This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

42395 

Vol. 87, No. 135 

Friday, July 15, 2022 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 71 

[Docket No. FAA–2022–0826; Airspace 

Docket No. 21–AEA–21] 

RIN 2120–AA66 

Proposed Amendment and 

Establishment of Area Navigation 

(RNAV) Routes; Northeast United 

States 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Notice of proposed rulemaking 

(NPRM). 

SUMMARY: This action proposes to 

amend three low altitude Area 

Navigation (RNAV) routes (T-routes) 

and establish two T-routes in support of 

the VHF Omnidirectional Range (VOR) 

Minimum Operational Network (MON) 

Program. The purpose is to enhance the 

efficiency of the National Airspace 

System (NAS) by transitioning from 

ground-based navigation aids to a 

satellite-based navigation system. 

DATES: Comments must be received on 

or before August 15, 2022. 

ADDRESSES: Send comments on this 

proposal to the U.S. Department of 

Transportation, Docket Operations, 1200 

New Jersey Avenue SE, West Building 

Ground Floor, Room W12–140, 

Washington, DC 20590; telephone: (800) 

647–5527, or (202) 366–9826. You must 

identify FAA Docket No. FAA–2022– 

0826; Airspace Docket No. 21–AEA–21 

at the beginning of your comments. You 

may also submit comments through the 

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

FAA Order JO 7400.11F, Airspace 

Designations and Reporting Points, and 

subsequent amendments can be viewed 

online at https://www.faa.gov/air_

traffic/publications/. For further 

information, you can contact the Rules 

and Regulations Group, Federal 

Aviation Administration, 800 

Independence Avenue SW, Washington, 

DC 20591; telephone: (202) 267–8783. 

FOR FURTHER INFORMATION CONTACT: Paul 

Gallant, Rules and Regulations Group, 

Office of Policy, Federal Aviation 

Administration, 800 Independence 

Avenue SW, Washington, DC 20591; 

telephone: (202) 267–8783. 

SUPPLEMENTARY INFORMATION: 

Authority for This Rulemaking 

The FAA’s authority to issue rules 

regarding aviation safety is found in 

Title 49 of the United States Code. 

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. This rulemaking is 

promulgated under the authority 

described in Subtitle VII, Part A, 

Subpart I, Section 40103. Under that 

section, the FAA is charged with 

prescribing regulations to assign the use 

of the airspace necessary to ensure the 

safety of aircraft and the efficient use of 

airspace. This regulation is within the 

scope of that authority as it would 

expand the availability of RNAV and 

enhance the efficiency of the NAS by 

transitioning from ground-based 

navigation aids to a satellite-based 

navigation system 

Comments Invited 

Interested parties are invited to 

participate in this proposed rulemaking 

by submitting such written data, views, 

or arguments as they may desire. 

Comments that provide the factual basis 

supporting the views and suggestions 

presented are particularly helpful in 

developing reasoned regulatory 

decisions on the proposal. Comments 

are specifically invited on the overall 

regulatory, aeronautical, economic, 

environmental, and energy-related 

aspects of the proposal. 

Communications should identify both 

docket numbers (FAA Docket No. FAA– 

2022–0826; Airspace Docket No. 21– 

AEA–21) and be submitted in triplicate 

to the Docket Management Facility (see 

ADDRESSES section for address and 

phone number). You may also submit 

comments through the internet at 

https://www.regulations.gov. 

Commenters wishing the FAA to 

acknowledge receipt of their comments 

on this action must submit with those 

comments a self-addressed, stamped 

postcard on which the following 

statement is made: ‘‘Comments to FAA 

Docket No. FAA–2022–0826; Airspace 

Docket No. 21–AEA–21.’’ The postcard 

will be date/time stamped and returned 

to the commenter. 

All communications received on or 

before the specified comment closing 

date will be considered before taking 

action on the proposed rule. The 

proposal contained in this action may 

be changed in light of comments 

received. All comments submitted will 

be available for examination in the 

public docket both before and after the 

comment closing date. A report 

summarizing each substantive public 

contact with FAA personnel concerned 

with this rulemaking will be filed in the 

docket. 

