Importer of Controlled Substances Application: Scottsdale Research Institute, 20738-20739 [2021-08162]
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Federal Register / Vol. 86, No. 75 / Wednesday, April 21, 2021 / Notices
Drug
code
Controlled substance
Etorphine HCl ..........................................................................................................................................................................
Dihydrocodeine ........................................................................................................................................................................
Diphenoxylate ..........................................................................................................................................................................
Ecgonine ..................................................................................................................................................................................
Ethylmorphine ..........................................................................................................................................................................
Levomethorphan ......................................................................................................................................................................
Levorphanol .............................................................................................................................................................................
Isomethadone ..........................................................................................................................................................................
Meperidine ...............................................................................................................................................................................
Meperidine intermediate–A ......................................................................................................................................................
Meperidine intermediate–B ......................................................................................................................................................
Meperidine intermediate–C .....................................................................................................................................................
Metazocine ..............................................................................................................................................................................
Oliceridine (N-[(3-methoxythiophen-2yl)methyl] ({2-[9r)-9-(pyridin-2-yl)-6-oxaspiro [4.5]decan-9-yl]ethyl{time})amine fumarate).
Metopon ...................................................................................................................................................................................
Dextropropoxyphene, bulk (non-dosage forms) ......................................................................................................................
Dihydroetorphine .....................................................................................................................................................................
Opium tincture .........................................................................................................................................................................
Opium, powdered ....................................................................................................................................................................
Opium, granulated ...................................................................................................................................................................
Noroxymorphone .....................................................................................................................................................................
Phenazocine ............................................................................................................................................................................
Thiafentanil ..............................................................................................................................................................................
Piminodine ...............................................................................................................................................................................
Racemethorphan .....................................................................................................................................................................
Racemorphan ..........................................................................................................................................................................
Alfentanil ..................................................................................................................................................................................
Remifentanil .............................................................................................................................................................................
Sufentanil .................................................................................................................................................................................
Carfentanil ...............................................................................................................................................................................
Tapentadol ...............................................................................................................................................................................
Bezitramide ..............................................................................................................................................................................
Moramide-intermediate ............................................................................................................................................................
The company plans to import small
quantities of the listed controlled
substances for the National Institute on
Drug Abuse for research activities. The
company plans to import analytical
reference standards for distribution to
its customers for research and analytical
purposes.
Approval of permit applications will
occur only when the registrant’s
business activity is consistent with what
is authorized under 21 U.S.C. 952(a)(2).
Authorization will not extend to the
import of Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021–08166 Filed 4–20–21; 8:45 am]
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18:12 Apr 20, 2021
Jkt 253001
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–822]
Importer of Controlled Substances
Application: Scottsdale Research
Institute
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Scottsdale Research Institute
has applied to be registered as an
importer of basic class(es) of controlled
substance(s). Refer to SUPPLEMENTAL
INFORMATION listed below for further
drug information.
DATES: Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before May 21, 2021. Such persons
may also file a written request for a
hearing on the application on or before
May 21, 2021.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
SUMMARY:
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9245
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22152. All requests for a hearing must
be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for a
hearing should also be sent to: (1) Drug
Enforcement Administration, Attn:
Hearing Clerk/OALJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/DPW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on January 28, 2021,
Scottsdale Research Institute, 5436 East
Tapekim Road, Cave Creek, Arizona
85331, applied to be registered as an
importer of the following basic class(es)
of controlled substance(s):
Controlled substance
Marihuana ........................
Tetrahydrocannabinols ....
Psilocybin ........................
Psilocyn ...........................
Drug
code
Schedule
7360
7370
7437
7438
I
I
I
I
The company plans to import
Marijuana (7360) and
Tetrahydrocannabinols (7370) as
E:\FR\FM\21APN1.SGM
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Federal Register / Vol. 86, No. 75 / Wednesday, April 21, 2021 / Notices
flowering plants to support analytical
purposes, research, and the
manufacturing of dosage forms for
clinical trials. This notice does not
constitute an evaluation or
determination of the merits of the
company’s application.
