26618 Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Proposed Rules 

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– 

2017–N–6107 for ‘‘Regulation of 

Premium Cigars.’’ Received comments, 

those filed in a timely manner (see 

ADDRESSES), 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 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.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, 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: 

Deirdre Jurand or Nate Mease, Center for 

Tobacco Products, Food and Drug 

Administration, Document Control 

Center, 10903 New Hampshire Ave., 

Bldg. 71, Rm. G335, Silver Spring, MD 

20993, 1–877–287–1373, AskCTP@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of March 26, 2018, 

FDA published an ANPRM with a 90- 

day comment period to obtain 

information related to the regulation of 

premium cigars under the Federal Food, 

Drug, and Cosmetic Act, as amended by 

the Family Smoking Prevention and 

Tobacco Control Act, and regulations 

regarding the sale and distribution of 

tobacco products. FDA is seeking 

comments, data, research results, or 

other information that may inform 

regulatory actions FDA might take with 

respect to premium cigars. Specifically, 

FDA is seeking information related to 

the following topics: Definition of 

premium cigars, use patterns of 

premium cigars, and public health 

considerations associated with premium 

cigars. 

The Agency has received requests for 

a 90-day extension of the comment 

period for the ANPRM. FDA has 

considered the requests and is 

extending the comment period for the 

ANPRM for 30 days, until July 25, 2018. 

The Agency believes that a 30-day 

extension allows adequate time for 

interested persons to submit comments 

without significantly delaying any 

potential regulatory action on these 

important issues. 

Dated: June 5, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12367 Filed 6–7–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 1100, 1140, and 1143 

[Docket No. FDA–2017–N–6565] 

RIN 0910–AH60 

Regulation of Flavors in Tobacco 

Products; Extension of Comment 

Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Advance notice of proposed 

rulemaking; extension of comment 

period. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

extending the comment period for the 

advance notice of proposed rulemaking 

(ANPRM) that appeared in the Federal 

Register of March 21, 2018. In the 

ANPRM, FDA requested information 

related to the role that flavors play in 

tobacco products. The Agency is taking 

this action in response to requests for an 

extension to allow interested persons 

additional time to submit comments. 

DATES: FDA is extending the comment 

period on the ANPRM published on 

March 21, 2018 (83 FR 12294). Submit 

either electronic or written comments 

by July 19, 2018. 

ADDRESSES: 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 July 19, 2018. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of July 19, 2018. 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. 

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 


amozie on DSK3GDR082PROD with PROPOSALS1
Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Proposed Rules 26619 

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– 

2017–N–6565 for ‘‘Regulation of Flavors 

in Tobacco Products.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), 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 

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.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, 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: 

Laura Rich or Katherine Collins, Center 

for Tobacco Products, Food and Drug 

Administration, Document Control 

Center, 10903 New Hampshire Ave., 

Bldg. 71, Rm. G335, Silver Spring, MD 

20993, 1–877–287–1373, AskCTP@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of March 21, 2018, 

FDA published an ANPRM with a 90- 

day comment period to obtain 

information related to the role that 

flavors play in tobacco products. 

Specifically, the ANPRM is seeking 

comments, data, research results, or 

other information about, among other 

things, how flavors attract youth to 

initiate tobacco product use and about 

whether and how certain flavors may 

help adult cigarette smokers reduce 

cigarette use and switch to potentially 

less harmful products. FDA is seeking 

this information to inform regulatory 

actions FDA might take with respect to 

tobacco products with flavors, under the 

Federal Food, Drug, and Cosmetic Act, 

as amended by the Family Smoking 

Prevention and Tobacco Control Act. 

Potential regulatory actions include, but 

are not limited to, tobacco product 

standards and restrictions on sale and 

distribution of tobacco products with 

flavors. 

The Agency has received a number of 

requests for a 90-day extension of the 

comment period for the ANPRM and 

one request for a 105-day extension. 

FDA has considered these requests and 

is extending the comment period for the 

ANPRM for 30 days, until July 19, 2018. 

The Agency believes that a 30-day 

extension allows adequate time for 

interested persons to submit comments 

without significantly delaying any 

potential regulatory action on these 

important issues. 

Dated: June 5, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12369 Filed 6–7–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 1130 

[Docket No. FDA–2017–N–6189] 

RIN 0910–AH86 

Tobacco Product Standard for Nicotine 

Level of Combusted Cigarettes; 

Extension of Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Advance notice of proposed 

rulemaking; extension of comment 

period. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

extending the comment period for the 

advance notice of proposed rulemaking 

(ANPRM) that appeared in the Federal 

Register of March 16, 2018. In the 

ANPRM, FDA requested information for 

consideration in developing a tobacco 

product standard to set a maximum 

nicotine level in combusted cigarettes so 

that they are minimally addictive or 

nonaddictive. The Agency is taking this 

action in response to requests for an 

extension to allow interested persons 

additional time to submit comments. 

DATES: FDA is extending the comment 

period on the ANPRM published on 

March 16, 2018 (83 FR 11818). Submit 

either electronic or written comments 

by July 16, 2018. 

ADDRESSES: 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 July 16, 2018. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of July 16, 2018. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 


amozie on DSK3GDR082PROD with PROPOSALS1