83 FR 54380 - Training and Experience Requirements for Different Categories of Radiopharmaceuticals

NUCLEAR REGULATORY COMMISSION

Federal Register Volume 83, Issue 209 (October 29, 2018)

The U.S. Nuclear Regulatory Commission (NRC) is requesting comments on its training and experience (T&E) requirements. Specifically, the NRC would like input on whether it should establish tailored T&E requirements for different categories of radiopharmaceuticals for which a written directive is required in accordance with its regulations. The input will be used to determine whether significant regulatory changes to the NRC's T&E requirements for authorized users (AUs) are warranted.

[Federal Register Volume 83, Number 209 (Monday, October 29, 2018)]
[Notices]
[Pages 54380-54382]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-23521]


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NUCLEAR REGULATORY COMMISSION

[NRC-2018-0230]


Training and Experience Requirements for Different Categories of 
Radiopharmaceuticals

AGENCY: Nuclear Regulatory Commission.

ACTION: Training and experience requirements; request for comment.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is requesting 
comments on its training and experience (T&E) requirements. 
Specifically, the NRC would like input on whether it should establish 
tailored T&E requirements for different categories of 
radiopharmaceuticals for which a written directive is required in 
accordance with its regulations. The input will be used to determine 
whether significant regulatory changes to the NRC's T&E requirements 
for authorized users (AUs) are warranted.

DATES: Submit comments by January 29, 2019. Comments received after 
this date will be considered if it is practical to do so, but the NRC 
is only able to ensure consideration for comments received on or before 
this date.

ADDRESSES: You may submit comments by any of the following methods:
     Federal Rulemaking Website: Go to http://www.regulations.gov and search for Docket ID NRC-2018-0230. Address 
questions about Docket IDs in Regulations.gov to Jennifer Borges; 
telephone: 301-287-9127; email: [email protected]. For technical 
questions, contact the individual listed in the FOR FURTHER INFORMATION 
CONTACT section of this document.
     Mail comments to: May Ma, Office of Administration, Mail 
Stop: TWFN-7-A60M, U.S. Nuclear Regulatory Commission, Washington, DC 
20555-0001.
    For additional direction on obtaining information and submitting 
comments, see ``Obtaining Information and Submitting Comments'' in the 
SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: Sarah Lopas, Office of Nuclear 
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001; telephone: 301-415-6360, email: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Obtaining Information and Submitting Comments

A. Obtaining Information

    Please refer to Docket ID NRC-2018-0230 when contacting the NRC 
about the availability of information for this action. You may obtain 
publicly-available information related to this action by any of the 
following methods:
     Federal Rulemaking Website: Go to http://www.regulations.gov and search for Docket ID NRC-2018-0230.
     NRC's Agencywide Documents Access and Management System 
(ADAMS): You may obtain publicly-available documents online in the 
ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select ``Begin Web-based ADAMS 
Search.'' For problems with ADAMS, please contact the NRC's Public 
Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or 
by email to [email protected]. The ADAMS accession number for each 
document referenced is provided the first time that it is mentioned in 
the SUPPLEMENTARY INFORMATION section.
     NRC's PDR: You may examine and purchase copies of public 
documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 
Rockville Pike, Rockville, Maryland 20852.

B. Submitting Comments

    Please include Docket ID NRC-2018-0230 in your comment submission. 
The NRC cautions you not to include identifying or contact information 
in comment submissions that you do not want to be publicly disclosed in 
your comment submission. All comment submissions are posted at http://www.regulations.gov and entered into ADAMS. Comment submissions are not 
routinely edited to remove identifying or contact information.
    If you are requesting or aggregating comments from other persons 
for submission to the NRC, then you should inform those persons not to 
include identifying or contact information that they do not want to be 
publicly disclosed in their comment submission. Your request should 
state that the NRC does not routinely edit comment submissions to 
remove such information before making the comment submissions available 
to the public or entering the comment into ADAMS.

