Federal Register / Vol. 87, No. 62 / Thursday, March 31, 2022 / Proposed Rules 18747 

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 SAS: Docket No. FAA–2022–0382; 

Project Identifier MCAI–2021–01452–T. 

(a) Comments Due Date 

The FAA must receive comments on this 

airworthiness directive (AD) by May 16, 

2022. 

(b) Affected ADs 

None. 

(c) Applicability 

This AD applies to all Airbus SAS Model 

A350–941 and –1041 airplanes, certificated 

in any category. 

(d) Subject 

Air Transport Association (ATA) of 

America Code 52, Doors. 

(e) Unsafe Condition 

This AD was prompted by reports that 

passenger door stop screws were found with 

missing screw heads. The FAA is issuing this 

AD to address the missing door stop screw 

heads, which could result in reduced 

structural integrity of the airplane. 

(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 

accordance with, European Union Aviation 

Safety Agency (EASA) AD 2021–0291, dated 

December 22, 2021 (EASA AD 2021–0291). 

(h) Exceptions to EASA AD 2021–0291 

(1) Where EASA AD 2021–0291 refers to its 

effective date, this AD requires using the 

effective date of this AD. 

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

2021–0291 does not apply to this AD. 

(3) Paragraph (4) of EASA AD 2021–0291 

specifies to report results of the initial 

inspection to Airbus within a certain 

compliance time. For this AD, report 

inspection results of the initial inspection at 

the applicable time specified in paragraph 

(h)(3)(i) or (ii) of this AD. 

(i) If the inspection was done on or after 

the effective date of this AD: Submit the 

report within 30 days after the inspection. 

(ii) If the inspection was done before the 

effective date of this AD: Submit the report 

within 30 days after the effective date of this 

AD. 

(4) Where Note 2 of paragraph (2) of EASA 

AD 2021–0291 specifies using ‘‘the 

instructions from an applicable Airbus 

Repair Design Approval Form (RDAF)’’ is 

acceptable for compliance with the corrective 

actions, this AD requires using corrective 

actions approved using a method approved 

by the Manager, Large Aircraft Section, 

International Validation Branch, FAA; or 

EASA; or Airbus SAS’s EASA DOA. If 

approved by the DOA, the approval must 

include the DOA-authorized signature. 

(5) Where paragraph (2) of EASA AD 2021– 

0291 refers to passenger door stop screws 

that are ‘‘damaged, as defined in the SB’’ this 

AD defines damage as broken passenger door 

stop screws. 

(6) Where service information referenced 

in EASA AD 2021–0291 specifies ‘‘a general 

visual inspection of the adjacent door stop 

area and surrounding structure (no lining 

removal required),’’ for this AD do a general 

visual inspection for any damage (e.g., 

broken passenger door stop screws), and 

repair any damage before further flight using 

a method approved by the Manager, Large 

Aircraft Section, International Validation 

Branch, FAA; or EASA; or Airbus SAS’s 

EASA Design Organization Approval (DOA). 

If approved by the DOA, the approval must 

include the DOA-authorized signature. 

(i) Return of Parts 

Although the service information 

referenced in EASA AD 2021–0291 specifies 

to send broken screws to Airbus, this AD 

does not include that requirement. 

(j) Special Flight Permit 

Special flight permits may be issued in 

accordance with 14 CFR 21.197 and 21.199 

to operate the airplane to a location where 

the actions of this AD can be performed (if 

the operator elects to do so), provided no 

passengers are onboard. 

(k) Additional AD Provisions 

The following provisions also apply to this 

AD: 

(1) Alternative Methods of Compliance 

(AMOCs): The Manager, Large Aircraft 

Section, International Validation 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 Large Aircraft 

Section, International Validation Branch, 

send it to the attention of the person 

identified in paragraph (l)(2) of this AD. 

Information may be emailed to: 9-AVS-AIR730-AMOC@faa.gov. 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, Large Aircraft Section, 

International Validation Branch, FAA; or 

EASA; or Airbus SAS’s EASA Design 

Organization Approval (DOA). If approved by 

the DOA, the approval must include the 

DOA-authorized signature. 

(3) Required for Compliance (RC): Except 

as required by paragraph (k)(2) of this AD, if 

any service information contains procedures 

or tests that are identified as RC, those 

procedures and tests must be done to comply 

with this AD; any procedures or tests that are 

not identified as RC are recommended. Those 

procedures and tests that are not identified 

as RC may be deviated from using accepted 

methods in accordance with the operator’s 

maintenance or inspection program without 

obtaining approval of an AMOC, provided 

the procedures and tests identified as RC can 

be done and the airplane can be put back in 

an airworthy condition. Any substitutions or 

changes to procedures or tests identified as 

RC require approval of an AMOC. 

