83_FR_64052 83 FR 63814 - List of Approved Spent Fuel Storage Casks: Holtec International HI-STORM 100 Multipurpose Canister Cask System, Certificate of Compliance No. 1014, Amendment Nos. 11 and 12

83 FR 63814 - List of Approved Spent Fuel Storage Casks: Holtec International HI-STORM 100 Multipurpose Canister Cask System, Certificate of Compliance No. 1014, Amendment Nos. 11 and 12

NUCLEAR REGULATORY COMMISSION

Federal Register Volume 83, Issue 238 (December 12, 2018)

Page Range63814-63817
FR Document2018-26878

The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend its spent fuel storage regulations by revising the Holtec International HI-STORM 100 Multipurpose Canister Cask System (HI-STORM 100 System) listing within the ``List of approved spent fuel storage casks'' to include Amendment Nos. 11 and 12 to Certificate of Compliance No. 1014. Amendment Nos. 11 and 12 propose to revise multiple items in the Technical Specifications for multi-purpose canister models listed under Certificate of Compliance No. 1014; most of these revisions involve changes to the authorized contents. In addition, Amendment No. 11 makes several other editorial changes.

Federal Register, Volume 83 Issue 238 (Wednesday, December 12, 2018)
[Federal Register Volume 83, Number 238 (Wednesday, December 12, 2018)]
[Proposed Rules]
[Pages 63814-63817]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-26878]


========================================================================
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. 83, No. 238 / Wednesday, December 12, 2018 / 
Proposed Rules

[[Page 63814]]



NUCLEAR REGULATORY COMMISSION

10 CFR Part 72

[NRC-2018-0221]
RIN 3150-AK18


List of Approved Spent Fuel Storage Casks: Holtec International 
HI-STORM 100 Multipurpose Canister Cask System, Certificate of 
Compliance No. 1014, Amendment Nos. 11 and 12

AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule.

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

SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is proposing to 
amend its spent fuel storage regulations by revising the Holtec 
International HI-STORM 100 Multipurpose Canister Cask System (HI-STORM 
100 System) listing within the ``List of approved spent fuel storage 
casks'' to include Amendment Nos. 11 and 12 to Certificate of 
Compliance No. 1014. Amendment Nos. 11 and 12 propose to revise 
multiple items in the Technical Specifications for multi-purpose 
canister models listed under Certificate of Compliance No. 1014; most 
of these revisions involve changes to the authorized contents. In 
addition, Amendment No. 11 makes several other editorial changes.

DATES: Submit comments by January 11, 2019. Comments received after 
this date will be considered if it is practical to do so, but the NRC 
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 http://www.regulations.gov and search for Docket ID NRC-2018-0221. Address 
questions about NRC dockets to Carol Gallagher; telephone: 301-415-
3463; email: [email protected]. For technical questions contact 
the individuals listed in the FOR FURTHER INFORMATION CONTACT section 
of this document.
     Email comments to: [email protected]. 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 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: Yen-Ju Chen, Office of Nuclear 
Material Safety and Safeguards; telephone: 301-415-1018; email: [email protected] or Vanessa Cox, Office of Nuclear Material Safety and 
Safeguards; telephone: 301-415-8342; email: [email protected]. Both 
are staff of the U.S. Nuclear Regulatory Commission, Washington, DC 
20555-0001.

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Obtaining Information and Submitting Comments
II. Rulemaking Procedure
III. Background
IV. Plain Writing
V. Availability of Documents

I. Obtaining Information and Submitting Comments

A. Obtaining Information

    Please refer to Docket ID NRC-2018-0221 when contacting the NRC 
about the availability of information for this action. You may obtain 
publicly-available information related to this action by any of the 
following methods:
     Federal Rulemaking Website: Go to http://www.regulations.gov and search for Docket ID NRC-2018-0221.
     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 ``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]. For the convenience of the reader, 
instructions about obtaining materials referenced in this document are 
provided in the ``Availability of Documents'' section.
     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-2018-0221 in your comment submission.
    The NRC cautions you not to include identifying or contact 
information that you do not want to be 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. 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 into ADAMS.

II. Rulemaking Procedure

    This proposed rule is limited to the changes contained in Amendment 
Nos. 11 and 12 to Certificate of Compliance 1014 and does not include 
other aspects of the Holtec International HI-STORM 100 System design. 
Because the NRC considers this action to be non-controversial, the NRC 
is publishing this proposed rule concurrently with a direct final rule 
in the Rules and Regulations section of this issue of the Federal 
Register (FR). The direct final rule will become effective on February 
25, 2019. However, if the NRC receives significant adverse comments on 
this proposed rule by January 11, 2019, then the NRC will publish a 
document that withdraws the

[[Page 63815]]

direct final rule. If the direct final rule is withdrawn, the NRC will 
address the comments received in response to these proposed revisions 
in a subsequent final rule. Absent significant modifications to the 
proposed revisions requiring republication, the NRC will not initiate a 
second comment period on this action in the event the direct final rule 
is withdrawn.
    A significant adverse comment is a comment where the commenter 
explains why the rule would be inappropriate, including challenges to 
the rule's underlying premise or approach, or would be ineffective or 
unacceptable without a change. A comment is adverse and significant if:
    (1) The comment opposes the rule and provides a reason sufficient 
to require a substantive response in a notice-and-comment process. For 
example, a substantive response is required when:
    (a) The comment causes the NRC staff to reevaluate (or reconsider) 
its position or conduct additional analysis;
    (b) The comment raises an issue serious enough to warrant a 
substantive response to clarify or complete the record; or
    (c) The comment raises a relevant issue that was not previously 
addressed or considered by the NRC staff.
    (2) The comment proposes a change or an addition to the rule, and 
it is apparent that the rule would be ineffective or unacceptable 
without incorporation of the change or addition.
    (3) The comment causes the NRC staff to make a change (other than 
editorial) to the rule.
    For procedural information and the regulatory analysis, see the 
direct final rule published in the Rules and Regulations section of 
this issue of the FR.

