International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Isotonitazene; MDMB-4en-PINACA; CUMYL-PEGACLONE; Flubromazolam; Clonazolam; Diclazepam; 3-MeO-PCP; DIPHENIDINE; 2-MEO-DIPHENIDINE; 5-MEO-DALT; and 3-FLUOROPHENMETRAZINE (3-FPM); Request for Comments, 47217-47220 [2020-16905]
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Federal Register / Vol. 85, No. 150 / Tuesday, August 4, 2020 / Notices
Comments due within 60 days of
publication. In compliance with the
requirements of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
ACF is soliciting public comment on the
specific aspects of the information
collection described above.
ADDRESSES: Copies of the proposed
collection of information can be
obtained and comments may be
forwarded by emailing infocollection@
acf.hhs.gov. Alternatively, copies can
also be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research,
and Evaluation (OPRE), 330 C Street
SW, Washington, DC 20201, Attn: ACF
Reports Clearance Officer. All requests,
emailed or written, should be identified
by the title of the information collection.
SUPPLEMENTARY INFORMATION:
Description: State child support
enforcement agencies are statutorily
required to enter into data matching
agreements with financial institutions
DATES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
[OMB #0970–0196]
Proposed Information Collection
Activity; Multistate Financial Institution
Data Match With Federally Assisted
State Transmitted Levy
Office of Child Support
Enforcement, Administration for
Children and Families, HHS.
ACTION: Request for Public Comment.
AGENCY:
The Administration for
Children and Families’ (ACF) Office of
Child Support Enforcement (OCSE) is
requesting a 3-year extension of the
currently approved Multistate Financial
Institution Data Match with Federally
Assisted State Transmitted Levy
(MSFIDM/FAST Levy) (current OMB
approval expires 1/31/2021).
SUMMARY:
doing business in their state to locate
obligors’ accounts. OCSE operates the
MSFIDM program through the Federal
Parent Locator Service (FPLS) and
facilitates the required data match
between state child support agencies
and financial institutions doing
business in multiple states. State child
support enforcement agencies use the
data match outcomes to fulfill a
statutory requirement to seize an
obligor’s assets to satisfy overdue child
support payments.
OCSE also operates FAST Levy,
which is an automated application
within the FPLS to exchange electronic
lien/levy information securely and
efficiently. State child support
enforcement agencies and multistate
financial institutions (MSFIs) use FAST
Levy to seize financial assets more
quickly and efficiently.
Respondents: MSFIs and state child
support agencies.
ANNUAL BURDEN ESTIMATES
Annual
number of
responses per
respondent
Annual
number of
respondents
Instrument
Financial Data Match Record Specifications: Match File Upload/Download:
Portal Users .................................................................................................
Election Form ...................................................................................................
FAST Levy Response Withhold Record Specifications: Financial Institutions
FAST Levy Request Withhold Record Specifications: State Child Support
Agencies .......................................................................................................
Average
annual
burden hours
per response
Annual
burden hours
184
15
1
4
1
1
.083
.5
1,716
61.1
7.5
1,716.0
1
1
1,610
1,610.0
Estimated Total Annual Burden Hours: 3,394.6.
jbell on DSKJLSW7X2PROD with NOTICES
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
666(a)(17)(A), 42 U.S.C. 652(a)(7), and 45
CFR 303.7(a)(5).
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
John M. Sweet Jr.,
ACF/OPRE Certifying Officer.
Food and Drug Administration
[FR Doc. 2020–16891 Filed 8–3–20; 8:45 am]
International Drug Scheduling;
Convention on Psychotropic
Substances; Single Convention on
Narcotic Drugs; Isotonitazene; MDMB4en-PINACA; CUMYL-PEGACLONE;
Flubromazolam; Clonazolam;
Diclazepam; 3-MeO-PCP;
DIPHENIDINE; 2-MEO-DIPHENIDINE; 5MEO-DALT; and 3FLUOROPHENMETRAZINE (3-FPM);
Request for Comments
BILLING CODE 4184–41–P
AGENCY:
18:14 Aug 03, 2020
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Food and Drug Administration,
HHS.
ACTION:
Authority: 42 U.S.C. 652(l), 42 U.S.C.
666(a)(2) and (c)(1)(G)(ii), 42 U.S.C.
VerDate Sep<11>2014
[Docket No. FDA–2020–N–1680]
Notice; request for comments.
