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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Federal Register / Vol. 87, No. 135 / Friday, July 15, 2022 / Proposed Rules 42399 

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: 

Holli Kubicki, Office of Regulatory 

Affairs, Food and Drug Administration, 

12420 Parklawn Drive, Rockville, MD 

20852, 240–402–4557. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Executive Summary 

A. Purpose of the Proposed Rule 

B. Summary of the Major Provisions of the 

Proposed Rule 

C. Legal Authority 

D. Costs and Benefits 

II. Background 

A. Introduction 

B. Need for Regulation 

III. Legal Authority 

IV. Description of the Proposed Rule 

V. Proposed Effective Date 

VI. Economic Analysis of Impacts 

VII. Analysis of Environmental Impact 

VIII. Paperwork Reduction Act of 1995 

IX. Federalism 

X. Consultation and Coordination With 

Indian Tribal Governments 

XI. Reference 

I. Executive Summary 

A. Purpose of the Proposed Rule 

This proposed rule would revoke the 

Methods of analysis regulation, § 2.19 

(21 CFR 2.19), 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. The regulation is 

unnecessary. 

B. Summary of the Major Provisions of 

the Proposed Rule 

The proposed rule revokes § 2.19, 

which states that it is FDA policy to use 

the methods of analysis of the 

Association of Analytical Chemists 

(AOAC) International as published in 

the 1980 edition of ‘‘Official Methods of 

Analysis of the Association of 

Analytical Chemists’’ for FDA 

enforcement programs when the method 

of analysis is not prescribed in a 

regulation. 

C. Legal Authority 

FDA is taking this action under the 

general administrative provisions of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act). 

D. Costs and Benefits 

Because this proposed rule would not 

impose any additional regulatory 

burdens, this regulation is not 

anticipated to result in any compliance 

costs and the economic impact is 

expected to be minimal. 

II. Background 

A. Introduction 

FDA’s regulation concerning its 

policy on methods of analysis in 

enforcement programs dates back nearly 

50 years (37 FR 16174, Aug. 11, 1972). 

Early versions of the regulation stated 

that unless a regulation prescribed a 

specific method of analysis, it would be 

FDA’s policy to use the methods of 

analysis in the ‘‘latest edition of [the 

AOAC’s] publication . . . and 

supplements thereto. . . .’’ (see, e.g., 21 

CFR 3.89 (1976 ed.). However, in 1982, 

1 CFR 51.1 was amended to limit 

incorporation by reference of a 

publication to the edition of the 

publication that is approved, and to 

exclude future amendments or revisions 

of the publication. 

FDA has revised the methods of 

analysis regulation several times, 

including in 1982 to meet the drafting 

requirements for incorporation by 

reference set forth in 1 CFR part 51, and 

after to make several technical 

amendments to update names and 

addresses. However, since the 1982 

revision, the regulation has referred to 

the methods of analysis in the 13th 

Edition, 1980 of AOAC’s publication. 

FDA is now proposing to revoke the 

methods of analysis regulation as 

specified in this proposed rule. 

B. Need for Regulation 

The Agency believes that the 

regulation is unnecessary as a general 

matter. Absent specifying a method of 

analysis in a regulation, FDA believes it 

is more appropriate, flexible, and 

efficient to identify the Agency’s 

preferred methods of analysis in 

documents such as the Office of 

Regulatory Affairs Laboratory 

Procedures Manual, FDA compliance 

programs, and other resources. 

III. Legal Authority 

FDA is issuing this proposed rule 

under the following provisions of the 

FD&C Act: 21 U.S.C. 321, 331, 335, 342, 

343, 346a, 348, 351, 352, 355, 360b, 361, 

362, 371, 372, 374. 

IV. Description of the Proposed Rule 

The proposed rule revokes § 2.19, 

which states that it is FDA policy to use 

the methods of analysis of the AOAC 

International as published in the 1980 

edition of ‘‘Official Methods of Analysis 

of the Association of Analytical 

Chemists’’ for FDA enforcement 

programs when the method of analysis 

is not prescribed in a regulation. Repeal 

of this regulation would eliminate an 

unnecessary policy. 

FDA is proposing this action because 

a general reference to the 1980 edition 

of the ‘‘Official Methods of Analysis of 

the Association of Analytical Chemists’’ 

is unnecessary and because newer, 

updated methods of analysis may exist. 

