[Federal Register Volume 84, Number 85 (Thursday, May 2, 2019)]
[Notices]
[Pages 18874-18877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08996]
-----------------------------------------------------------------------
NUCLEAR REGULATORY COMMISSION
[NRC-2018-0230]
Draft Approaches for Addressing Training and Experience
Requirements for Radiopharmaceuticals Requiring a Written Directive
AGENCY: Nuclear Regulatory Commission.
ACTION: Draft approaches for training and experience requirements;
request for comment and notice of public meetings.
-----------------------------------------------------------------------
SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) would like input
on draft approaches the staff has developed that would potentially
revise the training and experience (T&E) requirements for
radiopharmaceuticals requiring a written directive. The input will be
used to determine whether regulatory changes to the NRC's T&E
requirements for authorized users (AUs)
[[Page 18875]]
are warranted and potential advantages, disadvantages, and other
considerations associated with each approach.
DATES: Submit comments by June 3, 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. Two public meetings to solicit comments will be held on May
14, 2019 and May 23, 2019.
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 NRC dockets 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: Office of Administration, Mail Stop:
TWFN-7-A60M, U.S. Nuclear Regulatory Commission, Washington, DC 20555-
0001, ATTN: Program Management, Announcements and Editing Staff.
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)
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 Package
Accession No. ML18135A276).
In SECY-18-0084, the staff concluded that it may be feasible to
establish tailored T&E requirements however, additional outreach with
the medical community was needed to determine whether and how to tailor
those requirements. Revising the T&E requirements could provide
additional pathways for physicians to become AUs for specific types of
radiopharmaceuticals under 10 CFR 35.300, ``Use of unsealed byproduct
material for which a written directive is required.''
As part of the needed additional outreach discussed in SECY-18-
0084, the NRC published a notice in the Federal Register on October 29,
2018 (83 FR 54380) requesting comments on the staff's evaluation of the
T&E requirements for radiopharmaceuticals under 10 CFR 35.300. The NRC
held four public meetings on this topic and collected public comments
through January 29, 2019. Public comments and meeting transcripts are
available on the Federal Rulemaking website at https://www.regulations.gov/ under Docket ID NRC-2018-0230. Following the
conclusion of the initial public comment period, the staff developed
several draft approaches to address the directions in SRM-M170817. The
NRC is now interested in obtaining input on these draft approaches.
During the comment period between May 2, 2019, and June 3, 2019,
the NRC will hold two public meetings to discuss the draft approaches
in this document and accept oral comments on those draft approaches.
Both public meetings will be available for remote participation by
moderated bridge line and webinar and one meeting will also be open for
in-person attendance at the NRC's headquarters in Rockville, Maryland.
The public meetings are scheduled for May 14, 2019 (webinar and in-
person attendance) and May 23, 2019 (webinar-only). The public meetings
will be noticed on the NRC's public meeting website at least 10
calendar days before each 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).
[[Page 18876]]
III. Draft Approaches for Comment
The NRC staff has developed the following draft approaches based on
input received during the initial public comment period and the
Advisory Committee on Medical Uses of Isotopes T&E subcommittee's
report dated February 27, 2019 (ADAMS Accession No. ML19058A598). The
NRC is requesting comments on the draft approaches, including potential
advantages, disadvantages, and other considerations associated with
each and whether some approaches could be revised, combined, or if more
than one approach could be implemented. The NRC staff is also
requesting input on specific questions associated with the approaches.
A. Status Quo
``Status Quo'' presents no changes to the current T&E requirements
for radiopharmaceuticals requiring a written directive under 10 CFR
35.300.
Question 1: If the ``Status Quo'' is maintained, how
should the NRC ready itself for the expected increase in number and
complexity of future radiopharmaceuticals?
Question 2: Is there a challenge with the current T&E
requirements--such as concerns regarding patient access to
radiopharmaceuticals--that should be addressed through a rulemaking?
