ML18108A245
Text
L.
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 April 19, 2018 Cindy Tomlinson Senior Patient Safety and Regulatory Affairs Manager American Society for Radiation Oncology 251 18th St. South, 8th Floor Arlington, VA 22202
SUBJECT:
EVALUATION OF TAILORED TRAINING AND EXPERIENCE REQUIREMENTS FOR DIFFERENT CATEGORIES OF RADIOPHARMACEUTICALS
Dear Ms. Tomlinson:
The U.S. Nuclear Regulatory Commission (NRC) is currently evaluating the training and experience requirements for different categories of radiopharmaceuticals as directed by the Staff Requirements Memorandum for SECY-16-0080, Final Rule: Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments (RIN 3150-AI63; NRC-2008-0175) (Agencywide Documents Access and Management System Accession No. ML17229B284). Specifically, staff is looking at the training and experience requirements for radiopharmaceuticals under Title 10 of the Code of Federal Regulations (10 CFR) 35.390, Training for use of unsealed byproduct material for which a written directive is required.
The NRC is asking for your assistance in completing the attached questionnaire, which you should have already received by e-mail. We are requesting your voluntary feedback on four areas: (1) the fundamental knowledge necessary for administering any radiopharmaceutical under 10 CFR 35.390; (2) the additional knowledge necessary for administering specific types of radiopharmaceuticals under 10 CFR 35.390; (3) how to best acquire this knowledge; and (4) how this knowledge and ability to function independently should best be evaluated
[i.e., competency]. Your voluntary response will help us in our evaluation.
C. Tomlinson In your response, make sure not to include any proprietary Information in accordance with 10 CFR 2.390, Public inspections, exemptions, requests for withholding. For further information or for questions, please contact Maryann Ayoade at (301) 415-0862 or via e-mail at Maryann.Ayoade@nrc.gov, or Irene Wu at (301) 415-1951 or via e-mail at Irene.Wu@nrc.gov.
Sincerely,
/RA/
Douglas R. Bollock, Chief Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
Enclosure:
Questionnaire on the Evaluation of Tailored Training and Experience Requirements for Different Categories of Radiopharmaceuticals
C. Tomlinson
SUBJECT:
EVALUATION OF TAILORED TRAINING AND EXPERIENCE REQUIREMENTS FOR DIFFERENT CATEGORIES OF RADIOPHARMACEUTICALS.
DATED: APRIL 19, 2018 IDENTICAL LETTERS SENT TO: See Attached ML18108A266(P)
OFFICE MSST/MSEB MSST/MSEB MSTR/MSEB NAME IWu Via e-mail DBollock MAyoade DATE 4/19/18 4/19/18 4/19/18 OFFICIAL RECORD COPY
Identical Letters sent to:
Daniel Pryma, MD Bryan Ruiz Chair Radiation Safety Officer The American Board of The Regents of the University Nuclear Medicine of California, Los Angeles 4555 Forest Park Blvd., Suite 119 UCLA Radiation Safety Division St. Louis, MO 63108-2173 501 Westwood Plaza, Fourth Floor Los Angeles, CA 90095-1605 Michael Guastella Director Hung Dam, MD Council on Radionuclides Radiation Safety Committee Chair and Radiopharmaceuticals, Inc. Christiana Care Health Services, Inc.
