Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised); Guidance for Industry; Availability, 36560-36562 [2021-14674]

Download as PDF 36560 Federal Register / Vol. 86, No. 130 / Monday, July 12, 2021 / Notices written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). khammond on DSKJM1Z7X2PROD with NOTICES 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the Docket No. FDA– 2019–D–1997 for ‘‘FDA Oversight of Food Products Covered by Systems Recognition Arrangements; Draft Guidance for FDA Staff.’’ 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 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 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-201509-18/pdf/2015-23389.pdf. VerDate Sep<11>2014 17:26 Jul 09, 2021 Jkt 253001 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 a single hard copy of the draft guidance entitled ‘‘FDA Oversight of Food Products Covered by Systems Recognition Arrangements’’ to the Office of Strategic Planning and Operational Policy, Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr., Element Building, Rm. 4148, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance. II. Paperwork Reduction Act of 1995 FOR FURTHER INFORMATION CONTACT: [Docket No. FDA–2019–D–5364] Marla Hallacy, Office of Regulatory Affairs, Division of Operational Policy, Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857, 240–402–6674. Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised); Guidance for Industry; Availability SUPPLEMENTARY INFORMATION: AGENCY: I. Background HHS. FDA is announcing the availability of a draft guidance for FDA staff entitled ‘‘FDA Oversight of Food Products Covered by Systems Recognition Arrangements; Draft Guidance for FDA Staff.’’ The draft guidance is part of FDA’s larger effort to take a risk-based approach to food safety to include ensuring the safety of imported food, consistent with the FDA Food Safety Modernization Act. The guidance covers FDA’s regulatory oversight activities for food products covered by SRAs between FDA and its foreign regulatory counterparts. Currently, the FDA has signed SRAs with food safety agencies in Australia, Canada, and New Zealand. The draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on the topic of Systems Recognition Arrangement implementation. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternate approach if it satisfies the requirements of the applicable statutes and regulations. PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 FDA tentatively concludes that this draft guidance contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments or https:// www.regulations.gov. Dated: July 6, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–14789 Filed 7–9–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ACTION: Food and Drug Administration, Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised final guidance for industry entitled ‘‘Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised).’’ This is a revision to the third edition of this final guidance, which issued in February 2021, 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 May 21, 2021, court order that postponed the effective date of the final rule entitled ‘‘Tobacco Products; Required Warnings for Cigarette Packages and Advertisements’’ to July 13, 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 the recommended submission date, which is currently September 13, 2021. SUMMARY: E:\FR\FM\12JYN1.SGM 12JYN1 Federal Register / Vol. 86, No. 130 / Monday, July 12, 2021 / Notices The announcement of the revised final guidance is published in the Federal Register on July 12, 2021. ADDRESSES: You may submit electronic or written comments on Agency guidances at any time as follows: DATES: khammond on DSKJM1Z7X2PROD with NOTICES 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 VerDate Sep<11>2014 17:26 Jul 09, 2021 Jkt 253001 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.govinfo.gov/content/pkg/FR-201509-18/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: 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. PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 36561 SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a revised final 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 of 1965 (Pub. L. 89–92) (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 E:\FR\FM\12JYN1.SGM 12JYN1 36562 Federal Register / Vol. 86, No. 130 / Monday, July 12, 2021 / Notices 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 On March 2, 2021, 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.4 On May 21, 2021, 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.5 The new effective date of the final rule is July 13, 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 September 13, 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 khammond on DSKJM1Z7X2PROD with NOTICES 1 R.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). 2 R.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. 3 R.J. Reynolds Tobacco Co. et al., No. 6:20–cv– 00176 (E.D. Tex. December 2, 2020) (order granting Plaintiffs’ motion and postponing effective date), Doc. No. 80. 4 R.J. Reynolds Tobacco Co. et al., No. 6:20–cv– 00176 (E.D. Tex. March 2, 2021) (order granting Plaintiffs’ motion and postponing effective date), Doc. No. 89. 5 R.J. Reynolds Tobacco Co. et al., No. 6:20–cv– 00176 (E.D. Tex. May 21, 2021) (order granting Plaintiffs’ motion and postponing effective date), Doc. No. 91. VerDate Sep<11>2014 17:26 Jul 09, 2021 Jkt 253001 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 https:// www.regulations.gov, https:// www.fda.gov/tobacco-products/ products-guidance-regulations/rulesregulations-and-guidance, and https:// www.fda.gov/regulatory-information/ search-fda-guidance-documents. Dated: June 24, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–14674 Filed 7–9–21; 8:45 am] Silver Spring, MD 20993–0002, 240– 402–6980, Martha.Nguyen@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In the Federal Register of Monday, December 2, 2019, 84 FR 65986, appearing on page 65986 in FR Doc. 2019–25946, the following correction is made: On page 65986, in the table, the entries for ANDAs 076709 and 077062 are removed. Dated: July 6, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–14717 Filed 7–9–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–4590] Morton Grove Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 21 Abbreviated New Drug Applications; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of December 2, 2019. The document announced the withdrawal of approval of 21 abbreviated new drug applications (ANDAs) from multiple applicants, effective January 2, 2020. The document erroneously included ANDA 076709 for Fentanyl ExtendedRelease Film, 25 micrograms (mcg)/hour (hr), 50 mcg/hr, 75 mcg/hr, 100 mcg/hr, held by Actavis Laboratories UT, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 577 Chipeta Way, Salt Lake City, UT 84108, and ANDA 077062 for Fentanyl Extended-Release Film, 25 mcg/hr, 50 mcg/hr, 75 mcg/hr, and 100 mcg/hr, held by Mayne Pharma LLC, 1240 Sugg Parkway, Greenville, NC 27834. This correction is being made because FDA previously withdrew the approval of ANDAs 076709 and 077062 in the Federal Register of November 18, 2019. This notice corrects that error. FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1676, SUMMARY: PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 Meeting of the COVID–19 Health Equity Task Force Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. ACTION: Notice of meeting. AGENCY: As required by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS) is hereby giving notice that the COVID–19 Health Equity Task Force (Task Force) will hold a virtual meeting on July 30, 2021. The purpose of this meeting is to consider interim recommendations addressing future pandemic preparedness, mitigation, and resilience needed to ensure equitable response and recovery in communities of color and other underserved populations. This meeting is open to the public and will be live-streamed at www.hhs.gov/live. Information about the meeting will be posted on the HHS Office of Minority Health website: www.minorityhealth.hhs.gov/ healthequitytaskforce/ prior to the meeting. SUMMARY: The Task Force meeting will be held on Friday, July 30, 2021, from 2 p.m. to approximately 6 p.m. ET (date and time are tentative and subject to change). The confirmed time and agenda will be posted on the COVID–19 Health Equity Task Force web page: www.minorityhealth.hhs.gov/ healthequitytaskforce/ when this information becomes available. FOR FURTHER INFORMATION CONTACT: Samuel Wu, Designated Federal Officer for the Task Force; Office of Minority Health, Department of Health and Human Services, Tower Building, 1101 Wootton Parkway, Suite 100, Rockville, DATES: E:\FR\FM\12JYN1.SGM 12JYN1

