Medical Use of Byproduct Material-Medical Event Definitions, Training and Experience, and Clarifying Amendments; Correction, 56524-56525 [2014-22522]

Download as PDF 56524 Proposed Rules Federal Register Vol. 79, No. 183 Monday, September 22, 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–2008–0175] RIN 3150–AI63 Medical Use of Byproduct Material— Medical Event Definitions, Training and Experience, and Clarifying Amendments; Correction Nuclear Regulatory Commission. ACTION: Proposed rule; correction. AGENCY: The U.S. Nuclear Regulatory Commission (NRC) published a proposed rule appearing in the Federal Register (FR) on July 21, 2014, to amend the NRC’s regulations related to the medical use of byproduct material. The public comment period for the information collection aspects of the proposed rule was to have ended on August 20, 2014. However, the proposed rule inadvertently omitted the one-time implementation costs from the information collection burden estimate. This action sets out the corrected information collection burden estimate in its entirety and allows the public 30 days to comment from the date of publication of this action. DATES: This correction is effective on September 22, 2014. Submit comments on the information collection aspects of the proposed rule by October 22, 2014. ADDRESSES: Please refer to Docket ID NRC–2008–0175 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods: • Federal Rulemaking Web site: Go to https://www.regulations.gov and search for Docket ID NRC–2008–0175. Address questions about NRC dockets to Carol Gallagher; telephone: 301–287–3422; email: Carol.Gallagher@nrc.gov. For technical questions, contact the individuals listed in the FOR FURTHER asabaliauskas on DSK5VPTVN1PROD with RULES SUMMARY: VerDate Sep<11>2014 16:54 Sep 19, 2014 Jkt 232001 section of this document. • NRC’s Agencywide Documents Access and Management System (ADAMS): You may obtain publicly available documents online in the ADAMS Public Documents collection 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 proposed rule is available electronically in ADAMS under Accession No. ML14183B493. The draft proposed guidance document may be found 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. FOR FURTHER INFORMATION CONTACT: Neelam Bhalla, Office of Federal and State Materials and Environmental Management Programs, U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001, telephone: 301–415– 0978, email: Neelam.Bhalla@nrc.gov. SUPPLEMENTARY INFORMATION: In FR Doc. 2014–16753 appearing on page 42409 in the Federal Register of Monday, July 21, 2014, beginning on page 42435, in the middle column, Section XV, ‘‘Paperwork Reduction Act Statement,’’ is corrected to read as follows: This proposed rule amends information collection requirements that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). The rule would reduce the burden for existing information collection requirements associated with NRC Form 313, but would increase burden for 10 CFR parts 30 and 35. This rule has been submitted to the Office of Management and Budget for review and approval of the paperwork requirements. Type of submission, new or revision: Revision. The title of the information collection: 10 CFR parts 30, 32, and 35, Medical Use of Byproduct Material—Medical Event Definitions, Training and Experience, and Clarifying Amendments, Proposed Rule. INFORMATION CONTACT PO 00000 Frm 00001 Fmt 4702 Sfmt 4702 The form number if applicable: NRC Form 313A Series, ‘‘Authorized User Training and Experience and Preceptor Attestation.’’ How often the collection is required: The information is collected as needed. Reports required under the proposed rule are based on events that exceed limits stipulated by various sections of the proposed rule. The NRC Form 313A Series or equivalent is required when an applicant or licensee applies to have a new individual identified as an Authorized User (AU), Radiation Safety Officer (RSO), Alternate Radiation Safety Officer (ARSO), Authorized Nuclear Pharmacists, or an Authorized Medical Physicist on a medical use license during a new license, a renewal, or an amendment request. Who will be required or asked to report: Persons licensed under 10 CFR parts 30, 32, and 35 who possess and use certain byproduct material for medical use. An estimate of the number of annual responses: 12,392 (10 CFR Part 30: 366 responses, 10 CFR Part 35: 8,301 responses, NRC Form 313: 3,725 responses). The estimated number of annual respondents: 7,845 (1,085 NRC/6,401 Agreement State medical use licensees and 52 NRC/307 Agreement State radiopharmacy licensees). An estimate of the total number of hours needed annually to complete the requirement or request: 33,038.33 hours (10 CFR Part 30: 4,670.5 hours, 10 CFR Part 35: 33,551.58 hours, NRC Form 313: ¥5,183.75 hours). Of the 33,038.33 hours of total burden, an estimated 6,671 hours are associated with recurring requirements and 26,367.33 hours are one-time implementation burdens. Abstract: The NRC is proposing to amend its regulations related to the medical use of byproduct material. In this action the NRC addresses three ongoing rulemaking projects and several other related topics. First, this rule proposes amendments to the reporting and notification requirements for a Medical Event for permanent implant brachytherapy. Second, the rule proposes changes to the Training and Experience requirements for AUs, medical physicists, RSOs, and nuclear pharmacists; changes to the requirements for measuring Mo contaminations and reporting of failed E:\FR\FM\22SEP1.SGM 22SEP1 asabaliauskas on DSK5VPTVN1PROD with RULES Federal Register / Vol. 79, No. 183 / Monday, September 22, 2014 / Proposed Rules technetium and rubidium generators; and changes that would allow ARSOs to be named on a medical license, as well as other clarifying and conforming amendments. Third, the NRC is considering a request filed in a petition for rulemaking (PRM–35–20) to ‘‘grandfather’’ certain board-certified individuals. The NRC is seeking public comment on the potential impact of the information collections contained in the proposed rule and on the following issues: 1. Is the proposed information collection necessary for the proper performance of the functions of the NRC, including whether the information will have practical utility? 