500 North Capitol Street, NW, Suite 210 Management Suite - Room 1270 Washington, DC 20001-7407 4755 Olgetown-Stanton Road Newark, DE 19718 Mike Fuller Radioactive Material Program Supervisor Thomas Moenster Virginia Department of Health Radiation Safety Officer Office of Radiological Health Missouri Baptist Medical Center 109 Governor Street, 7th Floor 3015 N. Ballas Road Richmond, VA 23219 St. Louis, MO 63131 Michael Bohan Kimberly Alston, MAJ Radiation Safety Officer Radiation Safety Officer Yale - New Haven Hospital Uniformed Services University Radiological Physics - WWW 229 of the Health Sciences 20 York Street 4301 Jones Bridge Road New Haven, CT 06510 Bethesda, MD 20814 Ravinder Nath, PhD Catherine Ribaudo Director of Radiation Physics Radiation Safety Officer Yale - New Haven Hospital Department of Health &
Radiation Oncology Human Services 20 York Street - CB 3 National Institutes of Health New Haven, CT 06510 21 Wilson Drive, MSC 6780 Bethesda, MD 20892-6780 Lawrence Spaerstein, MD Director of Nuclear Medicine Kevin Martilla Yale - New Haven Hospital Radiation Safety Officer Nuclear Medicine Department of the Army 20 York Street Smilow 2 Brooke Army Medical Center New Haven, CT 06510 Attn: MCHE-ZHP-H (Health Physics Service)
Mary Beth Taormina 3551 Roger Brooke Drive, Radiation Safety Officer Building 3600 Virginia Commonwealth University Fort Sam Houston, JBSA, TX 78234-6200 Office of Environmental Health & Safety P.O. Box 980112 Richmond, VA 23298-0112
Kaisha Nesmith, CPT Radiation Safety Officer Department of the Army Womack Army Medical Center 2817 Reilly Road Attn: MCXC-DPM-RP Office Fort Bragg, NC 28310 Suyog Chhetri, CPT Radiation Safety Officer Department of the Army Carl R. Darnall Army Medical Center 36065 Santa Fe Avenue Fort Hood, TX 76544-4752
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 April 19, 2018 Daniel Pryma, MD Chair The American Board of Nuclear Medicine 4555 Forest Park Blvd., Suite 119 St. Louis, MO 63108-2173
SUBJECT:
EVALUATION OF TAILORED TRAINING AND EXPERIENCE REQUIREMENTS FOR DIFFERENT CATEGORIES OF RADIOPHARMACEUTICALS
Dear Dr. Pryma:
The U.S. Nuclear Regulatory Commission (NRC) is currently evaluating the training and experience requirements for different categories of radiopharmaceuticals as directed by the Staff Requirements Memorandum for SECY-16-0080, Final Rule: Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments (RIN 3150-AI63; NRC-2008-0175) (Agencywide Documents Access and Management System Accession No. ML17229B284). Specifically, staff is looking at the training and experience requirements for radiopharmaceuticals under Title 10 of the Code of Federal Regulations (10 CFR) 35.390, Training for use of unsealed byproduct material for which a written directive is required.
The NRC is asking for your assistance in completing the attached questionnaire, which you should have already received by e-mail. We are requesting your voluntary feedback on four areas: (1) the fundamental knowledge necessary for administering any radiopharmaceutical under 10 CFR 35.390; (2) the additional knowledge necessary for administering specific types of radiopharmaceuticals under 10 CFR 35.390; (3) how to best acquire this knowledge; and (4) how this knowledge and ability to function independently should best be evaluated
[i.e., competency]. Your voluntary response will help us in our evaluation.
D. Pryma In your response, make sure not to include any proprietary Information in accordance with 10 CFR 2.390, Public inspections, exemptions, requests for withholding. For further information or for questions, please contact Maryann Ayoade at (301) 415-0862 or via e-mail at Maryann.Ayoade@nrc.gov, or Irene Wu at (301) 415-1951 or via e-mail at Irene.Wu@nrc.gov.
Sincerely,
/RA/
Douglas R. Bollock, Chief Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
Enclosure:
Questionnaire on the Evaluation of Tailored Training and Experience Requirements for Different Categories of Radiopharmaceuticals
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 April 19, 2018 Michael Guastella Director Council on Radionuclides and Radiopharmaceuticals, Inc.
500 North Capitol Street, NW, Suite 210 Washington, DC 20001-7407
SUBJECT:
EVALUATION OF TAILORED TRAINING AND EXPERIENCE REQUIREMENTS FOR DIFFERENT CATEGORIES OF RADIOPHARMACEUTICALS
Dear Mr. Guastella:
The U.S. Nuclear Regulatory Commission (NRC) is currently evaluating the training and experience requirements for different categories of radiopharmaceuticals as directed by the Staff Requirements Memorandum for SECY-16-0080, Final Rule: Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments (RIN 3150-AI63; NRC-2008-0175) (Agencywide Documents Access and Management System Accession No. ML17229B284). Specifically, staff is looking at the training and experience requirements for radiopharmaceuticals under Title 10 of the Code of Federal Regulations (10 CFR) 35.390, Training for use of unsealed byproduct material for which a written directive is required.
The NRC is asking for your assistance in completing the attached questionnaire, which you should have already received by e-mail. We are requesting your voluntary feedback on four areas: (1) the fundamental knowledge necessary for administering any radiopharmaceutical under 10 CFR 35.390; (2) the additional knowledge necessary for administering specific types of radiopharmaceuticals under 10 CFR 35.390; (3) how to best acquire this knowledge; and (4) how this knowledge and ability to function independently should best be evaluated
[i.e., competency]. Your voluntary response will help us in our evaluation.
M. Guastella In your response, make sure not to include any proprietary Information in accordance with 10 CFR 2.390, Public inspections, exemptions, requests for withholding. For further information or for questions, please contact Maryann Ayoade at (301) 415-0862 or via e-mail at Maryann.Ayoade@nrc.gov, or Irene Wu at (301) 415-1951 or via e-mail at Irene.Wu@nrc.gov.