Availability of NPRMs 

An electronic copy of this document 

may be downloaded through the 

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

Recently published rulemaking 

documents can also be accessed through 

the FAA’s web page at https://

www.faa.gov/air_traffic/publications/ 

airspace_amendments/. 

You may review the public docket 

containing the proposal, any comments 

received and any final disposition in 

person in the Dockets Office (see 

ADDRESSES section for address and 

phone number) between 9:00 a.m. and 

5:00 p.m., Monday through Friday, 

except Federal holidays. An informal 

docket may also be examined during 

normal business hours at the office of 

the Eastern Service Center, Federal 

Aviation Administration, Room 210, 

1701 Columbia Ave., College Park, GA 

30337. 

Availability and Summary of 

Documents for Incorporation by 

Reference 

This document proposes to amend 

FAA Order JO 7400.11F, Airspace 

Designations and Reporting Points, 

dated August 10, 2021, and effective 

September 15, 2021. FAA Order JO 

7400.11F is publicly available as listed 

in the ADDRESSES section of this 

document. FAA Order JO 7400.11F lists 

Class A, B, C, D, and E airspace areas, 

air traffic service routes, and reporting 

points. 

The Proposal 

The FAA is proposing an amendment 

to 14 CFR part 71 to amend three low 

altitude RNAV T-routes, designated T– 

287, T–358, and T–608; and to establish 

two T-routes designated T–318, and T– 


jspears on DSK121TN23PROD with PROPOSALS1
42396 Federal Register / Vol. 87, No. 135 / Friday, July 15, 2022 / Proposed Rules 

320, in the northeast United States; to 

support the VOR MON Program, and the 

transition of the NAS from groundbased navigation aids to satellite-based 

navigation. 

T–287: T–287 extends between the 

DENNN, VA waypoint (WP) (located 

northwest of the Gordonsville, VA, 

(GVE) VHF Omnidirectional Range and 

Tactical Air Navigational System 

(VORTAC)) and the TOMYD, MD, WP 

(located northwest of the Westminster, 

MD, (EMI) VORTAC). The TOMYD WP 

would be relocated 2.8 nautical miles 

(NM) to the north of its current position 

which would change its state location 

from MD to PA. This action proposes to 

extend T–287 from the TOMYD, PA, WP 

to the Kennebunk, ME, (ENE) VHF 

Omnidirectional Range/Distance 

Measuring Equipment (VOR/DME). The 

CAARY, VA, WP and the WILMY, VA, 

WP would be removed from the route 

description because they do not denote 

a turn point on the route. However, 

those WPs will continue to be shown on 

aeronautical charts for air traffic control 

purposes. T–287 would overlay portions 

of VOR Federal airway V–44 from the 

VYSOR, MD, WP to the WNSTN, NJ, 

WP. It would also overlay airway V–139 

from the WNSTN, NJ, WP, to the 

Kennebunk VOR/DME. In the 

description of T–287, the WNSTN, NJ, 

WP replaces the Sea Isle, NJ, (SIE) 

VORTAC. The ORCHA, NY, WP 

replaces the Hampton, NY, (HTO) 

VORTAC. The PROVI, RI, WP replaces 

the Providence, RI, (PVD) VOR/DME. As 

amended, T–287 would extend between 

the DENNN, VA, WP, and the 

Kennebunk, ME, VOR/DME. 

T–358: T–358 extends between the 

Martinsburg, WV, (MRB) VORTAC, and 

the AVALO, NJ, Fix. This action 

proposes to extend T–358 from the 

AVALO Fix, to the Augusta, ME, (AUG) 

VOR/DME. The HOGZZ, MD, WP would 

be changed to the TWIRK, MD, WP per 

request from air traffic control (ATC). 

The latitude/longitude coordinates of 

the WP would remain unchanged. The 

GOLDA, MD, Fix; the BROSS, MD, Fix; 

and the LEEAH, NJ, Fix would be 

removed from the route description 

because they don’t denote turn points 

on the route. The Fixes will remain on 

aeronautical charts for ATC purposes. 

