[Federal Register Volume 85, Number 70 (Friday, April 10, 2020)]
[Notices]
[Pages 20302-20305]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-07593]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-508A]


Adjustments to Aggregate Production Quotas for Certain Schedule 
II Controlled Substances and Assessment of Annual Needs for the List I 
Chemicals Ephedrine and Pseudoephedrine for 2020, in Response to the 
Coronavirus Disease 2019 Public Health Emergency

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice; final order.

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SUMMARY: The Drug Enforcement Administration is adjusting the 2020 
aggregate production quotas for certain controlled substances in 
schedule II of the Controlled Substances Act and the assessment of 
annual needs for the list I chemicals ephedrine and pseudoephedrine. 
This increase is in response to the current nationwide COVID-19 public 
health emergency as declared by the Secretary of Health and Human 
Services on January 31, 2020.

DATES: Effective April 10, 2020. Interested persons may file written 
comments on this notice in accordance with 21 CFR 1303.13(c) and 
1315.13(d). Electronic comments must be submitted, and written comments 
must be postmarked, on or before May 11, 2020. Commenters should be 
aware that

[[Page 20303]]

the electronic Federal Docket Management System will not accept 
comments after 11:59 p.m. Eastern Time on the last day of the comment 
period.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-508A'' on all correspondence, including any 
attachments. The Drug Enforcement Administration encourages that all 
comments be submitted electronically through the Federal eRulemaking 
Portal which provides the ability to type short comments directly into 
the comment field on the web page or attach a file for lengthier 
comments. Please go to http://www.regulations.gov and follow the online 
instructions at that site for submitting comments. Upon completion of 
your submission you will receive a Comment Tracking Number for your 
comment. Please be aware that submitted comments are not 
instantaneously available for public view on Regulations.gov. If you 
have received a Comment Tracking Number, your comment has been 
successfully submitted and there is no need to resubmit the same 
comment. Paper comments that duplicate electronic submissions are not 
necessary and are discouraged. Should you wish to mail a paper comment 
in lieu of an electronic comment, it should be sent via regular or 
express mail to: Drug Enforcement Administration, Attention: DEA 
Federal Register Representative/DPW, 8701 Morrissette Drive, 
Springfield, Virginia 22152.

FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting 
and Policy Support Section, Diversion Control Division, Drug 
Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 
22152, Telephone: (571) 362-3261.

SUPPLEMENTARY INFORMATION: 

Legal Authority and Background

    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.
    DEA established the 2020 aggregate production quotas and assessment 
of annual needs on December 2, 2019, (84 FR 66014) to 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 to provide for the estimated 
medical, scientific, research, and industrial needs of the United 
States, for lawful export requirements, and for 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. The 
order stipulated that all aggregate production quotas and assessments 
of annual needs are subject to adjustment, in accordance with 21 CFR 
1303.13 and 1315.13.

Public Health Emergency

    Coronavirus disease 2019 (COVID-19) is a respiratory illness that 
can spread from person to person which can result in multi-organ 
failures, pneumonia, or death.\1\ COVID-19 has rapidly spread through 
numerous countries, including the United States. COVID-19 poses a 
serious public health risk and all 50 states have reported cases of 
COVID-19.\2\ On January 31, 2020, the Secretary of Health and Human 
Services (HHS) declared a public health emergency. DEA is closely 
collaborating with HHS to ensure an adequate and uninterrupted supply 
of controlled substances in order to meet the estimated medical, 
scientific, research, and industrial needs of the United States, for 
lawful export requirements, and for the establishment and maintenance 
of reserve stocks.
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    \1\ https://www.cdc.gov/coronavirus/2019-ncov/downloads/2019-ncov-factsheet.pdf.
    \2\ https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/summary.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fsummary.html.
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Analysis for the Proposed Adjustments to the 2020 Aggregate Production 
Quotas and Assessment of Annual Needs

    DEA is adjusting the established 2020 aggregate production quotas 
and assessment of annual needs for selected schedule II controlled 
substances and list I chemicals, to be manufactured in the United 
States to provide for the estimated needs of the United States. These 
adjustments are necessary to ensure that the United States has an 
adequate and uninterrupted supply of these substances as the country 
moves through this public health emergency. Although the existing 2020 
quota level is sufficient to meet current needs, DEA is acting 
proactively to ensure that--should the public health emergency become 
more acute--there is sufficient quota for these important drugs.