Sincerely,
/RA/
Douglas R. Bollock, Chief Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
Enclosure:
Questionnaire on the Evaluation of Tailored Training and Experience Requirements for Different Categories of Radiopharmaceuticals
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 April 19, 2018 Mike Fuller Radioactive Material Program Supervisor Virginia Department of Health Office of Radiological Health 109 Governor Street, 7th Floor Richmond, VA 23219
SUBJECT:
EVALUATION OF TAILORED TRAINING AND EXPERIENCE REQUIREMENTS FOR DIFFERENT CATEGORIES OF RADIOPHARMACEUTICALS
Dear Mr. Fuller:
The U.S. Nuclear Regulatory Commission (NRC) is currently evaluating the training and experience requirements for different categories of radiopharmaceuticals as directed by the Staff Requirements Memorandum for SECY-16-0080, Final Rule: Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments (RIN 3150-AI63; NRC-2008-0175) (Agencywide Documents Access and Management System Accession No. ML17229B284). Specifically, staff is looking at the training and experience requirements for radiopharmaceuticals under Title 10 of the Code of Federal Regulations (10 CFR) 35.390, Training for use of unsealed byproduct material for which a written directive is required.
The NRC is asking for your assistance in completing the attached questionnaire, which you should have already received by e-mail. We are requesting your voluntary feedback on four areas: (1) the fundamental knowledge necessary for administering any radiopharmaceutical under 10 CFR 35.390; (2) the additional knowledge necessary for administering specific types of radiopharmaceuticals under 10 CFR 35.390; (3) how to best acquire this knowledge; and (4) how this knowledge and ability to function independently should best be evaluated
[i.e., competency]. Your voluntary response will help us in our evaluation.
M. Fuller In your response, make sure not to include any proprietary Information in accordance with 10 CFR 2.390, Public inspections, exemptions, requests for withholding. For further information or for questions, please contact Maryann Ayoade at (301) 415-0862 or via e-mail at Maryann.Ayoade@nrc.gov, or Irene Wu at (301) 415-1951 or via e-mail at Irene.Wu@nrc.gov.
Sincerely,
/RA/
Douglas R. Bollock, Chief Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
Enclosure:
Questionnaire on the Evaluation of Tailored Training and Experience Requirements for Different Categories of Radiopharmaceuticals
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 April 19, 2018 Michael Bohan Radiation Safety Officer Yale - New Haven Hospital Radiological Physics - WWW 229 20 York Street New Haven, CT 06510
SUBJECT:
EVALUATION OF TAILORED TRAINING AND EXPERIENCE REQUIREMENTS FOR DIFFERENT CATEGORIES OF RADIOPHARMACEUTICALS
Dear Mr. Bohan:
The U.S. Nuclear Regulatory Commission (NRC) is currently evaluating the training and experience requirements for different categories of radiopharmaceuticals as directed by the Staff Requirements Memorandum for SECY-16-0080, Final Rule: Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments (RIN 3150-AI63; NRC-2008-0175) (Agencywide Documents Access and Management System Accession No. ML17229B284). Specifically, staff is looking at the training and experience requirements for radiopharmaceuticals under Title 10 of the Code of Federal Regulations (10 CFR) 35.390, Training for use of unsealed byproduct material for which a written directive is required.
The NRC is asking for your assistance in completing the attached questionnaire, which you should have already received by e-mail. We are requesting your voluntary feedback on four areas: (1) the fundamental knowledge necessary for administering any radiopharmaceutical under 10 CFR 35.390; (2) the additional knowledge necessary for administering specific types of radiopharmaceuticals under 10 CFR 35.390; (3) how to best acquire this knowledge; and (4) how this knowledge and ability to function independently should best be evaluated
[i.e., competency]. Your voluntary response will help us in our evaluation.
M. Bohan In your response, make sure not to include any proprietary Information in accordance with 10 CFR 2.390, Public inspections, exemptions, requests for withholding. For further information or for questions, please contact Maryann Ayoade at (301) 415-0862 or via e-mail at Maryann.Ayoade@nrc.gov, or Irene Wu at (301) 415-1951 or via e-mail at Irene.Wu@nrc.gov.