T–358 would overlay portions of airway 

V–268 from the AVALO Fix to the 

Augusta VOR/DME. The ‘‘OA’’ 

abbreviation for the HAVNS WP means 

‘‘Offshore Atlantic.’’ 

T–318: T–318 is a proposed new route 

that would extend between the 

Rochester, NY, (ROC) VOR/DME and 

the Kennebunk, ME, (ENE) VOR/DME. 

T–318 would overlay airway V–34 from 

the Rochester VOR/DME to the ARRKK, 

NY, WP. It would overlay airway V–167 

from the ARRKK WP, to the Kennebunk 

VOR/DME. The location abbreviation 

‘‘OA’’ used for the CBIRD and HUBELL 

WPs, and the SCUPP Fix, means 

‘‘Offshore Atlantic.’’ 

T–320: T–320 is a proposed new route 

that would extend between the GILFF, 

VA, WP and the Gardner, MA, (GDM) 

VOR/DME. T–320 would overlay 

portions of airway V–308 from the 

BILIT, MD, Fix, to the CHOPS, MD Fix, 

and from the WNSTN, NJ, WP to the 

YANCT, CT, WP. 

T–608: T–608 is an existing Canadian 

T route that extends into U.S. airspace 

between the HOCKE, MI, WP, and the 

YANTC, CT, WP. The FAA proposes to 

modify the eastern end of the route by 

removing the segments between the 

Gardner, MA, (GDM) VOR/DME and the 

YANCT, CT, WP. Instead, the route will 

be realigned to proceed eastward from 

the Gardner VOR/DME through the 

BRONC, MA; LOBBY, MA; and SOSYO, 

MA Fixes; terminating at the REVER, 

MA, Fix (located 5 NM north of the 

Boston, MA, (BOS) VOR/DME). The 

proposed new T–320 (described above) 

would incorporate the segments 

between the YANCT WP, and the 

Gardner VOR/DME that is being 

proposed for removal from T–608. 

In addition, the following points 

would be removed from the T–608 legal 

description because they do not denote 

a turn point on the route: MONCK, NY, 

WP; LORTH, NY, Fix; MAGEN, NY, WP; 

KONDO, NY, WP; WIFFY, NY, WP; 

STODA, NY, WP; VASTS, NY, Fix; 

NORSE, NY, WP; MARIA, NY, WP; 

WARUV, NY, WP; GRISY, MA, WP; 

WARIC, MA, WP; HURLY, MA, Fix; 

GRAYM, MA, WP; BLATT, CT, WP; 

MOGUL, CT, WP; and YANCT, CT, WP;. 

Full route descriptions of the above T 

routes are listed in the amendments to 

part 71 set forth below. 

United States RNAV T-routes are 

published in paragraph 6011, and 

Canadian RNAV T-routes are published 

in paragraph 6023, respectively, of FAA 

Order JO 7400.11F, dated August 10, 

2021, and effective September 15, 2021, 

which is incorporated by reference in 14 

CFR 71.1. The RNAV routes listed in 

this document would be subsequently 

published in FAA Order 7400.11. 

FAA Order JO 7400.11, Airspace 

Designations and Reporting Points, is 

published yearly and effective on 

September 15. 

Regulatory Notices and Analyses 

The FAA has determined that this 

proposed regulation only involves an 

established body of technical 

regulations for which frequent and 

routine amendments are necessary to 

keep them operationally current. It, 

therefore: (1) is not a ‘‘significant 

regulatory action’’ under Executive 

Order 12866; (2) is not a ‘‘significant 

rule’’ under Department of 

Transportation (DOT) Regulatory 

Policies and Procedures (44 FR 11034; 

February 26, 1979); and (3) does not 

warrant preparation of a regulatory 

evaluation as the anticipated impact is 

so minimal. Since this is a routine 

matter that will only affect air traffic 

procedures and air navigation, it is 

certified that this proposed rule, when 

promulgated, will not have a significant 

economic impact on a substantial 

number of small entities under the 

criteria of the Regulatory Flexibility Act. 

