Southern Nuclear Operating Company, Inc., Vogtle Electric Generating Plant, Units 3 and 4; Inspections, Tests, Analyses, and Acceptance Criteria Consolidation, 58657-58658 [2017-26807]
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58657
Federal Register / Vol. 82, No. 238 / Wednesday, December 13, 2017 / Notices
Controlled substance
Drug code
Meperidine intermediate-A ..............................................................................................................................................
Meperidine intermediate-B ..............................................................................................................................................
Meperidine intermediate-C ..............................................................................................................................................
Metazocine ......................................................................................................................................................................
Metopon ...........................................................................................................................................................................
Dextropropoxyphene, bulk (non-dosage forms) ..............................................................................................................
Dihydroetorphine .............................................................................................................................................................
Levo-alphacetylmethadol .................................................................................................................................................
Noroxymorphone .............................................................................................................................................................
Phenazocine ....................................................................................................................................................................
Piminodine .......................................................................................................................................................................
Racemethorphan .............................................................................................................................................................
Racemorphan ..................................................................................................................................................................
Alfentanil ..........................................................................................................................................................................
Remifentanil .....................................................................................................................................................................
Sufentanil .........................................................................................................................................................................
Carfentanil .......................................................................................................................................................................
Tapentadol .......................................................................................................................................................................
Bezitramide ......................................................................................................................................................................
Moramide-intermediate ....................................................................................................................................................
The company plans to import
analytical reference standards for
distribution to its customers for research
and analytical purposes. Placement of
these drug codes onto the company’s
registration does not translate into
automatic approval of subsequent
permit applications to import controlled
substances. Approval of permit
applications will occur only when the
registrant’s business activity is
consistent with what is authorized
under 21 U.S.C. 952(a)(2). Authorization
will not extend to the import of FDA
approved or non-approved finished
dosage forms for commercial sale.
Dated: December 7, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017–26855 Filed 12–12–17; 8:45 am]
BILLING CODE 4410–09–P
NUCLEAR REGULATORY
COMMISSION
[Docket Nos. 52–025 and 52–026; NRC–
2008–0252]
Southern Nuclear Operating Company,
Inc., Vogtle Electric Generating Plant,
Units 3 and 4; Inspections, Tests,
Analyses, and Acceptance Criteria
Consolidation
Nuclear Regulatory
Commission.
ACTION: Exemption and combined
license amendment; issuance.
sradovich on DSK3GMQ082PROD with NOTICES
AGENCY:
The U.S. Nuclear Regulatory
Commission (NRC) is granting an
exemption to allow a departure from
elements of the certification information
of Tier 1 of the generic AP1000 design
control document (DCD) and is issuing
License Amendment Nos. 85 and 84 to
SUMMARY:
VerDate Sep<11>2014
18:53 Dec 12, 2017
Jkt 244001
Combined Licenses (COL), NPF–91 and
NPF–92, respectively. The COLs were
issued to Southern Nuclear Operating
Company, Inc. (SNC), and Georgia
Power Company, Oglethorpe Power
Corporation, MEAG Power SPVM, LLC,
MEAG Power SPVJ, LLC, MEAG Power
SPVP, LLC, Authority of Georgia, and
the City of Dalton, Georgia (the
licensee); for construction and operation
of the Vogtle Electric Generating Plant
(VEGP) Units 3 and 4, located in Burke
County, Georgia.
The granting of the exemption allows
the changes to Tier 1 information asked
for in the amendment. Because the
acceptability of the exemption was
determined in part by the acceptability
of the amendment, the exemption and
amendment are being issued
concurrently.
DATES: The exemption and amendment
were issued on August 24, 2017.
ADDRESSES: Please refer to Docket ID
NRC–2008–0252 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–2008–0252. 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.
• 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/
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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 (if it is available in
ADAMS) is provided the first time that
it is mentioned in this document. The
request for the amendment and
exemption was submitted by letter
dated March 2, 2017, and supplemented
by letter dated July 28, 2017, (ADAMS
Accession Nos. ML17061A747 and
ML17209A770, respectively) designated
License Amendment Request (LAR) 17–
006.
