Bulk Manufacturer of Controlled Substances Application: Janssen Pharmaceuticals Inc., 78149 [2020-26651]
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Federal Register / Vol. 85, No. 233 / Thursday, December 3, 2020 / Notices
development of SC-related manuscripts,
models, standards and other guidance
materials (collectively, ‘‘Guidance’’); (b)
provide a venue for reviewing,
developing, maintaining and supporting
the Guidance; (c) promote the Guidance
worldwide; (d) provide for testing and
conformity assessment of
implementations in order to ensure and/
or facilitate compliance with Guidance;
(e) operate a branding program based
upon distinctive trademarks to create
high customer awareness of, demand
for, and confidence in the Guidance,
and products or services designed in
compliance therewith; and (f) undertake
such other activities as may from time
to time be appropriate to further the
purposes and achieve the goals set forth
above.
Membership in Subcutaneous Drug
Development & Delivery Consortium,
Inc. remains open and Subcutaneous
Drug Development & Delivery
Consortium, Inc. intends to file
additional written notifications
disclosing all changes in membership.
In
accordance with 21 CFR 1301.33(a), this
is notice that on November 11, 2020,
Janssen Pharmaceuticals Inc., 1440
Olympic Drive, Athens, Georgia, 30601–
1645, applied to be registered as an bulk
manufacturer of the following basic
class(es) of controlled substance(s):
SUPPLEMENTARY INFORMATION:
Drug
code
Controlled substance
Methylphenidate ............
Hydromorphone .............
Hydrocodone .................
Oripavine .......................
Thebaine ........................
Tapentadol .....................
1724
9150
9193
9330
9333
9780
Schedule
II
II
II
II
II
II
The company plans to manufacture
the above-listed controlled substances
in bulk for distribution to its customers.
No other activities for these drug codes
are authorized for this registration.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–26651 Filed 12–2–20; 8:45 am]
BILLING CODE 4410–09–P
Suzanne Morris,
Chief, Premerger and Division Statistics,
Antitrust Division.
DEPARTMENT OF JUSTICE
[FR Doc. 2020–26626 Filed 12–2–20; 8:45 am]
Federal Bureau of Investigation
BILLING CODE 4410–11–P
[OMB Number 1110–0051]
DEPARTMENT OF JUSTICE
Agency Information Collection
Activities; Proposed eCollection
eComments Requested; Revision of a
Currently Approved Collection; Final
Disposition Report (R–84), With
Supplemental Questions R–84(a), R–
84(b), R–84(c), R–84(d), R–84(e), R–
84(f), R–84(g), R–84(h), R–84(i), and R–
84(j)
Drug Enforcement Administration
[Docket No. DEA–750]
Bulk Manufacturer of Controlled
Substances Application: Janssen
Pharmaceuticals Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Janssen Pharmaceuticals Inc.,
has applied to be registered as a bulk
manufacturer 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 February 1, 2021. Such
persons may also file a written request
for a hearing on the application on or
before February 1, 2021.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
19:48 Dec 02, 2020
Jkt 253001
Criminal Justice Information
Services Division, Federal Bureau of
Investigation, Department of Justice.
ACTION: 30-day notice.
AGENCY:
The Criminal Justice
Information Services (CJIS) Division,
Federal Bureau of Investigation (FBI),
Department of Justice (DOJ), 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 an additional 30
days until January 4, 2021.
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
SUMMARY:
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
78149
‘‘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 agency, including
whether the information will have
practical utility;
—Evaluate the accuracy of the agencies
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.
Overview of This Information
Collection
(1) Type of Information Collection:
Revision of a currently approved
collection.
(2) Title of the Form/Collection: Final
Disposition Report.
(3) Agency form number, if any, and
the applicable component of the
Department sponsoring the collection:
Agency form number: R–84, with
supplemental questions R–84(a), R–
84(b), R–84(c), R–84(d), R–84(e), R–
84(f), R–84(g), R–84(h), R–84(i), and R–
84(j).
Sponsoring component: Department
of Justice, Criminal Justice Information
Services Division.
(4) Affected public who will be asked
or required to respond, as well as a brief
abstract: Primary: City, county, state,
federal and tribal law enforcement
agencies. This collection is needed to
report completion of an arrest event.
Acceptable data is stored as part of the
Next Generation Identification (NGI)
system of the FBI.
(5) An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
respond/reply: It is estimated that
75,605 respondents will complete each
form within approximately 5 minutes.
E:\FR\FM\03DEN1.SGM
03DEN1
]]>Agencies
[Federal Register Volume 85, Number 233 (Thursday, December 3, 2020)]
[Notices]
[Page 78149]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26651]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-750]
Bulk Manufacturer of Controlled Substances Application: Janssen
Pharmaceuticals Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Janssen Pharmaceuticals Inc., has applied to be registered as
a bulk manufacturer 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 February 1,
2021. Such persons may also file a written request for a hearing on the
application on or before February 1, 2021.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DPW,
8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on November 11, 2020, Janssen Pharmaceuticals Inc., 1440
Olympic Drive, Athens, Georgia, 30601-1645, applied to be registered as
an bulk manufacturer of the following basic class(es) of controlled
substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Methylphenidate........................ 1724 II
Hydromorphone.......................... 9150 II
Hydrocodone............................ 9193 II
Oripavine.............................. 9330 II
Thebaine............................... 9333 II
Tapentadol............................. 9780 II
------------------------------------------------------------------------
The company plans to manufacture the above-listed controlled
substances in bulk for distribution to its customers. No other
activities for these drug codes are authorized for this registration.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-26651 Filed 12-2-20; 8:45 am]
BILLING CODE 4410-09-P