Sincerely,
/RA/
Douglas R. Bollock, Chief Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
Enclosure:
Questionnaire on the Evaluation of Tailored Training and Experience Requirements for Different Categories of Radiopharmaceuticals
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 April 19, 2018 Ravinder Nath, PhD Director of Radiation Physics Yale - New Haven Hospital Radiation Oncology 20 York Street - CB 3 New Haven, CT 06510
SUBJECT:
EVALUATION OF TAILORED TRAINING AND EXPERIENCE REQUIREMENTS FOR DIFFERENT CATEGORIES OF RADIOPHARMACEUTICALS
Dear Mr. Nath:
The U.S. Nuclear Regulatory Commission (NRC) is currently evaluating the training and experience requirements for different categories of radiopharmaceuticals as directed by the Staff Requirements Memorandum for SECY-16-0080, Final Rule: Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments (RIN 3150-AI63; NRC-2008-0175) (Agencywide Documents Access and Management System Accession No. ML17229B284). Specifically, staff is looking at the training and experience requirements for radiopharmaceuticals under Title 10 of the Code of Federal Regulations (10 CFR) 35.390, Training for use of unsealed byproduct material for which a written directive is required.
The NRC is asking for your assistance in completing the attached questionnaire, which you should have already received by e-mail. We are requesting your voluntary feedback on four areas: (1) the fundamental knowledge necessary for administering any radiopharmaceutical under 10 CFR 35.390; (2) the additional knowledge necessary for administering specific types of radiopharmaceuticals under 10 CFR 35.390; (3) how to best acquire this knowledge; and (4) how this knowledge and ability to function independently should best be evaluated
[i.e., competency]. Your voluntary response will help us in our evaluation.
R. Nath In your response, make sure not to include any proprietary Information in accordance with 10 CFR 2.390, Public inspections, exemptions, requests for withholding. For further information or for questions, please contact Maryann Ayoade at (301) 415-0862 or via e-mail at Maryann.Ayoade@nrc.gov, or Irene Wu at (301) 415-1951 or via e-mail at Irene.Wu@nrc.gov.
Sincerely,
/RA/
Douglas R. Bollock, Chief Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
Enclosure:
Questionnaire on the Evaluation of Tailored Training and Experience Requirements for Different Categories of Radiopharmaceuticals
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 April 19, 2018 Lawrence Spaerstein, MD Director of Nuclear Medicine Yale - New Haven Hospital Nuclear Medicine 20 York Street Smilow 2 New Haven, CT 06510
SUBJECT:
EVALUATION OF TAILORED TRAINING AND EXPERIENCE REQUIREMENTS FOR DIFFERENT CATEGORIES OF RADIOPHARMACEUTICALS
Dear Dr. Spaerstein:
The U.S. Nuclear Regulatory Commission (NRC) is currently evaluating the training and experience requirements for different categories of radiopharmaceuticals as directed by the Staff Requirements Memorandum for SECY-16-0080, Final Rule: Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments (RIN 3150-AI63; NRC-2008-0175) (Agencywide Documents Access and Management System Accession No. ML17229B284). Specifically, staff is looking at the training and experience requirements for radiopharmaceuticals under Title 10 of the Code of Federal Regulations (10 CFR) 35.390, Training for use of unsealed byproduct material for which a written directive is required.
The NRC is asking for your assistance in completing the attached questionnaire, which you should have already received by e-mail. We are requesting your voluntary feedback on four areas: (1) the fundamental knowledge necessary for administering any radiopharmaceutical under 10 CFR 35.390; (2) the additional knowledge necessary for administering specific types of radiopharmaceuticals under 10 CFR 35.390; (3) how to best acquire this knowledge; and (4) how this knowledge and ability to function independently should best be evaluated
[i.e., competency]. Your voluntary response will help us in our evaluation.
L. Spaerstein In your response, make sure not to include any proprietary Information in accordance with 10 CFR 2.390, Public inspections, exemptions, requests for withholding. For further information or for questions, please contact Maryann Ayoade at (301) 415-0862 or via e-mail at Maryann.Ayoade@nrc.gov, or Irene Wu at (301) 415-1951 or via e-mail at Irene.Wu@nrc.gov.
Sincerely,
/RA/
Douglas R. Bollock, Chief Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
Enclosure:
Questionnaire on the Evaluation of Tailored Training and Experience Requirements for Different Categories of Radiopharmaceuticals
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 April 19, 2018 Mary Beth Taormina Radiation Safety Officer Virginia Commonwealth University Office of Environmental Health & Safety P.O. Box 980112 Richmond, VA 23298-0112
SUBJECT:
EVALUATION OF TAILORED TRAINING AND EXPERIENCE REQUIREMENTS FOR DIFFERENT CATEGORIES OF RADIOPHARMACEUTICALS
Dear Ms. Taromina:
The U.S. Nuclear Regulatory Commission (NRC) is currently evaluating the training and experience requirements for different categories of radiopharmaceuticals as directed by the Staff Requirements Memorandum for SECY-16-0080, Final Rule: Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments (RIN 3150-AI63; NRC-2008-0175) (Agencywide Documents Access and Management System Accession No. ML17229B284). Specifically, staff is looking at the training and experience requirements for radiopharmaceuticals under Title 10 of the Code of Federal Regulations (10 CFR) 35.390, Training for use of unsealed byproduct material for which a written directive is required.
