[Federal Register Volume 87, Number 231 (Friday, December 2, 2022)]
[Notices]
[Pages 74168-74175]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-26351]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1051E]


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 2023

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final order.

-----------------------------------------------------------------------

SUMMARY: This final order establishes the initial 2023 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: The order is effective December 2, 2022.

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 2023 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 
2023, 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 October 18, 2022, 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 2023'' was published in 
the Federal Register. 87 FR 63091. This notice proposed the 2023 APQ 
for each basic class of controlled substance listed in schedules I and 
II and the 2023 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 November 17, 2022.

III. Comments Received

    Within the public comment period, DEA received 357 comments from 
DEA registrants, chronic pain patients, patients with attention 
deficit/hyperactivity disorder, pain advocacy associations, 
professional associations, nurses, and others. The comments included 
concerns about potential opioid and stimulant drug shortages due to 
further quota reductions; concerns that medical professionals might be 
impeded from exercising their medical expertise regarding opioid 
prescriptions; one request for a public hearing; and comments not 
pertaining to DEA regulated activities. DEA restricted eight comments 
from public view due to confidential business information and/or 
confidential personal identifying information.

DEA's Regulatory Authority

    Issue: DEA received comments that raised the question of whether 
DEA has the authority to regulate activities related to controlled 
substances, including the manufacture of Food and Drug Administration 
(FDA)-approved pharmaceutical products containing controlled 
substances.
    DEA Response: The CSA, which was initially enacted in 1970 and has 
been amended several times, requires DEA to establish production quotas 
for certain controlled substances. 21 U.S.C. 826(a). In the CSA, 
Congress granted DEA (as delegated by the Attorney General under 21 
U.S.C. 871(a)) the authority to promulgate ``rules and regulations''

[[Page 74169]]

relating to the ``registration and control of the manufacture, 
distribution, and dispensing of controlled substances and to listed 
chemicals'' (21 U.S.C. 821), and to the ``registration and control of 
importers and exporters of controlled substances'' (21 U.S.C. 958(f)), 
as well as those ``necessary and appropriate for the efficient 
execution'' of the authorities granted by the CSA (21 U.S.C. 871(b)), 
among other provisions. In its findings, Congress acknowledged that 
many controlled substances ``have a useful and legitimate medical 
purpose.'' 21 U.S.C. 801(1).
    Congress explicitly directed DEA to establish production quotas for 
controlled substances in schedule I and II and for ephedrine, 
pseudoephedrine, and phenylpropanolamine. 21 U.S.C. 826(a). In 
recognition of FDA's related, but distinct, role in regulating 
pharmaceutical products, DEA's regulations require DEA to consider 
relevant information from FDA before DEA establishes the APQs. 21 CFR 
1303.11(b)(6). For instance, FDA provides estimates of legitimate 
domestic medical needs. DEA considers this important information in 
proposing and revising the APQs.

