Federal Register / Vol. 89, No. 2 / Wednesday, January 3, 2024 / Notices 407 

Indian Tribes, the U.S. Army Corps of 

Engineers, Nashville District has 

determined that: 

• The human remains described in 

this notice represent the physical 

remains of six individuals of Native 

American ancestry. 

• The 42 objects described in this 

notice are reasonably believed to have 

been placed with or near individual 

human remains at the time of death or 

later as part of the death rite or 

ceremony. 

• No relationship of shared group 

identity can be reasonably traced 

between the human remains and 

associated funerary objects and any 

Indian Tribe. 

• The associated funerary objects 

described in this notice were removed 

from the aboriginal land of the Cherokee 

Nation; Eastern Band of Cherokee 

Indians; and the United Keetoowah 

Band of Cherokee Indians in Oklahoma. 

Requests for Disposition 

Written requests for disposition of the 

human remains and associated funerary 

objects in this notice must be sent to the 

Responsible Official identified in 

ADDRESSES. Requests for disposition 

may be submitted by: 

1. Any one or more of the Indian 

Tribes identified in this notice. 

2. Any lineal descendant, Indian 

Tribe, or Native Hawaiian organization 

not identified in this notice who shows, 

by a preponderance of the evidence, that 

the requestor is a lineal descendant or 

a culturally affiliated Indian Tribe or 

Native Hawaiian organization, or who 

shows that the requestor is an aboriginal 

land Indian Tribe. 

Disposition of the human remains and 

associated funerary objects described in 

this notice to a requestor may occur on 

or after February 2, 2024. If competing 

requests for disposition are received, the 

U.S. Army Corps of Engineers, Nashville 

District must determine the most 

appropriate requestor prior to 

disposition. Requests for joint 

disposition of the human remains and 

associated funerary objects are 

considered a single request and not 

competing requests. The U.S. Army 

Corps of Engineers, Nashville District is 

responsible for sending a copy of this 

notice to the Indian Tribes identified in 

this notice. 

Authority: Native American Graves 

Protection and Repatriation Act, 25 

U.S.C. 3003, and the implementing 

regulations, 43 CFR 10.9 and 10.11. 

Dated: December 20, 2023. 

Melanie O’Brien, 

Manager, National NAGPRA Program. 

[FR Doc. 2023–28929 Filed 1–2–24; 8:45 am] 

BILLING CODE 4312–52–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–1228E] 

Established Aggregate Production 

Quotas for Schedule I and II Controlled 

Substances and Assessment of 

Annual Needs for the List I Chemicals 

Ephedrine, Pseudoephedrine, and 

Phenylpropanolamine for 2024 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Final order. 

SUMMARY: This final order establishes 

the initial 2024 aggregate production 

quotas for controlled substances in 

schedules I and II of the Controlled 

Substances Act and the assessment of 

annual needs for the list I chemicals 

ephedrine, pseudoephedrine, and 

phenylpropanolamine. 

DATES: This Notice is effective January 

3, 2024. 

FOR FURTHER INFORMATION CONTACT: 

Scott A. Brinks, Regulatory Drafting and 

Policy Support Section, Diversion 

Control Division, Drug Enforcement 

Administration; Mailing Address: 8701 

Morrissette Drive, Springfield, VA 

22152, Telephone: (571) 776–3882. 

SUPPLEMENTARY INFORMATION: 

I. Legal Authority 

Section 306 of the Controlled 

Substances Act (CSA) (21 U.S.C. 826) 

requires the Attorney General to 

establish aggregate production quotas 

for each basic class of controlled 

substance listed in schedule I and II and 

for the list I chemicals ephedrine, 

pseudoephedrine, and 

phenylpropanolamine. The Attorney 

General has delegated this function to 

the Administrator of the Drug 

Enforcement Administration (DEA) 

pursuant to 28 CFR 0.100. 

II. Background 

The 2024 aggregate production quotas 

(APQ) and assessment of annual needs 

(AAN) represent those quantities of 

schedule I and II controlled substances 

and the list I chemicals ephedrine, 

pseudoephedrine, and 

phenylpropanolamine that may be 

manufactured in the United States in 

2024, in order to provide for the 

estimated medical, scientific, research, 

and industrial needs of the U.S., lawful 

export requirements, and the 

establishment and maintenance of 

reserve stocks. These quotas include 

imports of ephedrine, pseudoephedrine, 

and phenylpropanolamine, but do not 

include imports of controlled 

substances for use in industrial 

processes. 

On November 2, 2023, a notice titled 

‘‘Proposed Aggregate Production Quotas 

for Schedule I and II Controlled 

Substances and Assessment of Annual 

Needs for the List I Chemicals 

Ephedrine, Pseudoephedrine, and 

Phenylpropanolamine for 2024’’ was 

published in the Federal Register. 88 FR 

75312. This notice proposed the 2024 

APQ for each basic class of controlled 

substance listed in schedules I and II 

and the 2024 AAN for the list I 

chemicals ephedrine, pseudoephedrine, 

and phenylpropanolamine. All 

interested persons were invited to 

comment on or object to the proposed 

APQ and the proposed AAN on or 

before December 4, 2023. 

III. Comments Received 

Within the public comment period, 

DEA received 4,699 comments from 

DEA registrants, people with chronic 

pain, patients with attention deficit/ 

hyperactivity disorder (ADHD), pain 

advocacy associations, U.S. professional 

associations, U.S. nurses, the Royal 

Australian and New Zealand College of 

Psychiatrists, the Australian ADHD 

Professionals Association, the ADHD 

Foundation Australia, and others. The 

comments included concerns about 

potential domestic opioid drug 

shortages due to further quota 

reductions; stimulant drug shortages in 

the United States and Australia; 

concerns that medical professionals 

might be impeded from exercising their 

medical expertise regarding opioid 

prescriptions; two requests for a public 

hearing; concerns with the 

implementation of quarterly quota 

allotments, and comments not 

pertaining to DEA regulated activities. 

DEA restricted seven comments from 

public view due to confidential business 

information and/or confidential 

personal identifying information. 

Opioid Adequacy 

Issue (Medication Out of Stock at 

Pharmacy Level): Commenters 

questioned whether the 2024 proposed 

APQs for Schedule II opioids will be 

adequate to meet legitimate medical 

needs of patients. Commenters said that 

because of decreases in aggregate 

production quotas for specific opioids, 

they have had difficulty filling 

legitimate prescriptions at pharmacies. 


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These issues have negatively impacted 

their quality of life and caused mental 

health-related issues, possibly leading to 

suicide. 

DEA Response: DEA is committed to 

ensuring an adequate and uninterrupted 

supply of controlled substances in order 

to meet legitimate medical, scientific, 

and export needs of the United States. 

DEA sets the APQs for controlled 

substances based on the available data 

and information received at that specific 

point in time set by the regulations, 

however, subsequent factors and 

manufacturers’ business practices may 

arise afterwards and potentially 

contribute to a temporary lack of 

inventory of controlled substances at the 

point of dispensation. In recent years, 

this has included labor shortages and a 

lack of production capacity. In such 

circumstances, DEA, in coordination 

with the Food and Drug Administration 

(FDA), can utilize tools under the CSA 

to prevent or alleviate drug shortages 

and ensure that patients are able to fill 

legitimate prescriptions for controlled 

substances without undue delay. 

Additionally, if a patient is faced with 

a delay in receiving their medications, 

the patient may request a one-time 

transfer of initial dispensing of an 

electronic prescription for Schedules II– 

V controlled substances from one retail 

pharmacy to another retail pharmacy. If 

the medication is a controlled substance 

in Schedules III–V and includes 

authorized refills, the refills can also be 

transferred with the initial prescription 

to the receiving pharmacy. 

Issue (Nationwide Shortages): Some 

commenters stated that there is a 

nationwide shortage of opioid 

medication because their local 

pharmacies were often out of stock. One 

commenter also stated that the 

American Society of Health-System 

Pharmacists (ASHP) has warned about 

shortages of immediate release 

oxycodone and hydrocodone 

medications, but shortages have not 

been publicly acknowledged by DEA or 

FDA. 

DEA Response: DEA utilizes the 

available, reliable data and information 

received by the agency at the time APQs 

are proposed and proactively monitors 

drug production, distribution and 

supply during the year. However, drug 

shortages may occur subsequently due 

to factors outside of DEA control such 

as manufacturing and quality problems, 

processing delays, supply chain 

disruptions, or discontinuations. In 

such circumstances, if the drug 

manufacturer notifies the FDA Drug 

Shortage Staff, FDA will coordinate 

with DEA to address and minimize the 

impact of drug shortages if both 

agencies believe action is warranted. 

Currently, FDA has not issued any 

nationwide shortages of oxycodone and 

hydrocodone products. 

Issue (Patients Switching to Illicit 

Fentanyl or Medications Obtained from 

Illegal Sources): Several commenters 

expressed concerns that because of 

DEA’s reduction of quotas for pain 

relieving controlled substances, patients 

with chronic pain who were unable to 

fill their legitimate prescriptions 

eventually turned to illegal fentanyl or 

medications obtained from illegitimate 

sources as a substitute relief that could 

increase the risk of overdose death. 

