Importer of Controlled Substances Application: National Center for Natural Products Research, 30983-30984 [2021-12209]

Download as PDF 30983 Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Notices import of the Food and Drug Administration-approved or nonapproved finished dosage forms for commercial sale. William T. McDermott, Assistant Administrator. [FR Doc. 2021–12212 Filed 6–9–21; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–845] Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Maridose, LLC Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: 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. SUMMARY: 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 August 9, 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–845 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 khammond on DSKJM1Z7X2PROD with NOTICES DATES: VerDate Sep<11>2014 17:15 Jun 09, 2021 Jkt 253001 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). In addition to seeking to produce marihuana extract, this applicant is separately seeking to cultivate marihuana. See Notice of Application, Bulk Manufacturers of Marihuana, 84 FR 44920, 44922 (Aug. 27, 2019). DEA thus 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 May 6, 2021, Maridose, LLC., 74 Orion Street, Brunswick, Maine 04011, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substances: Drug code Controlled substance I Marihuana Extract ........ 7350 Schedule II William T. McDermott, Assistant Administrator. [FR Doc. 2021–12213 Filed 6–9–21; 8:45 am] ACTION: Notice of application. National Center for Natural Products Research 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. SUMMARY: 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 12, 2021. Such persons may also file a written request for a hearing on the application on or before July 12, 2021. DATES: 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 request 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. ADDRESSES: In accordance with 21 CFR 1301.34(a), this is notice that on April 14, 2021, National Center for Natural Products Research, 806 Hathorn Road, 135 Coy Waller Lab, University, Mississippi 38677–1848, applied to be registered as an importer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Controlled substance Marihuana Extract .......... Marihuana ....................... Tetrahydrocannabinols ... Drug code Schedule 7350 7360 7370 I I I BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–843] Importer of Controlled Substances Application: National Center for Natural Products Research Drug Enforcement Administration, Justice. AGENCY: PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 The company plans to acquire new genetic materials with improved Cannabinoids for research and manufacturing purposes. 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 FDA-approved or non- E:\FR\FM\10JNN1.SGM 10JNN1 30984 Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Notices approved finished dosage forms for commercial sale. William T. McDermott, Assistant Administrator. [FR Doc. 2021–12209 Filed 6–9–21; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Clean Air Act On June 2, 2021, the Department of Justice lodged with the United States District Court for the Southern District of Indiana a Consent Decree in United States and State of Indiana v. Lone Star Industries, Inc. Civ. No. 2:21–cv–233– JRS–MJD. The proposed Consent Decree settles claims brought by the United States and State of Indiana against Lone Star for violations of the Clean Air Act and Title 13 of the Indiana Code (including regulations and permits issued thereunder) at the cement manufacturing facility it owns and operates in Greencastle, Indiana. The Consent Decree resolves these claims and requires Lone Star to (1) pay a civil penalty of $729,000 to be split evenly between the state and United States; (2) implement specified measures designed to prevent the continuation or reoccurrence of the violations alleged, and (3) complete various mitigation projects to offset harm caused by its past violations. The publication of this notice opens a period for public comment on the proposed Consent Decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division and should refer to United States and State of Indiana v. Lone Star Industries, Inc. D.J. Ref. No. 90–5–2–1–09889/4. All comments must be submitted no later than thirty (30) days after the publication date of this notice. Comments may be submitted either by email or by mail: To submit comments: Send them to: By email ....... pubcomment-ees.enrd@ usdoj.gov. Assistant Attorney General, U.S. DOJ—ENRD, P.O. Box 7611, Washington, DC 20044–7611. khammond on DSKJM1Z7X2PROD with NOTICES By mail ......... During the public comment period, the proposed Consent Decree may be examined and downloaded at this Justice Department website: https:// www.justice.gov/enrd/consent-decrees. VerDate Sep<11>2014 17:15 Jun 09, 2021 Jkt 253001 We will provide a paper copy of the proposed Consent Decree upon written request and payment of reproduction costs. Please mail your request and payment to: Consent Decree Library, U.S. DOJ—ENRD, P.O. Box 7611, Washington, DC 20044–7611. Please enclose a check or money order for $12.25 (25 cents per page reproduction cost) payable to the United States Treasury. should contact their State Workforce Agency. FOR FURTHER INFORMATION CONTACT: U.S. Department of Labor, Employment and