(l) Related Information 

(1) For EASA AD 2021–0291, contact 

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, 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. This 

material may be found in the AD docket at 

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

and locating Docket No. FAA–2022–0382. 

(2) For more information about this AD, 

contact Dan Rodina, Aerospace Engineer, 

Large Aircraft Section, International 

Validation Branch, FAA, 2200 South 216th 

Street, Des Moines, WA 98198; telephone 

and fax 206–231–3225; email dan.rodina@

faa.gov. 

Issued on March 24, 2022. 

Lance T. Gant, 

Director, Compliance & Airworthiness 

Division, Aircraft Certification Service. 

[FR Doc. 2022–06601 Filed 3–30–22; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2022–0387; Project 

Identifier AD–2021–01225–R] 

RIN 2120–AA64 

Airworthiness Directives; Bell Textron 

Inc., 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 


jspears on DSK121TN23PROD with PROPOSALS1
18748 Federal Register / Vol. 87, No. 62 / Thursday, March 31, 2022 / Proposed Rules 

certain Bell Textron Inc., Model 212, 

412, 412CF, and 412EP helicopters. This 

proposed AD was prompted by a report 

of a cracked check valve. This proposed 

AD would require inspecting certain 

engine oil and fuel check valves, and 

depending on the results, repetitively 

inspecting and removing the check 

valve from service. This proposed AD 

would also prohibit installing affected 

engine oil and fuel check valves on any 

helicopter. 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 May 16, 2022. 

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. 

• Hand Delivery: Deliver to Mail 

address above between 9 a.m. and 5 

p.m., Monday through Friday, except 

Federal holidays. 

For service information identified in 

this NPRM, contact Bell Textron, Inc., 

P.O. Box 482, Fort Worth, TX 76101; 

telephone 1–450–437–2862 or 1–800– 

363–8023; fax 1–450–433–0272; email 

productsupport@bellflight.com; or at 

https://www.bellflight.com/support/ 

contact-support. 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. 

Examining the AD Docket 

You may examine the AD docket at 

https://www.regulations.gov by 

searching for and locating Docket No. 

FAA–2022–0387; 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. 

FOR FURTHER INFORMATION CONTACT: 

Kuethe Harmon, Safety Management 

Program Manager, Certification & 

Program Management Section, DSCO 

Branch, Compliance & Airworthiness 

Division, FAA, 10101 Hillwood Pkwy., 

Fort Worth, TX 76177; telephone (817) 

222–5198; email kuethe.harmon@

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–2022–0387; Project Identifier AD– 

2021–01225–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 https://

www.regulations.gov, including any 

personal information you provide. The 

agency will also post a report 

summarizing each substantive verbal 

contact received about this NPRM. 

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 Kuethe Harmon, 

Safety Management Program Manager, 

Certification & Program Management 

Section, DSCO Branch, Compliance & 

Airworthiness Division, FAA, 10101 

Hillwood Pkwy., Fort Worth, TX 76177; 

telephone (817) 222–5198; email 

kuethe.harmon@faa.gov. Any 

commentary that the FAA receives 

which is not specifically designated as 

CBI will be placed in the public docket 

for this rulemaking. 

Background 

The FAA proposes to adopt a new AD 

for Bell Textron Inc., Model 212, 412, 

412CF, and 412EP helicopters with an 

engine oil check valve part number (P/ 

N) 209–062–520–001 or fuel check valve 

P/N 209–062–607–001 manufactured by 

Circor Aerospace that is marked ‘‘Circle 

Seal’’ and ‘‘CORONA CA,’’ and has a 

manufacturing date code of, or prior to, 

‘‘9/11’’ (September 2011), or does not 

have a manufacturing date code, 

installed. This proposed AD would not 

apply to check valves marked with 

‘‘TQL.’’ This proposed AD was 

prompted by a report of a cracked check 

valve manufactured in 2009 by Circor 

Aerospace. An incorrect torque value 

applied on the threaded fitting at the 

check valve inlet end during the 

assembly process resulted in the crack. 

Indication of this condition may also 

include an enlarged outside diameter 

(O.D.) measurement of the check valve 

housing at the inlet end where the 

threaded fitting is installed or a leak. 

