82 FR 8227 - Program-Specific Guidance About Commercial Radiopharmacy Licenses

NUCLEAR REGULATORY COMMISSION

Federal Register Volume 82, Issue 14 (January 24, 2017)

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.

[Federal Register Volume 82, Number 14 (Tuesday, January 24, 2017)]
[Notices]
[Pages 8227-8228]
From the Federal Register Online  [www.thefederalregister.org]
[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

[[Page 8228]]

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]
 BILLING CODE 7590-01-P