[Federal Register Volume 82, Number 214 (Tuesday, November 7, 2017)]
[Notices]
[Pages 51655-51657]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24129]


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NUCLEAR REGULATORY COMMISSION

[NRC-2017-0215]


Yttrium-90 Microsphere Brachytherapy Sources and Devices 
TheraSphere[supreg] and SIR-Spheres[supreg]

AGENCY: Nuclear Regulatory Commission.

ACTION: Draft guidance; request for comment.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is revising its 
licensing guidance for licenses authorizing the use of Yttrium-90 (Y-
90) Microsphere Brachytherapy Sources and Devices TheraSphere[supreg] 
and SIR-Spheres[supreg]. The NRC is requesting public comment on the 
draft revision of the licensing guidance (Rev. 10). The document has 
been revised to significantly update the criteria for training and 
experience, medical event reporting, inventory requirement 
specifications, and waste disposal issues. The revised guidance 
document

[[Page 51656]]

also provides new information regarding cremation and autopsy. This 
guidance is intended for use by NRC applicants, NRC licensees, and the 
NRC staff.

DATES: Submit comments by January 8, 2018. Comments received after this 
date will be considered if it is practical to do so, but the NRC is 
only able to ensure consideration of comments received on or before 
this date.

ADDRESSES: You may submit comments by any of the following methods:
     Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2017-0215. Address 
questions about NRC dockets to Carol Gallagher; telephone: 301-415-
3463; 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: OWFN-2-A13, 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: Lisa Dimmick, Office of Nuclear 
Material Safety and Safeguards; U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001; telephone: 301-415-0694; email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Obtaining Information and Submitting Comments

A. Obtaining Information

    Please refer to Docket ID NRC-2017-0215 when contacting the NRC 
about the availability of information regarding this action. You may 
obtain publicly-available information related to this action by the 
following methods:
     Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2017-0215.
     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 ``ADAMS Public Documents'' and 
then 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 
draft Y-90 Microsphere Brachytherapy Sources and Devices Licensing 
Guidance, Revision 10, is available in ADAMS under Accession No. 
ML17107A375.
     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.
    The draft Y-90 Microsphere Brachytherapy Sources and Devices 
Licensing Guidance, Revision 10, is also available on the NRC's public 
Web site on the ``Medical Uses Licensee Toolkit'' page at https://www.nrc.gov/materials/miau/med-use-toolkit.html.

B. Submitting Comments

    Please include Docket ID NRC-2017-0215 in your comment submission.
    The NRC cautions you not to include identifying or contact 
information that you do not want publicly disclosed in your comment 
submission. The NRC will post all comment submissions at http://www.regulations.gov as well as enter the comment submissions into 
ADAMS. The NRC does not routinely edit comment submissions 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 submissions into ADAMS.

