Federal Register / Vol. 88, No. 197 / Friday, October 13, 2023 / Rules and Regulations 70887 

or more and 18,000 total flight cycles or 

fewer as of April 14, 2022 (phase-in Effective 

Date of TR ALI–0763): Within 5,000 flight 

cycles from April 14, 2022, or before 

exceeding 20,000 total flight cycles, 

whichever occurs first. 

(3) For a MLG retract actuator piston rod 

that has accumulated more than 18,000 total 

flight cycles as of April 14, 2022 (phase-in 

Effective Date of TR ALI–0763): Within 2,000 

flight cycles from April 14, 2022. 

(h) No Alternative Actions or Intervals 

After the existing maintenance or 

inspection program has been revised as 

required by paragraph (g) of this AD, no 

alternative actions (e.g., inspections) or 

intervals may be used unless they are 

approved as an alternative method of 

compliance in accordance with paragraph 

(i)(1) of this AD. 

(i) Additional AD Provisions 

The following provisions also apply to this 

AD: 

(1) Alternative Methods of Compliance 

(AMOCs): The Manager, International 

Validation Branch, FAA, has the authority to 

approve AMOCs for this AD, if requested 

using the procedures found in 14 CFR 39.19. 

In accordance with 14 CFR 39.19, send your 

request to your principal inspector or local 

Flight Standards District Office, as 

appropriate. If sending information directly 

to the manager of the International Validation 

Branch, mail it to the address identified in 

paragraph (j)(3) of this AD or email to: 9- 

AVS-AIR-730-AMOC@faa.gov. If mailing 

information, also submit information by 

email. Before using any approved AMOC, 

notify your appropriate principal inspector, 

or lacking a principal inspector, the manager 

of the responsible Flight Standards Office. 

(2) Contacting the Manufacturer: For any 

requirement in this AD to obtain instructions 

from a manufacturer, the instructions must 

be accomplished using a method approved 

by the Manager, International Validation 

Branch, FAA; or Transport Canada; or MHI 

RJ Aviation ULC Transport Canada Design 

Approval Organization (DAO). If approved by 

the DAO, the approval must include the 

DAO-authorized signature. 

(j) Additional Information 

(1) Refer to Transport Canada AD CF– 

2022–56, dated September 26, 2022, for 

related information. This Transport Canada 

AD may be found in the AD docket at 

regulations.gov under Docket No. FAA– 

2023–1992. 

(2) For more information about this AD, 

contact Gabriel D. Kim, Aviation Safety 

Engineer, FAA, 1600 Stewart Avenue, Suite 

410, Westbury, NY 11590; telephone 516– 

228–7343; email 9-avs-nyaco-cos@faa.gov. 

(3) For MHI RJ service information 

identified in this AD that is not incorporated 

by reference, contact MHI RJ Aviation Group, 

Customer Response Center, 3655 Ave. des 

Grandes-Tourelles, Suite 110, Boisbriand, 

Que ́bec J7H 0E2 Canada; North America tollfree telephone 833–990–7272 or direct-dial 

telephone 450–990–7272; fax 514–855–8501; 

email thd.crj@mhirj.com; website mhirj.com. 

(k) Material Incorporated by Reference 

None. 

Issued on October 4, 2023. 

Victor Wicklund, 

Deputy Director, Compliance & Airworthiness 

Division, Aircraft Certification Service. 

[FR Doc. 2023–22486 Filed 10–12–23; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 1 

[Docket No. FDA–2011–N–0179] 

Prior Notice of Imported Food 

Questions and Answers (Edition 4): 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing the availability of a final 

guidance entitled ‘‘Prior Notice of 

Imported Food Questions and Answers 

(Edition 4): Guidance for Industry.’’ The 

guidance document updates the current 

version of the guidance by including 

three additional questions. One question 

relates to any effect systems recognition 

or equivalency determinations have on 

prior notice requirements. The other 

two questions relate to FDA’s notice to 

a submitter or transmitter of prior notice 

of an FDA refusal for inadequate prior 

notice or hold, if the food article is from 

a foreign facility that is not registered 

and addresses the timeframe for making 

requests for FDA review of such refusal 

or hold. FDA is also making other 

technical editorial changes. The 

guidance announced in this notice 

finalizes the draft guidance of the same 

title dated September 13, 2022. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on October 13, 2023. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

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– 

2011–N–0179 for ‘‘Prior Notice of 

Imported Food Questions and Answers 

(Edition 4): Guidance for Industry.’’ 

Received comments 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 


lotter on DSK11XQN23PROD with RULES1
70888 Federal Register / Vol. 88, No. 197 / Friday, October 13, 2023 / Rules and Regulations 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the guidance to the Division of 

Operational Policy, Office of Regulatory 

Affairs, Food and Drug Administration, 

Element Building, 12420 Parklawn Dr., 

Rockville, MD 20852. Send one selfaddressed adhesive label to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Peter Ajuonuma, Office of Regulatory 

Affairs, Food and Drug Administration, 

Element Building, 12420 Parklawn Dr., 

Rockville, MD 20852, 301–796–2277, 

Peter.Ajuonuma@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a document entitled ‘‘Prior Notice of 

Imported Food Questions and Answers 

(Edition 4): Guidance for Industry.’’ In 

the Federal Register of September 13, 

2022 (87 FR 55932), FDA announced the 

availability of the draft guidance 

entitled ‘‘Prior Notice of Imported Food 

Questions and Answers (Edition 4); 

Draft Guidance for Industry.’’ FDA 

received no comments on the draft 

guidance. As a result, we are publishing 

the guidance as drafted, with minor 

editorial changes to improve clarity, 

such as replacing the term ‘‘animal 

feed’’ with ‘‘animal food.’’ The guidance 

announced in this notice finalizes the 

draft guidance dated September 13, 

2022, and replaces ‘‘Prior Notice of 

Imported Food Questions and Answers 

(Edition 3): Guidance for Industry,’’ 

dated June 2016. 

