PMNS20191137, Notice of Pre-Submittal Meeting with Exubrion Therapeutics, Inc

Notice of Pre-Submittal Meeting with Exubrion Therapeutics, Inc

ML19309D594
Person / Time
Issue date:	11/05/2019
From:	Office of Nuclear Material Safety and Safeguards
To:
References
PMNS20191137
Download: ML19309D594 (3)

Text

Title:

Notice of Pre-Submittal Meeting with Exubrion Therapeutics, Inc.

Date(s) and Time(s): November 06, 2019, 09:00 AM to 01:00 PM Location: NRC One White Flint North, O-11B4 11555 Rockville Pike Rockville, MD Category: This is a Category 1 meeting. The public is invited to observe this meeting and will have one or more opportunities to communicate with the NRC after the business portion of the meeting but before the meeting is adjourned.

Purpose:

This is a pre-submittal meeting with Exubrion Therapeutics, Inc. to discuss a hypothetical license amendment request for the treatment of dogs with Synovetin OA containing Sn-117m.

Contact:

Irene Wu 301-415-1951 Irene.Wu@nrc.gov

Participants:

NRC Office of Nuclear Material Safety and Safeguards Bridge Number Pass Code Teleconference:

(888) 677-2595 54479

PUBLIC MEETING AGENDA

Notice of Pre-Submittal Meeting with Exubrion Therapeutics, Inc.

November 06, 2019, 09:00 AM to 01:00 PM NRC One White Flint North, O-11B4 11555 Rockville Pike Rockville, MD

The time of the meeting is local to the jurisdiction where the meeting is being held.

The NRC provides reasonable accommodation to individuals with disabilities where appropriate. If reasonable accommodation is needed to participate in this meeting, or if a meeting notice, transcript, or other information from this meeting is needed in another format (e.g., Braille, large print), please notify the NRC meeting contact.

Determinations on requests for reasonable accommodation will be made on a case-by-case basis.

ADAMS Accession Number: ML19309D594 OFFICIAL RECORD COPY Link to meeting details: https://www.nrc.gov/pmns/mtg?do=details&Code=20191137 Commission's Policy Statement on "Enhancing Public Participation in NRC Meetings" 67 Federal Register 36920, May 28, 2002 The policy statement may be found on the NRC website http://www.nrc.gov/reading-rm/doc-collections/commission/policy/67fr36920.html