ML18312A413

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Slide Presentation for 11/14/2018 Webinar on NRC Staff Evaluation of Training and Experience Requirements for Different Categories of Radiopharmaceuticals
ML18312A413
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Issue date: 11/14/2018
From: Sarah Lopas
NRC/NMSS/DMSST/MSEB
To:
Sarah Lopas
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Download: ML18312A413 (22)
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The NRC Staff Evaluation of Training and Experience Requirements for Administering Different Categories of Radiopharmaceuticals WEBINAR November 14, 2018 Medical Radiation Safety Team Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards

Bridge Line Information for Webinar Bridge Number: 8884525182 Passcode: 3340287

Agenda 1:00 - 1:05 p.m. Welcome and Meeting Information 1:05 - 1:30 p.m. NRC Presentation 1:30 - 3:00 p.m. Comments 2

Welcome

  • Christian Einberg, Chief of the Medical Safety and Events Assessment Branch in the NRCs Division of Materials Safety, Security, State, and Tribal Programs - Office of Nuclear Material Safety and Safeguards 3

Purpose of Todays Webinar

  • Provide information on the NRC staffs evaluation of training and experience (T&E) requirements for administering different categories of radiopharmaceuticals for which a written directive is required in accordance with Title 10 of the Code of Federal Regulations (10 CFR) Part 35, Medical Use of Byproduct Material, Subpart E, Unsealed Byproduct Material-Written Directive Required.
  • Listen to and accept comments on the T&E Federal Register docket (NRC20180230).

4

Meeting Information

  • Training and Experience will often be referred to as T&E.
  • Authorized User(s) will often be referred to as AU(s).
  • Todays meeting is being transcribed by a court reporter.
  • All comments made today will be captured for the T&E docket (NRC20180230) and for inclusion in our review.
  • If you speak a comment today, you do not need to again submit that same comment on Regulations.gov.
  • Oral and written comments have equal weight.
  • Comments will begin after the NRC presentation.
  • Press *1 on your phone.

5

Current T&E Regulations Current regulations provide three ways a physician can be approved as an authorized user (AU) to administer unsealed byproduct materials or radiopharmaceuticals requiring a written directive:

  • Certification by a medical specialty board whose certification is recognized by the NRC or an Agreement State.
  • Completion of T&E, also known as the alternate pathway:

200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> classroom and lab training and 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> supervised work experience for a total of 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> T&E (requires preceptor attestation).

  • Previous identification as an AU on an NRC or Agreement State license or permit.

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Current T&E Regulations, continued Training and Experience Requirements in 10 CFR 35, Subpart E:

1) 10 CFR 35.390 - Training for use of unsealed byproduct material for which a written directive is required.
2) 10 CFR 35.392 - Training for oral administration of sodium iodide I131 requiring a written directive in quantities less than or equal to 33 millicuries.
3) 10 CFR 35.394 - Training for oral administration of sodium iodide I131 requiring a written directive in quantities greater than 33 millicuries.
4) 10 CFR 35.396 - Training for the parenteral administration of unsealed byproduct material requiring a written directive.

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Background - Stakeholder Concerns

  • Since revisions to the NRCs T&E regulations in 2002 and 2005, stakeholders have raised concerns that the 700hour requirement (10 CFR 35.390) is overly burdensome for physicians not boardcertified or grandfathered.
  • The requirement could create a shortage of AUs, thus limiting patient access to radiopharmaceuticals.
  • The NRC continues to work with the ACMUI on the T&E evaluation.

8

Background - SRM M170817 In Staff Requirements Memorandum M170817 (August 17, 2017; ML17229B284), the Commission directed staff to evaluate:

  • Whether it makes sense to establish tailored T&E requirements for different categories of radiopharmaceuticals;
  • How those categories should be determined;
  • What the appropriate T&E requirements would be for each category; and
  • Whether the requirements should be based on hours of T&E or on competency.

9

Background - SECY180084 In 2018, staff conducted an initial evaluation of T&E under 10 CFR Part 35, Subpart E, and documented their review in SECY180084 (August 28, 2018; ML18135A277):

  • It may be feasible to establish tailored T&E requirements for different categories of radiopharmaceuticals, and to create limited authorized user statuses.
  • There are viable options for creating a competencybased approach to demonstrating acceptable T&E for limited authorized user status.
  • However, the staff needs to conduct more extensive outreach before making a recommendation to the Commission.

10

The NRCs T&E Evaluation Information Input from Review Paper Input from Medical Additional Agreement States Input from ACMUI or Stakeholders Information Rulemaking Plan*

  • If staff recommends rulemaking, the Commission will vote on whether the staff should proceed with rulemaking.

