ML20169A440
| ML20169A440 | |
| Person / Time | |
|---|---|
| Issue date: | 06/17/2020 |
| From: | Duane White NRC/NMSS/DMSST/MSEB |
| To: | Selover P Exubrion Therapeutics |
| Irene Wu, NRC/NMSSS | |
| Shared Package | |
| ML20169A412 | List: |
| References | |
| Download: ML20169A440 (2) | |
Text
June 17, 2020 Mr. Peter Selover Chief Executive Officer Exubrion Therapeutics, Inc.
5203 Bristol Industrial Way Buford, GA 30518
SUBJECT:
SECOND 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 May 15, 2020 (Agencywide Documents Access and Management System Accession No. ML20142A291), 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 second 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 within 30 days of receipt of this letter.
If you have any questions regarding this request, please contact me at 301-287-3627, or via e-mail at Duane.White@nrc.gov.
Sincerely, Duane White, Acting 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
P. Selover 2
SUBJECT:
SECOND REQUEST FOR ADDITIONAL INFORMATION FOR THE REVIEW OF THE HYPOTHETICAL LICENSE AMENDMENT APPLICATION FOR TREATMENT OF DOGS WITH SYNOVETIN OATM DATE: JUNE 17, 2020 DISTRIBUTION:
VHolahan, NMSS EUllrich, RI ADAMS Accession Package Number ML20169A412 *via e-mail OFFICE MSST MSST MSST MSST NAME IWu KTapp LDimmick DWhite DATE 06/17/20 06/17/20 06/17/20 06/17/20 OFFICIAL RECORD COPY