Program-Specific Guidance About Commercial Radiopharmacy Licenses, 20438-20439 [2019-09485]

Download as PDF 20438 Federal Register / Vol. 84, No. 90 / Thursday, May 9, 2019 / Notices Event Date All Parties Status Conference ............................................................................................................................................. April 23, 2019. Evidentiary Hearing Schedule: Position Statement/Prefiled Direct Testimony from NRC Staff ................................................................................... May 17, 2019. Response Position Statements/Prefiled Direct Testimony Supporting NRC Staff’s Prefiled Direct Testimony .......... May 22, 2019 Response Position Statements/Prefiled Response Testimony Opposing NRC Staff’s Prefiled Testimony and any Supporting Prefiled Testimony. June 28, 2019. Reply Position Statement/Prefiled Reply Testimony from NRC Staff ......................................................................... July 12, 2019. Proposed Cross-Examination Questions/Requests for Cross-Examination/In Limine Motions on Direct/Response/ Reply Testimony Due. August 2, 2019. Responses to Requests for Cross-Examination and In Limine Motions on Direct/Response/Reply Testimony Due August 9, 2019. Licensing Board Ruling on Requests for Cross-Examination and In Limine Motions ................................................ August 19, 2019. Evidentiary Hearing ...................................................................................................................................................... August 28–30, 2019.24 Proposed Findings of Fact/Conclusions of Law Due .................................................................................................. September 27, 2019. Reply Findings of Fact/Conclusions of Law Due ........................................................................................................ October 11, 2019. Licensing Board Initial Decision ................................................................................................................................... November 29, 2019. 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 document using any of the following methods: • Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC–2016–0190. Address questions about NRC Docket IDs in regulations.gov to Jennifer Borges; telephone: 301–287–9127; email: Jennifer.Borges@nrc.gov. For technical questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document. • NRC’s Agencywide Documents Access and Management System (ADAMS): You may obtain publiclyavailable 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. NUREG– 1556, Volumes 13, Revision 2, is located at ADAMS Accession Number ML18180A187. This document is also available on the NRC’s public website at https://www.nrc.gov/reading-rm/doccollections/nuregs/staff/sr1556/ under ‘‘Consolidated Guidance About Materials Licenses (NUREG–1556).’’ ADDRESSES: [FR Doc. 2019–09532 Filed 5–8–19; 8:45 am] BILLING CODE 7590–01–P NUCLEAR REGULATORY COMMISSION [NRC–2016–0190] Program-Specific Guidance About Commercial Radiopharmacy Licenses Nuclear Regulatory Commission. ACTION: NUREG; issuance. AGENCY: The U.S. Nuclear Regulatory Commission (NRC) has issued Revision 2 to NUREG–1556, Volume 13, ‘‘Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Commercial Radiopharmacy Licenses.’’ Volume 13 of NUREG–1556 has been revised to include information on updated regulatory requirements, safety culture, security of radioactive materials, protection of sensitive information, and changes in regulatory policies and practices consistent with current regulations. This volume is intended for use by applicants, licensees, and the NRC staff. DATES: NUREG–1556, Volume 13, Revision 2, was published in March 2019. jbell on DSK3GLQ082PROD with NOTICES SUMMARY: 24 A final Board assessment regarding the length of the evidentiary hearing will await the receipt of the parties’ direct, response, and reply testimony. VerDate Sep<11>2014 19:39 May 08, 2019 Jkt 247001 PO 00000 Frm 00117 Fmt 4703 Sfmt 4703 • 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: Anthony McMurtray, Office of Nuclear Material Safety and Safeguards; U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001; telephone: 301–415–2746; email: Anthony.McMurtray@nrc.gov. SUPPLEMENTARY INFORMATION: I. Discussion The NRC issued a revision to NUREG–1556, Volumes 13, to provide guidance to existing materials licensees covered under commercial radiopharmacy licenses and to applicants preparing an application for a commercial radiopharmacy license. This NUREG volume also provides the NRC staff with criteria for evaluating commercial radiopharmacy license applications. The purpose of this notice is to notify the public that the NUREG– 1556 volume listed in this document was issued as a final report. II. Additional Information The NRC published a notice of the availability of the draft report for comment version of NUREG–1556, Volume 13, Revision 2 in the Federal Register on January 24, 2017 (82 FR 8227), with a public comment period of 59 days. The public comment period closed on March 24, 2017. Public comments and the NRC staff responses E:\FR\FM\09MYN1.SGM 09MYN1 Federal Register / Vol. 84, No. 90 / Thursday, May 9, 2019 / Notices the teleconference should contact Ms. Jamerson using the contact information below or may register for the GoToWebinar for the June 10, 2019, meeting at https:// attendee.gotowebinar.com/register/ 8147066000509193473. Contact Information: Kellee Jamerson, email: Kellee.Jamerson@nrc.gov, telephone: (301) 415–7408. to the public comments for NUREG– 1556, Volume 13, Revision 2 are available in ADAMS under Accession