Yttrium-90 Microsphere Brachytherapy Sources and Devices TheraSphere® and SIR-Spheres®, 159-160 [2017-28271]

Download as PDF Federal Register / Vol. 83, No. 1 / Tuesday, January 2, 2018 / Notices Secretary with respect to: (1) The Site Exposure Matrices (SEM) of the Department of Labor; (2) medical guidance for claims examiners for claims with the EEOICPA program, with respect to the weighing of the medical evidence of claimants; (3) evidentiary requirements for claims under Part B of EEOICPA related to lung disease; and (4) the work of industrial hygienists and staff physicians and consulting physicians of the Department of Labor and reports of such hygienists and physicians to ensure quality, objectivity, and consistency. The Advisory Board sunsets on December 19, 2024. The Advisory Board operates in accordance with the Federal Advisory Committee Act (FACA) (5 U.S.C. App. 2) and its implementing regulations (41 CFR part 102–3). Agenda: The tentative agenda for the Advisory Board meeting includes: • Respond to the recommendation responses and requests for information provided by the program; • Discuss matters from SEM subcommittee meeting or other subcommittees; and • Administrative issues raised by Advisory Board functions and future Advisory Board activities. OWCP transcribes and prepares detailed minutes of Advisory Board meetings. OWCP will post the transcripts and minutes on the Advisory Board web page, https://www.dol.gov/ owcp/energy/regs/compliance/ AdvisoryBoard.htm, along with written comments, speaker presentations, and other materials submitted to the Advisory Board or presented at Advisory Board meetings. daltland on DSKBBV9HB2PROD with NOTICES Public Participation, Submissions, and Access to the Public Record Advisory Board meetings: The Advisory Board will meet via teleconference on Tuesday, January 30, 2018, from 1:00 p.m. to 5:00 p.m. Eastern time. All Advisory Board meetings are open to the public. The teleconference number and other details for listening to the meeting will be posted on the Advisory Board’s website no later than 72 hours prior to the meeting. This information will be posted at https://www.dol.gov/owcp/ energy/regs/compliance/ AdvisoryBoard.htm. Requests for special accommodations: Please submit requests for special accommodations to access the telephonic Advisory Board meeting by email, telephone, or hard copy to Ms. Carrie Rhoads, OWCP, Room S–3524, U.S. Department of Labor, 200 Constitution Ave. NW, Washington, DC VerDate Sep<11>2014 19:54 Dec 29, 2017 Jkt 244001 20210; telephone (202) 343–5580; email EnergyAdvisoryBoard@dol.gov. Submission of written comments for the record: You may submit written comments, identified as for the Advisory Board and the meeting date of June 19, 2017, by any of the following methods: • Electronically: Send to: EnergyAdvisoryBoard@dol.gov (specify in the email subject line, ‘‘Advisory Board Meeting January 30, 2018’’). • Mail, express delivery, hand delivery, messenger, or courier service: Submit one copy to the following address: U.S. Department of Labor, Office of Workers’ Compensation Programs, Advisory Board on Toxic Substances and Worker Health, Room S–3522, 200 Constitution Ave. NW, Washington, DC 20210. Due to securityrelated procedures, receipt of submissions by regular mail may experience significant delays. Comments must be received by January 23, 2018. OWCP will make available publically, without change, any written comments, including any personal information that you provide. Therefore, OWCP cautions interested parties against submitting personal information such as Social Security numbers and birthdates. Electronic copies of this Federal Register notice are available at https:// www.regulations.gov. This notice, as well as news releases and other relevant information, are also available on the Advisory Board’s web page at https:// www.dol.gov/owcp/energy/regs/ compliance/AdvisoryBoard.htm. You may contact Douglas Fitzgerald, Designated Federal Officer, at fitzgerald.douglas@dol.gov, or Carrie Rhoads, Alternate Designated Federal Officer, at rhoads.carrie@dol.gov, U.S. Department of Labor, 200 Constitution Avenue NW, Suite S–3524, Washington, DC 20210, telephone (202) 343–5580. This is not a toll-free number. FOR FURTHER INFORMATION CONTACT: Signed at Washington, DC, on December 19, 2017. Julia K. Hearthway, Director, Office of Workers’ Compensation Programs. [FR Doc. 2017–28227 Filed 12–29–17; 8:45 am] NUCLEAR REGULATORY COMMISSION [NRC–2017–0215] Yttrium-90 Microsphere Brachytherapy Sources and Devices TheraSphere® and SIR-Spheres® Nuclear Regulatory Commission. ACTION: Draft guidance; extension of comment period. AGENCY: 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® and SIRSpheres®. 