ML24053A097

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NRC Medical Webinar Training Medical User Authorizations Under 10CFR353300 110515
ML24053A097
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Issue date: 11/05/2015
From: Abogunde M
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NRC Medical Webinar Training

MEDICAL USER AUTHORIZATIONS FOR USE OF MATERIALS UNDER 10 CFR 35.300

Maryann Abogunde Medical Radiation Safety Team MSTR, NMSS, U.S. NRC November 5th, 2015

Outline

  • Definition and Overview
  • Types of Authorization
  • Training Requirements
  • Licensing Guidance
  • Sample License Actions/Cases
  • Questions and Answers
  • Note that Agreement States may have regulatory requirements that are similar or more limiting than NRCs regulatory requirements. Please review and reference your State regulations to determine if the NRC regulations referenced in this training are the same and applicable.

2 Definition & Overview

  • 10 CFR 35.300 - Use of unsealed byproduct material for which a written directive (WD) is required.
  • Some common radiopharmaceuticals containing byproduct materials:

- Iodine-131 for treatment of hyperthyroidism and thyroid cancer.

- Strontium-89 (Metastron) for treatment of pain caused by metastatic bone cancer

- Samarium-153 (Quadramet) for treatment of pain caused by metastatic bone cancer

- Radium-223 (Xofigo) for treatment of metastatic bone cancer.

- Yttrium-90 (Zevalin) for treatment of non-Hodgkins lymphoma.

3 Definition - 10 CFR 35.300

  • Unsealed byproduct material may be used by a licensee for medical purposes requiring a WD if:
a. It is obtained from: [1] A manufacturer or preparer for commercial distribution; or [2] A PET radioactive drug producer; OR
b. It is prepared by (excluding production of PET radionuclides): [1]

An authorized nuclear pharmacist (ANP); [2] A physician who is an authorized user (AU) and meets the requirements in 10 CFR 35.290, 35.390; or [3] An individual under the supervision of the ANP or AU; OR

c. The material is obtained from and prepared by an NRC or AS licensee for use in research in accordance with an Investigational New Drug (IND) protocol accepted by FDA; OR
d. The material is prepared by the licensee for use in research in accordance with an IND protocol accepted by FDA. 4

Types of Authorization

  • An AU may be authorized for one or more of the subcategories below, but not for all unsealed byproduct material. Based on the current regulations, no new user may be authorized for all of 10 CFR 35.300.

10 CFR 35.300 AUTHORIZATION SUBCATEGORIES

[from 10 CFR 35.390(b)(1)(ii)(G)]

Subcategory #1 Oral administration of less than or equal to 33 mCi (1.22 GBq) of sodium iodide I-131, for which a written directive is required Subcategory #2 Oral administration of greater than 33 mCi (1.22 GBq) of sodium iodide I-131 Subcategory #3 Parenteral administration of any beta emitter, or a photon-emitting radionuclide with a photon energy less than 150 keV, for which a written directive is required Subcategory #4 Parenteral administration of any other radionuclide, for which a written directive is required **Note: There are no known clinical uses in this subcategory. 5 Training Requirements

  • Training Requirements:

- 10 CFR 35.390 Training for use of unsealed byproduct material for which a written directive is required

- 10 CFR 35.392 Training for the oral administration of sodium iodide I-131 requiring a WD in quantities less than or equal to 33 millicuries (1.22 GBq)

- 10 CFR 35.394 Training for the oral administration of sodium iodide I-131 requiring a WD in quantities greater than 33 millicuries (1.22 GBq)

- 10 CFR 35.396 Training for the parenteral administration of unsealed byproduct material requiring a written directive

6 Training Requirements

Pathways to AU Approval

1. Is the individual currently an AU on an NRC or Agreement State license for the same use being requested?
2. Is the individual board certified?
3. Is the individual a current AU for 10 CFR 35.300 (unsealed material),

35.400 (manual brachytherapy), or 35.600 (remote afterloader, teletherapy, gamma stereotactic radiosurgery units), seeking additional authorizations?

