85104 Federal Register / Vol. 88, No. 234 / Thursday, December 7, 2023 / Rules and Regulations 

1As discussed in a memorandum of 

understanding entered into by the Food and Drug 

Administration (FDA) and the National Institute on 

Drug Abuse (NIDA), FDA acts as the lead agency 

within HHS in carrying out the Secretary’s 

scheduling responsibilities under the CSA, with the 

concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. 

The Secretary of HHS has delegated to the Assistant 

Secretary for Health of HHS the authority to make 

domestic drug scheduling recommendations. 58 FR 

35460, July 1, 1993. 

2 21 U.S.C. 811(a). 

Country Entity License 

requirement License review policy Federal Register citation 

R2, Sharjah Airport Free Zone Street, 

Office 806, Sharjah, United Arab 

Emirates; and PO Box 120683, SaifZone, Sharjah, United Arab Emirates; 

and . SM-Office E1–1414D, Ajman 

Free Zone, Ajman, United Arab Emirates. 

******

* * * * * 

Matthew S. Borman, 

Deputy Assistant Secretary for Export 

Administration. 

[FR Doc. 2023–26935 Filed 12–5–23; 11:15 am] 

BILLING CODE 3510–33–P 

SOCIAL SECURITY ADMINISTRATION 

20 CFR Part 404 

Federal Old-Age, Survivors and 

Disability Insurance (1950– ) 

CFR Correction 

This rule is being published by the 

Office of the Federal Register to correct 

an editorial or technical error that 

appeared in the most recent annual 

revision of the Code of Federal 

Regulations. 

■ In Title 20 of the Code of Federal 

Regulations, Parts 400 to 499, revised as 

of April 1, 2023, in Appendix I to 

Subpart P of Part 404, in Part B, section 

101.00, revise the first sentence of 

paragraph C.7.c. to read as follows: 

Appendix 1 to Subpart P of Part 404— 

Listing of Impairments 

* * * * * 

Part B 

* * * * * 

101.00 Musculoskeletal Disorders. 

* * * * * 

C. * * * 

7. * * * 

c. For 101.15, 101.16, 101.17, 101.18, 

101.20C, 101.20D, 101.22, and 101.23, all of 

the required criteria must be present 

simultaneously, or within a close proximity 

of time, to satisfy the level of severity needed 

to meet the listing. * * * 

[FR Doc. 2023–26983 Filed 12–6–23; 8:45 am] 

BILLING CODE 0099–10–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–1036] 

Schedules of Controlled Substances: 

Placement of Nine Specific FentanylRelated Substances in Schedule I 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Final rule. 

SUMMARY: With the issuance of this final 

rule, the Drug Enforcement 

Administration places nine fentanylrelated substances, as identified in this 

final rule, including their isomers, 

esters, ethers, salts, and salts of isomers, 

esters, and ethers whenever the 

existence of such isomers, esters, ethers, 

and salts is possible, in schedule I of the 

Controlled Substances Act. These nine 

fentanyl-related substances are currently 

listed in schedule I pursuant to a 

temporary scheduling order. This action 

makes permanent the imposition of the 

regulatory controls and administrative, 

civil, and criminal sanctions applicable 

to schedule I controlled substances on 

persons who handle (manufacture, 

distribute, import, export, engage in 

research, conduct instructional 

activities or chemical analysis with, or 

possess), or propose to handle these 

nine specific fentanyl-related controlled 

substances. 

DATES: Effective date: December 7, 2023. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Terrence L. Boos, Drug and Chemical 

Evaluation Section, Diversion Control 

Division, Drug Enforcement 

Administration; Telephone: (571) 362– 

3249. 

SUPPLEMENTARY INFORMATION: In this 

rule, the Drug Enforcement 

Administration (DEA) is permanently 

scheduling the following nine 

controlled substances including their 

isomers, esters, ethers, salts, and salts of 

isomers, esters, and ethers whenever the 

existence of such isomers, esters, ethers, 

and salts is possible, in schedule I of the 

Controlled Substances Act (CSA): 

• meta-fluorofentanyl (N-(3- 

fluorophenyl)-N-(1-phenethylpiperidin4-yl)propionamide), 

• meta-fluoroisobutyryl fentanyl (N- 

(3-fluorophenyl)-N-(1- 

phenethylpiperidin-4-yl)isobutyramide), 

• para-methoxyfuranyl fentanyl (N- 

(4-methoxyphenyl)-N-(1- 

phenethylpiperidin-4-yl)furan-2- 

carboxamide), 

• 3-furanyl fentanyl (N-(1- 

phenethylpiperidin-4-yl)-Nphenylfuran-3-carboxamide), 

• 2′,5′-dimethoxyfentanyl (N-(1-(2,5- 

dimethoxyphenethyl)piperidin-4-yl)-Nphenylpropionamide), 

• isovaleryl fentanyl (3-methyl-N-(1- 

phenethylpiperidin-4-yl)-Nphenylbutanamide), 

• ortho-fluorofuranyl fentanyl (N-(2- 

fluorophenyl)-N-(1-phenethylpiperidin4-yl)furan-2-carboxamide), 

• alpha′-methyl butyryl fentanyl (2- 

methyl-N-(1-phenethylpiperidin-4-yl)- 

N-phenylbutanamide), and 

• para-methylcyclopropyl fentanyl 

(N-(4-methylphenyl)-N-(1- 

phenethylpiperidin-4- 

yl)cyclopropanecarboxamide). 

