58498 Federal Register / Vol. 88, No. 165 / Monday, August 28, 2023 / Rules and Regulations 

AIRAC date State City Airport name FDC No. FDC date Procedure name 

5-Oct-23 ....... AR Fayetteville .............. Drake Fld ................................. 3/7180 8/9/23 LOC RWY 16, Orig. 

5-Oct-23 ....... AR Fayetteville .............. Drake Fld ................................. 3/7182 8/9/23 RNAV (GPS) RWY 34, Amdt 1C.

[FR Doc. 2023–18463 Filed 8–25–23; 8:45 a.m.] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Chapter I 

[Docket No. FDA–2023–D–1909] 

Enhanced Drug Distribution Security 

Requirements Under Section 582(g)(1) 

of the Federal Food, Drug, and 

Cosmetic Act—Compliance Policies; 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (HHS). 

ACTION: Notification of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing the availability of a final 

guidance for industry entitled 

‘‘Enhanced Drug Distribution Security 

Requirements Under Section 582(g)(1) 

of the Federal Food, Drug, and Cosmetic 

Act—Compliance Policies.’’ This 

guidance describes FDA’s compliance 

policies regarding enforcement of 

requirements for the interoperable, 

electronic, package level product tracing 

(referred to as enhanced drug 

distribution security requirements) 

under the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) that will go 

into effect on November 27, 2023. FDA 

believes the compliance policies 

outlined in this guidance will help 

supply chain stakeholders, particularly 

trading partners, by accommodating the 

additional time that may be needed to 

continue to develop and refine 

appropriate systems and processes to 

conduct interoperable, electronic tracing 

at the package level, to achieve robust 

supply chain security under the Drug 

Supply Chain Security Act (DSCSA) 

while helping ensure continued patient 

access to prescription drugs. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on August 28, 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– 

2023–D–1909 for ‘‘Enhanced Drug 

Distribution Security Requirements 

Under Section 582(g)(1) of the Federal 

Food, Drug, and Cosmetic Act— 

Compliance Policies.’’ 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 

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 this guidance to the Division 

of Drug Information, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002 or to the Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 


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Federal Register / Vol. 88, No. 165 / Monday, August 28, 2023 / Rules and Regulations 58499 

1The Office of the Federal Register has published 

this document under the category ‘‘Rules and 

Regulations’’ pursuant to its interpretation of 1 CFR 

5.9(b). We note that the categorization as such for 

purposes of publication in the Federal Register 

does not affect the content or intent of the 

document. See 1 CFR 5.1(c). 

3128, Silver Spring, MD 20993–0002. 

Send one self-addressed 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: 

Elizabeth Pepinsky, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 4258, 

Silver Spring, MD 20993–0002, 301– 

796–3130, email: drugtrackandtrace@

fda.hhs.gov; or Anne Taylor, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

7301, Silver Spring, MD 20993–0002, 

240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Enhanced Drug Distribution Security 

Requirements Under Section 582(g)(1) 

of the Federal Food, Drug, and Cosmetic 

Act—Compliance Policies.’’ This 

guidance describes FDA’s compliance 

policies regarding enforcement of 

requirements for the interoperable, 

electronic, package level product tracing 

(referred to as enhanced drug 

distribution security requirements) 

under section 582(g)(1) of the FD&C Act 

(21 U.S.C. 360eee-1(g)(1)) that will go 

into effect on November 27, 2023. FDA 

believes that these compliance policies 

will facilitate the continued use of 

product tracing and verification 

methods currently being used while 

accommodating the additional time that 

may be needed by trading partners to 

continue to develop and refine the 

systems and processes for such 

activities required under section 

582(g)(1) of the FD&C Act. 

We are issuing this guidance 

consistent with our good guidance 

practices (GGP) regulation (21 CFR 

10.115). We are implementing this 

guidance without prior public comment 

because we have determined that prior 

public participation is not feasible or 

appropriate (21 CFR 10.115(g)(2)). The 

Agency made this determination 

because the Agency needs to 

communicate its compliance policy in a 

timely manner and provide stakeholders 

notice of the compliance policy ahead of 

the effective date of the enhanced 

distribution security requirements. 

