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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 FDAs 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
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1 R.J.

Reynolds Tobacco Co. et al. v. United States Food and Drug Administration et al., No. 6:20cv 00176 E.D. Tex. filed April 3, 2020.
2 R.J. Reynolds Tobacco Co. et al., No. 6:20cv 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. 6:20cv 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. 6:20cv 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. 6:20cv 00176 E.D. Tex. May 21, 2021 order granting Plaintiffs motion and postponing effective date, Doc. No. 91.

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information are subject to review by OMB under the PRA. The collections of information in 21 CFR 1141.10 have been approved under 09100877.
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. 202114674 Filed 7921; 8:45 am
Silver Spring, MD 209930002, 240
4026980, 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. 201925946, 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. 202114717 Filed 7921; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2019N4590

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:

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Meeting of the COVID19 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 COVID19 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 COVID19
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:

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