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 


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1An e-cigarette is one type of electronic nicotine 

delivery system, which also includes e-cigars, ehookah, vape pens, personal vaporizers, and 

electronic pipes. See https://www.fda.gov/ 

TobaccoProducts/Labeling/ProductsIngredie

ntsComponents/ucm456610.htm and Ref. 2. 

2https://www.fda.gov/TobaccoProducts/ 

PublicHealthEducation/ProtectingKids

fromTobacco/ucm608433.htm. 

3https://www.fda.gov/tobaccoproducts/ 

publichealtheducation/publiceducationcampaigns/ 

therealcostcampaign/default.htm. 

4https://www.fda.gov/NewsEvents/Newsroom/ 

PressAnnouncements/ucm620788.htm. 

a.m. and 4 p.m., Monday through 

Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.fda.gov/ 

regulatoryinformation/dockets/ 

default.htm. 

Docket: For access to the docket to 

read background documents or the 

received electronic and written/paper 

comments, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Theresa Wells, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, Rm. 1202, Silver Spring, 

MD 20993, 703–380–3900, 

Theresa.wells@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Nearly all tobacco product use begins 

during youth and young adulthood (Ref. 

1). While the current use of any tobacco 

product among U.S. middle and high 

school students has decreased from 

2011 to 2017, there has been an 

alarming increase in e-cigarette use over 

this time. In fact, since 2014, ecigarettes 1 have been the most 

commonly used tobacco products 

among youth, used by 1.73 million (11.7 

percent) high school students and 

390,000 (3.3 percent) middle school 

students in 2017 (Ref. 2). Youth ecigarette use raises a number of health 

concerns including risk of addiction to 

nicotine early on in life, potential harm 

to the developing adolescent brain, and 

exposure to chemicals including 

carbonyl compounds and volatile 

organic compounds known to have 

adverse health effects; the full range of 

possible health effects is not yet 

completely understood (Ref. 3). 

On April 24, 2018, FDA announced 

its Youth Tobacco Prevention Plan. This 

plan focuses on three key strategies: 

Prevention of youth access to tobacco 

products, curbing the marketing of 

tobacco products aimed at youth, and 

educating teens about the dangers of 

using any tobacco products.2 FDA 

recently launched an expansion of its 

‘‘The Real Cost’’ campaign to educate 

youth on the dangers of e-cigarette use 3

and increased enforcement actions to 

address this critically important public 

health concern.4

In addition to the prevention of 

initiation, which will be the cornerstone 

of any successful effort to curb youth ecigarette use, FDA is also exploring 

additional approaches to address youth 

e-cigarette use. One such approach may 

be the development of drug therapies, as 

part of multimodal treatment strategies, 

including behavioral interventions, to 

support tobacco product cessation. To 

date, research on youth tobacco product 

cessation has been limited and focused 

on smoking (i.e., combustible products) 

cessation. One recent review found a 

paucity of data on either behavioral or 

drug therapies for smoking cessation in 

young people (age less than 20 years) 

and concluded that ‘‘there continues to 

be a need for well-designed, adequately 

powered, randomized controlled trials 

of interventions for this population of 

smokers’’ (Ref. 4). FDA is not aware of 

any research examining either drug or 

behavioral interventions for the 

cessation of youth or adult e-cigarette 

use. In contrast, there is a large body of 

research on adult smoking cessation, 

and multiple drugs for smoking 

cessation are approved for the adult 

population, including a variety of 

prescription and over-the-counter 

nicotine replacement therapy (NRT) 

products, as well as the prescription 

drugs varenicline and bupropion 

hydrochloride sustained release (see 

Appendix A). 

II. Purpose and Scope of the Public 

Hearing 

FDA is holding a public hearing to 

obtain the public’s perspectives on the 

potential role drug therapies may play 

in the broader effort to eliminate youth 

e-cigarette and other tobacco product 

use, as well as the appropriate methods 

and study designs for evaluating youth 

e-cigarette cessation therapies and the 

safety and efficacy of such therapies. 

The Agency has determined that a 

public hearing is the most appropriate 

way to ensure public engagement on 

this issue, which is of great importance 

to the public health. FDA believes it is 

critical to obtain input across the 

medical and research fields, the 

pharmaceutical and tobacco industries, 

and among public health stakeholders 

(including adolescents) regarding 

approaches to eliminate youth ecigarette and other tobacco product use, 

including exploring whether there is a 

need for drug therapies to support youth 

e-cigarette cessation, and if so, how FDA 

can support the development of such 

therapies. 