Unless a method of analysis is specified 

in regulations, FDA believes it is more 

appropriate, flexible, and efficient to 

identify the Agency’s preferred methods 

of analysis in documents such as the 

Office of Regulatory Affairs Laboratory 

Procedures Manual and other resources. 

FDA is proposing to remove § 2.19 

from the regulations. 

V. Proposed Effective Date 

FDA is proposing that any final rule 

based on this proposed rule become 

effective 30 days after the date of its 

publication in the Federal Register. 

VI. Economic Analysis of Impacts 

We have examined the impacts of the 

proposed rule under Executive Order 

12866, Executive Order 13563, the 

Regulatory Flexibility Act (5 U.S.C. 

601–612), and the Unfunded Mandates 

Reform Act of 1995 (Pub. L. 104–4). 

Executive Orders 12866 and 13563 

direct us to assess all costs and benefits 

of available regulatory alternatives and, 

when regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). This 

proposed rule is not a significant 

regulatory action as defined by 

Executive Order 12866. 

The Regulatory Flexibility Act 

requires us to analyze regulatory options 

that would minimize any significant 

impact of a rule on small entities. 

Because this proposed rule does not add 

any new regulatory burden on the 

industry, we propose to certify that the 

proposed rule will not have a significant 

economic impact on a substantial 

number of small entities. 

The Unfunded Mandates Reform Act 

of 1995 (section 202(a)) requires us to 

prepare a written statement, which 

includes an assessment of anticipated 

costs and benefits, before proposing 

‘‘any rule that includes any Federal 

mandate that may result in the 

expenditure by State, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $100,000,000 or more 

(adjusted annually for inflation) in any 


jspears on DSK121TN23PROD with PROPOSALS1
42400 Federal Register / Vol. 87, No. 135 / Friday, July 15, 2022 / Proposed Rules 

one year.’’ The current threshold after 

adjustment for inflation is $165 million, 

using the most current (2021) Implicit 

Price Deflator for the Gross Domestic 

Product. This proposed rule would not 

result in an expenditure in any year that 

meets or exceeds this amount. 

We believe industry will largely 

maintain their current practices 

following the removal of § 2.19 Methods 

of analysis regulation. FDA will also 

maintain its current practices, similarly 

generating no quantifiable cost savings. 

Therefore, we expect this proposed rule 

to be cost neutral. Table 1 summarizes 

the estimated benefits and costs of the 

proposed rule, if finalized. 

TABLE 1—SUMMARY OF BENEFITS, COSTS AND DISTRIBUTIONAL EFFECTS OF PROPOSED RULE

Category Primary 

estimate 

Low 

estimate 

High 

estimate 

Units 

Notes Year 

dollars 

Discount 

rate 

(years) 

Period 

covered 

(%) 

Benefits: 

Annualized ................................................ $0 $0 $0 2019 7 10 

Monetized $millions/year .......................... 0 0 0 2019 3 10 

Annualized ................................................ .................. .................. .................. .................. .................. ..................

Quantified .................................................. .................. .................. .................. .................. .................. ..................

Qualitative ................................................. There would no longer be any 

inefficiencies due to keeping 

unnecessary regulations on the 

books. 

.................. .................. ..................

Costs: 

Annualized ................................................ $0 $0 $0 2019 7 10 

Monetized $millions/year .......................... 0 0 0 2019 3 10 

Annualized ................................................ .................. .................. .................. .................. 7 ..................

Quantified .................................................. .................. .................. .................. .................. 3 ..................

Qualitative ................................................. .................. .................. .................. .................. .................. ..................

Transfers: 

Federal Annualized ................................... .................. .................. .................. .................. 7 ..................

Monetized $millions/year .......................... .................. .................. .................. .................. 3 ..................

From/To ..................................................... From: To: 

Other Annualized ...................................... .................. .................. .................. .................. 7 ..................

Monetized $millions/year .......................... .................. .................. .................. .................. 3 ..................

From/To ..................................................... From: To: 

Effects: 

State, Local or Tribal Government: None. 

Small Business: None. 

Wages: None. 

Growth: None. 