The NRC is asking for your assistance in completing the attached questionnaire, which you should have already received by e-mail. We are requesting your voluntary feedback on four areas: (1) the fundamental knowledge necessary for administering any radiopharmaceutical under 10 CFR 35.390; (2) the additional knowledge necessary for administering specific types of radiopharmaceuticals under 10 CFR 35.390; (3) how to best acquire this knowledge; and (4) how this knowledge and ability to function independently should best be evaluated
[i.e., competency]. Your voluntary response will help us in our evaluation.
B. Taromina In your response, make sure not to include any proprietary Information in accordance with 10 CFR 2.390, Public inspections, exemptions, requests for withholding. For further information or for questions, please contact Maryann Ayoade at (301) 415-0862 or via e-mail at Maryann.Ayoade@nrc.gov, or Irene Wu at (301) 415-1951 or via e-mail at Irene.Wu@nrc.gov.
Sincerely,
/RA/
Douglas R. Bollock, Chief Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
Enclosure:
Questionnaire on the Evaluation of Tailored Training and Experience Requirements for Different Categories of Radiopharmaceuticals
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 April 19, 2018 Bryan Ruiz Radiation Safety Officer The Regents of the University of California, Los Angeles UCLA Radiation Safety Division 501 Westwood Plaza, Fourth Floor Los Angeles, CA 90095-1605
SUBJECT:
EVALUATION OF TAILORED TRAINING AND EXPERIENCE REQUIREMENTS FOR DIFFERENT CATEGORIES OF RADIOPHARMACEUTICALS
Dear Mr. Ruiz:
The U.S. Nuclear Regulatory Commission (NRC) is currently evaluating the training and experience requirements for different categories of radiopharmaceuticals as directed by the Staff Requirements Memorandum for SECY-16-0080, Final Rule: Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments (RIN 3150-AI63; NRC-2008-0175) (Agencywide Documents Access and Management System Accession No. ML17229B284). Specifically, staff is looking at the training and experience requirements for radiopharmaceuticals under Title 10 of the Code of Federal Regulations (10 CFR) 35.390, Training for use of unsealed byproduct material for which a written directive is required.
The NRC is asking for your assistance in completing the attached questionnaire, which you should have already received by e-mail. We are requesting your voluntary feedback on four areas: (1) the fundamental knowledge necessary for administering any radiopharmaceutical under 10 CFR 35.390; (2) the additional knowledge necessary for administering specific types of radiopharmaceuticals under 10 CFR 35.390; (3) how to best acquire this knowledge; and (4) how this knowledge and ability to function independently should best be evaluated
[i.e., competency]. Your voluntary response will help us in our evaluation.
B. Ruiz In your response, make sure not to include any proprietary Information in accordance with 10 CFR 2.390, Public inspections, exemptions, requests for withholding. For further information or for questions, please contact Maryann Ayoade at (301) 415-0862 or via e-mail at Maryann.Ayoade@nrc.gov, or Irene Wu at (301) 415-1951 or via e-mail at Irene.Wu@nrc.gov.
Sincerely,
/RA/
Douglas R. Bollock, Chief Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
Enclosure:
Questionnaire on the Evaluation of Tailored Training and Experience Requirements for Different Categories of Radiopharmaceuticals
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 April 19, 2018 Hung Dam, MD Radiation Safety Committee Chair Christiana Care Health Services, Inc.
Management Suite - Room 1270 4755 Olgetown-Stanton Road Newark, DE 19718
SUBJECT:
EVALUATION OF TAILORED TRAINING AND EXPERIENCE REQUIREMENTS FOR DIFFERENT CATEGORIES OF RADIOPHARMACEUTICALS
Dear Dr. Dam:
The U.S. Nuclear Regulatory Commission (NRC) is currently evaluating the training and experience requirements for different categories of radiopharmaceuticals as directed by the Staff Requirements Memorandum for SECY-16-0080, Final Rule: Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments (RIN 3150-AI63; NRC-2008-0175) (Agencywide Documents Access and Management System Accession No. ML17229B284). Specifically, staff is looking at the training and experience requirements for radiopharmaceuticals under Title 10 of the Code of Federal Regulations (10 CFR) 35.390, Training for use of unsealed byproduct material for which a written directive is required.
