Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Proposed Rules 82977 

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Incorporation by reference, 

Safety. 

The Proposed Amendment 

Accordingly, under the authority 

delegated to me by the Administrator, 

the FAA proposes to amend 14 CFR part 

39 as follows: 

PART 39—AIRWORTHINESS 

DIRECTIVES 

■ 1. The authority citation for part 39 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40113, 44701. 

§ 39.13 [Amended] 

■ 2. The FAA amends § 39.13 by adding 

the following new airworthiness 

directive: 

MHI RJ Aviation ULC (Type Certificate 

Previously Held by Bombardier, Inc.): 

Docket No. FAA–2020–1137; Project 

Identifier MCAI–2020–00816–T. 

(a) Comments Due Date 

The FAA must receive comments by 

February 4, 2021. 

(b) Affected Airworthiness Directives (ADs) 

None. 

(c) Applicability 

This AD applies to MHI RJ Aviation ULC 

airplanes identified in paragraphs (c)(1) and 

(2) of this AD, certificated in any category. 

(1) Model CL–600–2C10 (Regional Jet 

Series 700, 701 & 702) and Model CL–600– 

2C11 (Regional Jet Series 550) airplanes 

having serial numbers (S/Ns) 10082, 10135, 

10141, 10155, 10166, 10173, 10178, 10186, 

10249, 10296, and 10327. 

(2) Model CL–600–2D24 (Regional Jet 

Series 900) airplanes having S/Ns 15099, 

15102, 15144, 15159, 15201, 15212, 15279, 

15396, 15409 through 15413 inclusive, 

15415, 15419 through 15427 inclusive, 

15430, 15449, and 15453. 

(d) Subject 

Air Transport Association (ATA) of 

America Code 30, Ice and Rain Protection. 

(e) Reason 

This AD was prompted by a report that 

some piccolo ducts for the wing anti-ice 

system have bleed holes that do not conform 

to requirements (such as being undersized, 

un-burred, or in the wrong location). The 

FAA is issuing this AD to address nonconforming piccolo duct bleed holes, which 

could lead to degradation of the wing antiice protection of the leading edge of certain 

slats, and possibly result in airplane handling 

issues during critical phases of flight. 

(f) Compliance 

Comply with this AD within the 

compliance times specified, unless already 

done. 

(g) Inspection and Corrective Action 

Within 8,800 flight hours after the effective 

date of this AD, inspect for the presence of 

affected piccolo duct assemblies, as 

applicable, and replace each affected piccolo 

duct with a new piccolo duct, as applicable, 

in accordance with the Accomplishment 

Instructions of Bombardier Service Bulletin 

670BA–30–025, dated December 17, 2019. 

(h) Other FAA AD Provisions 

The following provisions also apply to this 

AD: 

(1) Alternative Methods of Compliance 

(AMOCs): The Manager, New York ACO 

Branch, FAA, has the authority to approve 

AMOCs for this AD, if requested using the 

procedures found in 14 CFR 39.19. In 

accordance with 14 CFR 39.19, send your 

request to your principal inspector or 

responsible Flight Standards Office, as 

appropriate. If sending information directly 

to the manager of the certification office, 

send it to ATTN: Program Manager, 

Continuing Operational Safety, FAA, New 

York ACO Branch, 1600 Stewart Avenue, 

Suite 410, Westbury, NY 11590; telephone 

516–228–7300; fax 516–794–5531. Before 

using any approved AMOC, notify your 

appropriate principal inspector, or lacking a 

principal inspector, the manager of the 

responsible Flight Standards Office. 

(2) Contacting the Manufacturer: For any 

requirement in this AD to obtain instructions 

from a manufacturer, the instructions must 

be accomplished using a method approved 

by the Manager, New York ACO Branch, 

FAA; or Transport Canada Civil Aviation 

(TCCA); or MHI RJ Aviation ULC’s TCCA 

Design Approval Organization (DAO). If 

approved by the DAO, the approval must 

include the DAO-authorized signature. 