II. Background

    On August 17, 2017, the Commission issued a staff requirements 
memorandum (SRM), SRM-M170817 (ADAMS Accession No. ML17229B284), 
approving the final rule revising parts 30, 32, and 35 of title 10 of 
the Code of Federal Regulations (10 CFR), ``Medical Use of Byproduct 
Material--Medical Event Definitions, Training and Experience, and 
Clarifying Amendments,'' and directing the staff to evaluate (1) 
whether it makes sense to establish tailored T&E requirements for 
different categories of radiopharmaceuticals, (2) how those categories 
should be determined (such as by risks posed by groups of radionuclides 
or by delivery method), (3) what the appropriate T&E requirements would 
be for each category, and (4) whether those requirements should be 
based on hours of T&E or focused more on competency. In response to the 
SRM, the NRC staff documented its initial results, status, and next 
steps related to this evaluation in SECY-18-0084, ``Staff Evaluation of 
Training and Experience Requirements for Administering Different 
Categories of Radiopharmaceuticals in Response to SRM-M170817'' (ADAMS 
Accession No. ML18135A276). In SECY-18-0084, the staff concluded that 
additional outreach with the medical community is needed to determine 
whether and how to tailor the T&E requirements to establish a limited 
AU status, the specific T&E requirements that should apply, how the T&E 
requirements should be met (e.g., hours of training, demonstration of 
competency), and whether a competency-based approach makes sense for 
the T&E requirements for all the medical uses authorized under 10 CFR 
35.300, ``Use of unsealed byproduct material for which a written 
directive is required.''
    The NRC is interested in obtaining input from as many stakeholders 
as possible, including members of the Advisory Committee on the Medical

[[Page 54381]]

Uses of Isotopes, professional organizations, physicians, patients, 
patient advocacy groups, licensees, Agreement States, and other 
interested individuals. The focus of this request is to gather 
information that will permit the NRC staff to determine whether changes 
to the T&E requirements are warranted for different categories of 
radiopharmaceuticals for physicians seeking AU status for the medical 
use of specific categories of radiopharmaceuticals requiring a written 
directive under 10 CFR 35.300.
    During the comment period between October 29, 2018 and January 29, 
2019, the NRC will hold four public meetings that will discuss the 
information being requested and to accept comments on the docket. All 
four public meetings will be available for remote participation by 
moderated bridge line and webinar, and two of the four meetings will be 
open for in-person attendance at NRC's headquarters in Rockville, 
Maryland.
    The public meetings are scheduled for November 14, 2018 (webinar-
only); December 11, 2018 (webinar and in-person attendance); January 
10, 2019 (webinar and in-person attendance); and January 22, 2019 
(webinar-only). The public meetings will be noticed on the NRC's public 
meeting website at least 10 calendar days before the meeting. Members 
of the public should monitor the NRC's public meeting website at 
https://www.nrc.gov/pmns/mtg. The NRC will also post the meeting 
notices on the Federal Rulemaking website at https://www.regulations.gov/ under Docket ID NRC-2018-0230.
    The NRC may post additional materials related to this document, 
including public comments, on the Federal Rulemaking website. The 
Federal Rulemaking website allows you to receive alerts when changes or 
additions occur in a docket folder. To subscribe: (1) Navigate to the 
docket folder NRC-2018-0230; (2) click the ``Sign up for Email Alerts'' 
link; and (3) enter your email address and select how frequently you 
would like to receive emails (daily, weekly, or monthly).