The NRC is asking for your assistance in completing the attached questionnaire, which you should have already received by e-mail. We are requesting your voluntary feedback on four areas: (1) the fundamental knowledge necessary for administering any radiopharmaceutical under 10 CFR 35.390; (2) the additional knowledge necessary for administering specific types of radiopharmaceuticals under 10 CFR 35.390; (3) how to best acquire this knowledge; and (4) how this knowledge and ability to function independently should best be evaluated
[i.e., competency]. Your voluntary response will help us in our evaluation.
H. Dam In your response, make sure not to include any proprietary Information in accordance with 10 CFR 2.390, Public inspections, exemptions, requests for withholding. For further information or for questions, please contact Maryann Ayoade at (301) 415-0862 or via e-mail at Maryann.Ayoade@nrc.gov, or Irene Wu at (301) 415-1951 or via e-mail at Irene.Wu@nrc.gov.
Sincerely,
/RA/
Douglas R. Bollock, Chief Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
Enclosure:
Questionnaire on the Evaluation of Tailored Training and Experience Requirements for Different Categories of Radiopharmaceuticals
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 April 19, 2018 Thomas Moenster Radiation Safety Officer Missouri Baptist Medical Center 3015 N. Ballas Road St. Louis, MO 63131
SUBJECT:
EVALUATION OF TAILORED TRAINING AND EXPERIENCE REQUIREMENTS FOR DIFFERENT CATEGORIES OF RADIOPHARMACEUTICALS
Dear Mr. Moenster:
The U.S. Nuclear Regulatory Commission (NRC) is currently evaluating the training and experience requirements for different categories of radiopharmaceuticals as directed by the Staff Requirements Memorandum for SECY-16-0080, Final Rule: Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments (RIN 3150-AI63; NRC-2008-0175) (Agencywide Documents Access and Management System Accession No. ML17229B284). Specifically, staff is looking at the training and experience requirements for radiopharmaceuticals under Title 10 of the Code of Federal Regulations (10 CFR) 35.390, Training for use of unsealed byproduct material for which a written directive is required.
The NRC is asking for your assistance in completing the attached questionnaire, which you should have already received by e-mail. We are requesting your voluntary feedback on four areas: (1) the fundamental knowledge necessary for administering any radiopharmaceutical under 10 CFR 35.390; (2) the additional knowledge necessary for administering specific types of radiopharmaceuticals under 10 CFR 35.390; (3) how to best acquire this knowledge; and (4) how this knowledge and ability to function independently should best be evaluated
[i.e., competency]. Your voluntary response will help us in our evaluation.
T. Moenster In your response, make sure not to include any proprietary Information in accordance with 10 CFR 2.390, Public inspections, exemptions, requests for withholding. For further information or for questions, please contact Maryann Ayoade at (301) 415-0862 or via e-mail at Maryann.Ayoade@nrc.gov, or Irene Wu at (301) 415-1951 or via e-mail at Irene.Wu@nrc.gov.
Sincerely,
/RA/
Douglas R. Bollock, Chief Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
Enclosure:
Questionnaire on the Evaluation of Tailored Training and Experience Requirements for Different Categories of Radiopharmaceuticals
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 April 19, 2018 Kimberly Alston, MAJ Radiation Safety Officer Uniformed Services University of the Health Sciences 4301 Jones Bridge Road Bethesda, MD 20814
SUBJECT:
EVALUATION OF TAILORED TRAINING AND EXPERIENCE REQUIREMENTS FOR DIFFERENT CATEGORIES OF RADIOPHARMACEUTICALS
Dear MAJ. Alston:
The U.S. Nuclear Regulatory Commission (NRC) is currently evaluating the training and experience requirements for different categories of radiopharmaceuticals as directed by the Staff Requirements Memorandum for SECY-16-0080, Final Rule: Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments (RIN 3150-AI63; NRC-2008-0175) (Agencywide Documents Access and Management System Accession No. ML17229B284). Specifically, staff is looking at the training and experience requirements for radiopharmaceuticals under Title 10 of the Code of Federal Regulations (10 CFR) 35.390, Training for use of unsealed byproduct material for which a written directive is required.
The NRC is asking for your assistance in completing the attached questionnaire, which you should have already received by e-mail. We are requesting your voluntary feedback on four areas: (1) the fundamental knowledge necessary for administering any radiopharmaceutical under 10 CFR 35.390; (2) the additional knowledge necessary for administering specific types of radiopharmaceuticals under 10 CFR 35.390; (3) how to best acquire this knowledge; and (4) how this knowledge and ability to function independently should best be evaluated
[i.e., competency]. Your voluntary response will help us in our evaluation.
