36562 Federal Register / Vol. 86, No. 130 / Monday, July 12, 2021 / Notices 

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. December 2, 2020) (order granting 

Plaintiffs’ motion and postponing effective date), 

Doc. No. 80. 

4R.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. 

5R.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. 

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 

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] 

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. 

SUMMARY: 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, 

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 

Meeting of the COVID–19 Health Equity 

Task Force 

AGENCY: Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services. 

ACTION: Notice of meeting. 

SUMMARY: 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. 

DATES: 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, 


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Federal Register / Vol. 86, No. 130 / Monday, July 12, 2021 / Notices 36563 

Maryland 20852. Phone: 240–453–6173; 

email: COVID19HETF@hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Background: The COVID–19 Health 

Equity Task Force (Task Force) was 

established by Executive Order 13995, 

dated January 21, 2021. The Task Force 

is tasked with providing specific 

recommendations to the President, 

through the Coordinator of the COVID– 

19 Response and Counselor to the 

President (COVID–19 Response 

Coordinator), for mitigating the health 

inequities caused or exacerbated by the 

COVID–19 pandemic and for preventing 

such inequities in the future. The Task 

Force shall submit a final report to the 

COVID–19 Response Coordinator 

addressing any ongoing health 

inequities faced by COVID–19 survivors 

that may merit a public health response, 

describing the factors that contributed to 

disparities in COVID–19 outcomes, and 

recommending actions to combat such 

disparities in future pandemic 

responses. 

The meeting is open to the public and 

will be live-streamed at www.hhs.gov/ 

live. No registration is required. A 

public comment session will be held 

during the meeting. Pre-registration is 

required to provide public comment 

during the meeting. To pre-register, 

please send an email to 

COVID19HETF@hhs.gov and include 

your name, title, and organization by 

close of business on Friday, July 23, 

2021. Comments will be limited to no 

more than three minutes per speaker 

and should be pertinent to the meeting 

discussion. Individuals are encouraged 

to provide a written statement of any 

public comment(s) for accurate minutetaking purposes. If you decide you 

would like to provide public comment 

but do not pre-register, you may submit 

your written statement by emailing 

COVID19HETF@hhs.gov no later than 

close of business on Thursday, August 

5, 2021. Individuals who plan to attend 

and need special assistance, such as 

sign language interpretation or other 

reasonable accommodations, should 

contact: COVID19HETF@hhs.gov and 

reference this meeting. Requests for 

special accommodations should be 

made at least 10 business days prior to 

the meeting. 

Dated: July 6, 2021. 

Samuel Wu, 

Designated Federal Officer, COVID–19 Health 

Equity Task Force. 

[FR Doc. 2021–14703 Filed 7–9–21; 8:45 am] 

BILLING CODE 4150–29–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of an Exclusive 

Patent License: Oligonucleotides 

Analogues Targeting Human LMNA 

‘‘lamin A’’ Gene 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The National Human Genome 

Research Institute (NHGRI), an institute 

of the National Institutes of Health, 

Department of Health and Human 

Services, is contemplating the grant of 

an Exclusive, Sublicensable Patent 

License to consolidate co-owned rights 

to the inventions and the Patents and 

Patent Applications listed in the 

Supplementary Information section of 

this notice to The Progeria Research 

Foundation (‘‘PRF’’), having a place of 

business in 200 Lake Street, Unit 102, 

Peabody, MA 01960. 

DATES: Only written comments and/or 

applications for a license that are 

received by the NHGRI Office of 

Technology Transfer Office on or before 

July 27, 2021 will be considered. 

ADDRESSES: Requests for a copy of the 

patent application(s), inquiries, and 

comments relating to the contemplated 

license should be directed to: Eggerton 

Campbell, License and Patent Manager, 

NHGRI Technology Transfer Office, 

Telephone: 301–402–1648; email: 

eggerton.campbell@nih.gov. 

SUPPLEMENTARY INFORMATION: The 

following and all continuing U.S. and 

foreign patents/patent applications 

thereof are the intellectual properties to 

be licensed under the prospective 

agreement: 

Country Title Application No. Patent No. 

United States ......... Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human 

LMNA NIH E–044–2013–0–US–01.

61/568,590.

WIPO ..................... Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human 

LMNA NIH E–044–2013–0–PCT–03.

PCT/US12/068609 

WO 2013/086444.

United Kingdom ..... Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human 

LMNA NIH E–044–2013–0–GB–12.

12806796.4 .......... 2788488 

United States ......... Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human 

LMNA NIH E–044–2013–0–US–02.

13/708,709 ........... 9,326,992 

United States ......... Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human 

LMNA NIH E–044–2013–0–US–06.

15/084,255 ........... 9,833,468 

United States ......... Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human 

LMNA NIH E–044–2013–0–US–07.

15/727,483 CON .. 10,398,721 

Europe ................... Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human 

LMNA NIH E–044–2013–0–EP–04.

12806796.4 .......... 2788488 

Japan ..................... Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human 

LMNA NIH E–044–2013–0–JP–15.

2019–109410.

France .................... Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human 

LMNA NIH E–044–2013–0–FR–11.

12806796.4 .......... 2788488 

Germany ................ Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human 

LMNA NIH E–044–2013–0–DE–10.

12806796.4 .......... 2788488 

Ireland .................... Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human 

LMNA NIH E–044–2013–0–IE–13.

12806796.4 .......... 2788488 

Japan ..................... Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human 

LMNA NIH E–044–2013–0–JP–05.

2014–546152 ....... 6132849 

Japan ..................... Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human 

LMNA NIH E–044–2013–0–JP–08.

2017–41744.

Netherlands ............ Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human 

LMNA NIH E–044–2013–0–NL–14.

12806796.4 .......... 2788488 

Switzerland ............ Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human 

LMNA NIH E–044–2013–0–CH–09.

12806796.4 .......... 2788488 

United States ......... Oligonucleotide Analogues Targeting Human LMNA NIH E–044–2013–1–US–01 ...................................... 62/330,027.

WIPO ..................... Oligonucleotide Analogues Targeting Human LMNA NIH E–044–2013–1–PCT–02 .................................... PCT/US17/30174

WO 2017/190041.


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