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ICR 202607-3150-004 · OMB 3150-0120 · Object 171168500.
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| File Type | application/pdf |
|---|---|
| File Title | c:\temp\ffdah1.wpf |
| Author | dah1 |
| Last Modified By | Designer 6.5 |
| File Modified | 2023-07-31 |
| File Created | 2023-07-31 |
| Conversion State | complete |
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NRC FORM 313A (AUS) (07-31-2023) U. S. NUCLEAR REGULATORY COMMISSION AUTHORIZED USER TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35.400 and 35.600) [10 CFR 35.57, 35.490, 35.491, and 35.690] Name of Proposed Authorized User Requested Authorization(s) (check all that apply) APPROVED BY OMB: NO. 3150-0120 EXPIRES: 07/31/2026 Estimated burden per response to comply with this mandatory collection request: 4.3 hours. Submittal of the application is necessary to determine that the applicant is qualified and that adequate procedures exist to protect the public health and safety. Send comments regarding burden estimate to the FOIA, Library, and Information Collections Branch (T-6 A10M), U. S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or by email to [email protected], and the OMB Reviewer at: OMB Office of Information and Regulatory Affairs, (3150-0120), Attn: Desk Officer for the Nuclear Regulatory Commission, 725 17th Street NW, Washington, DC 20503; email: [email protected]. The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the document requesting or requiring the collection displays a currently valid OMB control number. State or Territory Where Licensed 35.400 Manual brachytherapy sources 35.600 Teletherapy unit(s) 35.400 Ophthalmic use of strontium-90 35.600 Gamma stereotactic radiosurgery unit(s) 35.600 Remote afterloader unit(s) PART I -- TRAINING AND EXPERIENCE (Select one of the three methods below) *Training and Experience, including Board Certification, must have been obtained within the 7 years preceding the date of application or the individual must have obtained related continuing education and experience since the required training and experience was completed. Provide dates, duration, and description of continuing education and experience related to the uses checked above. 1. Board Certification a. Provide a copy of the board certification. b. For 35.690, go to the table in 3.e. and describe training provider and dates of training for each type of use for which authorization is sought. c. For a board certification issued on or before October 24, 2005, that is listed in 10 CFR 35.57(b)(2)(iii), provide the following: (i) Documentation that the individual performed each use checked above on or before October 24, 2005. (ii) Dates, duration, and description of continuing education and experience within the past seven years for each use checked above. d. Stop here. 2. Current 35.600 Authorized User Requesting Additional Authorization for 35.600 Use(s) Checked Above a. Go to the table in section 3.e. to document training for new device. b. If board certified, provide a copy of the certificate and stop here. If not board certified, provide completed Part II Preceptor Attestation. 3. Training and Experience for Proposed Authorized User a. Classroom and Laboratory Training Description of Training 35.490 35.491 Location of Training 35.690 Clock Hours Dates of Training* Radiation physics and instrumentation Radiation protection Mathematics pertaining to the use and measurement of radioactivity Radiation biology Total Hours of Training: NRC FORM 313A (AUS) (07-31-2023) PAGE 1 U. S. NUCLEAR REGULATORY COMMISSION NRC FORM 313A (AUS) (07-31-2023) AUTHORIZED USER TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35.400 and 35.600) [10 CFR 35.57, 35.490, 35.491, and 35.690] (continued) 3. Training and Experience for Proposed Authorized User (continued) b. Supervised Work and Clinical Experience for 10 CFR 35.490 (If more than one supervising individual is necessary to document supervised work experience, provide multiple copies of this page.) Supervised Work Experience Description of Experience Must Include: Total Hours of Experience: Location of Experience/License or Permit Number of Facility Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys Dates of Experience* Yes No Yes Checking survey meters for proper operation No Yes Preparing, implanting, and safely removing brachytherapy sources No Yes Maintaining running inventories of material on hand No Using administrative controls to prevent a medical event involving the use of byproduct material Yes No Yes Using emergency procedures to control byproduct material Clinical experience in radiation oncology as part of an approved formal training program Confirm No Location of Experience/License or Permit Number of Facility Dates of Experience* Approved by: Residency Review Committee for Radiation Oncology of the ACGME Royal College of Physicians and Surgeons of Canada Council on Postdoctoral Training of the American Osteopathic Association Supervising Individual NRC FORM 313A (AUS) (07-31-2023) License/Permit Number listing supervising individual as an Authorized User PAGE 2 U. S. NUCLEAR REGULATORY COMMISSION NRC FORM 313A (AUS) (07-31-2023) AUTHORIZED USER TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35.400 and 35.600) [10 CFR 35.57, 35.490, 35.491, and 35.690] (continued) 3. Training and Experience for Proposed Authorized User (continued) c. Supervised Clinical Experience for 10 CFR 35.491 Description of Experience Location of Experience/License or Permit Number of Facility Clock Hours Dates of Experience* Use of strontium-90 for ophthalmic treatment, including: examination of each individual to be treated; calculation of the dose to be administered; administration of the dose; and follow up and review of each individual's case history Supervising Individual License/Permit Number listing supervising individual as an Authorized User d. Supervised Work and Clinical Experience for 10 CFR 35.690 Remote afterloader unit(s) Supervised Work Experience Description of Experience Must Include: Reviewing full calibration measurements and periodic spot-checks Preparing treatment plans and calculating treatment doses and times Using administrative controls to prevent a medical event involving the use of byproduct material Implementing emergency procedures to be followed in the event of the abnormal operation of the medical unit or console Checking and using survey