Federal Register / Vol. 85, No. 244 / Friday, December 18, 2020 / Proposed Rules 82393 

consumer perception studies, or 

consumer complaints, that demonstrates 

the extent of such practices. Provide any 

evidence that demonstrates whether 

such practices cause consumer injury, 

and quantify or estimate that injury if 

possible. 

(10) Technological or Economic 

Changes: What modifications, if any, 

should be made to the Rule to account 

for current or impending changes in 

technology or economic conditions? 

How would these modifications affect 

the costs and benefits of the Rule for 

consumers and businesses, particularly 

small businesses? 

(11) Conflicts With Other 

Requirements: Does the Rule overlap or 

conflict with other federal, state, or local 

laws or regulations? If so, how? Provide 

any evidence that supports your 

position. With reference to the asserted 

conflicts, should the Rule be modified? 

If so, why, and how? If not, why not? 

Are there any Rule changes necessary to 

help state law enforcement agencies 

combat deceptive practices in the 

market for amplifiers utilized in home 

entertainment products? Provide any 

evidence concerning whether the Rule 

has assisted in promoting national 

consistency with respect to the 

advertising of amplifiers utilized in 

home entertainment products. 

IV. Comment Submissions 

You can file a comment online or on 

paper. For the Commission to consider 

your comment, we must receive it on or 

before February 16, 2021. Include 

‘‘Amplifier Rule Review, 16 CFR part 

432, Project No. P974222’’ on your 

comment. Your comment, including 

your name and your state, will be 

placed on the public record of this 

proceeding, including, to the extent 

practicable, on the https://

www.regulations.gov website. 

Because of the public health 

emergency in response to the COVID–19 

outbreak and the agency’s heightened 

security screening, postal mail 

addressed to the Commission will be 

subject to delay. We strongly encourage 

you to submit your comment online 

through the https://www.regulations.gov 

website. To ensure the Commission 

considers your online comment, please 

follow the instructions on the webbased form. 

If you file your comment on paper, 

write ‘‘Amplifier Rule Review, 16 CFR 

part 432, Project No. P974222’’ on your 

comment and on the envelope, and mail 

your comment to the following address: 

Federal Trade Commission, Office of the 

Secretary, 600 Pennsylvania Avenue 

NW, Suite CC–5610 (Annex A), 

Washington, DC 20580, or deliver your 

comment to the following address: 

Federal Trade Commission, Office of the 

Secretary, Constitution Center, 400 7th 

Street SW, 5th Floor, Suite 5610, 

Washington, DC 20024. If possible, 

please submit your paper comment to 

the Commission by courier or overnight 

service. 

Because your comment will be placed 

on the publicly accessible website, 

https://www.regulations.gov, you are 

solely responsible for making sure that 

your comment does not include any 

sensitive or confidential information. In 

particular, your comment should not 

include any sensitive personal 

information such as your or anyone’s 

Social Security number, date of birth, 

driver’s license number or other state 

identification number or foreign country 

equivalent, passport number, financial 

account number, or credit or debit card 

number. You are also solely responsible 

for making sure that your comment does 

not include any sensitive health 

information, such as medical records or 

other individually identifiable health 

information. In addition, your comment 

should not include any ‘‘[t]rade secret or 

any commercial or financial information 

which . . . is privileged or 

confidential’’—as provided in section 

6(f) of the FTC Act, 15 U.S.C. 46(f), and 

FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)— 

including in particular competitively 

sensitive information such as costs, 

sales statistics, inventories, formulas, 

patterns, devices, manufacturing 

processes, or customer names. 

Comments containing material for 

which confidential treatment is 

requested must be filed in paper form, 

must be clearly labeled ‘‘Confidential,’’ 

and must comply with FTC Rule 4.9(c). 

In particular, the written request for 

confidential treatment that accompanies 

the comment must include the factual 

and legal basis for the request, and must 

identify the specific portions of the 

comment to be withheld from the public 

record. See FTC Rule 4.9(c). Your 

comment will be kept confidential only 

if the General Counsel grants your 

request in accordance with the law and 

the public interest. Once your comment 

has been posted publicly at 

www.regulations.gov—as legally 

required by FTC Rule 4.9(b)—we cannot 

redact or remove your comment, unless 

you submit a confidentiality request that 

meets the requirements for such 

treatment under FTC Rule 4.9(c), and 

the General Counsel grants that request. 

Visit the FTC website to read this 

request for comment and the news 

release describing it. The FTC Act and 

other laws that the Commission 

administers permit the collection of 

public comments to consider and use in 

this proceeding as appropriate. The 

Commission will consider all timely 

and responsive public comments that it 

receives on or before February 16, 2021. 

For information on the Commission’s 

privacy policy, including routine uses 

permitted by the Privacy Act, see 

https://www.ftc.gov/site-information/ 

privacy-policy. 

By direction of the Commission. 

April J. Tabor, 

Acting Secretary. 

[FR Doc. 2020–27569 Filed 12–17–20; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 1 

[Docket No. FDA–2014–N–0053] 

RIN 0910–AI44 

Requirements for Additional 

Traceability Records for Certain 

Foods; Extension of Comment Period; 

Reopening of the Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule; extension of 

comment period; reopening of the 

comment period. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is extending the comment period for 

the proposed rule and reopening the 

comment period for the information 

collection related to the proposed rule 

entitled ‘‘Requirements for Additional 

Traceability Records for Certain Foods’’ 

that appeared in the Federal Register of 

September 23, 2020. We are taking this 

action in response to a request from 

stakeholders to extend the comment 

period to allow additional time for 

interested persons to submit comments 

on the proposed rule. We also are taking 

this action to keep the comment period 

for the information collection provisions 

associated with the rule consistent with 

the comment period for the proposed 

rule. 