Although this guidance document is 

being implemented immediately, it 

remains subject to comment in 

accordance with FDA’s GGP regulation 

and the Agency will consider all 

comments received and determine 

whether revisions to the guidance 

document are appropriate. 

The DSCSA, enacted on November 27, 

2013, outlines critical steps for building 

an electronic, interoperable system by 

November 27, 2023, that will identify 

and trace certain prescription drugs as 

they are distributed within the United 

States. Since the enactment of DSCSA, 

FDA and trading partners have been 

preparing for the implementation of the 

enhanced drug distribution security 

requirements imposed by section 

582(g)(1) of the FD&C Act. Trading 

partners are continuing to work to have 

the necessary systems and processes in 

place in anticipation of the November 

27, 2023, effective date for these 

requirements. While trading partners 

have the obligation to comply with 

section 582 requirements, including for 

enhanced drug distribution security, 

there are other stakeholders involved 

and affected, including but not limited 

to: solution providers, standards 

organizations, trade and professional 

organizations, state authorities, and 

other Federal authorities. 

FDA understands that collaboration 

and alignment among trading partners 

and other stakeholders throughout the 

supply chain are critical for achieving 

interoperability under the DSCSA. FDA 

has heard from stakeholders, including 

a broad representation of trading 

partners, about concerns regarding 

trading partner readiness and the need 

for clarity and flexibility to ensure 

trading partners can continue to move 

product through the supply chain when 

the enhanced drug distribution security 

requirements under section 582(g)(1) of 

the FD&C Act take effect. Most recently, 

at a virtual public meeting on DSCSA 

Implementation and Readiness Efforts 

for 2023 held on December 7 and 8, 

2022 (87 FR 67047, November 7, 2022), 

stakeholders indicated that trading 

partners throughout the supply chain 

are at different stages of readiness, with 

some trading partners being further 

behind not only in terms of 

understanding their obligations under 

section 582(g)(1) of the FD&C Act, but 

also being aware of the time and 

resources necessary to meet those 

obligations. Stakeholders also expressed 

a need for clarity with respect to 

treatment of product that is already in 

the supply chain on November 27, 2023, 

and the need for flexibility when the 

requirements under section 582(g)(1) 

take effect, to minimize potential 

disruptions in the supply chain. In 

addition, stakeholders are experiencing 

challenges with predicting and planning 

for the possible volume of requests for 

product tracing information from 

Federal and State authorities and other 

trading partners, and the resources 

needed to respond to such requests, in 

accordance with section 582(g)(1) of the 

FD&C Act. 

While FDA generally expects trading 

partners to have the systems and 

processes in place to meet the enhanced 

drug distribution security requirements 

of section 582(g)(1) as of November 27, 

2023, we recognize that some technical 

and operational issues, including issues 

involving trading partners and other 

affected stakeholders, may not be fully 

resolved by that time. The Agency also 

understands that additional time 

beyond November 27, 2023, may be 

needed for systems to stabilize and be 

fully interoperable for accurate, secure, 

and timely electronic data exchange. 

This guidance is intended to provide 

clarity and flexibility to trading partners 

to help ensure continued patient access 

to prescription drugs as the supply 

chain transitions to the interoperable, 

electronic product tracing at the package 

level under the DSCSA. The compliance 

policies in this guidance can help 

trading partners throughout the supply 

chain implement the requirements 

under section 582(g)(1) of the FD&C Act 

by accommodating the additional time 

that may be needed to implement, 

troubleshoot, and mature their systems 

and processes while supporting the 

continued availability of products to 

patients. 

The guidance represents the current 

thinking of FDA on ‘‘Enhanced Drug 

Distribution Security Requirements 

Under Section 582(g)(1) of the Federal 

Food, Drug, and Cosmetic Act— 

Compliance Policies.’’ 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.1

II. Paperwork Reduction Act 

FDA concludes that this guidance 

contains no collection of information. 

