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

than 2 business days before the meeting. committee-meetings for procedures on instructions for submitting comments. If FDA is unable to post the background public conduct during advisory Comments submitted electronically, material on its website prior to the committee meetings. including attachments, to https:// meeting, the background material will Notice of this meeting is given under www.regulations.gov will be posted to be made publicly available at the the Federal Advisory Committee Act (5 the docket unchanged. Because your location of the advisory committee U.S.C. app. 2). comment will be made public, you are meeting, and the background material Dated: February 8, 2021. solely responsible for ensuring that your will be posted on FDA’s website after comment does not include any Lauren K. Roth, the meeting. Background material is confidential information that you or a available at https://www.fda.gov/ Acting Principal Associate Commissioner for third party may not wish to be posted, Policy. advisory-committees/advisory- such as medical information, your or committee-calendar. Scroll down to the [FR Doc. 2021–03014 Filed 2–12–21; 8:45 am] anyone else’s Social Security number, or appropriate advisory committee meeting BILLING CODE 4164–01–P confidential business information, such link. The meeting will include slide as a manufacturing process. Please note presentations with audio components to that if you include your name, contact DEPARTMENT OF HEALTH AND allow the presentation of materials in a information, or other information that HUMAN SERVICES manner that most closely resembles an identifies you in the body of your in-person advisory committee meeting. Food and Drug Administration comments, that information will be Procedure: Interested persons may posted on https://www.regulations.gov. present data, information, or views, [Docket No. FDA–2019–D–5364] • If you want to submit a comment orally or in writing, on issues pending with confidential information that you before the committee. Written Submission of Plans for Cigarette do not wish to be made available to the submissions made to the Docket (see Packages and Cigarette public, submit the comment as a ADDRESSES) on or before February 24, Advertisements (Revised); Guidance written/paper submission and in the 2021, will be provided to the committee. for Industry; Availability manner detailed (see ‘‘Written/Paper Comments received after February 24, AGENCY: Food and Drug Administration, Submissions’’ and ‘‘Instructions’’). 2021, and by March 4, 2021, will be HHS. Written/Paper Submissions taken into consideration by FDA. Oral ACTION: Notice of availability. presentations from the public will be Submit written/paper submissions as scheduled between approximately 1:30 follows: SUMMARY: The Food and Drug • p.m. Eastern Time and 2:30 p.m. Eastern Administration (FDA or Agency) is Mail/Hand Delivery/Courier (for Time. Those individuals interested in announcing the availability of a revised written/paper submissions): Dockets making formal oral presentations should guidance for industry entitled Management Staff (HFA–305), Food and notify the contact person and submit a ‘‘Submission of Plans for Cigarette Drug Administration, 5630 Fishers brief statement of the general nature of Packages and Cigarette Advertisements Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments the evidence or arguments they wish to (Revised).’’ This is a revision to the submitted to the Dockets Management present, the names and addresses of second edition of this final guidance, Staff, FDA will post your comment, as proposed participants, and an which issued in May 2020, and is well as any attachments, except for indication of the approximate time intended to assist those required to information submitted, marked and requested to make their presentation on submit cigarette plans for cigarette identified, as confidential, if submitted or before February 18, 2021. Time packages and cigarette advertisements as detailed in ‘‘Instructions.’’ allotted for each presentation may be by providing content, timing, and other limited. If the number of registrants Instructions: All submissions received recommendations related to those must include the Docket No. FDA– requesting to speak is greater than can submissions. FDA is revising this be reasonably accommodated during the 2019–D–5364 for ‘‘Submission of Plans guidance to reflect the December 2, for Cigarette Packages and Cigarette scheduled open public hearing session, 2020, court order that postponed the FDA may conduct a lottery to determine Advertisements (Revised).’’ Received effective date of the final rule entitled comments will be placed in the docket the speakers for the scheduled open ‘‘Tobacco Products; Required Warnings public hearing session. The contact and, except for those submitted as for Cigarette Packages and ‘‘Confidential Submissions,’’ publicly person will notify interested persons Advertisements’’ to January 14, 2022. regarding their request to speak by viewable at https://www.regulations.gov Pursuant to the court order, this revised or at the Dockets Management Staff February 19, 2021. guidance strongly encourages entities to For press inquiries, please contact the office between 9 a.m. and 4 p.m., submit cigarette plans to FDA as soon as Office of Media Affairs at fdaoma@ Monday through Friday, 240–402–7500. possible after publication of the final fda.hhs.gov or 301–796–4540. • Confidential Submissions—To FDA welcomes the attendance of the rule, and in any event, by March 16, submit a comment with confidential public at its advisory committee 2021. information that you do not wish to be meetings and will make every effort to DATES: The announcement of the made publicly available, submit your accommodate persons with disabilities. revised guidance is published in the comments only as a written/paper If you require accommodations due to a Federal Register on February 16, 2021. submission. You should submit two disability, please contact Kathleen ADDRESSES: You may submit electronic copies total. One copy will include the Hayes, [email protected], at or written comments on Agency information you claim to be confidential least 7 days in advance of the meeting. guidances at any time as follows: with a heading or cover note that states FDA is committed to the orderly ‘‘THIS DOCUMENT CONTAINS conduct of its advisory committee Electronic Submissions CONFIDENTIAL INFORMATION.’’ The meetings. Please visit our website at Submit electronic comments in the Agency will review this copy, including https://www.fda.gov/advisory- following way: the claimed confidential information, in committees/about-advisory-committees/ • Federal eRulemaking Portal: its consideration of comments. The public-conduct-during-fda-advisory- https://www.regulations.gov. Follow the second copy, which will have the

VerDate Sep<11>2014 17:04 Feb 12, 2021 Jkt 253001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\16FEN1.SGM 16FEN1 khammond on DSKJM1Z7X2PROD with NOTICES Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices 9509

claimed confidential information (Tobacco Control Act) (Pub. L. 111–31) the same Court granted a new motion by redacted/blacked out, will be available was enacted on June 22, 2009, and Plaintiffs in the same case to postpone for public viewing and posted on granted FDA important new authority to the effective date of the final rule by an https://www.regulations.gov. Submit regulate the manufacture, marketing, additional 90 days.3 The new effective both copies to the Dockets Management and distribution of tobacco products. date of the final rule is January 14, 2022. Staff. If you do not wish your name and The Tobacco Control Act also amended Pursuant to the court order, any contact information to be made publicly section 4 of the Federal Cigarette obligation to comply with a deadline available, you can provide this Labeling and Advertising Act (FCLAA) tied to the effective date of the final rule information on the cover sheet and not to direct FDA to issue regulations is similarly postponed, and those in the body of your comments and you requiring each cigarette package and obligations and deadlines are now tied must identify this information as advertisement to bear a new textual to the postponed effective date. As such, ‘‘confidential.’’ Any information marked warning label statement accompanied this revised guidance strongly as ‘‘confidential’’ will not be disclosed by color graphics depicting the negative encourages entities to submit cigarette except in accordance with 21 CFR 10.20 health consequences of smoking plans to FDA as soon as possible after and other applicable disclosure law. For (section 201 of the Tobacco Control publication of the final rule, and in any more information about FDA’s posting Act). In enacting this legislation, event, by March 16, 2021. Congress also provided that FDA may of comments to public dockets, see 80 FDA is issuing this guidance adjust the required warnings if FDA FR 56469, September 18, 2015, or access consistent with FDA’s good guidance found that such a change would the information at: https:// practices regulation (21 CFR 10.115). www.govinfo.gov/content/pkg/FR-2015- promote greater public understanding of the risks associated with the use of The guidance represents the current 09-18/pdf/2015-23389.pdf. thinking