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’’). 

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-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 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. 

FOR FURTHER INFORMATION CONTACT: 

Marla Hallacy, Office of Regulatory 

Affairs, Division of Operational Policy, 

Food and Drug Administration, 12420 

Parklawn Dr., Rockville, MD 20857, 

240–402–6674. 

SUPPLEMENTARY INFORMATION: 

I. Background 

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. 

II. Paperwork Reduction Act of 1995 

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 

[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. 


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

AskCTPRegulations@fda.hhs.gov. 

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 


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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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