[Federal Register Volume 79, Number 183 (Monday, September 22, 2014)]
[Proposed Rules]
[Pages 56524-56525]
From the Federal Register Online via the Government Publishing 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]]


10 CFR Parts 30, 32 and 35

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 http://www.regulations.gov and search for Docket ID NRC-2008-0175. Address 
questions about NRC dockets to Carol Gallagher; telephone: 301-287-
3422; email: [email protected]. 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 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 
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: [email protected].

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 
    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: http://www.nrc.gov/public-involve/doc-comment/omb/index.html for 60 days after the signature date of this 
    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 
[email protected] 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. [email protected] 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]