III. Specific Requests for Comments

A. Tailored Training & Experience Requirements

    The NRC is requesting comments on whether it should establish 
tailored T&E requirements for different categories of 
radiopharmaceuticals for physicians seeking AU status for the medical 
use of specific categories of radiopharmaceuticals requiring a written 
directive under 10 CFR 35.300 (i.e., a limited AU status). This would 
be for physicians seeking AU status via the alternate non-board 
certified pathway, and for physicians certified by a medical specialty 
board that is not currently recognized by the NRC under 10 CFR 35.390, 
35.392, 35.394, or 35.396 (Unsealed Byproduct Material--Written 
Directive Required).
    1. Are the current pathways for obtaining AU status reasonable and 
accessible? Provide a rationale for your answer.
    2. Are the current pathways for obtaining AU status adequate for 
protecting public health and safety? Provide a rationale for your 
answer.
    3. Should the NRC develop a new tailored T&E pathway for these 
physicians? If so, what would be the appropriate way to categorize 
radiopharmaceuticals for tailored T&E requirements? If not, explain why 
the regulations should remain unchanged. [Some options to categorize 
radiopharmaceuticals include radiopharmaceuticals with similar delivery 
methods (oral, parenteral); same type of radiation characteristics or 
emission (alpha, beta, gamma, low-energy photon); similar preparation 
method (patient-ready doses); or a combination thereof (e.g., 
radiopharmaceuticals containing alpha- and beta-emitting radioisotopes 
that are administered intravenously and are prepared as patient-ready 
doses).]
    4. 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 for all oral and parenteral 
administrations under 10 CFR 35.300?
    5. How should the requirements for this fundamental T&E be 
structured for a specific category of radiopharmaceuticals?
    a. Describe what the requirements should include:
    i. Classroom and laboratory training--What topics need to be 
covered in this training requirement? How many hours of classroom and 
laboratory training should be required? Provide the basis for the 
number of hours. If not hours, explain how this training should be 
quantified. [Note: The topics currently required in the regulations to 
be included in the classroom and laboratory training and work 
experience are listed in 10 CFR 35.390, 35.392, 35.394, and 35.396.]
    ii. Work experience--What should the work experience requirement 
involve? How many hours of work experience should be required and what 
is the minimum number of patient or human research subject 
administrations that an individual must perform? Provide the basis for 
the number of hours and administrations. What should be the 
qualifications of the supervising individual?
    iii. Competency--How should competency be evaluated? Should a 
written and/or practical examination by an independent examining 
committee be administered? Provide a rationale for your answer.
    b. Should a preceptor attestation be required for the fundamental 
T&E? Provide a rationale for your answer.
    c. Should the radiopharmaceutical manufacturer be able to provide 
the preceptor attestation? Provide a rational for your answer.
    d. Who should establish and administer the curriculum and 
examination? Provide specific group(s). [Some options are: NRC, medical 
specialty boards, medical professional societies, educational 
professional groups, and NRC in collaboration with any or more of the 
aforementioned groups.]
    e. Should AU competency be periodically assessed? If so, how should 
it be assessed, how often, and by whom?

B. NRC's Recognition of Medical Specialty Boards

    The NRC is requesting comments on its recognition of medical 
specialty boards. The NRC's procedures for recognizing medical 
specialty boards are located on the Medical Uses Licensee Toolkit 
website (https://www.nrc.gov/materials/miau/med-use-toolkit/certif-process-boards.html). The NRC staff periodically reviews information to 
determine a board's continued eligibility for recognition.
    1. What boards other than those already recognized by the NRC 
(American Board of Nuclear Medicine [ABNM], American Board of Radiology 
[ABR], American Osteopathic Board of Radiology [AOBR], Certification 
Board of Nuclear Endocrinology [CBNE]) 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?

C. Patient Access

    The NRC is requesting comments on whether there is a shortage in 
the number of AUs for 10 CFR 35.300.
    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? Explain how.
    2. Are there certain geographic areas with an inadequate number of 
AUs? Identify these areas.

[[Page 54382]]

    3. Do current NRC regulations on AU T&E requirements unnecessarily 
limit patient access to procedures involving radiopharmaceuticals? 
Explain how.
    4. Do current NRC regulations on AU T&E requirements unnecessarily 
limit research and development in nuclear medicine? Explain how.

D. Other Suggested Changes to the T&E Regulations

    In 2002, the NRC revised its regulatory framework for medical use. 
The goal was to focus the NRC's regulations on those medical procedures 
that pose the highest risk to workers, the general public, patients, 
and human research subjects and to structure the regulations to be more 
risk-informed and more performance-based. The 2002 rule reduced the 
unnecessary regulatory burden by either reducing or eliminating the 
prescriptiveness of some regulations. Instead, the rule provided for a 
performance-based approach that relied on the training and experience 
of the AUs, authorized nuclear pharmacists, and radiation safety 
officers. The NRC is requesting comments on whether there are any other 
changes to the T&E regulations in 10 CFR part 35 that should be 
considered. Please discuss your suggested changes.
    1. Should the NRC regulate the T&E of physicians for medical uses?
    2. Are there requirements in the NRC's T&E regulatory framework for 
physicians that are non-safety 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?

    Dated at Rockville, Maryland, this 23rd day of October 2018.

    For the Nuclear Regulatory Commission.
Daniel S. Collins,
Director, Division of Materials Safety, Security, State, and Tribal 
Programs, Office of Nuclear Material Safety and Safeguards.
[FR Doc. 2018-23521 Filed 10-26-18; 8:45 am]
 BILLING CODE 7590-01-P