Legal Authority 

The CSA provides that proceedings 

for the issuance, amendment, or repeal 

of the scheduling of any drug or other 

substance may be initiated by the 

Attorney General (1) on his own motion; 

(2) at the request of the Secretary of the 

Department of Health and Human 

Services (HHS); 1 or (3) on the petition 

of any interested party.2 This action was 

initiated on the Attorney General’s own 

motion, as delegated to the 

Administrator of the DEA 

(Administrator), and is supported by, 

inter alia, a recommendation from the 

Assistant Secretary for Health of HHS 


ddrumheller on DSK120RN23PROD with RULES1
Federal Register / Vol. 88, No. 234 / Thursday, December 7, 2023 / Rules and Regulations 85105 

(Assistant Secretary) and an evaluation 

of all relevant data by DEA. This action 

continues the imposition of the 

regulatory controls and administrative, 

civil, and criminal sanctions of schedule 

I controlled substances on any person 

who handles or proposes to handle 

meta-fluorofentanyl, metafluoroisobutyryl fentanyl, paramethoxyfuranyl fentanyl, 3-furanyl 

fentanyl, 2′,5′-dimethoxyfentanyl, 

isovaleryl fentanyl, ortho-fluorofuranyl 

fentanyl, alpha′-methyl butyryl 

fentanyl, and para-methylcyclopropyl 

fentanyl. 

Background 

On February 6, 2018, DEA published 

an order in the Federal Register (FR) (83 

FR 5188) amending 21 CFR 1308.11(h), 

temporarily placing fentanyl-related 

substances, as defined in that order, in 

schedule I of the CSA based upon a 

finding that these substances pose an 

imminent hazard to the public safety 

and pursuant to the temporary 

scheduling provisions of 21 U.S.C. 

811(h). The nine substances named in 

this final rule meet the existing 

definition of fentanyl-related 

substances, as they are not otherwise 

controlled in any other schedule (i.e., 

not included under another DEA 

Controlled Substance Code Number) 

and are structurally related to fentanyl 

by one or more of the five modifications 

listed under the definition. That 

temporary scheduling order was 

effective on the date of publication and 

was based on findings by the former 

Acting Administrator that the temporary 

scheduling of these substances was 

necessary to avoid an imminent hazard 

to the public safety pursuant to 21 

U.S.C. 811(h)(1). Pursuant to 21 U.S.C. 

811(h)(2), the temporary control of 

fentanyl-related substances, a class of 

substances as defined in the order, as 

well as these nine specific substances 

already covered by that order, was set to 

expire on February 6, 2020. However, 

on February 6, 2020, as explained in 

DEA’s April 10, 2020, correcting 

amendment (85 FR 20155), Congress 

extended that expiration date until May 

6, 2021, by enacting the Temporary 

Reauthorization and Study of the 

Emergency Scheduling of Fentanyl 

Analogues Act (Pub. L. 116–114, sec. 2, 

134 Stat. 103). This temporary order was 

subsequently extended multiple times, 

most recently on December 29, 2022, 

through the Consolidated 

Appropriations Act, 2023, which 

extended the order until December 31, 

2024. 

Comment: One commenter stated that 

fentanyl and the list of related 

substances is a hazard due to the 

overdose deaths that have been 

occurring. This commenter also 

referenced the National Institute on 

Drug Abuse, stating that fentanyl-related 

overdoses have been increasing in the 

United States. Lastly, this commenter 

stated that permanently placing fentanyl 

and the list of related substances in 

schedule I would improve public health 

and allow for regulation of these 

substances. 

DEA Response: DEA appreciates the 

comments in support of this 

rulemaking. One clarification to note is 

that fentanyl remains a schedule II 

substance. This final rule only applies 

to the fentanyl-related substances that 

are listed in this final order. 

Comment: One commenter stated the 

proposed rule would make it more 

difficult to produce and distribute these 

dangerous fentanyl-related substances, 

which would help combat the opioid 

epidemic in the United States. This 

commenter also referenced a news 

article by National Public Radio, stating 

that these nine fentanyl-related 

substances are not currently classified 

as controlled substances, making it easy 

to produce and distribute these 

substances without legal consequences. 

Lastly, this commenter recognized that 

this proposal could have significant 

impacts on the healthcare industry, 

such as increased oversight and 

regulation of fentanyl-related 

substances, which could prevent their 

misuse and abuse. 

DEA Response: DEA appreciates the 

comments in support of this 

rulemaking. One clarification to note 

based on the comment above is that, by 

temporary order on February 6, 2018, 

DEA placed these nine fentanyl-related 

substances under schedule I. 83 FR 

5188. That temporary order defined a 

fentanyl-related substance to mean any 

substance not otherwise controlled in 

any schedule (i.e., not listed under 

another DEA Controlled Substance Code 

Number), and for which no exemption 

or approval is in effect under section 

505 of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 355), that is 

structurally related to fentanyl by one or 

more of five specified structural 

modifications. Therefore, these nine 

fentanyl-related substances are in fact 

already schedule I controlled 

substances. 