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T&E Federal Register Notice

  • The T&E Federal Register notice (83 FR 54380) was published on October 29, 2018:

https://www.gpo.gov/fdsys/pkg/FR20181029/pdf/2018 23521.pdf

  • Opened the comment period from October 29, 2018 through January 29, 2019.
  • The Federal Register notice (FRN) asks a series of specific questions on the NRCs T&E requirements.

12

Questions in the FRN A. Tailored Training & Experience Requirements

1) Are the current pathways for obtaining AU status reasonable and accessible, are they adequate for protecting public health and safety?
2) Should the NRC develop a new tailored T&E pathway? What would be the appropriate way to categorize radiopharmaceuticals for tailored T&E requirements?
3) Should the fundamental T&E required of physicians seeking limited AU status need to have the same fundamental T&E required of physicians seeking full AU status?
4) How should the requirements for this fundamental T&E be structured for a specific category of radiopharmaceuticals?

13

Questions in the FRN, continued B. NRCs Recognition of Medical Specialty Boards The NRCs procedures for recognizing medical specialty boards are located on the Medical Uses Licensee Toolkit Web site:

https://www.nrc.gov/materials/miau/medusetoolkit/certifprocess boards.html.

1) What boards other than those already recognized by the NRC (American Board of Nuclear Medicine, American Board of Radiology, American Osteopathic Board of Radiology, Certification Board of Nuclear Endocrinology) could be considered for recognition for medical uses under 10 CFR 35.300?
2) Are the current NRC medical specialty board recognition criteria sufficient? If not, what additional criteria should the NRC use?

14

Questions in the FRN, continued C. Patient Access

1) Is there a shortage in the number of AUs for medical uses under 10 CFR 35.300? If so, is the shortage associated with the use of a specific radiopharmaceutical?
2) Are there certain geographic areas with an inadequate number of AUs?
3) Do current NRC regulations on AU T&E requirements unnecessarily limit patient access to procedures involving radiopharmaceuticals?
4) Do current NRC regulations on AU T&E requirements unnecessarily limit research and development in nuclear medicine?

15

Questions in the FRN, continued D. Other Suggested Changes to the T&E Regulations

1) Should the NRC regulate the T&E of physicians for medical uses?
2) Are there requirements in the NRCs T&E regulatory framework for physicians that are nonsafety related?
3) How can the NRC transform its regulatory approach for T&E while still ensuring that adequate protection is maintained for workers, the general public, patients, and human research subjects?

16

Submitting Written Comments Submit written comments via Regulations.gov by January 29, 2019

  • Go to www.regulations.gov and search NRC20180230
  • Direct comment submission link:

https://www.regulations.gov/comment?D=NRC20180230 0001

  • The NRC immediately receives comments submitted to Regulations.gov, but it takes a few weeks for comments to be publicly posted.
  • Comments will also be posted to ADAMS.
  • The NRC will consider, but not provide a response to, comments.

17

Additional Public Comment Meetings

  • Tuesday, December 11, 2018, 1:00 p.m. - 4:00 p.m. EST
  • Inperson meeting at NRC headquarters and webinar
  • Thursday, January 10, 2019, 1:00 p.m. - 4:00 p.m. EST
  • Inperson meeting at NRC headquarters and webinar
  • Tuesday, January 22, 2019, 10:00 a.m. - 12:00 p.m. EST

18

Next Steps Comment Period and Public Meetings October 29, 2018 - January 29, 2019 Evaluation of Comments, Review Additional Information, ACMUI T&E Report February - March 2019 Development of Draft Commission Paper March - May 2019 ACMUI and Agreement States Review Draft Commission Paper May - August 2019 ACMUI T&E Subcommittee Public Teleconference on Draft Paper (TENTATIVE)

August 2019 Finalize Commission Paper August and September 2019 Deliver Paper to Commission Fall 2019 19

For More Information

  • The NRCs Training and Experience Evaluation Web site:

https://www.nrc.gov/materials/miau/meduse toolkit/trainingexperienceevaluation.html

  • The T&E docket (NRC20180230) at Regulations.gov:

https://www.regulations.gov/docket?D=NRC20180230

  • NRC T&E contacts:
  • Sarah Lopas, Project Manager Sarah.Lopas@nrc.gov and (301) 4156360
  • Maryann Ayoade, Health Physicist Maryann.Ayoade@nrc.gov and (301) 4150862 20

Comments

  • Press *1 on your phone to ask a question or make a comment.
  • Your comments are being transcribed by a court reporter.
  • Please begin by providing your name.
  • Please speak clearly so the court reporter can obtain an accurate transcript.

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