• 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:
William (Billy) Gleaves, Office of New
Reactors, U.S. Nuclear Regulatory
Commission, Washington, DC 20555–
0001; telephone: 301–415–5848; email:
Bill.Gleaves@nrc.gov.
SUPPLEMENTARY INFORMATION:
I. Introduction
The NRC is granting an exemption
from paragraph B of section III, ‘‘Scope
and Contents,’’ of appendix D, ‘‘Design
Certification Rule for the AP1000,’’ to
part 52 of title 10 of the Code of Federal
Regulations (10 CFR), and issuing
License Amendment Nos. 85 and 84 to
COLs, NPF–91 and NPF–92,
respectively, to the licensee. The
exemption is required by paragraph A.4
of section VIII, ‘‘Processes for Changes
and Departures,’’ appendix D, to 10 CFR
E:\FR\FM\13DEN1.SGM
13DEN1
58658
Federal Register / Vol. 82, No. 238 / Wednesday, December 13, 2017 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
part 52 to allow the licensee to depart
from Tier 1 information. With the
requested amendment, the licensee
proposed changes to COL Appendix C
and plant-specific DCD Tier 1 to
consolidate a number of Inspections,
Tests, Analyses, and Acceptance
Criteria (ITAAC) to improve the
efficiency of the ITAAC completion and
closure process. SNC also requested
related exemptions from the
Commission’s regulations.
Part of the justification for granting
the exemption was provided by the
review of the amendment. Because the
exemption is necessary in order to issue
the requested license amendment, the
NRC granted the exemption and issued
the amendment concurrently, rather
than in sequence. This included issuing
a combined safety evaluation containing
the NRC staff’s review of both the
exemption request and the license
amendment. The exemption met all
applicable regulatory criteria set forth in
§§ 50.12, 52.7, and section VIII.A.4 of
appendix D to 10 CFR part 52. The
license amendment was found to be
acceptable as well. The combined safety
evaluation is available in ADAMS under
Accession No. ML17216A065.
Identical exemption documents
(except for referenced unit numbers and
license numbers) were issued to the
licensee for VEGP Units 3 and 4 (COLs
NPF–91 and NPF–92). The exemption
documents for VEGP Units 3 and 4 can
be found in ADAMS under Accession
Nos. ML17216A070 and ML17216A069,
respectively. The exemption is
reproduced (with the exception of
abbreviated titles and additional
citations) in Section II of this document.
The amendment documents for COLs
NPF–91 and NPF–92 are available in
ADAMS under Accession Nos.
ML17216A072 and ML17216A071,
respectively. A summary of the
amendment documents is provided in
Section III of this document.
II. Exemption
Reproduced below is the exemption
document issued to VEGP Units 3 and
Unit 4. It makes reference to the
combined safety evaluation that
provides the reasoning for the findings
made by the NRC (and listed under Item
1) in order to grant the exemption:
1. In a letter dated March 2, 2017, as
supplemented by letter dated July 28,
2017, Southern Nuclear Operating
Company, Inc., (licensee) requested
from the Nuclear Regulatory
Commission (NRC or Commission) an
exemption to allow departures from Tier
1 information in the certified DCD
incorporated by reference in 10 CFR
part 52, appendix D, ‘‘Design
VerDate Sep<11>2014
18:53 Dec 12, 2017
Jkt 244001
Certification Rule for the AP1000
Design,’’ as part of license amendment
request (LAR) 17–006, ‘‘Inspections,
Tests, Analyses, and Acceptance
Criteria (ITAAC) Consolidation.’’
For the reasons set forth in Section 3.1
of the NRC staff’s Safety Evaluation,
which can be found at ADAMS
Accession No. ML17216A065, the
Commission finds that
A. the exemption is authorized by
law;
B. the exemption presents no undue
risk to public health and safety;
C. the exemption is consistent with
the common defense and security;
D. special circumstances are present
in that the application of the rule in this
circumstance is not necessary to serve
the underlying purpose of the rule;
E. the special circumstances outweigh
any decrease in safety that may result
from the reduction in standardization
caused by the exemption; and
F. the exemption will not result in a
significant decrease in the level of safety
otherwise provided by the design.
