ML18302A095
| ML18302A095 | |
| Person / Time | |
|---|---|
| Issue date: | 10/29/2018 |
| From: | Lopas S L NRC/NMSS/DMSST/MSEB |
| To: | |
| Lopas S L | |
| References | |
| Download: ML18302A095 (3) | |
Text
54380 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 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 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:
Jennifer.Borges@nrc.gov. For technical
questions, contact the individual listed
in the FORFURTHERINFORMATION CONTACT section of this document.
- Mail comments to:
May Ma, Office of Administration, Mail Stop: TWFN
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 SUPPLEMENTARYINFORMATION section of this document. FORFURTHERINFORMATIONCONTACT
- 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. SUPPLEMENTARYINFORMATION
- 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 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 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 VerDate Sep<11>2014 17:48 Oct 26, 2018Jkt 247001PO 00000Frm 00073Fmt 4703Sfmt 4703E:\FR\FM\29OCN1.SGM29OCN1 amozie on DSK3GDR082PROD with NOTICES1 54381 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 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
The NRC will also post the meeting notices
on the Federal Rulemaking website at
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. VerDate Sep<11>2014 17:48 Oct 26, 2018Jkt 247001PO 00000Frm 00074Fmt 4703Sfmt 4703E:\FR\FM\29OCN1.SGM29OCN1 amozie on DSK3GDR082PROD with NOTICES1 54382 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.
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
[NRC-2018-0062]
Information Collection: Physical
Protection of Category 1 and Category
2 Quantities of Radioactive Material AGENCY: Nuclear Regulatory Commission.
ACTION: Renewal of existing information collection; request for comment.
SUMMARY
- 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 http://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 FORFURTHERINFORMATION 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 SUPPLEMENTARYINFORMATION section of this document. FORFURTHERINFORMATIONCONTACT
- 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. SUPPLEMENTARYINFORMATION
- 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 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-2018-0062.
- 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 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 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 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 VerDate Sep<11>2014 17:48 Oct 26, 2018Jkt 247001PO 00000Frm 00075Fmt 4703Sfmt 4703E:\FR\FM\29OCN1.SGM29OCN1 amozie on DSK3GDR082PROD with NOTICES1