II. Background

    The NRC is requesting public comment on the draft licensing 
guidance entitled ``Yttrium-90 Microsphere Brachytherapy Sources and 
Devices TheraSphere[supreg] and SIR-Spheres[supreg] Licensing 
Guidance.'' This draft would be revision 10 to this licensing guidance. 
The licensing guidance provides medical use applicants with an 
acceptable means of satisfying the requirements for a license for the 
use of TheraSphere[supreg] and SIR-Spheres[supreg] and is not intended 
to be the only means of satisfying the requirements for a license. The 
licensing guidance provides the NRC with a set of standard criteria for 
evaluating a license application, although an applicant may submit 
alternative information and commitments for review by the NRC staff to 
make a licensing determination unless the information is specifically 
required by regulation. This guidance will also be available for 
voluntary use by Agreement States.
    The licensing guidance for Y-90 microsphere brachytherapy was 
initially published in October 2002 and subsequently revised in 2004, 
2007, 2008, 2011, 2012, and 2016. Following years of using the current 
licensing guidance, the NRC staff, stakeholders, and the Advisory 
Committee on the Medical Uses of Isotopes (ACMUI) have identified 
numerous issues that need to be addressed. A working group comprised of 
Agreement State representatives and NRC staff was formed to address 
identified issues. The document has been revised to significantly 
update the criteria for training and experience, medical event 
reporting, inventory requirement specifications, and waste disposal 
issues. The revised guidance document also provides new information 
regarding cremation and autopsy.
    As described in the draft licensing guidance, the NRC is 
recommending removal of the alternate, manufacturer provided clinical 
training pathway to complete the training and experience criteria 
listed in Section B of the training and experience section of the 
licensing guidance. During an ACMUI meeting on October 7, 2016 
(ML16357A688), the ACMUI recommended that the NRC leave this alternate 
pathway in the Y-90 microsphere licensing guidance to allow access to 
Y-90 microsphere brachytherapy in areas where there may not already be 
approved AUs to supervise new physicians. However, after licensing Y-90 
microspheres under 10 CFR 35.1000 for over 10 years, there should be 
substantial facilities and AUs available to offer training for Y-90 
microspheres, similar to other therapeutic modalities, and therefore 
this pathway should be removed to bring Y-90 microsphere brachytherapy 
training and experience (T&E) in line with other T&E requirements in 10 
CFR part 35.
    The manufacturers stated, during the same ACMUI meeting, that 
training under the supervision of a manufacturer representative should 
remain as a T&E pathway because their representatives are highly 
knowledgeable about their devices. The NRC agrees with the 
manufacturers that the individual who provides the training in the 
operation of the device should be knowledgeable about the device, and 
this could include a manufacturer representative as well as the 
licensees' personnel. The proposed licensing guidance still requires 
the physician to receive training on the operation of the device. 
However, the

[[Page 51657]]

clinical experience a physician received during the 3 patient cases 
should include more than operation of the device. At a minimum, the 
clinical experience should also include evaluation of dose and activity 
of Y-90 microspheres to be administered to each treatment site, 
calculating and measuring the activity and safely preparing the Y-90 
microspheres to be delivered, using administrative controls to prevent 
a medical event, and following up and reviewing each patient's case 
history. During the ACMUI meeting, the ACMUI recommended that this type 
of training be provided by someone with defined medical experience, but 
left it up to the NRC to decide what medical experience would be 
necessary. As this T&E is specific to patient care and patient follow-
up, the proposed licensing guidance recommends this type of training be 
provided by an AU for each type of Y-90 microsphere for which the 
individual is seeking AU status, similar to how other modalities are 
regulated in 10 CFR part 35. Additionally, changing the criteria would 
not preclude the manufacturer representatives from providing training, 
as is normally done for other therapies.