These check valves may be installed as 

engine oil check valve P/N 209–062– 

520–001 and fuel check valve P/N 209– 

062–607–001 on Bell Textron Inc., 

Model 212, 412, 412CF, and 412EP 

helicopters. 

The FAA previously issued AD 2019– 

09–02, Amendment 39–19636 (84 FR 

22695, May 20, 2019), which applies to 

the same model helicopters with the 

same part-numbered check valves 

installed, except it is only for check 

valves marked ‘‘Circle Seal’’ and with a 

manufacturing date code of ‘‘10/11’’ 

(October 2011) through ‘‘03/15’’ (March 

2015). 

This condition, if not addressed, 

could result in loss of lubrication or fuel 

to the engine, failure of the engine or a 

fire, and subsequent loss of control of 

the helicopter. 

FAA’s Determination 

The FAA is issuing this NPRM after 

determining that the unsafe condition 

described previously is likely to exist or 

develop on other products of the same 

type designs. 

Related Service Information 

The FAA reviewed Bell Alert Service 

Bulletin (ASB) 212–20–163, Revision B, 

dated April 6, 2021 (ASB 212–20–163), 

Bell ASB 212–20–164, Revision B, dated 

April 6, 2021 (ASB 212–20–164), Bell 

ASB 412–20–182, Revision B, dated 

April 6, 2021 (ASB 412–20–182), and 

Bell ASB 412–20–183, Revision C, dated 

April 6, 2021 (ASB 412–20–183). ASB 

212–20–163 and ASB 412–20–182 

specify procedures for inspecting and 

replacing engine oil check valve P/N 

209–062–520–001. ASB 212–20–164 

and ASB 412–20–183 specify 

procedures for inspecting and replacing 

fuel check valve P/N 209–062–607–001. 


jspears on DSK121TN23PROD with PROPOSALS1
Federal Register / Vol. 87, No. 62 / Thursday, March 31, 2022 / Proposed Rules 18749 

Proposed AD Requirements in This 

NPRM 

This proposed AD would require 

measuring the O.D. of an affected 

(engine oil or fuel) check valve housing 

at the center and at the inlet end where 

the threaded fitting is installed. If the 

dimension measured at the inlet end is 

greater than 0.003 inch (0.0762 mm) 

compared to the measurement at the 

center, this proposed AD would require 

repetitively inspecting the check valve 

for a crack and leak, and depending on 

the results, removing the check valve 

from service. This proposed AD would 

also require removing the check valve 

from service at a longer compliance 

time, which would terminate the 

repetitive inspections. Lastly, this 

proposed AD would prohibit installing 

affected check valves on any helicopter. 

Costs of Compliance 

The FAA estimates that this AD, if 

adopted as proposed, would affect 169 

helicopters of U.S. registry. Labor rates 

are estimated at $85 per work-hour. 

Based on these numbers, the FAA 

estimates the following costs to comply 

with this proposed AD. 

Measuring up to four check valves 

(two engine oil and two fuel) would take 

up to about 1 work-hour for an 

estimated cost of up to $85 per 

helicopter and $14,365 for the U.S. fleet. 

Inspecting up to four check valves (two 

engine oil and two fuel) would take up 

to about 2 work-hours for an estimated 

cost of up to $170 per helicopter and 

$28,730 for the U.S. fleet, per inspection 

cycle as applicable. Replacing up to four 

valves (two engine oil and two fuel) 

would take up to about 4 work-hours 

and parts would cost up to about $340, 

for an estimated cost of up to $680 per 

helicopter and $114,920 for the U.S. 

fleet. 

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) Would not affect intrastate 

aviation in Alaska, and 

(3) Would 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: 

Bell Textron Inc.: Docket No. FAA–2022– 

0387; Project Identifier AD–2021–01225– 

R. 

(a) Comments Due Date 

The FAA must receive comments on this 

airworthiness directive (AD) by May 16, 

2022. 

(b) Affected ADs 

None. 

(c) Applicability 

This AD applies to Bell Textron Inc., 

Model 212, 412, 412CF, and 412EP 

helicopters, certificated in any category, with 

an engine oil check valve part number (P/N) 

209–062–520–001 or fuel check valve P/N 

209–062–607–001 manufactured by Circor 

Aerospace that: 

(1) Is marked ‘‘Circle Seal’’ and ‘‘CORONA 

CA,’’ except not a check valve marked with 

‘‘TQL,’’ and 

(2) Has a manufacturing date code of, or 

prior to, ‘‘9/11’’ (September 2011), or does 

not have a manufacturing date code, 

installed. 