We have developed a comprehensive 

Preliminary Economic Analysis of 

Impacts that assesses the impacts of the 

proposed rule. The full preliminary 

analysis of economic impacts is 

available in the docket for this proposed 

rule and at https://www.fda.gov/ 

AboutFDA/ReportsManualsForms/ 

Reports/EconomicAnalyses/default.htm. 

VII. Analysis of Environmental Impact 

We have determined under 21 CFR 

25.31(h) that this action is of a type that 

does not individually or cumulatively 

have a significant effect on the human 

environment. Therefore, neither an 

environmental assessment nor an 

environmental impact statement is 

required. 

VIII. Paperwork Reduction Act of 1995 

FDA tentatively concludes that this 

proposed rule contains no collection of 

information. Therefore, clearance by the 

Office of Management and Budget under 

the Paperwork Reduction Act of 1995 is 

not required. 

IX. Federalism 

We have analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13132. We 

have determined that this proposed rule 

does not contain policies that have 

substantial direct effects 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. Accordingly, we 

conclude that this proposed rule does 

not contain policies that have 

federalism implications as defined in 

the Executive Order and, consequently, 

a federalism summary impact statement 

is not required. 

X. Consultation and Coordination With 

Indian Tribal Governments 

We have analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13175. We 

have tentatively determined that this 

proposed rule does not contain policies 

that would have a substantial direct 

effect on one or more Indian Tribes, on 

the relationship between the Federal 

Government and Indian Tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian Tribes. The 

Agency solicits comments from tribal 

officials on any potential impact on 

Indian Tribes from this proposed action. 

XI. Reference 

The following reference is on display 

at the Dockets Management Staff (see 

ADDRESSES) and is available for viewing 

by interested persons between 9 a.m. 

and 4 p.m. Monday through Friday; it is 

also available electronically at https://

www.regulations.gov. FDA has verified 

the website address, as of the date this 

document publishes in the Federal 

Register, but websites are subject to 

change over time. 


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Federal Register / Vol. 87, No. 135 / Friday, July 15, 2022 / Proposed Rules 42401 

1. FDA/Economics Staff, ‘‘Revocation of 

Methods of Analysis Regulation, 

Preliminary Regulatory Impact Analysis, 

Preliminary Regulatory Flexibility 

Analysis, Unfunded Mandates Reform 

Act Analysis,’’ 2020. (Available at: 

https://www.fda.gov/AboutFDA/ 

ReportsManualsForms/Reports/ 

EconomicAnalyses/default.htm.) 

List of Subjects in 21 CFR Part 2 

Administrative practice and 

procedure, Cosmetics, Drugs, Foods. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act, and under 

authority delegated to the Commissioner 

of Food and Drugs, FDA proposes that 

21 CFR part 2 be amended as follows: 

PART 2—GENERAL ADMINISTRATIVE 

RULINGS AND DECISIONS 

■ 1. The authority citation for part 2 

continues to read as follows: 

Authority: 15 U.S.C. 402, 409; 21 U.S.C. 

321, 331, 335, 342, 343, 346a, 348, 351, 352, 

355, 360b, 361, 362, 371, 372, 374; 42 U.S.C. 

7671 et seq. 

§ 2.19 [Removed] 

■ 2. Remove § 2.19. 

Dated: July 11, 2022. 

Robert M. Califf, 

Commissioner of Food and Drugs. 

[FR Doc. 2022–15109 Filed 7–14–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF TRANSPORTATION 

Federal Highway Administration 

23 CFR Part 490 

[Docket No. FHWA–2021–0004] 

RIN 2125–AF99 

National Performance Management 

Measures; Assessing Performance of 

the National Highway System, 

Greenhouse Gas Emissions Measure 

AGENCY: Federal Highway 

Administration (FHWA), U.S. 

Department of Transportation (DOT). 

ACTION: Notice of proposed rulemaking 

(NPRM); request for comments. 