K. Alston In your response, make sure not to include any proprietary Information in accordance with 10 CFR 2.390, Public inspections, exemptions, requests for withholding. For further information or for questions, please contact Maryann Ayoade at (301) 415-0862 or via e-mail at Maryann.Ayoade@nrc.gov, or Irene Wu at (301) 415-1951 or via e-mail at Irene.Wu@nrc.gov.
Sincerely,
/RA/
Douglas R. Bollock, Chief Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
Enclosure:
Questionnaire on the Evaluation of Tailored Training and Experience Requirements for Different Categories of Radiopharmaceuticals
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 April 19, 2018 Catherine Ribaudo Radiation Safety Officer Department of Health &
Human Services National Institutes of Health 21 Wilson Drive, MSC 6780 Bethesda, MD 20892-6780
SUBJECT:
EVALUATION OF TAILORED TRAINING AND EXPERIENCE REQUIREMENTS FOR DIFFERENT CATEGORIES OF RADIOPHARMACEUTICALS
Dear Ms. Ribaudo:
The U.S. Nuclear Regulatory Commission (NRC) is currently evaluating the training and experience requirements for different categories of radiopharmaceuticals as directed by the Staff Requirements Memorandum for SECY-16-0080, Final Rule: Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments (RIN 3150-AI63; NRC-2008-0175) (Agencywide Documents Access and Management System Accession No. ML17229B284). Specifically, staff is looking at the training and experience requirements for radiopharmaceuticals under Title 10 of the Code of Federal Regulations (10 CFR) 35.390, Training for use of unsealed byproduct material for which a written directive is required.
The NRC is asking for your assistance in completing the attached questionnaire, which you should have already received by e-mail. We are requesting your voluntary feedback on four areas: (1) the fundamental knowledge necessary for administering any radiopharmaceutical under 10 CFR 35.390; (2) the additional knowledge necessary for administering specific types of radiopharmaceuticals under 10 CFR 35.390; (3) how to best acquire this knowledge; and (4) how this knowledge and ability to function independently should best be evaluated
[i.e., competency]. Your voluntary response will help us in our evaluation.
C. Ribaudo In your response, make sure not to include any proprietary Information in accordance with 10 CFR 2.390, Public inspections, exemptions, requests for withholding. For further information or for questions, please contact Maryann Ayoade at (301) 415-0862 or via e-mail at Maryann.Ayoade@nrc.gov, or Irene Wu at (301) 415-1951 or via e-mail at Irene.Wu@nrc.gov.
Sincerely,
/RA/
Douglas R. Bollock, Chief Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
Enclosure:
Questionnaire on the Evaluation of Tailored Training and Experience Requirements for Different Categories of Radiopharmaceuticals
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 April 19, 2018 Kevin Martilla Radiation Safety Officer Department of the Army Brooke Army Medical Center Attn: MCHE-ZHP-H (Health Physics Service) 3551 Roger Brooke Drive, Building 3600 Fort Sam Houston, JBSA, TX 78234-6200
SUBJECT:
EVALUATION OF TAILORED TRAINING AND EXPERIENCE REQUIREMENTS FOR DIFFERENT CATEGORIES OF RADIOPHARMACEUTICALS
Dear Mr. Martilla:
The U.S. Nuclear Regulatory Commission (NRC) is currently evaluating the training and experience requirements for different categories of radiopharmaceuticals as directed by the Staff Requirements Memorandum for SECY-16-0080, Final Rule: Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments (RIN 3150-AI63; NRC-2008-0175) (Agencywide Documents Access and Management System Accession No. ML17229B284). Specifically, staff is looking at the training and experience requirements for radiopharmaceuticals under Title 10 of the Code of Federal Regulations (10 CFR) 35.390, Training for use of unsealed byproduct material for which a written directive is required.
The NRC is asking for your assistance in completing the attached questionnaire, which you should have already received by e-mail. We are requesting your voluntary feedback on four areas: (1) the fundamental knowledge necessary for administering any radiopharmaceutical under 10 CFR 35.390; (2) the additional knowledge necessary for administering specific types of radiopharmaceuticals under 10 CFR 35.390; (3) how to best acquire this knowledge; and (4) how this knowledge and ability to function independently should best be evaluated
[i.e., competency]. Your voluntary response will help us in our evaluation.
K. Martilla In your response, make sure not to include any proprietary Information in accordance with 10 CFR 2.390, Public inspections, exemptions, requests for withholding. For further information or for questions, please contact Maryann Ayoade at (301) 415-0862 or via e-mail at Maryann.Ayoade@nrc.gov, or Irene Wu at (301) 415-1951 or via e-mail at Irene.Wu@nrc.gov.
