Bulk Manufacturer of Controlled Substances Application: Noramco

CourtDrug Enforcement Administration
Citation86 FR 66589
Publication Date23 November 2021
Record Number2021-25578
66589
Federal Register / Vol. 86, No. 223 / Tuesday, November 23, 2021 / Notices
Not all the potential respondents will
submit information in any given year,
and some may submit multiple times.
Total Estimated Number of Annual
Responses: 7,454.
Estimated Completion Time per
Response: Varies from 30 minutes to 48
hours, depending on activity.
Total Estimated Number of Annual
Burden Hours: 95,488.
Respondent’s Obligation: Mandatory.
Frequency of Collection: Generally, on
occasion.
Total Estimated Annual Nonhour
Burden Cost: $10,547,442.
An agency may not conduct, or
sponsor and a person is not required to
respond to a collection of information
unless it displays a currently valid OMB
control number.
The authority for this action is the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
Kirk Malstrom,
Chief, Regulations and Standards Branch.
[FR Doc. 2021–25538 Filed 11–22–21; 8:45 am]
BILLING CODE 4310–VH–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–924]
Importer of Controlled Substances
Application: Mylan Technologies, Inc.
AGENCY
: Drug Enforcement
Administration, Justice.
ACTION
: Notice of application.
SUMMARY
: Mylan Technologies, Inc. has
applied to be registered as an importer
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 23, 2021. Such
persons may also file a written request
for a hearing on the application on or
before December 23, 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 October 22, 2021,
Mylan Technologies, Inc., 110 Lake
Street, Saint Albans, Vermont 05478–
2266, applied to be registered as an
importer of the following basic class(es)
of controlled substance(s):
Controlled substance Drug
code Schedule
Methylphenidate ....... 1724 II
Fentanyl .................... 9801 II
The company plans to import the
listed controlled substances in finished
dosage form (FDF) from foreign sources
for analytical testing and clinical trials
in which the foreign FDF will be
compared to the company’s own
domestically manufactured FDF. This
analysis is required to allow the
company to export domestically
manufactured finished dosage form to
foreign markets. 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.
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021–25575 Filed 11–22–21; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–925]
Bulk Manufacturer of Controlled
Substances Application: Noramco
AGENCY
: Drug Enforcement
Administration, Justice.
ACTION
: Notice of application.
SUMMARY
: Noramco, 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 January 24, 2022. Such
persons may also file a written request
for a hearing on the application on or
before January 24, 2022.
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 October 19, 2021,
Noramco, 500 Swedes Landing Road,
Wilmington, Delaware 19801–4417,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
Controlled substance Drug
code Schedule
Marihuana ................................. 7360 I
Tetrahydrocannabinols ............. 7370 I
Dihydromorphine ....................... 9145 I
Hydromorphinol ......................... 9301 I
Amphetamine ............................ 1100 II
Lisdexamfetamine ..................... 1205 II
Methylphenidate ........................ 1724 II
Nabilone .................................... 7379 II
Codeine ..................................... 9050 II
Dihydrocodeine ......................... 9120 II
Oxycodone ................................ 9143 II
Hydromorphone ........................ 9150 II
Hydrocodone ............................. 9193 II
Morphine ................................... 9300 II
Oripavine ................................... 9330 II
Thebaine ................................... 9333 II
Opium extracts .......................... 9610 II
Opium fluid extract .................... 9620 II
Opium, tincture ......................... 9630 II
Opium, powdered ..................... 9639 II
Opium, granulated .................... 9640 II
Oxymorphone ........................... 9652 II
Noroxymorphone ...................... 9668 II
Tapentadol ................................ 9780 II
The company plans to bulk
manufacture the listed controlled
substances as an Active Pharmaceutical
Ingredient (API) for supply to its
customers. In reference to dug codes
7360 (Marihuana), and 7370
(Tetrahydrocannabinols), the company
plans to bulk manufacture these drugs
as synthetic. No other activities for these
drug codes are authorized for this
registration.
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021–25578 Filed 11–22–21; 8:45 am]
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