No. ML18305B303. III. Congressional Review Act This NUREG volume is a rule as defined in the Congressional Review Act (5 U.S.C. 801–808). However, the Office of Management and Budget has not found this NUREG revision to be a major rule as defined in the Congressional Review Act. Conduct of the Meeting Dated at Rockville, Maryland, this 2nd day of May 2019. For the Nuclear Regulatory Commission. Andrea L. Kock, Director, Division of Materials Safety, Security, State and Tribal Programs, Office of Nuclear Material Safety and Safeguards. [FR Doc. 2019–09485 Filed 5–8–19; 8:45 am] BILLING CODE 7590–01–P NUCLEAR REGULATORY COMMISSION Advisory Committee on the Medical Uses of Isotopes: Meeting Notice Nuclear Regulatory Commission. ACTION: Notice of meeting. AGENCY: The U.S. Nuclear Regulatory Commission (NRC) will convene a teleconference meeting of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) on June 10, 2019, to discuss: (1) The revisions to the ACMUI bylaws and (2) the draft report of the ACMUI Regulatory Guide 8.39 Subcommittee. This report will include the subcommittee’s comments and recommendations on Phase 1 of the revisions to Regulatory Guide 8.39, ‘‘Release of Patients Administered Radioactive Material.’’ A phased approach is being conducted by the NRC staff to comprehensively update Regulatory Guide 8.39. Phase 1 of the revision provides licensees with more detailed instructions to patients before and after they have been administered radioactive material than what is currently provided in Regulatory Guide 8.39. Meeting information, including a copy of the agenda and handouts, will be available at https://www.nrc.gov/ reading-rm/doc-collections/acmui/ meetings/2019.html. The agenda and handouts may also be obtained by contacting Ms. Kellee Jamerson using the information below. DATES: The teleconference meeting will be held on Monday, June 10, 2019, 2:00 p.m. to 4:00 p.m. Eastern Time. Public Participation: Any member of the public who wishes to participate in jbell on DSK3GLQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 19:39 May 08, 2019 Jkt 247001 Dr. Christopher Palestro, ACMUI Chairman, will preside over the meeting. Dr. Palestro will conduct the meeting in a manner that will facilitate the orderly conduct of business. The following procedures apply to public participation in the meeting: 1. Persons who wish to provide a written statement should submit an electronic copy to Ms. Jamerson at the contact information listed above. All submittals must be received by June 4, 2019, three business days prior to the June 10, 2019, meeting, and must pertain to the topic on the agenda for the meeting. 2. Questions and comments from members of the public will be permitted during the meeting at the discretion of the Chairman. 3. The draft transcript and meeting summary will be available on ACMUI’s website https://www.nrc.gov/reading-rm/ doc-collections/acmui/meetings/ 2019.html on or about July 23, 2019. This meeting will be held in accordance with the Atomic Energy Act of 1954, as amended (primarily Section 161a); the Federal Advisory Committee Act (5 U.S.C. App); and the Commission’s regulations in 10 CFR part 7. Dated: May 6, 2019. Russell E. Chazell, Federal Advisory Committee Management Officer. [FR Doc. 2019–09525 Filed 5–8–19; 8:45 am] BILLING CODE 7590–01–P NUCLEAR REGULATORY COMMISSION [NRC–2019–0103] Information Collection: Criteria and Procedures for Determining Eligibility for Access to or Control Over Special Nuclear Material Nuclear Regulatory Commission. ACTION: Renewal of existing information collection; request for comment. AGENCY: The U.S. Nuclear Regulatory Commission (NRC) invites public SUMMARY: PO 00000 Frm 00118 Fmt 4703 Sfmt 4703 20439 comment on the renewal of Office of Management and Budget (OMB) approval for an existing collection of information. The information collection is entitled, ‘‘Criteria and Procedures for Determining Eligibility for Access to or Control Over Special Nuclear Material.’’ DATES: Submit comments by July 8, 2019. Comments received after this date will be considered if it is practical to do so, but the Commission is able to ensure consideration only for comments received on or before this date. ADDRESSES: You may submit comments by any of the following methods: • Federal Rulemaking website: Go to https://www.regulations.gov and search for Docket ID NRC–2019–0103. Address questions about NRC dockets to Jennifer Borges; telephone: 301–287–9127; email: Jennifer.Borges@nrc.gov. For technical questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document. • Mail comments to: David Cullison, Office of the Chief Information Officer, Mail Stop: T6–A10M, U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001. 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: David Cullison, Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001; telephone: 301–415– 2084; email: Infocollects.Resource@ nrc.gov. SUPPLEMENTARY INFORMATION: I. Obtaining Information and Submitting Comments A. Obtaining Information Please refer to Docket ID NRC–2019– 0103 when contacting the NRC about the availability of information for this action. You may obtain publiclyavailable information related to this action by any of the following methods: • Federal Rulemaking website: Go to https://www.regulations.gov and search for Docket ID NRC–2019–0103. • NRC’s Agencywide Documents Access and Management System (ADAMS): You may obtain publicly available documents online in the ADAMS Public Document collection at https://www.nrc.gov/reading-rm/ adams.html. To begin the search, select ‘‘Begin Web-based ADAMS Search.’’ For problems with ADAMS, contact the NRC’s Public Document Room (PDR) E:\FR\FM\09MYN1.SGM 09MYN1

