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/advisory- committee-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/advisory- committees/about-advisory-committees/ public-conduct-during-fda-advisory- committee-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 
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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.
1On 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.
2On 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.
3The 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/rules- regulations-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] 
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