FDA continues to believe that it is 

reasonable to maintain responses to 

questions concerning prior notice of 

imported food in a single document that 

is periodically updated in response to 

additional questions or regulatory or 

policy changes. As in the previous 

editions, the following indicators are 

used to help users identify revisions: (1) 

the guidance is identified as a revision 

of a previously issued document; (2) the 

revision date appears on the cover of the 

guidance; (3) the edition number of the 

guidance is included in its title; and (4) 

revised or added questions and answers 

are identified as such in the body of the 

guidance. 

On November 7, 2008, we published 

a final rule in the Federal Register 

requiring submission to FDA of prior 

notice of food, including food for 

animals, that is imported or offered for 

import into the United States (73 FR 

66294). The rule implements section 

801(m) of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 U.S.C. 

381(m)), which was added by section 

307 of the Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002 (the Bioterrorism 

Act) (Pub. L. 107–188) and requires that 

FDA receive prior notice of food 

imported or offered for import into the 

United States. 

On December 16, 2003, FDA issued a 

guidance entitled ‘‘Prior Notice of 

Imported Food Questions and Answers 

(Edition 1).’’ FDA issued a second 

edition of the guidance on May 3, 2004, 

and a third edition on June 16, 2016. 

FDA issued a draft fourth edition, which 

was published for public comment from 

September 13, 2022, to November 14, 

2022. We are issuing this guidance 

entitled ‘‘Prior Notice of Imported Food 

Questions and Answers (Edition 4): 

Guidance for Industry’’ as a level 1 

guidance, finalizing the draft guidance 

issued on September 13, 2022. 

The fourth edition of the prior notice 

guidance adds three additional 

questions. One question relates to any 

effect systems recognition or 

equivalency determinations have on 

prior notice requirements. The other 

two questions relate to FDA’s notice of 

a refusal under 801(m)(1) of the FD&C 

Act (in accordance with § 1.283 (21 CFR 

1.283)) for inadequate prior notice or a 

hold under 801(l) (in accordance with 

§ 1.285 (21 CFR 1.285)) if the food 

article is from a foreign facility that is 

not registered, as well as address the 

timeframe for making requests for FDA 

review of such a refusal or hold. The 

guidance is intended to help clarify 

whether food imported from a country 

with which FDA has a Systems 

Recognition Arrangement or 

equivalence determination is exempted 

from prior notice requirements. The 

guidance also clarifies when FDA will 

provide notice of the refusal or hold to 

the relevant party, and when the 5- 

calendar-day clock to request a review 

of the refusal or hold begins. 

We are also making other technical 

amendments to the guidance due to the 

expanded capabilities of the U.S. 

Customs and Border Protection’s (CBP) 

Automated Broker Interface of the 

Automated Commercial Environment 

(ABI/ACE) system and FDA’s 2017 

technical amendments to the prior 

notice rule (82 FR 15627, March 30, 

2017), such as replacing references to 

the Automated Commercial System 

(ACS) and successor system with the 

ABI/ACE system, removing references to 

requirements that certain prior notice 

submissions be submitted in FDA’s 

Prior Notice System Interface (FDA 

PNSI), and updating outdated links and 

FDA contact information. The fourth 

edition guidance clarifies that the 

existence of a Systems Recognition 

Arrangement with or an equivalence 

determination of a foreign country does 

not exempt foods imported from that 

country from FDA’s prior notice 

requirements. 

FDA’s policy on and practice of 

communicating prior notice refusals and 

holds has changed over time. FDA 

previously stated that we intended to 

provide notice regarding refusals to 

carriers. Those carriers could then 

notify others, such as the entity that 

hired the carrier to transport the article 

of food, of a problem with the prior 

notice (see 73 FR 66294 at 66365). 

Subsequently, FDA’s Guidance for 

Industry ‘‘Prior Notice of Imported Food 

Questions and Answers (Edition 3)’’ was 

published with the explanation that 

FDA will communicate the decision to 

examine articles of food to CBP. 

The fourth edition clarifies that 

notification of these prior notice refusals 

and holds will be communicated to CBP 

and provided to the relevant party (i.e., 

the submitter or transmitter of prior 

notice) upon arrival of the article. FDA 

is clarifying its policy because providing 

advanced notice of a refusal or hold to 

a submitter or transmitter could create 

incentives for bad actors, who may 

attempt to reroute their entries for the 

purpose of evading FDA requirements 

and importing unsafe food. 

The fourth edition of the guidance 

also clarifies the 5-calendar-day clock to 

request a review of these refusals and 


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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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