Federal Register / Vol. 87, No. 9 / Thursday, January 13, 2022 / Proposed Rules 2093 

Environmental Review 

This proposal will be subject to an 

environmental analysis in accordance 

with FAA Order 1050.1F, 

‘‘Environmental Impacts: Policies and 

Procedures’’ prior to any FAA final 

regulatory action. 

List of Subjects in 14 CFR Part 71 

Airspace, Incorporation by reference, 

Navigation (air). 

The Proposed Amendment 

In consideration of the foregoing, the 

Federal Aviation Administration 

proposes to amend 14 CFR part 71 as 

follows: 

PART 71—DESIGNATION OF CLASS A, 

B, C, D, AND E AIRSPACE AREAS; AIR 

TRAFFIC SERVICE ROUTES; AND 

REPORTING POINTS 

■ 1. The authority citation for 14 CFR 

part 71 continues to read as follows: 

Authority: 49 U.S.C. 106(f), 106(g); 40103, 

40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 

1959–1963 Comp., p. 389. 

§ 71.1 [Amended] 

■ 2. The incorporation by reference in 

14 CFR 71.1 of FAA Order JO 7400.11F, 

Airspace Designations and Reporting 

Points, dated August 10, 2021, and 

effective September 15, 2021, is 

amended as follows: 

Paragraph 6011 United States Area 

Navigation Routes. 

* * * * * 

T–367 JOPES, AK TO CABGI, AK [NEW] 

JOPES, AK WP (Lat. 62°03′33.30′′ N, long. 163°17′07.68′′ W) 

WOMEV, AK WP (Lat. 62°18′43.29′′ N, long. 162°57′55.67′′ W) 

JERDN, AK WP (Lat. 63°44′57.33′′ N, long. 160°44′31.91′′ W) 

HALUS, AK WP (Lat. 64°41′43.78′′ N, long. 162°04′03.53′′ W) 

FEMEP, AK WP (Lat. 65°14′24.15′′ N, long. 160°58′41.58′′ W) 

JIGUM, AK WP (Lat. 65°59′34.37′′ N, long. 161°56′53.01′′ W) 

Kotzebue, AK (OTZ) VOR/DME (Lat. 66°53′08.46′′ N, long. 162°32′23.77′′ W) 

CABGI, AK WP (Lat. 68°52′16.94′′ N, long. 166°04′50.37′′ W) 

* * * * * 

Issued in Washington, DC, on January 3, 

2022. 

Scott M. Rosenbloom, 

Acting Manager, Rules and Regulations 

Group. 

[FR Doc. 2022–00004 Filed 1–12–22; 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 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public hearing; request 

for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is 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. 

DATES: The public hearing will be held 

virtually on March 10, 2022, from 1 p.m. 

to 5 p.m., Eastern Time. Persons 

interested in attending this public 

hearing must register no later than 11:59 

p.m. Eastern Time on March 9, 2022. 

Persons interested in making oral 

presentations and comments at the 

public hearing must submit requests by 

February 18, 2022. Submit either 

electronic or written comments on this 

hearing by April 11, 2022. See the 

SUPPLEMENTARY INFORMATION section for 

registration dates and information. 

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 April 11, 

2022. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of April 11, 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; Public Hearing; 

Request for Comments.’’ 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 


jspears on DSK121TN23PROD with PROPOSALS1
2094 Federal Register / Vol. 87, No. 9 / Thursday, January 13, 2022 / Proposed Rules 

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 

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: 

Kelly Covington, Center for Veterinary 

Medicine (HFV–6), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, CarbadoxPublic

Hearing2022@fda.hhs.gov, 240–402– 

5661. 

SUPPLEMENTARY INFORMATION: 

I. Background and Purpose of Hearing 

Under the Delaney Clause (section 

512(d)(1)(I) (21 U.S.C. 360b(d)(1)(I)) of 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act)), FDA generally cannot 

approve a new animal drug application 

(NADA) if the drug that is the subject of 

that application induces cancer in 

humans or animals. An exception to this 

general rule is commonly known as the 

Diethylstilbestrol ‘‘DES’’ Proviso, which 

allows for the approval of a carcinogenic 

new animal drug where FDA finds that 

under the approved conditions of use: 

(1) The drug will not adversely affect 

the animals treated with the drug and 

(2) no residues of the drug will be found 

by an approved regulatory method in 

any edible tissues of, or in any foods 

yielded by, the animal (section 

512(d)(1)(I) of the FD&C Act). 

On July 20, 2020, the Agency 

published a notice in the Federal 

Register proposing an order to revoke 

the approved method for detecting 

residues of carbadox, a carcinogenic 

new animal drug used in swine feed. (85 

FR 43853, July 20, 2020; Docket No. 

