82 FR 8227 - Program-Specific Guidance About Commercial Radiopharmacy Licenses
NUCLEAR REGULATORY COMMISSION Federal Register Volume 82, Issue 14 (January 24, 2017)
Federal Register Volume 82, Issue 14 (January 24, 2017)
| Page Range | 8227-8228 | |
| FR Document | 2017-01546 |
[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]] ----------------------------------------------------------------------- NUCLEAR REGULATORY COMMISSION [NRC-2016-0190] Program-Specific Guidance About Commercial Radiopharmacy Licenses AGENCY: Nuclear Regulatory Commission. ACTION: Draft NUREG; request for comments. ----------------------------------------------------------------------- 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: 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, 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: Said.Daibes@nrc.gov. 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 pdr.resource@nrc.gov. 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
![Federal Register / Vol. 82, No. 14 / Tuesday, January 24, 2017 / Notices 8227
NUCLEAR REGULATORY SUPPLEMENTARY INFORMATION: submission to the NRC, then you should
COMMISSION inform those persons not to include
I. Obtaining Information and
identifying or contact information that
[NRC–2016–0190] Submitting Comments
they do not want to be publicly
Program-Specific Guidance About A. Obtaining Information disclosed in their comment submission.
Commercial Radiopharmacy Licenses Please refer to Docket ID NRC–2016– Your request should state that the NRC
0190 when contacting the NRC about does not routinely edit comment
AGENCY: Nuclear Regulatory submissions to remove such information
Commission. the availability of information regarding
this document. You may obtain before making the comment
ACTION: Draft NUREG; request for submissions available to the public or
publicly-available information related to
comments. entering the comment submissions into
this action by the following methods:
• Federal Rulemaking Web site: Go to ADAMS.
SUMMARY: The U.S. Nuclear Regulatory
Commission (NRC) is revising its http://www.regulations.gov and search II. Further Information
licensing guidance for licenses for Docket ID NRC–2016–0190. NUREG–1556, Volume 13, Revision 2
authorizing commercial nuclear • NRC’s Agencywide Documents provides program-specific guidance to
pharmacy use of byproduct material. Access and Management System assist applicants and licensees in
The NRC is requesting public comment (ADAMS): You may obtain publicly- preparing applications for materials
on draft NUREG–1556, Volume 13, available documents online in the licenses for commercial
Revision 2, ‘‘Consolidated Guidance ADAMS Public Documents collection at radiopharmacies. In particular, it
About Materials Licenses: Program- http://www.nrc.gov/reading-rm/ describes the types of information
Specific Guidance About Commercial adams.html. To begin the search, select needed to complete NRC Form 313,
Radiopharmacy Licenses.’’ The ‘‘ADAMS Public Documents’’ and then ‘‘Application for Materials License.’’ It
document has been updated from the select ‘‘Begin Web-based ADAMS also provides the NRC with criteria for
previous revision to include information Search.’’ For problems with ADAMS, evaluating a license application. The
on safety culture, security of radioactive please contact the NRC’s Public purpose of this notice is to provide the
materials, protection of sensitive Document Room (PDR) reference staff at public with an opportunity to review
information, and changes in regulatory 1–800–397–4209, 301–415–4737, or by and provide comments on draft
policies and practices. This document is email to pdr.resource@nrc.gov. The draft NUREG–1556, Volume 13, Revision 2,
intended for use by applicants, NUREG–1556, Volume 13, Revision 2, is ‘‘Consolidated Guidance About
licensees, and the NRC staff. available in ADAMS under Accession Materials Licenses: Program-Specific
DATES: Submit comments by March 24, No. ML16356A040. Guidance About Commercial
2017. Comments received after this date • NRC’s PDR: You may examine and Radiopharmacy Licenses.’’ These
will be considered if it is practical to do purchase copies of public documents at comments will be considered in the
so, but the NRC is only able to assure the NRC’s PDR, Room O1–F21, One final version or subsequent revisions.