(i) Related Information 

(1) Refer to Mandatory Continuing 

Airworthiness Information (MCAI) Canadian 

AD CF–2020–23, dated June 24, 2020, for 

related information. This MCAI may be 

found in the AD docket on the internet at 

https://www.regulations.gov by searching for 

and locating Docket No. FAA–2020–1137. 

(2) For more information about this AD, 

contact Siddeeq Bacchus, Aerospace 

Engineer, Mechanical Systems and 

Administrative Services Section, FAA, New 

York ACO Branch, 1600 Stewart Avenue, 

Suite 410, Westbury, NY 11590; telephone 

516–228–7362; email 9-avs-nyaco-cos@

faa.gov. 

(3) For service information identified in 

this AD, contact MHI RJ Aviation ULC, 12655 

Henri-Fabre Blvd., Mirabel, Que ́bec J7N 1E1 

Canada; Widebody Customer Response 

Center North America toll-free telephone +1– 

844–272–2720 or direct-dial telephone +1– 

514–855–8500; fax +1–514–855–8501; email 

thd.crj@mhirj.com; internet https://

mhirj.com. You may view this service 

information at the FAA, Airworthiness 

Products Section, Operational Safety Branch, 

2200 South 216th St., Des Moines, WA. For 

information on the availability of this 

material at the FAA, call 206–231–3195. 

Issued on December 15, 2020. 

Lance T. Gant, 

Director, Compliance & Airworthiness 

Division, Aircraft Certification Service. 

[FR Doc. 2020–27907 Filed 12–18–20; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2020–1136; Project 

Identifier MCAI–2020–01301–R] 

RIN 2120–AA64 

Airworthiness Directives; Airbus 

Helicopters 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Notice of proposed rulemaking 

(NPRM). 

SUMMARY: The FAA proposes to adopt a 

new airworthiness directive (AD) for all 

Airbus Helicopters Model AS332L, 

AS332L1, AS332C, and AS332C1 

helicopters. This proposed AD was 

prompted by the failure of a second 

stage planet gear installed in the main 

gearbox (MGB). This proposed AD 

would require identifying the part 

number of each second stage planet gear 

assembly installed in the MGB, 

replacing an MGB having certain second 

stage planet gear assembly part numbers 

with a serviceable MGB, modifying the 

helicopter by installing a full flow 

magnetic plug (FFMP), repetitively 

inspecting the FFMP and the MGB 

bottom housing and conical housing for 

metal particles, analyzing any metal 

particles that are found, and applying 

corrective actions if necessary, as 

specified in a European Union Aviation 

Safety Agency (EASA) AD, which is 

proposed for incorporation by reference. 

The FAA is proposing this AD to 

address the unsafe condition on these 

products. 

DATES: The FAA must receive comments 

on this proposed AD by February 4, 

2021. 

ADDRESSES: You may send comments, 

using the procedures found in 14 CFR 

11.43 and 11.45, by any of the following 

methods: 

• Federal eRulemaking Portal: Go to 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

• Fax: 202–493–2251. 

• Mail: U.S. Department of 

Transportation, Docket Operations, M– 

30, West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue SE, 

Washington, DC 20590. 

82978 Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Proposed Rules 

• Hand Delivery: Deliver to Mail 

address above between 9 a.m. and 5 

p.m., Monday through Friday, except 

Federal holidays. 

For material that will be incorporated 

by reference (IBR) in this AD, contact 

the EASA, Konrad-Adenauer-Ufer 3, 

50668 Cologne, Germany; telephone +49 

221 8999 000; email ADs@

easa.europa.eu; internet 

www.easa.europa.eu. You may find this 

IBR material on the EASA website at 

https://ad.easa.europa.eu. You may 

view this IBR material at the FAA, 

Office of the Regional Counsel, 

Southwest Region, 10101 Hillwood 

Pkwy., Room 6N–321, Fort Worth, TX 

76177. For information on the 

availability of this material at the FAA, 

call 817–222–5110. It is also available in 

the AD docket on the internet at https:// 

www.regulations.gov by searching for 

and locating Docket No. FAA–2020– 

1136. 

