2019-02694. Advisory Committee on the Medical Uses of Isotopes: Meeting Notice

AGENCY:

U.S. Nuclear Regulatory Commission.

ACTION:

Notice of meeting.

SUMMARY:

The U.S. Nuclear Regulatory Commission will convene a meeting of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) on April 3-4, 2019. A sample of agenda items to be discussed during the public session includes: A discussion on medical-related events; a discussion on the ACMUI's recommendations and comments on revision 10 of the draft Yttrium-90 Microsphere Brachytherapy Sources and Devices TheraSphere® and SIR_Spheres® Licensing Guidance; a discussion on the summary of changes to the NRC's requirements regarding medical use of byproduct material; a discussion of the ACMUI's recommendations related to the appropriateness of the required reporting and notification of a medical event; a presentation from Lucerno Dynamics on the detection of nuclear medicine injection infiltrations; and a discussion on the ACMUI's recommendations and comments on the draft Germanium-68/Gallium-68 Pharmacy Grade Generator Licensing Guidance. The agenda is subject to change. The current agenda and any updates will be available at http://www.nrc.gov/​reading-rm/​doc-collections/​acmui/​meetings/​2019.html or by emailing Ms. Kellee Jamerson at the contact information below.

FOR FURTHER INFORMATION CONTACT:

Ms. Kellee Jamerson, email: [e-mail], telephone: [phone].

SUPPLEMENTARY INFORMATION:

Purpose: Discuss issues related to 10 CFR part 35 Medical Use of Byproduct Material.

Date and Time for Open Sessions: April 3, 2019, from 8:30 a.m. to 2:45 p.m. and April 4, 2019, from 8:30 a.m. to 2:45 p.m. Eastern Standard Time.

Date and Time for Closed Session: April 3, 2019, from 2:45 p.m. to 5:00 p.m. Eastern Standard Time.

Address for Public Meeting: U.S. Nuclear Regulatory Commission, Three White Flint North Building, Rooms 3WFN-1C03/1-C05, 11601 Landsdown Street, North Bethesda, Maryland 20852.

Public Participation

Any member of the public who wishes to participate in the meeting in person or via phone should contact Ms. Jamerson using the information below. The meeting will also be webcast live at https://video.nrc.gov/​.

Conduct of the Meeting

Christopher J. Palestro, M.D., will chair the meeting. Dr. Palestro will conduct the meeting in a manner that will facilitate the orderly conduct of business. The following procedures apply to public participation in the meeting:

1. Persons who wish to provide a written statement should submit an electronic copy to

Ms. Jamerson using the contact information listed above. All submittals must be received by March 29, 2019, three business days before the meeting, and must pertain to the topics on the agenda for the meeting.

2. Questions and comments from members of the public will be permitted during the meeting, at the discretion of the Chairman.

3. The draft transcript and meeting summary will be available on ACMUI's website http://www.nrc.gov/​reading-rm/​doc-collections/​acmui/​meetings/​2019.html on or about May 16, 2019.

4. Persons who require special services, such as those for the hearing impaired, should notify Ms. Jamerson of their planned attendance.

This meeting will be held in accordance with the Atomic Energy Act of 1954, as amended (primarily Section 161a); the Federal Advisory Committee Act (5 U.S.C. App); and the Commission's regulations in title 10 of the Code of Federal Regulations, Part 7.

Dated at Rockville, Maryland, on February 13, 2019.

For the U.S. Nuclear Regulatory Commission.

Russell E. Chazell,

Federal Advisory Committee Management Officer.