Federal Register / Vol. 87, No. 137 / Tuesday, July 19, 2022 / Proposed Rules 42985 

If finalized, the proposed rule will 

affect all persons who would handle, or 

propose to handle fenfluramine. 

Fenfluramine as a pharmaceutical 

product (Fintepla) is currently available 

and marketed in the U.S. Because 

fenfluramine is currently a schedule IV 

drug, all legal handling of fenfluramine 

is currently done under appropriate 

DEA license. In such instances, DEA’s 

knowledge of its registrant population 

forms the basis for estimating the 

number of affected entities and small 

entities that are affected by this 

rulemaking. There are currently 40 

unique registrations authorized to 

handle fenfluramine specifically, as 

well as a number of registered analytical 

labs that are authorized to handle 

schedule IV controlled substances 

generally. From review of entity names, 

DEA estimates these 40 registrations 

represent 27 entities. Some of these 

entities are likely to be small entities. 

However, since DEA does not have 

information of registrant size and the 

majority of DEA registrants are small 

entities or are employed by small 

entities, DEA estimates a maximum of 

27 entities are small entities. Therefore, 

DEA conservatively estimates as many 

as 27 small entities are affected by this 

proposed rule. However, because this 

rule would remove fenfluramine from 

regulatory controls of the CSA, it is 

likely to result in some cost savings. 

Any person planning to handle 

fenfluramine will realize cost savings in 

the form of saved DEA registration fees, 

and the elimination of physical security, 

recordkeeping, and reporting 

requirements. Because of these factors, 

DEA projects that this rule will not 

result in a significant economic impact 

on a substantial number of small 

entities. 

Unfunded Mandates Reform Act of 1995 

On the basis of information contained 

in the ‘‘Regulatory Flexibility Act’’ 

section above, DEA has determined 

pursuant to the Unfunded Mandates 

Reform Act (UMRA) of 1995, (2 U.S.C. 

1501 et seq.), that this proposed action 

would not result in 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 

1 year. . . .’’ Therefore, neither a Small 

Government Agency Plan nor any other 

action is required under UMRA of 1995. 

Paperwork Reduction Act of 1995 

This proposed action does not impose 

a new collection of information 

requirement under the Paperwork 

Reduction Act of 1995. (44 U.S.C. 3501– 

3521). 

Signing Authority 

This document of the Drug 

Enforcement Administration was signed 

on July 13, 2022, by Administrator Anne 

Milgram. That document with the 

original signature and date is 

maintained by DEA. For administrative 

purposes only, and in compliance with 

requirements of the Office of the Federal 

Register, the undersigned DEA Federal 

Register Liaison Officer has been 

authorized to sign and submit the 

document in electronic format for 

publication, as an official document of 

DEA. This administrative process in no 

way alters the legal effect of this 

document upon publication in the 

Federal Register. 

List of Subjects in 21 CFR Part 1308 

Administrative practice and 

procedure, Drug traffic control, 

Reporting and recordkeeping 

requirements. 

For the reasons set out above, DEA 

proposes to amend 21 CFR part 1308 as 

follows: 

PART 1308—SCHEDULES OF 

CONTROLLED SUBSTANCES 

■ 1. The authority citation for 21 CFR 

part 1308 continues to read as follows: 

Authority: 21 U.S.C. 811, 812, 871(b), 

956(b), unless otherwise noted. 

§ 1308.14 [Amended] 

■ 2. In § 1308.14, remove and reserve 

paragraph (d). 

Scott Brinks, 

Federal Register Liaison Officer, Drug 

Enforcement Administration. 

[FR Doc. 2022–15335 Filed 7–18–22; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket Number USCG–2022–0595] 

RIN 1625–AA00 

Safety Zone; Ironman Michigan, 

Frankfort Harbor, MI 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Coast Guard is proposing 

to establish a temporary safety zone for 

certain waters of Betsie Lake in 

Frankfort, MI. This action is necessary 

to provide for the safety of life on these 

navigable waters during the swim 

portion of an Ironman event on 

September 11, 2022. This proposed 

rulemaking would restrict usage by 

persons and vessels within the safety 

zone. At no time during the effective 

period may vessels transit the waters of 

Betsie Lake in the vicinity of a 

triangular shaped race course enclosed 

by the following three coordinates: 

44°37.80′ N, ¥086°13.91′ W to 44°37.81′ 

N, ¥086°14.22′ W to 44°37.58′ N, 

¥086°13.75′ W, then back to the 

starting point. The race course will be 

marked by buoys. These restrictions 

would apply to all perons and vessels 

during the effective period unless 

authorized by the Captain of the Port 

Lake Michigan or a designated 

representative. We invite your 

comments on this proposed rulemaking. 

DATES: Comments and related material 

must be received by the Coast Guard on 

or before August 18, 2022. 