These commenters stated that overdose 

deaths in the United States continue to 

rise because of illegal fentanyl or 

illegitimate medications, not from 

pharmaceutical medications prescribed 

to patients with chronic pain. 

DEA Response: In proposing and 

establishing APQs for opioids, DEA 

considers rates of overdose deaths. 

Congress, in 21 U.S.C. 826(i), mandates 

DEA to estimate diversion for five 

controlled substances—fentanyl, 

hydrocodone, hydromorphone, 

oxycodone, and oxymorphone. This 

estimation must consider the rates of 

overdose deaths, among other factors. 

While overdose deaths may occur as a 

result of use of illicit substances, DEA’s 

quotas help prevent misuse and 

diversion of pharmaceutical controlled 

substances. In this way, these quotas 

can reduce the occurrence of overdose 

and death from the use of legitimate 

controlled substances. Patients should 

work closely with their providers to 

utilize other FDA-approved medications 

for their conditions and fill their 

prescriptions only from DEA-registered 

pharmacies. The only safe medications 

are ones prescribed by a trusted, DEAregistered medical professional and 

dispensed by a licensed pharmacist at a 

DEA-registered pharmacy. The 

medications received from unregistered 

internet sources may, in fact, be 

manufactured or laced with illicit 

substances including illicit fentanyl, 

which contributes to rates of overdose 

deaths. 

Issue (Prescribing Hesitancy): Many 

commenters, mostly self-identified 

patients with chronic pain patients, 

expressed that the goal of the 2016 

Centers for Disease Control and 

Prevention (CDC) Guidelines was to 

decrease opioid overdoses, but instead 

there has been an increase in overdoses 

nationwide of over 400 percent due to 

illegal fentanyl or illegally 

manufactured pain pills. Commenters 

stated that many patients with chronic 

pain patients have been harmed, and 

some have died by suicide, due to the 

inability to get prescriptions because of 

the APQ reductions made by DEA. 

Many commenters also stated that 

restrictions imposed by DEA have 

caused opioid medications to be underprescribed due to fear of prosecution. 

Commenters said doctors should have 

latitude in making treatment decisions 

to prescribe opioid pain medications 

based on individual patient needs. 

DEA Response: Pursuant to the 

Substance Use-Disorder Prevention that 

Promotes Opioid Recovery and 

Treatment for Patients and Communities 

(SUPPORT) Act, DEA is mandated to 

estimate diversion for 5 controlled 

substances—fentanyl, hydrocodone, 

hydromorphone, oxycodone and 

oxymorphone, and this estimation 

includes the consideration of rates of 

overdose deaths. While overdose deaths 

may occur as a result of the use of illegal 

fentanyl or illegally manufactured pain 

medications, quotas are being set by the 

DEA to prevent misuse and diversion of 

pharmaceutical controlled substances, 

and thus reducing the occurrence of 

overdose and death from the use of 

legitimate controlled substances. 

Additionally, DEA’s regulations do not 

impose restrictions on the amount and 

the type of medication that licensed 

practitioners can prescribe. DEA has 

consistently emphasized and supported 

the authority of individual practitioners 

under the CSA to administer, dispense, 

and prescribe controlled substances for 

the legitimate treatment of pain within 

acceptable medical standards, as 

outlined in DEA’s policy statement 

published in the Federal Register on 

September 6, 2006, titled Dispensing 

Controlled Substances for the Treatment 

of Pain. 71 FR 52716. 

Attention Deficit/Hyperactivity Disorder 

Medications Medication Shortages 

Issue: DEA received comments 

expressing general concerns regarding 

the ongoing shortages experienced with 

ADHD medications produced from 

amphetamine and methylphenidate. 

DEA Response: DEA is committed to 

ensuring an adequate and uninterrupted 

supply of controlled substances in order 

to meet the estimated legitimate 

medical, scientific, research, and 

industrial needs of the United States, for 

lawful export requirements, and for the 

establishment and maintenance of 

reserve stocks. DEA sets the APQs to 

provide for all legitimate medical 

purposes and for anticipated foreign 

demand. Additionally, DEA and FDA 

coordinate efforts to prevent or alleviate 

drug shortages. Such efforts may 

include the adjustment of the APQs and 

individual domestic manufacturers’ 

quotas, FDA’s approval of additional 


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Federal Register / Vol. 89, No. 2 / Wednesday, January 3, 2024 / Notices 409 

market competitors, and coordination 

between the agencies to allow 

importation of foreign-manufactured 

drug products that meet FDA approval. 

Based on the data DEA considers in 

setting the APQs, including any new 

FDA approved drug products, as well as 

manufacturing issues that DEA 

considers under 21 CFR 1303.11(b)(7), 

DEA determined that the proposed 

APQs for amphetamine, 

lisdexamfetamine and methylphenidate 

are sufficient to supply legitimate 

medical needs, reserve stocks, and 

export requirements for 2024. If the 

actual prescribing rates of these 

substances are significantly higher than 

the 2024 estimates of medical needs, the 

Administrator has the authority to 

increase the aggregate production quota 

at any time. 21 CFR 1303.13(a). For 

example, in 2023, DEA adjusted the 

methylphenidate (for sale) APQ to 

address shortages of methylphenidate 

HCL extended release tablets upon 

consideration of the criteria in 

accordance with 21 CFR 1303.13. 

Adjustment of Aggregate Production 

Quota for Methylphenidate (for sale) for 

2023, 88 FR 68147 (October 3, 2023). 

Issue (Lisdexamfetamine Shortages in 

Australia): DEA received comments 

from The ADHD Foundation Australia, 

Australian ADHD Professionals 

Association and the Royal Australian 

and New Zealand College of 

Psychiatrists. The ADHD Foundation 

Australia stated that the Australian 

Therapeutic Goods Administration 

(TGA) has advised of current shortages 

of lisdexamfetamine, with more 

shortages predicted into 2024, under the 

current production quotas. This 

commenter also asserted that Australia’s 

domestic prescriptions of 

lisdexamfetamine have increased by 

over 150% from 2020–2022 due to 

increased awareness and diagnosis of 

ADHD. The Royal Australian and New 

Zealand College of Psychiatrists 

commented that they endorse the 

guidelines from the Australian ADHD 

Professionals Association. Both the 

ADHD Foundation Australia and 

Australian ADHD Professionals 

Association stated that Vyvanse 

(lisdexamfetamine) and 

methylphenidate are the only two 

extended-release medications approved 

by the TGA to treat ADHD in Australia. 

Although Vyvanse’s patent expired in 

August 2023 in the United States, 

Vyvanse remains under patent in 

Australia and generic lisdexamfetamine 

products will not be available. The 

commenters are concerned that the 

proposed 2024 lisdexamfetamine APQ 

has not been increased from 2023 levels 

despite reports of shortages in both the 

United States and Australia. They are 

also concerned that any U.S. production 

quotas allocated for production of 

Vyvanse will decrease as U.S. 

production quotas will instead be 

allotted to manufacture domestic 

generic products instead. The 

commenters requested that DEA 

consider increasing 2024 

lisdexamfetamine APQ to resolve 

shortages in Australia and Aotearoa 

New Zealand. 

DEA Responses: DEA considered the 

comments, additional export data, 

recent domestic consumption data, and 

determined that the proposed APQ for 

lisdexamfetamine will remain at the 

level proposed based on its belief that 

inventory of bulk active pharmaceutical 

ingredient (API) and the quantities 

which will be produced in 2024 will be 

sufficient to meet the growing medical 

usage in domestic and foreign markets. 

DEA is closely monitoring 

manufacturing and distribution data 

from manufacturers of FDA-approved 

drug products as reported by the 

company, Automation of Reports and 

Consolidated Orders System (ARCOS) 

reports, prescription dispensing data 

from IQVIA, and estimated and actual 

inventories to ensure that there is an 

adequate and uninterrupted supply. In 

addition, DEA is pursuing the purchase 

of additional third-party data to better 

understand market penetration and 

demand in foreign countries—such as 

Australia—where American-made API 

and/or pharmaceutical preparations are 

dispensed. 

Market Entry of Generic 

Lisdexamfetamine Products 

Issue: DEA received comments from 

one association representing 

manufacturers and one dosage form 

manufacturer. They stated that DEA 

generally allocates procurement quotas 

using a company’s historical sales of a 

drug. They asserted that this practice 

denies greater quota allocation to 

generic drug manufacturers who are 

entering the market following the 

expiration of a patent, due to the fact 

that new entrants do not have an 

established sales history. The 

association claimed that DEA’s 

application process does not solicit 

information tailored to this situation. 

The association said that DEA’s practice 

hindered the competition of generic 

lisdexamfetamine products, with the 

patent holder of Vyvanse holding onto 

a high share of the market. 

DEA Response: DEA typically grants 

individual commercial manufacturing 

procurement quotas based on the sales 

history of the drug as reported by the 

company, ARCOS and IQVIA data, 

inventory estimated and actual, 

inventory allowed by regulation, and 

manufacturing process loss of existing 

manufacturers. DEA has always been 

cognizant that new manufacturers 

entering the market for the first time 

would not have any established sales 

history, and thus the manufacturer’s 

past sales history is not a factor when 

determining the amount of quota 

needed to launch a new product. 