Agencies

[Federal Register Volume 86, Number 130 (Monday, July 12, 2021)]
[Notices]
[Pages 36560-36562]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14674]


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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 final guidance for industry entitled 
``Submission of Plans for Cigarette Packages and Cigarette 
Advertisements (Revised).'' This is a revision to the third edition of 
this final guidance, which issued in February 2021, 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 May 21, 2021, court order that postponed the 
effective date of the final rule entitled ``Tobacco Products; Required 
Warnings for Cigarette Packages and Advertisements'' to July 13, 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 the recommended 
submission date, which is currently September 13, 2021.

[[Page 36561]]


DATES: The announcement of the revised final guidance is published in 
the Federal Register on July 12, 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 
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: 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: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised final 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 of 1965 (Pub. L. 89-92) (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

[[Page 36562]]

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\ On March 2, 2021, 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.\4\ On May 21, 2021, 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.\5\ The new 
effective date of the final rule is July 13, 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 September 13, 2021.
---------------------------------------------------------------------------

    \1\ R.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).
    \2\ R.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.
    \3\ R.J. Reynolds Tobacco Co. et al., No. 6:20-cv-00176 (E.D. 
Tex. December 2, 2020) (order granting Plaintiffs' motion and 
postponing effective date), Doc. No. 80.
    \4\ R.J. Reynolds Tobacco Co. et al., No. 6:20-cv-00176 (E.D. 
Tex. March 2, 2021) (order granting Plaintiffs' motion and 
postponing effective date), Doc. No. 89.
    \5\ R.J. Reynolds Tobacco Co. et al., No. 6:20-cv-00176 (E.D. 
Tex. May 21, 2021) (order granting Plaintiffs' motion and postponing 
effective date), Doc. No. 91.
---------------------------------------------------------------------------

    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 https://www.regulations.gov, https://www.fda.gov/tobacco-products/products-guidance-regulations/rules-regulations-and-guidance, and https://www.fda.gov/regulatory-information/search-fda-guidance-documents.

    Dated: June 24, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-14674 Filed 7-9-21; 8:45 am]
BILLING CODE 4164-01-P

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