The final rule being issued today 

applies to nine fentanyl-related 

substances that were the subject of a 

February 6, 2018, temporary scheduling 

order. These nine substances will now 

be listed in 21 CFR 1308.11(b), as 

specified in the text of the rule that 

appears below. This final rule should 

not have a significant impact on the 

healthcare industry because these nine 

fentanyl-related substances have no 

medical use and they have already been 

added as schedule I controlled 

substances since 2018. 

Comment: One commenter discussed 

the direct and indirect effects on federal 

and state healthcare from this 

regulation. The commenter suggested 

that this regulation will boost federal 

oversight of manufacturing and 

disseminating harmful chemicals. In 

addition, this regulation would limit 

availability and expected use, ensure 

protection of residents, and increases 

confidence in the medical field. In 

addition, the commenter stated that is 

critical to restrict the use of ‘‘fentanyl 

replicates’’ to those who may need them 

for medical conditions. Lastly, the 

commenter stated that raising awareness 

of the risks of abusing these drugs 

benefits their prevention. 

DEA Response: DEA appreciates the 

comments in support of this 

rulemaking. As mentioned previously, 

FDA has not approved a marketing 

application for a drug product 

containing any of these nine substances 

for any therapeutic indication. These 

substances have no medical use in the 

United States. 

Comment: One commenter stated that 

this rule will affect federal healthcare 

because many federal agencies are 

trying to tackle the opioid crisis. The 

commenter discussed the rising number 

of pediatric deaths from fentanyl in 

2021 and the surge in 2018 of fentanyl 

overdoses among older adolescents as 

well as in children younger than five. 

The commenter agrees with this final 

rule to schedule these fentanyl-related 

substances. The commenter also stated 

that fentanyl is highly addictive and 

that while fentanyl is prescribed for 

chronic pain or major surgery, it should 

be a last resort. 

DEA Response: DEA appreciates the 

comments in support of this 

rulemaking. 

Comment: One commenter agreed 

with this final rule to make permanent 

these nine specific fentanyl-related 

substances rather than continuing 

multiple temporary extensions. Once 

finalized, the commenter stated that the 

federal government could act against 

anyone handling these substances since 

over 150 people die each day from a 

fentanyl-related drug overdose. 

DEA Response: DEA appreciates the 

comments in support of this 

rulemaking. Again, DEA notes that 

fentanyl is a schedule II controlled 

substance that can be prescribed for 

approved medical uses. However, the 

nine fentanyl-related substances 

addressed in this rule are already 


ddrumheller on DSK120RN23PROD with RULES1
85106 Federal Register / Vol. 88, No. 234 / Thursday, December 7, 2023 / Rules and Regulations 

3 21 U.S.C. 812(b). 

4Although there is no evidence suggesting that 

meta-fluorofentanyl, meta-fluoroisobutyryl 

fentanyl, para-methoxyfuranyl fentanyl, 3-furanyl 

fentanyl, 2′,5′-dimethoxyfentanyl, isovaleryl 

fentanyl, ortho-fluorofuranyl fentanyl, alpha′- 

methyl butyryl fentanyl, and paramethylcyclopropyl fentanyl have a currently 

accepted medical use in treatment in the United 

States, it bears noting that a drug cannot be found 

to have such medical use unless DEA concludes 

that it satisfies a five-part test. Specifically, with 

respect to a drug that has not been approved by 

FDA, to have a currently accepted medical use in 

treatment in the United States, all of the following 

must be demonstrated: 

i. The drug’s chemistry must be known and 

reproducible; 

ii. there must be adequate safety studies; 

iii. there must be adequate and well-controlled 

studies proving efficacy; 

iv. the drug must be accepted by qualified 

experts; and 

v. the scientific evidence must be widely 

available. 

57 FR 10499 (1992). 

5 21 U.S.C. 812(b)(1). 

6 meta-fluorofentanyl, meta-fluoroisobutyryl 

fentanyl, para-methoxyfuranyl fentanyl, 3-furanyl 

fentanyl, 2′,5′-dimethoxyfentanyl, isovaleryl 

fentanyl, ortho-fluorofuranyl fentanyl, alpha′- 

methyl butyryl fentanyl, and/or paramethylcyclopropyl fentanyl have been subject to 

schedule I controls on a temporary basis, pursuant 

to 21 U.S.C. 811(h), by virtue of the February 6, 

2018 temporary scheduling order (83 FR 5188) and 

the subsequent statutory extension of that order 

through December 31, 2024 (Pub. L. 117–328, 

Division O, Title VI, Sec. 601). 

schedule I controlled substances and 

none of them have any medical use in 

the United States. 

Comment: One commenter stated that 

fentanyl should be placed in schedule I. 

The commenter compared this 

substance to marijuana, which is a 

schedule I drug and thought it was 

mind-blowing that fentanyl was not a 

schedule I substance. It was suggested 

that the rising number of deaths, the risk 

to public health, abuse potential, and 

dependency should classify fentanyl as 

a schedule I. 

DEA Response: DEA appreciates this 

comment. As stated previously, fentanyl 

remains a schedule II substance. 

Fentanyl has approved medical uses in 

the United States. This final rule only 

applies to the fentanyl-related 

substances that are listed in this final 

order. 

