Importer of Controlled Substances Application: Mylan Pharmaceuticals Inc., 21269 [2020-08001]
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Federal Register / Vol. 85, No. 74 / Thursday, April 16, 2020 / Notices
of the requested registration, as
provided in this notice. This notice does
not constitute any evaluation or
determination of the merits of the
application submitted.
The applicant plans to manufacture
bulk active pharmaceutical ingredients
(APIs) for product development and
distribution to DEA registered
researchers. If the application for
registration is granted, the registrant
would not be authorized to conduct
other activity under this registration
aside from those coincident activities
specifically authorized by DEA
regulations. DEA will evaluate the
application for registration as a bulk
manufacturer for compliance with all
applicable laws, treaties, and
regulations and to ensure adequate
safeguards against diversion are in
place.
As this applicant has applied to
become registered as a bulk
manufacturer of marihuana, the
application will be evaluated under the
criteria of 21 U.S.C. 823(a). DEA
proposes to conduct this evaluation in
the manner described in the rule
proposed at 85 FR 16292, published on
March 23, 2020, if finalized.
In accordance with 21 CFR
1301.33(a), DEA is providing notice that
on March 2, 2020, Denco, LLC, 5155
East 46th Avenue, Denver, Colorado
80216, applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substances:
Controlled
substance
jbell on DSKJLSW7X2PROD with NOTICES
Marihuana .................
Tetrahydrocannabinols.
Drug
code
Schedule
7360
7370
DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[OMB Number 1121–0094]
[Docket No. DEA–629]
Importer of Controlled Substances
Application: Mylan Pharmaceuticals
Inc.
ACTION:
Notice of application.
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.
ADDRESSES:
In
accordance with 21 CFR 1301.34(a), this
is notice that on March 31, 2020, Mylan
Pharmaceuticals Inc., 2898
Manufacturers Road, Greensboro, North
Carolina 27406, applied to be registered
as an importer of the following basic
class(es) of controlled substances:
The applicant’s notice above applied
to become registered with DEA to grow
marihuana as a bulk manufacturer
subsequent to a 2016 DEA policy
statement that provided information on
how it intended to expand the number
of registrations, and described in general
terms the way it would oversee those
additional growers. In order to complete
the evaluation and registration process
for applicants to grow marihuana, DEA
has proposed regulations that, if
finalized, would supersede the 2016
policy statement and govern persons
seeking to become registered with DEA
to grow marihuana as a bulk
manufacturer, consistent with
applicable law. The proposed
regulations are available at 85 FR 16292.
The company plans to import the
above-controlled substance as the FDAapproved drug product in finished
dosage form for commercial distribution
to its customers. 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).
William T. McDermott,
Assistant Administrator.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–07999 Filed 4–15–20; 8:45 am]
[FR Doc. 2020–08001 Filed 4–15–20; 8:45 am]
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Controlled Substance
Drug
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Schedule
Remifentanil ..............
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Agency Information Collection
Activities; Proposed eCollection
eComments Requested;
Reinstatement, With Change, of a
Previously Approved Collection for
Which Approval Has Expired: 2019
Census of Jails
Bureau of Justice Statistics,
Department of Justice.
ACTION: 30-Day notice.
AGENCY:
Registered bulk manufacturer 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 18, 2020. Such persons
may also file a written request for a
hearing on the application on or before
May 18, 2020.
DATES:
SUPPLEMENTARY INFORMATION:
I
I
21269
The Department of Justice
(DOJ), Office of Justice Programs,
Bureau of Justice Statistics, will be
submitting the following information
collection request to the Office of
Management and Budget (OMB) for
review and approval in accordance with
the Paperwork Reduction Act of 1995.
DATES: Comments are encouraged and
will be accepted for 30 days until May
18, 2020.
FOR FURTHER INFORMATION CONTACT:
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.
SUPPLEMENTARY INFORMATION: Written
comments and suggestions from the
public and affected agencies concerning
the proposed collection of information
are encouraged. Your comments should
address one or more of the following
four points:
—Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the Bureau of Justice
Statistics, including whether the
information will have practical utility;
—Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
—Evaluate whether and if so how the
quality, utility, and clarity of the
information to be collected can be
enhanced; and
—Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses.
SUMMARY:
E:\FR\FM\16APN1.SGM
16APN1
]]>Agencies
[Federal Register Volume 85, Number 74 (Thursday, April 16, 2020)]
[Notices]
[Page 21269]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08001]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-629]
Importer of Controlled Substances Application: Mylan
Pharmaceuticals Inc.
ACTION: Notice of application.
-----------------------------------------------------------------------
DATES: Registered bulk manufacturer 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 18, 2020.
Such persons may also file a written request for a hearing on the
application on or before May 18, 2020.
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 March 31, 2020, Mylan Pharmaceuticals Inc., 2898
Manufacturers Road, Greensboro, North Carolina 27406, applied to be
registered as an importer of the following basic class(es) of
controlled substances:
------------------------------------------------------------------------
Controlled Substance Drug code Schedule
------------------------------------------------------------------------
Remifentanil......................... 9739 II
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The company plans to import the above-controlled substance as the
FDA-approved drug product in finished dosage form for commercial
distribution to its customers. 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).
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-08001 Filed 4-15-20; 8:45 am]
BILLING CODE 4410-09-P
