[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
------------------------------------------------------------------------
------------------------------------------------------------------------
Diversion estimates for 2019 (kg)
------------------------------------------------------------------------
Fentanyl..................................................... .090
Hydromorphone................................................ 1.288
Oxymorphone.................................................. N/A
------------------------------------------------------------------------
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:
----------------------------------------------------------------------------------------------------------------
Current APQ Adjusted APQ
Controlled substance (g) (g)
----------------------------------------------------------------------------------------------------------------
Schedule II
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
List I Chemicals
----------------------------------------------------------------------------------------------------------------
Ephedrine (for sale).......................................................... 4,136,000 4,756,400
Pseudoephedrine (for sale).................................................... 174,246,000 200,382,900
----------------------------------------------------------------------------------------------------------------
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