Scheduling Conclusion 

After consideration of the relevant 

matter presented through public 

comments, the scientific and medical 

evaluation and accompanying 

recommendation of HHS, and after its 

own eight-factor evaluation, DEA finds 

that these facts and all other relevant 

data constitute substantial evidence of 

the potential for abuse of metafluorofentanyl, meta-fluoroisobutyryl 

fentanyl, para-methoxyfuranyl fentanyl, 

3-furanyl fentanyl, 2′,5′- 

dimethoxyfentanyl, isovaleryl fentanyl, 

ortho-fluorofuranyl fentanyl, alpha′- 

methyl butyryl fentanyl, and paramethylcyclopropyl fentanyl. DEA is 

permanently scheduling these nine 

fentanyl-related substances as schedule 

I controlled substances under the CSA. 

Determination of Appropriate Schedule 

The CSA establishes five schedules of 

controlled substances known as 

schedules I, II, III, IV, and V. The CSA 

also specifies the findings required to 

place a drug or other substance in any 

particular schedule.3 After 

consideration of the analysis and 

recommendation of the Assistant 

Secretary for HHS and review of all 

other available data, the Administrator, 

pursuant to 21 U.S.C. 811(a) and 

812(b)(1), finds the following: 

(1) The abuse potential of metafluorofentanyl, meta-fluoroisobutyryl 

fentanyl, para-methoxyfuranyl fentanyl, 

3-furanyl fentanyl, 2′,5′- 

dimethoxyfentanyl, isovaleryl fentanyl, 

ortho-fluorofuranyl fentanyl, alpha′- 

methyl butyryl fentanyl, and paramethylcyclopropyl fentanyl is 

associated with each substance’s 

pharmacological similarity to other 

schedule I and II mu-opioid receptor 

agonist substances which have a high 

potential for abuse. Similar to morphine 

(schedule II), fentanyl (schedule II), and 

several schedule I opioid substances 

that are structurally related to fentanyl, 

these nine fentanyl-related substances 

have been shown to bind and act as muopioid receptor agonists; 

(2) meta-Fluorofentanyl, metafluoroisobutyryl fentanyl, paramethoxyfuranyl fentanyl, 3-furanyl 

fentanyl, 2′,5′-dimethoxyfentanyl, 

isovaleryl fentanyl, ortho-fluorofuranyl 

fentanyl, alpha′-methyl butyryl 

fentanyl, and para-methylcyclopropyl 

fentanyl, have no currently accepted 

medical use in treatment in the United 

States; 4 and 

(3) There is a lack of accepted safety 

for use of meta-fluorofentanyl, metafluoroisobutyryl fentanyl, paramethoxyfuranyl fentanyl, 3-furanyl 

fentanyl, 2′,5′-dimethoxyfentanyl, 

isovaleryl fentanyl, ortho-fluorofuranyl 

fentanyl, alpha′-methyl butyryl 

fentanyl, and para-methylcyclopropyl 

fentanyl under medical supervision. 

Based on these findings, the 

Administrator concludes that metafluorofentanyl, meta-fluoroisobutyryl 

fentanyl, para-methoxyfuranyl fentanyl, 

3-furanyl fentanyl, 2′,5′- 

dimethoxyfentanyl, isovaleryl fentanyl, 

ortho-fluorofuranyl fentanyl, alpha′- 

methyl butyryl fentanyl, and paramethylcyclopropyl fentanyl, including 

their isomers, esters, ethers, salts, and 

salts of isomers, esters, and ethers 

whenever the existence of such isomers, 

esters, ethers, and salts is possible, 

warrant control in schedule I of the 

CSA.5

This final rule does not affect the 

scheduling of fentanyl itself, which 

remains a schedule II controlled 

substance. 

Requirements for Handling MetaFluorofentanyl, Meta-Fluoroisobutyryl 

Fentanyl, Para-Methoxyfuranyl 

Fentanyl, 3-Furanyl Fentanyl, 2′,5′- 

Dimethoxyfentanyl, Isovaleryl 

Fentanyl, Ortho-Fluorofuranyl 

Fentanyl, Alpha′-Methyl Butyryl 

Fentanyl, and Para-Methylcyclopropyl 

Fentanyl 

Meta-Fluorofentanyl, metafluoroisobutyryl fentanyl, paramethoxyfuranyl fentanyl, 3-furanyl 

fentanyl, 2′,5′-dimethoxyfentanyl, 

isovaleryl fentanyl, ortho-fluorofuranyl 

fentanyl, alpha′-methyl butyryl 

fentanyl, and para-methylcyclopropyl 

fentanyl will continue, on a permanent 

basis,6 to be subject to the CSA’s 

schedule I regulatory controls and 

administrative, civil, and criminal 

sanctions applicable to the manufacture, 

distribution, dispensing, importing, 

exporting, research, and conduct of 

instructional activities, including the 

following: 

1. Registration. Any person who 

handles (manufactures, distributes, 

dispenses, imports, exports, engages in 

research, or conducts instructional 

activities or chemical analysis with, or 

possesses) meta-fluorofentanyl, metafluoroisobutyryl fentanyl, paramethoxyfuranyl fentanyl, 3-furanyl 

fentanyl, 2′,5′-dimethoxyfentanyl, 

isovaleryl fentanyl, ortho-fluorofuranyl 

fentanyl, alpha′-methyl butyryl 

fentanyl, and para-methylcyclopropyl 

fentanyl, or who desires to handle these 

nine substances, is required to be 

registered with DEA to conduct such 

activities pursuant to 21 U.S.C. 822, 

823, 957, and 958, and in accordance 

with 21 CFR parts 1301 and 1312. Retail 

sales of schedule I controlled substances 

to the general public are not allowed 

under the CSA. Possession of any 

quantity of these substances in a manner 

not authorized by the CSA is unlawful 

and those in possession of any quantity 

of these substances may be subject to 

prosecution pursuant to the CSA. 

