ML20238B821: Difference between revisions
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==Dear Mr. Selover:== | ==Dear Mr. Selover:== | ||
By letter dated June 26, 2020 (Agencywide Documents Access and Management System Accession No. ML20178A654), Exubrion Therapeutics, Inc. (Exubrion) submitted a revised hypothetical license amendment application to the U.S. Nuclear Regulatory Commission (NRC) for review containing its generic procedures for release of a dog following treatment with Synovetin OATM. The NRC has reviewed the revised application and has identified certain areas where additional information is needed to complete its review. Enclosed are the NRC staffs third round of requests for additional information (RAIs). Staff is willing to meet with Exubrion representatives to discuss and/or clarify staffs expectations for these RAIs; otherwise, please either respond to these RAIs or provide a schedule for submitting your responses as soon as possible. | By {{letter dated|date=June 26, 2020|text=letter dated June 26, 2020}} (Agencywide Documents Access and Management System Accession No. ML20178A654), Exubrion Therapeutics, Inc. (Exubrion) submitted a revised hypothetical license amendment application to the U.S. Nuclear Regulatory Commission (NRC) for review containing its generic procedures for release of a dog following treatment with Synovetin OATM. The NRC has reviewed the revised application and has identified certain areas where additional information is needed to complete its review. Enclosed are the NRC staffs third round of requests for additional information (RAIs). Staff is willing to meet with Exubrion representatives to discuss and/or clarify staffs expectations for these RAIs; otherwise, please either respond to these RAIs or provide a schedule for submitting your responses as soon as possible. | ||
If you have any questions regarding this request, please contact me at 301-415-5422, or via e-mail at Christian.Einberg@nrc.gov. | If you have any questions regarding this request, please contact me at 301-415-5422, or via e-mail at Christian.Einberg@nrc.gov. | ||
Sincerely, Christian Digitally signed by Christian Einberg Einberg Date: 2020.08.25 16:28:57 -04'00' Christian Einberg, Chief Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards | Sincerely, Christian Digitally signed by Christian Einberg Einberg Date: 2020.08.25 16:28:57 -04'00' Christian Einberg, Chief Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards | ||
Latest revision as of 12:38, 9 March 2021
| ML20238B821 | |
| Person / Time | |
|---|---|
| Issue date: | 08/25/2020 |
| From: | Christian Einberg NRC/NMSS/DMSST |
| To: | Selover P Exubrion Therapeutics |
| Katie Tapp | |
| Shared Package | |
| ML20238B820 | List: |
| References | |
| Download: ML20238B821 (2) | |
Text
J. Fulks UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 August 25, 2020 Mr. Peter Selover Chief Executive Officer Exubrion Therapeutics, Inc.
5203 Bristol Industrial Way Buford, GA 30518
SUBJECT:
THIRD REQUEST FOR ADDITIONAL INFORMATION FOR THE REVIEW OF THE HYPOTHETICAL LICENSE AMENDMENT APPLICATION FOR TREATMENT OF DOGS WITH SYNOVETIN OATM
Dear Mr. Selover:
By letter dated June 26, 2020 (Agencywide Documents Access and Management System Accession No. ML20178A654), Exubrion Therapeutics, Inc. (Exubrion) submitted a revised hypothetical license amendment application to the U.S. Nuclear Regulatory Commission (NRC) for review containing its generic procedures for release of a dog following treatment with Synovetin OATM. The NRC has reviewed the revised application and has identified certain areas where additional information is needed to complete its review. Enclosed are the NRC staffs third round of requests for additional information (RAIs). Staff is willing to meet with Exubrion representatives to discuss and/or clarify staffs expectations for these RAIs; otherwise, please either respond to these RAIs or provide a schedule for submitting your responses as soon as possible.
If you have any questions regarding this request, please contact me at 301-415-5422, or via e-mail at Christian.Einberg@nrc.gov.
Sincerely, Christian Digitally signed by Christian Einberg Einberg Date: 2020.08.25 16:28:57 -04'00' Christian Einberg, Chief Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
Enclosure:
Requests for Additional Information cc w/encl: Vince Holahan, NMSS EUllrich, RI
SUBJECT:
THIRD REQUEST FOR ADDITIONAL INFORMATION FOR THE REVIEW OF THE HYPOTHETICAL LICENSE AMENDMENT APPLICATION FOR TREATMENT OF DOGS WITH SYNOVETIN OATM DATE: August 25, 2020 DISTRIBUTION:
VHolahan, NMSS EUllrich, RI ADAMS Accession Package Number ML20238B820 *via e-mail OFFICE MSST MSST MSST NAME KTapp* LDimmick* CEinberg*
DATE 8/24/20 8/25/20 8/25/20 OFFICIAL RECORD COPY