2 3 - PDF Document

Presentation Transcript

  1. GE Healthcare July 15, 2019 U.S. Nuclear Regulatory Commission - Region Ill Materials Licensing Section 2443 Warrenville Road, Suite 210 Lisle, IL 60532-4352 RE: Radioactive Material License No. 21-24828-01 MD Radioactive Material License No. 21-26707-01 MD Radioactive Material License No. 24-32462-01 MD Dear Licensing Reviewer: Please allow this letter to serve notice that Radioisotope Life Sciences (RLS (USA) Inc.) have agreed to purchase the United States network of radiopharmacies currently owned by Medi-Physics, Inc. d.b.a. GE Healthcare. Although it will be under a new company's ownership, this change will have no impact on the radiation protection programs authorized under this license. The oversight of all licensed activities, site management and operational personnel (except for normal turnover), as well as established policies and procedures to ensure compliance with applicable regulations, will remain unchanged. Therefore, we request, at the effective date of the sale, that the name on the above referenced license be changed to RLS (USA) Inc. In addition, previous correspondence may have referenced Mark Szczesniak as the Corporate RSO. We will no longer designate a Corporate RSO with the change in ownership. Currently, the expected effective date of the sale is October 31, 2019. We will notify you if that date changes. For the sake of consistency, the information provided in this notification will follow the format of Appendix E of NUREG-1556, Volume 15, Rev. 1, Guidance About Changes of Control and About Bankruptcy Involving Byproduct, Source, or Special Nuclear Materials Licenses. 1. Radioisotope Life Sciences (RLS (USA) Inc.) will purchase the entire United States radiopharmacy network including company, regional, and local business management as well as all the site assets, operations, personnel, and radiation safety professional support staff. There are no planned changes to the current operations structure at this time. The new licensee name and corporate address are as follows: RLS (USA) Inc. 8345 NW 66TH ST STE 6479 Miami, FL 33166 Federal Tax Identification Number: 83-3111597 The current Radiation Safety Officer and their contact information will remain unchanged. RECEIVED JUL 2 3 2019

  2. 2. There are no planned organizational changes to personnel who have oversight and control over licensed activities at the radiopharmacy at this time. The site RSO and Authorized Nuclear Pharmacists (ANP) will remain the same. There are no planned changes in the training program at this time. 3. There are no planned changes to locations of authorized use, facilities, equipment, radiation safety program, use, possession, waste management, or other procedures that relate to the licensed program to ensure compliance with all applicable regulations and license conditions. 4. The licensed facility and equipment will all transfer with the sale. It will be unnecessary to perform any decontamination of equipment or the facility prior to transfer. All compliance related surveillance (e.g., leak tests, inventory, surveys, etc.) are up to date. Documentation will remain on site and frequency of performance will continue to follow the existing program. 5. The license does not incorporate a decommissioning funding plan and does not require financial assurance. 6. We confirm that RLS (USA) Inc. agrees to accept full liability for the existing conditions at the site and will abide by all commitments and representations previously made by Medi-Physic, Inc. d.b.a. GE Healthcare. Medi-Physics, Inc. d.b.a. GE Healthcare confirms that all records concerning the safe and effective decommissioning of the facility will be transferred to RLS (USA) Inc. 7. Medi-Physics, Inc. d.b.a. GE Healthcare and RLS (USA) Inc. both agree that the full control of licensed material and activities will be transferred to RLS (USA) Inc. on the date of sale which is currently estimated to be October 31, 2019. Currently, there are no open inspection items or enforcement actions. 8. The buyer, RLS (USA) Inc., agrees to abide by all commitments and representations previously made to the Agency by Medi-Physics, Inc. d.b.a. GE Healthcare. 9. Not applicable. This license does not involve a fuel cycle facility. The commitments in this letter are authorized by the representatives of Medi-Physics, Inc. and RLS (USA) Inc. identified below. Sin~;1f' I appreciate your attention to this request. If you have any questions regarding this matter, please contact me at 847-385-5649 or mark.szczesniak@ge.com. Mark Szczesniak Corporate Radiation Safety Officer Medi-Physics, Inc. RLS (USA) Inc. Chris~ Medi-Physics, Inc.

  3. 1/1 unless you declare a higher value, pay an additional charge, document your actual loss and file a timely claim.Limitations found in the current FedEx precious metals, negotiable instruments and other items listed in our ServiceGuide. Written claims must be filed within strict time limits, see current Use of this system constitutes your agreement to the service conditions in the current FedEx Service Guide, available on fedex.com.FedEx will not be responsible for any claim in excess of $100 per package, whether the result of loss, damage, delay, non-delivery,misdelivery,or misinformation, Service Guide apply. Your right to recover from FedEx for any loss, including intrinsic value of the package, loss of sales, income interest, profit, Warning: Use only the printed original label for shipping. Using a photocopy of this label for shipping purposes is fraudulent and could result in authorized declared value. Recovery cannot exceed actual documented loss.Maximum for items of extraordinary value is $1,000, e.g. jewelry, attorney's fees, costs, and other forms of damage whether direct, incidental.consequential, or special is limited to the greater of $100 or the OJ ;= (./) m ;:o CJ m z r 567 J2/A6F9i05A2 3. Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned. FedEx Ship Manager - Print Your Label(s) lffi,I @ J192019062401uu additional billing charges, along with the cancellation of your FedEx account number. 1. Use the 'Print' button on this page to print your label to your laser or inkjet printer. https://www.fedex.com/shipping/shipAction.handle?method=doContinue )> m z CD ......_. r- u, C: 2. Fold the printed page along the horizontal line. r After printing this label: FedEx Service Guide. 7/22/2019