consideration of comments received on White Flint North, 11555 Rockville This draft NUREG–1556, Volume 13,
or before this date. Pike, Rockville, Maryland 20852. Revision 2 does not include any
ADDRESSES: You may submit comments The draft NUREG–1556, Volume 13, revisions associated with the proposed
by any of the following methods (unless Revision 2, is also available on the rule ‘‘Medical Use of Byproduct
this document describes a different NRC’s public Web site on the: (1) Material-Medical Event Definitions,
method for submitting comments on a ‘‘Consolidated Guidance About Training and Experience, and Clarifying
specific subject): Materials Licenses (NUREG–1556)’’ Amendments.’’ That proposed rule
• Federal Rulemaking Web site: Go to page at https://www.nrc.gov/reading-rm/ would amend the following
http://www.regulations.gov and search doc-collections/nuregs/staff/sr1556; and requirements in parts 30, 32, and 35 of
for Docket ID NRC–2016–0190. Address the (2) ‘‘Draft NUREG-Series title 10 of the Code of Federal
questions about NRC dockets to Carol Publications for Comment’’ page at Regulations related to commercial
Gallagher; telephone: 301–415–3463; http://www.nrc.gov/public-involve/doc- nuclear pharmacies:
email: Carol.Gallagher@nrc.gov. For comment.html#nuregs. • Removal of the requirement for the
technical questions, contact the B. Submitting Comments board certified nuclear pharmacist to
individual listed in the FOR FURTHER have an attestation statement in
INFORMATION CONTACT section of this Please include Docket ID NRC–2016– addition to the board certificate;
document. 0190 in the subject line of your • measuring molybdenum
• Mail comments to: Cindy Bladey, comment submission, in order to ensure contamination and reporting of failed
Office of Administration, Mail Stop: that the NRC is able to make your technetium generators;
OWFN–12–H8, U.S. Nuclear Regulatory comment submission available to the • labeling requirements for
Commission, Washington, DC 20555– public in this docket. radioactive drugs; and
0001. The NRC cautions you not to include • clarifying other revisions to the
For additional direction on accessing identifying or contact information that regulations.
information and submitting comments, you do not want publicly disclosed in This draft NUREG–1556, Volume 13,
see ‘‘Obtaining Information and your comment submission. The NRC Revision 2 does not include any
Submitting Comments’’ in the will post all comment submissions at guidance for the proposed rule revisions
SUPPLEMENTARY INFORMATION section of http://www.regulations.gov as well as
sradovich on DSK3GMQ082PROD with NOTICES
because that rule is not final at this
this document. enter the comment submissions into time.
FOR FURTHER INFORMATION CONTACT: Said ADAMS, and the NRC does not The proposed rule, ‘‘Medical Use of
Daibes, Office of Nuclear Material Safety routinely edit comment submissions to Byproduct Material-Medical Event
and Safeguards; U.S. Nuclear Regulatory remove identifying or contact Definitions, Training and Experience,
Commission, Washington, DC 20555– information. and Clarifying Amendments,’’ and
0001; telephone: 301–415–6863; email: If you are requesting or aggregating proposed changes to NUREG–1556
Said.Daibes@nrc.gov. comments from other persons for commercial radiopharmacy licenses
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![8228 Federal Register / Vol. 82, No. 14 / Tuesday, January 24, 2017 / Notices
associated with the proposed rule were supporting documentation, may be Affected Public: Individuals.
published for public comment in the obtained by contacting the U.S. Office of Number of Respondents: 4,196,336.
Federal Register (79 FR 42409 and 79 Personnel Management, Chief Estimated Time per Respondent: 43
FR 42224) on July 21, 2014. Comments Information Officer, Employee Services minutes.
received on those changes in the IT PMO, USAJOBS, 1900 E. Street NW., Total Burden Hours: 3,007,374.
proposed rule and guidance are being Washington, DC 20415, Attention: John U.S. Office of Personnel Management.
considered by the NRC staff separately. Still, or by sending a request via Beth F. Cobert,
If the proposed rule becomes final, the electronic mail to john.still@opm.gov
Acting Director.
proposed revisions to NUREG–1556, SUPPLEMENTARY INFORMATION: As
[FR Doc. 2017–01475 Filed 1–23–17; 8:45 am]
Volume 13 addressing the required by the Paperwork Reduction
implementation of the proposed rule BILLING CODE 6325–38–P
Act of 1995, (Pub. L. 104–13, 44 U.S.C.
will be incorporated into NUREG–1556, chapter 35) as amended by the Clinger-
Volume 13, Revision 2 before its final Cohen Act (Pub. L. 104–106), OPM is
publication. OFFICE OF PERSONNEL
soliciting comments for this collection. MANAGEMENT
Dated at Rockville, Maryland, this 13th day USAJOBS is the Federal Government’s
of January, 2017. centralized source for most Federal jobs Excepted Service
For the U.S. Nuclear Regulatory and employment information, including
Commission. both positions that are required by law AGENCY: U.S. Office of Personnel
to be posted at that location and Management (OPM).