The Food and Drug
Administration (FDA or the Agency) is
requesting interested persons to submit
comments concerning abuse potential,
actual abuse, medical usefulness,
trafficking, and impact of scheduling
SUMMARY:
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Federal Register / Vol. 85, No. 150 / Tuesday, August 4, 2020 / Notices
changes on availability for medical use
of 11 drug substances. These comments
will be considered in preparing a
response from the United States to the
World Health Organization (WHO)
regarding the abuse liability and
diversion of these drugs. WHO will use
this information to consider whether to
recommend that certain international
restrictions be placed on these drug
substances. This notice requesting
comments is required by the Controlled
Substances Act (CSA).
DATES: Submit either electronic or
written comments by August 28, 2020.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before August 28,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of August 28, 2020.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
jbell on DSKJLSW7X2PROD with NOTICES
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
VerDate Sep<11>2014
18:14 Aug 03, 2020
Jkt 250001
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2020–N–1680 for ‘‘International Drug
Scheduling; Convention on
Psychotropic Substances; Single
Convention on Narcotic Drugs;
Isotonitazene; MDMB-4en-PINACA;
CUMYL-PEGACLONE; Flubromazolam;
Clonazolam; Diclazepam; 3-MeO-PCP;
DIPHENIDINE; 2-MEO-DIPHENIDINE;
5-MEO-DALT; and 3FLUOROPHENMETRAZINE (3-FPM);
Request for Comments.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
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Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
James R. Hunter, Center for Drug
Evaluation and Research, Controlled
Substance Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 5150, Silver Spring,
MD 20993–0002, 301–796–3156,
james.hunter@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The United States is a party to the
1971 Convention on Psychotropic
Substances (Psychotropic Convention).
Article 2 of the Psychotropic
Convention provides that if a party to
the convention or WHO has information
about a substance, which in its opinion
may require international control or
change in such control, it shall so notify
the Secretary-General of the United
Nations (the U.N. Secretary-General)
and provide the U.N. Secretary-General
with information in support of its
opinion.
Paragraph (d)(2)(A) of the CSA (21
U.S.C. 811) (Title II of the
Comprehensive Drug Abuse Prevention
and Control Act of 1970) provides that
when WHO notifies the United States
under Article 2 of the Psychotropic
Convention that it has information that
may justify adding a drug or other
substances to one of the schedules of the
Psychotropic Convention, transferring a
drug or substance from one schedule to
another, or deleting it from the
schedules, the Secretary of State must
transmit the notice to the Secretary of
Health and Human Services (Secretary
of HHS). The Secretary of HHS must
then publish the notice in the Federal
Register and provide opportunity for
interested persons to submit comments
that will be considered by HHS in its
preparation of the scientific and medical
evaluations of the drug or substance.
II. WHO Notification
The Secretary of HHS received the
following notice from WHO (nonrelevant text removed):
Ref.: C.L.22.2020
The World Health Organization (WHO)
presents its compliments to Member States
and Associate Members and in reference to
C.L.14.2019 has the pleasure of informing
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Federal Register / Vol. 85, No. 150 / Tuesday, August 4, 2020 / Notices
that the 43rd Expert Committee on Drug
Dependence (ECDD) will meet from 12 to 16
October 2020 in Geneva, Switzerland. In the
event that the meeting should be held
virtually due to exceptional circumstances,
corresponding arrangements will be made.
Given that ECDD meetings are of a closed
nature, this letter serves to notify Member
States of the substances under review at the
43rd ECDD, which are in the Annex I for
reference.
WHO is mandated by the 1961 and 1971
International Drug Control Conventions to
make recommendations to the UN SecretaryGeneral on the need for and level of
international control of psychoactive
substances based on the advice of its
independent scientific advisory body, the
ECDD. To assess the appropriate control of a
psychoactive substance, the ECDD convenes
annually to review the potential of this
substance to cause dependence, abuse and
harm to health, as well as any therapeutic
applications. In order to perform this review
and make scientific and evidence-based
decisions, the ECDD conducts medical,
scientific, and public health evaluations of
the selected psychoactive substances using
the best available information.
Although the meetings are of a closed
nature, Member States are invited to
contribute to the ECDD review process by
joining the 43rd ECDD Open Session on 12
October 2020. The Open Session will allow
interested parties to present information
concerning substances under review to the
Expert Committee. Registration information
will be made available on the ECDD website:
https://www.who.int/medicines/access/
controlled-substances/en/.
As in the past and in line with the
publication ‘‘Guidance on the WHO review of
psychoactive substances for international
control’’ (EB126/2010/REC1, Annex 6),1
Member States can also contribute to the
ECDD review process by providing accurate
information concerning the substances under
review in advance of the meeting. For this
purpose, a questionnaire will be sent to
Member States to gather country information
on the legitimate use, harmful use, status of
national control and potential impact of
international control for each substance
under evaluation.
