Importer of Controlled Substances Application: Galephar Pharmaceutical Research Inc.

Published date19 August 2021
Citation86 FR 46716
Record Number2021-17765
SectionNotices
CourtDrug Enforcement Administration,Justice Department
46716
Federal Register / Vol. 86, No. 158 / Thursday, August 19, 2021 / Notices
Commission is properly sought will be
treated accordingly. All information,
including confidential business
information and documents for which
confidential treatment is properly
sought, submitted to the Commission for
purposes of this Investigation may be
disclosed to and used: (i) By the
Commission, its employees and Offices,
and contract personnel (a) for
developing or maintaining the records
of this or a related proceeding, or (b) in
internal investigations, audits, reviews,
and evaluations relating to the
programs, personnel, and operations of
the Commission including under 5
U.S.C. Appendix 3; or (ii) by U.S.
government employees and contract
personnel, solely for cybersecurity
purposes. All contract personnel will
sign appropriate nondisclosure
agreements. All nonconfidential written
submissions will be available for public
inspection on EDIS.
This action is taken under the
authority of section 337 of the Tariff Act
of 1930, as amended (19 U.S.C. 1337),
and Part 210 of the Commission’s Rules
of Practice and Procedure (19 CFR part
210).
By order of the Commission.
Issued: August 16, 2021.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2021–17816 Filed 8–18–21; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–887]
Importer of Controlled Substances
Application: Galephar Pharmaceutical
Research Inc.
AGENCY
: Drug Enforcement
Administration, Justice.
ACTION
: Notice of application.
SUMMARY
: Galephar 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 September 20, 2021. Such
persons may also file a written request
for a hearing on the application on or
before September 20, 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 July 23, 2021, Galephar
Pharmaceutical Research Inc., 100 Carr
198 Industrial Park, Juncos, Puerto Rico
00777–3873, applied to be registered as
an importer of the following basic
class(es) of controlled substance(s):
Controlled substance Drug
code Schedule
Hydromorphone .............. 9150 II
The company plans to import the
listed controlled substance in finished
dosage form for analytical purpose only.
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 non-
approved finished dosage forms for
commercial sale.
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021–17765 Filed 8–18–21; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–886]
Importer of Controlled Substances
Application: Chattem Chemicals, Inc.
AGENCY
: Drug Enforcement
Administration, Justice.
ACTION
: Notice of application.
SUMMARY
: Chattem Chemicals, 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 September 20, 2021. Such
persons may also file a written request
for a hearing on the application on or
before September 20, 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 July 23, 2021, Chattem
Chemicals, Inc., 3801 Saint Elmo
Avenue, Chattanooga, Tennessee
37409–1237, applied to be registered as
an importer of the following basic
class(es) of controlled substance(s):
Controlled substance Drug
code Schedule
Methamphetamine ........... 1105 II
4-Anilino-N-Phenethyl-4-
Piperidine (ANPP). 8333 II
Phenylacetone ................. 8501 II
Coca Leaves ................... 9040 II
Opium, Raw ..................... 9600 II
Poppy Straw Concentrate 9670 II
Tapentadol ...................... 9780 II
The company plans to import the listed
controlled substances to manufacture
bulk controlled substances for sale to its
customers. The company plans to
import an intermediate of Tapentadol
(9780), to bulk manufacture Tapentadol
for distribution to its customers. 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 non-
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