[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]


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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.

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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