B. Tailored Training and Experience Requirements
The four approaches under this section would modify the existing
T&E requirements under 10 CFR 35.390, ``Training for use of unsealed
byproduct material for which a written directive is required.'' The
approaches described under Sections B.1, B.2, and B.3 would require a
set amount of T&E tailored to the specific radiopharmaceuticals, and
the ``Emerging Radiopharmaceuticals'' approach described under Section
B.4 would tailor T&E requirements for each new radiopharmaceutical as
they were developed, similar to the approach for regulating new
technologies under 10 CFR 35.1000, ``Other Medical Uses of Byproduct
Material or Radiation from Byproduct Material.''
Question 3: How should the complexity of the
radiopharmaceutical administration protocol be considered in
establishing the T&E requirements for the limited approaches described
in Sections B.1 and B.2 below?
1. Limited AU for Alpha- or Beta-Emitting Radiopharmaceuticals
Under this approach, any physician could complete at least 400
hours of T&E to be authorized to administer any alpha- or beta-emitting
radiopharmaceutical. The T&E would consist of 200 hours of classroom
and laboratory training and a minimum of 200 hours of supervised work
experience tailored to alpha- and beta-emitting radiopharmaceuticals.
Preceptor attestation would be required.
Question 4: How should the NRC categorize
radiopharmaceuticals with mixed emissions?
2. Limited AU for Unit-Dose, Patient-Ready Radiopharmaceuticals
Under this approach, any physician could complete at least 400
hours of T&E to be authorized to administer any unit-dose, patient-
ready radiopharmaceutical. The T&E would consist of 200 hours of
classroom and laboratory training and a minimum of 200 hours of
supervised work experience tailored to unit-dose, patient-ready
radiopharmaceuticals. Preceptor attestation would be required.
Question 5: Under what conditions should a
radiopharmaceutical be considered ``patient ready'' such that the T&E
requirements could be tailored?
3. Limited AU for Any One Parenteral Radiopharmaceutical
Under this approach any physician could complete at least 400 hours
of T&E to be authorized to administer any one parenteral
radiopharmaceutical. The T&E would consist of 200 hours of classroom
and laboratory training and a minimum of 200 hours of supervised work
experience tailored to the radiopharmaceutical they wish to administer.
Preceptor attestation would be required. Limited AUs who have initially
completed their at least 400 hours of T&E and then wish to administer a
different radiopharmaceutical would be required to complete, minimally,
an additional 80 hours of tailored, supervised work experience for each
additional radiopharmaceutical.
4. Emerging Radiopharmaceuticals
Like the NRC's regulations at 10 CFR 35.1000, under this approach
the NRC would conduct individual reviews of each new emerging
radiopharmaceutical to determine T&E requirements specific to the new
radiopharmaceutical. The T&E requirements could be tailored to consider
potential users of the radiopharmaceutical (e.g., non-nuclear medicine
or non-radiation oncology physicians wishing to administer the
radiopharmaceutical for their patients with indicated cancers), thus
creating alternate T&E pathways for each new radiopharmaceutical.
C. Performance-Based
The approaches described in this section would remove prescriptive
T&E requirements from the regulations and instead would focus oversight
on the performance-based aspects of a licensee's medical program for
the administration of radiopharmaceuticals.
1. Competency-Based Evaluation
Under this approach, proposed AUs would be required to demonstrate
competency in radiation safety topics and radiation safety-related job
duties through a formal competency evaluation (e.g., an examination or
preceptor attestation).
Question 6: How could a competency-based evaluation ensure
appropriate training and experience for AUs administering
radiopharmaceuticals?
2. Credentialing of Authorized Users
Under this approach, the NRC would no longer review and approve T&E
qualifications for all AUs under 10 CFR part 35. Instead, licensees
would develop and use their own policies and procedures to make self-
determinations of whether their credentialed physicians have the
appropriate T&E to be an AU for one or more radiopharmaceuticals under
10 CFR 35.300. Licensees would be required to maintain a training
program that ensures compliance with the requirements in 10 CFR 35.41,
``Procedures for administrations requiring a written directive,'' and
10 CFR part 20, ``Standards for Protection Against Radiation.''
Question 7: How could physicians in small practices be
credentialed (e.g., physicians not associated with hospitals or other
large institutions and their credentialing boards)?