III. Request for Comments

    The NRC is requesting comments on the proposed licensing guidance, 
entitled, ``Yttrium-90 Microsphere Brachytherapy Sources and Devices 
TheraSphere[supreg] and SIR-Spheres[supreg] Licensing Guidance, 
Revision 10.'' While the NRC is requesting comments on the entirety of 
the proposed guidance, the NRC is specifically seeking comments on 
several sections.
    (1) Recommended Minimum Clinical Experience: Due to the complexity 
of delivery of Y-90 microspheres, the licensing guidance historically 
and currently recommends that a prospective AU demonstrate he or she 
has clinical experience with the device. The current recommendation is 
that 3 patient cases for each type of microsphere should be completed 
for each prospective authorized user prior to approval. This 
recommendation is similar to requirements in other therapy modalities, 
such as section 35.390 of title 10 of the Code of Federal Regulations 
(10 CFR). The NRC is seeking specific comments on whether 3 patient 
cases provide adequate clinical experience for a physician to gain AU 
status for Y-90 microspheres.
    (2) Adding Authorization for Other Microsphere Type: The NRC is 
seeking comments to determine additional training needed when an AU who 
is already authorized to use one type of microsphere requests 
authorization for use of another type of microsphere. For instance, are 
3 additional cases for the other type of microsphere necessary for the 
AU to gain the knowledge to safely administer the new microsphere, or 
should the number of cases be left to the discretion of the supervising 
AU?
    (3) Written Attestation from Preceptor: Historically, the NRC has 
not required a written attestation, signed by a preceptor AU, because 
there was not a sufficient number of AUs to supervise the training and 
sign the written attestation. However, given that the NRC and Agreement 
States have licensed Y-90 microsphere brachytherapy AUs for over 10 
years, the NRC is seeking comments to determine if there is anything 
unique about Y-90 microsphere brachytherapy compared to other types of 
manual brachytherapy that would obviate the need for a written 
attestation.
    (4) Clinical Experience under the Supervision of a Manufacturer 
Representative: The proposed licensing guidance removes the alternate 
pathway, which allows an individual to become an AU for Y-90 
microsphere brachytherapy prior to completing any patient cases if the 
applicant commits that the first three patient cases completed by that 
AU will be hands-on and supervised in the physical presence of a 
manufacturer representative. This alternate pathway remained in the 
licensing guidance for several years because there were a limited 
number of AUs who were authorized for each type of Y-90 microsphere, 
which made it difficult for physicians who were seeking authorization 
to complete the necessary clinical experience described in Section B 
under the supervision of another AU already authorized for the use of 
Y-90 microspheres. The NRC is seeking comments on whether completing 
the recommended clinical experience under the supervision of AU(s) 
authorized for the type of microsphere for which the new physician is 
seeking authorization still presents an undue burden on physicians. 
Further, the NRC is seeking comments on whether any unique 
characteristics of Y-90 microsphere brachytherapy warrant continuation 
of this alternate training pathway. Additionally, the NRC is seeking 
comments on whether finding licensed facilities at which the physicians 
could complete this clinical experience would be difficult.
    (5) Timeliness for Completion of In-Vivo Cases: The NRC is seeking 
comments on whether the proposed one in-vivo case prior to treating 
patients would be appropriate if 6 months has passed to ensure 
recentness of training or whether this proposal could potentially lower 
licensee's safety standards for the patients being treated.
    (6) Medical Event Definition: The NRC is seeking comments on the 
definition of medical events (ME) for Y-90 microspheres as provided in 
the proposed guidance. A primary purpose of ME reporting is to identify 
the cause of the event in order to correct them and prevent their 
recurrence. In the last 2 years there have been several MEs reported 
where the administration of the Y-90 results in dose or activity to the 
lobe opposite the lobe documented in the written directive. The working 
group was informed that in some instances, the AU may determine in the 
interventional radiology suite that they may be unable to deliver the 
amount of Y-90 microspheres to the intended lobe, but still wish to 
perform the treatment knowing some dose or activity may go to the lobe 
opposite the lobe documented in the written directive. The NRC is 
seeking specific comments on whether the delivery of Y-90 microspheres 
can be controlled to a specific lobe or location as described in the 
written directive and, if not, whether flexibility in the written 
directive is necessary to avoid reporting of events that cannot be 
controlled using the current technology. If flexibility is necessary, 
the NRC is seeking comments on whether the use of dose or activity 
ranges in the written directive or an ability to change the written 
directive in the interventional radiology suite prior to administering 
the Y-90 microspheres would be adequate. This type of revision could be 
made verbally by the AU, as long as the revision is documented in 
writing and signed by the AU within 24 hours of providing the revision 
verbally, consistent with other uses in 10 CFR part 35.

    Dated at Rockville, Maryland, this 1st day of November, 2017.

    For the U.S. Nuclear Regulatory Commission.
Daniel S. Collins,
Director, Division of Material Safety, State, Tribal and Rulemaking 
Programs, Office of Nuclear Material Safety and Safeguards.
[FR Doc. 2017-24129 Filed 11-6-17; 8:45 am]
 BILLING CODE 7590-01-P