In addition to the questionnaire, Member
States are also encouraged to provide any
additional relevant information (unpublished
or published) on substances to be reviewed
by the 43rd ECDD by emailing
ecddsecretariat@who.int with the subject
‘‘Ref: C.L.22.2020’’.
The World Health Organization takes this
opportunity to renew to Member States and
Associate Members the assurance of its
highest consideration.
GENEVA, 23 June 2020
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1 https://apps.who.int/gb/ebwha/pdf_files/
EB126-REC1/B126_REC1-en.pdf#page=58.
Annex I
43nd Expert Committee on Drug
Dependence (ECDD), 12–16 October
2020, Substances for Review
The substances listed below have
never been formally reviewed by WHO
VerDate Sep<11>2014
18:14 Aug 03, 2020
Jkt 250001
and are not currently under
international control. Information was
brought to WHO’s attention that these
substances are clandestinely
manufactured, of especially serious risk
to public health and society, and of no
recognized therapeutic use by any Party.
CRITICAL REVIEW
Synthetic Opioids ............
Synthetic Cannabinoid
Receptor Agonists.
Benzodiazepines ............
Dissociative-type substances.
Hallucinogen ...................
Synthetic Stimulant .........
1. Isotonitazene
2. MDMB-4en-PINACA
3. CUMYL-PEGALONE
4. Flubromazolam
5. Clonazolam
6. Diclazepam
7. 3-MeO-PCP
8. DIPHENIDINE
9. 2-MEO-DIPHENIDINE
10. 5-MEO-SALT
11. 3FLUROPHENMETRAZINE (3-FPM)
FDA has verified the website
addresses contained in the WHO notice,
as of the date this document publishes
in the Federal Register, but websites are
subject to change over time. Access to
view the WHO questionnaire can be
found at https://www.who.int/teams/
health-product-and-policy-standards/
controlled-substances/ecdd-memberstate-questionnaire.
III. Substances Under WHO Review
Isotonitazene (chemical name: N,Ndiethyl-2-(2-(4 isopropoxybenzyl)-5nitro-1H-benzimidazol-1-yl)ethan-1amine) is a potent synthetic opioid that
is abused similar to other synthetic
opioids. Its use has resulted in adverse
health effects, including positively
identified in 49 death investigation
cases in the United States between
August 2019 and April 2020. Law
enforcement data indicate that
isotonitazene has appeared in the
United States’ illicit drug market.
According to the National Forensic
Laboratory Information System (NFLIS)
database, there have been 53 encounters
of isotonitazene in the United States (as
of June 2020). There are no commercial
or approved medical uses for
isotonitazene. On June 18, 2020, the
Drug Enforcement Administration
issued a notice of intent to temporarily
control isotonitazene as a schedule I
substance under the CSA.
MDMB-4en-PINACA is a synthetic
cannabinoid that has been sold online
and used to mimic the biological effects
of tetrahydrocannabinol (THC), the
main psychoactive constituent in
marijuana. Research and clinical reports
have demonstrated that synthetic
cannabinoids are applied onto plant
material so that the material may be
smoked as users attempt to obtain a
euphoric and psychoactive ‘‘high’’.
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47219
Synthetic cannabinoids have been
marketed under the guise of ‘‘herbal
incense,’’ and promoted by drug
traffickers as legal alternatives to
marijuana. According to the NFLIS
database, MDMB-4en-PINACA was first
encountered in the United States in
January 2019. There have been 1,436
encounters of MDMB-4en-PINACA in
the United States (as of July 6, 2020).
MDMB-4en-PINACA has also been
encountered mixed with opioids
including heroin and fentanyl, with
some incidents resulting in violent
behaviors, tachycardia, and
hypertension. There are no commercial
or approved medical uses for MDMB4en-PINACA and MDMB-4en-PINACA
is not a controlled substance under the
CSA.
CUMYL-PEGACLONE is a synthetic
cannabinoid that has been sold online
and used to mimic the biological effects
of THC, the main psychoactive
constituent in marijuana. Research and
clinical reports have demonstrated that
synthetic cannabinoids are applied onto
plant material so that the material may
be smoked as users attempt to obtain a
euphoric and psychoactive ‘‘high’’.
Synthetic cannabinoids have been
marketed under the guise of ‘‘herbal
incense,’’ and promoted by drug
traffickers as legal alternatives to
marijuana. In vitro studies demonstrate
that CUMYL-PEGALCONE binds to and
activates the cannabinoid one receptor.
