Bulk Manufacturer of Controlled Substances Application: Novitium Pharma LLC, 59199 [2021-23282]
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Federal Register / Vol. 86, No. 204 / Tuesday, October 26, 2021 / Notices
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 July 30, 2021,
Indigenous Peyote Conservation
Initiative, 826 North FM 649,
Hebbronville, Texas 78361, applied to
be registered as an importer of the
following basic class(es) of controlled
substance(s):
ADDRESSES:
Controlled substance
Peyote .............................
Drug
code
Schedule
7415
I
Novitium Pharma LLC has
applied to be registered as a bulk
manufacturer of basic class(es) of
controlled substance(s). Refer to
Supplementary 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 December 27, 2021. Such
persons may also file a written request
for a hearing on the application on or
before December 27, 2021.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
SUMMARY:
In
accordance with 21 CFR 1301.33(a), this
is notice that on September 8, 2021,
Novitium Pharma LLC, 70 Lake Drive,
East Windsor, New Jersey 08520,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
SUPPLEMENTARY INFORMATION:
Controlled substance
Drug
code
Schedule
7437
7438
9220
I
I
II
The above controlled substance will
be imported as live plants for research,
analytical purposes, enhancing the plant
population, and improving conservation
strategies of the plant in situ in its
native habit. No other activity for this
drug code 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.
The company plans to bulk
manufacture drug codes 7438 and 7437
to produce Active Pharmaceutical
Ingredient (API) and finished dosage
forms for use in clinical trial studies
only. In reference to drug code 9220, the
company plans to bulk manufacture this
drug code to support commercial drug
product manufacturing and drug
development purposes. No other
activities for these drug codes are
authorized for this registration.
Brian S. Besser,
Acting Assistant Administrator.
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021–23281 Filed 10–25–21; 8:45 am]
Psilocybin ........................
Psilocyn ...........................
Levorphanol .....................
[FR Doc. 2021–23282 Filed 10–25–21; 8:45 am]
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DEPARTMENT OF JUSTICE
NATIONAL SCIENCE FOUNDATION
Drug Enforcement Administration
Request for Information:
Undergraduate Training in Biology
Mathematics and Computer Science
(UBMC)
[Docket No. DEA–916]
Bulk Manufacturer of Controlled
Substances Application: Novitium
Pharma LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
VerDate Sep<11>2014
22:39 Oct 25, 2021
Jkt 256001
National Science Foundation.
Request for information.
AGENCY:
ACTION:
The National Science
Foundation’s (NSF) Division of
Undergraduate Education (DUE), the
SUMMARY:
PO 00000
Frm 00088
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59199
Division of Biological Infrastructure
(DBI), the Division of Mathematical
Sciences (DMS) and the Division of
Computer and Information Science and
Engineering (CISE) request input from
interested parties the value and need for
an interdisciplinary program that trains
undergraduate students at the
intersections of biological science,
mathematics and computer sciences.
This RFI will help inform NSF as it
considers programs for educating the
workforce of tomorrow.
DATES: Interested persons are invited to
submit comments on or before
December 31, 2021.
ADDRESSES: Submit comments to Mary
L. Crowe, mcrowe@nsf.gov. Submissions
should include the ‘‘RFI Response:
Undergraduate Training Program in
Biological, Mathematical and Computer
Science UBMC’’ in the subject line of
the message. Phone calls can be made to
Mary L. Crowe at the following number:
703–292–7177.
FOR FURTHER INFORMATION CONTACT:
Suzanne H. Plimpton, Reports Clearance
Officer, National Science Foundation,
2415 Eisenhower Avenue, Suite
W18200, Alexandria, Virginia 22314;
telephone (703) 292–7556; or send email
to splimpto@nsf.gov. Individuals who
use a telecommunications device for the
deaf (TDD) may call the Federal
Information Relay Service (FIRS) at 1–
800–877–8339, which is accessible 24
hours a day, 7 days a week, 365 days a
year (including Federal holidays).
SUPPLEMENTARY INFORMATION:
Instructions: Response to this RFI is
voluntary. Each individual or institution
is requested to submit only one
response. Responses should include the
name of the person(s) or organization(s)
filing the comment. Please include the
number of the question or questions to
which you are responding. Please limit
your response to no more than six
pages.
In accordance with FAR 15.202(3),
responses to this notice are not offers
and cannot be accepted by the
Government to form a binding contract.
Responders are solely responsible for all
expenses associated with responding to
this RFI.
Background Information: The
National Science Foundation (NSF)
plays a critical role in establishing U.S.
leadership in science and engineering
(S&E), creating innovations that drive
the nation’s economy and educating the
next generation of scientists and
engineers. The NSF 10 Big Ideas support
this role through ideas such as the
Future of Work at the Human
Technology Frontier, Harnessing the
Data Revolution, and others, that foster
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[Federal Register Volume 86, Number 204 (Tuesday, October 26, 2021)]
[Notices]
[Page 59199]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23282]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-916]
Bulk Manufacturer of Controlled Substances Application: Novitium
Pharma LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Novitium Pharma LLC has applied to be registered as a bulk
manufacturer of basic class(es) of controlled substance(s). Refer to
Supplementary 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 December 27,
2021. Such persons may also file a written request for a hearing on the
application on or before December 27, 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 September 8, 2021, Novitium Pharma LLC, 70 Lake
Drive, East Windsor, New Jersey 08520, applied to be registered as a
bulk manufacturer of the following basic class(es) of controlled
substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Psilocybin.............................. 7437 I
Psilocyn................................ 7438 I
Levorphanol............................. 9220 II
------------------------------------------------------------------------
The company plans to bulk manufacture drug codes 7438 and 7437 to
produce Active Pharmaceutical Ingredient (API) and finished dosage
forms for use in clinical trial studies only. In reference to drug code
9220, the company plans to bulk manufacture this drug code to support
commercial drug product manufacturing and drug development purposes. No
other activities for these drug codes are authorized for this
registration.
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021-23282 Filed 10-25-21; 8:45 am]
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