III. Background

    Section 218(a) of the Nuclear Waste Policy Act (NWPA) of 1982, as 
amended, requires that ``the Secretary [of the Department of Energy] 
shall establish a demonstration program, in cooperation with the 
private sector, for the dry storage of spent nuclear fuel at civilian 
nuclear power reactor sites, with the objective of establishing one or 
more technologies that the [Nuclear Regulatory] Commission may, by 
rule, approve for use at the sites of civilian nuclear power reactors 
without, to the maximum extent practicable, the need for additional 
site-specific approvals by the Commission.'' Section 133 of the NWPA 
states, in part, that ``[the Commission] shall, by rule, establish 
procedures for the licensing of any technology approved by the 
Commission under Section 219(a) [sic: 218(a)] for use at the site of 
any civilian nuclear power reactor.''
    To implement this mandate, the Commission approved dry storage of 
spent nuclear fuel in NRC-approved casks under a general license by 
publishing a final rule that added a new subpart K in part 72 of Title 
10 of the Code of Federal Regulations (10 CFR) entitled, ``General 
License for Storage of Spent Fuel at Power Reactor Sites'' (55 FR 
29181; July 18, 1990). This rule also established a new subpart L in 10 
CFR part 72 entitled, ``Approval of Spent Fuel Storage Casks,'' which 
contains procedures and criteria for obtaining NRC approval of spent 
fuel storage cask designs. The NRC subsequently issued a final rule on 
May 1, 2000 (65 FR 25241) that approved the Holtec International HI-
STORM 100 System design and added it to the list of NRC-approved cask 
designs in Sec.  72.214 as Certificate of Compliance No. 1014.

IV. Plain Writing

    The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal 
agencies to write documents in a clear, concise, well-organized manner. 
The NRC has written this document to be consistent with the Plain 
Writing Act as well as the Presidential Memorandum, ``Plain Language in 
Government Writing,'' published June 10, 1998 (63 FR 31883). The NRC 
requests comment on the proposed rule with respect to clarity and 
effectiveness of the language used.

V. Availability of Documents

    The documents identified in the following table are available to 
interested persons through one or more of the following methods, as 
indicated.

------------------------------------------------------------------------
                                               ADAMS accession No./web
                  Document                      link/ Federal Register
                                                       citation
------------------------------------------------------------------------
Subpart K of 10 CFR part 72, ``General       55 FR 29181
 License for Storage of Spent Fuel at Power
 Reactor Sites''.
10 CFR part 72, ``List of Approved Spent     65 FR 25241
 Fuel Storage Casks: Holtec HI-STORM 100
 Addition''.
Letter from Holtec International to NRC,     ML16029A528
 ``Holtec International HI-STORM 100
 Multipurpose Canister Storage System
 Amendment Request 1014-11'' dated January
 29, 2016.
Letter from Holtec International to NRC,     ML16069A246
 ``Supporting Information for License
 Amendment Request 11 (1014-11) to the HI-
 STORM 100 CoC'' dated February 16, 2016.
 (This letter contains five enclosures, and
 Enclosures 1 through 4 are proprietary
 information and not publicly available.).
Letter from Holtec International to NRC,     ML16159A344
 ``Transmittal of Requests for Supplemental
 Information Responses Supporting HI-STORM
 100 License Amendment Request 1014-11''
 dated June 6, 2016.
Letter from Holtec International to NRC,     ML17005A236
 ``Submittal of Responses to NRC's Requests
 for Additional Information for HI-STORM
 100 License Amendment Request 1014-11''
 dated December 22, 2016.
Letter from Holtec International to NRC,     ML16113A394
 ``Modification to Requested Changes on HI-
 STORM 100 Amendment 11 Request'' dated
 April 22, 2016.
Letter from Holtec International to NRC,     ML17261A159
 ``Submittal of Responses to NRC's 2nd
 Round Requests for Additional Information
 for HI-STORM 100 License Amendment Request
 1014-11'' dated September 8, 2017.
Letter from Holtec International to NRC,     ML17325A555
 ``Submittal of Supplemental Information on
 NRC's Requests for Additional Information
 for HI-STORM 100 License Amendment Request
 1014-11'' dated November 10, 2017. (This
 package contains nine attachments, and
 Attachments 1, 6, 7, and 8 are proprietary
 information and not publicly available.).
Letter from Holtec International to NRC,     ML17362A113
 ``Submittal of Revised Supplemental
 Information on NRC's Requests for
 Additional Information for HI-STORM 100
 License Amendment Request 1014-11'' dated
 December 21, 2017.
User Need Memorandum for Rulemaking for the  ML18141A568
 Holtec International HI-STORM 100 Cask
 System, Amendment 11.
Proposed Certificate of Compliance 1014,     ML18141A561
 Amendment 11, Certificate of Compliance
 for Spent Fuel Storage Casks.
Proposed Certificate of Compliance 1014,     ML18141A562
 Amendment 11, Technical Specifications,
 Appendix A.
Proposed Certificate of Compliance 1014,     ML18141A563
 Amendment 11, Approved Contents and Design
 Features, Appendix B.
Proposed Certificate of Compliance 1014,     ML18141A564
 Amendment 11, Technical Specifications,
 Appendix A-100U.
Proposed Certificate of Compliance 1014,     ML18141A565
 Amendment 11, Approved Contents and Design
 Features, Appendix B-100U.
Certificate of Compliance 1014, Amendment    ML18141A567
 11, Preliminary Safety Evaluation Report.

[[Page 63816]]

