Bulk Manufacturer of Controlled Substances Application: SpecGx LLC, 29741-29742 [2020-10601]
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29741
Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Notices
Determination.—The Commission has
determined these reviews are
extraordinarily complicated and
therefore has determined to exercise its
authority to extend the review period by
up to 90 days pursuant to 19 U.S.C.
1675(c)(5)(B).
Authority: These reviews are being
conducted under authority of title VII of the
Tariff Act of 1930; this notice is published
pursuant to section 207.62 of the
Commission’s rules.
FOR FURTHER INFORMATION CONTACT:
By order of the Commission.
Issued: May 12, 2020.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2020–10537 Filed 5–15–20; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Bureau of Alcohol, Tobacco, Firearms,
and Explosives
[Docket No. ATF 2018R–02]
International Trade Data System Test—
Cessation of Voluntary Export Pilot
Project
Bureau of Alcohol, Tobacco,
Firearms, and Explosives, Department of
Justice.
ACTION: Notice.
AGENCY:
The Bureau of Alcohol,
Tobacco, Firearms, and Explosives
(ATF) announces cessation of its
voluntary participation in a U.S.
Customs and Border Protection (CBP)
pilot test of the International Trade Data
System (ITDS) for processing import
and export-related ATF forms and data
using the Partner Government Agency
(PGA) Message Set and the Automated
Commercial Environment (ACE). The
Border Interagency Executive Counsel
(which oversees ITDS implementation)
requires each agency to announce the
start and cessation of the required
pilots. ATF’s participation for the
imports and exports requirements were
done separately with the imports pilot
being completed in 2015. See 81 FR
60022 (August 31, 2016). This notice
now concludes ATF participation in the
pilot for the exportation requirements.
While this notice announces the
cessation of the pilot program, CBP has
not yet announced the date that filing
entries in ACE will be mandatory. The
pilot test allowed participating
exporters to submit ATF Form 9,
Application and Permit for Permanent
SUMMARY:
jbell on DSKJLSW7X2PROD with NOTICES
Exportation of Firearms (Form 9), and
additional information to CBP
electronically to obtain CBP certification
of exportation. During the pilot, CBP
validated that information and
electronically transmitted export
information to ATF to satisfy CBP’s
certification requirements.
DATES: This notice is effective on the
date of publication in the Federal
Register.
National Firearms Act, Industry
Processing Branch Chief, 244 Needy
Road, Martinsburg, WV, 25045, 304–
616–4500, IPB@atf.gov.
SUPPLEMENTARY INFORMATION: ATF
participated in a voluntary CBP pilot
test of the ITDS involving the use of the
PGA Message Set and ACE. See 81 FR
70441 (October 12, 2016). The pilot
allowed exporters to submit required
data to CBP through ACE for the
purposes of obtaining CBP release and
receipt. CBP validated that information
electronically, and transmitted entry
and release information to ATF to
satisfy certification requirements. More
than a dozen agencies participated in
various pilots all of which are at
different stages of testing and
implementation.
In compliance with Executive Order
13659, Streamlining the Export/Import
Process for America’s Businesses (79 FR
10657, Feb. 25, 2014), ATF joined CBP’s
pilot test and encouraged voluntary
participation of U.S. exporters of
National Firearms Act (NFA) firearms,
as defined under title 26, United States
Code (U.S.C.), section 5845(a)). The
NFA (and the implementing regulations
in title 27, Code of Federal Regulations
(CFR), part 479, require any person
desiring to export a firearm without
payment of transfer tax to apply for a
permit (ATF Form 9). See 26 U.S.C.
5854; 27 CFR 479.114. The approval
provides for deferment of tax liability.
In accordance with Federal regulation,
the exporter would furnish ATF
evidence of the exportation of the
firearm(s) within a six-month’s period of
the date of issuance of the permit to
relieve the tax liability. See 27 CFR
479.115. After the merchandise is
exported, CBP would execute the
certificate of exportation (Part 3 of Form
9) and send a copy of the executed
certificate to ATF. See 27 CFR 479.117.