2. Disposal of stocks. metafluorofentanyl, meta-fluoroisobutyryl 

fentanyl, para-methoxyfuranyl fentanyl, 

3-furanyl fentanyl, 2′,5′- 


ddrumheller on DSK120RN23PROD with RULES1
Federal Register / Vol. 88, No. 234 / Thursday, December 7, 2023 / Rules and Regulations 85107 

dimethoxyfentanyl, isovaleryl fentanyl, 

ortho-fluorofuranyl fentanyl, alpha′- 

methyl butyryl fentanyl, and paramethylcyclopropyl fentanyl must be 

disposed of in accordance with 21 CFR 

part 1317, in addition to all other 

applicable federal, state, local, and tribal 

laws. 

3. Security. meta-fluorofentanyl, 

meta-fluoroisobutyryl fentanyl, paramethoxyfuranyl fentanyl, 3-furanyl 

fentanyl, 2′,5′-dimethoxyfentanyl, 

isovaleryl fentanyl, ortho-fluorofuranyl 

fentanyl, alpha′-methyl butyryl 

fentanyl, and para-methylcyclopropyl 

fentanyl are subject to schedule I 

security requirements and must be 

handled and stored pursuant to 21 

U.S.C. 823, and in accordance with 21 

CFR 1301.71–1301.76. Non-practitioners 

handling these nine substances must 

also comply with the employee 

screening requirements of 21 CFR 

1301.90–1301.93. 

4. Labeling and Packaging. All labels 

and labeling for commercial containers 

of meta-fluorofentanyl, metafluoroisobutyryl fentanyl, paramethoxyfuranyl fentanyl, 3-furanyl 

fentanyl, 2′,5′-dimethoxyfentanyl, 

isovaleryl fentanyl, ortho-fluorofuranyl 

fentanyl, alpha′-methyl butyryl 

fentanyl, and para-methylcyclopropyl 

fentanyl, must be in compliance with 21 

U.S.C. 825, and be in accordance with 

21 CFR part 1302. 

5. Quota. Only registered 

manufacturers are permitted to 

manufacture meta-fluorofentanyl, metafluoroisobutyryl fentanyl, paramethoxyfuranyl fentanyl, 3-furanyl 

fentanyl, 2′,5′-dimethoxyfentanyl, 

isovaleryl fentanyl, ortho-fluorofuranyl 

fentanyl, alpha′-methyl butyryl 

fentanyl, and para-methylcyclopropyl 

fentanyl in accordance with a quota 

assigned pursuant to 21 U.S.C. 826 and 

in accordance with 21 CFR part 1303. 

6. Inventory. Any person registered 

with DEA to handle metafluorofentanyl, meta-fluoroisobutyryl 

fentanyl, para-methoxyfuranyl fentanyl, 

3-furanyl fentanyl, 2′,5′- 

dimethoxyfentanyl, isovaleryl fentanyl, 

ortho-fluorofuranyl fentanyl, alpha′- 

methyl butyryl fentanyl, and paramethylcyclopropyl fentanyl must have 

an initial inventory of all stocks of 

controlled substances (including these 

substances) on hand on the date the 

registrant first engages in the handling 

of controlled substances pursuant to 21 

U.S.C. 827 and 958(e), and in 

accordance with 21 CFR 1304.03, 

1304.04, and 1304.11. 

After the initial inventory, every DEA 

registrant must take a new inventory of 

all stocks of controlled substances 

(including meta-fluorofentanyl, metafluoroisobutyryl fentanyl, paramethoxyfuranyl fentanyl, 3-furanyl 

fentanyl, 2′,5′-dimethoxyfentanyl, 

isovaleryl fentanyl, ortho-fluorofuranyl 

fentanyl, alpha′-methyl butyryl 

fentanyl, and para-methylcyclopropyl 

fentanyl) on hand every two years 

pursuant to 21 U.S.C. 827 and 958(e), 

and in accordance with 21 CFR 1304.03, 

1304.04, and 1304.11. 

7. Records and Reports. Every DEA 

registrant must maintain records and 

submit reports with respect to metafluorofentanyl, meta-fluoroisobutyryl 

fentanyl, para-methoxyfuranyl fentanyl, 

3-furanyl fentanyl, 2′,5′- 

dimethoxyfentanyl, isovaleryl fentanyl, 

ortho-fluorofuranyl fentanyl, alpha′- 

methyl butyryl fentanyl, and paramethylcyclopropyl fentanyl, pursuant to 

21 U.S.C. 827 and 958(e), and in 

accordance with 21 CFR parts 

1301.74(b) and (c), 1301.76(b), 1307.11 

and parts 1304, 1312, and 1317. 

Manufacturers and distributors must 

submit reports regarding these 

substances to the Automation of Reports 

and Consolidated Order System 

pursuant to 21 U.S.C. 827 and in 

accordance with 21 CFR parts 1304 and 

1312. 