 
Letter from Holtec International to NRC,     ML16169A363
 ``Holtec International HI-STORM 100
 Multipurpose Canister Storage System
 Amendment Request 1014-12'' dated June 14,
 2016.
Letter from Holtec International to NRC,     ML16210A133
 ``Holtec International HI-STORM 100
 Multipurpose Canister Storage System
 Amendment Request 1014-12 Supporting
 Calculation Packages'' dated July 22,
 2016. (This package contains four
 attachments, and Attachments 1 through 3
 are proprietary information and not
 publicly available.).
Letter from Holtec International to NRC,     ML16313A216
 ``HI-STORM 100 Amendment 12 Responses to
 Requests for Supplemental Information''
 dated November 4, 2016. (This package
 contains five attachments, and Attachment
 4 is proprietary information and not
 publicly available.).
Letter from Holtec International to NRC,     ML17251A739
 ``Submittal of Responses to NRC's Requests
 Additional Information for HI-STORM 100
 License Amendment Request 1014-12'' dated
 August 25, 2017. (This package contains 13
 attachments, and Attachments 1, 5, 7, 8,
 9, 10, 11, and 12 are proprietary
 information and not publicly available.).
Letter from Holtec International to NRC,     ML17261A159
 ``Submittal of Responses to NRC's 2nd
 Round Requests Additional Information for
 HI-STORM 100 License Amendment Request
 1014-11'' dated September 8, 2017. (This
 package contains seven attachments, and
 Attachments 1, 5, and 6 are proprietary
 information and not publicly available.).
Letter from Holtec International to NRC,     ML17326A174
 ``Submittal of Supplemental Information on
 NRC's Requests for Additional Information
 for HI-STORM 100 License Amendment Request
 1014-12'' dated November 10, 2017. (This
 package contains six attachments, and
 Attachment 1 is proprietary information
 and not publicly available.).
Letter from Holtec International to NRC,     ML17362A130
 ``Submittal of Revised Supplemental
 Information on NRC's Requests for
 Additional Information for HI-STORM 100
 License Amendment Request 1014-12'' dated
 December 22, 2017.
User Need Memorandum for Rulemaking for the  ML18087A056
 Holtec International HI-STORM 100 Cask
 System, Amendment 12.
Proposed Certificate of Compliance 1014,     ML18087A057
 Amendment 12, Certificate of Compliance
 for Spent Fuel Storage Casks.
Proposed Certificate of Compliance 1014,     ML18087A058
 Amendment 12, Technical Specifications,
 Appendix A.
Proposed Certificate of Compliance 1014,     ML18087A059
 Amendment 12, Approved Contents and Design
 Features, Appendix B.
Proposed Certificate of Compliance 1014,     ML18087A060
 Amendment 12, Technical Specifications,
 Appendix A-100U.
Proposed Certificate of Compliance 1014,     ML18087A061
 Amendment 12, Approved Contents and Design
 Features, Appendix B-100U.
Certificate of Compliance 1014, Amendment    ML18087A062
 12, Preliminary Safety Evaluation Report.
------------------------------------------------------------------------

    The NRC may post materials related to this document, including 
public comments, on the Federal Rulemaking website at http://www.regulations.gov under Docket ID NRC-2018-0221. The Federal 
Rulemaking website allows you to receive alerts when changes or 
additions occur in a docket folder. To subscribe: (1) Navigate to the 
docket folder (NRC-2018-0221); (2) click the ``Sign up for Email 
Alerts'' link; and (3) enter your email address and select how 
frequently you would like to receive emails (daily, weekly, or 
monthly).

List of Subjects in 10 CFR Part 72

    Administrative practice and procedure, Hazardous waste, Indians, 
Intergovernmental relations, Nuclear energy, Penalties, Radiation 
protection, Reporting and recordkeeping requirements, Security 
measures, Spent fuel, Whistleblowing.

    For the reasons set out in the preamble and under the authority of 
the Atomic Energy Act of 1954, as amended; the Energy Reorganization 
Act of 1974, as amended; the Nuclear Waste Policy Act of 1982, as 
amended; and 5 U.S.C. 552 and 553, the NRC is proposing to adopt the 
following amendments to 10 CFR part 72:

PART 72--LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF 
SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-
RELATED GREATER THAN CLASS C WASTE

0
1. The authority citation for part 72 continues to read as follows:

    Authority: Atomic Energy Act of 1954, secs. 51, 53, 57, 62, 63, 
65, 69, 81, 161, 182, 183, 184, 186, 187, 189, 223, 234, 274 (42 
U.S.C. 2071, 2073, 2077, 2092, 2093, 2095, 2099, 2111, 2201, 2210e, 
2232, 2233, 2234, 2236, 2237, 2238, 2273, 2282, 2021); Energy 
Reorganization Act of 1974, secs. 201, 202, 206, 211 (42 U.S.C. 
5841, 5842, 5846, 5851); National Environmental Policy Act of 1969 
(42 U.S.C. 4332); Nuclear Waste Policy Act of 1982, secs. 117(a), 
132, 133, 134, 135, 137, 141, 145(g), 148, 218(a) (42 U.S.C. 
10137(a), 10152, 10153, 10154, 10155, 10157, 10161, 10165(g), 10168, 
10198(a)); 44 U.S.C. 3504 note.

0
2. In Sec.  72.214, Certificate of Compliance 1014 is revised to read 
as follows:


Sec.  72.214   List of approved spent fuel storage casks.

* * * * *
    Certificate Number: 1014.
    Initial Certificate Effective Date: May 31, 2000.
    Amendment Number 1 Effective Date: July 15, 2002.
    Amendment Number 2 Effective Date: June 7, 2005.
    Amendment Number 3 Effective Date: May 29, 2007.
    Amendment Number 4 Effective Date: January 8, 2008.
    Amendment Number 5 Effective Date: July 14, 2008.
    Amendment Number 6 Effective Date: August 17, 2009.
    Amendment Number 7 Effective Date: December 28, 2009.
    Amendment Number 8 Effective Date: May 2, 2012, as corrected on 
November 16, 2012 (ADAMS Accession No. ML12213A170); superseded by 
Amendment Number 8, Revision 1, Effective Date: February 16, 2016.
    Amendment Number 8, Revision 1, Effective Date: February 16, 2016.
    Amendment Number 9 Effective Date: March 11, 2014, superseded by 
Amendment Number 9, Revision 1, on March 21, 2016.
    Amendment Number 9, Revision 1, Effective Date: March 21, 2016, as 
corrected (ADAMS Accession No. ML17236A451).
    Amendment Number 10 Effective Date: May 31, 2016, as corrected 
(ADAMS Accession No. ML17236A452).
    Amendment Number 11 Effective Date: February 25, 2019.
    Amendment Number 12 Effective Date: February 25, 2019.
    Safety Analysis Report Submitted by: Holtec International.
    Safety Analysis Report Title: Final Safety Analysis Report for the 
HI-STORM 100 Cask System.
    Docket Number: 72-1014.

[[Page 63817]]

    Certificate Expiration Date: May 31, 2020.
    Model Number: HI-STORM 100.
* * * * *

    Dated at Rockville, Maryland, this 29th day of November 2018.

