ML19325E671
| ML19325E671 | |
| Person / Time | |
|---|---|
| Issue date: | 11/18/2019 |
| From: | Advisory Committee on the Medical Uses of Isotopes, Office of Nuclear Material Safety and Safeguards |
| To: | |
| Jamerson, Kellee NMSS | |
| References | |
| Download: ML19325E671 (6) | |
Text
2019 Current Fiscal Year Report: Advisory Committee on the Medical Uses of Isotopes Report Run Date: 11/18/2019 03:42:52 PM
- 1. Department or Agency 2. Fiscal Year Nuclear Regulatory Commission 2019
- 3. Committee or Subcommittee 3b. GSA Committee No.
Advisory Committee on the Medical Uses of Isotopes 1102
- 4. Is this New During Fiscal 5. Current 6. Expected Renewal 7. Expected Term Year? Charter Date Date No 03/01/2018 03/01/2020 8a. Was Terminated During 8b. Specific Termination 8c. Actual Term FiscalYear? Authority Date No 42 U.S.C. 2201
- 9. Agency Recommendation for Next 10a. Legislation Req to 10b. Legislation FiscalYear Terminate? Pending?
Continue Not Applicable
- 11. Establishment Authority Agency Authority
- 12. Specific Establishment 13. Effective 14. Commitee 14c.
Authority Date Type Presidential?
42 U.S.C. 2201 07/01/1958 Continuing No
- 15. Description of Committee Scientific Technical Program Advisory Board 16a. Total Number of Reports 6 16b. Report Report Title Date Nursing Mother Guidelines for the Medical Administration of Radionuclides, 01/31/2019 Final Report (Table Revised)
Training and Experience for All Modalities Subcommittee, Final Report 02/27/2019 (35.390) 04/10/2019Subcommittee on the ACMUI Bylaws, Final Report Germanium-68/Gallium-68 Generator Licensing Guidance, Revision 1, Final 05/06/2019 Report Yttrium-90 Microsphere Brachytherapy Sources and Devices Licensing 05/09/2019 Guidance, Revision 10, Final Report Draft Proposed Regulatory Guide 8.39, "Release of Patients Administered 06/19/2019 Radioactive Materials," Revision 1 (Phase 1), Final Report Number of Committee Reports Listed: 6 17a. Open 2 17b. Closed 0 17c. Partially Closed 3 Other Activities 0 17d. Total 5 Meetings and Dates Purpose Start End
To discuss the ACMUI Training and Experience (T&E) Draft Subcommittee Report regarding the requirements for authorized users under Title 10 Code of Federal Regulations (10 CFR) 35.300, Use of 02/26/2019 - 02/26/2019 unsealed byproduct material for which a written directive is required.
To discuss issues related to the implementation of the medical regulations in Title 10 of the Code of 04/03/2019 - 04/04/2019 Federal Regulations (10 CFR) Part 35, "Medical Use of Byproduct Material."
To Discuss (1) the revised 2019 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Bylaws and (2) the ACMUI Regulatory Guide 8.39, Release of Patients Administered Radioactive Material 06/10/2019 - 06/10/2019 Draft Subcommittee Report To Discuss (1) the NRCs Abnormal Occurrence Criteria and (2) the ACMUI Subcommittees report on a 07/24/2019 - 07/24/2019 draft guidance document To discuss issues related to the implementation of the medical regulations in Title 10 of the Code of 09/10/2019 - 09/11/2019 Federal Regulations (10 CFR) Part 35, "Medical Use of Byproduct Material."
Number of Committee Meetings Listed: 5 Current FY Next FY 18a(1). Personnel Pmts to Non-Federal Members $90,709.86 $94,416.00 18a(2). Personnel Pmts to Federal Members $0.00 $0.00 18a(3). Personnel Pmts to Federal Staff $264,735.80 $207,740.00 18a(4). Personnel Pmts to Non-Member Consultants $0.00 $0.00 18b(1). Travel and Per Diem to Non-Federal Members $20,667.38 $29,000.00 18b(2). Travel and Per Diem to Federal Members $0.00 $0.00 18b(3). Travel and Per Diem to Federal Staff $3,296.15 $6,300.00 18b(4). Travel and Per Diem to Non-member Consultants $3,402.37 $0.00 18c. Other(rents,user charges, graphics, printing, mail, etc.) $0.00 $0.00 18d. Total $382,811.56 $337,456.00
- 19. Federal Staff Support Years (FTE) 1.44 1.13 20a. How does the Committee accomplish its purpose?
The NRC staff believes that licensees, the general public, and medical professionals benefit when recognized experts provide advice to the staff. This advice enables staff to develop rules that will maintain public safety, while not inappropriately intruding upon the practice of medicine.The staff provides a summary of issues to be addressed during meetings, and the ACMUI discusses the issues and gives advice and makes recommendations to the Staff. Furthermore, the ACMUI keeps staff abreast of new developments. This ongoing communication helps ensure that staff is aware of important issues during critical stages of rule development. When issues that need special emphasis arise, working groups and subcommittees are formed.
20b. How does the Committee balance its membership?
Membership is balanced by placing individuals of diverse specialty on the committee. For instance, there are members who represent both diagnostic and therapeutic applications of medicine. There are members who have a regulatory function within their specialties.