CUMYL-PEGALCONE has not been
encountered within the United States
according to the NFLIS database (as of
July 6, 2020). There are no commercial
or approved medical uses for CUMYLPEGALCONE and is not a controlled
substance under the CSA.
Flubromazolam, clonazolam, and
diclazepam belong to a class of
substances known as benzodiazepines.
Benzodiazepines produce central
nervous system depression and are
commonly used to treat insomnia,
anxiety, and seizure disorders.
Flubromazolam is a triazole analogue of
the designer benzodiazepine,
flubromazepam. Flubromazolam can be
purchased on the internet and is used as
a recreational substance in the United
States. Flubromazolam has been
identified in an increasing number of
law enforcement seizures and has been
associated with an increasing number of
drug overdose deaths. It is abused by a
broad range of groups including youths,
young adults, and older adults.
Clonazolam has been involved in an
increasing number of drug seizure
events as well as drug overdose deaths,
alone and in combination with alcohol.
Diclazepam is a designer
benzodiazepine sold on the internet and
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most often found as a liquid solution,
but it may be sold as a powder, tablet,
blotter paper, or pellet. In 2018,
flubromazolam, clonazolam, and
dicalazepam were all identified by law
enforcement in driving under the
influence of drugs cases in the United
States. Flubromazolam, clonazolam, and
diclazepam are not approved for
medical use in the United States and are
not controlled substances under the
CSA.
3-MeO-PCP (3methoxyphencyclidine; chemical name:
1-(1-(3methoxyphenyl)cyclohexyl)piperidine)
is a novel N-methyl-D-aspartate (NMDA)
receptor antagonist with structural and
biochemical similarities to
phencyclcycidine (PCP) and other
arylcyclohexylamines. 3-MeO-PCP is
classified as an arylcyclohexylamine
and produces dissociative anesthetic
and hallucinogenic effects. Use of this
substance is associated with
intoxication and published case reports
of both fatal and non-fatal overdose. 3MeO-PCP is encountered by law
enforcement in drug seizure reports. 3MeO-PCP is an analogue of the
Schedule II hallucinogen PCP. There is
no approved medical use for 3-MeOPCP in the United States. 3-MeO-PCP is
not a controlled substance under the
CSA. If intended for human
consumption, 3-MeO-PCP may be
treated as a ‘‘controlled substance
analogue’’ under the CSA pursuant to 21
U.S.C 802(32) (A) and 813.
DIPHENIDINE (chemical name: 1-(1,2diphenylethyl) piperidine) is a noncompetitive NMDA receptor antagonist
classified as a diarylethylamine and
produces dissociative anesthetic and
hallucinogenic effects. It was originally
synthesized in the 1920s, but reports of
abuse started in the last decade. Use of
this substance is associated with
intoxication and published case reports
of both fatal and non-fatal overdose
outside of the United States.
DIPHENIDINE is encountered by law
enforcement in drug seizure reports.
DIPHENIDINE is not approved for
medical use in the United States and is
not a controlled substance under the
CSA.
2-MeO-DIPHENIDINE (2-methoxydiphenidine, methoxphenidine) is a
non-competitive NMDA receptor
antagonist classified as a
diarylethylamine and produces
dissociative anesthetic and
hallucinogenic effects that may produce
effects similar to high doses of
dextromethorphan. Use of this
substance is associated with
intoxication and non-fatal overdose in
published case reports outside the
VerDate Sep<11>2014
18:14 Aug 03, 2020
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United States. 2-MeO-DIPHENIDINE is
encountered by law enforcement in drug
seizure reports. There is no approved
medical use for 2-MeO-DIPHENIDINE in
the United States and 2-MeODIPHENIDINE is not a controlled
substance under the CSA.
5-MeO-DALT (chemical name: N,NDiallyl-5-methoxytryptamine) is a
tryptamine hallucinogen and is an
agonist of the serotonin (5–HT) 5–HT2A
receptor. 5-MeO-DALT appears to
produce hallucinogenic effects similar
to other tryptamine hallucinogens and
fully substituted for 2,5-dimethoxy-4methylamphetamine (DOM) in DOMtrained rats. 5-MeO-DALT is an
analogue of the Schedule I controlled
substance 5methoxy-N,Ndiisopropyltryptamine (5-MeO-DiPT). 5MeO-DALT has been encountered by
law enforcement in drug seizure reports.
5-MeO-DALT is not approved for
medical use in the United States and is
not controlled under the CSA.