Sincerely,
/RA/
Douglas R. Bollock, Chief Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
Enclosure:
Questionnaire on the Evaluation of Tailored Training and Experience Requirements for Different Categories of Radiopharmaceuticals
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 April 19, 2018 Kaisha Nesmith, CPT Radiation Safety Officer Department of the Army Womack Army Medical Center 2817 Reilly Road Attn: MCXC-DPM-RP Office Fort Bragg, NC 28310
SUBJECT:
EVALUATION OF TAILORED TRAINING AND EXPERIENCE REQUIREMENTS FOR DIFFERENT CATEGORIES OF RADIOPHARMACEUTICALS
Dear CPT. Nesmith:
The U.S. Nuclear Regulatory Commission (NRC) is currently evaluating the training and experience requirements for different categories of radiopharmaceuticals as directed by the Staff Requirements Memorandum for SECY-16-0080, Final Rule: Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments (RIN 3150-AI63; NRC-2008-0175) (Agencywide Documents Access and Management System Accession No. ML17229B284). Specifically, staff is looking at the training and experience requirements for radiopharmaceuticals under Title 10 of the Code of Federal Regulations (10 CFR) 35.390, Training for use of unsealed byproduct material for which a written directive is required.
The NRC is asking for your assistance in completing the attached questionnaire, which you should have already received by e-mail. We are requesting your voluntary feedback on four areas: (1) the fundamental knowledge necessary for administering any radiopharmaceutical under 10 CFR 35.390; (2) the additional knowledge necessary for administering specific types of radiopharmaceuticals under 10 CFR 35.390; (3) how to best acquire this knowledge; and (4) how this knowledge and ability to function independently should best be evaluated
[i.e., competency]. Your voluntary response will help us in our evaluation.
K. Nesmith In your response, make sure not to include any proprietary Information in accordance with 10 CFR 2.390, Public inspections, exemptions, requests for withholding. For further information or for questions, please contact Maryann Ayoade at (301) 415-0862 or via e-mail at Maryann.Ayoade@nrc.gov, or Irene Wu at (301) 415-1951 or via e-mail at Irene.Wu@nrc.gov.
Sincerely,
/RA/
Douglas R. Bollock, Chief Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
Enclosure:
Questionnaire on the Evaluation of Tailored Training and Experience Requirements for Different Categories of Radiopharmaceuticals
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 April 19, 2018 Suyog Chhetri, CPT Radiation Safety Officer Department of the Army Carl R. Darnall Army Medical Center 36065 Santa Fe Avenue Fort Hood, TX 76544-4752
SUBJECT:
EVALUATION OF TAILORED TRAINING AND EXPERIENCE REQUIREMENTS FOR DIFFERENT CATEGORIES OF RADIOPHARMACEUTICALS
Dear CPT. Chhetri:
The U.S. Nuclear Regulatory Commission (NRC) is currently evaluating the training and experience requirements for different categories of radiopharmaceuticals as directed by the Staff Requirements Memorandum for SECY-16-0080, Final Rule: Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments (RIN 3150-AI63; NRC-2008-0175) (Agencywide Documents Access and Management System Accession No. ML17229B284). Specifically, staff is looking at the training and experience requirements for radiopharmaceuticals under Title 10 of the Code of Federal Regulations (10 CFR) 35.390, Training for use of unsealed byproduct material for which a written directive is required.
The NRC is asking for your assistance in completing the attached questionnaire, which you should have already received by e-mail. We are requesting your voluntary feedback on four areas: (1) the fundamental knowledge necessary for administering any radiopharmaceutical under 10 CFR 35.390; (2) the additional knowledge necessary for administering specific types of radiopharmaceuticals under 10 CFR 35.390; (3) how to best acquire this knowledge; and (4) how this knowledge and ability to function independently should best be evaluated
[i.e., competency]. Your voluntary response will help us in our evaluation.
S. Chhetri In your response, make sure not to include any proprietary Information in accordance with 10 CFR 2.390, Public inspections, exemptions, requests for withholding. For further information or for questions, please contact Maryann Ayoade at (301) 415-0862 or via e-mail at Maryann.Ayoade@nrc.gov, or Irene Wu at (301) 415-1951 or via e-mail at Irene.Wu@nrc.gov.
Sincerely,
/RA/
Douglas R. Bollock, Chief Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
Enclosure:
Questionnaire on the Evaluation of Tailored Training and Experience Requirements for Different Categories of Radiopharmaceuticals