Examining the AD Docket 

You may examine the AD docket on 

the internet at https://

www.regulations.gov by searching for 

and locating Docket No. FAA–2020– 

1136; or in person at Docket Operations 

between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

The AD docket contains this NPRM, any 

comments received, and other 

information. The street address for 

Docket Operations is listed above. 

Comments will be available in the AD 

docket shortly after receipt. 

FOR FURTHER INFORMATION CONTACT: 

Mahmood Shah, Aviation Safety 

Engineer, Fort Worth ACO Branch, 

FAA, 10101 Hillwood Pkwy., Fort 

Worth, TX 76177; telephone 817–222– 

5538; email mahmood.g.shah@faa.gov. 

SUPPLEMENTARY INFORMATION: 

Comments Invited 

The FAA invites you to send any 

written relevant data, views, or 

arguments about this proposal. Send 

your comments to an address listed 

under ADDRESSES. Include ‘‘Docket No. 

FAA–2020–1136; Project Identifier 

MCAI–2020–01301–R’’ at the beginning 

of your comments. The most helpful 

comments reference a specific portion of 

the proposal, explain the reason for any 

recommended change, and include 

supporting data. The FAA will consider 

all comments received by the closing 

date and may amend this proposal 

because of those comments. 

Except for Confidential Business 

Information (CBI) as described in the 

following paragraph, and other 

information as described in 14 CFR 

11.35, the FAA will post all comments 

received, without change, to http://

www.regulations.gov, including any 

personal information you provide. The 

agency will also post a report 

summarizing each substantive verbal 

contact received about this proposal. 

Confidential Business Information 

CBI is commercial or financial 

information that is both customarily and 

actually treated as private by its owner. 

Under the Freedom of Information Act 

(FOIA) (5 U.S.C. 552), CBI is exempt 

from public disclosure. If your 

comments responsive to this NPRM 

contain commercial or financial 

information that is customarily treated 

as private, that you actually treat as 

private, and that is relevant or 

responsive to this NPRM, it is important 

that you clearly designate the submitted 

comments as CBI. Please mark each 

page of your submission containing CBI 

as ‘‘PROPIN.’’ The FAA will treat such 

marked submissions as confidential 

under the FOIA, and they will not be 

placed in the public docket of this 

NPRM. Submissions containing CBI 

should be sent to Mahmood Shah, 

Aviation Safety Engineer, Fort Worth 

ACO Branch, FAA, 10101 Hillwood 

Pkwy., Fort Worth, TX 76177; telephone 

817–222–5538; email 

mahmood.g.shah@faa.gov. Any 

commentary that the FAA receives that 

is not specifically designated as CBI will 

be placed in the public docket for this 

rulemaking. 

Discussion 

The EASA, which is the Technical 

Agent for the Member States of the 

European Union, has issued EASA AD 

2020–0022R1, dated September 18, 2020 

(EASA AD 2020–0022R1) (also referred 

to as the Mandatory Continuing 

Airworthiness Information, or the 

MCAI), to correct an unsafe condition 

for all Airbus Helicopters Model 

AS332L, AS332L1, AS332C, and 

AS332C1 helicopters. This proposed AD 

was prompted by the failure of a second 

stage planet gear installed in the MGB 

of an Airbus Helicopters Model 

EC225LP helicopter. Airbus Helicopters 

Model AS332L, AS332L1, AS332C, and 

AS332C1 helicopters have a similar 

design to the affected Model EC225LP 

helicopter, therefore, these models may 

be subject to the unsafe condition 

revealed on the Model EC225LP 

helicopter. The FAA is proposing this 

AD to address failure of a second stage 

planet gear installed in the MGB, which 

could result in failure of the MGB and 

subsequent loss of control of the 

helicopter. See the MCAI for additional 

background information. 