3-FLUOROPHENMETRAZINE (3FPM) (chemical name: 1-(3fluorophenyl)-2-(methylamino)propan1-one) shares substantial chemical
structural similarity to phenmetrazine, a
Schedule II controlled substance that
was prescribed as an appetite
suppressant before being withdrawn
from the pharmaceutical drug market in
the United States because of its abuse
potential. 3-FPM, which is similar to
phenmetrazine and other stimulant
drugs of abuse, increases extracellular
concentrations of the neurotransmitter
dopamine by inhibiting the uptake of
this neurotransmitter at the dopamine
transporter. Elevated extracellular
dopamine concentrations have been
implicated in the mechanism of action
of stimulant drugs of abuse. There is no
approved medical use for 3-FPM in the
United States and 3-FPM is not a
controlled substance under the CSA.
IV. Opportunity To Submit Domestic
Information
As required by paragraph (d)(2)(A) of
the CSA, FDA, on behalf of HHS, invites
interested persons to submit comments
regarding the 11 drug substances. Any
comments received will be considered
by HHS when it prepares a scientific
and medical evaluation for drug
substances that is responsive to the
WHO Questionnaire for these drug
substances. HHS will forward such
evaluation of these drug substances to
WHO, for WHO’s consideration in
deciding whether to recommend
international control/decontrol of any of
these drug substances. Such control
could limit, among other things, the
manufacture and distribution (import/
export) of these drug substances and
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could impose certain recordkeeping
requirements on them.
Although FDA is, through this notice,
requesting comments from interested
persons, which will be considered by
HHS when it prepares an evaluation of
these drug substances, HHS will not
now make any recommendations to
WHO regarding whether any of these
drugs should be subjected to
international controls. Instead, HHS will
defer such consideration until WHO has
made official recommendations to the
Commission on Narcotic Drugs, which
are expected to be made in late-2020.
Any HHS position regarding
international control of these drug
substances will be preceded by another
Federal Register notice soliciting public
comments, as required by paragraph
(d)(2)(B) of the CSA.
Dated: July 29, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–16905 Filed 8–3–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–3560]
Biosimilar User Fee Rates for Fiscal
Year 2021
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
rates for biosimilar user fees for fiscal
year (FY) 2021. The Federal Food, Drug,
and Cosmetic Act (FD&C Act), as
amended by the Biosimilar User Fee
Amendments of 2017 (BsUFA II),
authorizes FDA to assess and collect
user fees for certain activities in
connection with biosimilar biological
product development; review of certain
applications for approval of biosimilar
biological products; and each biosimilar
biological product approved in a
biosimilar biological product
application. BsUFA II directs FDA to
establish, before the beginning of each
fiscal year, the amount of initial and
annual biosimilar biological product
development (BPD) fees, the
reactivation fee, and the biosimilar
biological product application and
program fees for such year. These fees
apply to the period from October 1,
2020, through September 30, 2021.
FOR FURTHER INFORMATION CONTACT:
Andrew Bank, Office of Financial
SUMMARY:
E:\FR\FM\04AUN1.SGM
04AUN1
]]>Agencies
[Federal Register Volume 85, Number 150 (Tuesday, August 4, 2020)]
[Notices]
[Pages 47217-47220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16905]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1680]
International Drug Scheduling; Convention on Psychotropic
Substances; Single Convention on Narcotic Drugs; Isotonitazene; MDMB-
4en-PINACA; CUMYL-PEGACLONE; Flubromazolam; Clonazolam; Diclazepam; 3-
MeO-PCP; DIPHENIDINE; 2-MEO-DIPHENIDINE; 5-MEO-DALT; and 3-
FLUOROPHENMETRAZINE (3-FPM); Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
requesting interested persons to submit comments concerning abuse
potential, actual abuse, medical usefulness, trafficking, and impact of
scheduling
[[Page 47218]]
changes on availability for medical use of 11 drug substances. These
comments will be considered in preparing a response from the United
States to the World Health Organization (WHO) regarding the abuse
liability and diversion of these drugs. WHO will use this information
to consider whether to recommend that certain international
restrictions be placed on these drug substances. This notice requesting
comments is required by the Controlled Substances Act (CSA).
DATES: Submit either electronic or written comments by August 28, 2020.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before August 28, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 28, 2020. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2020-N-1680 for ``International Drug Scheduling; Convention on
Psychotropic Substances; Single Convention on Narcotic Drugs;
Isotonitazene; MDMB-4en-PINACA; CUMYL-PEGACLONE; Flubromazolam;
Clonazolam; Diclazepam; 3-MeO-PCP; DIPHENIDINE; 2-MEO-DIPHENIDINE; 5-
MEO-DALT; and 3-FLUOROPHENMETRAZINE (3-FPM); Request for Comments.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: James R. Hunter, Center for Drug
Evaluation and Research, Controlled Substance Staff, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5150, Silver
Spring, MD 20993-0002, 301-796-3156, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
The United States is a party to the 1971 Convention on Psychotropic
Substances (Psychotropic Convention). Article 2 of the Psychotropic
Convention provides that if a party to the convention or WHO has
information about a substance, which in its opinion may require
international control or change in such control, it shall so notify the
Secretary-General of the United Nations (the U.N. Secretary-General)
and provide the U.N. Secretary-General with information in support of
its opinion.
