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, 20302-20305 [2020-07593]
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20302
Federal Register / Vol. 85, No. 70 / Friday, April 10, 2020 / Notices
DEPARTMENT OF JUSTICE
Antitrust Division
Notice Pursuant to the National
Cooperative Research and Production
Act of 1993—ODPi, Inc.
Notice is hereby given that, on March
26, 2020, pursuant to Section 6(a) of the
National Cooperative Research and
Production Act of 1993, 15 U.S.C. 4301
et seq. (‘‘the Act’’), ODPi, Inc. (‘‘ODPi’’)
has filed written notifications
simultaneously with the Attorney
General and the Federal Trade
Commission disclosing changes in its
membership. The notifications were
filed for the purpose of extending the
Act’s provisions limiting the recovery of
antitrust plaintiffs to actual damages
under specified circumstances.
Specifically, Cloudera, Inc., Santa Clara,
CA; and ArenaData, Moscow, RUSSIA,
have withdrawn as parties to this
venture.
No other changes have been made in
either the membership or planned
activity of the group research project.
Membership in this group research
project remains open, and ODPi intends
to file additional written notifications
disclosing all changes in membership.
On November 23, 2015, ODPi filed its
original notification pursuant to Section
6(a) of the Act. The Department of
Justice published a notice in the Federal
Register pursuant to Section 6(b) of the
Act on December 23, 2015 (80 FR
79930).
The last notification was filed with
the Department on January 6, 2020. A
notice was published in the Federal
Register pursuant to Section 6(b) of the
Act on January 31, 2020 (85 FR 5720).
Suzanne Morris,
Chief, Premerger and Division Statistics Unit,
Antitrust Division.
[FR Doc. 2020–07594 Filed 4–9–20; 8:45 am]
BILLING CODE 4410–11–P
DEPARTMENT OF JUSTICE
Antitrust Division
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Notice Pursuant to the National
Cooperative Research and Production
Act of 1993—Advanced Media
Workflow Association, Inc.
Notice is hereby given that, on March
20, 2020, pursuant to Section 6(a) of the
National Cooperative Research and
Production Act of 1993, 15 U.S.C. 4301
et seq. (‘‘the Act’’), Advanced Media
Workflow Association, Inc. has filed
written notifications simultaneously
with the Attorney General and the
Federal Trade Commission disclosing
VerDate Sep<11>2014
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Jkt 250001
changes in its membership. The
notifications were filed for the purpose
of extending the Act’s provisions
limiting the recovery of antitrust
plaintiffs to actual damages under
specified circumstances. Specifically,
Euro Media Group, St. Denis, France;
and Qvest Media GmbH, Cologne,
Germany, have been added as parties to
this venture.
Also, MOG Solutions, Maia, Portugal;
and William Claghorn (individual
member), Benicia, CA, have withdrawn
as parties to this venture.
No other changes have been made in
either the membership or planned
activity of the group research project.
Membership in this group research
project remains open, and Advanced
Media Workflow Association, Inc.
intends to file additional written
notifications disclosing all changes in
membership.
On March 28, 2000, Advanced Media
Workflow Association, Inc. filed its
original notification pursuant to Section
6(a) of the Act. The Department of
Justice published a notice in the Federal
Register pursuant to Section 6(b) of the
Act on June 29, 2000 (65 FR 40127).
The last notification was filed with
the Department on December 12, 2019.
A notice was published in the Federal
Register pursuant to Section 6(b) of the
Act on December 30, 2019 (84 FR
71977).
Suzanne Morris,
Chief, Premerger and Division Statistics Unit,
Antitrust Division.
