81 FR 87978 - Program-Specific Guidance About Medical Use Licenses

NUCLEAR REGULATORY COMMISSION

Federal Register Volume 81, Issue 234 (December 6, 2016)

The U.S. Nuclear Regulatory Commission (NRC) is revising its licensing guidance for licenses authorizing medical use of byproduct material. The NRC is requesting public comment on draft NUREG-1556, Volume 9, Revision 3, ``Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses.'' The document has been updated from the previous revision to include information on safety culture, security of radioactive materials, protection of sensitive information, and changes in regulatory policies and practices. This document is intended for use by applicants, licensees, and the NRC staff.

[Federal Register Volume 81, Number 234 (Tuesday, December 6, 2016)]
[Notices]
[Pages 87978-87979]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-29214]


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NUCLEAR REGULATORY COMMISSION

[NRC-2016-0122]


Program-Specific Guidance About Medical Use Licenses

AGENCY: Nuclear Regulatory Commission.

ACTION: Draft NUREG; request for comments.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is revising its 
licensing guidance for licenses authorizing medical use of byproduct 
material. The NRC is requesting public comment on draft NUREG-1556, 
Volume 9, Revision 3, ``Consolidated Guidance About Materials Licenses: 
Program-Specific Guidance About Medical Use Licenses.'' The document 
has been updated from the previous revision to include information on 
safety culture, security of radioactive materials, protection of 
sensitive information, and changes in regulatory policies and 
practices. This document is intended for use by applicants, licensees, 
and the NRC staff.

[[Page 87979]]


DATES: Submit comments by February 6, 2017. Comments received after 
this date will be considered if it is practical to do so, but the NRC 
is only able to assure consideration of comments received on or before 
this date.

ADDRESSES: You may submit comment by any of the following methods 
(unless this document describes a different method for submitting 
comments on a specific subject):
     Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2016-0122. 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: Cindy Bladey, Office of Administration, 
Mail Stop: OWFN-12-H8, U.S. Nuclear Regulatory Commission, Washington, 
DC 20555-0001.
    For additional direction on accessing information and submitting 
comments, see ``Obtaining Information and Submitting Comments'' in the 
SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: Katie Tapp, Office of Nuclear Material 
Safety and Safeguards; U.S. Nuclear Regulatory Commission, Washington, 
DC 20555-0001; telephone: 301-415-0236; email: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Obtaining Information and Submitting Comments

A. Obtaining Information

    Please refer to Docket ID NRC-2016-0122 when contacting the NRC 
about the availability of information regarding this document. 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-2016-0122.
     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 NUREG-1556, Volume 9, Revision 3, is available in ADAMS under 
Accession No. ML16328A214.
     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 NUREG-1556, Volume 9, Revision 3, is also available on 
the NRC's public Web site on the: (1) ``Consolidated Guidance About 
Materials Licenses (NUREG-1556)'' page at http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/; and the (2) ``Draft NUREG-
Series Publications for Comment'' page at http://www.nrc.gov/public-involve/doc-comment.html#nuregs.

B. Submitting Comments

    Please include Docket ID NRC-2016-0122 in the subject line of your 
comment submission, in order to ensure that the NRC is able to make 
your comment submission available to the public in this docket.
    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, and 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. Further Information

    The NUREG provides guidance to existing medical use of byproduct 
material licensees and to an applicant that are preparing a medical use 
of byproduct material license application. The NUREG also provides the 
NRC with criteria for evaluating a license application. The purpose of 
this notice is to provide the public with an opportunity to review and 
provide comments on draft NUREG-1556, Volume 9, Revision 3, 
``Consolidated Guidance About Materials Licenses: Program-Specific 
Guidance About Medical Use Licenses.'' These comments will be 
considered in the final version or subsequent revisions.
    This draft of NUREG-1556, Volume 9, Revision 3 does not include any 
revisions associated with the proposed rule ``Medical Use of Byproduct 
Material-Medical Event Definitions, Training and Experience, and 
Clarifying Amendments.'' This proposed rule amends requirements in 
parts 30, 32, and 35 of title 10 of the Code of Federal Regulations for 
the following:
     Reporting and notification of medical event for permanent 
implant brachytherapy; training and experience for authorized users, 
medical physicists, Radiation Safety Officers and nuclear pharmacists;
     measuring molybdenum contamination and reporting of failed 
technetium and rubidium generators;
     allowing Associate Radiation Safety Officers to be named 
on a medical use license; and,
     clarifying other revisions to the regulations.

This draft of NUREG-1556, Volume 9, Revision 3 does not include any 
guidance for the proposed rule revisions as that rule is not final at 
this time.
    The proposed rule and proposed changes to NUREG-1556, Volume 9, 
associated with the proposed rule were published for public comment in 
the Federal Register (79 FR 42409, 79 FR 42224) on July 21, 2014. 
Comments received on those changes are being considered by the NRC 
staff separately. If the proposed rule becomes final, the proposed 
revisions to NUREG-1556, Volume 9 addressing the implementation of the 
proposed rule will be incorporated into this NUREG-1556, Volume 9, 
Revision 3 before its final publication.

    Dated at Rockville, Maryland, this 30th day of November, 2016.

    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. 2016-29214 Filed 12-5-16; 8:45 am]
 BILLING CODE 7590-01-P