4. Does the individual have any Training and Experience?

7 Training Requirements 10 CFR 35.390 - Training for use of unsealed byproduct material for which a written directive is required

Except for experienced AUs under 10 CFR 35.57, an AU has to be a:

1. Board certified physician + AU supervised work experience + written attestation
2. Physician with 700 hrs T&E (including a minimum of 200 hrs of class & lab)

NOTE:

  • AU supervised work experience includes a minimum of 3 cases in administration of dosages in each of the following categories:
i. Oral administration of sodium iodide I-131 33mCi (1.22GBq), for which a WD is required; ii. Oral administration of sodium iodide I-131 33mCi (1.22GBq);

iii.Parenteral administration of any beta emitter, or a photon-emitting radionuclide a photon energy less than 150 keV, for which a WD is required; and/or iv. Parenteral administration of any other radionuclide, that requires a WD

  • Written attestation signed by a preceptor AU 8 Training Requirements 10 CFR 35.392 - Training for oral administration of sodium iodide I-131 requiring a WD in quantities 33 mCi (1.22 GBq)

Except for experienced AUs under 10 CFR 35.57, AU is:

1. Board certified physician + written attestation
2. A physician that is an AU (listed on a license or permit) for administrations or than 33 mCi, or for administration of only than 33 mCi.
3. Physician with 80 hrs class & lab training + AU supervised work experience +

written attestation

NOTE:

  • Board certification process:

(i) includes 80hrs of applicable class & lab; (ii) includes AU supervised work experience of 3 case minimum in administration of dosages for Oral administration of I-131 33mCi (WD required); and (ii) has been recognized by NRC or an AS;

  • Written attestation signed by a preceptor AU

9 Training Requirements 10 CFR 35.394 - Training for oral administration of sodium iodide I-131 requiring a WD in quantities 33 mCi (1.22 GBq)

Except for experienced AUs (under 10 CFR 35.57), AU is:

1. Board certified physician + written attestation; OR
2. A physician that is an AU (listed on a license or permit) for oral administrations of sodium iodide I-131 33 mCi; OR
3. Physician with 80 hrs of applicable class & lab training + AU supervised work experience + written attestation

NOTE:

  • Board certification process:

(i) includes 80hrs of applicable class & lab; (ii) includes AU supervised work experience; and (iii) has been recognized by NRC (http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html) or an AS.

  • AU supervised work experience includes a minimum of 3 cases in oral administration of dosages of I-131 33mCi
  • Written attestation signed by a preceptor AU 10 Training Requirements

10 CFR 35.396 - Training for parenteral administration of unsealed byproduct material requiring a WD

Parenteral administration of:

i. Any beta emitter, or any photon-emitting radionuclide with a photon energy less than 150 keV.

ii.Any other radionuclide for which a WD is required.

NOTE:

  • Currently no known clinical uses in 10 CFR 35.300 subcategory #4 -

parenteral administration of any other radionuclide, for which a WD is required.

11 Training Requirements 10 CFR 35.396 - Training for parenteral administration of unsealed byproduct material requiring a WD

Except for experienced AUs (under§35.57), AU is:

1. Physician AU (on a license or permit) under 10 CFR 35.390 for parenteral administration (i) or (ii); OR
2. Physician AU (on a license or permit) under 10 CFR 35.490 or 35.690 or equivalent AS requirements, + 80 hrs of class & lab training + AU supervised work experience + written attestation; OR
3. Board certified physician under 10 CFR 35.490 or 35.690 + has completed 80 hrs of class and lab training + supervised work experience + written attestation.

NOTE:

  • AU supervised work experience in the parenteral administration of (i) and/or (ii), for which a WD is required.
  • Written attestation signed by a preceptor AU 12 Licensing Guidance

NUREG-1556, Volume 9, Rev. 2: Consolidated Guidance About Materials Licensees - Program-Specific Guidance About Medical Use Licenses (http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/)

  • Provides guidance to:

- NRC and AS licensees and MML permittees - for preparation of applications

- NRC, AS, and MML staff - for review of applications

- NRC Form 313A (AUT), AU Training and Experience and Preceptor Attestation (for uses defined under 10 CFR 35.300)

- NRC Form 313, Application for Materials License

- NRC Form 313A (RSO), RSO Medical Use Training & Experience & Preceptor Attestation

- NRC Forms 313A (AMP), (ANP), (AUD), (AUS) 13 Licensing Guidance

NRC FORM 313A (AUT)

  • Part I - Training &

Experience

14 Licensing Guidance

NRC FORM 313A (AUT)

  • Part II - Preceptor Attestation

15 Licensing Actions - Case Examples

16 REMEMBER!!!

Pathways to AU Approval

1. Current AU on an NRC or Agreement State license for the same use being requested
2. Board Certification
3. Current AU for 35.300 (unsealed material), 35.400 (manual brachytherapy), or 35.600 (remote afterloader, teletherapy, gamma stereotactic radiosurgery units) seeking additional authorizations
4. Training and Experience

17 Current AU for same uses requested Case 1:

Dr. Goodfellow has been employed by South Hospital as a nuclear medicine physician since 1989. He is listed on their NRC license for use of unsealed byproduct materials under 10 CFR 35.300. He has been offered a position at North Hospital across town.

