Federal Register / Vol. 88, No. 197 / Friday, October 13, 2023 / Rules and Regulations 70889 

holds. Under §§ 1.283(d) and 1.285(j), 

certain parties may, for the enumerated 

reasons, request reviews of the prior 

notice refusals and holds within 5 

calendar days of the hold or refusal. The 

fourth edition clarifies that FDA 

considers the 5-calendar-day clock to 

begin when FDA provides notice of the 

refusal or hold to the submitter or 

transmitter. 

Additionally, in 2016, CBP issued a 

notice announcing that ABI/ACE would 

replace ACS as the sole electronic data 

interchange system authorized by CBP 

for the processing of electronic entries 

of FDA-regulated products (see 81 FR 

30320, May 16, 2016). ABI/ACE became 

the successor system to ACS. In 2017, 

we amended 21 CFR part 1, subpart I to 

replace references to ACS and successor 

system with ABI/ACE (see 82 FR 

15627). As part of this rulemaking, we 

eliminated some requirements for 

submitting prior notice due to the 

expanded capabilities of ABI/ACE, such 

as the requirement to submit articles 

that have been refused under section 

801(m)(1) of the FD&C Act or subpart I 

in FDA PNSI. Further, ABI/ACE can 

now accommodate entries it previously 

could not, such as articles of food 

arriving through international mail. 

Therefore, to reflect these changes that 

were implemented in the rulemaking 

and the expanded capabilities of ABI/ 

ACE, we are replacing references in the 

prior notice guidance to ACS with the 

successor system ABI/ACE. In addition, 

we are providing clarification regarding 

how persons may submit prior notice 

for articles of food imported or offered 

for import by international mail. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on guidance for 

industry on the prior notice 

requirements. It does not establish any 

rights for any person and is not binding 

on FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501–3521). The collections of 

information in 21 CFR 1.278 to 1.282 

have been approved under OMB control 

number 0910–0520. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/vaccines-blood-biologics/ 

guidance-compliance-regulatoryinformation-biologics/biologicsguidances, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. Use the FDA 

website listed in the previous sentence 

to find the most current version of the 

guidance. 

Dated: October 10, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–22649 Filed 10–12–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket Number USCG–2023–0735] 

RIN 1625–AA00 

Safety Zone; Atlantic Ocean, 

Jacksonville Beach, FL 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary safety zone on 

the waterways surrounding Jacksonville, 

Florida during the 2023 Jacksonville 

Beach Sea and Sky Air Show. The safety 

zone is necessary to ensure the safety of 

event participants and spectators. Entry 

of vessels or persons into this zone is 

prohibited unless specifically 

authorized by the Captain of the Port 

(COTP) Jacksonville or a designated 

representative. 

DATES: This rule is effective from 7 a.m. 

until 5 p.m. on October 20, 2023, 

through October 22, 2023. 

ADDRESSES: To view documents 

mentioned in this preamble as being 

available in the docket, go to https://

www.regulations.gov, type USCG–2023– 

0735 in the search box and click 

‘‘Search.’’ Next, in the Document Type 

column, select ‘‘Supporting & Related 

Material.’’ 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

email Marine Science Technician First 

Class Anthony DeAngelo, Waterways 

Management Division, Sector 

Jacksonville, FL, U.S. Coast Guard; 

telephone 904–714–7631; email 

Anthony.DeAngelo@uscg.mil. 

SUPPLEMENTARY INFORMATION: 

I. Table of Abbreviations 

COTP Captain of the Port 

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 

II. Background Information and 

Regulatory History 

The Coast Guard is issuing this 

temporary rule without prior notice and 

opportunity to comment pursuant to 

authority under section 4(a) of the 

Administrative Procedure Act (APA) (5 

U.S.C. 553(b)). This provision 

authorizes an agency to issue a rule 

without prior notice and opportunity to 

comment when the agency for good 

cause finds that those procedures are 

‘‘impracticable, unnecessary, or contrary 

to the public interest.’’ Under 5 U.S.C. 

