Training and Experience Requirements for Different Categories of Radiopharmaceuticals, 54380-54382 [2018-23521]
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Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Notices
revised to address the comments
received.
III. Finding of No Significant Impact
Based on its review of the proposed
action, as documented in the EA, the
NRC staff concludes that the renewal of
License SUC–1591 with an expanded
scope of authorized activities will not
have a significant effect on the quality
of the human environment. Therefore,
the NRC staff has determined not to
prepare an EIS for the proposed action
and that, pursuant to 10 CFR 51.32, a
finding of no significant impact is
appropriate.
Dated at Rockville, Maryland, on October
23, 2018.
For the Nuclear Regulatory Commission.
Brian W. Smith,
Acting Director, Division of Fuel Cycle Safety,
Safeguards and Environmental Review, Office
of Nuclear Material Safety and Safeguards.
[FR Doc. 2018–23509 Filed 10–26–18; 8:45 am]
BILLING CODE 7590–01–P
NUCLEAR REGULATORY
COMMISSION
[NRC–2018–0230]
Training and Experience Requirements
for Different Categories of
Radiopharmaceuticals
Nuclear Regulatory
Commission.
ACTION: Training and experience
requirements; request for comment.
AGENCY:
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
https://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:
amozie on DSK3GDR082PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
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Jennifer.Borges@nrc.gov. 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: Sarah.Lopas@nrc.gov.
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 publiclyavailable information related to this
action by any of the following methods:
• Federal Rulemaking Website: Go to
https://www.regulations.gov and search
for Docket ID NRC–2018–0230.
• NRC’s Agencywide Documents
Access and Management System
(ADAMS): You may obtain publiclyavailable documents online in the
ADAMS Public Documents collection at
https://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 pdr.resource@
nrc.gov. 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 https://
www.regulations.gov and entered into
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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
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Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Notices
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 inperson 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).
amozie on DSK3GDR082PROD with NOTICES1
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
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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, lowenergy photon); similar preparation
method (patient-ready doses); or a
combination thereof (e.g.,
radiopharmaceuticals containing alphaand 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
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54381
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/certifprocess-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.
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Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Notices
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
NUCLEAR REGULATORY
COMMISSION
amozie on DSK3GDR082PROD with NOTICES1
[NRC–2018–0062]
Information Collection: Physical
Protection of Category 1 and Category
2 Quantities of Radioactive Material
Nuclear Regulatory
Commission.
ACTION: Renewal of existing information
collection; request for comment.
AGENCY:
VerDate Sep<11>2014
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Jkt 247001
The U.S. Nuclear Regulatory
Commission (NRC) invites public
comment on the renewal of Office of
Management and Budget (OMB)
approval for an existing collection of
information. The information collection
is entitled, ‘‘Physical Protection of
Category 1 and Category 2 Quantities of
Radioactive Material.’’
DATES: Submit comments by December
28, 2018. Comments received after this
date will be considered if it is practical
to do so, but the Commission is able to
ensure consideration only for comments
received on or before this date.
ADDRESSES: You may submit comments
by any of the following methods:
• Federal Rulemaking Website: Go to
https://www.regulations.gov and search
for Docket ID NRC–2018–0062. Address
questions about Docket IDs in
Regulations.gov to Jennifer Borges;
telephone: 301–287–9127; email:
Jennifer.Borges@nrc.gov. For technical
questions, contact the individual listed
in the FOR FURTHER INFORMATION
CONTACT section of this document.
• Mail comments to: David Cullison,
Office of the Chief Information Officer,
Mail Stop: T–2 F43, 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:
David Cullison, Office of the Chief
Information Officer, U.S. Nuclear
Regulatory Commission, Washington,
DC 20555–0001; telephone: 301–415–
2084; email: INFOCOLLECTS.Resource@
nrc.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Obtaining Information and
Submitting Comments
A. Obtaining Information
Please refer to Docket ID NRC–2018–
0062 when contacting the NRC about
the availability of information for this
action. You may obtain publiclyavailable information related to this
action by any of the following methods:
• Federal Rulemaking Website: Go to
https://www.regulations.gov and search
for Docket ID NRC–2018–0062.
• NRC’s Agencywide Documents
Access and Management System
(ADAMS): You may obtain publiclyavailable documents online in the
ADAMS Public Documents collection at
https://www.nrc.gov/reading-rm/
adams.html. To begin the search, select
‘‘Begin Web-based ADAMS Search.’’ For
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
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 pdr.resource@
nrc.gov. The supporting statement
associated with the part 37 information
collections, the burden table, and the
NRC Form 755 are available in ADAMS
under Accession Nos. ML18172A301,
ML18172A300, and ML18295A594.
• 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.
• NRC’s Clearance Officer: A copy of
the collection of information and related
instructions may be obtained without
charge by contacting the NRC’s
Clearance Officer, David Cullison,
Office of the Chief Information Officer,
U.S. Nuclear Regulatory Commission,
Washington, DC 20555–0001; telephone:
301–415–2084; email:
INFOCOLLECTS.Resource@nrc.gov.
B. Submitting Comments
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 https://
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 OMB, 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 submissions into
ADAMS.
II. Background
In accordance with the Paperwork
Reduction Act of 1995 (44 U.S.C.
Chapter 35), the NRC is requesting
public comment on its intention to
request the OMB’s approval for the
information collection summarized in
this section.
1. The title of the information
collection: 10 CFR part 37, Physical
Protection of Category 1 and Category 2
Quantities of Radioactive Material.’’
2. OMB approval number: 3150–0214.
3. Type of submission: Revision.
4. The form number, if applicable:
NRC Form 755, ‘‘Notification to the NRC
E:\FR\FM\29OCN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 209 (Monday, October 29, 2018)]
[Notices]
[Pages 54380-54382]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23521]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 https://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 https://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 https://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
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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