Factors for Determining the Proposed Adjustments

    In determining these adjustments, the Acting Administrator has 
taken into account the criteria in accordance with 21 CFR 1303.13 
(adjustment of aggregate production quotas for controlled substances). 
The Acting Administrator is authorized to increase or reduce the 
aggregate production quota at any time. 21 CFR 1303.13(a). DEA 
regulations state that there are five factors that shall be considered 
in determining to adjust the aggregate production quota. 21 CFR 
1303.13(b). Accordingly, the Acting Administrator has taken into 
account the following factors when determining to make the adjustments 
described below for 2020: (1) Changes in the demand for that class, 
changes in the national rate of net disposal of the class, changes in 
the rate of net disposal of the class by registrants holding individual 
manufacturing quotas for that class, and changes in the extent of any 
diversion in the class; (2) whether any increased demand for that 
class, the national and/or individual rates of net disposal of that 
class are temporary, short term, or long term; (3) whether any 
increased demand for that class can be met through existing 
inventories, increased individual manufacturing quotas, or increased 
importation, without increasing the aggregate production quota, taking 
into account production delays and the probability that other 
individual manufacturing quotas may be suspended pursuant to 21 CFR 
1303.24(b); (4) whether any decreased demand for that class will result 
in excessive inventory accumulation by all persons registered to handle 
that class (including manufacturers, distributors, practitioners, 
importers, and exporters), notwithstanding the possibility that 
individual manufacturing quotas may be suspended pursuant to 21 CFR 
1303.24(b) or abandoned pursuant to 21 CFR 1303.27; and (5) other 
factors affecting medical, scientific, research, and industrial needs 
in the United States and lawful export requirements, as the Acting 
Administrator finds relevant, including changes in the currently 
accepted medical use in treatment with the class or the substances 
which are manufactured from it, the economic and physical availability 
of raw materials for use in manufacturing and for inventory purposes, 
yield and stability problems, potential disruptions to production 
(including possible labor strikes), and recent unforeseen emergencies 
such as floods and fires. 21 CFR 1303.13(b). The Acting Administrator 
has taken into consideration, in particular, the

[[Page 20304]]

unforeseen emergency posed by COVID-19 and the effect the emergency is 
having on the need for certain controlled substances, particularly for 
patients who are on ventilators.

Considerations Based Upon the Substance Use-Disorder Prevention That 
Promotes Opioid Recovery and Treatment for Patients and Communities Act

    Pursuant to 21 U.S.C. 826(a)(1), ``production quotas shall be 
established in terms of quantities of each basic class of controlled 
substance and not in terms of individual pharmaceutical dosage forms 
prepared from or containing such a controlled substance.'' However, the 
Substance Use-Disorder Prevention that Promotes Opioid Recovery 
Treatment for Patients and Communities Act of 2018 (SUPPORT Act), (Pub. 
L. 115-271), provides an exception to that general rule by now giving 
DEA the authority to establish quotas in terms of pharmaceutical dosage 
forms if the agency determines that doing so will assist in avoiding 
the overproduction, shortages, or diversion of a controlled substance.
    In addition to the factors listed above, DEA must estimate the 
amount of diversion of any substance that is considered a ``covered 
controlled substance,'' as defined by the SUPPORT Act. 21 U.S.C. 
826(i)(1)(A). The SUPPORT Act lists fentanyl, oxycodone, hydrocodone, 
oxymorphone, and hydromorphone as the ``covered controlled 
substances.'' Through the SUPPORT Act, DEA is also required to ``make 
appropriate quota reductions, as determined by the [Administrator],\3\ 
from the quota the [Administrator] would have otherwise established had 
such diversion not been considered.'' 21 U.S.C. 826(i)(1). When 
estimating diversion, the ``[Administrator] (i) shall consider 
information the [Administrator], in consultation with the Secretary of 
[HHS], determines reliable on rates of overdose deaths and abuse and 
overall public health impact related to the covered controlled 
substance in the United States; and (ii) may take into consideration 
whatever other sources of information the [Administrator] determines 
reliable.'' \4\ Id.
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    \3\ All functions vested in the Attorney General by the CSA have 
been delegated to the Administrator of DEA. 28 CFR 0.100(b).
    \4\ DEA intends to finalize amendments to the Agency's 
regulations that will implement the amendments to the CSA made by 
the SUPPORT Act. Although these amendments to the regulations have 
not yet been issued, the statutory requirements stated above became 
effective upon enactment of the SUPPORT Act, and DEA is therefore 
obligated to adhere to them in issuing these adjusted aggregate 
production quotas.
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Information Considered To Satisfy the Factors for Determining the 
Adjustments