Instead, DEA considers other data 

including the historic timelines of the 

shift in prescribing from a branded 

product to a generic product(s) for 

controlled substances. For example, 

when the patent for Vyvanse expired in 

August 2023, DEA solicited additional 

information from each FDA-approved 

manufacturer and considered the 

following factors to determine the 

amount of quota a dosage form 

manufacturer needed to launch a new 

generic lisdexamfetamine product: (1) 

the overall patient utilization for the 

branded product for the past 3 years, (2) 

the current estimated patient utilization 

for the current year, (3) the remaining 

months in the current year needed to 

meet patient needs, (4) the amount of 

quota previously granted for saleable 

validation, (5) current inventory of 

finished goods, in-process material and 

API, and (6) the amount of finished 

goods already shipped into the 

distribution chain. 

The assertion that DEA’s practice 

allowed the patent holder of Vyvanse to 

hold onto a higher share of the market 

is incorrect. However, DEA did consider 

that the current year (2023) would only 

allow for 4 months of brand erosion 

when allocating quota necessary to 

launch the generic lisdexamfetamine 

products. Some manufacturers were 

denied additional quota because their 

current inventory of saleable products 

was sufficient for a product launch 

during the remaining four months of the 

calendar year. 

Diversion Estimates 

Issue (Impact of Diversion Estimate on 

Opioids): Several commenters stated 

that the APQs of prescription opioids 

should not be reduced from calendar 

year 2023 APQ levels, given that less 

than 1 percent of prescription opioids 

are diverted. 

DEA Response: DEA not only 

considers the extent of diversion, but it 

also considers other factors, as required 

by regulation, when determining the 

APQ. 21 U.S.C. 826(a), 21 CFR 

1303.11(b). These factors include total 

net disposal of the class by all 

manufacturers during the current and 2 

preceding years, trends in the national 


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1Compton WM, Jones CM, Baldwin J. 

Relationship between nonmedical prescriptionopioid use and heroin use. N Engl J Med. 

2016;374(2):154–63, accessed from https://

www.nejm.org/doi/full/10.1056/NEJMra1508490. 

rate of net disposal of the class, total 

actual or estimated inventories of the 

class and of all substances 

manufactured from the class, 

information obtained from the Food and 

Drug Administration, and changes in 

the currently accepted medical use in 

treatment. Additional factors considered 

can be found in 21 CFR 1303.11(b). 

After considering all of the relevant 

factors, DEA has determined that the 

APQs of prescription opioids should be 

reduced from calendar year 2023 APQ 

levels and they are sufficient to meet the 

forecasted domestic and foreign medical 

needs. 

Issue (Underestimation of Opioid 

Diversion): One pharmaceutical 

company suggested that DEA 

underestimated actual diversion of 

opioids. The commenter said 

nonmedical use of prescription opioids 

is not a legitimate medical purpose, but 

DEA rejected this point in calculating 

diversion, and thus the 2024 APQ must 

be reduced for nonmedical use of 

prescription opioids. The commenter 

also asserted that the estimate is 

incomplete because a number of states 

did not provide Prescription Drug 

Monitoring Program (PDMP) data for the 

five covered controlled substances. 

Additionally, the commenter asserted 

that DEA rejected CDC guidelines of not 

prescribing greater than 90 morphine 

milligram equivalence (MME) daily and 

used 240 MME to calculate diversion. 

DEA Response: The cited 2016 

report 1provides insightful information 

regarding the relationship between 

nonmedical prescription-opioid use and 

heroin use. However, it does not 

provide data in a form which DEA could 

utilize to modify its nationwide estimate 

for the diversion of oxycodone. 

Additionally, as stated in the published 

2024 Proposed APQ, DEA used 

available data at wholesale distribution 

and retail dispensing channels, i.e., 

DEA’s Theft/Loss Reports and available 

individual state PDMP data. 

The state PDMP data submitted was 

adequate to allow DEA to draw reliable 

inferences regarding the state and U.S. 

population. The sample is large enough 

to allow DEA to accurately generalize 

the data to the whole population of the 

United States for use in the calculation 

of estimated national levels of diversion 

of the covered controlled substances. 

The 2022 CDC Clinical Practice 

Guideline includes information that 

updates and replaces the 2016 CDC 

Guideline for Prescribing Opioids for 

Chronic Pain. The 2022 CDC guidelines 

no longer set rigid dosage thresholds or 

duration of opioid therapy. Although 

DEA accepts CDC guidelines for 

prescribing opioids, DEA believes that 

higher dosages place individuals at 

higher risk of overdose and death, and 

prescriptions involving dosages 

exceeding 240 MME daily may indicate 

diversion, such as illegal distribution of 

controlled substances or prescribing 

outside the usual course of professional 

practice. 

Issue (Use of Diversion Estimate for 

all Controlled Substances): One 

commenter questioned why diversion 

estimates were not considered for the 

stimulants when proposing the initial 

2024 APQ. 

DEA Response: Pursuant to 21 CFR 

1303.11(b)(5), DEA considered the 

extent of diversion of the basic class as 

a factor in setting each APQ for each 

respective basic class, as well as the 

extent of diversion for all other schedule 

I and II controlled substances in 

proposing the estimated APQ. Under 21 

U.S.C. 826(i)(A), DEA is only required to 

publish the diversion estimates for 5 

specific opioids. 

Data Collection and Analysis 

Issue (Data Accuracy): Several 

commenters stated FDA’s estimation of 

medical needs and DEA’s data 

collection process are flawed and 

inaccurate. 

DEA Response: FDA utilizes a variety 

of data sources in developing its 

estimates of domestic medical needs. 

When determining the 2024 APQs, DEA 

considered the estimation of domestic 

medical needs data provided by FDA, 

and also considered other data sources 

including prescriptions dispensed in 

prior and current years reported in 

IQVIA, research and clinical trials 

information from DEA-registered 

researchers and manufacturers, 

information provided in quota 

applications from DEA-registered 

manufacturers, as well as historic and 

current year export data and future 

estimations of export requirements. DEA 

is actively reevaluating and improving 

the data collection process to ensure the 

APQs are set at an adequate level to 

meet legitimate medical, scientific, 

research, and export needs while 

establishing and maintaining reserve 

stocks. 

Issue (Lack of Real-Time Data): One 

commenter opined that DEA lacks realtime data on opioid production and 

distribution. The lack of real-time data 

makes it difficult to accurately assess 

legitimate medical needs of patients and 

ensure adequate supply of opioid pain 

medications. 

DEA Response: DEA has access to 

sales data provided by manufacturers 

from the Quota and Year-end Reporting 

Management System (QMS), ARCOS 

reports, and monthly IQVIA data when 

determining legitimate medical needs to 

ensure an adequate supply of 

medications containing schedule II 

controlled substances. Additionally, 

DEA is considering regulatory changes 

to gain access to more real-time data 

such as requiring manufacturers and 

distributors to report sales data into the 

ARCOS database on a monthly basis to 

improve the timeliness and accuracy of 

data points being used to estimate 

legitimate medical needs. 

Issue (Lack of Data Transparency): 

Two commenters stated that there is a 

lack of transparency in the quota setting 

process. 

DEA Response: DEA is considering 

methods that might increase 

transparency in its quota setting 

process. Future regulatory proposals 

may include steps such as public 

notification and an opportunity for 

public input when prescribing rates for 

controlled substances substantially 

deviate from FDA’s estimate of medical 

needs. DEA must strike a balance 

between increasing transparency and 

complying with laws and regulations 

aimed at protecting confidential 

business and patient information. 

Schedule I Controlled Substances 

Issue (Religious Use of Schedule I 

Substances): Two commenters 

requested that DEA increase APQs for 

certain schedule I controlled substances, 

including: psilocin, psilocybin, 

mescaline, ibogaine, lysergic acid 

diethylamide (LSD), 2-(4-Iodo-2,5- 

dimethoxyphenyl)ethanamine (2CI), 

dimethyltryptamine (DMT), 5-methoxyN,N-dimethyltryptamine (5-MeO-DMT) 

for religious use. They also commented 

that the APQ for mescaline should be 

increased in order to allow access to 

members of the Native American 

Church, as well as replanting into the 

wild because of shortages. They opined 

that DEA has disregarded their legal 

religious use of psychedelics as a factor 

when setting the production quotas of 

these substances. They also requested a 

hearing with the Administrator if DEA 

does not take their freedom of religion 

into consideration. 

DEA Response: In the past, DEA held 

discussions with representatives of 

indigenous communities when 

requested and continued to welcome 

further engagement and input. The 

APQs are determined in part by the 

individual manufacturing quota 

requests submitted by DEA-registered 

manufacturers of these substances. DEA 


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Federal Register / Vol. 89, No. 2 / Wednesday, January 3, 2024 / Notices 411 

2FDA clarifies results of recent advisory 

committee meeting on oral phenylephrine | FDA. 

received quota applications from DEAregistered manufacturers for 5-MeODMT, psilocin, psilocybin, mescaline, 

LSD, 2CI, DMT and 5-MeO-DMT. DEA 

has considered these applications, along 

with the factors listed in 21 CFR 

1303.11 (b) when determining the 

aggregate production quotas. 