    For the Nuclear Regulatory Commission.
Margaret M. Doane,
Executive Director for Operations.
[FR Doc. 2018-26878 Filed 12-11-18; 8:45 am]
 BILLING CODE 7590-01-P



                                                63814

                                                Proposed Rules                                                                                                Federal Register
                                                                                                                                                              Vol. 83, No. 238

                                                                                                                                                              Wednesday, December 12, 2018



                                                This section of the FEDERAL REGISTER                       • Email comments to:                               adams.html. To begin the search, select
                                                contains notices to the public of the proposed          Rulemaking.Comments@nrc.gov. If you                   ‘‘Begin Web-based ADAMS Search.’’ For
                                                issuance of rules and regulations. The                  do not receive an automatic email reply               problems with ADAMS, please contact
                                                purpose of these notices is to give interested          confirming receipt, then contact us at                the NRC’s Public Document Room (PDR)
                                                persons an opportunity to participate in the            301–415–1677.                                         reference staff at 1–800–397–4209, 301–
                                                rule making prior to the adoption of the final
                                                                                                           • Fax comments to: Secretary, U.S.                 415–4737, or by email to pdr.resource@
                                                rules.
                                                                                                        Nuclear Regulatory Commission at 301–                 nrc.gov. For the convenience of the
                                                                                                        415–1101.                                             reader, instructions about obtaining
                                                NUCLEAR REGULATORY                                         • Mail comments to: Secretary, U.S.                materials referenced in this document
                                                COMMISSION                                              Nuclear Regulatory Commission,                        are provided in the ‘‘Availability of
                                                                                                        Washington, DC 20555–0001, ATTN:                      Documents’’ section.
                                                10 CFR Part 72                                          Rulemakings and Adjudications Staff.                     • NRC’s PDR: You may examine and
                                                                                                           • Hand deliver comments to: 11555                  purchase copies of public documents at
                                                [NRC–2018–0221]                                         Rockville Pike, Rockville, Maryland                   the NRC’s PDR, Room O1–F21, One
                                                                                                        20852, between 7:30 a.m. and 4:15 p.m.                White Flint North, 11555 Rockville
                                                RIN 3150–AK18
                                                                                                        (Eastern Time) Federal workdays;                      Pike, Rockville, Maryland 20852.
                                                List of Approved Spent Fuel Storage                     telephone: 301–415–1677.                              B. Submitting Comments
                                                Casks: Holtec International HI–STORM                       For additional direction on obtaining
                                                                                                        information and submitting comments,                    Please include Docket ID NRC–2018–
                                                100 Multipurpose Canister Cask
                                                                                                        see ‘‘Obtaining Information and                       0221 in your comment submission.
                                                System, Certificate of Compliance No.                                                                           The NRC cautions you not to include
                                                1014, Amendment Nos. 11 and 12                          Submitting Comments’’ in the
                                                                                                        SUPPLEMENTARY INFORMATION section of                  identifying or contact information that
                                                AGENCY:  Nuclear Regulatory                             this document.                                        you do not want to be publicly
                                                Commission.                                                                                                   disclosed in your comment submission.
                                                                                                        FOR FURTHER INFORMATION CONTACT: Yen-
                                                ACTION: Proposed rule.
                                                                                                                                                              The NRC will post all comment
                                                                                                        Ju Chen, Office of Nuclear Material
                                                                                                                                                              submissions at http://
                                                                                                        Safety and Safeguards; telephone: 301–
                                                SUMMARY:   The U.S. Nuclear Regulatory                                                                        www.regulations.gov as well as enter the
                                                                                                        415–1018; email: Yen-Ju.Chen@nrc.gov
                                                Commission (NRC) is proposing to                                                                              comment submissions into ADAMS.
                                                                                                        or Vanessa Cox, Office of Nuclear                     The NRC does not routinely edit
                                                amend its spent fuel storage regulations                Material Safety and Safeguards;
                                                by revising the Holtec International HI–                                                                      comment submissions to remove
                                                                                                        telephone: 301–415–8342; email:                       identifying or contact information.
                                                STORM 100 Multipurpose Canister Cask                    Vanessa.Cox@nrc.gov. Both are staff of
                                                System (HI–STORM 100 System) listing                                                                            If you are requesting or aggregating
                                                                                                        the U.S. Nuclear Regulatory                           comments from other persons for
                                                within the ‘‘List of approved spent fuel                Commission, Washington, DC 20555–
                                                storage casks’’ to include Amendment                                                                          submission to the NRC, then you should
                                                                                                        0001.                                                 inform those persons not to include
                                                Nos. 11 and 12 to Certificate of
                                                Compliance No. 1014. Amendment Nos.                     SUPPLEMENTARY INFORMATION:                            identifying or contact information that
                                                11 and 12 propose to revise multiple                                                                          they do not want to be publicly
                                                                                                        Table of Contents                                     disclosed in their comment submission.
                                                items in the Technical Specifications for
                                                multi-purpose canister models listed                    I. Obtaining Information and Submitting               Your request should state that the NRC
                                                                                                              Comments                                        does not routinely edit comment
                                                under Certificate of Compliance No.                     II. Rulemaking Procedure
                                                1014; most of these revisions involve                                                                         submissions to remove such information
                                                                                                        III. Background                                       before making the comment
                                                changes to the authorized contents. In                  IV. Plain Writing
                                                addition, Amendment No. 11 makes                                                                              submissions available to the public or
                                                                                                        V. Availability of Documents
                                                several other editorial changes.                                                                              entering the comment into ADAMS.
                                                                                                        I. Obtaining Information and
                                                DATES: Submit comments by January 11,                                                                         II. Rulemaking Procedure
                                                                                                        Submitting Comments
                                                2019. Comments received after this date                                                                          This proposed rule is limited to the
                                                will be considered if it is practical to do             A. Obtaining Information                              changes contained in Amendment Nos.
                                                so, but the NRC is able to ensure                         Please refer to Docket ID NRC–2018–                 11 and 12 to Certificate of Compliance
                                                consideration only for comments                         0221 when contacting the NRC about                    1014 and does not include other aspects
                                                received on or before this date.                        the availability of information for this              of the Holtec International HI–STORM
                                                ADDRESSES: You may submit comments                      action. You may obtain publicly-                      100 System design. Because the NRC
                                                by any of the following methods:                        available information related to this                 considers this action to be non-
                                                   • Federal Rulemaking Website: Go to                  action by any of the following methods:               controversial, the NRC is publishing this
                                                http://www.regulations.gov and search                     • Federal Rulemaking Website: Go to                 proposed rule concurrently with a direct
amozie on DSK3GDR082PROD with PROPOSALS1