2. Accordingly, the licensee is granted
an exemption from the certified DCD
Tier 1 information, with corresponding
changes to Appendix C of the Facility
Combined License as described in the
licensee’s request dated March 2, 2017,
as supplemented by letter dated July 28,
2017. This exemption is related to, and
necessary for, the granting of License
Amendment No. 85 and 84,
respectively, which is being issued
concurrently with this exemption.
3. As explained in Section 6.0 of the
NRC staff’s Safety Evaluation (ADAMS
Accession No. ML17216A065, this
exemption meets the eligibility criteria
for categorical exclusion set forth in 10
CFR 51.22(c)(9). Therefore, pursuant to
10 CFR 51.22(b), no environmental
impact statement or environmental
assessment needs to be prepared in
connection with the issuance of the
exemption.
4. This exemption is effective as of the
date of its issuance.
III. License Amendment Request
By letter dated March 2, 2017
(ADAMS Accession No. ML17061A747),
as supplemented by letter dated July 28,
2017 (ADAMS Accession No.
ML17209A770), the licensee requested
that the NRC amend the COLs for VEGP,
Units 3 and 4, COLs NPF–91 and NPF–
92. The proposed amendment is
described in Section I of this Federal
Register notice.
The Commission has determined for
these amendments that the application
complies with the standards and
requirements of the Atomic Energy Act
of 1954, as amended (the Act), and the
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
Commission’s rules and regulations.
The Commission has made appropriate
findings as required by the Act and the
Commission’s rules and regulations in
10 CFR Chapter I, which are set forth in
the license amendment.
A notice of consideration of issuance
of amendment to facility operating
license or COL, as applicable, proposed
no significant hazards consideration
determination, and opportunity for a
hearing in connection with these
actions, was published in the Federal
Register on March 28, 2017 (82 FR
15377). No comments were received
during the 30-day comment period.
The Commission has determined that
these amendments satisfy the criteria for
categorical exclusion in accordance
with 10 CFR 51.22. Therefore, pursuant
to 10 CFR 51.22(b), no environmental
impact statement or environmental
assessment need be prepared for these
amendments.
IV. Conclusion
Using the reasons set forth in the
combined safety evaluation, the staff
granted the exemption and issued the
amendment that the licensee requested
on March 2, 2017, as supplemented by
letter dated July 28, 2017.
The exemption and amendment were
issued on August 24, 2017, as part of a
combined package to the licensee
(ADAMS Accession No. ML17216A064).
Dated at Rockville, Maryland, this 7th day
of December, 2017.
For the Nuclear Regulatory Commission.
Jennifer L. Dixon-Herrity,
Chief, Licensing Branch 4, Division of New
Reactor Licensing, Office of New Reactors.
[FR Doc. 2017–26807 Filed 12–12–17; 8:45 am]
BILLING CODE 7590–01–P
POSTAL REGULATORY COMMISSION
[Docket No. CP2018–79]
New Postal Product
Postal Regulatory Commission.
Notice.
AGENCY:
ACTION:
The Commission is noticing a
recent Postal Service filing for the
Commission’s consideration concerning
a negotiated service agreement. This
notice informs the public of the filing,
invites public comment, and takes other
administrative steps.
DATES: Comments are due: December
15, 2017.
ADDRESSES: Submit comments
electronically via the Commission’s
Filing Online system at https://
www.prc.gov. Those who cannot submit
comments electronically should contact
SUMMARY:
E:\FR\FM\13DEN1.SGM
13DEN1
Agencies
[Federal Register Volume 82, Number 238 (Wednesday, December 13, 2017)]
[Notices]
[Pages 58657-58658]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26807]
=======================================================================
-----------------------------------------------------------------------
NUCLEAR REGULATORY COMMISSION
[Docket Nos. 52-025 and 52-026; NRC-2008-0252]
Southern Nuclear Operating Company, Inc., Vogtle Electric
Generating Plant, Units 3 and 4; Inspections, Tests, Analyses, and
Acceptance Criteria Consolidation
AGENCY: Nuclear Regulatory Commission.