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. SUMMARY: 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 https://www.regulations.gov and search for Docket ID NRC–2017–0215. Address questions about NRC dockets to Carol Gallagher; telephone: 301–415–3463; email: Carol.Gallagher@nrc.gov. 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. DATES: Lisa Dimmick, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001; telephone: 301–415– 0694; email: Lisa.Dimmick@nrc.gov. SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: I. Obtaining Information and Submitting Comments BILLING CODE 4510–24–P PO 00000 159 A. Obtaining Information Please refer to Docket ID NRC–2017– 0215 when contacting the NRC about Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\02JAN1.SGM 02JAN1 160 Federal Register / Vol. 83, No. 1 / Tuesday, January 2, 2018 / Notices the availability of information regarding this action. You may obtain publiclyavailable information related to this action by any of the following methods: • Federal rulemaking website: Go to https://www.regulations.gov and search for Docket ID NRC–2017–0215. • NRC’s Agencywide Documents Access and Management System (ADAMS): You may obtain publiclyavailable documents online in the ADAMS Public Documents collection at https://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 pdr.resource@nrc.gov. 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. daltland on DSKBBV9HB2PROD with NOTICES 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 https:// 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. VerDate Sep<11>2014 19:54 Dec 29, 2017 Jkt 244001 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® and SIRSpheres® 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 NUCLEAR REGULATORY COMMISSION [NRC–2017–0001] Sunshine Act Meeting Notice Weeks of January 1, 8, 15, 22, 29, February 5, 2018. DATE: Commissioners’ Conference Room, 11555 Rockville Pike, Rockville, Maryland. PLACE: STATUS: Public and Closed. Week of January 1, 2018 There are no meetings scheduled for the week of January 1, 2018. PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 Week of January 8, 2018—Tentative There are no meetings scheduled for the week of January 8, 2018. Week of January 15, 2018—Tentative Thursday, January 18, 2018 9:00 a.m. Strategic Programmatic Overview of the Decommissioning and Low-Level Waste and Spent Fuel Storage and Transportation Business Lines (Public Meeting) (Contact: Damaris Marcano: 301– 415–7328) This meeting will be webcast live at the Web address—https://www.nrc.gov/. Week of January 22, 2018—Tentative Tuesday, January 23, 2018 9:00 a.m. Hearing on Construction Permit for Northwest Medical Isotopes Production Facility: Section 189a of the Atomic Energy Act Proceeding (Public Meeting) (Contact: Michael Balazik: 301– 415–2856) This meeting will be webcast live at the Web address—https://www.nrc.gov/. Thursday, January 25, 2018 10:00 a.m. Strategic Programmatic Overview of the New Reactors Business Line (Public Meeting) (Contact: Donna Williams: 301– 415–1322) This meeting will be webcast live at the Web address—https://www.nrc.gov/. Week of January 29, 2018—Tentative There are no meetings scheduled for the week of January 29, 2018. Week of February 5, 2018—Tentative Thursday, February 8, 2018 9:00 a.m. Discussion of Potential Changes to the 10 CFR 2.206 Enforcement Petition Process (Public Meeting) (Contact: Doug Broaddus: 301–415–8124) This meeting will be webcast live at the Web address—https://www.nrc.gov/. * * * * * The schedule for Commission meetings is subject to change on short notice. For more information or to verify the status of meetings, contact Denise McGovern at 301–415–0681 or via email at Denise.McGovern@nrc.gov. * * * * * The NRC Commission Meeting Schedule can be found on the internet at: https://www.nrc.gov/public-involve/ public-meetings/schedule.html. * * * * * The NRC provides reasonable accommodation to individuals with disabilities where appropriate. If you need a reasonable accommodation to E:\FR\FM\02JAN1.SGM 02JAN1

Agencies

[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.

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

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 https://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 https://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 https://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 https://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
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