Medication Shortages

    Issue (Attention Deficit/Hyperactivity Disorder Medications 
[ADHD]): DEA received comments expressing general concerns regarding 
the ongoing shortages experienced with ADHD medications produced from 
amphetamine, dexmethylphenidate, methylphenidate, and lisdexamfetamine. 
Some commenters expressed a concern that patients will turn to black 
market or diverted products if they cannot obtain their prescribed 
medications through legitimate channels. Two manufacturers commented 
that the proposed quotas for lisdexamfetamine and methylphenidate may 
not be adequate to meet forecasted increases in foreign demand for 
exported products.
    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 U.S., for lawful export requirements, and for the 
establishment and maintenance of reserve stocks. DEA sets APQs in a 
manner to provide for all legitimate medical purposes and for 
anticipated foreign demand. Additionally, DEA and FDA are required to, 
and routinely do, coordinate efforts to prevent or alleviate drug 
shortages. Such efforts may include adjusting the APQ, adjusting 
individual domestic manufacturers' quotas, FDA's approval of additional 
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 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, dexmethylphenidate, methylphenidate, and 
lisdexamfetamine are sufficient to supply legitimate medical needs, 
reserve stocks, and export requirements for 2023.
    Issue (Adderall Shortages): DEA received comments expressing 
general concerns regarding the ongoing shortages experienced with ADHD 
drug medications, specifically mentioning the branded drug product 
Adderall.
    DEA Response: DEA is aware of patient reports that pharmacies are 
unable to fill prescriptions for their prescribed Adderall or one of 
its generic versions. DEA consults with FDA to set the APQ for 
amphetamine each calendar year. The majority of the manufacturers 
contacted by DEA and/or FDA have responded that they currently have 
sufficient quota to meet their contracted production quantities for 
legitimate patient medical needs. According to DEA's data, 
manufacturers have not fully utilized the APQ for amphetamine in 
support of domestic manufacturing, reserve stocks, and export 
requirements for the past three calendar years 2020, 2021 and 2022.
    Based on this trend, DEA has not implemented an increase to the APQ 
for amphetamine at this time. Should the proposed established 
amphetamine APQ become inadequate to meet legitimate medical and 
scientific needs, sufficient reserve stocks, and export requirements, 
DEA has the authority and ability to adjust the APQ during the course 
of the year. 21 CFR 1303.13. DEA remains in communication with FDA 
regarding these shortage reports.
    Issue (Opioid Shortage): There were commenters including pain 
associations and DEA-registered medical professionals that expressed 
concerns about the decrease in aggregate production quotas for opioids. 
These commenters alleged that decreases to the aggregate production 
quotas have resulted in a shortage of opioid medications, interfered 
with the treatment of patients, and impacted the quality of life for 
patients 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. 
Although DEA sets the APQs for all schedule II opioids, there can be 
other factors and manufacturers' business practices that may contribute 
to a temporary shortage of controlled substances at the point of 
dispensation, despite the adequacy of the APQ set by DEA. In recent 
years, this has included plant shutdowns necessary to complete 
federally-mandated maintenance, labor shortages and a lack of 
production capacity. In such circumstances, DEA coordinates with FDA 
and can use the tools at its disposal under its CSA authority to 
prevent or alleviate drug shortages and ensure that patients are able 
to fill legitimate prescriptions for controlled substances without 
undue delay.
    Issue (Hospital-Administered Injectable Opioid Shortage): DEA 
received many comments expressing concern that the proposed decreases 
to the production quotas of opioid controlled substances may result in 
shortages of drug products containing those controlled substances. 
These commenters alleged that decreases to the APQ have resulted in a 
shortage of injectable opioid medications and interfere with the 
treatment of patients.
    A top U.S. manufacturer of generic sterile injectable medicines to 
U.S. hospitals and healthcare providers opined that DEA's prior 
production quota initially prevented manufacturers from addressing and 
solving the shortage. This commenter noted that today, hospitals are 
providing ongoing COVID-19 patient care and managing a backlog in 
elective surgeries. As a result, this commenter suggested that DEA 
reconsider the APQ reductions for schedule II opioids used in sterile 
injectable pain medicines.
    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 U.S., for lawful export requirements, and for the 
establishment and maintenance of reserve stocks. DEA sets APQs in a 
manner to provide for all legitimate medical purposes. Opioid 
injectable products constitute less than 5% of their relevant APQ, 
therefore injectable shortages do not usually require changes to the 
relevant APQ. Based on the data that DEA is required to consider for 
setting the APQs, DEA has determined that the established APQs for 
opioids are sufficient to meet all legitimate needs for 2023. 
Additionally, DEA and FDA are required to, and routinely do, coordinate 
efforts to prevent or alleviate

