Bulk Manufacturer of Controlled Substances Application: SpecGx LLC, 29741-29742 [2020-10601]

Download as PDF 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 ............................................................................................................................................ VerDate Sep<11>2014 18:03 May 15, 2020 Jkt 250001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\18MYN1.SGM 18MYN1 2010 Schedule I 29742 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 jbell on DSKJLSW7X2PROD with NOTICES DEPARTMENT OF JUSTICE Jkt 250001 PO 00000 Frm 00064 Fmt 4703 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 Sfmt 4703 I I I I I I I I I I II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II 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 VerDate Sep<11>2014 Schedule E:\FR\FM\18MYN1.SGM 18MYN1 7360 Schedule I

Agencies

[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]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-610]


Bulk Manufacturer of Controlled Substances Application: SpecGx 
LLC

ACTION: Notice of application.

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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