553(b)(B), the Coast Guard finds that 

good cause exists for not publishing a 

notice of proposed rulemaking (NPRM) 

with respect to this rule because it is 

impracticable. The Coast Guard was 

notified of the event without ample time 

for the NPRM process. We must 

establish the safety zone by October 20, 

2023, and lack sufficient time to provide 

for a reasonable comment period and 

then consider those comments before 

issuing this rule. 

Under 5 U.S.C. 553(d)(3), the Coast 

Guard finds that good cause exists for 

making this rule effective less than 30 

days after publication in the Federal 

Register. Delaying the effective date of 

this rule would be contrary to the public 

interest because immediate action is 

needed to ensure the safety of the 

participants and vessels during the 2023 

Jacksonville Beach Sea and Sky Air 

Show. 

III. Legal Authority and Need for Rule 

The Coast Guard is issuing this rule 

under authority in 46 U.S.C. 70034. The 

Captain of the Port Sector Jacksonville 

(COTP) has determined that potential 

hazards associated with the 2023 

Jacksonville Beach Sea and Sky Air 

Show will be a safety concern for 

persons and vessels in the regulated 

area. This rule is needed to ensure the 

safety of the event participants, the 

general public, vessels and the marine 

environment in the navigable waters 

within the safety zone during the 2023 

Jacksonville Beach Sea and Sky Air 

Show. 

IV. Discussion of the Rule 

This rule establishes a safety zone on 

certain waters of Jacksonville, Florida, 

during the 2023 Jacksonville Beach Sea 


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70890 Federal Register / Vol. 88, No. 197 / Friday, October 13, 2023 / Rules and Regulations 

and Sky Air Show. The safety zone will 

be enforced from 7 a.m. until 5 p.m. on 

October 20, 2023, through October 22, 

2023. The safety zone will cover waters 

within the points starting at 30°18′00′′ 

N, 081°23′06′′ W, then proceeding to the 

East to point 30°17′54′′ N, 081°21′54′′ W, 

then to the Southeast to point 30°16′12′′ 

N, 081°21′34′′ W, then to the Southwest 

to point 30°16′06′′ N, 081°22′43′′ W, 

then proceeding to the first point. 

No person or vessel will be permitted 

to enter, transit through, anchor in, or 

remain within the safety zone without 

first obtaining permission from the 

COTP or a designated representative. If 

authorization to enter, transit through, 

anchor in, or remain within the safety 

zone is granted by the COTP or a 

designated representative, all persons 

and vessels receiving such authorization 

must comply with the instructions of 

the COTP or a designated 

representative. The Coast Guard will 

provide notice of the safety zone by 

Broadcast Notice to Mariners, and/or by 

on-scene designated representatives. 

V. Regulatory Analyses 

We developed this 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 rule has not been designated a 

‘‘significant regulatory action,’’ under 

section 3(f) of Executive Order 12866, as 

amended by Executive Order 14094 

(Modernizing Regulatory Review). 

Accordingly, this rule has not been 

reviewed by the Office of Management 

and Budget (OMB). 

This regulatory action determination 

is based on following reasons: (1) the 

temporary safety zone will only be 

enforced for a total of 10 hours per day, 

for 3 consecutive days; (2) although 

persons and vessels may not enter, 

transit through, anchor in, or remain 

within the safety zone without 

authorization from the COTP or a 

designated representative, they may 

operate in the surrounding area during 

the enforcement period; (3) persons and 

vessels may still enter, transit through, 

anchor in, or remain within the areas 

during the enforcement period if 

authorized by the COTP or a designated 

representative. 

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 rule will 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 V.A above, this 

rule will not have a significant 

economic impact on any vessel owner 

or operator. 

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 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. 