Related Service Information Under 1 

CFR Part 51 

EASA AD 2020–0022R1 describes 

procedures for identifying the part 

number of each second stage planet gear 

assembly installed in the MGB, 

replacing a MGB having certain second 

stage plane gear assembly part numbers 

with a serviceable MGB, modifying the 

helicopter by installing an FFMP, 

repetitively inspecting the FFMP and 

the MGB bottom housing and conical 

housing for metal particles, analyzing 

any metal particles that are found, and 

applicable corrective actions. The 

corrective actions include replacing an 

affected MGB with a serviceable MGB. 

This material is reasonably available 

because the interested parties have 

access to it through their normal course 

of business or by the means identified 

in the ADDRESSES section. 

FAA’s Determination and Requirements 

of This Proposed AD 

This product has been approved by 

the aviation authority of another 

country, and is approved for operation 

in the United States. Pursuant to the 

bilateral agreement with the State of 

Design Authority, the FAA has been 

notified of the unsafe condition 

described in the MCAI referenced 

above. The FAA is proposing this AD 

because the FAA evaluated all the 

relevant information and determined 

the unsafe condition described 

previously is likely to exist or develop 

in other products of the same type 

design. 

Proposed AD Requirements 

This proposed AD would require 

accomplishing the actions specified in 

EASA AD 2020–0022R1, described 

previously, as incorporated by 

reference, except for any differences 

identified as exceptions in the 

regulatory text of this proposed AD. 

Explanation of Required Compliance 

Information 

In the FAA’s ongoing efforts to 

improve the efficiency of the AD 

process, the FAA initially worked with 

Airbus and EASA to develop a process 

to use certain EASA ADs as the primary 

source of information for compliance 

with requirements for corresponding 

FAA ADs. The FAA has since 

coordinated with other manufacturers 

and civil aviation authorities (CAAs) to 

use this process. As a result, EASA AD 

2020–0022R1 will be incorporated by 

reference in the FAA final rule. This 

proposed AD would, therefore, require 

compliance with EASA AD 2020– 

0022R1 in its entirety, through that 

incorporation, except for any differences 

Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Proposed Rules 82979 

identified as exceptions in the 

regulatory text of this proposed AD. 

Using common terms that are the same 

as the heading of a particular section in 

the EASA AD does not mean that 

operators need comply only with that 

section. For example, where the AD 

requirement refers to ‘‘all required 

actions and compliance times,’’ 

compliance with this AD requirement is 

not limited to the section titled 

‘‘Required Action(s) and Compliance 

Time(s)’’ in the EASA AD. Service 

information specified in EASA AD 

2020–0022R1 that is required for 

compliance with EASA AD 2020– 

0022R1 will be available on the internet 

at https://www.regulations.gov by 

searching for and locating Docket No. 

FAA–2020–1136 after the FAA final 

rule is published. 

Costs of Compliance 

The FAA estimates that this proposed 

AD affects 11 helicopters of U.S. 

registry. The FAA estimates the 

following costs to comply with this 

proposed AD: 

ESTIMATED COSTS FOR REQUIRED ACTIONS

Labor cost Parts cost Cost per 

product 

Cost on U.S. 

operators 

8.50 work-hours × $85 per hour = $722.50 ................................................................................ $17,625 $18,347.50 $201,822.50 

The FAA estimates the following 

costs to do any necessary on-condition 

actions that would be required based on 

the results of any required actions. The 

FAA has no way of determining the 

number of helicopters that might need 

these on-condition actions: 

ESTIMATED COSTS OF ON-CONDITION ACTIONS

Labor cost Parts cost Cost per 

product 

40.50 work-hour × $85 per hour = $3,442.50 ............................ $275,000 (overhauled part) ....................................................... $278,442.50 

According to the manufacturer, some 

or all of the costs of this proposed AD 

may be covered under warranty, thereby 

reducing the cost impact on affected 

operators. The FAA does not control 

warranty coverage for affected operators. 

As a result, the FAA has included all 

known costs in the cost estimate. 

Authority for This Rulemaking 

Title 49 of the United States Code 

specifies the FAA’s authority to issue 

rules on aviation safety. Subtitle I, 

section 106, describes the authority of 

the FAA Administrator. Subtitle VII: 

Aviation Programs, describes in more 

detail the scope of the Agency’s 

authority. 