There is a member who represents medicine from an administrative standpoint, and there is a patient advocate member, who represents patients' interests. ACMUI members also
perform regular self-evaluations, in which they give feedback on the appropriateness of the committee's composition.
20c. How frequent and relevant are the Committee Meetings?
Committee meetings are generally held semi-annually. The committee will hold more frequent meetings when important issues emerge or when issues need timely resolution.
20d. Why can't the advice or information this committee provides be obtained elsewhere?
The NRC continues to strive to achieve its goal of creating risk-informed, performance-based regulations that provide for the health and safety of the public while imposing no unnecessary burden on licensees. Furthermore, the medical profession continues to see regular advances that create unique regulatory challenges. The advice and recommendations from medical professionals who are exposed to these advances is crucial to the NRC staff's ability to continue to regulate effectively.
20e. Why is it necessary to close and/or partially closed committee meetings?
Meetings are closed to conduct annual ethics briefings, annual allegations training, annual information security awareness training, conduct reviews of paperwork of a personal and confidential nature, and to discuss administrative matters that are purely internal to Committee business. It would be inappropriate to conduct these types of meetings openly.
They must be conducted privately to allow Committee members the freedom to ask and answer personal questions and to protect individuals' privacy.
- 21. Remarks None Designated Federal Officer Kellee Jamerson DFO Committee Members Start End Occupation Member Designation Bloom, Gary 09/23/2019 09/22/2023 Patients' Rights Advocate Special Government Employee (SGE) Member Dilsizian, Vasken 05/12/2014 05/11/2022 Nuclear Cardiologist Special Government Employee (SGE) Member Ennis, Ronald 03/18/2015 03/17/2023 Radiation Oncologist Special Government Employee (SGE) Member Green, Richard 05/27/2018 05/26/2022 Nuclear Pharmacist Special Government Employee (SGE) Member Martin, Melissa 08/19/2018 08/18/2022 Nuclear Medicine Physicist Special Government Employee (SGE) Member Metter, Darlene 03/05/2016 03/04/2020 Diagnostic Radiologist Special Government Employee (SGE) Member O'Hara, Michael 11/01/2014 09/30/2023 FDA Representative Regular Government Employee (RGE) Member Ouhib, Zoubir 04/15/2018 04/14/2022 Therapy Medical Physicist Special Government Employee (SGE) Member Palestro, Christopher 09/22/2011 09/21/2019 Nuclear Medicine Physician Special Government Employee (SGE) Member Schleipman, Arthur 09/16/2018 09/15/2022 Health Care Administrator Special Government Employee (SGE) Member Sheetz, Michael 09/29/2017 09/28/2021 Radiation Safety Officer Special Government Employee (SGE) Member Shober, Megan 04/15/2018 04/14/2022 Agreement State Representative Special Government Employee (SGE) Member Suh, John 10/18/2010 10/17/2018 Radiation Oncologist Special Government Employee (SGE) Member Weil, Laura 08/29/2011 08/28/2019 Patients' Rights Advocate Special Government Employee (SGE) Member
Wolkov, Harvey 04/29/2019 04/28/2023 Radiation Oncologist Special Government Employee (SGE) Member Number of Committee Members Listed: 15 Narrative Description The Committee provides input from the regulated medical community and the public that helps guide the NRC regulatory program.
What are the most significant program outcomes associated with this committee?
Checked if Applies Improvements to health or safety Trust in government Major policy changes Advance in scientific research Effective grant making Improved service delivery Increased customer satisfaction Implementation of laws or regulatory requirements Other Outcome Comments NA What are the cost savings associated with this committee?
Checked if Applies None Unable to Determine Under $100,000
$100,000 - $500,000
$500,001 - $1,000,000
$1,000,001 - $5,000,000
$5,000,001 - $10,000,000 Over $10,000,000 Cost Savings Other Cost Savings Comments Cost savings from improved regulations save medical institutions and patients, but totals can not be calculated.
What is the approximate Number of recommendations produced by this committee
for the life of the committee?
326 Number of Recommendations Comments Recommendations from 2007 to FY2019 are included in the current count.
What is the approximate Percentage of these recommendations that have been or will be Fully implemented by the agency?
87%
% of Recommendations Fully Implemented Comments Since 2007, 285 of 326 recommendations have been or will be fully implemented.
What is the approximate Percentage of these recommendations that have been or will be Partially implemented by the agency?
16%
% of Recommendations Partially Implemented Comments Since 2007, 54 of 326 recommendations have been or will be partially implemented or have pending status.
Does the agency provide the committee with feedback regarding actions taken to implement recommendations or advice offered?
Yes No Not Applicable Agency Feedback Comments NRC staff provides feedback at subsequent meetings by updating the Committee on the status of the list of recommendations.
What other actions has the agency taken as a result of the committee's advice or recommendation?
Checked if Applies Reorganized Priorities Reallocated resources Issued new regulation Proposed legislation Approved grants or other payments Other
Action Comments NA Is the Committee engaged in the review of applications for grants?
No Grant Review Comments NA How is access provided to the information for the Committee's documentation?
Checked if Applies Contact DFO Online Agency Web Site Online Committee Web Site Online GSA FACA Web Site Publications Other Access Comments http://www.nrc.gov/about-nrc/regulatory/advisory/acmui.html