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ICR 202607-3150-004 · OMB 3150-0120 · Object 171168200.
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| File Type | application/pdf |
|---|---|
| File Title | g:\forms\informs\fixforms\n313aud5.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 (AUD) (07-31-2023) U. S. NUCLEAR REGULATORY COMMISSION AUTHORIZED USER TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35.100, 35.200, and 35.500) [10 CFR 35.57, 35.190, 35.290, and 35.590] Name of Proposed Authorized User EXPIRES: 07/31/2026 APPROVED BY OMB: NO. 3150-0120 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 Infocollects.Resource@nrc. gov, 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]. gov. 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 Requested Authorization(s) (check all that apply) 35.100 Uptake, dilution, and excretion studies 35.200 Imaging and localization studies 35.500 Sealed sources for diagnosis (specify device) 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 a board certification issued on or before October 24, 2005 that is listed in 10 CFR 35.57(b)(2)(i), provide the following: c. (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. Stop here. 2. Current 35.390 Authorized User Seeking Additional 35.290 Authorization a. Authorized user on Materials License meeting 10 CFR 35.390, 10 CFR 35.57 for 35.300 uses, or equivalent Agreement State requirements seeking authorization for 35.290. b. Supervised Work Experience. (If more than one supervising individual is necessary to document supervised work experience, provide multiple copies of this section.) Description of Experience Location of Experience/License or Permit Number of Facility Clock Hours Dates of Experience* Eluting generator systems appropriate for the preparation of radioactive drugs for imaging and localization studies, measuring and testing the eluate for radionuclidic purity, and processing the eluate with reagent kits to prepare labeled radioactive drugs Total Hours of Experience: Supervising Individual License/Permit Number listing supervising individual as an authorized user or authorized nuclear pharmacist Supervisor meets the requirements below, or equivalent Agreement State requirements (check all that apply). 35.290 35.390 + generator experience in 32.290(c)(1)(ii)(G) 35.55 35.57 for 35.200 uses c. If board certified, provide a copy of the certificate and stop here. If not board certified, skip to and complete Part II Preceptor Attestation. NRC FORM 313A (AUD) (07-31-2023) PAGE 1 NRC FORM 313A (AUD) (07-31-2023) U. S. NUCLEAR REGULATORY COMMISSION AUTHORIZED USER TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35.100, 35.200, and 35.500) [10 CFR 35.57, 35.190, 35.290, and 35.590](continued) 3. Training and Experience for Proposed Authorized User a. Classroom and Laboratory Training. Description of Training Location of Training Clock Hours Dates of Training* Radiation physics and instrumentation Radiation protection Mathematics pertaining to the use and measurement of radioactivity Chemistry of byproduct material for medical use (not required for 35.590) Radiation biology Total Hours of Training: b. Supervised Work Experience (completion of this table is not required for 35.590). (If more than one supervising individual is necessary to document supervised work experience, provide multiple copies of this section.) Supervised Work Experience Total Hours of Experience: Description of Experience Must Include: Location of Experience/License or Permit Number of Facility Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters NRC FORM 313A (AUD) (07-31-2023) Confirm Dates of Experience* Yes No Yes No PAGE 2 U. S. NUCLEAR REGULATORY COMMISSION NRC FORM 313A (AUD) (07-31-2023) AUTHORIZED USER TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35.100, 35.200, and 35.500) [10 CFR 35.57, 35.190, 35.290, and 35.590](continued) 3. Training and Experience for Proposed Authorized User (continued) b. Supervised Work Experience. (continued) Description of Experience Must Include: Location of Experience/License or Permit Number of Facility Dates of Experience* Yes Calculating, measuring, and safely preparing patient or human research subject dosages No Using administrative controls to prevent a medical event involving the use of unsealed byproduct material Yes No Using procedures to contain spilled byproduct material safely and using proper decontamination procedures Yes No Yes Administering dosages of radioactive drugs to patients or human research subjects No Eluting generator systems appropriate for the preparation of radioactive drugs for imaging and localization studies, measuring and testing the eluate for radionuclidic purity, and processing the eluate with reagent kits to prepare labeled radioactive drugs Supervising Individual Confirm Yes No* License/Permit Number listing supervising individual as an authorized user or an authorized nuclear pharmacist for generator training Supervisor meets the requirements below, or equivalent Agreement State requirements (check one). 35.190 35.290 35.390 35.390 + generator experience in 35.290(c)(1)(ii)(G) 35.55 35.57 for 35.200 uses *Not required for 10 CFR 35.100 use. c. For 35.590 only, provide documentation of training on use of the device. Device Type of Training Location and Dates d. For 35.500 uses only, stop here. For 35.100 and 35.200 uses, skip to and complete Part II Preceptor Attestation. NRC FORM 313A (AUD) (07-31-2023) PAGE 3 U. S. NUCLEAR REGULATORY COMMISSION NRC FORM 313A (AUD) (07-31-2023) AUTHORIZED USER TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35.100, 35.200, and 35.500) [10 CFR 35.57, 35.190, 35.290, and 35.590](continued) PART II – PRECEPTOR ATTESTATION 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. (Not required to meet training requirements in 35.590) By checking the boxes below, the preceptor is not attesting to the individual's "general clinical competency." Note: First Section Check one of the following for each use requested: For 35.190 has satisfactorily completed the 60 hours of training and I attest that Name of Proposed Authorized User experience, including a minimum of 8 hours of classroom and laboratory training, required by 10 CFR 35.190(c)(1), and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under 10 CFR 35.100. For 35.290 has satisfactorily completed the 700 hours of training I attest that Name of Proposed Authorized User and experience, including a minimum of 80 hours of classroom and laboratory training, required by 10 CFR 35.290(c)(1), and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses under 10 CFR 35.100 and 35.200. Second Section Complete one of the following for attestation and signature: Authorized User: I meet the requirements below, or equivalent Agreement State requirements, as an authorized user for: 35.190 35.290 35.390 35.390 + generator experience 35.57 for 35.200 uses Residency Program Director: OR 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: 35.190 35.390 + generator experience 35.57 for 35.200 uses 35.290 35.390 I affirm that this facility 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 Post-Graduate Training of the American Osteopathic Association I affirm that the residency training program includes training and experience specified in: 35.190 35.290 Name of Facility: Name of Preceptor or Residency Program Director (Typed or Printed) License/Permit Number: Telephone Number Date Signature NRC FORM 313A (AUD) (07-31-2023) PAGE 4