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.

Proposed Rules Federal Register

64750 

Vol. 83, No. 242 

Tuesday, December 18, 2018 

NUCLEAR REGULATORY 

COMMISSION 

10 CFR Part 72 

[NRC–2018–0220] 

RIN 3150–AK17 

List of Approved Spent Fuel Storage 

Casks: NAC International MultiPurpose Canister Storage System, 

Certificate of Compliance No. 1025, 

Amendment Nos. 7 and 8 

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 NAC International MultiPurpose Canister (NAC–MPC) Storage 

System listing within the ‘‘List of 

approved spent fuel storage casks’’ to 

include Amendment Nos. 7 and 8 to 

Certificate of Compliance No. 1025. 

Amendment No. 7 would revise the 

technical specifications to eliminate the 

requirements for the heat removal 

system to be operable for La Crosse 

Boiling Water Reactor spent fuel stored 

in the NAC–MPC because convective 

cooling is not required, and to eliminate 

duplicative requirements. In addition, 

Amendment No. 8 removes duplicative 

surveillance requirements in the 

technical specifications because these 

requirements are already required by the 

revised Technical Specification A 3.1.6, 

‘‘CONCRETE CASK Heat Removal 

System.’’ 

DATES: Submit comments by January 17, 

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–2018–0220. Address 

questions about NRC dockets to Carol 

Gallagher; telephone: 301–415–3463; 

email: Carol.Gallagher@nrc.gov. For 

technical questions contact the 

individuals listed in the FOR FURTHER

INFORMATION CONTACT section of this 

document. 

• Email comments to: 

Rulemaking.Comments@nrc.gov. 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: 

Bernard H. White, Office of Nuclear 

Material Safety and Safeguards; 

telephone: 301–415–6577; email: 

Bernard.White@nrc.gov or Gregory R. 

Trussell, Office of Nuclear Material 

Safety and Safeguards; telephone: 301– 

415–6244; email: Gregory.Trussell@

nrc.gov. 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– 

0220 when contacting the NRC about 

the availability of information for this 

action. You may obtain publiclyavailable information related to this 

action by any of the following methods: 

• Federal Rulemaking Website: Go to 

http://www.regulations.gov and search 

for Docket ID NRC–2018–0220. 

• NRC’s Agencywide Documents 

Access and Management System 

(ADAMS): You may obtain publiclyavailable documents online in the 

ADAMS Public Documents collection at 

http://www.nrc.gov/reading-rm/ 

adams.html. To begin the search, select 

‘‘ADAMS Public Documents’’ and then 

select ‘‘Begin Web-based ADAMS 

Search.’’ For problems with ADAMS, 

please contact the NRC’s Public 

Document Room (PDR) reference staff at 

1–800–397–4209, 301–415–4737, or by 

email to pdr.resource@nrc.gov. 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– 

0220 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 

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 

March 4, 2019. However, if the NRC 

receives significant adverse comments 

on this proposed rule by January 17, 


amozie on DSK3GDR082PROD with PROPOSALS1
Federal Register / Vol. 83, No. 242 / Tuesday, December 18, 2018 / Proposed Rules 64751 

2019, then the NRC will publish a 

document that withdraws the 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-andcomment 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, Certificate of Compliance, or 

technical specifications. 

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 which 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 

March 9, 2000 (65 FR 12444), that 

approved the NAC–MPC Cask System 

design and added it to the list of NRCapproved cask designs in § 72.214 as 

Certificate of Compliance No. 1025. 

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 the 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. 

Document 

ADAMS 

accession No./ 

web link/Federal 

Register 

citation 

Request to Amend Certificate of Compliance No. 1025 for the NAC–MPC Storage System, dated November 14, 2017 ....... ML17326A128 

Request to Amend Certificate of Compliance No. 1025 for the NAC–MPC Storage System, dated February 12, 2018 ......... ML18045A440

Request to Amend Certificate of Compliance No. 1025 for the NAC–MPC Storage System, dated February 28, 2018 ......... ML18059A784

Proposed Certificate of Compliance No. 1025, Amendment No. 7 ............................................................................................ ML18255A024 

Proposed Technical Specification Appendices A and B for Amendment No. 7 ......................................................................... ML18255A022 

Preliminary Safety Evaluation Report for Amendment No. 7 ..................................................................................................... ML18255A026 

Proposed Certificate of Compliance No. 1025, Amendment No. 8 ............................................................................................ ML18255A025 