(d) Subject 

Joint Aircraft System Component (JASC) 

Code 2800 Aircraft Fuel System and 7900 

Engine Oil System (Airframe). 

(e) Unsafe Condition 

This AD was prompted by a report of a 

cracked check valve. The FAA is issuing this 

AD to detect a cracked check valve. The 

unsafe condition, if not addressed, could 

result in loss of lubrication or fuel to the 

engine, failure of the engine or a fire, and 

subsequent loss of control of the helicopter. 

(f) Compliance 

Comply with this AD within the 

compliance times specified, unless already 

done. 

(g) Required Actions 

(1) Within 25 hours time-in-service (TIS) or 

30 days, whichever occurs first after the 

effective date of this AD, using a caliper or 

equivalent, measure the outside diameter 

(O.D.) of the check valve housing at the 

center, and the O.D. of the check valve 

housing at the inlet end where the threaded 

fitting is installed. If the dimension measured 

at the inlet end is greater than 0.003 inch 

(0.0762 mm) compared to the measurement 

at the center, do the following: 

(i) Before further flight, and thereafter at 

intervals not to exceed 25 hours TIS or 30 

days, whichever occurs first, using a 

flashlight, visually inspect the check valve 

for a crack and leak, paying particular 

attention to the area at the inlet end where 

the threaded fitting is installed. If there is a 

crack or leak, before further flight, remove 

the check valve from service. Removing the 

check valve from service terminates the 

repetitive inspections required by this AD for 

that check valve. 

(ii) Within 600 hours TIS or 12 months, 

whichever occurs first, remove the check 

valve from service. Removing the check valve 

from service terminates the repetitive 

inspections required by this AD for that 

check valve. 

(2) As of the effective date of this AD, do 

not install an engine oil or fuel check valve 

identified in paragraph (c) of this AD on any 

helicopter. 

(h) Alternative Methods of Compliance 

(AMOCs) 

(1) The Manager, DSCO 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 local Flight Standards District Office, as 

appropriate. If sending information directly 

to the manager of the certification office, 

send it to the attention of the person 

identified in paragraph (i) of this AD. 

Information may be emailed to: 9–ASW–190– 

COS@faa.gov. 


jspears on DSK121TN23PROD with PROPOSALS1
18750 Federal Register / Vol. 87, No. 62 / Thursday, March 31, 2022 / Proposed Rules 

(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. 

(i) Related Information 

For more information about this AD, 

contact Kuethe Harmon, Safety Management 

Program Manager, Certification & Program 

Management Section, DSCO Branch, 

Compliance & Airworthiness Division, FAA, 

10101 Hillwood Pkwy., Fort Worth, TX 

76177; telephone (817) 222–5198; email 

kuethe.harmon@faa.gov. 

Issued on March 25, 2022. 

Ross Landes, 

Deputy Director for Regulatory Operations, 

Compliance & Airworthiness Division, 

Aircraft Certification Service. 

[FR Doc. 2022–06756 Filed 3–30–22; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 15 

[Docket No. FDA–2021–N–1326] 

Scientific Data and Information Related 

to the Residue of Carcinogenic 

Concern for the New Animal Drug 

Carbadox; Public Hearing; Request for 

Comments; Extension of Comment 

Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public hearing; request 

for comments; extension of comment 

period. 

SUMMARY: The Food and Drug 

Administration (FDA, we, or Agency) is 

extending the comment period for the 

notice of public hearing that appeared 

in the Federal Register of January 13, 

2022. In the notice, FDA requested 

comments on scientific data and 

information related to the residue of 

carcinogenic concern for the new 

animal drug carbadox. The Agency is 

taking this action in response to a 

request for an extension to allow 

interested persons additional time to 

submit comments. 

DATES: FDA is extending the comment 

period on the notice published January 

13, 2022 (87 FR 2093). Submit either 

electronic or written comments by June 

10, 2022. 

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 June 10, 2022. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of June 10, 2022. 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– 

2021–N–1326 for ‘‘Scientific Data and 

Information Related to the Residue of 

Carcinogenic Concern for the New 

Animal Drug Carbadox.’’ 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: 

Kelly Covington, Center for Veterinary 

Medicine (HFV–6), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 

CarbadoxPublicHearing2022@

fda.hhs.gov, 240–402–5661. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of January 13, 2022, 

FDA published a notice announcing a 

public hearing on scientific data and 

information related to the residue of 

carcinogenic concern for the new 

animal drug carbadox, a carcinogenic 

new animal drug used in swine feed, 

with a 90-day comment period. 


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