meters Selecting the proper dose and how it is to be administered NRC FORM 313A (AUS) (07-31-2023) Teletherapy unit(s) Gamma stereotactic radiosurgery unit(s) Total Hours of Experience: Location of Experience/License or Permit Number of Facility Confirm Dates of Experience* Yes No Yes No Yes No Yes No Yes No Yes No PAGE 3 U. S. NUCLEAR REGULATORY COMMISSION NRC FORM 313A (AUS) (07-31-2023) AUTHORIZED USER TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35.400 and 35.600) [10 CFR 35.57, 35.490, 35.491, and 35.690] (continued) 3. Training and Experience for Proposed Authorized User (continued) d. Supervised Work and Clinical Experience for 10 CFR 35.690 (continued) Clinical experience in radiation oncology as part of an approved formal training program Location of Experience/License or Permit Number of Facility Dates of Experience* Approved by: Residency Review Committee for Radiation Oncology of the ACGME Royal College of Physicians and Surgeons of Canada Council on Postdoctoral Training of the American Osteopathic Association Supervising Individual License/Permit Number listing supervising individual as an Authorized User e. For 35.600, describe training provider and dates of training for each type of use for which authorization is sought. Description of Training Training Provider and Dates Remote Afterloader Teletherapy Gamma Stereotactic Radiosurgery Device operation Safety procedures for the device use Clinical use of the device Supervising Individual. (If training provided by Supervising Individual (If more than one supervising individual is necessary to document supervised work experience, provide multiple copies of this page.) License/Permit Number listing supervising individual as an Authorized User Authorized for the following types of use: Remote afterloader unit(s) Teletherapy unit(s) Gamma stereotactic radiosurgery unit(s) f. Provide completed Part II Preceptor Attestation. NRC FORM 313A (AUS) (07-31-2023) PAGE 4 U. S. NUCLEAR REGULATORY COMMISSION NRC FORM 313A (AUS) (07-31-2023) AUTHORIZED USER TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35.400 and 35.600) [10 CFR 35.57, 35.490, 35.491, and 35.690] (continued) PART II – PRECEPTOR ATTESTATION Note: This part must be completed by the individual's preceptor. The preceptor does not have to be the supervising individual as long as the preceptor provides, directs, or verifies training and experience required. If more than one preceptor is necessary to document experience, obtain a separate preceptor statement from each. By checking the boxes below, the preceptor is attesting that the individual has knowledge to fulfill the duties of the position sought and not attesting to the individual's "general clinical competency." First Section Check one of the following for each requested authorization: For 35.490: has satisfactorily completed the 200 hours of I attest that Name of Proposed Authorized User classroom and laboratory training, 500 hours of supervised work experience, and 3 years of supervised clinical experience in radiation oncology, as required by 10 CFR 35.490(b)(1) and (b)(2), and is able to independently fulfill the radiation safety-related duties as an authorized user of manual brachytherapy sources for the medical uses authorized under 10 CFR 35.400. For 35.491: has satisfactorily completed the 24 hours of I attest that Name of Proposed Authorized User classroom and laboratory training applicable to the medical use of strontium-90 for ophthalmic radiotherapy, has used strontium-90 for ophthalmic treatment of 5 individuals, as required by 10 CFR 35.491(b), and is able to independently fulfill the radiation safety-related duties as an authorized user of strontium-90 for ophthalmic use. Second Section For 35.690: has satisfactorily completed 200 hours of classroom I attest that Name of Proposed Authorized User and laboratory training, 500 hours of supervised work experience, and 3 years of supervised clinical experience in radiation therapy, as required by 10 CFR 35.690(b)(1) and (b)(2). AND Third Section For 35.690: (continued) has received training required in 35.690(c) for device I attest that Name of Proposed Authorized User operation, safety procedures, and clinical use for the type(s) of use for which authorization is sought, as checked below. Remote afterloader unit(s) Teletherapy unit(s) Gamma stereotactic radiosurgery unit(s) AND NRC FORM 313A (AUS) (07-31-2023) PAGE 5 U. S. NUCLEAR REGULATORY COMMISSION NRC FORM 313A (AUS) (07-31-2023) AUTHORIZED USER TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35.400 and 35.600) [10 CFR 35.57, 35.490, 35.491, and 35.690] (continued) Fourth Section is able to independently fulfill the radiation safety- I attest that Name of Proposed Authorized User related duties as an authorized user for: Remote afterloader unit(s) Teletherapy unit(s) Gamma stereotactic radiosurgery unit(s) Fifth Section Complete one of the following for attestation and signature: Authorized User: I meet the requirements in 10 CFR 35.490, 35.491, 35.690, or equivalent Agreement State requirements, as an authorized user for: 35.400 Manual brachytherapy sources 35.600 Teletherapy unit(s) 35.400 Ophthalmic use of strontium-90 35.600 Gamma stereotactic radiosurgery unit(s) 35.600 Remote afterloader unit(s) 35.57 for 35.400 and/or 35.600 uses, as applicable OR Residency Program Director (for 35.490 and/or 35.690 only): I affirm that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements below or equivalent Agreement State requirements for: 35.400 Manual brachytherapy sources 35.57 for 35.400 uses 35.600 Teletherapy unit(s) 35.57 for teletherapy unit(s) 35.600 Remote afterloader unit(s) 35.57 for remote afterloader unit(s) 35.600 gamma stereotactic radiosurgery unit(s) 35.57 gamma stereotactic radiosurgery unit(s) I affirm that this faculty member concurs with the attestation I am providing as program director. I affirm that the residency training program is approved by the: Residency Review Committee of the Accreditation Council for Graduate Medical Education Royal College of Physicians and Surgeons of Canada Council on Postdoctoral Training of the American Osteopathic Association I affirm that the residency training program includes training and experience specified in: 35.490 35.690 Name of Facility: License/Permit Number: Name of Preceptor or Residency Program Director (Typed or printed) Telephone Number Date Signature NRC FORM 313A (AUS) (07-31-2023) PAGE 6