ACTION: Exemption and combined license amendment; issuance.
-----------------------------------------------------------------------
SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is granting an
exemption to allow a departure from elements of the certification
information of Tier 1 of the generic AP1000 design control document
(DCD) and is issuing License Amendment Nos. 85 and 84 to Combined
Licenses (COL), NPF-91 and NPF-92, respectively. The COLs were issued
to Southern Nuclear Operating Company, Inc. (SNC), and Georgia Power
Company, Oglethorpe Power Corporation, MEAG Power SPVM, LLC, MEAG Power
SPVJ, LLC, MEAG Power SPVP, LLC, Authority of Georgia, and the City of
Dalton, Georgia (the licensee); for construction and operation of the
Vogtle Electric Generating Plant (VEGP) Units 3 and 4, located in Burke
County, Georgia.
The granting of the exemption allows the changes to Tier 1
information asked for in the amendment. Because the acceptability of
the exemption was determined in part by the acceptability of the
amendment, the exemption and amendment are being issued concurrently.
DATES: The exemption and amendment were issued on August 24, 2017.
ADDRESSES: Please refer to Docket ID NRC-2008-0252 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-2008-0252. Address
questions about NRC dockets to Carol Gallagher; telephone: 301-415-
3463; 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]. The
ADAMS accession number for each document referenced (if it is available
in ADAMS) is provided the first time that it is mentioned in this
document. The request for the amendment and exemption was submitted by
letter dated March 2, 2017, and supplemented by letter dated July 28,
2017, (ADAMS Accession Nos. ML17061A747 and ML17209A770, respectively)
designated License Amendment Request (LAR) 17-006.
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: William (Billy) Gleaves, Office of New
Reactors, U.S. Nuclear Regulatory Commission, Washington, DC 20555-
0001; telephone: 301-415-5848; email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Introduction
The NRC is granting an exemption from paragraph B of section III,
``Scope and Contents,'' of appendix D, ``Design Certification Rule for
the AP1000,'' to part 52 of title 10 of the Code of Federal Regulations
(10 CFR), and issuing License Amendment Nos. 85 and 84 to COLs, NPF-91
and NPF-92, respectively, to the licensee. The exemption is required by
paragraph A.4 of section VIII, ``Processes for Changes and
Departures,'' appendix D, to 10 CFR
[[Page 58658]]
part 52 to allow the licensee to depart from Tier 1 information. With
the requested amendment, the licensee proposed changes to COL Appendix
C and plant-specific DCD Tier 1 to consolidate a number of Inspections,
Tests, Analyses, and Acceptance Criteria (ITAAC) to improve the
efficiency of the ITAAC completion and closure process. SNC also
requested related exemptions from the Commission's regulations.
Part of the justification for granting the exemption was provided
by the review of the amendment. Because the exemption is necessary in
order to issue the requested license amendment, the NRC granted the
exemption and issued the amendment concurrently, rather than in
sequence. This included issuing a combined safety evaluation containing
the NRC staff's review of both the exemption request and the license
amendment. The exemption met all applicable regulatory criteria set
forth in Sec. Sec. 50.12, 52.7, and section VIII.A.4 of appendix D to
10 CFR part 52. The license amendment was found to be acceptable as
well. The combined safety evaluation is available in ADAMS under
Accession No. ML17216A065.
Identical exemption documents (except for referenced unit numbers
and license numbers) were issued to the licensee for VEGP Units 3 and 4
(COLs NPF-91 and NPF-92). The exemption documents for VEGP Units 3 and
4 can be found in ADAMS under Accession Nos. ML17216A070 and
ML17216A069, respectively. The exemption is reproduced (with the
exception of abbreviated titles and additional citations) in Section II
of this document. The amendment documents for COLs NPF-91 and NPF-92
are available in ADAMS under Accession Nos. ML17216A072 and
ML17216A071, respectively. A summary of the amendment documents is
provided in Section III of this document.