8. Order Forms. Every DEA registrant 

who distributes meta-fluorofentanyl, 

meta-fluoroisobutyryl fentanyl, paramethoxyfuranyl fentanyl, 3-furanyl 

fentanyl, 2′,5′-dimethoxyfentanyl, 

isovaleryl fentanyl, ortho-fluorofuranyl 

fentanyl, alpha′-methyl butyryl 

fentanyl, and para-methylcyclopropyl 

fentanyl must continue to comply with 

the order form requirements, pursuant 

to 21 U.S.C. 828 and in accordance with 

21 CFR part 1305. 

9. Importation and Exportation. All 

importation and exportation of metafluorofentanyl, meta-fluoroisobutyryl 

fentanyl, para-methoxyfuranyl fentanyl, 

3-furanyl fentanyl, 2′,5′- 

dimethoxyfentanyl, isovaleryl fentanyl, 

ortho-fluorofuranyl fentanyl, alpha′- 

methyl butyryl fentanyl, and paramethylcyclopropyl fentanyl must 

comply with 21 U.S.C. 952, 953, 957, 

and 958, and in accordance with 21 CFR 

part 1312. 

10. Liability. Any activity involving 

meta-fluorofentanyl, metafluoroisobutyryl fentanyl, paramethoxyfuranyl fentanyl, 3-furanyl 

fentanyl, 2′,5′-dimethoxyfentanyl, 

isovaleryl fentanyl, ortho-fluorofuranyl 

fentanyl, alpha′-methyl butyryl 

fentanyl, and para-methylcyclopropyl 

fentanyl not authorized by, or in 

violation of, the CSA or its 

implementing regulations is unlawful 

and may subject the person to 

administrative, civil, and/or criminal 

sanctions. 

Regulatory Analyses 

Executive Orders (E.O.) 12866 

(Regulatory Planning and Review), 

13563 (Improving Regulation and 

Regulatory Review), and 14094 

(Modernizing Regulatory Review) 

This action is not a significant 

regulatory action as defined by 

Executive Order (E.O.) 12866 

(Regulatory Planning and Review), 

section 3(f), and the principles 

reaffirmed in E.O. 13563 (Improving 

Regulation and Regulatory Review); 

and, accordingly, this action has not 

been reviewed by the Office of 

Management and Budget (OMB). This 

action makes no change in the status 

quo, as meta-fluorofentanyl, metafluoroisobutyryl fentanyl, paramethoxyfuranyl fentanyl, 3-furanyl 

fentanyl, 2′,5′-dimethoxyfentanyl, 

isovaleryl fentanyl, ortho-fluorofuranyl 

fentanyl, alpha′-methyl butyryl 

fentanyl, and para-methylcyclopropyl 

fentanyl are already listed as a schedule 

I controlled substances. 

Executive Order 12988, Civil Justice 

Reform 

This action meets the applicable 

standards set forth in sections 3(a) and 

3(b)(2) of E.O. 12988 to eliminate 

drafting errors and ambiguity, minimize 

litigation, provide a clear legal standard 

for affected conduct, and promote 

simplification and burden reduction. 

Executive Order 13132, Federalism 

This rulemaking does not have 

federalism implications warranting the 

application of E.O. 13132. The rule does 

not have substantial direct effects on the 

states, on the relationship between the 

National Government and the states, or 

the distribution of power and 

responsibilities among the various 

levels of government. 

Executive Order 13175, Consultation 

and Coordination With Indian Tribal 

Governments 

This rule does not have tribal 

implications warranting the application 

of E.O. 13175. It does not have 

substantial direct effects 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. 

Regulatory Flexibility Act 

The Administrator, in accordance 

with the Regulatory Flexibility Act, 5 

U.S.C. 601–602, has reviewed this final 

rule and, by approving it, certifies that 

it will not have a significant economic 

impact on a substantial number of small 


ddrumheller on DSK120RN23PROD with RULES1
85108 Federal Register / Vol. 88, No. 234 / Thursday, December 7, 2023 / Rules and Regulations 

7Public Law 117–328, Division O, Title VI, Sec. 

601. 

entities. On February 6, 2018, DEA 

published an order to temporarily place 

fentanyl-related substances in schedule 

I of the CSA pursuant to the temporary 

scheduling provisions of 21 U.S.C. 

811(h). DEA estimates that all entities 

handling or planning to handle metafluorofentanyl, meta-fluoroisobutyryl 

fentanyl, para-methoxyfuranyl fentanyl, 

3-furanyl fentanyl, 2′,5′- 

dimethoxyfentanyl, isovaleryl fentanyl, 

ortho-fluorofuranyl fentanyl, alpha′- 

methyl butyryl fentanyl, and paramethylcyclopropyl fentanyl have 

already established and implemented 

the systems and processes required to 

handle these substances. 

As discussed in the NPRM, there are 

108 registrations authorized to handle 

one or more of the following substances: 

meta-fluorofentanyl, metafluoroisobutyryl fentanyl, paramethoxyfuranyl fentanyl, 3-furanyl 

fentanyl, 2′,5′-dimethoxyfentanyl, 

isovaleryl fentanyl, ortho-fluorofuranyl 

fentanyl, alpha′-methyl butyryl 

fentanyl, and para-methylcyclopropyl 

fentanyl, as well as a number of 

registered analytical labs that are 

authorized to handle schedule I 

controlled substances generally. These 

108 registrations represent a maximum 

of 95 small entities. Therefore, DEA 

conservatively estimates as many as 95 

small entities are affected by this rule. 