Questions for Commenters to Address: 

Considering the broad range of activities 

focused on this public health issue, FDA 

is interested in the public’s view on 

approaches to eliminating e-cigarette 

and other tobacco product use among 

youth. Although FDA welcomes all 

feedback on any public health, 

scientific, regulatory, or legal 

considerations relating to this topic, we 

particularly encourage commenters to 

consider the following questions as they 

prepare their comments or statements. 

Responses to questions should include 

supporting scientific justification. 

1. FDA notes that the factors driving 

e-cigarette use among youth likely differ 

from those in the adult population. How 

might such differences impact the need 

for, or use of, drug therapies for ecigarette cessation among youth? 

2. FDA is interested in whether there 

is a population of youth e-cigarette users 

who would be likely to benefit from the 

use of drug therapies for e-cigarette 

cessation. What age groups (older 

adolescent vs. younger adolescent), 

patterns in tobacco use (duration and 

frequency of use), and clinical features 

(level of addiction, presence/absence of 


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64754 Federal Register / Vol. 83, No. 242 / Tuesday, December 18, 2018 / Proposed Rules 

comorbidities including psychiatric 

disease) might characterize this 

population? What types of products 

(NRT vs. non-NRT; prescription vs. 

over-the-counter) might be useful? 

3. Describe the scientific, clinical, and 

societal factors that could either 

encourage or impede the conduct of 

clinical trials designed to evaluate drugs 

intended for youth e-cigarette cessation. 

What approaches could be used to 

encourage research and overcome 

barriers to research? 

4. What methods and study designs 

are appropriate for assessing drug 

therapies for youth e-cigarette cessation? 

What are the appropriate control 

groups? What are the most informative 

endpoints and the best assessment tools 

to evaluate these endpoints? 

5. Acknowledging that to date 

research has been limited, are there data 

available from the adult experience with 

smoking cessation that could potentially 

be leveraged in the effort to develop 

drug therapies for youth e-cigarette 

cessation? Have any drug therapies 

demonstrated potential to help adults 

discontinue e-cigarette use? Are there 

differences between adolescents and 

adults that impact the ability to 

extrapolate efficacy findings from the 

adult population to the adolescent 

population? Could existing NRT 

products be useful for youth e-cigarette 

cessation? 

6. While this hearing is focused on the 

topic of e-cigarette use among youth, as 

e-cigarettes are currently the most 

commonly used form of tobacco in this 

population, FDA also welcomes 

comments regarding the potential need 

for drug therapies to support cessation 

of other tobacco products, including 

combustible products (i.e., cigarettes or 

cigars) and smokeless tobacco products, 

among youth and the issues impacting 

the development of such therapies. 

III. Participating in the Public Hearing 

Registration and Requests for Oral 

Presentations: The FDA Conference 

Center at the White Oak location is a 

Federal facility with security procedures 

and limited seating. Attendance will be 

free and on a first-come, first-served 

basis. For those interested in presenting 

at the meeting with a formal oral 

presentation, please register by January 

8, 2019, at https://www.eventbrite.com/ 

e/fda-pediatric-tobacco-cessation-part15-public-hearing-tickets-50167147288. 

For those interested in participating as 

a speaker during the open public 

hearing, please register by January 15, 

2019, at https://www.eventbrite.com/e/ 

fda-pediatric-tobacco-cessation-part-15- 

public-hearing-tickets-50167147288. If 

you wish to attend either in person or 

by webcast (see Streaming Webcast of 

the Public Hearing), please register for 

the hearing by January 15, 2019, at 

https://www.eventbrite.com/e/fdapediatric-tobacco-cessation-part-15- 

public-hearing-tickets-50167147288. 

Those without internet or email access 

can register and/or request to participate 

as an open public hearing speaker or a 

formal presenter by contacting Theresa 

Wells by the above dates (see FOR

FURTHER INFORMATION CONTACT). 