18 19 Current AU for same uses requested Case 1:

Yes, Dr. Goodfellow may be listed on the new license for uses under 10 CFR 35.300 because he is currently listed on an NRC license for the same uses.

At this point, this is the only way a physician may be authorized for all of 10 CFR 35.300.

20 Current AU for same uses requested Case 2:

A licensee requests that Dr. Kupec be added to their NRC license for Oral administration of sodium iodide I-131 in quantities less than or equal to 33 mCi. As evidence of his experience, the licensee provides a copy of a current Agreement State license listing Dr.

Kupec for the identical use.

  • May Dr. Kupec be listed for this use on the NRC license?

21 22 Current AU for same uses requested Case 1:

Yes, Dr. Kupec may be listed for the use of sodium iodide I-131 based on his current listing of the use on the Agreement State license.*

  • Note that often, Agreement State licenses reference their State Regulations and you may have to review these to determine if the category of use is the same.

23 Board Certification

Three pieces of information are normally necessary to approve a proposed AU by the board certification pathway:

1. Specialty board certification recognized by NRC under 10 CFR 35.300 (The current list and certification dates allowing approval are found on the NRCs website: http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html)
2. Clinical case experience
3. Preceptor Attestation

Note: NRC Form 313A (AUT) may be used to document Items 2 and 3

24 Board Certification Case:

ABC Hospital has requested that Dr. Smith be added to their license for the use of sodium iodide I-131. Dr.

Smith is a board certified Nuclear Medicine physician.

  • What do you look for in the supporting information submitted?

25 Board Certification Approved Boards http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html

American Board of Radiology certificate (Diagnostic Radiology) dated from June 2011 forward with AU eligible appearing above the ABR seal OR Certification Board of Nuclear Endocrinology certification process from 2013 to present for all physicians issued a CBNE Nuclear Endocrinology-High Dose certificate.

OR American Osteopathic Board of Radiology certificate (Diagnostic Radiology) dated from May 17, 2015 forward with the words AU Eligible appearing above the D.O. symbol

26 Board Certification Preferred Documentation (10 CFR 35.392 & 35.394)

- Part I, Section 1 - indicating the Board Certification pathway

- Part I, Section 3.c. - documenting at least 3 cases each of oral administration of sodium iodide I-131 in quantities less than or equal to and greater than 33 mCi under the supervision of an AU*

  • the supervising AU must have experience in administering dosages in the same categories as the individual requesting AU Status

27 Board Certification Preferred Documentation (10 CFR 35.392 & 35.394)

  • NRC Form 313 (AUT) with the following sections completed (contd.):

- Part II - Preceptor Attestation

- First Section - indicating the proposed AU has completed 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of classroom and laboratory training, supervised work experience, and clinical casework

- Second Section - confirming that the proposed AU has completed the required clinical casework for Oral NaI-131 in quantities greater than and less than 33 mCi

- Third Section - confirming the proposed AU has achieved a level of competency necessary to function independently as an AU for oral administration of sodium iodide I-131 28 Board Certification Preferred Documentation (10 CFR 35.392 & 35.394)

  • NRC Form 313 (AUT) with the following sections completed (contd.):

- Fifth Section - Preceptor signature and confirmation of their training and experience*

- *Confirm the preceptor is an AU by obtaining the NRC or Agreement State license or permit, which lists the preceptor as an AU.

29 Board Certification

NRC Form 313 (AUT) with the following sections completed:

  • Part I, Section 1 indicating the Board Certification pathway

30 Board Certification

NRC Form 313 (AUT) with the following sections completed:

  • Part I, Section 3.c.

documenting at least 3 cases each of oral administration of sodium iodide I-131 in quantities and 33 mCi under the supervision of an AU*

  • the supervising AU must have experience in administering dosages in the same categories as the individual requesting AU status 31

Board Certification

NRC Form 313 (AUT) with the following sections completed:

  • Part II - Preceptor Attestation
  • First Section - indicating the proposed AU has completed 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of classroom and laboratory training, supervised work experience, and clinical casework 32 Board Certification

NRC Form 313 (AUT) with the following sections completed:

  • Part II - Preceptor Attestation
  • Second Section -

confirming that the proposed AU has completed the required clinical casework for Oral NaI-131 in quantities greater than and less than 33 mCi 33 Board Certification

NRC Form 313 (AUT) with the following sections completed:

  • Part II - Preceptor Attestation
  • Third Section -

confirming the proposed AU has achieved a level of competency necessary to function independently as an AU for Oral administration of sodium iodide I-131 34 Board Certification

NRC Form 313 (AUT) with the following sections completed:

  • Part II - Preceptor Attestation
  • Fifth Section - Preceptor signature and confirmation of their training and experience*
  • *Confirm the preceptor is an AU by obtaining the NRC or Agreement State license or permit, which lists the preceptor as an AU. 35 Current 10 CFR 35.300, 35.400, or 35.600 AU seeking additional authorizations REMINDER!