Paragraph (d)(2)(A) of the CSA (21 U.S.C. 811) (Title II of the
Comprehensive Drug Abuse Prevention and Control Act of 1970) provides
that when WHO notifies the United States under Article 2 of the
Psychotropic Convention that it has information that may justify adding
a drug or other substances to one of the schedules of the Psychotropic
Convention, transferring a drug or substance from one schedule to
another, or deleting it from the schedules, the Secretary of State must
transmit the notice to the Secretary of Health and Human Services
(Secretary of HHS). The Secretary of HHS must then publish the notice
in the Federal Register and provide opportunity for interested persons
to submit comments that will be considered by HHS in its preparation of
the scientific and medical evaluations of the drug or substance.
II. WHO Notification
The Secretary of HHS received the following notice from WHO (non-
relevant text removed):
Ref.: C.L.22.2020
The World Health Organization (WHO) presents its compliments to
Member States and Associate Members and in reference to C.L.14.2019
has the pleasure of informing
[[Page 47219]]
that the 43rd Expert Committee on Drug Dependence (ECDD) will meet
from 12 to 16 October 2020 in Geneva, Switzerland. In the event that
the meeting should be held virtually due to exceptional
circumstances, corresponding arrangements will be made. Given that
ECDD meetings are of a closed nature, this letter serves to notify
Member States of the substances under review at the 43rd ECDD, which
are in the Annex I for reference.
WHO is mandated by the 1961 and 1971 International Drug Control
Conventions to make recommendations to the UN Secretary-General on
the need for and level of international control of psychoactive
substances based on the advice of its independent scientific
advisory body, the ECDD. To assess the appropriate control of a
psychoactive substance, the ECDD convenes annually to review the
potential of this substance to cause dependence, abuse and harm to
health, as well as any therapeutic applications. In order to perform
this review and make scientific and evidence-based decisions, the
ECDD conducts medical, scientific, and public health evaluations of
the selected psychoactive substances using the best available
information.
Although the meetings are of a closed nature, Member States are
invited to contribute to the ECDD review process by joining the 43rd
ECDD Open Session on 12 October 2020. The Open Session will allow
interested parties to present information concerning substances
under review to the Expert Committee. Registration information will
be made available on the ECDD website: https://www.who.int/medicines/access/controlled-substances/en/.
As in the past and in line with the publication ``Guidance on
the WHO review of psychoactive substances for international
control'' (EB126/2010/REC1, Annex 6),\1\ Member States can also
contribute to the ECDD review process by providing accurate
information concerning the substances under review in advance of the
meeting. For this purpose, a questionnaire will be sent to Member
States to gather country information on the legitimate use, harmful
use, status of national control and potential impact of
international control for each substance under evaluation.
In addition to the questionnaire, Member States are also
encouraged to provide any additional relevant information
(unpublished or published) on substances to be reviewed by the 43rd
ECDD by emailing [email protected] with the subject ``Ref:
C.L.22.2020''.
The World Health Organization takes this opportunity to renew to
Member States and Associate Members the assurance of its highest
consideration.
GENEVA, 23 June 2020
\1\ https://apps.who.int/gb/ebwha/pdf_files/EB126-REC1/B126_REC1-en.pdf#page=58.
Annex I
43nd Expert Committee on Drug Dependence (ECDD), 12-16 October 2020,
Substances for Review
The substances listed below have never been formally reviewed by
WHO and are not currently under international control. Information was
brought to WHO's attention that these substances are clandestinely
manufactured, of especially serious risk to public health and society,
and of no recognized therapeutic use by any Party.
Critical Review
------------------------------------------------------------------------
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Synthetic Opioids......................... 1. Isotonitazene
Synthetic Cannabinoid Receptor Agonists... 2. MDMB-4en-PINACA
3. CUMYL-PEGALONE
Benzodiazepines........................... 4. Flubromazolam
5. Clonazolam
6. Diclazepam
Dissociative-type substances.............. 7. 3-MeO-PCP
8. DIPHENIDINE
9. 2-MEO-DIPHENIDINE
Hallucinogen.............................. 10. 5-MEO-SALT
Synthetic Stimulant....................... 11. 3-FLUROPHENMETRAZINE (3-
FPM)
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FDA has verified the website addresses contained in the WHO notice,
as of the date this document publishes in the Federal Register, but
websites are subject to change over time. Access to view the WHO
questionnaire can be found at https://www.who.int/teams/health-product-and-policy-standards/controlled-substances/ecdd-member-state-questionnaire.
