[Federal Register Volume 82, Number 14 (Tuesday, January 24, 2017)]
[Notices]
[Pages 8227-8228]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-01546]
[[Page 8227]]
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NUCLEAR REGULATORY COMMISSION
[NRC-2016-0190]
Program-Specific Guidance About Commercial Radiopharmacy 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 commercial nuclear pharmacy
use of byproduct material. The NRC is requesting public comment on
draft NUREG-1556, Volume 13, Revision 2, ``Consolidated Guidance About
Materials Licenses: Program-Specific Guidance About Commercial
Radiopharmacy 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.
DATES: Submit comments by March 24, 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 comments 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-2016-0190. 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: Said Daibes, Office of Nuclear
Material Safety and Safeguards; U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001; telephone: 301-415-6863; email:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Obtaining Information and Submitting Comments
A. Obtaining Information
Please refer to Docket ID NRC-2016-0190 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-2016-0190.
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 13, Revision 2, is available in ADAMS under
Accession No. ML16356A040.
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 13, Revision 2, is also available on
the NRC's public Web site on the: (1) ``Consolidated Guidance About
Materials Licenses (NUREG-1556)'' page at https://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-2016-0190 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
NUREG-1556, Volume 13, Revision 2 provides program-specific
guidance to assist applicants and licensees in preparing applications
for materials licenses for commercial radiopharmacies. In particular,
it describes the types of information needed to complete NRC Form 313,
``Application for Materials License.'' It 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 13, Revision 2,
``Consolidated Guidance About Materials Licenses: Program-Specific
Guidance About Commercial Radiopharmacy Licenses.'' These comments will
be considered in the final version or subsequent revisions.
This draft NUREG-1556, Volume 13, Revision 2 does not include any
revisions associated with the proposed rule ``Medical Use of Byproduct
Material-Medical Event Definitions, Training and Experience, and
Clarifying Amendments.'' That proposed rule would amend the following
requirements in parts 30, 32, and 35 of title 10 of the Code of Federal
Regulations related to commercial nuclear pharmacies:
Removal of the requirement for the board certified nuclear
pharmacist to have an attestation statement in addition to the board
certificate;
measuring molybdenum contamination and reporting of failed
technetium generators;
labeling requirements for radioactive drugs; and
clarifying other revisions to the regulations.
This draft NUREG-1556, Volume 13, Revision 2 does not include any
guidance for the proposed rule revisions because that rule is not final
at this time.
The proposed rule, ``Medical Use of Byproduct Material-Medical
Event Definitions, Training and Experience, and Clarifying
Amendments,'' and proposed changes to NUREG-1556 commercial
radiopharmacy licenses
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associated with the proposed rule were published for public comment in
the Federal Register (79 FR 42409 and 79 FR 42224) on July 21, 2014.
Comments received on those changes in the proposed rule and guidance
are being considered by the NRC staff separately. If the proposed rule
becomes final, the proposed revisions to NUREG-1556, Volume 13
addressing the implementation of the proposed rule will be incorporated
into NUREG-1556, Volume 13, Revision 2 before its final publication.
Dated at Rockville, Maryland, this 13th day of January, 2017.
For the U.S. Nuclear Regulatory Commission.
Pamela J. Henderson,
Deputy Director, Division of Material Safety, State, Tribal and
Rulemaking Programs, Office of Nuclear Material Safety and Safeguards.
[FR Doc. 2017-01546 Filed 1-23-17; 8:45 am]
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