Therefore, clearance by the Office of 

Management and Budget under the 

Paperwork Reduction Act of 1995 is not 

required. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 


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58500 Federal Register / Vol. 88, No. 165 / Monday, August 28, 2023 / Rules and Regulations 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. 

Dated: August 22, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–18359 Filed 8–25–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[USCG–USCG–2023–0043] 

RIN 1625–AA00 

Safety Zone, Illinois River MM 165.5 

Peoria, IL 

AGENCY: Coast Guard, Department of 

Homeland Security (DHS). 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary safety zone for 

all navigable waters within a half mile 

radius of a crane boom located in the 

Illinois River at Mile Marker (MM) 

165.5. The safety zone is needed to 

protect personnel, vessels, and the 

marine environment from all potential 

hazards associated with a crane boom 

blocking the navigable channel and the 

salvage operation for its removal. Entry 

of vessels or persons into this zone is 

prohibited unless specifically 

authorized by the Captain of the Port 

Sector Upper Mississippi River (COTP) 

or a designated representative. 

DATES: This rule is effective without 

actual notice from August 28, 2023, 

through August 29, 2023. For the 

purposes of enforcement, actual notice 

will be used from August 23, 2023, until 

August 28, 2023. 

ADDRESSES: To view documents 

mentioned in this preamble as being 

available in the docket, go to https://

www.regulations.gov, type USCG–2023– 

0043 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 MSTC Nathaniel Dibley, Sector 

Upper Mississippi River Waterways 

Management Division, U.S. Coast 

Guard; telephone 314–269–2560, email 

Nathaniel.D.Dibley@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 

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 a 

temporary safety zone must be 

established immediately to protect 

personnel, vessels, and the marine 

environment from potential hazards 

created by a crane boom protruding into 

the navigable channel and lack 

sufficient time to provide a reasonable 

comment period and then consider 

those comments before issuing the rule. 

It is impracticable to publish an NPRM 

because we must establish this safety 

zone by August 23, 2023. 

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 impracticable 

because immediate action is needed to 

respond to the potential safety hazards 

associated with a crane boom blocking 

the navigable channel. 

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 Upper 

Mississippi River (COTP) has 

determined that potential hazards 

associated with a crane boom blocking 

the navigable channel and the salvage 

operation taking place to remove it will 

be a safety concern for anyone operating 

or transiting within the Illinois River at 

MM 165.5. This rule is needed to 

protect personnel, vessels, and the 

marine environment in the navigable 

waters within the safety zone until the 

crane boom has been removed from the 

waterway. 

IV. Discussion of the Rule 

The salvaging of the crane boom will 

occur at MM 165.5 beginning August 23, 

2023. The safety zone is designed to 

protect waterway users until work is 

complete. 

No vessel or person will be permitted 

to enter the safety zone without 

obtaining permission from the COTP or 

a designated representative. A 

designated representative is a 

commissioned, warrant, or petty officer 

of the U.S. Coast Guard (USCG) assigned 

to units under the operational control of 

USCG Sector Upper Mississippi River. 

To seek permission to enter, contact the 

COTP or a designated representative via 

VHF–FM channel 16, or through USCG 

Sector Upper Mississippi River at 314– 

269–2332. Persons and vessels 

permitted to enter the safety zone must 

comply with all lawful orders or 

directions issued by the COTP or 

designated representative. The COTP or 

a designated representative will inform 

the public of the effective period for the 

safety zone as well as any changes in the 

dates and times of enforcement, as well 

as reductions in the size of the safety 

zone through Local Notice to Mariners 

(LNMs), Broadcast Notices to Mariners 

(BNMs), and/or Safety Marine 

Information Broadcast (SMIB), as 

appropriate. 

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 a safety zone located within 

a half mile radius of a crane boom on 

the Illinois River at MM 165.5, near 

Peoria, IL. The safety zone is expected 

to be active until the crane boom has 

been salvaged and the channel cleared. 


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