Medical Use of Byproduct Material-Medical Event Definitions and Training and Experience, 42224-42225 [2014-16752]

Download as PDF 42224 Proposed Rules Federal Register Vol. 79, No. 139 Monday, July 21, 2014 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. 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 Nuclear Regulatory Commission. ACTION: Draft guidance; request for comment. AGENCY: The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment a draft guidance document entitled ‘‘Draft Guidance for the Proposed Rule ‘Medical Use of Byproduct Material—Medical Events Definitions, Training and Experience, and Clarifying Amendments.’ ’’ This draft guidance document addresses implementation of the NRC’s proposed rule amending its medical use of byproduct material regulations.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 https://www.regulations.gov and search for Docket ID NRC–2014–0030. Address questions about NRC dockets to Carol Gallagher; telephone: 301–287–3422; 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: Cindy Bladey, Chief, Rules, Announcements, and Directives Branch (RADB), Office of Administration, Mail Stop: 3WFN–06– A44MP, U.S. Nuclear Regulatory tkelley on DSK3SPTVN1PROD with PROPOSALS SUMMARY: VerDate Mar<15>2010 16:47 Jul 18, 2014 Jkt 232001 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: Donna-Beth.Howe@nrc.gov. 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 https://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 https://www.nrc.gov/readingrm/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 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 PO 00000 Frm 00001 Fmt 4702 Sfmt 4702 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 https:// 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 boardcertified 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 E:\FR\FM\21JYP1.SGM 21JYP1 Federal Register / Vol. 79, No. 139 / Monday, July 21, 2014 / Proposed Rules 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 (https:// www.nrc.gov/materials/miau/med-usetoolkit.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] BILLING CODE 7590–01–P FEDERAL DEPOSIT INSURANCE CORPORATION 12 CFR Parts 348 and 390 RIN 3064–AE20 Transferred OTS Regulations and FDIC Regulations Regarding Management Official Interlocks Federal Deposit Insurance Corporation. ACTION: Notice of proposed rulemaking. tkelley on DSK3SPTVN1PROD with PROPOSALS AGENCY: In this notice of proposed rulemaking, the Federal Deposit Insurance Corporation (‘‘FDIC’’) proposes to rescind and remove parts of our regulations, entitled ‘‘Management SUMMARY: VerDate Mar<15>2010 16:47 Jul 18, 2014 Jkt 232001 Official Interlocks’’ relating to State savings associations. This subpart was included in the regulations that were transferred to the FDIC from the Office of Thrift Supervision (‘‘OTS’’) on July 21, 2011, in connection with the implementation of applicable provisions of Title III of the Dodd-Frank Wall Street Reform and Consumer Protection Act (‘‘Dodd-Frank Act’’). The requirements for State savings associations in the transferred OTS regulations are substantively similar to those in the FDIC’s regulations, which is also entitled ‘‘Management Official Interlocks’’ and is applicable for all insured depository institutions (‘‘IDIs’’) for which the FDIC has been designated the appropriate Federal banking agency. Upon removal of the transferred OTS regulations applicable for all IDIs for which the FDIC has been designated the appropriate Federal banking agency will be found in our regulations. DATES: Comments must be received on or before September 19, 2014. ADDRESSES: You may submit comments by any of the following methods: • FDIC Web site: https://www.fdic.gov/ regulations/laws/federal/. Follow instructions for submitting comments on the agency Web site. • FDIC Email: Comments@fdic.gov. Include RIN # 3064–AE20 on the subject line of the message. • FDIC Mail: Robert E. Feldman, Executive Secretary, Attention: Comments, Federal Deposit Insurance Corporation, 550 17th Street NW., Washington, DC 20429. • Hand Delivery to FDIC: Comments may be hand-delivered to the guard station at the rear of the 550 17th Street building (located on F Street) on business days between 7 a.m. and 5 p.m. Please include your name, affiliation, address, email address, and telephone number(s) in your comment. Where appropriate, comments should include a short Executive Summary consisting of no more than five single-spaced pages. All statements received, including attachments and other supporting materials, are part of the public record and are subject to public disclosure. You should submit only information that you wish to make publicly available. Please note: All comments received will be posted generally without change to https:// www.fdic.gov/regulations/laws/federal/, including any personal information provided. Paper copies of public comments may be requested from the Public Information Center by telephone at 1–877– 275–3342 or 1–703–562–2200. FOR FURTHER INFORMATION CONTACT: Martha L. Ellett, Legal Division, (202) PO 00000 Frm 00002 Fmt 4702 Sfmt 4702 42225 898–6765; Mark Mellon, Legal Division, (202) 898–3884; Jennifer Maree, Legal Division, (202) 898–6543; Deborah S. Calvert, Division of Risk Management Supervision, (703) 254–0976. SUPPLEMENTARY INFORMATION: I. Background The Dodd-Frank Act The Dodd-Frank Act 1 provided for a substantial reorganization of the regulation of State and Federal savings associations and their holding companies. Beginning July 21, 2011, the transfer date established by section 311 of the Dodd-Frank Act, codified at 12 U.S.C. 5411, (‘‘Transfer Date’’), the powers, duties, and functions formerly performed by the OTS were respectively divided among the FDIC, as to State savings associations, the Office of the Comptroller of the Currency (‘‘OCC’’), as to Federal savings associations, and the Board of Governors of the Federal Reserve System (‘‘FRB’’), as to savings and loan holding companies. Section 316(b) of the Dodd-Frank Act, codified at 12 U.S.C. 5414(b), provides the manner of treatment for all orders, resolutions, determinations, regulations, and advisory materials that had been issued, made, prescribed, or allowed to become effective by the OTS. The section provides that if such materials were in effect on the day before the Transfer Date, they continue to be in effect and are enforceable by or against the appropriate successor agency until they are modified, terminated, set aside, or superseded in accordance with applicable law by such successor agency, by any court of competent jurisdiction, or by operation of law. Section 316(c) of the Dodd-Frank Act, codified at 12 U.S.C. 5414(c), further directed the FDIC and the OCC to consult with one another and to publish a list of the continued OTS regulations which would be enforced by the FDIC and the OCC, respectively. On June 14, 2011, the FDIC’s Board of Directors approved a ‘‘List of OTS Regulations to be Enforced by the OCC and the FDIC Pursuant to the Dodd-Frank Wall Street Reform and Consumer Protection Act.’’ This list was published by the FDIC and the OCC as a Joint Notice in the Federal Register on July 6, 2011.2 Although section 312(b)(2)(B)(i)(II) of the Dodd-Frank Act, codified at 12 U.S.C. 5412(b)(2)(B)(i)(II), granted the OCC rulemaking authority relating to both State and Federal savings associations, nothing in the Dodd-Frank 1 Dodd-Frank Wall Street Reform and Consumer Protection Act, Public Law 111–203, 124 Stat. 1376 (2010) (codified at 12 U.S.C. 5301 et seq.). 2 76 FR 39247 (July 6, 2011). E:\FR\FM\21JYP1.SGM 21JYP1

Agencies

NUCLEAR REGULATORY COMMISSION

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


========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

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.

========================================================================


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.

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

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 https://www.regulations.gov and search for Docket ID NRC-2014-0030. Address 
questions about NRC dockets to Carol Gallagher; telephone: 301-287-
3422; 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: 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: Donna-Beth.Howe@nrc.gov.

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 https://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 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 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 https://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 (https://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]
BILLING CODE 7590-01-P

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