2019-17267. Advisory Committee on the Medical Uses of Isotopes: Meeting Notice

AGENCY:

U.S. Nuclear Regulatory Commission.

ACTION:

Notice of meeting.

The U.S. Nuclear Regulatory Commission (NRC) will convene a meeting of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) on September 10-11, 2019. A sample of agenda items to be discussed during the public session includes: (1) An update on medical-related events; (2) a discussion of the ACMUI's recommendations and comments on the draft Xcision® GammaPod Licensing Guidance; (3) a discussion on the status of emerging technologies licensed under Title 10 Code of Federal Regulations (10 CFR) Part 35.1000; (4) a discussion of the ACMUI's recommendations related to the appropriateness of the required medical event reporting in accordance with 10 CFR 35.3045; (5) a presentation from the National Nuclear Security Administration on their initiative to reduce the use of radioactive materials; (6) a discussion of the ACMUI's recommendations for improving the ACMUI's institutional memory; (7) a discussion of the ACMUI's recommendations and comments regarding the NRC's policy decision related to infiltrations and medical event reporting; (8) an update on the NRC staff's evaluation of training and experience requirements for radiopharmaceuticals requiring a written directive; and (9) a discussion on the U.S. Pharmacopeia General Chapter <825>. 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.

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

Date and Time for Open Sessions: September 10, 2019, from 8:30 a.m. to 2:45 p.m. and September 11, 2019, from 8:30 a.m. to 11:30 a.m. Eastern Standard Time (EST).

Date and Time for Closed Session: September 10, 2019, from 7:30 a.m. to 8:30 a.m. and 2:45 p.m. to 5:00 p.m. EST. These sessions will be closed on September 10, 2019, for badging and enrollment of new members to the ACMUI and for required annual training, respectively.

Address for Public Meeting: U.S. Nuclear Regulatory Commission, Two White Flint North Building, Room T-2D30, 11545 Rockville Pike, Rockville, 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/​.

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

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 September 5, 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 October 25, 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, this 8th day of August 2019.

For the U.S. Nuclear Regulatory Commission.

Russell E. Chazell,

Federal Advisory Committee Management Officer.