Issue: Two commenters commented 

that the APQs should include fruiting 

bodies containing psilocybin and 

psilocin and peyote buttons containing 

mescaline, rather than pure chemicals 

only. 

DEA Response: Psilocybin and 

psilocin are schedule I controlled 

substances naturally occurring in 

psychedelic mushrooms, while 

mescaline is the schedule I controlled 

substance naturally occurring in peyote. 

Because the CSA controls psilocybin 

and psilocin specifically, DEA will 

continue to establish APQ for those two 

substances. The APQs apply to 

psilocybin and psilocin that is 

manufactured synthetically as well as to 

substances that are derived naturally. 

Peyote is controlled under 21 U.S.C. 

812(e) Schedule I (c) as a separate 

controlled substance from mescaline. As 

noted below, the APQ for peyote was 

proposed and is established at zero 

Comments and Quota Applications 

From DEA-Registered Manufacturers 

Issue: DEA received comments from 

three DEA-registered manufacturers 

regarding 3 different schedule I and II 

controlled substances, requesting that 

the proposed APQ for 

dexmethylphenidate (for conversion), 

lisdexamfetamine, and psilocybin be 

established at sufficient levels to allow 

for manufacturers to meet medical and 

scientific needs. DEA also received 

additional or revised quota applications 

for 4-Anilino-N-phenethyl-4-piperidine 

(4-ANPP), all other 

tetrahydrocannabinol, delta-9- 

tetrahydrocannabinol, 

dimethyltryptamine, fentanyl and 

pentobarbital. 

DEA Response: DEA considered the 

comments and quota applications from 

the DEA-registered manufacturers and 

determined that DEA’s proposed APQs 

will be increased for the 

abovementioned controlled substances, 

except lisdexamfetamine. The increases 

are reflected below in the section titled 

Determination of 2024 Aggregate 

Production Quotas and Assessment of 

Annual Needs. 

List 1 Chemical (Pseudoephedrine) 

Issue: Several pharmaceutical 

companies and healthcare organizations 

asserted that at a recent advisory 

meeting convened by the FDA, the 

advisory committee voted that 

phenylephrine, a common ingredient 

found in many over-the counter (OTC) 

cold and cough medications, is a safe 

but is ineffective as a decongestant at 

the 10 mg dose. According to FDA’s 

website,2 FDA has yet to make a final 

decision on the status of phenylephrine. 

In light of this information, the 

commenters suggested that DEA should 

re-evaluate whether the 2024 

pseudoephedrine (for sale) AAN is 

adequate given potential repercussions 

on the supply of and demand for 

phenylephrine-containing products, 

should FDA no longer designate 

phenylephrine as ‘‘generally recognized 

as safe and effective’’ (GRASE). 

DEA Response: DEA considered the 

comments and consulted with the FDA 

and determined that an increase of the 

2024 pseudoephedrine (for sale) AAN 

from its proposed value currently is 

appropriate, and will continue to 

monitor inventory and use to ensure 

that there will be sufficient supply to 

address a potential increase in 

consumer demand for pseudoephedrine 

products should FDA determine that 

products containing phenylephrine are 

ineffective. The increase finalized 

herein will ensure that there is 

sufficient pseudoephedrine API for the 

manufacturing of OTC medications that 

are commonly used to treat congestion 

from cold, flu, allergy and COVID. 

Quarterly Quota Allotment 

Implementation 

Issue: DEA received comments from 

DEA-registered manufacturers and an 

association representing manufacturers 

regarding how DEA will implement 

quarterly quota allotment. They 

expressed concerns that DEA did not 

give sufficient notice of this significant 

change to adjust their business planning 

and schedules. They also believe that 

the quarterly quota allotment will cause 

a bottleneck and exacerbate shortages of 

medications. 

DEA Response: As part of its 

commitment to ensure that all 

Americans have access to appropriately 

prescribed medications, DEA studied 

the supply chain dynamics for 

controlled substances subject to quotas, 

especially for those schedule II 

controlled substances in shortage. 

Beyond the lack of real-time data and 

gaps in its understanding of production 

lead times which DEA is seeking to 

resolve in forthcoming proposed 

regulatory changes, DEA also concluded 

that its existing quota allocation model 

did not allow it to remain nimble when 

patent exclusivity for Vyvanse expired 

and FDA authorized fourteen (14) 

generic manufacturers to begin 

marketing. DEA’s challenges with its 

existing allocation model were 

exacerbated because the loss of patent 

exclusivity occurred late in the quota 

year, a time when DEA had already 

allocated significant authority to the 

manufacturer of Vyvanse and due to the 

Food and Drug Administration’s (FDA) 

decision that it would not provide 6- 

months of patent exclusivity to the first 

applicant who files a substantially 

complete abbreviated new drug 

application (commonly referred to as 

‘‘first filer exclusivity’’). 

With regard to comments that 

quarterly quotas will create bottlenecks 

and exacerbate drug shortages, DEA 

disagrees. There are several reasons why 

manufacturers of drugs containing 

controlled substances subject to quotas 

either gain (or lose) market share in any 

given calendar year for which a quota 

applies and include: changes in demand 

and a manufacturer’s ability to adjust to 

those changes relative to its competitors; 

inflationary pressures which impact a 

manufacturer’s profit margin and 

subsequent decisions to either continue 

(or discontinue) marketing; labor 

shortages in certain geographic areas; 

and supply chain difficulties which 

impact access to API, excipients, 

equipment and packaging material. In 

order for DEA to ensure an adequate and 

uninterrupted supply of schedule II 

controlled substances necessary to meet 

legitimate medical, commercial, and 

scientific needs, DEA believes that 

changes in its approach to allocating 

procurement quotas will ensure that it 

is best positioned to respond 

appropriately to changes in market 

demand. Along similar lines, DEA does 

not believe that applying these changes 

to schedule II drugs only after they enter 

shortage would be sufficient, as DEA 

would then need to gather data and 

information for those drugs, a process 

which would delay DEA’s efforts to 

address shortages and potentially 

exacerbate them. 

DEA has elected to make these 

changes at the beginning of the 2024 

quota year and will be providing 

guidance to manufacturers. Information 

gained from its approach will inform 

rulemaking which it is currently 

pursuing. 

Administrative Procedures Act 

Issue: DEA received comments from 

DEA-Registered manufacturers, an 

association representing manufacturers 

and the generic public that the quarterly 

quota allotment implementation did not 

go through a notice-and-comment 


ddrumheller on DSK120RN23PROD with NOTICES1
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rulemaking procedure as required by the 

Administrative Procedure Act. 

DEA Response: DEA has elected to 

make changes at the beginning of the 

2024 quota year as it believes that 

information gained from its approach 

will inform rulemaking which is 

currently being pursued. In addition, as 

discussed above, DEA is undertaking 

these changes for the 2024 quota year to 

allow it to more quickly and nimbly 

respond to fast-changing market trends, 

including potential shortages, with 

respect to medications subject to quotas. 

While these changes to the quota 

allotment process will impact the 

adjudication of individual quota 

applications, they do not affect any 

APQs set pursuant to this final order. 

Request for Public Hearing 

Issue: One pharmaceutical company 

requested a public hearing prior to 

publishing the Final Order to establish 

the initial 2024 APQ. This company 

requested a public hearing ‘‘to correct 

the omissions and inaccurate diversion 

calculation in the 2023 oxycodone 

Quota.’’ The company asserted that 

these omissions led to an inaccurate 

diversion calculation for oxycodone and 

that the 2024 APQ requires a significant 

reduction from the 2023 APQ. 

DEA Response: The decision whether 

to grant a hearing on the issues raised 

by the commenter lies solely within the 

discretion of the Administrator. 21 CFR 

1303.11(c). While hearings are required 

when requested by states in certain 

situations, this commenter is not a state. 

This request does not present any 

evidence that would lead to the 

conclusion that a hearing is necessary or 

warranted. DEA has addressed specific 

points raised by the commenter in 

Issues and Responses above. 

Out of Scope Comments 

DEA received comments that are 

outside the scope of this order. The 

comments were general in nature and 

raised issues with respect to specific 

medical illnesses, medical treatments 

and medication costs. These comments 

do not impact the analysis involved in 

establishing the 2024 APQ. 

IV. Determination of 2024 Aggregate 

Production Quotas and Assessment of 

Annual Needs 

In determining the established 2024 

aggregate production quotas and 

assessment of annual needs, DEA has 

considered the above comments along 

with the factors set forth in 21 CFR 

1303.11 and 21 CFR 1315.11, in 

accordance with 21 U.S.C. 826(a). These 

factors include, but are not limited to, 

the 2023 manufacturing quotas, current 

2023 sales and inventories, anticipated 

2024 export requirements, industrial 

use, additional applications for 2024 

quotas, and information on research and 

product development requirements. 

