9508 Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s website after 

the meeting. Background material is 

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

advisory-committees/advisorycommittee-calendar. Scroll down to the 

appropriate advisory committee meeting 

link. The meeting will include slide 

presentations with audio components to 

allow the presentation of materials in a 

manner that most closely resembles an 

in-person advisory committee meeting. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions made to the Docket (see 

ADDRESSES) on or before February 24, 

2021, will be provided to the committee. 

Comments received after February 24, 

2021, and by March 4, 2021, will be 

taken into consideration by FDA. Oral 

presentations from the public will be 

scheduled between approximately 1:30 

p.m. Eastern Time and 2:30 p.m. Eastern 

Time. Those individuals interested in 

making formal oral presentations should 

notify the contact person and submit a 

brief statement of the general nature of 

the evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before February 18, 2021. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. The contact 

person will notify interested persons 

regarding their request to speak by 

February 19, 2021. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Kathleen 

Hayes, CBERVRBPAC@fda.hhs.gov, at 

least 7 days in advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/advisorycommittees/about-advisory-committees/ 

public-conduct-during-fda-advisorycommittee-meetings for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: February 8, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–03014 Filed 2–12–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–D–5364] 

Submission of Plans for Cigarette 

Packages and Cigarette 

Advertisements (Revised); Guidance 

for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a revised 

guidance for industry entitled 

‘‘Submission of Plans for Cigarette 

Packages and Cigarette Advertisements 

(Revised).’’ This is a revision to the 

second edition of this final guidance, 

which issued in May 2020, and is 

intended to assist those required to 

submit cigarette plans for cigarette 

packages and cigarette advertisements 

by providing content, timing, and other 

recommendations related to those 

submissions. FDA is revising this 

guidance to reflect the December 2, 

2020, court order that postponed the 

effective date of the final rule entitled 

‘‘Tobacco Products; Required Warnings 

for Cigarette Packages and 

Advertisements’’ to January 14, 2022. 

Pursuant to the court order, this revised 

guidance strongly encourages entities to 

submit cigarette plans to FDA as soon as 

possible after publication of the final 

rule, and in any event, by March 16, 

2021. 

DATES: The announcement of the 

revised guidance is published in the 

Federal Register on February 16, 2021. 

ADDRESSES: You may submit electronic 

or written comments on Agency 

guidances at any time 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– 

2019–D–5364 for ‘‘Submission of Plans 

for Cigarette Packages and Cigarette 

Advertisements (Revised).’’ 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 

office between 9 a.m. and 4 p.m., 

Monday through Friday, 240–402–7500. 

• 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 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices 9509 

1R.J. Reynolds Tobacco Co. et al. v. United States 

Food and Drug Administration et al., No. 6:20–cv– 

00176 (E.D. Tex. filed April 3, 2020). 

2R.J. Reynolds Tobacco Co. et al., No. 6:20–cv– 

00176 (E.D. Tex. May 8, 2020) (order granting joint 

motion and establishing schedule), Doc. No. 33. 

3R.J. Reynolds Tobacco Co. et al., No. 6:20–cv– 

00176 (E.D. Tex. May 8, 2020) (order granting 

Plaintiffs’ motion and postponing effective date), 

Doc. No. 80. 

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.govinfo.gov/content/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, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of this guidance to the Center for 

Tobacco Products, Food and Drug 

Administration, Document Control 

Center, 10903 New Hampshire Ave., 

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

20993–0002. Send one self-addressed 

adhesive label to assist that office in 

processing your request or include a Fax 

number to which the guidance may be 

sent. See the SUPPLEMENTARY

INFORMATION section for information on 

electronic access to the guidance. 

FOR FURTHER INFORMATION CONTACT: 

Lauren Belcher or Courtney Smith, 

Center for Tobacco Products, Food and 

Drug Administration, Document Control 

Center, 10903 New Hampshire Ave., 

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

20993–0002, 1–877–287–1373, email: 

AskCTPRegulations@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a revised guidance for industry entitled 

‘‘Submission of Plans for Cigarette 

Packages and Cigarette Advertisements 

(Revised).’’ The Family Smoking 

Prevention and Tobacco Control Act 

(Tobacco Control Act) (Pub. L. 111–31) 

was enacted on June 22, 2009, and 

granted FDA important new authority to 

regulate the manufacture, marketing, 

and distribution of tobacco products. 

The Tobacco Control Act also amended 

section 4 of the Federal Cigarette 

Labeling and Advertising Act (FCLAA) 

to direct FDA to issue regulations 

requiring each cigarette package and 

advertisement to bear a new textual 

warning label statement accompanied 

by color graphics depicting the negative 

health consequences of smoking 

(section 201 of the Tobacco Control 

Act). In enacting this legislation, 

Congress also provided that FDA may 

adjust the required warnings if FDA 

found that such a change would 

promote greater public understanding of 

the risks associated with the use of 

tobacco products (section 202 of the 

Tobacco Control Act). The Tobacco 

Control Act also modified the 

requirements of the FCLAA regarding 

the submission of cigarette plans for the 

random and equal display and 

distribution of required warnings on 

cigarette packages and quarterly rotation 

of required warnings in cigarette 

advertisements. It also requires that 

such cigarette plans be submitted to 

FDA for review and approval, rather 

than to the Federal Trade Commission. 

In the Federal Register of March 18, 

2020, FDA issued a final rule entitled 

‘‘Tobacco Products; Required Warnings 

for Cigarette Packages and 

Advertisements’’ (85 FR 15638). The 

rule specifies the color graphics that 

must accompany the new textual 

warning label statements and 

establishes marketing requirements for 

cigarette packages and advertisements. 

The marketing requirements include, 

among other things, submission of a 

cigarette plan that provides for the 

random and equal display and 

distribution of the required warnings on 

cigarette packages and quarterly rotation 

of the required warnings in cigarette 

advertisements, as described under 

section 4 of FCLAA. 

On April 3, 2020, the final rule was 

challenged in the U.S. District Court for 

the Eastern District of Texas.1 On May 

8, 2020, the Court granted a joint motion 

to govern proceedings in that case and 

postpone the effective date of the final 

rule by 120 days.2 On December 2, 2020, 

the same Court granted a new motion by 

Plaintiffs in the same case to postpone 

the effective date of the final rule by an 

additional 90 days.3 The new effective 

date of the final rule is January 14, 2022. 

Pursuant to the court order, any 

obligation to comply with a deadline 

tied to the effective date of the final rule 

is similarly postponed, and those 

obligations and deadlines are now tied 

to the postponed effective date. As such, 

this revised guidance strongly 

encourages entities to submit cigarette 

plans to FDA as soon as possible after 

publication of the final rule, and in any 

event, by March 16, 2021. 

FDA is issuing this guidance 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA regarding the 

submission of plans for cigarette 

packages and cigarette advertisements. 

It does not establish any rights for any 

person and is not binding on FDA or the 

public. You can use an alternative 

approach if it satisfies the requirements 

of the applicable statutes and 

regulations. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in 21 CFR 1141.10 have 

been approved under 0910–0877. 

III. Electronic Access 

Persons with access to the internet 

may obtain an electronic version of the 

guidance at either https://

www.regulations.gov or https://

www.fda.gov/tobacco-products/ 

products-guidance-regulations/rulesregulations-and-guidance. 

Dated: February 8, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–03020 Filed 2–12–21; 8:45 am] 

BILLING CODE 4164–01–P 


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