2. Is the estimate of burden accurate? 3. Is there a way to enhance the quality, utility, and clarity of the information to be collected? 4. How can the burden of the information collection be minimized, including the use of automated collection techniques? The public may examine and have copied, for a fee, publicly-available documents, including the draft supporting statement, at the NRC’s PDR, One White Flint North, 11555 Rockville Pike, Room O–1 F21, Rockville, Maryland 20852. The OMB clearance package and rule are available at the NRC’s Web site: https://www.nrc.gov/ public-involve/doc-comment/omb/ index.html for 60 days after the signature date of this notice. Send comments on any aspect of these proposed information collections, including suggestions for reducing the burden and on the above issues, by October 22, 2014 to the FOIA, Privacy, and Information Collections Branch (T–5 F53), U.S. Nuclear Regulatory Commission, Washington, DC 20555– 0001, or by Internet electronic mail to INFOCOLLECTS.RESOURCE@NRC.GOV and to the Desk Officer, Danielle Y. Jones, Office of Information and Regulatory Affairs, NEOB–10202, (3150–AI63), Office of Management and Budget, Washington, DC 20503. Comments received after this date will be considered if it is practical to do so, but assurance of consideration cannot be given to comments received after this date. You may also email comments to Danielle Y. Jones@ omb.eop.gov or comment by telephone at 202–395–1741. Dated at Rockville, Maryland, this 15th day of September, 2014. VerDate Sep<11>2014 16:54 Sep 19, 2014 Jkt 232001 For the Nuclear Regulatory Commission. Annette Vietti-Cook, Secretary of the Commission. [FR Doc. 2014–22522 Filed 9–19–14; 8:45 am] BILLING CODE 7590–01–P NUCLEAR REGULATORY COMMISSION 10 CFR Part 73 [Docket No. PRM–73–18; NRC–2014–0165] Protection of Digital Computer and Communication Systems and Networks Nuclear Regulatory Commission. ACTION: Petition for rulemaking; docketing, and request for comment. AGENCY: The U.S. Nuclear Regulatory Commission (NRC) has received a petition for rulemaking (PRM) from Anthony Pietrangelo, filed on behalf of the Nuclear Energy Institute (NEI or the petitioner) on June 12, 2014. The petitioner requests that the NRC revise its cyber security requirements to ensure that its regulations prevent radiological sabotage and adequately protect the public health and safety and common defense and security. The NRC is requesting public comment on the petition for rulemaking. DATES: Submit comments by December 8, 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: • Federal rulemaking Web site: Go to https://www.regulations.gov and search for Docket ID NRC–2014–0165. Address questions about NRC dockets to Carol Gallagher; telephone: 301–492–3668; email: Carol.Gallagher@nrc.gov. For technical questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document. • Email comments to: Rulemaking.Comments@nrc.gov. If you do not receive an automatic email reply confirming receipt, then contact us at 301–415–1677. • Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at 301– 415–1101. • Mail comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001, ATTN: Rulemakings and Adjudications Staff. • Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland SUMMARY: PO 00000 Frm 00002 Fmt 4702 Sfmt 4702 56525 20852, between 7:30 a.m. and 4:15 p.m. (Eastern Time) Federal workdays; telephone: 301–415–1677. For additional direction on obtaining information and submitting comments, see ‘‘Obtaining Information and Submitting Comments’’ in the SUPPLEMENTARY INFORMATION section of this document. FOR FURTHER INFORMATION CONTACT: Robert Beall, Office of Nuclear Reactor Regulations, U.S. Nuclear Regulatory Commission, Washington, DC 20555– 0001; telephone: 301–415–3874, email: Robert.Beall@nrc.gov. SUPPLEMENTARY INFORMATION: I. Obtaining Information and Submitting Comments A. Obtaining Information Please refer to Docket ID NRC–2014– 0165 when contacting the NRC about the availability of information for this petition for rulemaking. You may obtain publicly available information related to this action by any of the following methods: • Federal Rulemaking Web site: Go to https://www.regulations.gov and search for Docket ID NRC–2014–0165. • NRC’s Agencywide Documents Access and Management System (ADAMS): You may obtain publicly available documents online in the ADAMS Public Documents collection 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, at 301–415–4737, or by email to pdr.resource@nrc.gov. The Petition to Amend section 73.54 of Title 10 of the Code of Federal Regulations (10 CFR), ‘‘Protection of Digital Computer and Communication Systems and Networks,’’ is available in ADAMS under Accession No. ML14184B120. • 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– 0165 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 E:\FR\FM\22SEP1.SGM 22SEP1