II. Exemption
Reproduced below is the exemption document issued to VEGP Units 3
and Unit 4. It makes reference to the combined safety evaluation that
provides the reasoning for the findings made by the NRC (and listed
under Item 1) in order to grant the exemption:
1. In a letter dated March 2, 2017, as supplemented by letter dated
July 28, 2017, Southern Nuclear Operating Company, Inc., (licensee)
requested from the Nuclear Regulatory Commission (NRC or Commission) an
exemption to allow departures from Tier 1 information in the certified
DCD incorporated by reference in 10 CFR part 52, appendix D, ``Design
Certification Rule for the AP1000 Design,'' as part of license
amendment request (LAR) 17-006, ``Inspections, Tests, Analyses, and
Acceptance Criteria (ITAAC) Consolidation.''
For the reasons set forth in Section 3.1 of the NRC staff's Safety
Evaluation, which can be found at ADAMS Accession No. ML17216A065, the
Commission finds that
A. the exemption is authorized by law;
B. the exemption presents no undue risk to public health and
safety;
C. the exemption is consistent with the common defense and
security;
D. special circumstances are present in that the application of the
rule in this circumstance is not necessary to serve the underlying
purpose of the rule;
E. the special circumstances outweigh any decrease in safety that
may result from the reduction in standardization caused by the
exemption; and
F. the exemption will not result in a significant decrease in the
level of safety otherwise provided by the design.
2. Accordingly, the licensee is granted an exemption from the
certified DCD Tier 1 information, with corresponding changes to
Appendix C of the Facility Combined License as described in the
licensee's request dated March 2, 2017, as supplemented by letter dated
July 28, 2017. This exemption is related to, and necessary for, the
granting of License Amendment No. 85 and 84, respectively, which is
being issued concurrently with this exemption.
3. As explained in Section 6.0 of the NRC staff's Safety Evaluation
(ADAMS Accession No. ML17216A065, this exemption meets the eligibility
criteria for categorical exclusion set forth in 10 CFR 51.22(c)(9).
Therefore, pursuant to 10 CFR 51.22(b), no environmental impact
statement or environmental assessment needs to be prepared in
connection with the issuance of the exemption.
4. This exemption is effective as of the date of its issuance.
III. License Amendment Request
By letter dated March 2, 2017 (ADAMS Accession No. ML17061A747), as
supplemented by letter dated July 28, 2017 (ADAMS Accession No.
ML17209A770), the licensee requested that the NRC amend the COLs for
VEGP, Units 3 and 4, COLs NPF-91 and NPF-92. The proposed amendment is
described in Section I of this Federal Register notice.
The Commission has determined for these amendments that the
application complies with the standards and requirements of the Atomic
Energy Act of 1954, as amended (the Act), and the Commission's rules
and regulations. The Commission has made appropriate findings as
required by the Act and the Commission's rules and regulations in 10
CFR Chapter I, which are set forth in the license amendment.
A notice of consideration of issuance of amendment to facility
operating license or COL, as applicable, proposed no significant
hazards consideration determination, and opportunity for a hearing in
connection with these actions, was published in the Federal Register on
March 28, 2017 (82 FR 15377). No comments were received during the 30-
day comment period.
The Commission has determined that these amendments satisfy the
criteria for categorical exclusion in accordance with 10 CFR 51.22.
Therefore, pursuant to 10 CFR 51.22(b), no environmental impact
statement or environmental assessment need be prepared for these
amendments.
IV. Conclusion
Using the reasons set forth in the combined safety evaluation, the
staff granted the exemption and issued the amendment that the licensee
requested on March 2, 2017, as supplemented by letter dated July 28,
2017.
The exemption and amendment were issued on August 24, 2017, as part
of a combined package to the licensee (ADAMS Accession No.
ML17216A064).
Dated at Rockville, Maryland, this 7th day of December, 2017.
For the Nuclear Regulatory Commission.
Jennifer L. Dixon-Herrity,
Chief, Licensing Branch 4, Division of New Reactor Licensing, Office of
New Reactors.
[FR Doc. 2017-26807 Filed 12-12-17; 8:45 am]
BILLING CODE 7590-01-P