III. Substances Under WHO Review
Isotonitazene (chemical name: N,N-diethyl-2-(2-(4
isopropoxybenzyl)-5-nitro-1H-benzimidazol-1-yl)ethan-1-amine) is a
potent synthetic opioid that is abused similar to other synthetic
opioids. Its use has resulted in adverse health effects, including
positively identified in 49 death investigation cases in the United
States between August 2019 and April 2020. Law enforcement data
indicate that isotonitazene has appeared in the United States' illicit
drug market. According to the National Forensic Laboratory Information
System (NFLIS) database, there have been 53 encounters of isotonitazene
in the United States (as of June 2020). There are no commercial or
approved medical uses for isotonitazene. On June 18, 2020, the Drug
Enforcement Administration issued a notice of intent to temporarily
control isotonitazene as a schedule I substance under the CSA.
MDMB-4en-PINACA is a synthetic cannabinoid that has been sold
online and used to mimic the biological effects of tetrahydrocannabinol
(THC), the main psychoactive constituent in marijuana. Research and
clinical reports have demonstrated that synthetic cannabinoids are
applied onto plant material so that the material may be smoked as users
attempt to obtain a euphoric and psychoactive ``high''. Synthetic
cannabinoids have been marketed under the guise of ``herbal incense,''
and promoted by drug traffickers as legal alternatives to marijuana.
According to the NFLIS database, MDMB-4en-PINACA was first encountered
in the United States in January 2019. There have been 1,436 encounters
of MDMB-4en-PINACA in the United States (as of July 6, 2020). MDMB-4en-
PINACA has also been encountered mixed with opioids including heroin
and fentanyl, with some incidents resulting in violent behaviors,
tachycardia, and hypertension. There are no commercial or approved
medical uses for MDMB-4en-PINACA and MDMB-4en-PINACA is not a
controlled substance under the CSA.
CUMYL-PEGACLONE is a synthetic cannabinoid that has been sold
online and used to mimic the biological effects of THC, the main
psychoactive constituent in marijuana. Research and clinical reports
have demonstrated that synthetic cannabinoids are applied onto plant
material so that the material may be smoked as users attempt to obtain
a euphoric and psychoactive ``high''. Synthetic cannabinoids have been
marketed under the guise of ``herbal incense,'' and promoted by drug
traffickers as legal alternatives to marijuana. In vitro studies
demonstrate that CUMYL-PEGALCONE binds to and activates the cannabinoid
one receptor. CUMYL-PEGALCONE has not been encountered within the
United States according to the NFLIS database (as of July 6, 2020).
There are no commercial or approved medical uses for CUMYL-PEGALCONE
and is not a controlled substance under the CSA.
Flubromazolam, clonazolam, and diclazepam belong to a class of
substances known as benzodiazepines. Benzodiazepines produce central
nervous system depression and are commonly used to treat insomnia,
anxiety, and seizure disorders. Flubromazolam is a triazole analogue of
the designer benzodiazepine, flubromazepam. Flubromazolam can be
purchased on the internet and is used as a recreational substance in
the United States. Flubromazolam has been identified in an increasing
number of law enforcement seizures and has been associated with an
increasing number of drug overdose deaths. It is abused by a broad
range of groups including youths, young adults, and older adults.
Clonazolam has been involved in an increasing number of drug seizure
events as well as drug overdose deaths, alone and in combination with
alcohol. Diclazepam is a designer benzodiazepine sold on the internet
and
[[Page 47220]]
most often found as a liquid solution, but it may be sold as a powder,
tablet, blotter paper, or pellet. In 2018, flubromazolam, clonazolam,
and dicalazepam were all identified by law enforcement in driving under
the influence of drugs cases in the United States. Flubromazolam,
clonazolam, and diclazepam are not approved for medical use in the
United States and are not controlled substances under the CSA.
3-MeO-PCP (3-methoxyphencyclidine; chemical name: 1-(1-(3-
methoxyphenyl)cyclohexyl)piperidine) is a novel N-methyl-D-aspartate
(NMDA) receptor antagonist with structural and biochemical similarities
to phencyclcycidine (PCP) and other arylcyclohexylamines. 3-MeO-PCP is
classified as an arylcyclohexylamine and produces dissociative
anesthetic and hallucinogenic effects. Use of this substance is
associated with intoxication and published case reports of both fatal
and non-fatal overdose. 3-MeO-PCP is encountered by law enforcement in
drug seizure reports. 3-MeO-PCP is an analogue of the Schedule II
hallucinogen PCP. There is no approved medical use for 3-MeO-PCP in the
United States. 3-MeO-PCP is not a controlled substance under the CSA.