The FAA is issuing this rulemaking 

under the authority described in 

Subtitle VII, Part A, Subpart III, Section 

44701: General requirements. Under 

that section, Congress charges the FAA 

with promoting safe flight of civil 

aircraft in air commerce by prescribing 

regulations for practices, methods, and 

procedures the Administrator finds 

necessary for safety in air commerce. 

This regulation is within the scope of 

that authority because it addresses an 

unsafe condition that is likely to exist or 

develop on products identified in this 

rulemaking action. 

Regulatory Findings 

The FAA determined that this 

proposed AD would not have federalism 

implications under Executive Order 

13132. This proposed AD would not 

have a substantial direct effect on the 

States, on the relationship between the 

national Government and the States, or 

on the distribution of power and 

responsibilities among the various 

levels of government. 

For the reasons discussed above, I 

certify this proposed regulation: 

(1) Is not a ‘‘significant regulatory 

action’’ under Executive Order 12866, 

(2) Will not affect intrastate aviation 

in Alaska, and 

(3) Will not have a significant 

economic impact, positive or negative, 

on a substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. 

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Incorporation by reference, 

Safety. 

The Proposed Amendment 

Accordingly, under the authority 

delegated to me by the Administrator, 

the FAA proposes to amend 14 CFR part 

39 as follows: 

PART 39—AIRWORTHINESS 

DIRECTIVES 

■ 1. The authority citation for part 39 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40113, 44701. 

§ 39.13 [Amended] 

■ 2. The FAA amends § 39.13 by adding 

the following new airworthiness 

directive: 

Airbus Helicopters: Docket No. FAA–2020– 

1136; Project Identifier MCAI–2020– 

01301–R. 

(a) Comments Due Date 

The FAA must receive comments by 

February 4, 2021. 

(b) Affected Airworthiness Directives (ADs) 

None. 

(c) Applicability 

This AD applies to all Airbus Helicopters 

Model AS332L, AS332L1, AS332C, and 

AS332C1 helicopters, certificated in any 

category. 

(d) Subject 

Joint Aircraft System Component (JASC) 

Code 6320, Main Rotor Gear Box. 

(e) Reason 

This AD was prompted by the failure of a 

second stage planet gear installed in the main 

gearbox (MGB). The FAA is issuing this AD 

to address failure of an MGB second stage 

planet gear, which could result in failure of 

the MGB and subsequent loss of control of 

the helicopter. 

(f) Compliance 

Comply with this AD within the 

compliance times specified, unless already 

done. 

(g) Requirements 

Except as specified in paragraph (h) of this 

AD: Comply with all required actions and 

compliance times specified in, and in 

82980 Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Proposed Rules 

accordance with, European Union Aviation 

Safety Agency (EASA) AD 2020–0022R1, 

dated September 18, 2020 (EASA AD 2020– 

0022R1). 

(h) Exceptions to EASA AD 2020–0022R1 

(1) Where EASA AD 2020–0022R1 refers to 

March 30, 2018 (the effective date of EASA 

AD 2018–0066, dated March 23, 2018) or 

February 21, 2020 (the effective date of EASA 

AD 2020–0022, dated February 21, 2020), 

this AD requires using the effective date of 

this AD. 

(2) The ‘‘Remarks’’ section of EASA AD 

2020–0022R1 does not apply to this AD. 

(3) Where EASA AD 2020–0022R1 refers to 

flight hours (FH), this AD requires using 

hours time-in-service. 

(4) Where the service information referred 

to in paragraphs (5) and (6) of EASA AD 

2020–0022R1 specifies to perform a 

metallurgical analysis and contact the 

manufacturer if unsure about the 

characterization of the particles collected, 

this AD does not require contacting the 

manufacturer to determine the 

characterization of the particles collected. 

(5) Although the service information 

referred to in paragraph (6) of EASA AD 

2020–0022R1 specifies that if any 16NCD13 

particles are found send a 1-liter sample of 

oil to the manufacturer, this AD does not 

require that action. 