[[Page 74170]]

drug shortages. Such efforts may include adjusting the APQ, adjusting 
individual domestic manufacturers' quotas, FDA approval of additional 
market competitors, and coordination between the agencies to allow 
importation of foreign-manufactured drug products that meet FDA 
approval. For example, in 2020, DEA adjusted its quota to increase the 
APQ for drug products containing fentanyl, hydromorphone, morphine, and 
codeine, and the assessments of annual needs for drug products 
containing pseudoephedrine and ephedrine. The increased production 
needs for those substances, which are used to treat patients in 
intensive care units and those on ventilators, was a result of the 
COVID-19 public health emergency. These actions were taken based on 
DEA's consultations with federal partners at the Department of Health 
and Human Services (HHS), drug manufacturers, drug distributors, and 
hospital associations. Similarly, in 2018, a domestic shortage of 
injectable hydromorphone was alleviated through FDA and DEA 
collaboration to identify other dosage-form manufacturers with 
injectable hydromorphone products in the market, and to determine 
whether those other dosage-form manufacturers had the capability to 
increase their production levels to meet legitimate patient need in a 
timely manner. When the agencies determined that the domestic 
manufacturers could not increase production adequately to meet 
legitimate patient need, DEA and FDA coordinated and used their 
respective regulatory authorities to allow for the limited importation 
of injectable hydromorphone into the United States.

Mental Health Concerns

    Issue: DEA received a number of comments that raised the issue of 
mental health diagnoses and treatment becoming more widespread in the 
last few years. Some commenters expressed the concern that COVID-19 and 
social media are the reason more people are becoming aware of mental 
health issues and treatment options. These commenters stated that this 
awareness has resulted in the increased use of some medicines. One 
commenter stated that mental health is now being taken seriously, and 
access to mental health treatment has grown. This commenter further 
asked why we as a nation would decide to further limit treatment when 
the medications are already controlled substances, tightly tracked when 
being prescribed and dispensed, with laws in place to deter and prevent 
their misuse.
    DEA Response: DEA is aware of the sensitivity surrounding the 
negative impact of COVID-19 on mental health and recognizes that mental 
health issues are a legitimate medical concern. When setting the APQ 
for controlled substances used in manufacturing the relevant FDA-
approved drug products, DEA considers the legitimate medical need for 
these medicines, as determined in part through the number of legitimate 
prescriptions dispensed in prior years and anticipated to be dispensed 
in the coming quota year.

Supply Chain Disruption

    Issue: DEA received several comments raising the concern of the 
potential cascade effect of limiting List 1 chemicals that are used to 
manufacture ADHD medications.
    DEA Response: DEA is aware of the synthesis process used by the 
manufacturers of FDA-approved ADHD drug products. DEA considers the 
manufacturing yields and requirements of all of the controlled 
substances and List 1 chemicals in the synthesis pathways to ensure 
that the APQs allow for sufficient quantities at each step to meet the 
legitimate domestic medical, scientific, and industrial needs of the 
United States as well as export requirements.

Ryan Haight Act and Telemedicine Flexibilities

    Issue: One commenter noted DEA's concern regarding the increased 
misuse of prescription stimulants among young adults. This commenter 
questioned why the agency does not end certain flexibilities granted in 
response to the COVID-19 pandemic that allow these substances to be 
prescribed and dispensed easily, in particular that which removed the 
in-person visit requirement generally mandated by the Ryan Haight Act.
    DEA Response: On January 31, 2020, the Secretary of HHS declared a 
public health emergency with regard to COVID-19. Shortly thereafter, on 
March 16, 2020, the Secretary, with the concurrence of the Acting DEA 
Administrator, designated that the telemedicine allowance under 21 
U.S.C. 802(54)(D) applies to all schedule II-V controlled substances in 
all areas of the United States. This allowance was part of the Ryan 
Haight Act's amendments to the CSA. Accordingly, as of March 16, 2020, 
and continuing for as long as the Secretary's designation of a public 
health emergency remains in effect, the telemedicine allowance under 21 
U.S.C. 802(54)(D) applies. However, the majority of the issues 
pertaining to telemedicine are outside the scope of this rule, which is 
limited to setting APQs for Schedule I and II controlled substances and 
the List I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine.