Training Administration, Office of Unemployment Insurance Room S– 4524, Attn: Thomas Stengle, 200 Constitution Avenue NW, Washington, DC 20210, telephone number (202) 693– 2991 (this is not a toll-free number) or by email: Stengle.Thomas@dol.gov. Patricia A. McKenna, Assistant Section Chief, Environmental Enforcement Section, Environment and Natural Resources Division. Signed in Washington, DC. Suzan G. LeVine, Principal Deputy Assistant Secretary for Employment and Training. [FR Doc. 2021–12115 Filed 6–9–21; 8:45 am] [FR Doc. 2021–12158 Filed 6–9–21; 8:45 am] BILLING CODE 4410–15–P BILLING CODE 4510–FW–P DEPARTMENT OF LABOR DEPARTMENT OF LABOR Mine Safety and Health Administration Employment and Training Administration Notice of a Change in Status of the Extended Benefit (EB) Program for Colorado Employment and Training Administration, Labor. ACTION: Notice. AGENCY: This notice announces a change in benefit period eligibility under the EB program that has occurred since the publication of the last notice regarding the State’s EB status: • Based on the data released by the Bureau of Labor Statistics on May 21, 2021, the seasonally-adjusted TUR for Colorado fell below the 6.5% threshold necessary to remain ‘‘on’’ in EB. Therefore the payable period in EB for Colorado will end on June 12, 2021. The trigger notice covering state eligibility for the EB program can be found at: http://ows.doleta.gov/ unemploy/claims_arch.as. Information for Claimants The duration of benefits payable in the EB program, and the terms and conditions on which they are payable, are governed by the Federal-State Extended Unemployment Compensation Act of 1970, as amended, and the operating instructions issued to the states by the U.S. Department of Labor. In the case of a state beginning an EB period, the State Workforce Agency will furnish a written notice of potential entitlement to each individual who has exhausted all rights to regular benefits and is potentially eligible for EB (20 CFR 615.13(c)(1)). Persons who believe they may be entitled to EB, or who wish to inquire about their rights under the program, PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 Petitions for Modification of Application of Existing Mandatory Safety Standards Mine Safety and Health Administration, Labor. ACTION: Notice. AGENCY: This notice includes the summaries of three petitions for modification submitted to the Mine Safety and Health Administration (MSHA) by the party listed below. DATES: All comments on the petitions must be received by MSHA’s Office of Standards, Regulations, and Variances on or before July 12, 2021. ADDRESSES: You may submit your comments including the docket number of the petition by any of the following methods: 1. Electronic Mail: zzMSHAcomments@dol.gov. Include the docket number of the petition in the subject line of the message. 2. Facsimile: 202–693–9441. 3. Regular Mail or Hand Delivery: MSHA, Office of Standards, Regulations, and Variances, 201 12th Street South, Suite 4E401, Arlington, Virginia 22202–5452, Attention: Jessica D. Senk, Director, Office of Standards, Regulations, and Variances. Persons delivering documents are required to check in at the receptionist’s desk in Suite 4E401. Individuals may inspect copies of the petition and comments during normal business hours at the address listed above. MSHA will consider only comments postmarked by the U.S. Postal Service or proof of delivery from another delivery service such as UPS or Federal Express on or before the deadline for comments. FOR FURTHER INFORMATION CONTACT: Jessica Senk, Office of Standards, SUMMARY: E:\FR\FM\10JNN1.SGM 10JNN1

Agencies

[Federal Register Volume 86, Number 110 (Thursday, June 10, 2021)]
[Notices]
[Pages 30983-30984]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-12209]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-843]


Importer of Controlled Substances Application: National Center 
for Natural Products Research

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: National Center for Natural Products Research 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 July 12, 2021. 
Such persons may also file a written request for a hearing on the 
application on or before July 12, 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 
request 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 April 14, 2021, National Center for Natural Products 
Research, 806 Hathorn Road, 135 Coy Waller Lab, University, Mississippi 
38677-1848, applied to be registered as an importer of the following 
basic class(es) of controlled substance(s):

------------------------------------------------------------------------
                                          Drug
          Controlled substance            code           Schedule
------------------------------------------------------------------------
Marihuana Extract......................    7350  I
Marihuana..............................    7360  I
Tetrahydrocannabinols..................    7370  I
------------------------------------------------------------------------

    The company plans to acquire new genetic materials with improved 
Cannabinoids for research and manufacturing purposes. 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 FDA-approved or non-

[[Page 30984]]

approved finished dosage forms for commercial sale.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-12209 Filed 6-9-21; 8:45 am]
BILLING CODE 4410-09-P