FDA–2020–N–0955, ‘‘Phibro Animal 

Health Corp.; Carbadox in Medicated 

Swine Feed; Revocation of Approved 

Method.’’) The currently approved 

method measures quinoxaline-2- 

carboxylic acid (QCA) as a marker 

residue to detect the presence of the 

residue of carcinogenic concern. 

(Determination of Carbadox (as 

Quinoxaline-2-Carboxylic [QCA]) 

Residues in Swine Liver and Muscle 

Tissues After Drug Withdrawal, https:// 

www.fda.gov/about-fda/centerveterinary-medicine/cvm-foia-electronic

-reading-room.) The proposal to revoke 

the approved method for carbadox is 

based on CVM’s determination that the 

method is inadequate to monitor residue 

of carcinogenic concern in compliance 

with FDA’s regulations in part 500, 

subpart E (21 CFR part 500, subpart E). 

These regulations set out the 

requirements for demonstrating that no 

residues of the drug will be found by an 

approved regulatory method in any 

edible tissues of or in any foods 

obtained from the animal, as required to 

meet the requirements of the DES 

Proviso. The purpose of the public 

hearing is to gather additional data and 

information related to the residue of 

carcinogenic concern for the new 

animal drug carbadox. 

II. Notice of Hearing Under 21 CFR Part 

15 

This public hearing will be held in 

accordance with part 15 (21 CFR part 

15). Pursuant to § 15.1(a) and authority 

delegated from the Commissioner of 

Food and Drugs as referenced in the 

FDA Staff Manual Guide 

1410.21(1)(B)(6) and (1)(D), the FDA 

Acting Chief Scientist concludes, as a 

matter of discretion, that it is in the 

public interest to permit persons to 

present information and views at a 

public hearing on this matter. The 

hearing will be conducted by a 

presiding officer, who will be 

accompanied by other United States 

Government employees serving as a 

panel in conducting the hearing. Under 

§ 15.30(f), the hearing is informal, and 

the rules of evidence do not apply. Only 

the presiding officer and panel members 

can pose questions; they can question 

any person during or at the conclusion 

of each presentation. To the extent that 

the conditions for the hearing, as 

described in this notice, conflict with 

any provisions set out in part 15, this 

notice acts as a waiver of those 

provisions as specified in § 15.30(h). 

III. Topics for the Public Hearing 

We encourage public comments and 

presentations at the public hearing. We 

are particularly interested in receiving 

comments, data, and information about 

the topics listed below. In submitting 

comments, data, and information to the 

docket, please identify available 

references for the data and information, 

as well as the specific item number 

listed below, if applicable. Please 

reference, but do not resubmit, any 

information already contained in Docket 

No. FDA–2020–N–0955, ‘‘Phibro 

Animal Health Corp.; Carbadox in 

Medicated Swine Feed; Revocation of 

Approved Method.’’ 

1. Data to inform our knowledge of 

the residue of carcinogenic concern not 

summarized in the Freedom of 

Information summary for the 1998 

supplemental approvals, including 

additional data regarding the fraction of 

noncarcinogenic residues in the total 

radiolabeled residues of carbadox. 

2. For any given concentration of a 

marker residue, the corresponding 

concentration of the residue of 

carcinogenic concern. 

3. Additional information not already 

contained in Docket No. FDA–2020–N– 

0955, ‘‘Phibro Animal Health Corp.; 

Carbadox in Medicated Swine Feed; 

Revocation of Approved Method’’ 

related to the adequacy of the current 

approved method to measure QCA as a 

marker residue for the residue of 

carcinogenic concern for the new 

animal drug carbadox. 

4. Any method, other than the current 

approved method, that demonstrates 

‘‘no residue’’ for the new animal drug 

carbadox in conformance with part 500, 

Subpart E. 

5. Detailed information on the 

conduct and quality of studies 

providing data to support the points 

above, including information on the 

extraction process and the stability of 

residues being analyzed. 


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Federal Register / Vol. 87, No. 9 / Thursday, January 13, 2022 / Proposed Rules 2095 

IV. Participating in the Public Hearing 

Registration: To register to attend the 

virtual public hearing, on ‘‘Scientific 

Data and Information Related to the 

Residue of Carcinogenic Concern for the 

New Animal Drug Carbadox; Public 

Hearing; Request for Comments’’ please 

register at https://fda.zoomgov.com/j/ 

1600135012?

pwd=MFdjMW9FRXg4RGllc

3FHWVhkWVAyZz09 by March 9, 2022. 

If you have any questions, you can 

contact CarbadoxPublicHearing2022@

fda.hhs.gov (See DATES and ADDRESSES). 

Please provide complete contact 

information for each attendee, including 

name, title, affiliation, address, email, 

and telephone. 

