[Federal Register Volume 79, Number 139 (Monday, July 21, 2014)]
[Proposed Rules]
[Pages 42224-42225]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-16752]


 ========================================================================
 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 79, No. 139 / Monday, July 21, 2014 / 
Proposed Rules  

[[Page 42224]]



NUCLEAR REGULATORY COMMISSION

10 CFR Parts 30, 32 and 35

[NRC-2014-0030]
RIN 3150-AI63


Medical Use of Byproduct Material--Medical Event Definitions and 
Training and Experience

AGENCY: Nuclear Regulatory Commission.

ACTION: Draft guidance; request for comment.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing for 
public comment a draft guidance document entitled ``Draft Guidance for 
the Proposed Rule `Medical Use of Byproduct Material--Medical Events 
Definitions, Training and Experience, and Clarifying Amendments.' '' 
This draft guidance document addresses implementation of the NRC's 
proposed rule amending its medical use of byproduct material 
regulations.

DATES: Submit comments by November 18, 2014. Comments received after 
this date will be considered if it is practical to do so, but the NRC 
is able to assure consideration only for 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-2014-0030. Address 
questions about NRC dockets to Carol Gallagher; telephone: 301-287-
3422; 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, Chief, Rules, 
Announcements, and Directives Branch (RADB), Office of Administration, 
Mail Stop: 3WFN-06-A44MP, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001.
    For additional direction on accessing information and submitting 
comments, see ``Accessing Information and Submitting Comments'' in the 
SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: Donna-Beth Howe, Office of Federal and 
State Materials and Environmental Management Programs, U.S. Nuclear 
Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-
7848; email: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Accessing Information and Submitting Comments

A. Accessing Information

    Please refer to Docket ID NRC-2014-0030 when contacting the NRC 
about the availability of information regarding this document. You may 
access publicly-available information related to this document by any 
of the following methods:
     Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2014-0030.
     NRC's Agencywide Documents Access and Management System 
(ADAMS): You may access publicly available documents online in the NRC 
Library 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 ADAMS accession number 
for each document referenced in this document (if that document is 
available in ADAMS) is provided the first time that a document is 
referenced. The draft guidance document is available in ADAMS under 
Accession No. ML13172A189.
     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.

B. Submitting Comments

    Please include Docket ID NRC-2014-0030 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 to be publicly disclosed in you 
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 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. Discussion

    In the Proposed Rule section of this issue of the Federal Register, 
the NRC published the proposed rule, ``Medical Use of Byproduct 
Material--Medical Event Definitions, Training and Experience, and 
Clarifying Amendments'' (RIN 3150-AI63, NRC-2014-0030). The proposed 
rule would amend requirements in parts 30, 32, and 35 of Title 10 of 
the Code of Federal Regulations, for reporting and notification of a 
medical event for permanent implant brachytherapy; training and 
experience for authorized users, medical physicists, Radiation Safety 
Officers and nuclear pharmacists; and measuring molybdenum 
contamination and reporting of failed technetium and rubidium 
generators. The rule also proposes changes that would allow Associate 
Radiation Safety Officers to be named on a medical use license and 
other clarifying revisions to the regulations. Finally, the proposed 
rule addresses a request filed in a petition for rulemaking (PRM), PRM-
35-20, to ``grandfather'' certain board-certified individuals so that 
they are exempt from certain training and experience requirements.
    In conjunction with the proposed rule, the NRC has developed a 
draft guidance document which would provide guidance to a licensee or

[[Page 42225]]

applicant for implementation of the proposed regulations. The draft 
guidance document is intended for use by applicants, licensees, 
Agreement States, and the NRC staff. The draft guidance document (ADAMS 
Accession No. ML13172A189) has three parts: The first two are revisions 
to existing guidance in the NUREG-1556, ``Consolidated Guidance About 
Materials Licenses'', series of volumes for medical uses and commercial 
nuclear pharmacies; and the third part is a series of questions and 
answers to assist licensees in understanding and implementing the new 
proposed regulatory changes. The NUREG-1556 documents mainly provide 
guidance to applicants in the completion and submission of materials 
license applications. The documents also include model procedures that 
an applicant may want to use when developing its radiation safety 
program, as well as tools that licensees may employ when completing the 
corresponding material license applications.
    Parts 1 and 2 of the draft guidance document will be incorporated 
into the next comprehensive revision of relevant volumes of NUREG-1556.
    Part 3 of the draft guidance document will be added to the NRC's 
Medical Uses Licensee Toolkit Web site (http://www.nrc.gov/materials/miau/med-use-toolkit.html) when the questions and answers are 
finalized.

    Dated at Rockville, Maryland, this 10th day of March 2014.
Laura A. Dudes,
Director, Division of Materials Safety and State Agreements, Office of 
Federal and State Materials, and Environmental Management Programs.
[FR Doc. 2014-16752 Filed 7-18-14; 8:45 am]
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