Small businesses may send comments 

on the actions of Federal employees 

who enforce, or otherwise determine 

compliance with, Federal regulations to 

the Small Business and Agriculture 

Regulatory Enforcement Ombudsman 

and the Regional Small Business 

Regulatory Fairness Boards. The 

Ombudsman evaluates these actions 

annually and rates each agency’s 

responsiveness to small business. If you 

wish to comment on actions by 

employees of the Coast Guard, call 1– 

888–REG–FAIR (1–888–734–3247). The 

Coast Guard will not retaliate against 

small entities that question or complain 

about this rule or any policy or action 

of the Coast Guard. 

C. Collection of Information 

This rule will 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 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 rule does not have Tribal 

implications under Executive Order 

13175, Consultation and Coordination 

with Indian Tribal Governments, 

because it does 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. 

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 rule 

will not result in such an expenditure, 

we do discuss the effects of this rule 

elsewhere in this preamble. 

F. Environment 

We have analyzed this 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 

determined 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 rule involves a 1.7 

nautical mile perimeter safety zone, 

lasting the duration of the marine event 

and thus limited in time and scope. This 

zone will prohibit entry while in effect. 

It is categorically excluded from further 

review under paragraph L60a of 

Appendix A, Table 1 of DHS Instruction 

Manual 023–01–001–01, Rev. 1. A 

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. 

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 


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Federal Register / Vol. 88, No. 197 / Friday, October 13, 2023 / Rules and Regulations 70891 

coordinate protest activities so that your 

message can be received without 

jeopardizing the safety or security of 

people, places, or vessels. 

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 amends 33 

CFR 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. 01.3. 

■ 2. Add § 165.T07–0735 to read as 

follows: 

§ 165.T07–0735 2023 Jacksonville Beach 

Sea and Sky Airshow. 

(a) Location. The following area is a 

safety zone: All waters of the Atlantic 

Ocean off the coast of Jacksonville 

Beach, from surface to bottom, that are 

within the 1.7 nautical mile perimeter 

that begins at 30°18′00′′ N, 081°23′06′′ 

W, then proceeding to the East to point 

30°17′54′′ N, 081°21′54′′ W, then to the 

Southeast to point 30°16′12′′ N, 

081°21′34′′ W, then to the Southwest to 

point 30°16′06′′ N, 081°22′43′′ W, then 

proceeding to the first point. 

(b) Definitions. As used in this 

section, the term ‘‘designated 

representative’’ means a Coast Guard 

Patrol Commander, including a Coast 

Guard coxswain, petty officer, or other 

officer operating a Coast Guard vessel 

and a Federal, State, and local officer 

designated by or assisting the Captain of 

the Port Jacksonville (COTP) in the 

enforcement of the safety zone. 

(c) Regulations. (1) All persons and 

vessels are prohibited from entering, 

transiting through, anchoring in, or 

remaining within the regulated area 

unless authorized by the COTP 

Jacksonville or a designated 

representative. 

(2) Persons and vessels desiring to 

enter, transit through, anchor in, or 

remain within the regulated area may 

contact the COTP Jacksonville by 

telephone at (904) 714–7557, or a 

designated representative via VHF–FM 

radio on channel 16 to request 

authorization. If authorization is 

granted, all persons and vessels 

receiving such authorization must 

comply with the instructions of the 

COTP Jacksonville or a designated 

representative. 

(3) The Coast Guard will provide 

notice of the regulated area by Local 

Notice to Mariners, Broadcast Notice to 

Mariners via VHF–FM channel 16, or 

the COTP’s designated representative. 

(d) Enforcement period. This section 

will be enforced from 7 a.m. until 5 p.m. 

on October 20, 2023, through October 

22, 2023. 

Dated: October 6, 2023. 

J.D. Espino-Young, 

Captain, U.S. Coast Guard, Captain of the 

Port Jacksonville. 