Agencies

NUCLEAR REGULATORY COMMISSION

[Federal Register Volume 79, Number 183 (Monday, September 22, 2014)]
[Proposed Rules]
[Pages 56524-56525]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22522]


========================================================================
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. 183 / Monday, September 22, 2014 / 
Proposed Rules

[[Page 56524]]



NUCLEAR REGULATORY COMMISSION

10 CFR Parts 30, 32 and 35

[NRC-2008-0175]
RIN 3150-AI63


Medical Use of Byproduct Material--Medical Event Definitions, 
Training and Experience, and Clarifying Amendments; Correction

AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule; correction.

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

SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) published a 
proposed rule appearing in the Federal Register (FR) on July 21, 2014, 
to amend the NRC's regulations related to the medical use of byproduct 
material. The public comment period for the information collection 
aspects of the proposed rule was to have ended on August 20, 2014. 
However, the proposed rule inadvertently omitted the one-time 
implementation costs from the information collection burden estimate. 
This action sets out the corrected information collection burden 
estimate in its entirety and allows the public 30 days to comment from 
the date of publication of this action.

DATES: This correction is effective on September 22, 2014. Submit 
comments on the information collection aspects of the proposed rule by 
October 22, 2014.

ADDRESSES: Please refer to Docket ID NRC-2008-0175 when contacting the 
NRC about the availability of information regarding this document. You 
may obtain publicly-available information related to this document 
using any of the following methods:
     Federal Rulemaking Web site: Go to https://www.regulations.gov and search for Docket ID NRC-2008-0175. Address 
questions about NRC dockets to Carol Gallagher; telephone: 301-287-
3422; email: Carol.Gallagher@nrc.gov. For technical questions, contact 
the individuals listed in the FOR FURTHER INFORMATION CONTACT section 
of this document.
     NRC's Agencywide Documents Access and Management System 
(ADAMS): You may obtain publicly available documents online in the 
ADAMS Public Documents collection 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 
proposed rule is available electronically in ADAMS under Accession No. 
ML14183B493. The draft proposed guidance document may be found 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.

FOR FURTHER INFORMATION CONTACT: Neelam Bhalla, Office of Federal and 
State Materials and Environmental Management Programs, U.S. Nuclear 
Regulatory Commission, Washington, DC 20555-0001, telephone: 301-415-
0978, email: Neelam.Bhalla@nrc.gov.