                                                for Docket ID NRC–2018–0221. Address                    http://www.regulations.gov and search                 final rule in the Rules and Regulations
                                                questions about NRC dockets to Carol                    for Docket ID NRC–2018–0221.                          section of this issue of the Federal
                                                Gallagher; telephone: 301–415–3463;                       • NRC’s Agencywide Documents                        Register (FR). The direct final rule will
                                                email: Carol.Gallagher@nrc.gov. For                     Access and Management System                          become effective on February 25, 2019.
                                                technical questions contact the                         (ADAMS): You may obtain publicly-                     However, if the NRC receives significant
                                                individuals listed in the FOR FURTHER                   available documents online in the                     adverse comments on this proposed rule
                                                INFORMATION CONTACT section of this                     ADAMS Public Documents collection at                  by January 11, 2019, then the NRC will
                                                document.                                               http://www.nrc.gov/reading-rm/                        publish a document that withdraws the


                                           VerDate Sep<11>2014   17:18 Dec 11, 2018   Jkt 247001   PO 00000   Frm 00001   Fmt 4702   Sfmt 4702   E:\FR\FM\12DEP1.SGM   12DEP1


                                                                   Federal Register / Vol. 83, No. 238 / Wednesday, December 12, 2018 / Proposed Rules                                                   63815

                                                direct final rule. If the direct final rule               (3) The comment causes the NRC staff                   subpart K in part 72 of Title 10 of the
                                                is withdrawn, the NRC will address the                  to make a change (other than editorial)                  Code of Federal Regulations (10 CFR)
                                                comments received in response to these                  to the rule.                                             entitled, ‘‘General License for Storage of
                                                proposed revisions in a subsequent final                  For procedural information and the                     Spent Fuel at Power Reactor Sites’’ (55
                                                rule. Absent significant modifications to               regulatory analysis, see the direct final                FR 29181; July 18, 1990). This rule also
                                                the proposed revisions requiring                        rule published in the Rules and                          established a new subpart L in 10 CFR
                                                republication, the NRC will not initiate                Regulations section of this issue of the                 part 72 entitled, ‘‘Approval of Spent
                                                a second comment period on this action                  FR.                                                      Fuel Storage Casks,’’ which contains
                                                in the event the direct final rule is                   III. Background                                          procedures and criteria for obtaining
                                                withdrawn.                                                                                                       NRC approval of spent fuel storage cask
                                                   A significant adverse comment is a                      Section 218(a) of the Nuclear Waste                   designs. The NRC subsequently issued a
                                                comment where the commenter                             Policy Act (NWPA) of 1982, as                            final rule on May 1, 2000 (65 FR 25241)
                                                explains why the rule would be                          amended, requires that ‘‘the Secretary                   that approved the Holtec International
                                                inappropriate, including challenges to                  [of the Department of Energy] shall                      HI–STORM 100 System design and
                                                the rule’s underlying premise or                        establish a demonstration program, in                    added it to the list of NRC-approved
                                                approach, or would be ineffective or                    cooperation with the private sector, for                 cask designs in § 72.214 as Certificate of
                                                unacceptable without a change. A                        the dry storage of spent nuclear fuel at                 Compliance No. 1014.
                                                comment is adverse and significant if:                  civilian nuclear power reactor sites,
                                                   (1) The comment opposes the rule and                 with the objective of establishing one or                IV. Plain Writing
                                                provides a reason sufficient to require a               more technologies that the [Nuclear
                                                                                                        Regulatory] Commission may, by rule,                       The Plain Writing Act of 2010 (Pub.
                                                substantive response in a notice-and-                                                                            L. 111–274) requires Federal agencies to
                                                comment process. For example, a                         approve for use at the sites of civilian
                                                                                                        nuclear power reactors without, to the                   write documents in a clear, concise,
                                                substantive response is required when:                                                                           well-organized manner. The NRC has
                                                   (a) The comment causes the NRC staff                 maximum extent practicable, the need
                                                                                                        for additional site-specific approvals by                written this document to be consistent
                                                to reevaluate (or reconsider) its position
                                                                                                        the Commission.’’ Section 133 of the                     with the Plain Writing Act as well as the
                                                or conduct additional analysis;
                                                   (b) The comment raises an issue                      NWPA states, in part, that ‘‘[the                        Presidential Memorandum, ‘‘Plain
                                                serious enough to warrant a substantive                 Commission] shall, by rule, establish                    Language in Government Writing,’’
                                                response to clarify or complete the                     procedures for the licensing of any                      published June 10, 1998 (63 FR 31883).
                                                record; or                                              technology approved by the                               The NRC requests comment on the
                                                   (c) The comment raises a relevant                    Commission under Section 219(a) [sic:                    proposed rule with respect to clarity
                                                issue that was not previously addressed                 218(a)] for use at the site of any civilian              and effectiveness of the language used.
                                                or considered by the NRC staff.                         nuclear power reactor.’’                                 V. Availability of Documents
                                                   (2) The comment proposes a change                       To implement this mandate, the
                                                or an addition to the rule, and it is                   Commission approved dry storage of                         The documents identified in the
                                                apparent that the rule would be                         spent nuclear fuel in NRC-approved                       following table are available to
                                                ineffective or unacceptable without                     casks under a general license by                         interested persons through one or more
                                                incorporation of the change or addition.                publishing a final rule that added a new                 of the following methods, as indicated.

                                                                                                                                                                                                ADAMS accession
                                                                                                                                                                                                  No./web link/
                                                                                                                Document                                                                        Federal Register
                                                                                                                                                                                                    citation