    For the factors listed in 21 CFR 1303.13(b)(1) and (2), DEA 
consulted with HHS and determined that the utilization rates for 
selected medications required to implement the treatment regimens for 
ventilator patients stricken with the COVID-19 virus have substantially 
increased compared to the previously estimated annual consumption 
rates. There is a substantial range in the number of patients that will 
require ventilation treatment due to COVID-19, as the United States is 
still in the early stages of modeling best-case/worst-case scenarios 
for infection and hospitalization rates. Although DEA has considered 
this crisis to be a short-term increase in rate of disposal, the 
unknown factor is the estimated number of patients requiring a 
ventilator regimen in addition to the patients with other medical 
conditions that already require ventilator assistance.
    For the factors listed in 21 CFR 1303.13(b)(3) and (4), DEA has 
already waived the requirement for manufacturers to suspend their 
manufacturing capacity pursuant to 1303.24(b) and cannot foresee any 
decrease in demand for the selected classes of controlled substances as 
currently modeled by HHS. DEA has considered the current requirements 
for social distancing that have been implemented by manufacturers which 
may lead to increases in production delays. DEA will monitor the 
individual manufacturing and procurement quotas granted in an effort to 
prevent excessive inventory accumulation by all persons registered to 
handle the classes. By monitoring individual manufacturing and 
procurement quotas, DEA will insure that the increase in APQ will be 
utilized primarily for the manufacturing of medications identified by 
the FDA as involved in the sedation, intubation, and pain relief of 
patients being treated for COVID-19. With respect to factor 21 CFR 
1303.13(b)(5), the Acting Administrator has determined that the COVID-
19 pandemic constitutes an unforeseen emergency supporting the increase 
in the aggregate production quotas and assessments of annual needs for 
the substances set forth below.

Setting APQ in Terms of Pharmaceutical Dosage Form and the Estimation 
of Diversion as Established by the SUPPORT Act

    While DEA is now allowed to issue quotas in terms of pharmaceutical 
dosage form, it is not required to do so. DEA will not be utilizing 
this authority at the aggregate production quota level, but will be 
doing so at the individual dosage-form manufacturing level where it 
will have a greater impact on averting potential shortages. Because 
quotas set at the individual dosage-form manufacturing level are more 
directly connected to distributions of current and new FDA-approved 
drug products, they allow DEA to manage manufacturing quotas to 
alleviate any potential shortage in a more timely manner than with 
quotas set at the aggregate production quota level. This is also true 
because the aggregate production quota is initially established prior 
to the start of the quota calendar year.
    To estimate diversion as is required by the SUPPORT Act, DEA 
aggregated the active pharmaceutical ingredient (API) of each covered 
controlled substance by metric weight where the data was available in 
internal databases. Based on the individual entries into the 
aforementioned databases, DEA calculated the estimated amount of 
diversion by multiplying the strength of the API listed for each 
finished dosage form by the total amount of units reported to estimate 
the metric weight in kilograms of the controlled substance being 
diverted. The estimate of diversion for each of the covered controlled 
substances is reported below.

