[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ACTION: Draft guidance; request for comment.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