Agencies

[Federal Register Volume 84, Number 90 (Thursday, May 9, 2019)]
[Notices]
[Pages 20438-20439]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-09485]


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NUCLEAR REGULATORY COMMISSION

[NRC-2016-0190]


Program-Specific Guidance About Commercial Radiopharmacy Licenses

AGENCY: Nuclear Regulatory Commission.

ACTION: NUREG; issuance.

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

SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) has issued 
Revision 2 to NUREG-1556, Volume 13, ``Consolidated Guidance About 
Materials Licenses: Program-Specific Guidance About Commercial 
Radiopharmacy Licenses.'' Volume 13 of NUREG-1556 has been revised to 
include information on updated regulatory requirements, safety culture, 
security of radioactive materials, protection of sensitive information, 
and changes in regulatory policies and practices consistent with 
current regulations. This volume is intended for use by applicants, 
licensees, and the NRC staff.

DATES: NUREG-1556, Volume 13, Revision 2, was published in March 2019.

ADDRESSES: 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 document 
using any of the following methods:
     Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC-2016-0190. Address 
questions about NRC Docket IDs in regulations.gov to Jennifer Borges; 
telephone: 301-287-9127; email: [email protected]. For technical 
questions, contact the individual 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 [email protected]. 
NUREG-1556, Volumes 13, Revision 2, is located at ADAMS Accession 
Number ML18180A187. This document is also available on the NRC's public 
website at https://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/ under ``Consolidated Guidance About Materials Licenses (NUREG-
1556).''
     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: Anthony McMurtray, Office of Nuclear 
Material Safety and Safeguards; U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001; telephone: 301-415-2746; email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Discussion

    The NRC issued a revision to NUREG-1556, Volumes 13, to provide 
guidance to existing materials licensees covered under commercial 
radiopharmacy licenses and to applicants preparing an application for a 
commercial radiopharmacy license. This NUREG volume also provides the 
NRC staff with criteria for evaluating commercial radiopharmacy license 
applications. The purpose of this notice is to notify the public that 
the NUREG-1556 volume listed in this document was issued as a final 
report.

II. Additional Information

    The NRC published a notice of the availability of the draft report 
for comment version of NUREG-1556, Volume 13, Revision 2 in the Federal 
Register on January 24, 2017 (82 FR 8227), with a public comment period 
of 59 days. The public comment period closed on March 24, 2017. Public 
comments and the NRC staff responses

[[Page 20439]]

to the public comments for NUREG-1556, Volume 13, Revision 2 are 
available in ADAMS under Accession No. ML18305B303.

III. Congressional Review Act

    This NUREG volume is a rule as defined in the Congressional Review 
Act (5 U.S.C. 801-808). However, the Office of Management and Budget 
has not found this NUREG revision to be a major rule as defined in the 
Congressional Review Act.

    Dated at Rockville, Maryland, this 2nd day of May 2019.

    For the Nuclear Regulatory Commission.
Andrea L. Kock,
Director, Division of Materials Safety, Security, State and Tribal 
Programs, Office of Nuclear Material Safety and Safeguards.
[FR Doc. 2019-09485 Filed 5-8-19; 8:45 am]
BILLING CODE 7590-01-P
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