ADDRESSES: You may submit comments 

identified by docket number USCG– 

2022–0595 using the Federal 

eRulemaking Portal at https://

www.regulations.gov. See the ‘‘Public 

Participation and Request for 

Comments’’ portion of the 

SUPPLEMENTARY INFORMATION section for 

further instructions on submitting 

comments. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions about this proposed 

rulemaking, call or email Chief Petty 

Officer Jeromy Sherrill, Sector Lake 

Michigan Waterways Management 

Division, U.S. Coast Guard; telephone 

414–747–7148, email 

Jeromy.N.Sherrill@uscg.mil. 

SUPPLEMENTARY INFORMATION: 

I. Table of Abbreviations 

CFR Code of Federal Regulations 

DHS Department of Homeland Security 

FR Federal Register 

NPRM Notice of proposed rulemaking 

§ Section 

U.S.C. United States Code 

On June 23, 2022, the Coast Guard 

was notified by the event sponsor of its 

intent to host Ironman Michigan in 

Frankfort, MI on September 11, 2022 

from 8:00 a.m. to 10:15 a.m. The swim 

will begin near Frankfort Municipal 

Marina in Betsie Lake. The race course 

will be triangular shaped area enclosed 

by the following coordinates: 44°37.80′ 

N, ¥086°13.91′ W to 44°37.81′ N, 

¥086°14.22′ W to 44°37.58′ N, 

¥086°13.75′ W, then back to the 

starting point. The race course will be 

marked by buoys. The COTP has 

determined that potential hazards 

associated with the triathlon would be 


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42986 Federal Register / Vol. 87, No. 137 / Tuesday, July 19, 2022 / Proposed Rules 

a safety concern for anyone within the 

safety zone that is not participating in 

the triathlon. 

The purpose of this rulemaking is to 

ensure the safety of person, vessels and 

the navigable waters of Betsie Lake, MI. 

The Coast Guard is proposing this 

rulemaking under authority in 46 U.S.C. 

70034 (previously 33 U.S.C. 1231). 

III. Discussion of Proposed Rule 

The COTP is proposing to establish a 

safety zone from 6:00 a.m. through 12:00 

a.m. on September 11, 2022. The safety 

zone will cover all waters of Betsie Lake 

in the vicinity of a triangular shaped 

race course near Frankfort Municipal 

Marina in Frankfort, MI. The duration of 

the zone is intended to ensure the safety 

of vessels and these navigable waters 

before, during, and after the triathlon 

event. No vessels or person would be 

permitted to enter the safety zone 

without obtaining permission from the 

COTP or a designated representative. 

The regulatory text we are proposing 

appears at the end of this document. 

IV. Regulatory Analyses 

We developed this proposed rule after 

considering numerous statutes and 

Executive orders related to rulemaking. 

Below we summarize our analyses 

based on a number of these statutes and 

Executive orders, and we discuss First 

Amendment rights of protestors. 

A. Regulatory Planning and Review 

Executive Orders 12866 and 13563 

direct agencies to assess the costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits. 

This NPRM has not been designated a 

‘‘significant regulatory action,’’ under 

Executive Order 12866. Accordingly, 

the NPRM has not been reviewed by the 

Office of Management and Budget 

(OMB). 

This regulatory action determination 

is based on the characteristics of the 

safety zone. The safety zone created by 

this proposed rule will relatively small 

and is designed to minimize its impact 

on navigable waters. This proposed rule 

will prohibit entry into certain 

navigable waters of Betsie Lake in 

Frankfort, MI, and it is not anticipated 

to exceed 6 hours in duration. Thus, 

restrictions on vessel movement within 

that particular area are expected to be 

minimal. Moreover, under certain 

conditions vessels may still transit 

through the safety zone when permitted 

by the COTP Lake Michigan. 

B. Impact on Small Entities 

The Regulatory Flexibility Act of 

1980, 5 U.S.C. 601–612, as amended, 

requires Federal agencies to consider 

the potential impact of regulations on 

small entities during rulemaking. The 

term ‘‘small entities’’ comprises small 

businesses, not-for-profit organizations 

that are independently owned and 

operated and are not dominant in their 

fields, and governmental jurisdictions 

with populations of less than 50,000. 

The Coast Guard certifies under 5 U.S.C. 

605(b) that this proposed rule would not 

have a significant economic impact on 

a substantial number of small entities. 

While some owners or operators of 

vessels intending to transit the safety 

zone may be small entities, for the 

reasons stated in section IV.A above, 

this proposed rule would not have a 

significant economic impact on any 

vessel owner or operator. 

If you think that your business, 

organization, or governmental 

jurisdiction qualifies as a small entity 

and that this rule would have a 

significant economic impact on it, 

please submit a comment (see 

ADDRESSES) explaining why you think it 

qualifies and how and to what degree 

this rule would economically affect it. 