On July 19, 2023, DEA published a 

temporary scheduling order placing 

Etizolam, Flualprazolam, Clonazolam, 

Flubromazolam, and Diclazepam in 

schedule I of the CSA (88 FR 48112), 

making all regulatory controls 

pertaining to schedule I controlled 

substances applicable to the 

manufacture of these substances, 

including the requirement to establish 

an aggregate production quota pursuant 

to 21 U.S.C. 826 and 21 CFR part 1303. 

On December 12, 2023, DEA 

published a temporary scheduling order 

placing 4F-MDMB-BUTICA, 5F-EDMBPICA, ADB-4en-PINACA, CUMYLPEGACLONE, MDMB-4en-PINACA, 

MMB-FUBICA in schedule I of the CSA 

(88 FR 86040), making all regulatory 

controls pertaining to schedule I 

controlled substances applicable to the 

manufacture of these substances, 

including the requirement to establish 

an aggregate production quota pursuant 

to 21 U.S.C. 826 and 21 CFR part 1303. 

On December 13, 2023, DEA 

published a final rule placing N-(1- 

amino-3,3-dimethyl-1-oxobutan-2-yl)-1- 

butyl-1H-indazole-3-carboxamide (ADBBUTINACA), 4-methyl-1-phenyl-2- 

(pyrrolidin-1-yl)pentan-1-one (a-PiHP 

or alpha-PiHP), and 2-(methylamino)-1- 

(3-methylphenyl)propan-1-one (3-MMC 

or 3-methylmethcathinone) in schedule 

I of the Controlled Substances Act (CSA) 

(88 FR 86266), making all regulatory 

controls pertaining to schedule I 

controlled substances applicable to the 

manufacture of these substances, 

including the requirement to establish 

an aggregate production quota pursuant 

to 21 U.S.C. 826 and 21 CFR part 1303. 

Based on all of the above, the 

Administrator is establishing the 2024 

APQs for Etizolam, Flualprazolam, 

Clonazolam, Flubromazolam, and 

Diclazepam, 4F-MDMB-BUTICA, 5FEDMB-PICA, ADB-4en-PINACA, 

CUMYL-PEGACLONE, MDMB-4enPINACA, MMB-FUBICA, N-(1-amino3,3-dimethyl-1-oxobutan-2-yl)-1-butyl1H-indazole-3-carboxamide (ADBBUTINACA), 4-methyl-1-phenyl-2- 

(pyrrolidin-1-yl)pentan-1-one (a-PiHP or 

alpha-PiHP), and 2-(methylamino)-1-(3- 

methylphenyl)propan-1-one (3-MMC or 

3-methylmethcathinone) at greater than 

zero; and 4-Anilino-N-phenethyl-4- 

piperidine (4-ANPP), all other 

tetrahydrocannabinol, 

dexmethylphenidate (for conversion), 

delta-9-tetrahydrocannabinol, 

dimethyltryptamine, fentanyl, 

pentobarbital and psilocybin at higher 

levels than previously proposed. 

The Administrator establishes the 

2024 AAN for pseudoephedrine (for 

sale) at a higher level than was 

proposed. 

Estimates of Diversion Pursuant to the 

SUPPORT Act 

As specified in the proposal, and as 

required by 21 U.S.C. 826(i), DEA 

calculated a national diversion estimate 

for each of the covered controlled 

substances. 

This data, which remains unchanged, 

was published in the Proposed 

Aggregate Production Quotas for 

Schedule I and II Controlled Substances 

and Assessment of Annual Needs for 

the List I Chemicals Ephedrine, 

Pseudoephedrine, and 

Phenylpropanolamine for 2024. 88 FR 

75312 (November 2, 2023). 

In accordance with 21 U.S.C. 826, 21 

CFR 1303.11, and 21 CFR 1315.11, the 

Administrator hereby establishes the 

2024 APQ for the following schedule I 

and II controlled substances and the 

2024 AAN for the list I chemicals 

ephedrine, pseudoephedrine, and 

phenylpropanolamine, expressed in 

grams of anhydrous acid or base, as 

follows: 

Basic class 

Established 

2024 quotas 

(g) 

New Temporary Controlled Schedule I Substances 

4F-MDMB-BUTICA .............................................................................................................................................................................. 30 

5F-EDMB-PICA .................................................................................................................................................................................... 30 

ADB-4en-PINACA ................................................................................................................................................................................ 30 

Clonazolam .......................................................................................................................................................................................... 30 

CUMYL-PEGACLONE ......................................................................................................................................................................... 30 

diclazepam ........................................................................................................................................................................................... 30 


ddrumheller on DSK120RN23PROD with NOTICES1
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Basic class 

Established 

2024 quotas 

(g) 

etizolam ................................................................................................................................................................................................ 30 

flualprazolam ........................................................................................................................................................................................ 30 

flubromazolam ..................................................................................................................................................................................... 30 

MDMB-4en-PINACA ............................................................................................................................................................................ 30 

MMB-FUBICA ...................................................................................................................................................................................... 30 

Schedule I 

-[1-(2-Thienyl)cyclohexyl]pyrrolidine .................................................................................................................................................... 20 

1-(1-Phenylcyclohexyl)pyrrolidine ........................................................................................................................................................ 30 

1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine .................................................................................................................................. 10 

1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201) ............................................................................................................................ 30 

1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694) ........................................................................................................................... 30 

1-[1-(2-Thienyl)cyclohexyl]piperidine ................................................................................................................................................... 15 

2′-fluoro 2-fluorofentanyl ...................................................................................................................................................................... 30 

1-Benzylpiperazine .............................................................................................................................................................................. 25 

1-Methyl-4-phenyl-4-propionoxypiperidine ........................................................................................................................................... 10 

2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E) ........................................................................................................................... 30 

2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D) ........................................................................................................................ 30 

2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N) .......................................................................................................................... 30 

2-(2,5-Dimethoxy-4-n-propylphenyl)ethanamine (2C-P) ...................................................................................................................... 30 

2-(2,5-Dimethoxyphenyl)ethanamine (2C-H) ....................................................................................................................................... 100 

2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B; Cimbi-36) ........................ 30 

2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C) ........................................................................................................................ 30 

2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82) ........................ 25

2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I) .............................................................................................................................. 30 

2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I; Cimbi-5) .................................. 30 

2,5-Dimethoxy-4-ethylamphetamine (DOET) ...................................................................................................................................... 25 

2,5-Dimethoxy-4-n-propylthiophenethylamine ..................................................................................................................................... 25 

2,5-Dimethoxyamphetamine ................................................................................................................................................................ 25 

2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-2) ................................................................................................................ 30 

2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-4) .......................................................................................................... 30 

3,4,5-Trimethoxyamphetamine ............................................................................................................................................................ 30 

3,4-Methylenedioxyamphetamine (MDA) ............................................................................................................................................ 12,000 

3,4-Methylenedioxymethamphetamine (MDMA) ................................................................................................................................. 12,000 

3,4-Methylenedioxy-N-ethylamphetamine (MDEA) ............................................................................................................................. 40 

3,4-Methylenedioxy-N-methylcathinone (methylone) .......................................................................................................................... 5,200 

3,4-Methylenedioxypyrovalerone (MDPV) ........................................................................................................................................... 35 

3-FMC; 3-Fluoro-N-methylcathinone ................................................................................................................................................... 25 

3-Methylfentanyl ................................................................................................................................................................................... 30 

3-Methylmethcathinone ........................................................................................................................................................................ 30 

3-Methylthiofentanyl ............................................................................................................................................................................. 30 

4,4′-Dimethylaminorex ......................................................................................................................................................................... 30 

4-Bromo-2,5-dimethoxyamphetamine (DOB) ...................................................................................................................................... 30 

4-Bromo-2,5-dimethoxyphenethylamine (2-CB) .................................................................................................................................. 5,100 

4-Chloro-alpha-pyrrolidinovalerophenone (4-chloro-alpha-PVP) ......................................................................................................... 25 

4-CN-Cumyl-Butinaca .......................................................................................................................................................................... 25 

4-Fluoroisobutyryl fentanyl ................................................................................................................................................................... 30 

4F-MDMB-BINACA .............................................................................................................................................................................. 30 

4-FMC; Flephedrone ............................................................................................................................................................................ 25 

4-MEC; 4-Methyl-N-ethylcathinone ...................................................................................................................................................... 25 

4-Methoxyamphetamine ...................................................................................................................................................................... 150 

4-methyl-1-phenyl-2-(pyrrolidin-1-yl)pentan-1-one (alpha-PiHP) ......................................................................................................... 30 

4-Methyl-2,5-dimethoxyamphetamine (DOM) ...................................................................................................................................... 25 

4-Methylaminorex ................................................................................................................................................................................ 25 

4-Methyl-N-methylcathinone (mephedrone) ........................................................................................................................................ 45 

4-Methyl-alpha-ethylaminopentiophenone (4-MEAP) .......................................................................................................................... 25 

4-Methyl-alpha-pyrrolidinohexiophenone (MPHP) ............................................................................................................................... 25 

4′-Methyl acetyl fentanyl ...................................................................................................................................................................... 30 

4-Methyl-a-pyrrolidinopropiophenone (4-MePPP) ............................................................................................................................... 25 

5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol ......................................................................................................... 50 

