Darice Bailey Texas Department of State Health Services ACMUI Agreement State Representative

Advisory Committee on the Medical Uses of Isotopes

Update to the Organization of Agreement States

August 29, 2012

Darice Bailey Texas Department of State Health Services

ACMUI Agreement State Representative

ACMUI Purpose

• Represents radioactive material users in the medical community.

• Provides a public forum to bring key issues and technical perspectives to the NRC’s attention.

• Provides technical and clinical expertise to NRC on medical uses of radioactive materials.

• Recommends and comments on changes to NRC regulations and guidance, as well as changes in procedures.

• Provides professional evaluation to NRC for new initiatives.

Membership “It truly is daunting”-Spring Awakening

Chairman: Leon S. Malmud, M.D., Health Care AdministratorVice Chairman: Bruce R. Thomadsen, Ph.D., Medical Physicist,

Radiation TherapyMembers:

Darice G. Bailey, Agreement State RepresentativeMilton J. Guiberteau, M.D., Diagnostic RadiologistSusan M. Langhorst, Ph.D., Radiation Safety OfficerSteven R. Mattmuller, Nuclear PharmacistChristopher J. Palestro, M.D., Nuclear Medicine PhysicianJohn H. Suh, M.D., Radiation Oncologist Orhan H. Suleiman, Ph.D., FDA RepresentativeWilliam A. Van Decker, M.D., Nuclear CardiologistLaura M. Weil, Patients' Rights AdvocateJames S. Welsh, M.D., Radiation OncologistPat B. Zanzonico, Ph.D., Medical Physicist, Nuclear Medicine

Personal Experience

• Steps required for appointment.

• Public meeting, fully transcribed – differs from working group meetings, etc.

• Seating assignments.

• Extremely kind treatment.

Agreement State and ACMUI Interaction

• ACMUI represents radioactive material users in the medical community.

• Through interaction with ACMUI, States have access to concerns and issues from a larger pool of licensees.

Agreement State and ACMUI Interaction

• ACMUI provides a public forum to bring key issues and technical perspectives to the NRC’s attention.

• Through interaction with ACMUI, the Agreement States have an additional forum to use for bringing information to NRC, as well as receiving information from medical licensees.

Agreement State and ACMUI Interaction

ACMUI provides technical and clinical expertise to NRC on medical uses of radioactive materials.

Through interaction with ACMUI the Agreement States have access to a wealth of knowledge and expertise.

Agreement State and ACMUI Interaction

• State issues and positions should be brought to ACMUI through the ACMUI Agreement State representative.

Representative Efforts

• Participate in NRC/OAS/CRCPD conference calls.

• Review NMED and ask questions of states regarding medical events.

• Provide agenda information to the OAS Board and bring issues/positions to ACMUI meetings.

• Provide post-meeting information to the Board• Offer agenda items for ACMUI as provided by

OAS.

OAS Board and Membership Efforts

• Review agenda items.• Seek information from membership.• Provide information to ACMUI

representative.• Contact representative with medical use

issues/positions/concerns as they arise.• Keep representative informed on state

efforts regarding medical use/issues.

Let the exchange

begin!

April 16-17, 2012 ACMUI Meeting Topic

Medical Event Definition

• ACMUI’s position was finalized prior to this meeting. NRC staff presented what they were proposing to the Commission. You received the most up to date information this morning.

April 16-17, 2012 ACMUI Meeting Topic

Medical Events Subcommittee Report

• Subcommittee reviews NMED and presents an annual review of medical events to the full ACMUI.

• Agreement State (AS) entries are included. A question arose regarding one AS entry.

April 16-17, 2012 ACMUI Meeting Topic

Electronic Signatures Subcommittee Report

• ACMUI approved the subcommittee’s report which provided guidance to NRC staff to accept electronic signatures as defined in the guidance of the E-Sign Act (Public Law No. 106-229).

• The term ‘‘electronic signature’’ means an electronic sound, symbol, or process, attached to or logically associated with a contract or other record and executed or adopted by a person with the intent to sign the record.

April 16-17, 2012 ACMUI Meeting Topic

Medical Use of Radium-223 Dichloride• A representative from the manufacturer

provided an overview of the clinical and radiation safety aspects of the medical use of Radium-223 dichloride.

• ACMUI member, Dr. Zanzonico, discussed the regulatory aspects of the medical use of Radium-223 dichloride.

April 16-17, 2012 ACMUI Meeting Topic

Medical Use of Radium-223 dichloride • A subcommittee was created to provide a

recommendation on licensing for alpha-emitters, including Radium-223.

• The subcommittee presented its report to the full ACMUI on July 9 via a publicly noticed conference call. The report was approved with modifications.

April 16-17, 2012 ACMUI Meeting Topic

Strontium/Rubidium Update • NRC staff provided an update on the

strontium breakthrough with rubidium-82 generators from an NRC perspective.

• ACMUI member, Dr. Suleiman, presented an update from the FDA perspective.

• A desire to hear lessons learned from Florida and Nevada was voiced by the committee.

April 16-17, 2012 ACMUI Meeting Topic

• NRC staff provided information regarding intentions to prepare a large Part 35 rule change for comment within the year.

• It is anticipated that the Medical Events definition will be included in that proposal.

• Large package is result of being responsive to the states and the impacts of cumulative effects of regulation.

• Reducing Occupational Dose Limits• Domestic production of Molybdenum-99• Part 35 Updates from NRC staff• Patient Release Data Collection update• Proposed Regulatory Changes for

Permanent Implant Brachytherapy Programs update

• Use of Dose Calibrators in Medicine• ACMUI Reporting Structure• Radium-223 Dichloride

September 20-21, 2012 ACMUI Draft Meeting Agenda

September 20-21, 2012 ACMUI Draft Meeting Agenda

OAS efforts• Do any states have unique patient release

criteria, inspection techniques, etc?

• Are there any special issues or situations regarding Molybdenum-99 availability in any of the Agreement States?

Next Steps

• Raise my awareness of medical issues in your state.

• Provide information to me that you want to bring to ACMUI’s attention.

• Provide to me any ideas/issues that I may suggest as topics for the April 2013 meeting.

Contact Information

Email me anytime [email protected]

ACMUI website

www.nrc.gov/about-nrc/regulatory/advisory/acmui.html

Acronyms

• ACMUI – Advisory Committee on the Medical Uses of Isotopes

• CRCPD – Conference of Radiation Control Program Directors

• FDA – U.S. Food and Drug Administration• NMED – Nuclear Materials Events Database• NRC – U.S. Nuclear Regulatory Commission• OAS – Organization of Agreement States