[FR Doc. 2023–22701 Filed 10–12–23; 8:45 am] 

BILLING CODE 9110–04–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 20 

[WT Docket No. 20–3; DA 23–914; FR ID 

133942] 

Wireless Telecommunications Bureau 

Conditionally Waives Certain Aspects 

of the Wireless Hearing Aid 

Compatibility Volume Control Testing 

Standard 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule; limited waiver. 

SUMMARY: The Wireless 

Telecommunications Bureau (Bureau) of 

the Federal Communications 

Commission (Commission) recently 

granted a limited waiver of the 

Commission’s wireless hearing aid 

compatibility rules with respect to the 

volume control technical standard that 

handset manufacturers use in part to 

certify handsets as hearing aidcompatible under the 2019 ANSI 

Standard. The Bureau took this step in 

response to a petition filed by the 

Alliance for Telecommunications 

Industry Solutions (ATIS) seeking 

waiver of certain aspects of these rules. 

By conditionally granting the waiver 

request, the Bureau ensures that handset 

manufacturers can continue to release 

new hearing aid-compatible handset 

models while a new volume control 

standard is developed that the 

Commission can adopt into its wireless 

hearing aid compatibility rules. 

DATES: The waiver is effective as of 

September 29, 2023. 

ADDRESSES: Federal Communications 

Commission, 45 L Street NE, 

Washington, DC 20554. 

FOR FURTHER INFORMATION CONTACT: Eli 

Johnson, Eli.Johnson@fcc.gov, of the 

Wireless Telecommunications Bureau, 

Competition & Infrastructure Policy 

Division, (202) 418–1395. 

SUPPLEMENTARY INFORMATION: This is a 

summary of the Commission document, 

WT Docket No. 20–3, DA 23–914, 

released on September 29, 2023. The 

full text of this document is available for 

public inspection on the FCC’s website 

at: https://docs.fcc.gov/public/ 

attachments/DA-23-914A1.pdf. The 

document is available electronically in 

ASCII, Microsoft Word, and/or Adobe 

Acrobat. Alternative formats are 

available for people with disabilities 

(Braille, large print, electronic files, 

audio format, etc.), and reasonable 

accommodations (accessible format 

documents, sign language interpreters, 

CART, etc.) may be requested by 

sending an email to FCC504@fcc.gov or 

call the Consumer & Governmental 

Affairs Bureau at 202–418–0530 (voice), 

202–418–0432 (TTY). 

Synopsis 

1. The Bureau grants a limited waiver 

of § 20.19(b)(1) and (3) of the 

Commission’s wireless hearing aid 

compatibility rules with respect to the 

volume control technical standard that 

handset manufacturers use in part to 

certify handsets as hearing aidcompatible under the 2019 ANSI 

Standard. This action is prompted by a 

request filed by the Alliance for 

Telecommunications Industry Solutions 

(ATIS) seeking waiver of certain aspects 

of these rules. Under the terms of the 

time-limited waiver the Bureau grants, a 

handset may be certified as hearing aidcompatible under the 2019 ANSI 

Standard if it meets the volume control 

testing requirements described in this 

Order as well as all other aspects of the 

2019 ANSI Standard. 

2. Consistent with ATIS’s September 

12, 2023, ex parte letter (ATIS Ex Parte 

Letter) and as a condition of this waiver, 

the Bureau requires a handset to pass 

the conversational gain test at the 2 

Newton (N) force level on all available 

narrowband and wideband codecs and 

air interface combinations. With respect 

to the 8N force level test, the Bureau 

agrees with the ATIS Ex Parte Letter that 

this test should be performed, and the 

Bureau waives the requirement that a 

handset achieve at least an 18 dB 

conversational gain. This waiver is 

conditioned on manufacturers 

performing the 8N force level test using 

the same testing parameters that the 

Bureau is requiring for the 2N force 

level test and to place on the handset’s 

package label the resulting 

conversational gain (even if it is below 

18 dB) in a manner consistent with the 


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