5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP-47,497 C8-homolog) ........................... 40 

5F-AB-PINACA ; (1-Amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide .............................................. 25 

5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) ............................ 25 

5F-CUMYL-P7AICA; 1-(5-Fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3carboximide ....................................... 25 

5F-CUMYL-PINACA ............................................................................................................................................................................ 25 

5F-EDMB-PINACA ............................................................................................................................................................................... 25 

5F-MDMB-PICA ................................................................................................................................................................................... 25 

5F-AMB (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate) ................................................................... 25 

5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide) ........................................................ 25 

5-Fluoro-PB-22; 5F-PB-22 ................................................................................................................................................................... 25 

5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1Hindol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone ............................................ 25 


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Basic class 

Established 

2024 quotas 

(g) 

5-Methoxy-3,4-methylenedioxyamphetamine ...................................................................................................................................... 25 

5-Methoxy-N,N-diisopropyltryptamine .................................................................................................................................................. 25 

5-Methoxy-N,N-dimethyltryptamine ..................................................................................................................................................... 11,000 

AB-CHMINACA .................................................................................................................................................................................... 30 

AB-FUBINACA ..................................................................................................................................................................................... 50 

AB-PINACA .......................................................................................................................................................................................... 30 

ADB-BUTINACA .................................................................................................................................................................................. 30 

ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide) .................................. 30 

Acetorphine .......................................................................................................................................................................................... 25 

Acetyl Fentanyl .................................................................................................................................................................................... 100 

Acetyl-alpha-methylfentanyl ................................................................................................................................................................. 30 

Acetyldihydrocodeine ........................................................................................................................................................................... 30 

Acetylmethadol .................................................................................................................................................................................... 25 

Acryl Fentanyl ...................................................................................................................................................................................... 25 

ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide) ...................................................... 50 

AH-7921 ............................................................................................................................................................................................... 30 

All other tetrahydrocannabinol ............................................................................................................................................................. 1,166,130 

Allylprodine .......................................................................................................................................................................................... 25 

Alphacetylmethadol .............................................................................................................................................................................. 25 

alpha-Ethyltryptamine .......................................................................................................................................................................... 25 

Alphameprodine ................................................................................................................................................................................... 25 

Alphamethadol ..................................................................................................................................................................................... 25 

alpha-Methylfentanyl ............................................................................................................................................................................ 30 

alpha-Methylthiofentanyl ...................................................................................................................................................................... 30 

alpha-Methyltryptamine (AMT) ............................................................................................................................................................ 25 

alpha-Pyrrolidinobutiophenone (a-PBP) .............................................................................................................................................. 25 

alpha-pyrrolidinoheptaphenone (PV8) ................................................................................................................................................. 25 

alpha-pyrrolidinohexabophenone (alpha-PHP) .................................................................................................................................... 25 

alpha-Pyrrolidinopentiophenone (a-PVP) ............................................................................................................................................ 25 

Amineptine ........................................................................................................................................................................................... 30 

Aminorex .............................................................................................................................................................................................. 25 

Anileridine ............................................................................................................................................................................................ 20 

APINCA, AKB48 (N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide) ......................................................................................... 25 

Benzethidine ........................................................................................................................................................................................ 25 

Benzylmorphine ................................................................................................................................................................................... 30 

Betacetylmethadol ............................................................................................................................................................................... 25 

beta-Hydroxy-3-methylfentanyl ............................................................................................................................................................ 30 

beta-Hydroxyfentanyl ........................................................................................................................................................................... 30 

beta-Hydroxythiofentanyl ..................................................................................................................................................................... 30 

beta-Methyl fentanyl ............................................................................................................................................................................ 30 

beta′-Phenyl fentanyl ........................................................................................................................................................................... 30 

Betameprodine ..................................................................................................................................................................................... 25 

Betamethadol ....................................................................................................................................................................................... 4 

Betaprodine .......................................................................................................................................................................................... 25 

Brorphine ............................................................................................................................................................................................. 30 

Bufotenine ............................................................................................................................................................................................ 15 

Butonitazene ........................................................................................................................................................................................ 30 

Butylone ............................................................................................................................................................................................... 25 

Butyryl fentanyl .................................................................................................................................................................................... 30 

Cathinone ............................................................................................................................................................................................. 40 

Clonitazene .......................................................................................................................................................................................... 25 

Codeine methylbromide ....................................................................................................................................................................... 30 

Codeine-N-oxide .................................................................................................................................................................................. 192 

Crotonyl Fentanyl ................................................................................................................................................................................. 25 

Cyclopentyl Fentanyl ........................................................................................................................................................................... 30 

Cyclopropyl Fentanyl ........................................................................................................................................................................... 20 

Cyprenorphine ..................................................................................................................................................................................... 25 

d-9-THC ............................................................................................................................................................................................... 1,523,040 

Desomorphine ...................................................................................................................................................................................... 25 

Dextromoramide .................................................................................................................................................................................. 25 

Diapromide ........................................................................................................................................................................................... 20 

Diethylthiambutene .............................................................................................................................................................................. 20 

Diethyltryptamine ................................................................................................................................................................................. 25 

Difenoxin .............................................................................................................................................................................................. 9,300 

Dihydromorphine .................................................................................................................................................................................. 639,954 

Dimenoxadol ........................................................................................................................................................................................ 25 

Dimepheptanol ..................................................................................................................................................................................... 25 

Dimethylthiambutene ........................................................................................................................................................................... 20 

Dimethyltryptamine .............................................................................................................................................................................. 11,000 

Dioxyaphetyl butyrate .......................................................................................................................................................................... 25 

Dipipanone ........................................................................................................................................................................................... 25 

Drotebanol ........................................................................................................................................................................................... 25 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 2 / Wednesday, January 3, 2024 / Notices 415 

Basic class 

Established 

2024 quotas 

(g) 

Ethylmethylthiambutene ....................................................................................................................................................................... 25 

Ethylone ............................................................................................................................................................................................... 25 

Etodesnitazene .................................................................................................................................................................................... 30 

Etonitazene .......................................................................................................................................................................................... 25 

Etorphine .............................................................................................................................................................................................. 30 

Etoxeridine ........................................................................................................................................................................................... 25 

Eutylone ............................................................................................................................................................................................... 30 

Fenethylline .......................................................................................................................................................................................... 30 

Fentanyl carbamate ............................................................................................................................................................................. 30 

Fentanyl related substances ................................................................................................................................................................ 600 

Flunitazene .......................................................................................................................................................................................... 30 

FUB-144 ............................................................................................................................................................................................... 25 

FUB-AKB48 ......................................................................................................................................................................................... 25 

Fub-AMB, MMB-Fubinaca, AMB-Fubinaca ......................................................................................................................................... 25 

Furanyl fentanyl ................................................................................................................................................................................... 30 

Furethidine ........................................................................................................................................................................................... 25 

gamma-Hydroxybutyric acid ................................................................................................................................................................ 29,417,000 

Heroin .................................................................................................................................................................................................. 150 

Hydromorphinol .................................................................................................................................................................................... 40 

Hydroxypethidine ................................................................................................................................................................................. 25 

Ibogaine ............................................................................................................................................................................................... 150 

Isobutyryl Fentanyl ............................................................................................................................................................................... 25 

Isotonitazine ......................................................................................................................................................................................... 25 

JWH-018 and AM678 (1-Pentyl-3-(1-naphthoyl)indole) ...................................................................................................................... 35 

JWH-019 (1-Hexyl-3-(1-naphthoyl)indole) ........................................................................................................................................... 45 

JWH-073 (1-Butyl-3-(1-naphthoyl)indole) ............................................................................................................................................ 45 

JWH-081 (1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole) ....................................................................................................................... 30 

JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl)indole) ........................................................................................................................... 30 

JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole) ............................................................................................................... 35 

JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl)indole) ............................................................................................................................ 30 

JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl)indole) ........................................................................................................................ 30 

JWH-398 (1-Pentyl-3-(4-chloro-1-naphthoyl)indole) ............................................................................................................................ 30 

Ketobemidone ...................................................................................................................................................................................... 30 

Levomoramide ..................................................................................................................................................................................... 25 

Levophenyacylmorphan ....................................................................................................................................................................... 25 

Lysergic acid diethylamide (LSD) ........................................................................................................................................................ 1,200 

MAB-CHMINACA; ADB-CHMINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3- 

carboxamide) .................................................................................................................................................................................... 30 

MDMB-CHMICA; MMB-CHMINACA(methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate) ................. 30 

MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) ........................................... 30 

MMB-CHMICA-(AMB-CHIMCA); Methyl-2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-methylbutanoate ............................. 25 

Mesocarb ............................................................................................................................................................................................. 30 

Metodesnitazene .................................................................................................................................................................................. 30 

Metonitazene ....................................................................................................................................................................................... 30 

Marijuana ............................................................................................................................................................................................. 6,675,000 

Marijuana extract ................................................................................................................................................................................. 1,000,000 

Mecloqualone ....................................................................................................................................................................................... 30 

Mescaline ............................................................................................................................................................................................. 1,200 

Methaqualone ...................................................................................................................................................................................... 60 

