Bulk Manufacturer of Controlled Substances Application: PCI Synthesis, 9539-9540 [2021-02973]

Download as PDF 9539 Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices manufacturer of schedule I controlled substances. In response, registered bulk manufacturers of the affected basic class(es), and applicants therefor, may file written comments on or objections of the requested registration, as provided in this notice. This notice does not constitute any evaluation or determination of the merits of the application submitted. The applicant plans to manufacture bulk active pharmaceutical ingredients (APIs) for product development and distribution to DEA-registered researchers. If the application for registration is granted, the registrant would not be authorized to conduct other activity under this registration aside from those coincident activities specifically authorized by DEA regulations. DEA will evaluate the application for registration as a bulk manufacturer for compliance with all applicable laws, treaties, and regulations and to ensure adequate safeguards against diversion are in place. As this applicant has applied to become registered as a bulk manufacturer of marihuana, the application will be evaluated under the criteria of 21 U.S.C. 823(a). DEA will conduct this evaluation in the manner described in the rule published at 85 FR 82333 on December 18, 2020, and reflected in DEA regulations at 21 CFR part 1318. In accordance with 21 CFR 1301.33(a), DEA is providing notice that on January 13, 2021, JW Colorado, LLC, 3601 Freedom Road, Trinidad, Colorado 81082, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substances: Controlled substance Marihuana Extract ........ Marihuana ..................... Drug code Schedule 7350 7360 I I William T. McDermott, Assistant Administrator. [FR Doc. 2021–02972 Filed 2–12–21; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE khammond on DSKJM1Z7X2PROD with NOTICES Drug Enforcement Administration [Docket No. DEA–779] Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Titan Health LLC Drug Enforcement Administration, Justice. AGENCY: VerDate Sep<11>2014 17:04 Feb 12, 2021 Jkt 253001 ACTION: Notice of application. The Drug Enforcement Administration (DEA) is providing notice of an application it has received from an entity applying to be registered to manufacture in bulk basic class(es) of controlled substances listed in schedule I. DEA intends to evaluate this and other pending applications according to its regulations governing the program of growing marihuana for scientific and medical research under DEA registration. DATES: Registered bulk manufacturers of the affected basic class(es), and applicants therefor, may file written comments on or objections to the issuance of the proposed registration on or before April 19, 2021. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW 8701 Morrissette Drive, Springfield, Virginia 22152. To ensure proper handling of comments, please reference Docket No. DEA–779 in all correspondence, including attachments. SUPPLEMENTARY INFORMATION: The Controlled Substances Act (CSA) prohibits the cultivation and distribution of marihuana except by persons who are registered under the CSA to do so for lawful purposes. In accordance with the purposes specified in 21 CFR 1301.33(a), DEA is providing notice that the entity identified below has applied for registration as a bulk manufacturer of schedule I controlled substances. In response, registered bulk manufacturers of the affected basic class(es), and applicants therefor, may file written comments on or objections of the requested registration, as provided in this notice. This notice does not constitute any evaluation or determination of the merits of the application submitted. The applicant plans to manufacture bulk active pharmaceutical ingredients (APIs) for product development and distribution to DEA registered researchers. If the application for registration is granted, the registrant would not be authorized to conduct other activity under this registration aside from those coincident activities specifically authorized by DEA regulations. DEA will evaluate the application for registration as a bulk manufacturer for compliance with all applicable laws, treaties, and regulations and to ensure adequate safeguards against diversion are in place. As this applicant has applied to become registered as a bulk SUMMARY: PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 manufacturer of marihuana, the application will be evaluated under the criteria of 21 U.S.C. 823(a). DEA will conduct this evaluation in the manner described in the rule published at 85 FR 82333 on December 18, 2020, and reflected in DEA regulations at 21 CFR part 1318. In accordance with 21 CFR 1301.33(a), DEA is providing notice that on January 18, 2021, Titan Health LLC, 5959 East 39th Avenue, Suite 102, Denver, Colorado 80207 applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substances: Controlled substance Marihuana Extract ........ Marihuana ..................... Drug code 7350 7360 Schedule I I William T. McDermott, Assistant Administrator. [FR Doc. 2021–02968 Filed 2–12–21; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–776] Bulk Manufacturer of Controlled Substances Application: PCI Synthesis Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: PCI Synthesis, 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 April 19, 2021. Such persons may also file a written request for a hearing on the application on or before April 19, 2021. ADDRESS: 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 March 24, 2020, PCI Synthesis, 9 Opportunity Way, Newburyport, Massachusetts 01950– 0195, applied to be registered as a bulk SUPPLEMENTARY INFORMATION: E:\FR\FM\16FEN1.SGM 16FEN1 9540 Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices manufacturer of the following basic class(es) of controlled substance(s): Controlled substance Amphetamine ............... Methamphetamine ........ Drug code Schedule 1100 1105 II II The company plans to use the listed controlled substances to develop manufacturing processes, and conduct analytical and stability testing. The company has demonstrated and received patent numbers U.S. 9,278,904 and U.S. 9,321,794 from the U.S. Patent Office for the synthesis process for amphetamines. William T. McDermott, Assistant Administrator. [FR Doc. 2021–02973 Filed 2–12–21; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–783] Importer of Controlled Substances Application: Siegfried USA, LLC Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Siegfried USA, LLC 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 March 18, 2021. Such persons may also file a written request for a hearing on the application on or before March 18, 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. khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:04 Feb 12, 2021 Jkt 253001 In accordance with 21 CFR 1301.34(a), this is notice that on January 6, 2021, Siegfried USA, LLC, 33 Industrial Park Road, Pennsville, New Jersey 08070, applied to be registered as an importer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Drug code Controlled substance Phenylacetone .............. Opium, Raw .................. Poppy Straw Concentrate. 8501 9600 9670 Schedule II II II The company plans to import the listed controlled substances to manufacture bulk active pharmaceutical ingredients (API) for distribution to its customers. Phenylacetone will be used to manufacture Amphetamine. 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. William T. McDermott, Assistant Administrator. [FR Doc. 2021–02974 Filed 2–12–21; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE National Institute of Corrections Advisory Board; Notice of Meeting This notice announces a forthcoming meeting of the National Institute of Corrections (NIC) Advisory Board. At least one portion of the meeting will be closed to the public. Name of the Committee: NIC Advisory Board. General Function of the Committee: To aid the National Institute of Corrections in developing long-range plans, advise on program development, and recommend guidance to assist NIC’s efforts in the areas of training, technical assistance, information services, and policy/program development assistance to Federal, state, and local corrections agencies. Date and Time: 1:00–4:00 p.m. EDT on Wednesday, March 10, 2021 (approximate time). Location: Virtual Platform. Contact Person: Leslie LeMaster, Executive Assistant, National Institute of Corrections, 320 First Street NW, PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 Room 901–3, Washington, DC 20534. To contact Ms. LeMaster, please call (303) 338–6620. Agenda: On March 10, 2021, the Advisory Board will: (1) Receive a brief Agency Report from the NIC Acting Director, (2) provide input and counsel into an agency decision regarding access to online training courses hosted by NIC, and (3) receive a Subcommittee Report related to the identification of potential NIC Director candidates. Time for questions and counsel is built in to the agenda. Procedure: On March 10, 2021, from 1:00 p.m. until 3:00 p.m., the meeting is open to the public. Interested persons may request to attend virtually, present data, information, or views, orally or in writing, on issues pending before the committee. Such requests must be made to the contact person on or before February 26, 2021. Oral presentations from the public will be scheduled between approximately 2:45 p.m. to 3:00 p.m. on March 10, 2021. Time allotted for each presentation may be limited. Those who wish to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before February 26, 2021. Closed Committee Deliberations: On March 10, 2021, between 3:00 p.m. and 4:00 p.m., the meeting will be closed to permit discussion of information that (1) relates solely to the internal personnel rules and practices of an agency (5 U.S.C. 552b(c)(2)), and (2) is of a personal nature where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The Advisory Board will discuss the outcomes of the subcommittee’s review of potential candidates for the position of Director of the National Institute of Corrections and make determinations as to the Advisory Board’s recommendations to the U.S. Attorney General. General Information: NIC welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Leslie LeMaster at least 7 days in advance of the meeting. Notice of this meeting is given under the E:\FR\FM\16FEN1.SGM 16FEN1

Agencies

[Federal Register Volume 86, Number 29 (Tuesday, February 16, 2021)]
[Notices]
[Pages 9539-9540]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-02973]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-776]


Bulk Manufacturer of Controlled Substances Application: PCI 
Synthesis

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: PCI Synthesis, 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 April 19, 2021. 
Such persons may also file a written request for a hearing on the 
application on or before April 19, 2021.

ADDRESS: 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 March 24, 2020, PCI Synthesis, 9 Opportunity Way, 
Newburyport, Massachusetts 01950-0195, applied to be registered as a 
bulk

[[Page 9540]]

manufacturer of the following basic class(es) of controlled 
substance(s):

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Amphetamine............................     1100  II
Methamphetamine........................     1105  II
------------------------------------------------------------------------

    The company plans to use the listed controlled substances to 
develop manufacturing processes, and conduct analytical and stability 
testing. The company has demonstrated and received patent numbers U.S. 
9,278,904 and U.S. 9,321,794 from the U.S. Patent Office for the 
synthesis process for amphetamines.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-02973 Filed 2-12-21; 8:45 am]
BILLING CODE P