If intended for human consumption, 3-MeO-PCP may be treated as a
``controlled substance analogue'' under the CSA pursuant to 21 U.S.C
802(32) (A) and 813.
DIPHENIDINE (chemical name: 1-(1,2-diphenylethyl) piperidine) is a
non-competitive NMDA receptor antagonist classified as a
diarylethylamine and produces dissociative anesthetic and
hallucinogenic effects. It was originally synthesized in the 1920s, but
reports of abuse started in the last decade. Use of this substance is
associated with intoxication and published case reports of both fatal
and non-fatal overdose outside of the United States. DIPHENIDINE is
encountered by law enforcement in drug seizure reports. DIPHENIDINE is
not approved for medical use in the United States and is not a
controlled substance under the CSA.
2-MeO-DIPHENIDINE (2-methoxy-diphenidine, methoxphenidine) is a
non-competitive NMDA receptor antagonist classified as a
diarylethylamine and produces dissociative anesthetic and
hallucinogenic effects that may produce effects similar to high doses
of dextromethorphan. Use of this substance is associated with
intoxication and non-fatal overdose in published case reports outside
the United States. 2-MeO-DIPHENIDINE is encountered by law enforcement
in drug seizure reports. There is no approved medical use for 2-MeO-
DIPHENIDINE in the United States and 2-MeO-DIPHENIDINE is not a
controlled substance under the CSA.
5-MeO-DALT (chemical name: N,N-Diallyl-5-methoxytryptamine) is a
tryptamine hallucinogen and is an agonist of the serotonin (5-HT) 5-
HT2A receptor. 5-MeO-DALT appears to produce hallucinogenic
effects similar to other tryptamine hallucinogens and fully substituted
for 2,5-dimethoxy-4-methylamphetamine (DOM) in DOM-trained rats. 5-MeO-
DALT is an analogue of the Schedule I controlled substance 5methoxy-
N,N-diisopropyltryptamine (5-MeO-DiPT). 5-MeO-DALT has been encountered
by law enforcement in drug seizure reports. 5-MeO-DALT is not approved
for medical use in the United States and is not controlled under the
CSA.
3-FLUOROPHENMETRAZINE (3-FPM) (chemical name: 1-(3-fluorophenyl)-2-
(methylamino)propan-1-one) shares substantial chemical structural
similarity to phenmetrazine, a Schedule II controlled substance that
was prescribed as an appetite suppressant before being withdrawn from
the pharmaceutical drug market in the United States because of its
abuse potential. 3-FPM, which is similar to phenmetrazine and other
stimulant drugs of abuse, increases extracellular concentrations of the
neurotransmitter dopamine by inhibiting the uptake of this
neurotransmitter at the dopamine transporter. Elevated extracellular
dopamine concentrations have been implicated in the mechanism of action
of stimulant drugs of abuse. There is no approved medical use for 3-FPM
in the United States and 3-FPM is not a controlled substance under the
CSA.
IV. Opportunity To Submit Domestic Information
As required by paragraph (d)(2)(A) of the CSA, FDA, on behalf of
HHS, invites interested persons to submit comments regarding the 11
drug substances. Any comments received will be considered by HHS when
it prepares a scientific and medical evaluation for drug substances
that is responsive to the WHO Questionnaire for these drug substances.
HHS will forward such evaluation of these drug substances to WHO, for
WHO's consideration in deciding whether to recommend international
control/decontrol of any of these drug substances. Such control could
limit, among other things, the manufacture and distribution (import/
export) of these drug substances and could impose certain recordkeeping
requirements on them.
Although FDA is, through this notice, requesting comments from
interested persons, which will be considered by HHS when it prepares an
evaluation of these drug substances, HHS will not now make any
recommendations to WHO regarding whether any of these drugs should be
subjected to international controls. Instead, HHS will defer such
consideration until WHO has made official recommendations to the
Commission on Narcotic Drugs, which are expected to be made in late-
2020. Any HHS position regarding international control of these drug
substances will be preceded by another Federal Register notice
soliciting public comments, as required by paragraph (d)(2)(B) of the
CSA.
Dated: July 29, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-16905 Filed 8-3-20; 8:45 am]
BILLING CODE 4164-01-P