                                                Subpart K of 10 CFR part 72, ‘‘General License for Storage of Spent Fuel at Power Reactor Sites’’ .....................................         55 FR 29181
                                                10 CFR part 72, ‘‘List of Approved Spent Fuel Storage Casks: Holtec HI–STORM 100 Addition’’ ..........................................          65 FR 25241
                                                Letter from Holtec International to NRC, ‘‘Holtec International HI–STORM 100 Multipurpose Canister Storage System                               ML16029A528
                                                  Amendment Request 1014–11’’ dated January 29, 2016.
                                                Letter from Holtec International to NRC, ‘‘Supporting Information for License Amendment Request 11 (1014–11) to the HI–                         ML16069A246
                                                  STORM 100 CoC’’ dated February 16, 2016. (This letter contains five enclosures, and Enclosures 1 through 4 are pro-
                                                  prietary information and not publicly available.).
                                                Letter from Holtec International to NRC, ‘‘Transmittal of Requests for Supplemental Information Responses Supporting HI–                        ML16159A344
                                                  STORM 100 License Amendment Request 1014–11’’ dated June 6, 2016.
                                                Letter from Holtec International to NRC, ‘‘Submittal of Responses to NRC’s Requests for Additional Information for HI–                          ML17005A236
                                                  STORM 100 License Amendment Request 1014–11’’ dated December 22, 2016.
                                                Letter from Holtec International to NRC, ‘‘Modification to Requested Changes on HI–STORM 100 Amendment 11 Re-                                   ML16113A394
                                                  quest’’ dated April 22, 2016.
                                                Letter from Holtec International to NRC, ‘‘Submittal of Responses to NRC’s 2nd Round Requests for Additional Information                        ML17261A159
                                                  for HI–STORM 100 License Amendment Request 1014–11’’ dated September 8, 2017.
                                                Letter from Holtec International to NRC, ‘‘Submittal of Supplemental Information on NRC’s Requests for Additional Infor-                        ML17325A555
                                                  mation for HI–STORM 100 License Amendment Request 1014–11’’ dated November 10, 2017. (This package contains
                                                  nine attachments, and Attachments 1, 6, 7, and 8 are proprietary information and not publicly available.).
                                                Letter from Holtec International to NRC, ‘‘Submittal of Revised Supplemental Information on NRC’s Requests for Additional                       ML17362A113
amozie on DSK3GDR082PROD with PROPOSALS1




                                                  Information for HI–STORM 100 License Amendment Request 1014–11’’ dated December 21, 2017.
                                                User Need Memorandum for Rulemaking for the Holtec International HI–STORM 100 Cask System, Amendment 11 ..........                              ML18141A568
                                                Proposed Certificate of Compliance 1014, Amendment 11, Certificate of Compliance for Spent Fuel Storage Casks ...........                       ML18141A561
                                                Proposed Certificate of Compliance 1014, Amendment 11, Technical Specifications, Appendix A ..........................................          ML18141A562
                                                Proposed Certificate of Compliance 1014, Amendment 11, Approved Contents and Design Features, Appendix B ..............                         ML18141A563
                                                Proposed Certificate of Compliance 1014, Amendment 11, Technical Specifications, Appendix A–100U ...............................                ML18141A564
                                                Proposed Certificate of Compliance 1014, Amendment 11, Approved Contents and Design Features, Appendix B–100U ....                              ML18141A565
                                                Certificate of Compliance 1014, Amendment 11, Preliminary Safety Evaluation Report ..........................................................   ML18141A567



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                                                63816              Federal Register / Vol. 83, No. 238 / Wednesday, December 12, 2018 / Proposed Rules

                                                                                                                                                                                                ADAMS accession
                                                                                                                                                                                                  No./web link/
                                                                                                                Document                                                                        Federal Register
                                                                                                                                                                                                    citation

                                                Letter from Holtec International to NRC, ‘‘Holtec International HI–STORM 100 Multipurpose Canister Storage System                               ML16169A363
                                                  Amendment Request 1014–12’’ dated June 14, 2016.
                                                Letter from Holtec International to NRC, ‘‘Holtec International HI–STORM 100 Multipurpose Canister Storage System                               ML16210A133
                                                  Amendment Request 1014–12 Supporting Calculation Packages’’ dated July 22, 2016. (This package contains four at-
                                                  tachments, and Attachments 1 through 3 are proprietary information and not publicly available.).
                                                Letter from Holtec International to NRC, ‘‘HI–STORM 100 Amendment 12 Responses to Requests for Supplemental Infor-                              ML16313A216
                                                  mation’’ dated November 4, 2016. (This package contains five attachments, and Attachment 4 is proprietary information
                                                  and not publicly available.).
                                                Letter from Holtec International to NRC, ‘‘Submittal of Responses to NRC’s Requests Additional Information for HI–                              ML17251A739
                                                  STORM 100 License Amendment Request 1014–12’’ dated August 25, 2017. (This package contains 13 attachments,
                                                  and Attachments 1, 5, 7, 8, 9, 10, 11, and 12 are proprietary information and not publicly available.).
                                                Letter from Holtec International to NRC, ‘‘Submittal of Responses to NRC’s 2nd Round Requests Additional Information for                        ML17261A159
                                                  HI–STORM 100 License Amendment Request 1014–11’’ dated September 8, 2017. (This package contains seven at-
                                                  tachments, and Attachments 1, 5, and 6 are proprietary information and not publicly available.).
                                                Letter from Holtec International to NRC, ‘‘Submittal of Supplemental Information on NRC’s Requests for Additional Infor-                        ML17326A174
                                                  mation for HI–STORM 100 License Amendment Request 1014–12’’ dated November 10, 2017. (This package contains
                                                  six attachments, and Attachment 1 is proprietary information and not publicly available.).
                                                Letter from Holtec International to NRC, ‘‘Submittal of Revised Supplemental Information on NRC’s Requests for Additional                       ML17362A130
                                                  Information for HI–STORM 100 License Amendment Request 1014–12’’ dated December 22, 2017.
                                                User Need Memorandum for Rulemaking for the Holtec International HI–STORM 100 Cask System, Amendment 12 ..........                              ML18087A056
                                                Proposed Certificate of Compliance 1014, Amendment 12, Certificate of Compliance for Spent Fuel Storage Casks ...........                       ML18087A057
                                                Proposed Certificate of Compliance 1014, Amendment 12, Technical Specifications, Appendix A ..........................................          ML18087A058
                                                Proposed Certificate of Compliance 1014, Amendment 12, Approved Contents and Design Features, Appendix B ..............                         ML18087A059
                                                Proposed Certificate of Compliance 1014, Amendment 12, Technical Specifications, Appendix A–100U ...............................                ML18087A060
                                                Proposed Certificate of Compliance 1014, Amendment 12, Approved Contents and Design Features, Appendix B–100U ....                              ML18087A061
                                                Certificate of Compliance 1014, Amendment 12, Preliminary Safety Evaluation Report ..........................................................   ML18087A062