The company plans to import fungi
material from which Psilocybin (7437)
and Psilocyn (7438) will be produced
for further manufacturing prior to use in
research and clinical trials. No other
activity for these drug codes is
authorized for this registration.
Approval of permit applications will
occur only when the registrant’s
business activity is consistent with what
is authorized under 21 U.S.C. 952(a)(2).
Authorization will not extend to the
import of Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021–08162 Filed 4–20–21; 8:45 am]
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DEPARTMENT OF JUSTICE
[CPCLO Order No. 001–2021]
Privacy Act of 1974; Systems of
Records
Justice Management Division,
United States Department of Justice.
ACTION: Notice of a new system of
records.
AGENCY:
Pursuant to the Privacy Act of
1974 and Office of Management and
Budget (OMB) Circular No. A–108,
notice is hereby given that the Justice
Management Division, (JMD), a
component within the United States
Department of Justice (DOJ or ‘‘the
Department’’), proposes to develop a
new system of records notice titled,
‘‘DOJ Personnel Public Health
Emergency Records System,’’ JUSTICE/
JMD–025. JMD proposes to establish this
system of records to protect the
Department’s workforce and respond to
Coronavirus Disease 2019 (COVID–19),
a declared public health emergency, and
other high-consequence public health
threats.
DATES: In accordance with 5 U.S.C.
552a(e)(4) and (11), this notice is
effective upon publication, subject to a
30-day period in which to comment on
the routine uses, described below.
Please submit any comments by May 21,
2021.
ADDRESSES: The public, OMB, and
Congress are invited to submit any
comments by mail to the United States
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
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18:12 Apr 20, 2021
Jkt 253001
Department of Justice, Office of Privacy
and Civil Liberties, ATTN: Privacy
Analyst, Two Constitution Square
(2CON), 145 N Street, NE, Suite 8W.300,
Washington, DC 20530; by facsimile at
202–307–0693; or by email at
privacy.compliance@usdoj.gov. To
ensure proper handling, please
reference the above CPCLO Order No.
on your correspondence.
FOR FURTHER INFORMATION CONTACT:
Michael H. Allen, Deputy Assistant
Attorney General, Policy, Management,
and Procurement, 950 Pennsylvania
Avenue NW, Washington, DC 20530–
0001, (202) 514–3101.
SUPPLEMENTARY INFORMATION: This
system of records covers information
necessary and relevant to Department
activities responding to and mitigating
COVID–19 and other high-consequence
public health threats, and diseases or
illnesses relating to a public health
emergency. Such information may
include information on Department
personnel, including employees,
interns, and contractors, who have
contracted or may have been exposed to
a suspected or confirmed disease or
illness that is the subject of a declared
public health emergency or who
undergo preventative testing for, or
receive a vaccination to prevent, a
disease or illness that is the subject of
a declared public health emergency, in
accordance with federal, state, or local
public health orders. The information
collected may include identifying and
contact information of individuals who
have been suspected or confirmed to
have contracted a disease or illness, or
who have been exposed to an individual
who had been suspected or confirmed to
have contracted a disease or illness,
related to a declared public health
emergency; individual circumstances
and dates of suspected exposure; testing
results, symptoms, and treatments;
vaccination records; health status
information; and other information
necessary and relevant to Department
activities responding to and mitigating
COVID–19 and other high-consequence
public health threats and diseases or
illnesses relating to a public health
emergency. The Department maintains
this information to understand the
impact of an illness or disease on the
Department workforce, and to assist in
reducing the spread of the disease or
illness among Department personnel. In
certain instances, depending on the type
of record collected and maintained,
records maintained in this system of
records may also be covered by Office
of Personnel Management/Government10 Employee Medical File System
Records, 75 FR 35,099 (June 21, 2010).
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However, JUSTICE/JMD–025 covers
additional records—specifically records
collected in response to COVID–19, a
high-consequence public health threat,
as well as other declared public health
emergencies.