FDA will try to accommodate all 

persons who wish to make a 

presentation. Formal oral presenters 

may use an accompanying slide deck, 

while those participating in the open 

public hearing will have less allotted 

time than formal oral presenters and 

will deliver oral testimony only (no 

accompanying slide deck). Individuals 

wishing to present should identify the 

number of the specific question, or 

questions, they wish to address. This 

will help FDA organize the 

presentations. Individuals and 

organizations with common interests 

should consolidate or coordinate their 

presentations and request time for a 

joint presentation. Individual 

organizations are limited to a single 

presentation slot. FDA will notify 

registered presenters of their scheduled 

presentation times. The time allotted for 

each presentation will depend on the 

number of individuals who wish to 

speak. Registered presenters making a 

formal oral presentation are encouraged 

to submit an electronic copy of their 

presentation (PowerPoint or PDF) to 

OMPTFeedback@fda.hhs.gov with the 

subject line ‘‘Eliminating Youth 

Electronic Cigarette and Other Tobacco 

Product Use: The Role for Drug 

Therapies’’ on or before January 11, 

2019. Persons registered to present are 

encouraged to arrive at the hearing room 

early and check in at the onsite 

registration table to confirm their 

designated presentation time. Actual 

presentation times, however, may vary 

based on how the meeting progresses in 

real time. An agenda for the hearing and 

any other background materials will be 

made available 5 days before the hearing 

at https://www.fda.gov/NewsEvents/ 

MeetingsConferencesWorkshops/ 

ucm620744.htm. 

If you need special accommodations 

because of a disability, please contact 

Theresa Wells (see FOR FURTHER

INFORMATION CONTACT) at least 7 days 

before the hearing. 

Streaming Webcast of the Public 

Hearing: For those unable to attend in 

person, FDA will provide a live webcast 

of the hearing. To join the hearing via 

the webcast, please go to https://

collaboration.fda.gov/ptc120518. 

Transcripts: Please be advised that as 

soon as a transcript is available, it will 

be accessible at https://

www.regulations.gov. It may be viewed 

at the Dockets Management Staff (see 

ADDRESSES). 

IV. Notice of Hearing Under 21 CFR 

Part 15 

The Commissioner of Food and Drugs 

is announcing that the public hearing 

will be held in accordance with part 15 

(21 CFR part 15). The hearing will be 

conducted by a presiding officer, who 

will be accompanied by FDA senior 

management from the Office of the 

Commissioner, the Center for Drug 

Evaluation and Research, and the Center 

for Tobacco Products. Under § 15.30(f) 

(21 CFR 15.30(f)), the hearing is 

informal and the rules of evidence do 

not apply. No participant may interrupt 

the presentation of another participant. 

Only the presiding officer and panel 

members can pose questions; they can 

question any person during or at the 

conclusion of each presentation. Public 

hearings under part 15 are subject to 

FDA’s policy and procedures for 

electronic media coverage of FDA’s 

public administrative proceedings (21 

CFR part 10, subpart C). Under 21 CFR 

10.205, representatives of the media 

may be permitted, subject to certain 

limitations, to videotape, film, or 

otherwise record FDA’s public 

administrative proceedings, including 

presentations by participants. The 

hearing will be transcribed as stipulated 

in § 15.30(b) (see Transcripts). To the 

extent that the conditions for the 

hearing, as described in this notice, 

conflict with any provisions set out in 

part 15, this notice acts as a waiver of 

those provisions as specified in 

§ 15.30(h). 

V. References 

The following references marked with 

an asterisk (*) are on display at the 

Dockets Management Staff (see 

ADDRESSES) and are available for 

viewing by interested persons between 

9 a.m. and 4 p.m., Monday through 

Friday; they also are available 

electronically at https://

www.regulations.gov. References 

without asterisks are not on public 

display at https://www.regulations.gov 

because they have copyright restriction. 

Some may be available at the website 

address, if listed. References without 

asterisks are available for viewing only 

at the Dockets Management Staff. FDA 

has verified the website addresses, as of 

the date this document publishes in the 

Federal Register, but websites are 

subject to change over time. 


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1.* U.S. Department of Health and Human 

Services (2014). ‘‘The Health 

Consequences of Smoking—50 Years of 

Progress: A Report of the Surgeon 

General, 2014.’’ Atlanta, GA: U.S. 