(6) Although the service information 

referenced in EASA AD 2020–0022R1 

specifies to discard certain parts, this AD 

does not include that requirement. 

(7) Although the service information 

referenced in EASA AD 2020–0022R1 

specifies returning certain parts to the 

manufacturer, this AD does not require that 

action. 

(8) Although the service information 

referenced in EASA AD 2020–0022R1 

specifies to contact the manufacturer if 

certain specified criteria are exceeded, this 

AD does not include that requirement. 

(9) Although the service information 

referenced in EASA AD 2020–0022R1 

specifies to submit certain information to the 

manufacturer, this AD does not include that 

requirement. 

(10) Although the service information 

referenced in EASA AD 2020–0022R1 

specifies to watch a video for removing the 

grease from the FFMP, using a cleaning 

agent, and collecting particles, this AD does 

not include that requirement. 

(11) Where EASA AD 2020–0022R1 

requires actions after the last flight of the day 

or ‘‘ALF,’’ this AD requires those actions 

before the first flight of the day. 

(i) Special Flight Permit 

Special flight permits may be issued in 

accordance with 14 CFR 21.197 and 21.199 

to operate the helicopter to a location where 

the helicopter can be modified (if the 

operator elects to do so), provided no 

passengers are onboard. 

(j) Alternative Methods of Compliance 

(AMOCs) 

(1) The Manager, Strategic Policy 

Rotorcraft Section, FAA, has the authority to 

approve AMOCs for this AD, if requested 

using the procedures found in 14 CFR 39.19. 

In accordance with 14 CFR 39.19, send your 

request to your principal inspector or local 

Flight Standards District Office, as 

appropriate. If sending information directly 

to the manager of the Strategic Policy 

Rotorcraft Section, send it to: Manager, 

Strategic Policy Rotorcraft Section, FAA, 

10101 Hillwood Pkwy., Fort Worth, TX 

76177; telephone 817–222–5110; email 9- 

ASW-FTW-AMOC-Requests@faa.gov. 

(2) Before using any approved AMOC, 

notify your appropriate principal inspector, 

or lacking a principal inspector, the manager 

of the local flight standards district office/ 

certificate holding district office. 

(k) Related Information 

(1) For EASA AD 2020–0022R1, contact the 

EASA, Konrad-Adenauer-Ufer 3, 50668 

Cologne, Germany; telephone +49 221 8999 

000; email ADs@easa.europa.eu; internet 

www.easa.europa.eu. You may find this 

EASA AD on the EASA website at https://

ad.easa.europa.eu. You may view this 

material at the FAA, Office of the Regional 

Counsel, Southwest Region, 10101 Hillwood 

Pkwy., Room 6N–321, Fort Worth, TX 76177. 

For information on the availability of this 

material at the FAA, call 817–222–5110. This 

material may be found in the AD docket on 

the internet at https://www.regulations.gov 

by searching for and locating Docket No. 

FAA–2020–1136. 

(2) For more information about this AD, 

contact Mahmood Shah, Aviation Safety 

Engineer, Fort Worth ACO Branch, FAA, 

10101 Hillwood Pkwy., Fort Worth, TX 

76177; telephone 817 222 5538; email 

mahmood.g.shah@faa.gov. 

Issued on December 15, 2020. 

Lance T. Gant, 

Director, Compliance & Airworthiness 

Division, Aircraft Certification Service. 

[FR Doc. 2020–28026 Filed 12–18–20; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 169 

[Docket No. FDA–2020–N–1807] 

RIN 0910–AI16 

French Dressing; Proposed 

Revocation of a Standard of Identity 

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 for 

French dressing. This action, in part, 

responds to a citizen petition submitted 

by the Association for Dressings and 

Sauces (ADS). We tentatively conclude 

that this standard no longer promotes 

honesty and fair dealing in the interest 

of consumers. Revocation of the 

standard of identity for French dressing 

could 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 22, 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 22, 

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

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of March 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. 

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