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 part 14 

CFR 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. 

* * * * * 


jspears on DSK121TN23PROD with PROPOSALS1
Federal Register / Vol. 87, No. 135 / Friday, July 15, 2022 / Proposed Rules 42397 

T–287 DENNN, VA to Kennebunk, ME (ENE) [Amended] 

DENNN, VA WP (Lat. 38°05′06′′ N, long. 078°12′28′′ W) 

KAIJE, VA WP (Lat. 38°44′35′′ N, long. 078°42′48′′ W) 

BAMMY, WV WP (Lat. 39°24′33′′ N, long. 078°25′46′′ W) 

REEES, PA WP (Lat. 39°47′52′′ N, long. 077°45′56′′ W) 

TOMYD, PA WP (Lat. 39°43′39.02′′ N, long. 077°07′58.89′′ W) 

MOYRR, MD WP (Lat. 39°30′03.42′′ N, long. 076°56′10.84′′ W) 

DANII, MD WP (Lat. 39°17′46.42′′ N, long. 076°42′19.36′′ W) 

VYSOR, MD WP (Lat. 39°02′03.86′′ N, long. 076°14′59.88′′ W) 

WNSTN, NJ WP (Lat. 39°05′43.81′′ N, long. 074°48′01.20′′ W) 

MANTA, NJ WP (Lat. 39°54′07.01′′ N, long. 073°32′31.63′′ W) 

BEADS, NY WP (Lat. 40°44′04.51′′ N, long. 072°32′34.21′′ W) 

ORCHA, NY WP (Lat. 40°54′55.46′′ N, long. 072°18′43.64′′ W) 

PARCH, NY WP (Lat. 41°05′57.22′′ N, long. 072°07′14.66′′ W) 

PROVI, RI WP (Lat. 41°43′25.46′′ N, long. 071°25′54.17′′ W) 

INNDY, MA WP (Lat. 41°46′19.19′′ N, long. 071°05′55.93′′ W) 

BURDY, MA WP (Lat. 41°57′19.14′′ N, long. 070°57′07.45′′ W) 

HAVNS, OA WP (Lat. 42°17′55.00′′ N, long. 070°27′42.00′′ W) 

GRGIO, MA WP (Lat. 42°35′09.36′′ N, long. 070°33′54.40′′ W) 

LBSTA, MA WP (Lat. 42°48′00.00′′ N, long. 070°36′48.70′′ W) 

Kennebunk, ME (ENE) VOR/DME (Lat. 43°25′32.42′′ N, long. 070°36′48.69′′ W) 

* * * * * * * 

T–358 Martinsburg, WV (MRB) to Augusta, ME (AUG) [Amended] 

Martinsburg, WV (MRB) VORTAC (Lat. 39°23′08.06′′ N, long. 077°50′54.08′′ W) 

CPTAL, MD WP (Lat. 39°32′16.02′′ N, long. 077°41′55.65′′ W) 

TWIRK, MD WP (Lat. 39°34′36.70′′ N, long. 077°12′44.75′′ W) 

MOYRR, MD WP (Lat. 39°30′03.42′′ N, long. 076°56′10.84′′ W) 

DANII, MD WP (Lat. 39°17′46.42′′ N, long. 076°42′19.36′′ W) 

OBWON, MD WP (Lat. 39°11′54.69′′ N, long. 076°32′04.84′′ W) 

SWANN, MD FIX (Lat. 39°09′05.28′′ N, long. 076°13′43.94′′ W) 

Smyrna, DE (ENO) VORTAC (Lat. 39°13′53.93′′ N, long. 075°30′57.49′′ W) 

AVALO, NJ FIX (Lat. 39°16′54.52′′ N, long. 074°30′50.75′′ W) 

MANTA, NJ FIX (Lat. 39°54′07.01′′ N, long. 073°32′31.63′′ W) 