Methcathinone ..................................................................................................................................................................................... 25 

Methiopropamine ................................................................................................................................................................................. 30 

Methoxetamine .................................................................................................................................................................................... 30 

Methoxyacetyl fentanyl ........................................................................................................................................................................ 30 

Methyldesorphine ................................................................................................................................................................................. 5 

Methyldihydromorphine ........................................................................................................................................................................ 25 

Morpheridine ........................................................................................................................................................................................ 25 

Morphine methylbromide ..................................................................................................................................................................... 5 

Morphine methylsulfonate .................................................................................................................................................................... 5 

Morphine-N-oxide ................................................................................................................................................................................ 150 

MT-45 ................................................................................................................................................................................................... 30 

Myrophine ............................................................................................................................................................................................ 25 

NM2201: Naphthalen-1-yl 1-(5-fluorpentyl)-1H-indole-3-carboxylate .................................................................................................. 25 

N,N-Dimethylamphetamine .................................................................................................................................................................. 25 

Naphyrone ........................................................................................................................................................................................... 25 

N-Ethyl-1-phenylcyclohexylamine ........................................................................................................................................................ 25 

N-Ethyl-3-piperidyl benzilate ................................................................................................................................................................ 10 

N-Ethylamphetamine ........................................................................................................................................................................... 24 

N-Ethylhexedrone ................................................................................................................................................................................ 25 

N-Ethylpentylone, ephylone ................................................................................................................................................................. 30 

N-Hydroxy-3,4-methylenedioxyamphetamine ...................................................................................................................................... 24 

Nicocodeine ......................................................................................................................................................................................... 25 

Nicomorphine ....................................................................................................................................................................................... 25 


ddrumheller on DSK120RN23PROD with NOTICES1
416 Federal Register / Vol. 89, No. 2 / Wednesday, January 3, 2024 / Notices 

Basic class 

Established 

2024 quotas 

(g) 

N-methyl-3-piperidyl benzilate ............................................................................................................................................................. 30 

N-Pyrrolidino Etonitazene .................................................................................................................................................................... 30 

Noracymethadol ................................................................................................................................................................................... 25 

Norlevorphanol ..................................................................................................................................................................................... 2,550 

Normethadone ..................................................................................................................................................................................... 25 

Normorphine ........................................................................................................................................................................................ 40 

Norpipanone ........................................................................................................................................................................................ 25 

Ocfentanil ............................................................................................................................................................................................. 25 

ortho-Fluoroacryl fentanyl .................................................................................................................................................................... 30 

ortho-Fluorobutyryl fentanyl ................................................................................................................................................................. 30 

Ortho-Fluorofentanyl,2-Fluorofentanyl ................................................................................................................................................. 30 

ortho-Fluoroisobutyryl fentanyl ............................................................................................................................................................ 30 

ortho-Methyl acetylfentanyl .................................................................................................................................................................. 30 

ortho-Methyl methoxyacetyl fentanyl ................................................................................................................................................... 30 

Para-Chlorisobutyrl fentanyl ................................................................................................................................................................ 30 

Para-flourobutyryl fentanyl ................................................................................................................................................................... 25 

Para-fluorofentanyl ............................................................................................................................................................................... 25 

para-Fluoro furanyl fentanyl ................................................................................................................................................................. 30 

Para-Methoxybutyrl fentanyl ................................................................................................................................................................ 30 

Para-methoxymethamphetamine ......................................................................................................................................................... 30 

para-Methylfentanyl ............................................................................................................................................................................. 30 

Parahexyl ............................................................................................................................................................................................. 5 

PB-22; QUPIC ..................................................................................................................................................................................... 20 

Pentedrone .......................................................................................................................................................................................... 25 

Pentylone ............................................................................................................................................................................................. 25 

Phenadoxone ....................................................................................................................................................................................... 25 

Phenampromide ................................................................................................................................................................................... 25 

Phenomorphan .................................................................................................................................................................................... 25 

Phenoperidine ...................................................................................................................................................................................... 25 

Phenyl fentanyl .................................................................................................................................................................................... 30 

Pholcodine ........................................................................................................................................................................................... 5 

Piritramide ............................................................................................................................................................................................ 25 

Proheptazine ........................................................................................................................................................................................ 25 

Properidine ........................................................................................................................................................................................... 25 

Propiram .............................................................................................................................................................................................. 25 

Protonitazene ....................................................................................................................................................................................... 30 

Psilocybin ............................................................................................................................................................................................. 20,000 

Psilocin ................................................................................................................................................................................................. 24,000 

Racemoramide ..................................................................................................................................................................................... 25 

SR-18 and RCS-8 (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole) ........................................................................................... 45 

SR-19 and RCS-4 (1-Pentyl-3-[(4-methoxy)-benzoyl]indole) .............................................................................................................. 30 

Tetrahydrofuranyl fentanyl ................................................................................................................................................................... 15 

Thebacon ............................................................................................................................................................................................. 25 

Thiafentanil .......................................................................................................................................................................................... 25 

Thiofentanyl ......................................................................................................................................................................................... 25 

Thiofuranyl fentanyl ............................................................................................................................................................................. 30 

THJ-2201 ([1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone) ...................................................................................... 30 

Tilidine .................................................................................................................................................................................................. 25 

Trimeperidine ....................................................................................................................................................................................... 25 

UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone ...................................................................................... 25 

U-47700 ............................................................................................................................................................................................... 30 

Valeryl fentanyl .................................................................................................................................................................................... 25 

Zipeprol ................................................................................................................................................................................................ 30 

Schedule II 

1-Phenylcyclohexylamine .................................................................................................................................................................... 15 

1-Piperidinocyclohexanecarbonitrile .................................................................................................................................................... 25 

4-Anilino-N-phenethyl-4-piperidine (ANPP) ......................................................................................................................................... 937,874 

Alfentanil .............................................................................................................................................................................................. 5,000 

Alphaprodine ........................................................................................................................................................................................ 25 

Amobarbital .......................................................................................................................................................................................... 20,100 

Bezitramide .......................................................................................................................................................................................... 25 

Carfentanil ............................................................................................................................................................................................ 20 

Cocaine ................................................................................................................................................................................................ 60,492 

Codeine (for conversion) ..................................................................................................................................................................... 942,452 

Codeine (for sale) ................................................................................................................................................................................ 19,262,957 

d-amphetamine (for sale) .................................................................................................................................................................... 21,200,000 

d,l-amphetamine .................................................................................................................................................................................. 21,200,000 

d-amphetamine (for conversion) .......................................................................................................................................................... 20,000,000 

Dexmethylphenidate (for sale) ............................................................................................................................................................. 6,200,000 

Dexmethylphenidate (for conversion) .................................................................................................................................................. 5,374,683 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 2 / Wednesday, January 3, 2024 / Notices 417 

Basic class 

Established 

2024 quotas 

(g) 

Dextropropoxyphene ............................................................................................................................................................................ 35 

Dihydrocodeine .................................................................................................................................................................................... 115,227 

Dihydroetorphine .................................................................................................................................................................................. 25 

Diphenoxylate (for conversion) ............................................................................................................................................................ 14,100 

Diphenoxylate (for sale) ....................................................................................................................................................................... 770,800 

Ecgonine .............................................................................................................................................................................................. 60,492 

Ethylmorphine ...................................................................................................................................................................................... 30 

Etorphine hydrochloride ....................................................................................................................................................................... 32 

Fentanyl ............................................................................................................................................................................................... 731,360 

Glutethimide ......................................................................................................................................................................................... 25 

Hydrocodone (for conversion) ............................................................................................................................................................. 1,250 

Hydrocodone (for sale) ........................................................................................................................................................................ 27,143,545 

Hydromorphone ................................................................................................................................................................................... 1,951,801 

Isomethadone ...................................................................................................................................................................................... 30 

L-amphetamine .................................................................................................................................................................................... 30 

Levo-alphacetylmethadol (LAAM) ........................................................................................................................................................ 25 

Levomethorphan .................................................................................................................................................................................. 30 

Levorphanol ......................................................................................................................................................................................... 20,000 

Lisdexamfetamine ................................................................................................................................................................................ 26,500,000 

Meperidine ........................................................................................................................................................................................... 681,184 

Meperidine Intermediate-A .................................................................................................................................................................. 30 

Meperidine Intermediate-B .................................................................................................................................................................. 30 

Meperidine Intermediate-C .................................................................................................................................................................. 30 

Metazocine ........................................................................................................................................................................................... 15 

Methadone (for sale) ........................................................................................................................................................................... 25,619,700 

Methadone Intermediate ...................................................................................................................................................................... 27,673,600 

d,l-Methamphetamine .......................................................................................................................................................................... 150 

d-methamphetamine (for conversion) .................................................................................................................................................. 485,020 

d-methamphetamine (for sale) ............................................................................................................................................................ 47,000 

l-methamphetamine ............................................................................................................................................................................. 587,229 

Methylphenidate (for sale) ................................................................................................................................................................... 53,283,000 

Methylphenidate (for conversion) ........................................................................................................................................................ 19,975,468 

Metopon ............................................................................................................................................................................................... 25 