Prescribing Hesitancy and Centers for Disease Control and Prevention 
(CDC) Guideline Changes

    Issue: Many commenters, most of whom self-identified as chronic 
pain patients, expressed general concerns that DEA has not considered 
the CDC Guidelines for Prescribing Opioids for Chronic Pain which were 
revised in 2022. Commenters noted that the goal of the 2016 Guidelines 
was to decrease overdoses, but instead there has been an increase in 
overdoses nationwide of over 400 percent. A commenter opined that since 
the initial CDC Guidelines for Prescribing came out (in 2016), the 
chronic pain community has been targeted. Commenters stated that many 
chronic pain patients have been harmed, and some have died by suicide, 
due to the inability to get prescriptions because of the limits set by 
the CDC and reductions made by DEA. Many commenters mentioned that CDC 
recently revised its guidelines, allowing doctors to have more latitude 
in making treatment decisions to prescribe the appropriate dosage based 
on individual patient needs. A commenter stated that the 2022 
Guidelines are supposed to reduce that harm of under-prescribing caused 
by the misapplication of the 2016 Guidelines. Commenters also stated 
that DEA needs to take the revised guidelines into consideration since 
there is no longer a hard limit to what a doctor can prescribe.
    DEA Response: The CDC published the updated clinical practice 
guidelines for prescribing opioids for pain on November 3, 2022,\1\ 
during the comment period for the 2023 Proposed APQ. 87 FR 70823. DEA 
will consider the impact of CDC's revised guidelines over time, in 
determining whether DEA may need to publish a revision to the currently 
proposed APQ values during the 2023 calendar year, when there is 
sufficient data to provide an understanding of the impact of the 
guidelines on the actual prescribing as practitioners seek to implement 
this guidance, provided that the prescriptions issued are for a 
legitimate medical purpose in the usual course of professional 
practice.
---------------------------------------------------------------------------

    \1\ The CDC Clinical Practice Guideline for Prescribing Opioids 
for Pain--United States, 2022, accessed November 23, 2022 from 
https://www.cdc.gov/mmwr/volumes/71/rr/rr7103a1.htm?s_cid=rr7103a1_w.
---------------------------------------------------------------------------

    In addition, DEA's regulations do not impose a maximum limit on the 
amount of medication that may be prescribed on a single prescription. 
DEA has consistently emphasized and supported

[[Page 74171]]

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.

Estimates of Diversion

    Issue: DEA received numerous comments expressing concerns that 
DEA's reduction of quotas for pain-relieving controlled substances does 
not correlate to a reduction in overdose deaths. According to the 
commenters, overdose deaths in the United States continue to rise 
because of illegal fentanyl, heroin, and illegally manufactured pain 
pills, not from pharmaceutical medications prescribed to chronic pain 
patients. These commenters discussed that legitimate fentanyl is the 
least diverted among the covered controlled substances.
    DEA Response: DEA is required to consider rates of overdose deaths 
pursuant to changes made by the SUPPORT Act. The Substance Use-Disorder 
Prevention that Promotes Opioid Recovery Treatment for Patients and 
Communities Act of 2018 (SUPPORT Act) (Pub. L. 115-271), codified at 21 
U.S.C. 826(i), mandates that DEA estimate diversion for 5 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 the use of illicit 
substances, DEA's quotas help prevent the 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.
    Issue: One commenter suggested that DEA's estimate of diversion for 
the five covered controlled substances underestimated actual diversion. 
The commenter stated nonmedical use of prescription opioids is not a 
legitimate medical purpose, but that DEA (allegedly) rejected this 
point in calculating diversion. 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.
    DEA Response: The cited 2016 report \2\ provides insightful 
information regarding the relationship between nonmedical prescription-
opioid use and heroin use. However, it does not provided adequate data 
for DEA to modify the oxycodone diversion estimate. Additionally, as 
stated in the published 2023 Proposed APQ, DEA used available (hard) 
data at wholesale distribution and retail dispensing channels, i.e., 
DEA's Theft/Loss Reports and state PDMP data.
    The PDMP data submitted was adequate to allow DEA to draw reliable 
inferences about the 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.
    Issue: Commenters raised questions regarding patient privacy issues 
relating to the PDMP data provided to DEA by states.
    DEA Response: DEA requested and received anonymized, aggregated 
PDMP data from the states. No individual patient names, addresses, or 
other discrete, personally identifiable information was shared with 
DEA.