To approve a proposed AU by this pathway:

1. AU under a subset of 10 CFR 35.390 or 35.490 or 35.690, and
2. Successful completion of 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of classroom and lab training applicable to parenteral administrations, for which a written directive is required, and
3. Work experience under an AU who is authorized for 10 CFR 35.390 or 35.396, and
  • Documented casework (at least 3), and
  • Preceptor attestation 36 Current 10 CFR 35.300, 35.400, or 35.600 AU seeking additional authorizations Case 1:

Dr. Stewart is listed as an AU at Main Line Hospital, a medical broad scope licensee, for oral administration of sodium iodide I-131 in quantities less than or equal to 33 mCi. The licensee has requested that Dr.

Stewarts authorization be expanded to include all uses of sodium iodide I-131.

37 38 Current 10 CFR 35.300, 35.400, or 35.600 AU seeking additional authorizations A copy of the broad scope permit authorizing him for the use of sodium iodide I-131 in quantities less than or equal to 33 mCi

- Part I, Section 2 - indicating current status as an AU for 10 CFR35.392

- Part I, Section 3 - documentation of casework (including the name and authorization of the supervising AU*

    • the supervising AU must have experience in administering dosages in the same categories as the individual requesting AU status

39 Current 10 CFR 35.300, 35.400, or 35.600 AU seeking additional authorizations

  • NRC Form 313 (AUT) with the following sections completed (contd.):

- Part II - Preceptor Attestation

- First Section - indicating the proposed AU has completed 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of classroom and laboratory training, supervised work experience, and clinical casework, as required by 10 CFR 35.394

- Third Section - confirming the proposed AU has achieved a level of competency necessary to function independently as an AU for oral administration of sodium iodide I-131

- Fifth Section-Preceptor signature and confirmation of their training and experience*

- *Confirm that preceptor is an AU by obtaining the NRC or Agreement State license or permit issued by a broad scope licensee that lists the preceptor as an AU. 40

Current AU NRC Form 313 (AUT) with the following sections completed:

  • Part I, Section 2 -

indicating current status as an AU for 10 CFR35.392

41 Current AU

NRC Form 313 (AUT) with the following sections completed:

  • Part I, Section 3 -

documentation of casework (including the name and authorization of the supervising AU*

-

  • the supervising AU must have experience in administering dosages in the same categories as the individual requesting AU Status

42 Current AU NRC Form 313 (AUT) with the following sections completed:

  • Part II - Preceptor Attestation
  • First Section - indicating the proposed AU has completed 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of classroom and laboratory training, supervised work experience, and clinical casework, as required by 10 CFR 35.394

43 Current AU NRC Form 313 (AUT) with the following sections completed:

  • Part II - Preceptor Attestation
  • Third Section -

confirming the proposed AU has achieved a level of competency necessary to function independently as an AU for Oral administration of sodium iodide I-131

44 Current AU

NRC Form 313 (AUT) with the following sections completed:

  • Part II - Preceptor Attestation
  • Fifth Section - Preceptor signature and confirmation of their training and experience*
  • *Confirm the preceptor is an AU by obtaining the NRC or Agreement State license or permit issued by a broad scope licensee which lists the 45 preceptor as an AU.

Current 10 CFR 35.300, 35.400, or 35.600 AU seeking additional authorizations Case 2:

Dr. Miller is a Radiation Oncologist at Suburban Hospital (AS licensee). She is listed on their license for the use of high dose rate remote afterloader (35.600).

The hospital intends to use Xofigo (parenteral administration of beta-emitter, or photon-emitting radionuclide with a photon energy less than 150 keV )

in the near future and would like her to be the AU.

  • What would Dr. Miller need to provide?

46 Current 10 CFR 35.300, 35.400, or 35.600 AU seeking additional authorizations A copy of the AS license listing her as an AU for 10 CFR 35.600.