                                                   The NRC may post materials related                   PART 72—LICENSING                                          Amendment Number 3 Effective Date:
                                                to this document, including public                      REQUIREMENTS FOR THE                                     May 29, 2007.
                                                comments, on the Federal Rulemaking                     INDEPENDENT STORAGE OF SPENT                               Amendment Number 4 Effective Date:
                                                website at http://www.regulations.gov                   NUCLEAR FUEL, HIGH-LEVEL                                 January 8, 2008.
                                                under Docket ID NRC–2018–0221. The                      RADIOACTIVE WASTE, AND                                     Amendment Number 5 Effective Date:
                                                Federal Rulemaking website allows you                   REACTOR-RELATED GREATER THAN                             July 14, 2008.
                                                                                                        CLASS C WASTE                                              Amendment Number 6 Effective Date:
                                                to receive alerts when changes or
                                                                                                                                                                 August 17, 2009.
                                                additions occur in a docket folder. To                                                                             Amendment Number 7 Effective Date:
                                                subscribe: (1) Navigate to the docket                   ■ 1. The authority citation for part 72
                                                                                                        continues to read as follows:                            December 28, 2009.
                                                folder (NRC–2018–0221); (2) click the                                                                              Amendment Number 8 Effective Date:
                                                ‘‘Sign up for Email Alerts’’ link; and (3)                Authority: Atomic Energy Act of 1954,
                                                                                                                                                                 May 2, 2012, as corrected on November
                                                enter your email address and select how                 secs. 51, 53, 57, 62, 63, 65, 69, 81, 161, 182,
                                                                                                        183, 184, 186, 187, 189, 223, 234, 274 (42               16, 2012 (ADAMS Accession No.
                                                frequently you would like to receive                    U.S.C. 2071, 2073, 2077, 2092, 2093, 2095,               ML12213A170); superseded by
                                                emails (daily, weekly, or monthly).                     2099, 2111, 2201, 2210e, 2232, 2233, 2234,               Amendment Number 8, Revision 1,
                                                                                                        2236, 2237, 2238, 2273, 2282, 2021); Energy              Effective Date: February 16, 2016.
                                                List of Subjects in 10 CFR Part 72
                                                                                                        Reorganization Act of 1974, secs. 201, 202,                Amendment Number 8, Revision 1,
                                                  Administrative practice and                           206, 211 (42 U.S.C. 5841, 5842, 5846, 5851);             Effective Date: February 16, 2016.
                                                                                                        National Environmental Policy Act of 1969                  Amendment Number 9 Effective Date:
                                                procedure, Hazardous waste, Indians,
                                                                                                        (42 U.S.C. 4332); Nuclear Waste Policy Act               March 11, 2014, superseded by
                                                Intergovernmental relations, Nuclear                    of 1982, secs. 117(a), 132, 133, 134, 135, 137,
                                                energy, Penalties, Radiation protection,                                                                         Amendment Number 9, Revision 1, on
                                                                                                        141, 145(g), 148, 218(a) (42 U.S.C. 10137(a),            March 21, 2016.
                                                Reporting and recordkeeping                             10152, 10153, 10154, 10155, 10157, 10161,
                                                                                                                                                                   Amendment Number 9, Revision 1,
                                                requirements, Security measures, Spent                  10165(g), 10168, 10198(a)); 44 U.S.C. 3504
                                                                                                        note.                                                    Effective Date: March 21, 2016, as
                                                fuel, Whistleblowing.                                                                                            corrected (ADAMS Accession No.
                                                  For the reasons set out in the                        ■ 2. In § 72.214, Certificate of                         ML17236A451).
                                                preamble and under the authority of the                 Compliance 1014 is revised to read as                      Amendment Number 10 Effective
                                                Atomic Energy Act of 1954, as amended;                  follows:                                                 Date: May 31, 2016, as corrected
                                                the Energy Reorganization Act of 1974,                                                                           (ADAMS Accession No. ML17236A452).
                                                                                                        § 72.214 List of approved spent fuel
                                                as amended; the Nuclear Waste Policy                    storage casks.
                                                                                                                                                                   Amendment Number 11 Effective
                                                                                                                                                                 Date: February 25, 2019.
amozie on DSK3GDR082PROD with PROPOSALS1




                                                Act of 1982, as amended; and 5 U.S.C.                   *     *     *     *     *                                  Amendment Number 12 Effective
                                                552 and 553, the NRC is proposing to                      Certificate Number: 1014.                              Date: February 25, 2019.
                                                adopt the following amendments to 10                      Initial Certificate Effective Date: May                  Safety Analysis Report Submitted by:
                                                CFR part 72:                                            31, 2000.                                                Holtec International.
                                                                                                          Amendment Number 1 Effective Date:                       Safety Analysis Report Title: Final
                                                                                                        July 15, 2002.                                           Safety Analysis Report for the HI–
                                                                                                          Amendment Number 2 Effective Date:                     STORM 100 Cask System.
                                                                                                        June 7, 2005.                                              Docket Number: 72–1014.


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                                                                  Federal Register / Vol. 83, No. 238 / Wednesday, December 12, 2018 / Proposed Rules                                          63817

