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MEETING AGENDA
ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES

October 27-28, 2008
Two White Flint North (T-2B3), Rockville, Maryland

(If Sessions are not hyperlinked then no handouts were provided.)

Monday, October 27, 2008
CLOSED SESSION
8:00 – 8:15 1. Opening Statements
Mr. Lewis will discuss internal Committee business.
R. Lewis, NRC
8:15 – 8:45 2. Ethics Briefing
Mr. Szabo will provide annual ethics training for Committee members.
J. Szabo, NRC
NOTE: The above session may be closed pursuant to 5 U.S.C. 552(b) to discuss organizational and personnel matters that relate solely to internal personnel rules and practices of the ACMUI; information the release of which would constitute a clearly unwarranted invasion of personal privacy; information the premature disclosure of which would be likely to significantly frustrate implementation of a proposed agency action; and disclosure of information which would risk circumvention of an agency regulation or statute.
Monday, October 27, 2008
OPEN SESSION
9:00 – 9:10 3. Opening Statements
Mr. Einberg will formally open the meeting.  Mr. Lewis will present opening remarks.
C. Einberg &
R. Lewis, NRC
9:10 – 10:00

4. Old Business
Ms. Tull will review previous Committee recommendations and provide NRC responses.

A. Tull, NRC
10:00 – 10:15 B R E A K  
10:15 – 11:00

5. Cesium Chloride (CsCl) Subcommittee Report 
Dr. Thomadsen will provide information from the CsCl Subcommittee Report.

B. Thomadsen, ACMUI
11:00 – 11:30

6. Fingerprinting Subcommittee Report 
Dr. Vetter will provide information from the Fingerprinting Subcommittee Report.

R. Vetter, ACMUI
11:30 – 12:15

7. Permanent Implant Brachytherapy Rulemaking Subcommittee Report
Dr. Nag will provide information from the Permanent Implant Brachytherapy Rulemaking Subcommittee Report.

S. Nag, ACMUI
12:15 – 1:15 L U N C H  
1:15 – 2:45

8. Yttrium-90 (Y-90) Microsphere Licensing Guidance
Dr. Salem will provide information on interventional radiologists as potential Authorized Users for Y-90 microspheres.

R. Salem, SIR
2:45 – 3:15

9. Potential Rulemaking and Associated Regulatory Information Summary (RIS) Regarding Multiple RSOs on a Medical-use License
Dr. Zelac will update the Committee on the status of the RIS and will also provide information on potential rulemaking to allow more than one RSO per license.

R. Zelac, NRC
3:15 – 3:30 B R E A K  
3:30 – 4:15

10. Status of Technical Basis for follow-up to Petition for Rulemaking (PRM) 35-20 (Ritenour Petition)
Dr. Zelac will provide an update on the status of the technical basis for PRM 35-20.

R. Zelac, NRC
4:15 – 5:00

11. Medical Isotope Shortages 
NRC staff is seeking advice from the Committee on the impacts of isotope shortages on the medical community.

TBD, NRC
Tuesday, October 28, 2008
OPEN SESSION
8:00 – 9:00

12. Revisions to the NRC Radiation Protection Requirements:Potential Impacts to the Medical Community
Dr. Cool will propose changes to 10 CFR Part 20 and seek Committee advice.

D. Cool, NRC
9:00 – 9:30

13. Infiltration of Fluorine-18 and Therapeutic Radiopharmaceuticals as Medical Events
Ms. Flannery will provide information on a recent infiltration and seek input from the Committee on the applicability of the medical event reporting requirements.

C. Flannery, NRC
9:30 – 10:15

14. Status of Commission Paper for Modifying Training and Experience (T&E) Attestation Requirements
Dr. Zelac will provide the status of the Commission Paper addressing the Committee’s recommendations for modifying the T&E attestation requirements.

R. Zelac, NRC
10:15 – 10:30 B R E A K  
10:30 – 11:00

15. Status of Current and Future 10 CFR Part 35 Rulemaking
NRC staff will provide information on current and future 10 CFR Part 35 rulemaking.

N. Bhalla &
E. Lohr, NRC
11:00 – 12:00

16. Potential Changes to 10 CFR Part 35
Dr. Howe will propose changes to 10 CFR Part 35 and seek Committee advice.

DB. Howe, NRC
12:00 – 1:00 L U N C H  
1:00 – 2:00

17. Medical Nuclear Materials Events
Dr. Howe and Mr. Lieto will provide a summary of recent medical-related events and seek Committee advice, recommendations, and insights.

DB. Howe, NRC &
R. Lieto, ACMUI
2:00 – 2:45 18. Intraocular Strontium-90 Eye Applicator
Dr. Heier will provide information on retinal surgery use of the NeoVista eye applicator in an ambulatory surgery center.
J. Heier, NeoVista, Inc.
2:45 – 3:00 B R E A K  
3:00 – 3:45

19. Patient Needs, Concerns, and Rights in Radiation Medicine 
Dr. Fisher will provide information from a patient’s perspective.

D. Fisher, ACMUI

 

3:45 – 4:30 20. Administrative Closing
Ms. Tull will provide a meeting summary and propose dates for the next meeting.
A. Tull, NRC