- Part I, Section 2 - indicating the current AU pathway

- Part I, Section 3 - documentation of 80 hrs of classwork and lab training; supervised work experience (including the name and authorization of the supervising AU); and casework*

    • the supervising AU must have experience in administering dosages in the same categories as the individual requesting AU status

47 Current 10 CFR 35.300, 35.400, or 35.600 AU seeking additional authorizations

  • NRC Form 313 (AUT) with the following sections completed (contd.):

- Part II - Preceptor Attestation

- Fourth Section - confirming current AU status; 80 hrs of classroom and lab training; supervised work experience; and casework

- Fifth Section-Preceptor signature and confirmation of their T&E*

- *Confirm that preceptor is an AU by obtaining the NRC or Agreement State license or permit that lists the preceptor as an AU.

NOTE: In addition, 10 CFR 35.396 T&E requirements are only for 35.400 and 35.600 users. If an individual is authorized under 35.400 or 35.600, then that individual would only need an additional 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of T&E, specifically in parenteral administrations and three cases of parenteral administration.

48 Current AU NRC Form 313 (AUT) with the following sections completed:

  • Part I, Section 2 -

indicating the current AU pathway

49 Current AU NRC Form 313 (AUT) with the following sections completed:

  • Part I, Section 3 -

documentation of 80 hrs of classroom and lab training; supervised work experience (including the name and authorization of the supervising AU);

and casework*

-

  • the supervising AU must have experience in administering dosages in the same categories as the individual requesting AU status 50 Current AU NRC Form 313 (AUT) with the following sections completed:
  • Part I, Section 3 -

documentation of 80 hrs of classroom and lab training; supervised work experience (including the name and authorization of the supervising AU);

and casework*

-

  • the supervising AU must have experience in administering dosages in the same categories as the individual requesting AU status 51 Current AU NRC Form 313 (AUT) with the following sections completed:
  • Part II - Preceptor Attestation
  • Fourth Section -

confirming current AU status; 80 hrs of classroom and lab training; supervised work experience; and casework

  • Fifth Section - Preceptor signature & confirmation of their T&E 52 Training & Experience Case:

Dr. Jones just completed her residency and has been hired by Metro Hospital. She is a nuclear medicine physician that has not completed her boards. Metro Hospital has requested that Dr. Jones be added to the license as an AU for the use of sodium iodide I-131 in quantities greater than 33 mCi (10 CFR 35.394). She has completed 4 clinical cases.

  • What evidence of training and experience would you expect to see?

53 Training & Exp NRC Form 313 (AUT) with the following sections completed:

  • Part I, Section 3a.,b.,c. -

documentation of 80 hrs of class and lab training applicable to administration of I-131; supervised work experience (including the name and authorization of the supervising AU);

and casework*

  • the supervising AU must have experience in administering dosages in the same categories as 54 the individual requesting AU status Training & Exp NRC Form 313 (AUT) with the following sections completed:
  • Part I, Section 3a.,b.,c. -

documentation of 80 hrs of class and lab training applicable to administration of I-131; supervised work experience (including the name and authorization of the supervising AU);

and casework*

  • the supervising AU must have experience in administering dosages in the same categories as 55 the individual requesting AU status Training & Exp NRC Form 313 (AUT) with the following sections completed - Part II -

Preceptor Attestation:

  • First Section - indicating proposed AU for 35.394, has completed 80 hrs of class & lab; supervised work experience; and clinical casework.
  • Second Section-confirming that the proposed AU has completed the required clinical casework for administrations 33 mCi 56 Training & Exp NRC Form 313 (AUT) with the following sections completed - Part II -

Preceptor Attestation:

  • Third Section -

confirming the proposed AU has achieved a level of competency necessary to function independently as an AU for administration of I-131

  • Fifth Section - Preceptor signature & confirmation of their T&E*
  • *Confirm the preceptor is an AU by obtaining the NRC or Agreement State license or permit, which lists the preceptor 57 as an AU.

Training & Experience NOTE:

10 CFR 35.392 (b) states that if a physician is authorized for the use of 35.394 materials, they may be authorized for 35.392.

Therefore, Dr. Jones could be approved for the use of sodium iodide I-131 for both less than and greater than 33 mCi.

58 Training & Experience Case (contd.):

What if Dr. Jones had documented 5 cases of sodium iodide I-131 less than or equal to 33 mCi and 2 cases of sodium iodide I-131 greater than 33 mCi?

  • 35.394(c)(2)(vi) requires that the proposed AU have experience administering dosages in at least 3 cases involving the oral administration of greater than 33 mCi of sodium iodide I-131.

Therefore, Dr. Jones would be authorized for sodium iodide I-131 less than or equal to 33 mCi only. 59

QUESTIONS ?

60

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