A review of the 108 registrations 

indicates that all entities that currently 

handle meta-fluorofentanyl, metafluoroisobutyryl fentanyl, paramethoxyfuranyl fentanyl, 3-furanyl 

fentanyl, 2′,5′-dimethoxyfentanyl, 

isovaleryl fentanyl, ortho-fluorofuranyl 

fentanyl, alpha′-methyl butyryl 

fentanyl, and para-methylcyclopropyl 

fentanyl, also handle other schedule I 

controlled substances and have 

established and implemented (or 

maintain) the systems and processes 

required to handle these substances. 

Therefore, DEA anticipates that this 

final rule will impose minimal or no 

economic impact on any affected 

entities, and, thus, will not have a 

significant economic impact on any of 

the small entities. Therefore, DEA has 

concluded that this final rule will not 

have a significant economic impact on 

a substantial number of small entities. 

Unfunded Mandates Reform Act of 1995 

In accordance with the Unfunded 

Mandates Reform Act (UMRA) of 1995, 

2 U.S.C. 1501 et seq., DEA has 

determined and certifies that this 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 million 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 final rule does not impose a new 

collection or modify an existing 

collection of information under the 

Paperwork Reduction Act of 1995. 44 

U.S.C. 3501–3521. Also, this final rule 

does not impose new or modify existing 

recordkeeping or reporting requirements 

on State or local governments, 

individuals, businesses, or 

organizations. However, this final rule 

does require compliance with the 

following existing OMB collections: 

1117–0003, 1117–0004, 1117–0006, 

1117–0008, 1117–0009, 1117–0010, 

1117–0012, 1117–0014, 1117–0021, 

1117–0023, 1117–0029, and 1117–0056. 

An agency may not conduct or sponsor, 

and a person is not required to respond 

to, a collection of information unless it 

displays a currently valid OMB control 

number. 

Congressional Review Act 

This rule is not a major rule as 

defined by the Congressional Review 

Act (CRA), 5 U.S.C. 804. Pursuant to the 

CRA, DEA is submitting a copy of this 

final rule to both Houses of Congress 

and to the Comptroller General. 

Determination To Make Rule Effective 

Immediately 

As indicated above, this rule finalizes 

the schedule I control status of nine 

substances that has already been in 

effect. These nine substances all fall 

within the definition of fentanyl-related 

substances set forth in the February 6, 

2018, temporary scheduling order (83 

FR 5188). Through the Temporary 

Reauthorization and Study of the 

Emergency Scheduling of Fentanyl 

Analogues Act, which became law on 

February 6, 2020, Congress extended the 

temporary control of fentanyl-related 

substances until May 6, 2021. This 

temporary order was subsequently 

extended multiple times, most recently 

on December 29, 2022, through the 

Consolidated Appropriations Act, 2023, 

which extended the order until 

December 31, 2024.7 The February 2018 

order was effective on the date of 

publication, and was based on findings 

by the then-Acting Administrator that 

the temporary scheduling of the 

fentanyl-related substances was 

necessary to avoid an imminent hazard 

to the public safety pursuant to 21 

U.S.C. 811(h)(1). Because this rule 

finalizes the control status of nine 

substances that has already been in 

effect, it does not alter the legal 

obligations of any person who handles 

these substances. Rather, it merely 

makes permanent the current 

scheduling status and corresponding 

legal obligations. Therefore, since this 

rule does not change the current 

scheduling status and corresponding 

legal obligations, DEA is making the 

rule effective on the date of publication 

in the Federal Register, as any delay in 

the effective date is unnecessary and 

would be contrary to the public interest. 

Signing Authority 

This document of the Drug 

Enforcement Administration was signed 

on November 29, 2023, 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. 

Scott Brinks, 

Federal Register Liaison Officer, Drug 

Enforcement Administration. 

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, 21 CFR 

part 1308 is amended 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. 

■ 2. In § 1308.11: 

■ a. Redesignate paragraphs (b)(10) 

through (94) to read as follows: 

Old paragraph New paragraph 

(b)(10) through (33) ........ (b)(11) through (34). 

(b)(34) through (43) ........ (b)(36) through (45). 

(b)(44) through (47) ........ (b)(47) through (50). 

(b)(48) through (50) ........ (b)(52) through (54). 

(b)(51) through (66) ........ (b)(57) through (72). 

(b)(67) through (74) ........ (b)(74) through (81). 

(b)(75) through (94) ........ (b)(84) through (103). 

■ b. Add new paragraphs (b)(10), (35), 

(46), (51), (55), (56), (73), (82), and (83); 

The additions to read as follows: 


ddrumheller on DSK120RN23PROD with RULES1
Federal Register / Vol. 88, No. 234 / Thursday, December 7, 2023 / Rules and Regulations 85109 

1See the proposed rule for further discussion. 

§ 1308.11 Schedule I. 