Department of Health and Human 

Services, Centers for Disease Control and 

Prevention, National Center for Chronic 

Disease Prevention and Health 

Promotion, Office on Smoking and 

Health. (Available at: https://

www.surgeongeneral.gov/library/reports/ 

50-years-of-progress/index.html.) 

2.* Wang T.W., A. Gentzke, S. Sharapova, et 

al. (2018). ‘‘Tobacco Product Use Among 

Middle and High School Students— 

United States, 2011–2017.’’ Morbidity 

and Mortality Weekly Report (MMWR) 

67:629–633. (Available at https://

www.cdc.gov/mmwr/volumes/67/wr/ 

mm6722a3.htm.) 

3.* U.S. Department of Health and Human 

Services (2016). ‘‘E-Cigarette Use Among 

Youth and Young Adults: A Report of 

the Surgeon General.’’ Atlanta, GA: U.S. 

Department of Health and Human 

Services, Centers for Disease Control and 

Prevention, National Center for Chronic 

Disease Prevention and Health 

Promotion, Office on Smoking and 

Health. (Available at: https://ecigarettes.surgeongeneral.gov/ 

documents/2016_sgr_full_report_non508.pdf.) 

4. Fanshawe T.R., W. Halliwell, N. Lindson, 

et al. (2017). ‘‘Tobacco Cessation 

Interventions for Young People.’’ 

Cochrane Database of Systematic 

Reviews, Rev.11:CD003289. (Available at 

https://www.cochranelibrary.com/cdsr/ 

doi/10.1002/14651858.CD003289.pub6/ 

epdf/full.) 

BILLING CODE 4164–01–P 


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amozie on DSK3GDR082PROD with PROPOSALS1EP18DE18.009</GPH>
Federal Register / Vol. 83, No. 242 / Tuesday, December 18, 2018 / Proposed Rules 64757 

Dated: December 13, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–27352 Filed 12–17–18; 8:45 am] 

BILLING CODE 4164–01–C 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[REG–132881–17] 

RIN 1545–BO30 

Regulations Reducing Burden Under 

FATCA and Chapter 3 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: This document contains 

proposed regulations eliminating 

withholding on payments of gross 

proceeds, deferring withholding on 

foreign passthru payments, eliminating 

withholding on certain insurance 

premiums, and clarifying the definition 

of investment entity. This notice of 

proposed rulemaking also includes 

guidance concerning certain due 

diligence requirements of withholding 

agents and guidance on refunds and 

credits of amounts withheld. 

DATES: Written or electronic comments 

and requests for a public hearing must 

be received by February 19, 2019. 

ADDRESSES: Send submissions to: 

CC:PA:LPD:PR (REG–132881–17), 

Internal Revenue Service, Room 5203, 

P.O. Box 7604, Ben Franklin Station, 

Washington, DC 20044. Submissions 

may also be hand-delivered Monday 

through Friday between the hours of 8 

a.m. and 4 p.m. to CC:PA:LPD:PR (REG– 

132881–17), Courier’s Desk, Internal 

Revenue Service, 1111 Constitution 

Avenue NW, Washington, DC 20224; or 

sent electronically via the Federal 

eRulemaking Portal at http://

www.regulations.gov (IRS REG–132881– 

17). 

FOR FURTHER INFORMATION CONTACT: 

Concerning the proposed regulations, 

John Sweeney, Nancy Lee, or Subin 

Seth, (202) 317–6942; concerning 

submissions of comments and/or 

requests for a public hearing, Regina 

Johnson, (202) 317–6901 (not toll free 

numbers). 

SUPPLEMENTARY INFORMATION: 

Background 

This document contains amendments 

to the Income Tax Regulations (26 CFR 

part 1) under chapter 4 (sections 1471 

through 1474) commonly known as the 

Foreign Account Tax Compliance Act 

(FATCA). This document also contains 

amendments to the Income Tax 

Regulations (26 CFR part 1) under 

sections 1441 and 1461. 