Percentage of Prescription Opioids Being Diverted

    Issue: Multiple commenters stated that the APQs should not be 
reduced from calendar year 2022 APQ levels, given that less than 1 
percent of prescription opioids are diverted. Several commenters 
calculated the percentage of estimated diversion for oxycodone and 
hydrocodone as 0.3 percent and 0.4 percent respectively.
    DEA Response: DEA's regulations require it to consider numerous 
relevant factors in its determination of the APQ. In the October 18 
Federal Register Notice, DEA did estimate that less than one percent of 
the total quantity of FDA-approved drug products containing the five 
specific opioid controlled substances were diverted. However, DEA also 
considers other relevant factors, as required by regulation, when 
determining the APQ. 21 U.S.C. 826(a), 21 CFR 1303.11(b). DEA's 
consideration of all of these relevant factors, including those 
discussed above such as legitimate prescriptions dispensed in prior 
years and anticipated to be dispensed in the coming quota year, 
resulted in the proposed 2023 APQ as published.

Schedule I Controlled Substances

    Issue: Several commenters requested that DEA consider increasing 
production quotas for certain schedule I controlled substances, 
including: 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT), 
dimethyltryptamine (DMT), 3,4-methylenedioxyamphetamine (MDA), 3,4-
methylenedioxymethamphetamine (MDMA), 2-CB, methylone, psilocyn, and 
psilocybin for research activities and clinical trials in the United 
States.
    DEA also received comments from biotech companies requesting that 
DEA consider adjusting the relevant schedule I controlled substance APQ 
to allow for future pre-clinical and clinical trial research for post-
traumatic stress disorder (PTSD), treatment-resistant depression, 
schizophrenia, and anxiety. One pharmaceutical company that intends to 
initiate clinical trials in 2023 for treatment of post-traumatic stress 
disorder (PTSD) suggested that DEA significantly increase the APQ for 
MDMA so that the company can initiate clinical development. Another 
biopharmaceutical company recommended a significant increase in the 
APQs for DMT and MDMA for scientific research into potential mental 
health treatments.
    DEA Response: The APQs established today reflect DEA's estimates of 
the medical, scientific, research, and industrial needs of the United 
States for 2023, as well as lawful export requirements and the 
establishment and maintenance of reserve stocks. DEA can adjust the 
established APQs if these needs change. For instance, if DEA receives 
additional research protocols from DEA-registered researchers, or 
additional quota applications from DEA-registered manufacturers, DEA 
will consider revising the relevant APQ.
    DEA did receive additional quota applications from DEA-registered 
manufacturers for 5-MeO-DMT, marijuana, psilocyn, psilocybin, MDMA, and 
MDA. DEA considered those applications accordingly, as discussed below. 
DEA has not received quota applications from DEA-registered 
manufacturers to support the requested changes in the APQ for the other 
controlled substances mentioned.
    Issue: One company suggested that DEA involve representatives from 
indigenous communities in determining APQ for controlled substances 
that are potentially derived from plants traditionally used by 
indigenous groups in the Americas and beyond.
    DEA Response: DEA has held discussions when requested with 
representatives of indigenous communities in the past and welcomes 
further engagement. The APQs and the individual manufacturing quotas 
are informed in part by the quota requests submitted by DEA-registered 
manufacturers of these substances, and the current needs of indigenous 
communities also may be reflected in the requests that DEA has 
received.

[[Page 74172]]

Schedule II Controlled Substances

    Issue: DEA received comments suggesting that DEA evaluate and 
establish the APQ of oral solid and injectable dosage forms of 
medicines separately. The commenters specifically highlighted 
differences between dosage forms of certain opioids.
    DEA Response: DEA sets APQ in a manner to include dispensing for 
legitimate medical purposes and, in turn, the APQ takes into 
consideration both injectable opioids and solid oral opioids to meet 
the estimated medical needs of the United States. The statute, at 21 
U.S.C. 826(a)(2), allows but does not require DEA to grant aggregate 
and individual quotas in terms of dosage forms if the Agency determines 
that doing so will assist in avoiding the overproduction, shortage, or 
diversion of controlled substances. By issuing a single APQ covering 
all dosage forms of the basic class, rather than estimating APQ for 
each dosage form, DEA retains the flexibility to alleviate potential 
shortages and to react to unforeseen emergencies by adjusting the 
individual quotas granted to manufacturers under that APQ.