* * * * * 

(b) * * * 

*******

(10) alpha′-Methyl butyryl fentanyl (2-methyl-N-(1-phenethylpiperidin-4-yl)-N-phenylbutanamide) ......................................................... 9864 

*******

(35) 2′,5′-Dimethoxyfentanyl (N-(1-(2,5-dimethoxyphenethyl)piperidin-4-yl)-N-phenylpropionamide) ...................................................... 9861 

*******

(46) 3-Furanyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylfuran-3-carboxamide) .............................................................................. 9860 

*******

(51) Isovaleryl fentanyl (3-methyl-N-(1-phenethylpiperidin-4-yl)-N-phenylbutanamide) ............................................................................. 9862 

*******

(55) meta-Fluorofentanyl (N-(3-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)propionamide) ....................................................................... 9857 

(56) meta-Fluoroisobutyryl fentanyl (N-(3-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide) .................................................... 9858 

*******

(73) ortho-Fluorofuranyl fentanyl (N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)furan-2-carboxamide) .............................................. 9863 

*******

(82) para-Methoxyfuranyl fentanyl (N-(4-methoxyphenyl)-N-(1-phenethylpiperidin-4-yl)furan-2-carboxamide ........................................ 9859 

(83) para-Methylcyclopropyl fentanyl (N-(4-methylphenyl)-N-(1-phenethylpiperidin-4-yl)cyclopropanecarboxamide) ............................ 9865 

* * * * * 

[FR Doc. 2023–26694 Filed 12–6–23; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF STATE 

22 CFR Part 42 

[Public Notice: 12224] 

RIN 1400–AE83 

Immigrant Visas 

AGENCY: Department of State. 

ACTION: Final rule. 

SUMMARY: The Department of State 

(‘‘Department’’) is amending its 

regulation governing immigrant visas by 

removing the section which allows a 

consular officer to conduct an informal 

evaluation of the family members of an 

immigrant visa applicant to identify 

potential grounds of ineligibility. The 

existing regulation was promulgated in 

1952, at a time when a consular officer 

could more readily assess a family 

member’s potential qualification for a 

visa without a formal visa application. 

Assessing eligibility for an immigrant 

visa is now a more complex task and not 

one which can be accomplished 

accurately with an informal evaluation. 

DATES: This final rule is effective on 

January 8, 2024. 

FOR FURTHER INFORMATION CONTACT: 

Claire Kelly, Office of Visa Services, 

Bureau of Consular Affairs, Department 

of State; telephone (202) 485–7586, 

VisaRegs@state.gov. 

SUPPLEMENTARY INFORMATION: The 

Department published a notice of 

proposed rulemaking, Public Notice 

11604 at 88 FR 16384 (Mar. 17, 2023) 

(hereafter ‘‘proposed rule’’), with a 

request for comments, proposing to 

amend Part 42 of Title 22 of the Code 

of Federal Regulations. The rule will 

eliminate 22 CFR 42.68 in its entirety. 

The regulatory amendment was 

discussed in detail in the proposed rule, 

and that discussion is adopted by 

reference in this final rule. The 

Department received two responsive 

comments, both in support of 

eliminating 22 CFR 42.68. The 

Department is now promulgating a final 

rule with no changes from the proposed 

rule. This rule results in no change for 

applicants, as the authority granted by 

22 CFR 42.68 was no longer used by 

consular officers.1

Analysis of Comments 

The proposed rule was published in 

the Federal Register on March 17, 2023. 

The comment period closed May 16, 

2023. The Department received two 

responsive comments, both in favor of 

the proposed elimination of 22 CFR 

42.68, and one non-responsive 

comment. 

One of the two responsive comments 

advocated for replacing 22 CFR 42.68 

with ‘‘supportive and accessible 

eligibility screenings for noncitizens 

seeking visas,’’ while the other comment 

only expressed its support for the 

proposed elimination. The Department 

has considered these comments. 

Considering the complexity required to 

evaluate a noncitizen’s eligibility for a 

visa, and limited resources to reliably 

assess eligibility absent a visa 

application, the Department is unable to 

offer any eligibility screenings. 

Noncitizens who wish to receive a 

nonimmigrant or immigrant visa must 

formally apply for a visa to allow a 

consular officer to assess their eligibility 

for the visa. 

Regulatory Findings 

A. Administrative Procedure Act 

As this rule involves amending visa 

policy, which is a foreign affairs 

function of the United States, it is 

exempt from both the delayed effective 

date and notice and comment 

requirements of 5 U.S.C. 553 per 

subsection (a)(1). Notwithstanding the 

applicability of the foreign affairs 

exception to this rule, the Department, 

for its own benefit, sought public 

comment on the proposed elimination 

of 22 CFR 42.68. See, e.g., Hoctor v. U.S. 

Dep’t of Agric., 82 F.3d 165, 171–72 (7th 

Cir. 1996) (observing that there is 

nothing in the APA that forbids an 

agency’s use of notice-and-comment 

procedures even if not required under 

the APA, and that courts should attach 

no weight to an agency’s varied 

approaches involving similar rules). 

Though this rule is not subject to 5 

U.S.C. 553(d), the Department is also 

choosing to delay the effective date of 

this rule for 30 days. 

B. Regulatory Flexibility Act 

As this rulemaking is not required to 

be published for notice and comment 

under 5 U.S.C. 553, it is exempt from 

the regulatory flexibility analysis 

requirements set forth by the Regulatory 


ddrumheller on DSK120RN23PROD with RULES1