BEADS, NY FIX (Lat. 40°44′04.51′′ N, long. 072°32′34.21′′ W) 

ORCHA, NY WP (Lat. 40°54′55.46′′ N, long. 072°18′43.64′′ W) 

Sandy Point, RI (SEY) VOR/DME (Lat. 41°10′02.77′′ N, long. 071°34′33.91′′ W) 

BURDY, MA FIX (Lat. 41°57′19.14′′ N, long. 070°57′07.45′′ W) 

HAVNS, OA WP (Lat. 42°17′55.00′′ N, long. 070°27′42.00′′ W) 

GRGIO, MA WP (Lat. 42°35′09.36′′ N, long. 070°33′54.40′′ W) 

LBSTA, MA FIX (Lat. 42°48′00.00′′ N, long. 070°36′48.70′′ W) 

MESHL, ME FIX (Lat. 43°19′12.07′′ N, long. 070°09′48.03′′ W) 

Augusta, ME (AUG) VOR/DME (Lat. 44°19′12.07′′ N, long. 069°47′47.63′′ W) 

*******

T–318 Rochester, NY (ROC) to Kennebunk, ME (ENE) [New] 

Rochester, NY (ROC) VOR/DME (Lat. 43°07′04.65′′ N, long. 077°40′22.06′′ W) 

FAULT, NY FIX (Lat. 42°59′03.01′′ N, long. 077°21′47.78′′ W) 

BEEPS, NY FIX (Lat. 42°49′13.26′′ N, long. 076°59′04.84′′ W) 

KOLTT, NY WP (Lat. 42°14′21.22′′ N, long. 075°41′48.39′′ W) 

ARRKK, NY WP (Lat. 42°03′48.52′′ N, long. 075°19′00.41′′ W) 

HELON, NY FIX (Lat. 41°40′02.72′′ N, long. 074°16′49.52′′ W) 

Kingston, NY (IGN) VOR/DME (Lat. 41°39′55.62′′ N, long. 073°49′20.01′′ W) 

MOONI, CT FIX (Lat. 41°37′53.28′′ N, long. 073°19′19.43′′ W) 

Hartford, CT (HFD) VOR/DME (Lat. 41°38′27.98′′ N, long. 072°32′50.70′′ W) 

PROVI, RI WP (Lat. 41°43′25.46′′ N, long. 071°25′54.17′′ W) 

PEAKE, MA FIX (Lat. 41°34′14.87′′ N, long. 070°24′31.61′′ W) 

Marconi, MA (LFV) VOR/DME (Lat. 42°01′01.88′′ N, long. 070°02′14.04′′ W) 

CBIRD, OA WP (Lat. 42°08′48.41′′ N, long. 070°04′46.69′′ W) 

HUBEL, OA WP (Lat. 42°16′34.88′′ N, long. 070°07′19.97′′ W) 

SCUPP, OA FIX (Lat. 42°36′11.01′′ N, long. 070°13′49.35′′ W) 

Kennebunk, ME (ENE) VOR/DME (Lat. 43°25′32.42′′ N, long. 070°36′48.69′′ W) 

*******

T–320 GILFF, VA to Gardner, MA (GDM) [New] 

GILFF, VA WP (Lat. 38°21′44.86′′ N, long. 077°26′05.38′′ W) 

HIGPO, VA WP (Lat. 38°22′16.09′′ N, long. 077°22′19.97′′ W) 

CAVDI, MD WP (Lat. 38°25′33.43′′ N, long. 076°54′43.49′′ W) 

DAILY, MD FIX (Lat. 38°33′37.83′′ N, long. 076°43′31.05′′ W) 

VAALI, MD WP (Lat. 38°44′00.85′′ N, long. 076°26′38.26′′ W) 

BILIT, MD FIX (Lat. 38°45′15.82′′ N, long. 076°03′57.59′′ W) 

CHOPS, MD FIX (Lat. 38°45′41.81′′ N, long. 075°57′36.18′′ W) 

EGGRS, DE WP (Lat. 38°53′30.52′′ N, long. 075°30′49.95′′ W) 