Comments From DEA-Registered Manufacturers

    Issue: DEA received comments from five DEA-registered manufacturers 
regarding 10 different schedule I and II controlled substances, 
requesting that the proposed APQ for d-amphetamine (for conversion), 
dexmethylphenidate (for conversion), dexmethylphenidate (for sale), 
isomethadone, lisdexamfetamine, methylphenidate (for conversion), 
methylphenidate (for sale), noroxymorphone (for conversion), oripavine, 
and oxymorphone (for conversion) be established at sufficient levels to 
allow for manufacturers to meet medical and scientific needs.
    DEA Response: DEA considered the comments for these specific 
controlled substances and determined that an increase from DEA's 
proposed APQs are not necessary at this time, as reflected below in the 
section titled Determination of 2023 Aggregate Production Quotas and 
Assessment of Annual Needs.

Request for Public Hearing

    Issue: One pharmaceutical company requested a public hearing prior 
to publishing the Final Order to establish the initial 2023 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 2023 APQ requires a 
significant reduction from the 2022 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). 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 of specific medical 
illnesses, and medical treatments. Other commenters suggested (1) 
making the United States a signatory to the Nagoya Protocol and the 
Convention on Biological Diversity; and (2) creating diversified 
categories for production and research on psilocybin-containing fungi 
fruiting bodies/sclerotia/liquid culture similar to cannabis (flower), 
fruiting body extract (akin to cannabis extract), and psilocybin and 
psilocyn separately as purified compounds (akin to delta-9-thc). 
Regarding this last suggestion, the commenter further suggested that 
the ``same system should then be replicated in regards to lophophora/
mescaline, as well as other plants, fungi and lifeforms, which produce 
these compounds being used in whole or closer to whole ways.'' These 
comments do not impact the analysis involved in establishing the 2023 
APQ.

IV. Determination of 2023 Aggregate Production Quotas and Assessment of 
Annual Needs

    In determining the established 2023 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 2022 manufacturing quotas, current 2022 sales and 
inventories, anticipated 2023 export requirements, industrial use, 
additional applications for 2023 quotas, and information on research 
and product development requirements.
    On November 17, 2022, DEA published a final order placing 
amineptine in schedule I of the CSA (87 FR 68895), making all 
regulatory controls pertaining to the schedule I controlled substances 
applicable to the manufacture of this substance, including the 
requirement to establish an aggregate production quota pursuant to 21 
U.S.C. 826 and 21 CFR part 1303. This final order establishes an 
aggregate production quota for this substance.
    Based on all of the above, the Administrator establishes the 2023 
APQ for 2-CB, 5-MEO-DMT, MDA, MDMA, methylone, psilocyn, d-
methamphetamine (for sale), fentanyl, and 4-anilino-n-phenethyl-4-
piperidine (ANPP), at higher levels than was proposed.
    DEA has determined that the proposed APQs for d-amphetamine (for 
conversion), dexmethylphenidate (for conversion), dexmethylphenidate 
(for sale), isomethadone, lisdexamphetamine, methylphenidate (for 
conversion), methylphenidate (for sale), and noroxymorphone (for 
conversion) are sufficient to provide for the 2023 estimated medical, 
scientific, research, and industrial needs of the United States, export 
requirements, and the establishment and maintenance of reserve stocks. 
This final order establishes these APQ at the same amounts as proposed.
    The Administrator establishes the 2023 AAN for ephedrine (for 
conversion) 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 2023.
    In accordance with 21 U.S.C. 826, 21 CFR 1303.11, and 21 CFR 
1315.11, the Administrator hereby establishes the 2023 APQ for the 
following schedule I and II controlled substances and the 2023 AAN for 
the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine, expressed in grams of anhydrous acid or base, as 
follows:

------------------------------------------------------------------------
                                                            Established
                       Basic class                          2023 quotas
                                                                (g)
------------------------------------------------------------------------
                               Schedule I
------------------------------------------------------------------------
-[1-(2-Thienyl)cyclohexyl]- pyrrolidine.................              20
1-(1-Phenylcyclohexyl)- pyrrolidine.....................              30

[[Page 74173]]

 
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-                                 30
 methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B;
 Cimbi-36)..............................................
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C).......              30
2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-                                25
 methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C;
 Cimbi-82)..............................................
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I).........              30
2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-                                  30
 methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I;
 Cimbi-5)...............................................
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-              30
 T-4)...................................................
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-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-              25
 PVP)...................................................
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-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-[alpha]-pyrrolidinopropiophenone (4-MePPP).....              25
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-               50
 phenol.................................................
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-                40
 phenol (cannabicyclohexanol or CP-47,497 C8-homolog)...
5F-AB-PINACA ; (1-Amino-3-methyl-1-oxobutan-2-yl)-1-(5-               25
 fluoropentyl)-1H-indazole-3-carboxamide................
5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-1H-              25
 indazole-3-carboxamido)-3,3-dimethylbutanoate).........
5F-CUMYL-P7AICA; 1-(5-Fluoropentyl)-N-(2-phenylpropan-2-              25
 yl)-1H-pyrrolo[2,3-b]pyridine-3carboximide.............
5F-CUMYL-PINACA.........................................              25
5F-EDMB-PINACA..........................................              25
5F-MDMB-PICA............................................              25
5F-AMB (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-                   25
 carboxamido)-3-methylbutanoate)........................
5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5-                        25
 fluoropentyl)-1H-indazole-3-carboxamide)...............
5-Fluoro-PB-22; 5F-PB-22................................              25
5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1Hindol-3-                25
 yl](2,2,3,3-tetramethylcyclopropyl)methanone...........
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-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-             30
 (4-fluorobenzyl)-1H-indazole-3-carboxamide)............
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-               50
 pentyl-1H-indazole-3-carboxamide)......................
AH-7921.................................................              30
All other tetrahydrocannabinol..........................          15,000
Allylprodine............................................              25
Alphacetylmethadol......................................              25
alpha-Ethyltryptamine...................................              25
Alphameprodine..........................................              25
Alphamethadol...........................................              25
alpha-Methylfentanyl....................................              30
alpha-Methylthiofentanyl................................              30
alpha-Methyltryptamine (AMT)............................              25
alpha-Pyrrolidinobutiophenone ([alpha]-PBP).............              25
alpha-pyrrolidinoheptaphenone (PV8).....................              25
alpha-pyrrolidinohexabophenone (alpha-PHP)..............              25
alpha-Pyrrolidinopentiophenone ([alpha]-PVP)............              25
Amineptine..............................................              30
Aminorex................................................              25
Anileridine.............................................              20
APINCA, AKB48 (N-(1-adamantyl)-1-pentyl-1H-indazole-3-                25
 carboxamide)...........................................
Benzethidine............................................              25
Benzylmorphine..........................................              30
Betacetylmethadol.......................................              25
beta-Hydroxy-3-methylfentanyl...........................              30
beta-Hydroxyfentanyl....................................              30
beta-Hydroxythiofentanyl................................              30

[[Page 74174]]