This pilot program allowed CBP to
transmit the certificate to ATF
electronically, with the exporter
continuing to apply on Form 9 for the
permit.
The Border Interagency Executive
Council, Departments of Treasury and
Homeland Security, which oversees
ITDS implementation, asked ATF to end
the pilot. Pilot participants can continue
to function as they did while on the
pilot. Participants will not notice any
differences after the pilot has ended. At
some point, CBP will mandate importers
and exporters to use the ACE single
window; however, DHS needs all pilots
successfully completed to move to their
next phase of implementation. The
termination of the pilot will not cause
any delays for participating exporters,
and CBP will continue to transmit the
certificate of exportation to ATF
electronically.
Exporters should be aware that no
changes have been made to the
requirement that they submit their copy
of ATF Form 9 to ATF within a six
month period from the date of issuance
of the permit to export firearms. See 27
CFR 479.118.
Regina Lombardo,
Acting Deputy Director.
[FR Doc. 2020–10581 Filed 5–15–20; 8:45 am]
BILLING CODE 4410–FY–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–610]
Bulk Manufacturer of Controlled
Substances Application: SpecGx LLC
ACTION:
Notice of application.
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 July 17, 2025.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration (DEA), 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 January 29, 2020,
SpecGx LLC, 3600 North Second Street,
Saint Louis, Missouri 63147–3457
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substances:
DATES:
Controlled substance
Drug code
Gamma Hydroxybutyric Acid ............................................................................................................................................
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Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Notices
Controlled substance
Drug code
Tetrahydrocannabinols .....................................................................................................................................................
Codeine-N-oxide ...............................................................................................................................................................
Dihydromorphine ..............................................................................................................................................................
Difenoxin ...........................................................................................................................................................................
Morphine-N-oxide .............................................................................................................................................................
Normorphine .....................................................................................................................................................................
Norlevorphanol .................................................................................................................................................................
Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) ................................................................................
Butyryl Fentanyl ................................................................................................................................................................
Fentanyl related-substances as defined in 21 CFR 1308.11(h) ......................................................................................
Amphetamine ...................................................................................................................................................................
Methamphetamine ............................................................................................................................................................
Lisdexamfetamine ............................................................................................................................................................
Methylphenidate ...............................................................................................................................................................
Nabilone ...........................................................................................................................................................................
4-Anilino-N-phenethyl-4-piperidine (ANPP) ......................................................................................................................
Codeine ............................................................................................................................................................................
Dihydrocodeine .................................................................................................................................................................
Oxycodone .......................................................................................................................................................................
Hydromorphone ................................................................................................................................................................
Diphenoxylate ...................................................................................................................................................................
Ecgonine ...........................................................................................................................................................................
Hydrocodone ....................................................................................................................................................................
Levorphanol ......................................................................................................................................................................
Meperidine ........................................................................................................................................................................
Methadone ........................................................................................................................................................................
Methadone intermediate ...................................................................................................................................................
Dextropropoxyphene, bulk (non-dosage forms) ...............................................................................................................
Morphine ...........................................................................................................................................................................
Oripavine ..........................................................................................................................................................................
Thebaine ...........................................................................................................................................................................
Opium tincture ..................................................................................................................................................................
Opium, powdered .............................................................................................................................................................
Oxymorphone ...................................................................................................................................................................
Noroxymorphone ..............................................................................................................................................................
Alfentanil ...........................................................................................................................................................................
Remifentanil ......................................................................................................................................................................
Sufentanil ..........................................................................................................................................................................
Tapentadol ........................................................................................................................................................................
Fentanyl ............................................................................................................................................................................
The company plans to manufacture
bulk active pharmaceutical ingredients
(APIs) for distribution to its customers.
In reference to drug code 7370
(Tetrahydrocannabinols), the company
plans to bulk manufacture this drug as
synthetic. No other activities for this
drug code is authorized for this
registration.
William T. McDermott,
Assistant Administrator.