SUPPLEMENTARY INFORMATION: In FR Doc. 2014-16753 appearing on page 
42409 in the Federal Register of Monday, July 21, 2014, beginning on 
page 42435, in the middle column, Section XV, ``Paperwork Reduction Act 
Statement,'' is corrected to read as follows:
    This proposed rule amends information collection requirements that 
are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et 
seq.). The rule would reduce the burden for existing information 
collection requirements associated with NRC Form 313, but would 
increase burden for 10 CFR parts 30 and 35. This rule has been 
submitted to the Office of Management and Budget for review and 
approval of the paperwork requirements.
    Type of submission, new or revision: Revision.
    The title of the information collection: 10 CFR parts 30, 32, and 
35, Medical Use of Byproduct Material--Medical Event Definitions, 
Training and Experience, and Clarifying Amendments, Proposed Rule.
    The form number if applicable: NRC Form 313A Series, ``Authorized 
User Training and Experience and Preceptor Attestation.''
    How often the collection is required: The information is collected 
as needed. Reports required under the proposed rule are based on events 
that exceed limits stipulated by various sections of the proposed rule. 
The NRC Form 313A Series or equivalent is required when an applicant or 
licensee applies to have a new individual identified as an Authorized 
User (AU), Radiation Safety Officer (RSO), Alternate Radiation Safety 
Officer (ARSO), Authorized Nuclear Pharmacists, or an Authorized 
Medical Physicist on a medical use license during a new license, a 
renewal, or an amendment request.
    Who will be required or asked to report: Persons licensed under 10 
CFR parts 30, 32, and 35 who possess and use certain byproduct material 
for medical use.
    An estimate of the number of annual responses: 12,392 (10 CFR Part 
30: 366 responses, 10 CFR Part 35: 8,301 responses, NRC Form 313: 3,725 
responses).
    The estimated number of annual respondents: 7,845 (1,085 NRC/6,401 
Agreement State medical use licensees and 52 NRC/307 Agreement State 
radiopharmacy licensees).
    An estimate of the total number of hours needed annually to 
complete the requirement or request: 33,038.33 hours (10 CFR Part 30: 
4,670.5 hours, 10 CFR Part 35: 33,551.58 hours, NRC Form 313: -5,183.75 
hours). Of the 33,038.33 hours of total burden, an estimated 6,671 
hours are associated with recurring requirements and 26,367.33 hours 
are one-time implementation burdens.
    Abstract: The NRC is proposing to amend its regulations related to 
the medical use of byproduct material. In this action the NRC addresses 
three ongoing rulemaking projects and several other related topics. 
First, this rule proposes amendments to the reporting and notification 
requirements for a Medical Event for permanent implant brachytherapy. 
Second, the rule proposes changes to the Training and Experience 
requirements for AUs, medical physicists, RSOs, and nuclear 
pharmacists; changes to the requirements for measuring Mo 
contaminations and reporting of failed

[[Page 56525]]

technetium and rubidium generators; and changes that would allow ARSOs 
to be named on a medical license, as well as other clarifying and 
conforming amendments. Third, the NRC is considering a request filed in 
a petition for rulemaking (PRM-35-20) to ``grandfather'' certain board-
certified individuals.
    The NRC is seeking public comment on the potential impact of the 
information collections contained in the proposed rule and on the 
following issues:
    1. Is the proposed information collection necessary for the proper 
performance of the functions of the NRC, including whether the 
information will have practical utility?
    2. Is the estimate of burden accurate?
    3. Is there a way to enhance the quality, utility, and clarity of 
the information to be collected?
    4. How can the burden of the information collection be minimized, 
including the use of automated collection techniques?
    The public may examine and have copied, for a fee, publicly-
available documents, including the draft supporting statement, at the 
NRC's PDR, One White Flint North, 11555 Rockville Pike, Room O-1 F21, 
Rockville, Maryland 20852. The OMB clearance package and rule are 
available at the NRC's Web site: https://www.nrc.gov/public-involve/doc-comment/omb/ for 60 days after the signature date of this 
notice.
    Send comments on any aspect of these proposed information 
collections, including suggestions for reducing the burden and on the 
above issues, by October 22, 2014 to the FOIA, Privacy, and Information 
Collections Branch (T-5 F53), U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001, or by Internet electronic mail to 
INFOCOLLECTS.RESOURCE@NRC.GOV and to the Desk Officer, Danielle Y. 
Jones, Office of Information and Regulatory Affairs, NEOB-10202, (3150-
AI63), Office of Management and Budget, Washington, DC 20503.
    Comments received after this date will be considered if it is 
practical to do so, but assurance of consideration cannot be given to 
comments received after this date. You may also email comments to 
Danielle Y. Jones@omb.eop.gov or comment by telephone at 202-395-1741.

    Dated at Rockville, Maryland, this 15th day of September, 2014.

    For the Nuclear Regulatory Commission.
Annette Vietti-Cook,
Secretary of the Commission.
[FR Doc. 2014-22522 Filed 9-19-14; 8:45 am]
BILLING CODE 7590-01-P

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