Proposed Technical Specification Appendices A and B for Amendment No. 8 ......................................................................... ML18255A023 

Preliminary Safety Evaluation Report for Amendment No. 8 ..................................................................................................... ML18255A027 

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–2018–0220. 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–2018–0220); (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, 

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: 


amozie on DSK3GDR082PROD with PROPOSALS1
64752 Federal Register / Vol. 83, No. 242 / Tuesday, December 18, 2018 / Proposed Rules 

PART 72—LICENSING 

REQUIREMENTS FOR THE 

INDEPENDENT STORAGE OF SPENT 

NUCLEAR FUEL, HIGH-LEVEL 

RADIOACTIVE WASTE, AND 

REACTOR-RELATED GREATER THAN 

CLASS C WASTE 

■ 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. 

■ 2. In § 72.214, Certificate of 

Compliance 1025 is revised to read as 

follows: 

§ 72.214 List of approved spent fuel 

storage casks. 

* * * * * 

Certificate Number: 1025. 

Initial Certificate Effective Date: April 

10, 2000. 

Amendment Number 1 Effective Date: 

November 13, 2001. 

Amendment Number 2 Effective Date: 

May 29, 2002. 

Amendment Number 3 Effective Date: 

October 1, 2003. 

Amendment Number 4 Effective Date: 

October 27, 2004. 

Amendment Number 5 Effective Date: 

July 24, 2007. 

Amendment Number 6 Effective Date: 

October 4, 2010. 

Amendment Number 7 Effective Date: 

March 4, 2019. 

Amendment Number 8 Effective Date: 

March 4, 2019. 

SAR Submitted by: NAC 

International, Inc. 

SAR Title: Final Safety Analysis 

Report for the NAC Multi-Purpose 

Canister System (NAC–MPC System). 

Docket Number: 72–1025. 

Certificate Expiration Date: April 10, 

2020. 

Model Number: NAC–MPC.

* * * * * 

Dated at Rockville, Maryland, this 4th day 

of December, 2018. 

For the Nuclear Regulatory Commission. 

Margaret M. Doane, 

Executive Director for Operations. 

[FR Doc. 2018–27286 Filed 12–17–18; 8:45 am] 

BILLING CODE 7590–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 15 

[Docket No. FDA–2018–N–3952] 

Eliminating Youth Electronic Cigarette 

and Other Tobacco Product Use: The 

Role for Drug Therapies; New Date for 

Public Hearing; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of new date for 

public hearing; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing a new date for the public 

hearing to discuss its efforts to eliminate 

youth electronic cigarette (e-cigarette) 

use as well as other tobacco product 

use, with a focus on the potential role 

of drug therapies to support youth ecigarette cessation and the issues 

impacting the development of such 

therapies. FDA is also extending the 

comment period. 

DATES: The public hearing will be held 

on January 18, 2019, from 9 a.m. to 5 

p.m. The public hearing may be 

extended or may end early depending 

on the level of public participation. 

Persons seeking to present at the public 

hearing must register by January 8, 

2019. Persons seeking to speak at the 

public hearing must register by January 

15, 2019. Persons seeking to attend, but 

not present at, the public hearing must 

register by January 15, 2019. Section III 

provides attendance and registration 

information. Electronic or written 

comments will be accepted after the 

public hearing until February 1, 2019. 

ADDRESSES: The public hearing will be 

held at the FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503A), Silver Spring, MD 20993–0002. 

Entrance for public hearing participants 

(non-FDA employees) is through 

Building 1, where routine security 

check procedures will be performed. For 

parking and security information, please 

refer to https://www.fda.gov/AboutFDA/ 

WorkingatFDA/BuildingsandFacilities/ 

WhiteOakCampusInformation/ 

ucm241740.htm. 

You may submit comments as 

follows. Please note that late, untimely 

filed comments will not be considered. 

Electronic comments must be submitted 

on or before February 1, 2019. The 

https://www.regulations.gov electronic 

filing system will accept comments 

until 11:59 p.m. Eastern Time at the end 

of February 1, 2019. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. You may submit comments as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked, and 

identified as confidential if submitted as 

detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2018–N–3952 for ‘‘Eliminating Youth 

Electronic Cigarette and Other Tobacco 

Product Use: The Role for Drug 

Therapies; Public Hearing; Request for 

Comments.’’ Received comments will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 


amozie on DSK3GDR082PROD with PROPOSALS1