Drug Enforcement Administration
[Docket No. DEA–646]
Importer of Controlled Substances
Application: Scientific Botanical
Pharmaceutical, Inc.
ACTION:
Notice of application.
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 June 17, 2020. Such persons
may also file a written request for a
hearing on the application on or before
June 17, 2020
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
DATES:
[FR Doc. 2020–10601 Filed 5–15–20; 8:45 am]
BILLING CODE 4410–09–P
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DEPARTMENT OF JUSTICE
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In
accordance with 21 CFR 1301.34(a), this
is notice that on January 27, 2017,
Scientific Botanical Pharmaceutical,
Inc., 1225 West Deer Valley Road
Phoenix, Arizona 85027, applied to be
registered as an importer of the
following basic class(es) of controlled
substances:
Drug Code
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SUPPLEMENTARY INFORMATION:
Marihuana ................................................................................................................................................................
18:03 May 15, 2020
7370
9053
9145
9168
9307
9313
9634
9821
9822
9850
1100
1105
1205
1724
7379
8333
9050
9120
9143
9150
9170
9180
9193
9220
9230
9250
9254
9273
9300
9330
9333
9630
9639
9652
9668
9737
9739
9740
9780
9801
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.
Controlled substance
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[Federal Register Volume 85, Number 96 (Monday, May 18, 2020)]
[Notices]
[Pages 29741-29742]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10601]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-610]
Bulk Manufacturer of Controlled Substances Application: SpecGx
LLC
ACTION: Notice of application.
-----------------------------------------------------------------------
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 July 17, 2025.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration (DEA), 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 January 29, 2020, SpecGx LLC, 3600 North Second
Street, Saint Louis, Missouri 63147-3457 applied to be registered as a
bulk manufacturer of the following basic class(es) of controlled
substances:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid................. 2010 I
[[Page 29742]]
Tetrahydrocannabinols..................... 7370 I
Codeine-N-oxide........................... 9053 I
Dihydromorphine........................... 9145 I
Difenoxin................................. 9168 I
Morphine-N-oxide.......................... 9307 I
Normorphine............................... 9313 I
Norlevorphanol............................ 9634 I
Acetyl Fentanyl (N-(1-phenethylpiperidin-4- 9821 I
yl)-N-phenylacetamide).
Butyryl Fentanyl.......................... 9822 I
Fentanyl related-substances as defined in 9850 I
21 CFR 1308.11(h).
Amphetamine............................... 1100 II
Methamphetamine........................... 1105 II
Lisdexamfetamine.......................... 1205 II
Methylphenidate........................... 1724 II
Nabilone.................................. 7379 II
4-Anilino-N-phenethyl-4-piperidine (ANPP). 8333 II
Codeine................................... 9050 II
Dihydrocodeine............................ 9120 II
Oxycodone................................. 9143 II
Hydromorphone............................. 9150 II
Diphenoxylate............................. 9170 II
Ecgonine.................................. 9180 II
Hydrocodone............................... 9193 II
Levorphanol............................... 9220 II
Meperidine................................ 9230 II
Methadone................................. 9250 II
Methadone intermediate.................... 9254 II
Dextropropoxyphene, bulk (non-dosage 9273 II
forms).
Morphine.................................. 9300 II
Oripavine................................. 9330 II
Thebaine.................................. 9333 II
Opium tincture............................ 9630 II
Opium, powdered........................... 9639 II
Oxymorphone............................... 9652 II
Noroxymorphone............................ 9668 II
Alfentanil................................ 9737 II
Remifentanil.............................. 9739 II
Sufentanil................................ 9740 II
Tapentadol................................ 9780 II
Fentanyl.................................. 9801 II
------------------------------------------------------------------------
The company plans to manufacture bulk active pharmaceutical
ingredients (APIs) for distribution to its customers. In reference to
drug code 7370 (Tetrahydrocannabinols), the company plans to bulk
manufacture this drug as synthetic. No other activities for this drug
code is authorized for this registration.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-10601 Filed 5-15-20; 8:45 am]
BILLING CODE 4410-09-P