of FDA regarding the Docket: For access to the docket to tobacco products (section 202 of the Tobacco Control Act). The Tobacco submission of plans for cigarette read background documents or the packages and cigarette advertisements. electronic and written/paper comments Control Act also modified the requirements of the FCLAA regarding It does not establish any rights for any received, go to https:// person and is not binding on FDA or the www.regulations.gov and insert the the submission of cigarette plans for the random and equal display and public. You can use an alternative docket number, found in brackets in the approach if it satisfies the requirements heading of this document, into the distribution of required warnings on cigarette packages and quarterly rotation of the applicable statutes and ‘‘Search’’ box and follow the prompts regulations. and/or go to the Dockets Management of required warnings in cigarette Staff, 5630 Fishers Lane, Rm. 1061, advertisements. It also requires that II. Paperwork Reduction Act of 1995 Rockville, MD 20852, 240–402–7500. such cigarette plans be submitted to You may submit comments on any FDA for review and approval, rather While this guidance contains no guidance at any time (see 21 CFR than to the Federal Trade Commission. collection of information, it does refer to 10.115(g)(5)). In the Federal Register of March 18, previously approved FDA collections of Submit written requests for single 2020, FDA issued a final rule entitled information. Therefore, clearance by the copies of this guidance to the Center for ‘‘Tobacco Products; Required Warnings Office of Management and Budget Tobacco Products, Food and Drug for Cigarette Packages and (OMB) under the Paperwork Reduction Administration, Document Control Advertisements’’ (85 FR 15638). The Act of 1995 (PRA) (44 U.S.C. 3501– Center, 10903 New Hampshire Ave., rule specifies the color graphics that 3521) is not required for this guidance. Bldg. 71, Rm. G335, Silver Spring, MD must accompany the new textual The previously approved collections of 20993–0002. Send one self-addressed warning label statements and information are subject to review by establishes marketing requirements for adhesive label to assist that office in OMB under the PRA. The collections of cigarette packages and advertisements. processing your request or include a Fax information in 21 CFR 1141.10 have The marketing requirements include, number to which the guidance may be been approved under 0910–0877. among other things, submission of a sent. See the SUPPLEMENTARY cigarette plan that provides for the III. Electronic Access INFORMATION section for information on random and equal display and electronic access to the guidance. Persons with access to the internet distribution of the required warnings on may obtain an electronic version of the FOR FURTHER INFORMATION CONTACT: cigarette packages and quarterly rotation guidance at either https:// Lauren Belcher or Courtney Smith, of the required warnings in cigarette www.regulations.gov or https:// Center for Tobacco Products, Food and advertisements, as described under www.fda.gov/tobacco-products/ Drug Administration, Document Control section 4 of FCLAA. Center, 10903 New Hampshire Ave., On April 3, 2020, the final rule was products-guidance-regulations/rules- Bldg. 71, Rm. G335, Silver Spring, MD challenged in the U.S. District Court for regulations-and-guidance. 20993–0002, 1–877–287–1373, email: the Eastern District of Texas.1 On May Dated: February 8, 2021. [email protected]. 8, 2020, the Court granted a joint motion Lauren K. Roth, SUPPLEMENTARY INFORMATION: to govern proceedings in that case and Acting Principal Associate Commissioner for postpone the effective date of the final Policy. I. Background 2 rule by 120 days. On December 2, 2020, [FR Doc. 2021–03020 Filed 2–12–21; 8:45 am] FDA is announcing the availability of BILLING CODE 4164–01–P a revised guidance for industry entitled 1 R.J. Reynolds Tobacco Co. et al. v. United States ‘‘Submission of Plans for Cigarette Food and Drug Administration et al., No. 6:20–cv– 00176 (E.D. Tex. filed April 3, 2020). 3 R.J. Reynolds Tobacco Co. et al., No. 6:20–cv– Packages and Cigarette Advertisements 2 R.J. Reynolds Tobacco Co. et al., No. 6:20–cv– 00176 (E.D. Tex. May 8, 2020) (order granting (Revised).’’ The Family Smoking 00176 (E.D. Tex. May 8, 2020) (order granting joint Plaintiffs’ motion and postponing effective date), Prevention and Tobacco Control Act motion and establishing schedule), Doc. No. 33. Doc. No. 80.

VerDate Sep<11>2014 17:04 Feb 12, 2021 Jkt 253001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\16FEN1.SGM 16FEN1 khammond on DSKJM1Z7X2PROD with NOTICES