 
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.................................................         384,460
Desomorphine............................................              25
Dextromoramide..........................................              25
Diapromide..............................................              20
Diethylthiambutene......................................              20
Diethyltryptamine.......................................              25
Difenoxin...............................................           9,300
Dihydromorphine.........................................         653,548
Dimenoxadol.............................................              25
Dimepheptanol...........................................              25
Dimethylthiambutene.....................................              20
Dimethyltryptamine......................................           3,000
Dioxyaphetyl butyrate...................................              25
Dipipanone..............................................              25
Drotebanol..............................................              25
Ethylmethylthiambutene..................................              25
Ethylone................................................              25
Etodesnitazene..........................................              30
Etonitazene.............................................              25
Etorphine...............................................              30
Etoxeridine.............................................              25
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................................................              30
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-                             35
 naphthoyl)indole)......................................
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-                30
 oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-
 carboxamide)...........................................
MDMB-CHMICA; MMB-CHMINACA(methyl 2-(1-(cyclohexylmethyl)-             30
 1H-indole-3-carboxamido)-3,3-dimethylbutanoate)........
MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1H-indazole-              30
 3-carboxamido)-3,3-dimethylbutanoate)..................
MMB-CHMICA-(AMB-CHIMCA); Methyl-2-(1-(cyclohexylmethyl)-              25
 1H-indole-3-carboxamido)-3-methylbutanoate.............
Metodesnitazene.........................................              30
Metonitazene............................................              30
Marijuana...............................................       6,675,000
Marijuana extract.......................................       1,000,000
Mecloqualone............................................              30
Mescaline...............................................           1,200
Methaqualone............................................              60
Methcathinone...........................................              25
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-                25
 carboxylate............................................
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
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..............................................           8,000
Psilocyn................................................          12,000
Racemoramide............................................              25
SR-18 and RCS-8 (1-Cyclohexylethyl-3-(2-                              45
 methoxyphenylacetyl)indole)............................
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-                          30
 yl](naphthalen-1-yl)methanone).........................
Tilidine................................................              25
Trimeperidine...........................................              25
UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3-                              25
 tetramethylcyclopropyl)methanone.......................
U-47700.................................................              30
Valeryl fentanyl........................................              25
------------------------------------------------------------------------
                               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

[[Page 74175]]

 
Bezitramide.............................................              25
Carfentanil.............................................              20
Cocaine.................................................          60,492
Codeine (for conversion)................................       1,085,024
Codeine (for sale)......................................      21,003,397
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).....................       4,200,000
Dextropropoxyphene......................................              35
Dihydrocodeine..........................................         132,658
Dihydroetorphine........................................              25
Diphenoxylate (for conversion)..........................          14,100
Diphenoxylate (for sale)................................         770,800
Ecgonine................................................          60,492
Ethylmorphine...........................................              30
Etorphine hydrochloride.................................              32
Fentanyl................................................         731,452
Glutethimide............................................              25
Hydrocodone (for conversion)............................           1,250
Hydrocodone (for sale)..................................      27,239,822
Hydromorphone...........................................       1,994,117
Isomethadone............................................              30
L-amphetamine...........................................              30
Levo-alphacetylmethadol (LAAM)..........................              25
Levomethorphan..........................................              30
Levorphanol.............................................          23,010
Lisdexamfetamine........................................      26,500,000
Meperidine..............................................         681,289
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
Methamphetamine.........................................             150
d-methamphetamine (for conversion)......................         485,020
d-methamphetamine (for sale)............................          47,000
l-methamphetamine.......................................         587,229
Methylphenidate (for sale)..............................      41,800,000
Methylphenidate (for conversion)........................      15,300,000
Metopon.................................................              25
Moramide-intermediate...................................              25
Morphine (for conversion)...............................       2,458,460
Morphine (for sale).....................................      21,747,625
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)....................................      53,840,608
Oxymorphone (for conversion)............................      28,204,371
Oxymorphone (for sale)..................................         516,351
Pentobarbital...........................................      33,843,337
Phenazocine.............................................              25
Phencyclidine...........................................              35
Phenmetrazine...........................................              25
Phenylacetone...........................................             100
Piminodine..............................................              25
Racemethorphan..........................................               5
Racemorphan.............................................               5
Remifentanil............................................           3,000
Secobarbital............................................         172,100
Sufentanil..............................................           4,000
Tapentadol..............................................      11,941,416
Thebaine................................................      57,137,944
------------------------------------------------------------------------
                            List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion)..............................          41,100
Ephedrine (for sale)....................................       4,136,000
Phenylpropanolamine (for conversion)....................      14,878,320
Phenylpropanolamine (for sale)..........................       7,990,000
Pseudoephedrine (for conversion)........................           1,000
Pseudoephedrine (for sale)..............................     174,246,000
------------------------------------------------------------------------

    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 
2023 APQ and AAN as needed.

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
November 29, 2022, 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. 2022-26351 Filed 11-30-22; 11:15 am]
BILLING CODE P