JILLI, NJ WP (Lat. 39°00′42.22′′ N, long. 075°05′46.21′′ W) 

WNSTN, NJ WP (Lat. 39°05′43.81′′ N, long. 074°48′01.20′′ W) 

MANTA, NJ FIX (Lat. 39°54′07.01′′ N, long. 073°32′31.63′′ W) 

BEADS, NY FIX (Lat. 40°44′04.51′′ N, long. 072°32′34.21′′ W) 

ORCHA, NY WP (Lat. 40°54′55.46′′ N, long. 072°18′43.64′′ W) 

BOROS, NY FIX (Lat. 41°09′24.45′′ N, long. 072°09′50.96′′ W) 

Groton, CT (GON) VOR/DME (Lat. 41°19′49.45′′ N, long. 072°03′07.14′′ W) 

YANTC, CT WP (Lat. 41°33′22.81′′ N, long. 071°59′56.95′′ W) 

Gardner, MA (GDM) VOR/DME (Lat. 42°32′45.31′′ N, long. 072°03′29.48′′ W) 


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42398 Federal Register / Vol. 87, No. 135 / Friday, July 15, 2022 / Proposed Rules 

* * * * * Paragraph 6013 Canadian Area Navigation 

Routes. 

* * * * * 

T–608 HOCKE, MI to REVER, MA [Amended] 

HOCKE, MI WP (Lat. 43°15′43.38′′ N, long. 082°42′38.27′′ W) 

KATNO, Canada WP (Lat. 43°10′34.00′′ N, long. 082°19′32.00′′ W) 

UKNIX, NY WP (Lat. 42°56′44.51′′ N, long. 078°55′05.60′′ W) 

WOZEE, NY WP (Lat. 42°56′01.65′′ N, long. 078°44′19.64′′ W) 

CLUNG, NY WP (Lat. 43°03′17.17′′ N, long. 078°00′13.38′′ W) 

Rochester, NY (ROC) VOR/DME (Lat. 43°07′04.65′′ N, long. 077°40′22.06′′ W) 

Syracuse, NY (SYR) VORTAC (Lat. 43°09′37.87′′ N, long. 076°12′16.41′′ W) 

LAMMS, NY WP (Lat. 43°01′35.30′′ N, long. 075°09′51.50′′ W) 

Albany, NY (ALB) VORTAC (Lat. 42°44′50.20′′ N, long. 073°48′11.47′′ W) 

GRAVE, NY WP (Lat. 42°46′47.34′′ N, long. 073°22′20.91′′ W) 

Gardner, MA (GDM) VOR/DME (Lat. 42°32′45.31′′ N, long. 072°03′29.48′′ W) 

BRONC, MA FIX (Lat. 42°30′53.93′′ N, long. 071°43′21.61′′ W) 

LOBBY, MA FIX (Lat. 42°30′15.53′′ N, long. 071°36′34.04′′ W) 

SOSYO, MA FIX (Lat. 42°29′14.45′′ N, long. 071°25′55.75′′ W) 

REVER, MA FIX (Lat. 42°26′27.48′′ N, long. 070°57′41.31′′ W) 

Excluding the airspace within Canada. 

* * * * * 

Issued in Washington, DC, on July 7, 2022. 

Scott M. Rosenbloom, 

Manager, Airspace Rules and Regulations. 

[FR Doc. 2022–14890 Filed 7–14–22; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 2 

[Docket No. FDA–2020–N–1383] 

Revocation of Methods of Analysis 

Regulation 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

proposing to revoke the Methods of 

analysis regulation describing an FDA 

policy to use certain methods of 

analysis for FDA enforcement programs 

when the method of analysis is not 

prescribed in a regulation. FDA is 

proposing this action because the 

existing regulation is unnecessary. 

DATES: Either electronic or written 

comments on the proposed rule must be 

submitted by September 28, 2022. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

September 28, 2022. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

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–1383 for ‘‘Revocation of 

Methods of Analysis Regulation.’’ 

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 


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