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                    Diversion estimates for 2019 (kg)
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Fentanyl.....................................................       .090
Hydromorphone................................................      1.288
Oxymorphone..................................................        N/A
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Additional Legal Considerations

    The procedures by which DEA adjusts aggregate production quotas are 
set forth in the DEA regulations. As stated in 21 CFR 1303.13, the 
Acting Administrator, upon determining that an adjustment of the 
aggregate production quota of any basic class of controlled substance 
is necessary, shall publish in the Federal Register general notice of 
an adjustment in the aggregate production quota for that class. Any 
interested person may file comments or objections to these adjusted 
aggregate production quotas within the time specified by the Acting 
Administrator in this notice.
    Section 1303.13 further provides that, ``[a]fter consideration of 
any comments

[[Page 20305]]

or objections . . . the Acting Administrator shall issue and publish in 
the Federal Register his final order determining the aggregate 
production quota for the basic class of controlled substance.'' The 
Acting Administrator has determined, however, that because of the 
nationwide public health emergency declared by the Secretary of HHS on 
January 31, 2020, in response to the COVID-19 public health emergency, 
the public interest requires that this final order be effective 
immediately. Accordingly, pursuant to 21 CFR 1307.03, the Acting 
Administrator hereby waives the provision of 21 CFR 1303.13 which 
requires consideration of any comments or objections prior to the 
publication of this final order. The Acting Administrator will, 
however, consider any comments or objections filed in response to this 
final order in determining whether any further adjustment to the 
aggregate production quota for calendar year 2020 is necessary. The 
Acting Administrator has made the same determination with respect to 
the adjustment of the assessment of annual need for ephedrine and 
pseudoephedrine.

Determination of 2020 Adjusted Aggregate Production Quotas and 
Assessment of Annual Needs

    In determining the adjustment of 2020 aggregate production quotas 
and assessment of annual needs, DEA has taken into consideration the 
factors set forth in 21 CFR 1303.13(b) and 21 CFR 1315.13(b), in 
accordance with 21 U.S.C. 826(a) and (i), and the current public health 
emergency due to COVID-19. Based on all of the above, the Acting 
Administrator is adjusting the 2020 aggregate production quotas for 4-
Anilino-N-Phenethyl-4-Piperidine (ANPP), Codeine (for sale), Fentanyl, 
Hydromorphone, Methadone (for sale), Methadone Intermediate, Morphine 
(for sale), Noroxymorphone (for conversion), Oripavine, and Oxymorphone 
(for conversion); as well as the 2020 annual assessment of needs for 
ephedrine (for sale) and pseudoephedrine (for sale). Based upon DEA's 
consultations with federal partners at HHS, drug manufacturers, drug 
distributors and hospital associations, DEA understands that products 
containing Fentanyl, Hydromorphone, Morphine, Codeine, Pseudoephedrine 
and Ephedrine, are often used to treat patients in intensive care units 
and those on ventilators or for individuals who may have conditions 
which impact their breathing. In order to produce those products, DEA 
must also increase the aggregate production quota for the following 
controlled substance intermediates: ANPP, Noroxymorphone (for 
conversion), Oripavine and Oxymorphone (for conversion).
    The Acting Administrator hereby adjusts the 2020 aggregate 
production quotas for the following schedule II controlled substances 
and the 2020 assessment of annual needs for the list I chemicals 
ephedrine and pseudoephedrine, expressed in grams of anhydrous acid or 
base, as follows:

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                                                                                  Current APQ      Adjusted APQ
                             Controlled substance                                     (g)              (g)
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                                                   Schedule II
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4-Anilino-N-Phenethyl-4-Piperidine (ANPP).....................................          813,005          934,956
Codeine (for sale)............................................................       30,731,558       35,341,292
Fentanyl......................................................................          813,005          934,956
Hydromorphone.................................................................        3,054,479        3,512,651
Methadone (for sale)..........................................................       22,278,000       25,619,700
Methadone Intermediate........................................................       24,064,000       27,673,600
Morphine (for sale)...........................................................       29,353,655       33,756,703
Noroxymorphone (for conversion)...............................................       19,169,340       22,044,741
Oripavine.....................................................................       28,705,000       33,010,750
Oxymorphone (for conversion)..................................................       24,525,540       28,204,371
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                                                List I Chemicals
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Ephedrine (for sale)..........................................................        4,136,000        4,756,400
Pseudoephedrine (for sale)....................................................      174,246,000      200,382,900
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    The aggregate production quotas for all other schedule I and II 
controlled substances included in the 2020 established aggregate 
production quotas and the 2020 assessment of annual needs for the list 
I chemical phenylpropanolamine remain at this time as previously 
established.

Uttam Dhillon,
Acting Administrator.
[FR Doc. 2020-07593 Filed 4-9-20; 8:45 am]
BILLING CODE 4410-09-P