DATES: FDA is extending the comment 

period on the proposed rule published 

September 23, 2020 (85 FR 59984). 

Submit either electronic or written 

comments on the proposed rule by 

February 22, 2021. Submit comments on 

information collection issues under the 

Paperwork Reduction Act of 1995 (PRA) 

by February 22, 2021. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 


khammond on DSKJM1Z7X2PROD with PROPOSALS
82394 Federal Register / Vol. 85, No. 244 / Friday, December 18, 2020 / Proposed Rules 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before February 22, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of February 22, 2021. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

To ensure that comments on the 

information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0560. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

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– 

2014–N–0053 for ‘‘Requirements for 

Additional Traceability Records for 

Certain Foods.’’ Received comments, 

those filed in a timely manner (see 

ADDRESSES), 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. 

FOR FURTHER INFORMATION CONTACT: 

Regarding the proposed rule: Brian 

Pendleton, Office of Policy, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002, 301–796–4614, 

Brian.Pendleton@fda.hhs.gov. 

Regarding the information collection: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of September 23, 2020 

(85 FR 59984), we published a proposed 

rule entitled ‘‘Requirements for 

Additional Traceability Records for 

Certain Foods’’ with a 120-day comment 

period on the provisions of the 

proposed rule and a 60-day comment 

period on the information collection 

provisions that are subject to review by 

the Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act (44 U.S.C. 3501–3521). 

FDA has received a request for a 60- 

day extension of the comment period for 

the provisions of the proposed rule and 

an extension of the comment period for 

the information collection provisions to 

align with the end of the comment 

period for the provisions of the 

proposed rule. The request conveyed 

concern that the current 120-day 

comment period does not allow 

stakeholders time to thoroughly analyze 

the rule due to its complexity and 

competing priorities. The request also 

noted that stakeholders cannot provide 

meaningful feedback on the information 

collection burden of the proposed rule 

without first having given the entire 

proposed rule thorough consideration, 

and therefore asked that the comment 

period for the information collection 

provisions be extended to align with the 

comment period for the provisions of 

the proposed rule. We have concluded 

that it is reasonable to extend for 30 

days the comment period for the 

provisions of the proposed rule. The 

Agency believes that this extension 

allows adequate time for any interested 

persons to submit comments on the 

proposed rule. We also are extending 

the comment period for the information 

collection provisions to February 22, 

2021, to align the comment period for 

the information collection provisions 

with the comment period for the 

provisions of the proposed rule. 


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Federal Register / Vol. 85, No. 244 / Friday, December 18, 2020 / Proposed Rules 82395 

Dated: December 2, 2020. 

Stephen M. Hahn, 

Commissioner of Food and Drugs. 

Dated: December 11, 2020. 

Alex M. Azar II, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2020–27829 Filed 12–17–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 152 

[Docket No. FDA–2020–N–1690] 

RIN 0910–AI17 

Frozen Cherry Pie; Proposed 

Revocation of a Standard of Identity 

and a Standard of Quality 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA or we) proposes to 

revoke the standard of identity and the 

standard of quality for frozen cherry pie. 

This action, in part, responds to a 

citizen petition submitted by the 

American Bakers Association (ABA). 

We tentatively conclude that these 

standards are no longer necessary to 

promote honesty and fair dealing in the 

interest of consumers. We also 

tentatively conclude that revoking the 

standards of identity and quality for 

frozen cherry pie would provide greater 

flexibility in the product’s manufacture, 

consistent with comparable, 

nonstandardized foods available in the 

marketplace. 

DATES: Submit either electronic or 

written comments on the proposed rule 

by March 18, 2021. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before March 18, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of March 18, 2021. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

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– 

2020–N–1690 for ‘‘Frozen Cherry Pie; 

Proposed Revocation of a Standard of 

Identity and a Standard of Quality.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), 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.’’ We 

will review this copy, including the 

claimed confidential information, in our 

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. 

FOR FURTHER INFORMATION CONTACT: 

Andrea Krause, Center for Food Safety 

and Applied Nutrition (HFS–820), Food 

and Drug Administration, 5001 Campus 

Dr., College Park, MD 20740, 240–402– 

3719. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Executive Summary 

A. Purpose of the Proposed Rule 

B. Summary of the Major Provisions of the 

Proposed Rule 

C. Legal Authority 

D. Costs and Benefits 

II. Background 

III. ABA Citizen Petition and Grounds 

IV. Description of the Proposed Rule 

V. Preliminary Economic Analysis of Impacts 

VI. Analysis of Environmental Impact 

VII. Paperwork Reduction Act of 1995 

VIII. Consultation and Coordination With 

Indian Tribal Governments 

IX. Federalism 

X. Reference 

I. Executive Summary 

A. Purpose of the Proposed Rule 

This proposed rule, if finalized, 

would revoke the standards of identity 

and quality for frozen cherry pie. This 

action, in part, responds to a citizen 

petition submitted by the American 


khammond on DSKJM1Z7X2PROD with PROPOSALS