratories 633679 Amend Minor increase in possession limits for Ge-68 calibration sources Labcorp Early Development Laboratories 629147 Amend Request to decommission former area of use that was used for storage of biological samples containing I-125 Labcorp Early Development Laboratories 633241 Amend Removed F-18 and sealed sources from the license that were no long in use. Increased Lu-177 limits and added Terbium-161.
Removed former AU Van Andel Research Institute 633269 Renewal Program renewal, removal of licensed materials that had been in possession only status.
Q Squared Solutions BioSciences, LLC 628099 Renewal License renewal with limited program changes.
R.M. Wester and Associates, Inc. 633386 Amend Addition of R&D program for research and development of fixed gauging devices.
MAHLE Industries, Incorporated 634290 Amend Request to name a new AU and remove three former AU's WMU Homer Stryker M.D. School of 632432 Amend Request to name a new RSO Medicine Labcorp Early Development Laboratories 635596 Amend Request to name a new RSO Inc.
J. Heck 8 Other - Manufacturing and Distribution (Other) and Civil Defense Licensee Control Type Description No.
State of Michigan 633958 Amend Addition of new AU's Sigma Aldrich MFG LLC 634343 Amend Change of RSO, addition and removal of AU's, and review of changes to dosimetry and bioassay commitments.
High Energy Devices, LLC 633337 Renewal License renewal with no significant program changes, addition of new AU Cammenga and Associates, LLC 635613 Amend Change of RSO, addition of new AU's