Moramide-intermediate ........................................................................................................................................................................ 25 

Morphine (for conversion) .................................................................................................................................................................... 2,393,200 

Morphine (for sale) .............................................................................................................................................................................. 20,805,957 

Nabilone ............................................................................................................................................................................................... 62,000 

Norfentanyl ........................................................................................................................................................................................... 25 

Noroxymorphone (for conversion) ....................................................................................................................................................... 22,044,741 

Noroxymorphone (for sale) .................................................................................................................................................................. 1,000 

Oliceridine ............................................................................................................................................................................................ 25,100 

Opium (powder) ................................................................................................................................................................................... 250,000 

Opium (tincture) ................................................................................................................................................................................... 530,837 

Oripavine .............................................................................................................................................................................................. 33,010,750 

Oxycodone (for conversion) ................................................................................................................................................................ 437,827 

Oxycodone (for sale) ........................................................................................................................................................................... 53,658,226 

Oxymorphone (for conversion) ............................................................................................................................................................ 28,204,371 

Oxymorphone (for sale) ....................................................................................................................................................................... 464,464 

Pentobarbital ........................................................................................................................................................................................ 40,000,000 

Phenazocine ........................................................................................................................................................................................ 25 

Phencyclidine ....................................................................................................................................................................................... 35 

Phenmetrazine ..................................................................................................................................................................................... 25 

Phenylacetone ..................................................................................................................................................................................... 100 

Piminodine ........................................................................................................................................................................................... 25 

Racemethorphan ................................................................................................................................................................................. 5 

Racemorphan ...................................................................................................................................................................................... 5 

Remifentanil ......................................................................................................................................................................................... 3,000 

Secobarbital ......................................................................................................................................................................................... 172,100 

Sufentanil ............................................................................................................................................................................................. 4,000 

Tapentadol ........................................................................................................................................................................................... 10,390,226 

Thebaine .............................................................................................................................................................................................. 57,137,944 

List I Chemicals 

Ephedrine (for conversion) .................................................................................................................................................................. 41,100 

Ephedrine (for sale) ............................................................................................................................................................................. 3,933,336 

Phenylpropanolamine (for conversion) ................................................................................................................................................ 14,878,320 

Phenylpropanolamine (for sale) ........................................................................................................................................................... 7,990,000 

Pseudoephedrine (for conversion) ...................................................................................................................................................... 1,000 

Pseudoephedrine (for sale) ................................................................................................................................................................. 186,617,466 


ddrumheller on DSK120RN23PROD with NOTICES1
418 Federal Register / Vol. 89, No. 2 / Wednesday, January 3, 2024 / Notices 

The Administrator also establishes 

APQ for all other schedule I and II 

controlled substances included in 21 

CFR 1308.11 and 1308.12 at zero. In 

accordance with 21 CFR 1303.13 and 21 

CFR 1315.13, upon consideration of the 

relevant factors, the Administrator may 

adjust the 2024 APQ and AAN as 

needed. 

Signing Authority 

This document of the Drug 

Enforcement Administration was signed 

on December 28, 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. 

[FR Doc. 2023–28962 Filed 12–29–23; 8:45 am] 

BILLING CODE 4410–09–P 

NUCLEAR REGULATORY 

COMMISSION 

[Docket No. 50–382; NRC–2023–0046] 

Entergy Operations, Inc.; Waterford 

Steam Electric Station, Unit 3; License 

Amendment Application 

AGENCY: Nuclear Regulatory 

Commission. 

ACTION: Notice; withdrawal by 

applicant. 

SUMMARY: The U.S. Nuclear Regulatory 

Commission (NRC, the Commission) has 

granted the request of Entergy 

Operations, Inc. (the licensee) to 

withdraw its application dated 

November 1, 2022, for a proposed 

amendment to Renewed Facility 

Operating License No. NPF–38 for the 

Waterford Steam Electric Station, Unit 

3. The proposed amendment would 

have revised Technical Specification 3/ 

4.3–2, Table 4.3–2, ‘‘Engineered Safety 

Features Actuation System 

Instrumentation Surveillance 

Requirements,’’ Table Notation (3), to 

remove the exemption from testing 

relays K114, K305, and K313 at power. 

DATES: This document was published in 

the Federal Register on January 3, 2024. 

ADDRESSES: Please refer to Docket ID 

NRC–2023–0046 when contacting the 

NRC about the availability of 

information regarding this document. 

You may obtain publicly available 

information related to this document 

using any of the following methods: 

• Federal Rulemaking Website: Go to 

https://www.regulations.gov and search 

for Docket ID NRC–2023–0046. Address 

questions about Docket IDs in 

Regulations.gov to Stacy Schumann; 

telephone: 301–415–0624; email: 

Stacy.Schumann@nrc.gov. For technical 

questions, contact the individual listed 

in the FOR FURTHER INFORMATION

CONTACT section of this document. 

• NRC’s Agencywide Documents 

Access and Management System 

(ADAMS): You may obtain publicly 

available documents online in the 

ADAMS Public Documents collection at 

https://www.nrc.gov/reading-rm/ 

adams.html. To begin the search, select 

‘‘Begin Web-based ADAMS Search.’’ For 

problems with ADAMS, please contact 

the NRC’s Public Document Room (PDR) 

reference staff at 1–800–397–4209, at 

301–415–4737, or by email to 

PDR.Resource@nrc.gov. The ADAMS 

accession number for each document 

referenced (if it is available in ADAMS) 

is provided the first time that it is 

mentioned in this document. 

• NRC’s PDR: The PDR, where you 

may examine and order copies of 

publicly available documents, is open 

by appointment. To make an 

appointment to visit the PDR, please 

send an email to PDR.Resource@nrc.gov 

or call 1–800–397–4209 or 301–415– 

4737, between 8 a.m. and 4 p.m. eastern 

time (ET), Monday through Friday, 

except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: 

Jason Drake, Office of Nuclear Reactor 

Regulation, U.S. Nuclear Regulatory 

Commission, Washington, DC 20555– 

0001, telephone: 301–415–8378; email: 

Jason.Drake@nrc.gov. 

SUPPLEMENTARY INFORMATION: The NRC 

has granted the request of the licensee 

to withdraw its application dated 

November 1, 2022 (ADAMS Accession 

No. ML22305A693) for the proposed 

amendment to Renewed Facility 

Operating License No. NPF–38 for the 

Waterford Steam Electric Station, Unit 

3, located in St. Charles Parish, 

Louisiana. 

The proposed amendment would 

have revised TS 3/4.3–2, Table 4.3–2, 

‘‘Engineered Safety Features Actuation 

system Instrumentation Surveillance 

Requirements,’’ Table Notation (3), to 

remove the exemption from testing 

relays K114, K305, and K313 at power. 

The Commission had previously 

issued a Notice of Consideration of 

Issuance of Amendment published in 

the Federal Register on February 21, 

2023 (88 FR 10557). However, by letter 

dated September 28, 2023 (ADAMS 

Accession No. ML23271A178), the 

licensee withdrew the proposed 

amendment. 

Dated: December 28, 2023. 

For the Nuclear Regulatory Commission. 

Jason J. Drake, 

Project Manager, Plant Licensing Branch IV, 

Division of Operating Reactor Licensing, 

Office of Nuclear Reactor Regulation. 

[FR Doc. 2023–28891 Filed 1–2–24; 8:45 am] 

BILLING CODE 7590–01–P 

NUCLEAR REGULATORY 

COMMISSION 

[Docket No. 50–255; NRC–2023–0193] 

Holtec Decommissioning International, 

LLC and Holtec Palisades, LLC; 

Palisades Nuclear Plant; Exemption 

AGENCY: Nuclear Regulatory 

Commission. 

ACTION: Notice; issuance. 

SUMMARY: The U.S. Nuclear Regulatory 

Commission (NRC) has issued an 

exemption in response to a request from 

Holtec Decommissioning International, 

LLC (HDI), an indirect wholly owned 

subsidiary of Holtec International, that 

would allow HDI and Holtec Palisades, 

LLC, to reduce the minimum coverage 

limit for onsite property damage 

insurance from $1.06 billion to $50 

million for the Palisades Nuclear Plant. 

DATES: The exemption was issued on 

December 21, 2023. 

ADDRESSES: Please refer to Docket ID 

NRC–2023–0193 when contacting the 

NRC about the availability of 

information regarding this document. 

You may obtain publicly available 

information related to this document 

using any of the following methods: 

• Federal Rulemaking Website: Go to 

https://www.regulations.gov and search 

for Docket ID NRC–2023–0193. Address 

questions about Docket IDs in 

Regulations.gov to Stacy Schumann; 

telephone: 301–415–0624; email: 

Stacy.Schumann@nrc.gov. For technical 

questions, contact the individual listed 

in the FOR FURTHER INFORMATION

CONTACT section of this document. 

• NRC’s Agencywide Documents 

Access and Management System 

(ADAMS): You may obtain publicly 

available documents online in the 

ADAMS Public Documents collection at 

https://www.nrc.gov/reading-rm/ 

adams.html. To begin the search, select 


ddrumheller on DSK120RN23PROD with NOTICES1