When collecting information on
Department employees, there are several
employment laws that govern the
collection, dissemination, and retention
of employee medical information. These
employment laws include the
Americans with Disability Act (ADA),
the Rehabilitation Act of 1973 (Rehab
Act), and the Occupational Safety and
Health Act of 1970 (OSH Act).
Generally, under federal employment
laws, medical information pertaining to
employees is confidential and may be
obtained by an employer only for
certain reasons and only at certain
points in the employment relationship.
In response to a high-consequence
public health threat such as COVID–19,
or relating to other public health
emergencies, an employer may be
permitted to collect certain employee
medical information that it would not
otherwise be permitted to collect,
depending upon the circumstances.
This system of records will apply if it
is determined that the circumstances
permit the Department to legally collect
the employee medical information at
issue.
Further, this system of records notice
(SORN) includes a reference to the
Genetic Information Nondiscrimination
Act of 2008 (GINA), 42 U.S.C. 2000ff to
ff-11. Title II of GINA prohibits
employment discrimination based on
genetic information, including family
medical history; restricts the
circumstances under which employers
may lawfully acquire applicants’ and
employees’ genetic information; and
prohibits the disclosure of applicants’
and employees’ genetic information,
with limited exceptions, including those
stated in 42 U.S.C. 2000ff–5(b) and 29
CFR 1635.9(b). The Department may
request the circumstances of an
individual’s suspected or actual
exposure to a disease or illness,
including the source of exposure.
Although it is not the intent for the
Department to collect family medical
information, an individual may indicate
that they were exposed to specific
family members who have been
diagnosed with, or are suspected to
have, the disease or illness in question.
To the extent this information may be
acquired inadvertently, such
information will be kept as a
‘‘confidential medical record’’ and
maintained separately from an
employee’s general medical files,
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]]>Agencies
[Federal Register Volume 86, Number 75 (Wednesday, April 21, 2021)]
[Notices]
[Pages 20738-20739]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08162]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-822]
Importer of Controlled Substances Application: Scottsdale
Research Institute
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Scottsdale Research Institute has applied to be registered as
an importer of basic class(es) of controlled substance(s). Refer to
Supplemental Information listed below for further drug information.
DATES: Registered bulk manufacturers of the affected basic class(es),
and applicants therefore, may file written comments on or objections to
the issuance of the proposed registration on or before May 21, 2021.
Such persons may also file a written request for a hearing on the
application on or before May 21, 2021.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DPW,
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a
hearing must be sent to: Drug Enforcement Administration, Attn:
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All
requests for a hearing should also be sent to: (1) Drug Enforcement
Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive,
Springfield, Virginia 22152; and (2) Drug Enforcement Administration,
Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive,
Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this
is notice that on January 28, 2021, Scottsdale Research Institute, 5436
East Tapekim Road, Cave Creek, Arizona 85331, applied to be registered
as an importer of the following basic class(es) of controlled
substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Marihuana............................... 7360 I
Tetrahydrocannabinols................... 7370 I
Psilocybin.............................. 7437 I
Psilocyn................................ 7438 I
------------------------------------------------------------------------
The company plans to import Marijuana (7360) and
Tetrahydrocannabinols (7370) as
[[Page 20739]]
flowering plants to support analytical purposes, research, and the
manufacturing of dosage forms for clinical trials. This notice does not
constitute an evaluation or determination of the merits of the
company's application.
The company plans to import fungi material from which Psilocybin
(7437) and Psilocyn (7438) will be produced for further manufacturing
prior to use in research and clinical trials. No other activity for
these drug codes is authorized for this registration.
Approval of permit applications will occur only when the
registrant's business activity is consistent with what is authorized
under 21 U.S.C. 952(a)(2). Authorization will not extend to the import
of Food and Drug Administration-approved or non-approved finished
dosage forms for commercial sale.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-08162 Filed 4-20-21; 8:45 am]
BILLING CODE P