                                                  Certificate Expiration Date: May 31,                  consider comments made at the public                  acids in size. A chemically synthesized
                                                2020.                                                   meeting in its review of the Rule.                    polypeptide would mean any alpha
                                                  Model Number: HI–STORM 100.                                                                                 amino acid polymer that is made
                                                                                                        Public Participation and Meeting
                                                *     *     *    *     *                                                                                      entirely by chemical synthesis and is
                                                                                                        Procedures
                                                                                                                                                              greater than 40 amino acids but less
                                                  Dated at Rockville, Maryland, this 29th day             The meeting will use a workshop
                                                of November 2018.                                                                                             than 100 amino acids in size. This
                                                                                                        format. FAA will have several stations                proposed rule is intended to clarify the
                                                  For the Nuclear Regulatory Commission.                covering a number of relevant aspects of              statutory framework under which such
                                                Margaret M. Doane,                                      the Rule. Each station will be staffed by             products are regulated.
                                                Executive Director for Operations.                      an FAA representative who is able to                  DATES: Submit either electronic or
                                                [FR Doc. 2018–26878 Filed 12–11–18; 8:45 am]            answer questions regarding that subject.              written comments on the proposed rule
                                                BILLING CODE 7590–01–P                                  There will also be a station where the                by February 25, 2019.
                                                                                                        public can submit a written statement or
                                                                                                                                                              ADDRESSES: You may submit comments
                                                                                                        have their oral comment transcribed. No
                                                                                                        formal presentations will be made.                    as follows. Please note that late,
                                                DEPARTMENT OF TRANSPORTATION                                                                                  untimely filed comments will not be
                                                                                                          Section 182 of the FAA
                                                Federal Aviation Administration                         Reauthorization Act of 2018 also calls                considered. Electronic comments must
                                                                                                        for a written comment period on the                   be submitted on or before February 25,
                                                14 CFR Part 93                                          North Shore Helicopter Rule. See docket               2019. The https://www.regulations.gov
                                                                                                        number FAA–2018–0954 to submit                        electronic filing system will accept
                                                RIN 2120–AK39                                                                                                 comments until midnight Eastern Time
                                                                                                        written comments.
                                                                                                          Sign and oral interpretation can be                 at the end of February 25, 2019.
                                                Notification of Replacement Public                                                                            Comments received by mail/hand
                                                Meeting on Requirement for                              made available at the meeting, as well
                                                                                                        as an assistive listening device, if                  delivery/courier (for written/paper
                                                Helicopters To Use the New York North                                                                         submissions) will be considered timely
                                                Shore Helicopter Route                                  requested 3 calendar days before the
                                                                                                        meeting. The meeting will be open to all              if they are postmarked or the delivery
                                                AGENCY: Federal Aviation                                persons on a space-available basis.                   service acceptance receipt is on or
                                                Administration (FAA), DOT.                              There will be no admission fee or other               before that date.
                                                ACTION: Notification of public meeting.                 charge to attend and participate.                     Electronic Submissions
                                                                                                          Issued in Washington, DC, on December 7,              Submit electronic comments in the
                                                SUMMARY:    Due to inclement weather on                 2018.
                                                November 15, 2018, the FAA announces                                                                          following way:
                                                a replacement public meeting to solicit
                                                                                                        Brandon Roberts,                                        • Federal eRulemaking Portal:
                                                feedback concerning the New York                        Deputy Executive Director, Office of                  https://www.regulations.gov. Follow the
                                                                                                        Rulemaking.                                           instructions for submitting comments.
                                                North Shore Helicopter Rule (‘‘the
                                                                                                        [FR Doc. 2018–26934 Filed 12–10–18; 4:15 pm]          Comments submitted electronically,
                                                Rule’’). This meeting is being held
                                                pursuant to Section 182 of the FAA                      BILLING CODE 4910–13–P                                including attachments, to https://
                                                Reauthorization Act of 2018. The Rule                                                                         www.regulations.gov will be posted to
                                                requires civil helicopter pilots operating                                                                    the docket unchanged. Because your
                                                under Visual Flight Rules (VFR), whose                  DEPARTMENT OF HEALTH AND                              comment will be made public, you are
                                                route of flight takes them over the north               HUMAN SERVICES                                        solely responsible for ensuring that your
                                                shore of Long Island between the Visual                                                                       comment does not include any
                                                Point Lloyd Harbor (VPLYD) waypoint                     Food and Drug Administration                          confidential information that you or a
                                                and Orient Point (VPOLT), to use the                                                                          third party may not wish to be posted,
                                                North Shore Helicopter Route.                           21 CFR Part 600                                       such as medical information, your or
                                                DATES: The public meeting will be held                  [Docket No. FDA–2018–N–2732]                          anyone else’s Social Security number, or
                                                on Thursday, December 13, 2018.                                                                               confidential business information, such
                                                                                                        RIN 0910–AH57                                         as a manufacturing process. Please note
                                                ADDRESSES: The public meeting will be
                                                                                                                                                              that if you include your name, contact
                                                held at Vaugh College, 8601 23rd                        Definition of the Term ‘‘Biological
                                                                                                                                                              information, or other information that
                                                Avenue, Flushing NY 11369. The                          Product’’
                                                                                                                                                              identifies you in the body of your
                                                meeting is 7:00 p.m.–9:00 p.m. EST.                                                                           comments, that information will be
                                                                                                        AGENCY:    Food and Drug Administration,
                                                FOR FURTHER INFORMATION CONTACT:                        HHS.                                                  posted on https://www.regulations.gov.
                                                Christopher Bailey, Office of                           ACTION:   Proposed rule.                                • If you want to submit a comment
                                                Rulemaking, Federal Aviation                                                                                  with confidential information that you
                                                Administration; telephone (202) 267–                    SUMMARY:   The Food and Drug                          do not wish to be made available to the
                                                4158; email Christopher.Bailey@faa.gov.                 Administration (FDA or the Agency) is                 public, submit the comment as a
                                                SUPPLEMENTARY INFORMATION:                              proposing to amend its regulation that                written/paper submission and in the
                                                                                                        defines ‘‘biological product’’ to                     manner detailed (see ‘‘Written/Paper
                                                Purpose of the Public Meeting                           incorporate changes made by the                       Submissions’’ and ‘‘Instructions.’’)
                                                   The purpose of the public meeting is                 Biologics Price Competition and
amozie on DSK3GDR082PROD with PROPOSALS1




                                                for the FAA to obtain feedback relevant                 Innovation Act of 2009 (BPCI Act), and                Written/Paper Submissions
                                                to the Rule at subpart H of part 93,                    to provide its interpretation of the                    Submit written/paper submissions as
                                                which requires civil helicopter pilots                  statutory terms ‘‘protein’’ and                       follows:
                                                operating under VFR, whose route of                     ‘‘chemically synthesized polypeptide.’’                 • Mail/Hand Delivery/Courier (for
                                                flight takes them over the north shore of               Under that interpretation, the term                   written/paper submissions): Dockets
                                                Long Island between the VPLYD                           protein would mean any alpha amino                    Management Staff (HFA–305), Food and
                                                waypoint and VPOLT, to use the North                    acid polymer with a specific, defined                 Drug Administration, 5630 Fishers
                                                Shore Helicopter Route. The FAA will                    sequence that is greater than 40 amino                Lane, Rm. 1061, Rockville, MD 20852.


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Document Created: 2018-12-12 01:39:18
Document Modified: 2018-12-12 01:39:18
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionProposed rule.
DatesSubmit comments by January 11, 2019. Comments received after this date will be considered if it is practical to do so, but the NRC is able to ensure consideration only for comments received on or before this date.
ContactYen-Ju Chen, Office of Nuclear Material Safety and Safeguards; telephone: 301-415-1018; email: Yen- [email protected] or Vanessa Cox, Office of Nuclear Material Safety and Safeguards; telephone: 301-415-8342; email: [email protected] Both are staff of the U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.
FR Citation83 FR 63814 
RIN Number3150-AK18
CFR AssociatedAdministrative Practice and Procedure; Hazardous Waste; Indians; Intergovernmental Relations; Nuclear Energy; Penalties; Radiation Protection; Reporting and Recordkeeping Requirements; Security Measures; Spent Fuel and Whistleblowing

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