83 FR 159 - Yttrium-90 Microsphere Brachytherapy Sources and Devices TheraSphere® and SIR-Spheres®

NUCLEAR REGULATORY COMMISSION

Federal Register Volume 83, Issue 1 (January 2, 2018)

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.

[Federal Register Volume 83, Number 1 (Tuesday, January 2, 2018)]
[Notices]
[Pages 159-160]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-28271]


=======================================================================
-----------------------------------------------------------------------

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ACTION: Draft guidance; extension of comment period.

-----------------------------------------------------------------------

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