On January 28, 2013, the Department 

of the Treasury (Treasury Department) 

and the IRS published final regulations 

under chapter 4 in the Federal Register 

(TD 9610, 78 FR 5873), and on 

September 10, 2013, corrections to the 

final regulations were published in the 

Federal Register (78 FR 55202). The 

regulations in TD 9610 and the 

corrections thereto are collectively 

referred to in this preamble as the 2013 

final chapter 4 regulations. On March 6, 

2014, the Treasury Department and the 

IRS published temporary regulations 

under chapter 4 (TD 9657, 79 FR 12812) 

that clarify and modify certain 

provisions of the 2013 final chapter 4 

regulations, and corrections to the 

temporary regulations were published 

in the Federal Register on July 1, 2014, 

and November 18, 2014 (79 FR 37175 

and 78 FR 68619, respectively). The 

regulations in TD 9657 and the 

corrections thereto are referred to in this 

preamble as the 2014 temporary chapter 

4 regulations. A notice of proposed 

rulemaking cross-referencing the 2014 

temporary chapter 4 regulations was 

published in the Federal Register on 

March 6, 2014 (79 FR 12868). 

On March 6, 2014, the Treasury 

Department and the IRS published 

temporary regulations under chapters 3 

and 61 in the Federal Register (TD 

9658, 79 FR 12726) to coordinate with 

the regulations under chapter 4, and 

corrections to those temporary 

regulations were published in the 

Federal Register (79 FR 37181) on July 

1, 2014. Collectively, the regulations in 

TD 9657 and the corrections thereto are 

referred to in this preamble as the 2014 

temporary coordination regulations. A 

notice of proposed rulemaking crossreferencing the 2014 temporary 

coordination regulations was published 

in the Federal Register on March 6, 

2014 (79 FR 12880). 

On January 6, 2017, the Treasury 

Department and the IRS published final 

and temporary regulations under 

chapter 4 in the Federal Register (TD 

9809, 82 FR 2124), and corrections to 

those final regulations were published 

on June 30, 2017 in the Federal Register 

(82 FR 27928). Collectively, the 

regulations in TD 9809 and the 

corrections thereto are referred to in this 

preamble as the 2017 chapter 4 

regulations. A notice of proposed 

rulemaking cross-referencing the 

temporary regulations in TD 9809 and 

proposing regulations under chapter 4 

relating to verification requirements for 

certain entities was published in the 

Federal Register on January 6, 2017 (82 

FR 1629). Also on January 6, 2017, the 

Treasury Department and the IRS 

published final and temporary 

regulations under chapters 3 and 61 in 

the Federal Register (TD 9808, 82 FR 

2046), and corrections to those final 

regulations were published on June 30, 

2017 in the Federal Register (82 FR 

29719). Collectively, the regulations in 

TD 9808 and the corrections thereto are 

referred to in this preamble as the 2017 

coordination regulations. A notice of 

proposed rulemaking cross-referencing 

the temporary regulations in TD 9808 

was published in the Federal Register 

on January 6, 2017 (82 FR 1645). 

Pursuant to Executive Order 13777, 

Presidential Executive Order on 

Enforcing the Regulatory Reform 

Agenda (82 FR 9339), the Treasury 

Department is responsible for 

conducting a broad review of existing 

regulations. In a Request for Information 

published on June 14, 2017 (82 FR 

27217), the Treasury Department invited 

public comment concerning regulations 

that should be modified or eliminated in 

order to reduce unnecessary burdens. In 

addition, in Notice 2017–28 (2017–19 

I.R.B. 1235), the Treasury Department 

and the IRS invited public comment on 

recommendations for the 2017–2018 

Priority Guidance Plan for tax guidance, 

including recommendations relating to 

Executive Order 13777. In response to 

the invitations for comments in the 

Request for Information and Notice 

2017–28, the Treasury Department and 

the IRS received comments suggesting 

modifications to the regulations under 

chapters 3 and 4. See also Executive 

Order 13789, Identifying and Reducing 

Tax Regulatory Burdens, issued on 

April 21, 2017 (82 FR 19317) and the 

second report issued in response (82 FR 

48013) (stating that the Treasury 

Department continues to analyze all 

recently issued significant regulations 

and is considering possible reforms of 

recent regulations, which include 

regulations under chapter 4). 

Based on public input, and taking into 

account the burden-reducing policies 

described in Executive Orders 13777 

and 13789, these regulations propose 

certain amendments to the regulations 

under chapters 3 and 4, including 

certain refund related issues for which 

comments were received. The 

Explanation of Provisions section of this 

preamble describes these proposed 

amendments and addresses public 

comments received in response to the 

Request for Information and Notice 

2017–28, other than comments that 

would require a statutory change or 


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