Under section 213(a) of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996 (Pub. L. 104–121), 

we want to assist small entities in 

understanding this proposed rule. If the 

rule would affect your small business, 

organization, or governmental 

jurisdiction and you have questions 

concerning its provisions or options for 

compliance, please call or email the 

person listed in the FOR FURTHER

INFORMATION CONTACT section. The Coast 

Guard will not retaliate against small 

entities that question or complain about 

this proposed rule or any policy or 

action of the Coast Guard. 

C. Collection of Information 

This proposed rule would not call for 

a new collection of information under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). 

D. Federalism and Indian Tribal 

Governments 

A rule has implications for federalism 

under Executive Order 13132 

(Federalism), if it has 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. We have analyzed 

this proposed rule under that Order and 

have determined that it is consistent 

with the fundamental federalism 

principles and preemption requirements 

described in Executive Order 13132. 

Also, this proposed rule does not have 

tribal implications under Executive 

Order 13175 (Consultation and 

Coordination with Indian Tribal 

Governments) because it would not 

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. 

If you believe this proposed rule has 

implications for federalism or Indian 

tribes, please call or email the person 

listed in the FOR FURTHER INFORMATION

CONTACT section. 

E. Unfunded Mandates Reform Act 

The Unfunded Mandates Reform Act 

of 1995 (2 U.S.C. 1531–1538) requires 

Federal agencies to assess the effects of 

their discretionary regulatory actions. In 

particular, the Act addresses actions 

that may result in the expenditure by a 

State, local, or tribal government, in the 

aggregate, or by the private sector of 

$100,000,000 (adjusted for inflation) or 

more in any one year. Though this 

proposed rule would not result in such 

an expenditure, we do discuss the 

effects of this rule elsewhere in this 

preamble. 

F. Environment 

We have analyzed this proposed rule 

under Department of Homeland 

Security Directive 023–01, Rev. 1, 

associated implementing instructions, 

and Environmental Planning 

COMDTINST 5090.1 (series), which 

guide the Coast Guard in complying 

with the National Environmental Policy 

Act of 1969 (42 U.S.C. 4321–4370f), and 

have made a preliminary determination 

that this action is one of a category of 

actions that do not individually or 

cumulatively have a significant effect on 

the human environment. This proposed 

rule involves a safety zone lasting 6 

hours that would prohibit entry within 

a relatively small portion of Betsie Lake. 

Normally such actions are categorically 

excluded from further review under 

paragraph L60(a) of Appendix A, Table 

1 of DHS Instruction Manual 023–01– 

001–01, Rev. 1. A preliminary Record of 

Environmental Consideration 

supporting this determination is 

available in the docket. For instructions 

on locating the docket, see the 

ADDRESSES section of this preamble. We 

seek any comments or information that 

may lead to the discovery of a 

significant environmental impact from 

this proposed rule. 


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Federal Register / Vol. 87, No. 137 / Tuesday, July 19, 2022 / Proposed Rules 42987 

1Petition of the United States Postal Service for 

the Initiation of a Proceeding to Consider Proposed 

Changes in Analytical Principles (Proposal Four), 

July 11, 2022 (Petition). The Postal Service also 

filed a notice of filing of non-public materials 

relating to Proposal Four. Notice of Filing of USPS– 

RM2022–10–NP1 and Application for Nonpublic 

Treatment, July 11, 2022. 

G. Protest Activities 

The Coast Guard respects the First 

Amendment rights of protesters. 

Protesters are asked to call or email the 

person listed in the FOR FURTHER

INFORMATION CONTACT section to 

coordinate protest activities so that your 

message can be received without 

jeopardizing the safety or security of 

people, places, or vessels. 

V. Public Participation and Request for 

Comments 

We view public participation as 

essential to effective rulemaking, and 

will consider all comments and material 

received during the comment period. 

Your comment can help shape the 

outcome of this rulemaking. If you 

submit a comment, please include the 

docket number for this rulemaking, 

indicate the specific section of this 

document to which each comment 

applies, and provide a reason for each 

suggestion or recommendation. 

We encourage you to submit 

comments through the Federal 

eRulemaking Portal at https://

www.regulations.gov. If your material 

cannot be submitted using https://

www.regulations.gov, call or email the 

person in the FOR FURTHER INFORMATION

CONTACT section of this document for 

alternate instructions. 

We accept anonymous comments. All 

comments received will be posted 

without change to https://

www.regulations.gov and will include 

any personal information you have 

provided. For more about privacy and 

submissions in response to this 

document, see DHS’s eRulemaking 

System of Records notice (85 FR 14226, 

March 11, 2020). 