Request for Oral Presentations: During 

online registration, you may indicate if 

you wish to make a formal presentation 

(with accompanying slide deck) or 

present oral comments during the 

public hearing session (with no slide 

deck). If you decide you wish to make 

a presentation after registering online, 

you may submit a request to 

CarbadoxPublicHearing2022@

fda.hhs.gov. All requests to make 

presentations must be received by 

February 18, 2022. FDA will do its best 

to accommodate requests to make public 

presentations. Individuals and 

organizations with common interests are 

urged to consolidate or coordinate their 

presentations. FDA will determine the 

amount of time allotted to each 

presenter and the approximate time 

each presentation is to begin and will 

select and notify participants by 

February 23, 2022. 

If selected for a formal oral 

presentation (with a slide deck), each 

presenter must submit an electronic 

copy of their presentation (PowerPoint 

or PDF) to 

CarbadoxPublicHearing2022@

fda.hhs.gov with the subject line 

‘‘Scientific Data and Information 

Related to the Residue of Carcinogenic 

Concern for the New Animal Drug 

Carbadox; Public Hearing; Request for 

Comments’’ on or before March 4, 2022. 

No commercial or promotional material 

will be permitted to be presented or 

distributed at the public hearing. 

Persons notified that they will be 

presenters are encouraged to be online 

early. Actual presentation times may 

vary based on how the hearing 

progresses in real time. An agenda for 

the hearing and any other background 

materials will be made available no later 

than 5 days before the hearing at https:// 

www.fda.gov/animal-veterinary/ 

workshops-conferences-meetings/part15-public-hearing-scientific-data-andinformation-related-residuecarcinogenic-concern-new. 

Transcripts: Please be advised that as 

soon as a transcript of the public 

hearing is available, it will be accessible 

at https://www.regulations.gov. It may 

also be viewed at the Dockets 

Management Staff (see ADDRESSES). A 

link to the transcript will also be 

available on the Agency’s website at 

https://www.fda.gov/animal-veterinary/ 

workshops-conferences-meetings/part15-public-hearing-scientific-data-andinformation-related-residuecarcinogenic-concern-new. 

Dated: January 7, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–00475 Filed 1–12–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF THE INTERIOR 

National Indian Gaming Commission 

25 CFR Part 559 

RIN 3141–AA76 

Facility License; Correction 

AGENCY: National Indian Gaming 

Commission, Department of the Interior. 

ACTION: Proposed rule; correction. 

SUMMARY: This document corrects the 

preamble to a proposed rule published 

in the Federal Register of December 1, 

2021, regarding Facility Licenses. The 

document contained incorrect dates for 

submitting comments. This correction 

clarifies that comments are due January 

31, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Michael Hoenig, 202–632–7003. 

SUPPLEMENTARY INFORMATION: 

Correction 

In the Federal Register of December 1, 

2021, in FR Doc. 2021–25845, on page 

68200, in the third column, change the 

DATES caption to read: 

DATES: Written comments on this 

proposed rule must be received on or 

before January 31, 2022. 

Dated: January 6, 2022. 

Michael Hoenig, 

General Counsel. 

[FR Doc. 2022–00625 Filed 1–12–22; 8:45 am] 

BILLING CODE 7565–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R04–OAR–2021–0428; FRL–9374–01– 

R4] 

Finding of Failure To Attain the 2010 

Sulfur Dioxide Standard; Tennessee; 

Sullivan County Nonattainment Area 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is proposing to determine 

that the Sullivan County, Tennessee 

sulfur dioxide (SO2) nonattainment area 

failed to attain the 2010 1-hour SO2

primary National Ambient Air Quality 

Standard (NAAQS or standard) by the 

applicable attainment date of October 4, 

2018, based upon a weight of evidence 

analysis of available quality-assured and 

certified SO2 ambient air monitoring 

data and SO2 emissions data from 

January 2015 through December 2017. If 

EPA finalizes this determination as 

proposed, the State of Tennessee will be 

required to submit revisions to the 

Tennessee State Implementation Plan 

(SIP) that, among other elements, 

provide for expeditious attainment of 

the 2010 SO2 standard. 

DATES: Comments must be received on 

or before February 14, 2022. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–R04– 

OAR–2021–0428 at https://

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Once submitted, comments cannot be 

edited or removed from Regulations.gov. 

EPA may publish any comment received 

to its public docket. Do not submit 

electronically any information you 

consider to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Multimedia submissions (audio, video, 

etc.) must be accompanied by a written 

comment. The written comment is 

considered the official comment and 

should include discussion of all points 

you wish to make. EPA will generally 

not consider comments or comment 

contents located outside of the primary 

submission (i.e., on the web, cloud, or 

other file sharing system). For 

additional submission methods, the full 

EPA public comment policy, 

information about CBI or multimedia 

submissions, and general guidance on 

making effective comments, please visit 

https://www2.epa.gov/dockets/ 

commenting-epa-dockets. 

FOR FURTHER INFORMATION CONTACT: 

Evan Adams, Air Regulatory 


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