Pamela J. Henderson,
positions that can be posted there at an ACTION: Notice.
Deputy Director, Division of Material Safety,
State, Tribal and Rulemaking Programs, agency’s discretion. The Applicant
Profile and Resume Builder are two SUMMARY: This notice identifies
Office of Nuclear Material Safety and
Safeguards. components of the USAJOBS Schedule A, B, and C appointing
application system. authorities applicable to a single agency
[FR Doc. 2017–01546 Filed 1–23–17; 8:45 am]
USAJOBS reflects the minimal critical that were established or revoked from
BILLING CODE 7590–01–P
elements collected across the Federal September 1, 2016 to September 30,
Government to begin an application for 2016.
Federal jobs under the authority of FOR FURTHER INFORMATION CONTACT:
U.S. OFFICE OF PERSONNEL sections 1104, 1302, 3301, 3304, 3320,
MANAGEMENT Senior Executive Resources Services,
3361, 3393, and 3394 of title 5, United Senior Executive Service and
Submission for Review: Revision of an States Code. This revision proposes to Performance Management, Employee
Existing Information Collection, renew a currently approved collection. Services, 202–606–2246.
USAJOBS®, OMB Control No. 3206– Therefore, we invite comments that:
SUPPLEMENTARY INFORMATION: In
0219 1. Evaluate whether the proposed
collection of information is necessary accordance with 5 CFR 213.103,
AGENCY: U.S. Office of Personnel for the proper performance of the Schedule A, B, and C appointing
Management. functions of the agency, including authorities available for use by all
whether the information will have agencies are codified in the Code of
ACTION: 60-Day Notice and request for
practical utility; Federal Regulations (CFR). Schedule A,
comments. B, and C appointing authorities
2. Evaluate the accuracy of the
SUMMARY: The Office of Personnel agency’s estimate of the burden of the applicable to a single agency are not
Management (OPM) offers the general proposed collection of information, codified in the CFR, but the Office of
public and other Federal agencies the including the validity of the Personnel Management (OPM)
opportunity to comment on a revised methodology and assumptions used; publishes a notice of agency-specific
information collection request (ICR), 3. Enhance the quality, utility, and authorities established or revoked each
OMB Control No. 3206–0219, USAJOBS. clarity of the information to be month in the Federal Register at
collected; and www.gpo.gov/fdsys/. OPM also
DATES: Comments are encouraged and
4. Minimize the burden of the publishes an annual notice of the
will be accepted until March 27, 2017.
collection of information on those who consolidated listing of all Schedule A,
This process is conducted in accordance
are to respond, including through the B, and C appointing authorities, current
with 5 CFR 1320.1.
use of appropriate automated, as of June 30, in the Federal Register.
ADDRESS: Interested persons are invited
to submit written comments on the electronic, mechanical, or other Schedule A
proposed information collection to the technological collection techniques or
other forms of information technology, No schedule A authorities to report
U.S. Office of Personnel Management, during September 2016.
Chief Information Officer, Employee e.g., permitting electronic submissions
Services IT PMO, USAJOBS, 1900 E. of responses. Schedule B
Analysis:
Street NW., Washington, DC 20415, Agency: Office of Personnel No schedule B authorities to report
Attention: John Still or send them via Management. during September 2016.
electronic mail to john.still@opm.gov. Title: USAJOBS. The following Schedule C appointing
FOR FURTHER INFORMATION CONTACT: A OMB Number: 3206–0219. authorities were approved during
sradovich on DSK3GMQ082PROD with NOTICES
copy of this ICR, with applicable Frequency: Annually. September 2016.
Agency name Organization name Position title Request No. Effective date
DEPARTMENT OF AGRI- Office of Communications .................. Press Assistant .................................. DA160166 ...... 09/06/2016
CULTURE. Deputy Press Secretary ..................... DA160176 ...... 09/26/2016
Foreign Agricultural Service ............... Speechwriter & Communications Ad- DA160169 ...... 09/06/2016
visor.
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Document Created: 2018-02-01 15:12:10
Document Modified: 2018-02-01 15:12:10
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Draft NUREG; request for comments. | |
| 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. | |
| 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] | |
| FR Citation | 82 FR 8227 |
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