[Federal Register Volume 83, Number 1 (Tuesday, January 2, 2018)]
[Notices]
[Pages 159-160]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-28271]
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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ACTION: Draft guidance; extension of comment period.
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SUMMARY: On November 7, 2017, the U.S. Nuclear Regulatory Commission
(NRC) solicited comments on 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
public comment period was originally scheduled to close on January 8,
2018. The NRC has decided to extend the public comment period to allow
more time for members of the public to develop and submit their
comments.
DATES: The due date of comments requested in the document published on
November 7, 2017 (82 FR 51655) is extended. Comments should be filed no
later than February 8, 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-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 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
[[Page 160]]
the availability of information regarding 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-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
website 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 to be 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 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 submission into ADAMS.
II. Discussion
On November 7, 2017, the NRC solicited comments on its draft
licensing guidance entitled ``Yttrium-90 (Y-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 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 identified
numerous issues that need to be addressed. A working group composed of
Agreement State representatives and NRC staff was formed to address
identified issues. This draft licensing guidance for Y-90 microsphere
brachytherapy has been revised to update criteria for training and
experience, medical event reporting, inventory requirement
specifications, and waste disposal issues. The draft guidance provides
new information regarding cremation and autopsy. The public comment
period was originally scheduled to close on January 8, 2018. The NRC
has decided to extend the public comment period on this document until
February 8, 2018, to allow more time for members of the public to
submit their comments.
Dated at Rockville, Maryland, this 27th day of December 2017.
For the Nuclear Regulatory Commission.
Kevin Williams,
Deputy Director, Division of Material Safety, State, Tribal and
Rulemaking Programs, Office of Nuclear Material Safety and Safeguards.
[FR Doc. 2017-28271 Filed 12-29-17; 8:45 am]
BILLING CODE 7590-01-P