Documents mentioned in this NPRM 

as being available in the docket, and all 

public comments, will be in our online 

docket at https://www.regulations.gov 

and can be viewed by following that 

website’s instructions. Additionally, if 

you go to the online docket and sign up 

for email alerts, you will be notified 

when comments are posted or a final 

rule is published. 

List of Subjects in 33 CFR Part 165 

Harbors, Marine safety, Navigation 

(water), Reporting and recordkeeping 

requirements, Security measures, 

Waterways. 

For the reasons discussed in the 

preamble, the Coast Guard proposes to 

amend 33 CFR part 165 as follows: 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

■ 1. The authority citation for part 165 

continues to read as follows: 

Authority: 46 U.S.C. 70034, 70051; 33 CFR 

1.05–1, 6.04–1, 6.04–6, and 160.5; 

Department of Homeland Security Delegation 

No. 00170.1, Revision No. 01.2. 

■ 2. Add § 165.T09–0595 to read as 

follows: 

§ 165.T09–0595 Safety Zone; Ironman 

Michigan, Frankfort, MI. 

(a) Location. All waters of Betsie Lake 

in the vicinity of a triangular shaped 

race course enclosed by the following 

three coordinates: 44°37.80′ N, 

¥086°13.91′ W to 44°37.81′ N, 

¥086°14.22′ W to 44°37.58′ N, 

¥086°13.75′ W, then back to the 

starting point. 

(b) Enforcement Period. The safety 

zone described in paragraph (a) would 

be effective on September 11, 2022 from 

6:00 a.m. through 12:00 p.m. 

(c) Regulations. 

(1) In accordance with the general 

regulations in section § 165.23, entry 

into, transiting, or anchoring within this 

safety zone is prohibited unless 

authorized by the Captain of the Port 

Lake Michigan (COTP) or a designated 

representative. 

(2) This safety zone is closed to all 

vessel traffic, except as may be 

permitted by the COTP or a designated 

representative. 

(3) The ‘‘designated representative’’ of 

the COTP is any Coast Guard 

commissioned, warrant, or petty officer 

who has been designated by the COTP 

to act on his or her behalf. 

(4) Persons and vessel operators 

desiring to enter or operate within the 

safety zone during the marine event 

must contact the COTP or an on-scene 

representative to obtain permission to 

do so. The COTP or an on-scene 

representative may be contacted via 

VHF Channel 16. Vessel operators given 

permission to enter or operate in the 

safety zone must comply with all 

directions given to them by the COTP or 

an on-scene representative. 

Dated: July 13, 2022. 

Doreen Mccarthy, 

Commander, U.S. Coast Guard, Alternant 

Captain of the Port Lake Michigan. 

[FR Doc. 2022–15333 Filed 7–18–22; 8:45 am] 

BILLING CODE 9110–04–P 

POSTAL REGULATORY COMMISSION 

39 CFR Part 3050 

[Docket No. RM2022–10; Order No. 6225] 

Periodic Reporting 

AGENCY: Postal Regulatory Commission. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Commission is 

acknowledging a recent filing requesting 

the Commission initiate a rulemaking 

proceeding to consider changes to 

analytical principles relating to periodic 

reports (Proposal Four). This document 

informs the public of the filing, invites 

public comment, and takes other 

administrative steps. 

DATES: Comments are due: August 31, 

2022. 

ADDRESSES: Submit comments 

electronically via the Commission’s 

Filing Online system at https://

www.prc.gov. Those who cannot submit 

comments electronically should contact 

the person identified in the FOR FURTHER

INFORMATION CONTACT section by 

telephone for advice on filing 

alternatives. 

FOR FURTHER INFORMATION CONTACT: 

David A. Trissell, General Counsel, at 

202–789–6820. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Introduction 

II. Proposal Four 

III. Notice and Comment 

IV. Ordering Paragraphs 

I. Introduction 

On July 11, 2022, the Postal Service 

filed a petition pursuant to 39 CFR 

3050.11 requesting that the Commission 

initiate a rulemaking proceeding to 

consider changes to analytical 

principles relating to periodic reports.1

The Petition identifies the proposed 

analytical changes filed in this docket as 

Proposal Four. 

II. Proposal Four 

Proposal. The Postal Service proposes 

the following five changes to improve 

and streamline the International Cost 

and Revenue Analysis (ICRA) model: (1) 

using Outbound International Service 

Agreement (negotiated service 

agreement, referred to as NSA) System 

for International Revenue and Volume, 

Outbound (SIRVO) data to attribute 

outbound settlement expenses and 

international transportation expenses to 

NSA products; (2) adding all countries 

to the outbound piece of the ICRA 

database and eliminating the 999X 

countries; (3) using the Settlement 

Workbooks file as the source for 

outbound settlement calculations 

instead of manually entering rates; (4) 


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