D. Team-Based
Team-based approaches could remove prescriptive T&E requirements
for AUs, focus training requirements on the competency of the entire
team, or revise the current 700-hour T&E requirement for AUs based on
pairing the AU with another individual with expertise in administering
radiopharmaceuticals.
Question 8: How should the AU's radiation safety
responsibilities be clearly distinguished from other members of the
team?
1. Radiopharmaceutical Team
Licensees would need a team to administer radiopharmaceuticals
under 10 CFR 35.300. The team would minimally consist of an AU, a
radiation safety officer, and a nuclear medicine technologist.
Additional team members could include an authorized medical
[[Page 18877]]
physicist, a health physicist, an authorized nuclear pharmacist, and
other physicians that manage patient care. The T&E for the
radiopharmaceutical team approach would be performance-based: Licensees
would develop policies and procedures to address how their teams would
meet the requirements in 10 CFR 35.41 and 10 CFR part 20.
2. Team AUs With Authorized Administrators
Licensees would need both an AU and an authorized administrator
(AA) to administer radiopharmaceuticals under 10 CFR 35.300. AAs would
be individuals authorized by the licensee to administer
radiopharmaceuticals in accordance with the written directive (e.g., a
nuclear medicine technologist or a nuclear medicine advanced
associate). The T&E for AUs would be performance-based and focus on the
licensee's policies and procedures for written directives, reporting
medical events, and patient release criteria. Because AAs would be
physically administering radiopharmaceuticals, AAs would be required to
have training on radiation safety, written directives, preparation and
administration protocols (or vendor training, if available), patient
release criteria, and medical event reporting.
3. Partner Limited-Trained AUs With Authorized Nuclear Pharmacists
The T&E for AUs would be at least 400 hours, however, the AU would
be required to physically partner with an authorized nuclear pharmacist
(ANP) for all administrations of radiopharmaceuticals. Unlike the
approaches in Sections D.1 and D.2 above, prescriptive T&E would be
required for the AU in this approach due to the AU's more prominent
role in the administration of radiopharmaceuticals. The minimum of 400
hours of T&E for the physician partnering with an ANP would be focused
on supervised work experience and patient cases, and preceptor
attestation would be required. The AU would be responsible for
administration of radiopharmaceuticals in accordance with the written
directive, and the ANP would be responsible for radiation safety-
related duties.
Question 9: How should the radiation safety
responsibilities be divided between the AU and ANP?
IV. Additional Questions for Consideration
The NRC is requesting input on the following questions as they
relate to the draft approaches discussed above.
Question 10: What are the advantages and disadvantages of
the draft approaches?
Question 11: Are there significant costs or benefits
associated with any of the approaches?
Question 12: Would any of the draft approaches impact
patient access to radiopharmaceuticals or address stakeholder concerns
of overly burdensome (regulatory) requirements?
Question 13: For the draft approaches that consider
tailored hours of T&E, what are the appropriate numbers of hours and
what radiation safety topics should comprise the limited T&E?
Question 14: Should the NRC consider inclusion of a formal
radiation safety competency assessment and periodic reassessments for
any of the draft approaches above? If so, who should establish and
administer these assessments?
Question 15: How would the draft approaches impact the
medical organizations that use the NRC's T&E requirements as a basis
for establishing their training programs?
Question 16: Are there concerns regarding implementation
and/or viability for any of the approaches discussed above?
Question 17: Are there any unintended consequences of the
draft approaches?
Question 18: Which of the draft approaches best positions
the NRC to effectively regulate future radiopharmaceuticals?
Question 19: Should the NRC continue to play a role in the
review and approval of AUs?
Dated at Rockville, Maryland, this 29th day of April 2019.
For the Nuclear Regulatory Commission.
Andrea L. Kock,
Director, Division of Materials Safety, Security, State, and Tribal
Programs, Office of Nuclear Material Safety and Safeguards.
[FR Doc. 2019-08996 Filed 5-1-19; 8:45 am]
BILLING CODE 7590-01-P