[FR Doc. 2020–07600 Filed 4–9–20; 8:45 am]
BILLING CODE 4410–11–P
DEPARTMENT OF JUSTICE
Notice Pursuant to the National
Cooperative Research and Production
Act of 1993—Cooperative Research
Group on ROS-Industrial Consortium
Americas
Notice is hereby given that, on March
24, 2020, pursuant to Section 6(a) of the
National Cooperative Research and
Production Act of 1993, 15 U.S.C. 4301
et seq. (‘‘the Act’’), Southwest Research
Institute—Cooperative Research Group
on ROS-Industrial Consortium-Americas
(‘‘RIC-Americas’’) has filed written
notifications simultaneously with the
Attorney General and the Federal Trade
Commission disclosing changes in its
membership. The notifications were
filed for the purpose of extending the
Act’s provisions limiting the recovery of
antitrust plaintiffs to actual damages
under specified circumstances.
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Suzanne Morris,
Chief, Premerger and Division Statistics Unit,
Antitrust Division.
[FR Doc. 2020–07597 Filed 4–9–20; 8:45 am]
BILLING CODE 4410–11–P
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
Drug Enforcement
Administration, Department of Justice.
ACTION: Notice; final order.
AGENCY:
Antitrust Division
PO 00000
Specifically, MegaChips Corporation,
Osaka, JAPAN, has been added as a
party to this venture.
No other changes have been made in
either the membership or planned
activity of the group research project.
Membership in this group research
project remains open, and RIC-Americas
intends to file additional written
notifications disclosing all changes in
membership.
On April 30, 2014, RIC-Americas filed
its original notification pursuant to
Section 6(a) of the Act. The Department
of Justice published a notice in the
Federal Register pursuant to Section
6(b) of the Act on June 9, 2014 (79 FR
32999).
The last notification was filed with
the Department on March 2, 2020. A
notice was published in the Federal
Register pursuant to Section 6(b) of the
Act on March 20, 2020 (85 FR 16132).
Sfmt 4703
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
SUMMARY:
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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 https://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
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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.
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.
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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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
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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
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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
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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.
to adhere to them in issuing these adjusted
aggregate production quotas.
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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 ........................................
Hydromorphone ............................
Oxymorphone ...............................
.090
1.288
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
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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 4Anilino-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
20305
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
(g)
Controlled substance
Adjusted APQ
(g)
Schedule II
4-Anilino-N-Phenethyl-4-Piperidine (ANPP) ........................................................................................................
Codeine (for sale) ................................................................................................................................................
Fentanyl ...............................................................................................................................................................
Hydromorphone ...................................................................................................................................................
Methadone (for sale) ...........................................................................................................................................
Methadone Intermediate ......................................................................................................................................
Morphine (for sale) ..............................................................................................................................................
Noroxymorphone (for conversion) .......................................................................................................................
Oripavine ..............................................................................................................................................................
Oxymorphone (for conversion) ............................................................................................................................
813,005
30,731,558
813,005
3,054,479
22,278,000
24,064,000
29,353,655
19,169,340
28,705,000
24,525,540
934,956
35,341,292
934,956
3,512,651
25,619,700
27,673,600
33,756,703
22,044,741
33,010,750
28,204,371
4,136,000
174,246,000
4,756,400
200,382,900
List I Chemicals
Ephedrine (for sale) .............................................................................................................................................
Pseudoephedrine (for sale) .................................................................................................................................
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.
DEPARTMENT OF LABOR
Uttam Dhillon,
Acting Administrator.
ACTION:
Office of the Secretary
Agency Information Collection
Activities; Submission for OMB
Review; Comment Request; Death
Gratuity
Notice of availability; request
for comments.
[FR Doc. 2020–07593 Filed 4–9–20; 8:45 am]
The Department of Labor
(DOL) is submitting this Office of
Workers’ Compensation Programs
(OWCP)-sponsored information
collection request (ICR) to the Office of
Management and Budget (OMB) for
review and approval in accordance with
the Paperwork Reduction Act of 1995
SUMMARY:
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(PRA). Public comments on the ICR are
invited.
DATES: The OMB will consider all
written comments that agency receives
on or before May 11, 2020.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
Comments are invited on: (1) Whether
the collection of information is
necessary for the proper performance of
the functions of the Department,
including whether the information will
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]]>Agencies
[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 https://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
----------------------------------------------------------------------------------------------------------------
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