SUMMARY: Extreme weather due to 

climate change threatens the safety and 

mobility of Americans and challenges 

the stability of supply chains. To help 

address the climate crisis, FHWA 

proposes to amend its regulations 

governing national performance 

management measures to require State 

departments of transportation (State 

DOTs) and metropolitan planning 

organizations (MPOs) to establish 

declining carbon dioxide (CO2) targets 

and to establish a method for the 

measurement and reporting of 

greenhouse gas (GHG) emissions 

associated with transportation under the 

Highways title of the United States Code 

(U.S.C.). The proposed rule would not 

mandate the level of the targets. Rather, 

State DOTs and MPOs would have 

flexibility to set targets that are 

appropriate for their communities and 

that work for their respective climate 

change and other policy priorities, as 

long as the targets would reduce 

emissions over time. Specifically, the 

proposed rule would require State DOTs 

and MPOs that have National Highway 

System (NHS) mileage within their State 

geographic boundaries and metropolitan 

planning area boundaries, respectively, 

to establish declining CO2 emissions 

targets to reduce CO2 emissions 

generated by on-road mobile sources 

relative to a reference year defined as 

calendar year 2021, that align with the 

Administration’s net-zero targets as 

outlined in the national policy 

established under Executive orders 

entitled ‘‘Protecting Public Health and 

the Environment and Restoring Science 

to Tackle the Climate Crisis’’ and 

‘‘Tackling the Climate Crisis at Home 

and Abroad’’ and at the Leaders Summit 

on Climate. The proposed rule would 

require MPOs serving urbanized areas 

with multiple MPOs to establish 

additional joint targets. The proposed 

rule also would require State DOTs and 

MPOs to biennially report on their 

progress in meeting the targets and 

require FHWA to assess significant 

progress toward achieving the targets. 

DATES: Comments must be received on 

or before October 13, 2022. 

ADDRESSES: To ensure that you do not 

duplicate your docket submissions, 

please submit comments by only one of 

the following means: 

• Federal eRulemaking Portal: Go to 

https://www.regulations.gov and follow 

the online instructions for submitting 

comments. 

• Mail: Docket Management Facility, 

U.S. Department of Transportation, 1200 

New Jersey Avenue SE, Washington, DC 

20590. 

• Hand Delivery: U.S. Department of 

Transportation, Docket Operations, 

West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue SE, 

Washington, DC 20590, between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. The telephone 

number is (202) 366–9329. 

All submissions should include the 

agency name and the docket number 

that appears in the heading of this 

document or the Regulation Identifier 

Number (RIN) for the rulemaking. All 

comments received will be posted 

without change to https://

www.regulations.gov, including any 

personal information provided. 

FOR FURTHER INFORMATION CONTACT: Mr. 

John Davies, Office of Planning, 

Environment, and Realty, (202) 366– 

6039, or via email at JohnG.Davies@

dot.gov, or Mr. Lev Gabrilovich, Office 

of the Chief Counsel (HCC–30), (202) 

366–3813, or via email at 

Lev.Gabrilovich@dot.gov. Office hours 

are from 8:00 a.m. to 4:30 p.m., E.T., 

Monday through Friday, except Federal 

holidays. 

SUPPLEMENTARY INFORMATION: 

Electronic Access and Filing 

This document and all comments 

received may be viewed online through 

the Federal eRulemaking portal at 

www.regulations.gov using the docket 

number listed above. Electronic retrieval 

help and guidelines are also available at 

www.regulations.gov. An electronic 

copy of this document may also be 

downloaded from the Office of the 

Federal Register’s website at 

www.FederalRegister.gov and the 

Government Publishing Office’s website 

at www.GovInfo.gov. 

All comments received before the 

close of business on the comment 

closing date indicated above will be 

considered and will be available for 

examination in the docket at the above 

address. Comments received after the 

comment closing date will be filed in 

the docket and will be considered to the 

extent practicable. In addition to late 

comments, FHWA will also continue to 

file relevant information in the docket 

as it becomes available after the 

comment period closing date and 

interested persons should continue to 

examine the docket for new material. A 

final rule may be published at any time 

after close of the comment period and 

after DOT has had the opportunity to 

review the comments submitted. 

Table of Contents for Supplementary 

Information 

I. Executive Summary 

II. Background and Regulatory History 

III. Statement of the Problem, Legal 

Authority, and Rationale 

A. Confronting the Climate Crisis 

B. Legal Authority for the Proposed GHG 

Measure 

C. Additional Rationale for the Proposed 

GHG Measure 

1. Costs and Benefits 

2. Duplication of Efforts 

D. Expected Schedule for Implementation 

IV. Section-by-Section Discussion of the 

Proposed Changes 

A. Subpart A—General Information 

B. Subpart E—National Performance 

Management Measures to Assess 


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