Importer of Controlled Substances Application: AndersonBrecon, Inc., 55859-55860 [2021-21876]

Download as PDF lotter on DSK11XQN23PROD with NOTICES1 Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Notices 5 CFR 1320.5, all information collections as defined in 5 CFR 1320.3, require approval by OMB. ONRR may not conduct or sponsor, and you are not required to respond to, a collection of information unless it displays a currently valid OMB control number. As part of ONRR’s continuing effort to reduce paperwork and respondent burdens, ONRR is inviting the public and other Federal agencies to comment on new, proposed, revised, and continuing collections of information in accordance with the PRA and 5 CFR 1320.8(d)(1). This helps ONRR assess the impact of its information collection requirements and minimize the public’s reporting burden. It also helps the public understand ONRR’s information collection requirements and provide the requested data in the desired format. ONRR is especially interested in public comments addressing the following: (1) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) The accuracy of ONRR’s estimate of the burden for this collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) How might the agency minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of response. ONRR published a notice, with a 60day public comment period soliciting comment of this collection of information, in the Federal Register on April 21, 2021 (86 FR 20710). ONRR received no comments from companies regarding the published 60-day Federal Register notice. Comments that you submit in response to this 30-day notice are a matter of public record. ONRR will include or summarize each comment in its request to OMB to approve this ICR. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask ONRR in your comment to withhold information from public review, ONRR cannot guarantee that it will be able to do so. VerDate Sep<11>2014 17:46 Oct 06, 2021 Jkt 256001 Abstract: (a) General Information: The Federal Oil and Gas Royalty Management Act of 1982 (‘‘FOGRMA’’) directs the Secretary of the Interior (‘‘Secretary’’) to maintain a comprehensive inspection, collection, and fiscal and production accounting and auditing system that: (1) Accurately determines mineral royalties, interest, and other payments owed, (2) collects and accounts for such amounts in a timely manner, and (3) disburses the funds collected. See 30 U.S.C. 1701 and 1711. ONRR performs these mineral revenue management responsibilities for the Secretary. See Secretarial Order No. 3306. Royalty payors submit royalty reports to ONRR on a monthly basis by submitting form ONRR–2014 (Report of Sales and Royalty Remittance reported in OMB Control Number 1012–0004), and form ONRR–4430 (Solid Minerals Production and Royalty Report reported in OMB Control Number 1012–0010). These forms result in accounts receivables and capture most of the mineral revenues that ONRR collects. (b) Information Collections: Every year, under the Chief Financial Officers Act of 1990 (‘‘CFO Act’’), the OIG or its agent audits the accounts receivable portions of the Department of the Interior’s financial statements, which includes ONRR accounts receivable. As part of the audit, the OIG or its agent randomly selects a sample of ONRR accounts receivable. For each one selected, ONRR generates an accounts receivable confirmation letter to the royalty payor to obtain third-party confirmation of the validity of the financial record for the audit. In order to meet the CFO Act’s requirements, the letter must be on ONRR letterhead and the Deputy Director for ONRR, or his or her designee, must sign the letter. The letter requests a response by a specified date to verify: (1) Customer identification; (2) royalty invoice number; (3) payor assigned document number; (4) date of ONRR’s receipt; (5) original amount the payor reported; and (6) remaining balance due to ONRR. The OIG or its agent mails the letter to the payor and instructs it to respond directly to the OIG or its agent. The information provided helps ensure that ONRR’s financial records are accurate. Title of Collections: Accounts Receivable Confirmations Reporting. OMB Control Number: 1012–0001. Form(s) Number: None. Type of Review: Extension of a currently approved collection. Respondent/Affected Public: Businesses. Total Estimated Number of Annual Respondents: 24 randomly-selected PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 55859 mineral payors from Federal and Indian lands and the Outer Continental Shelf. Total Estimated Number of Annual Responses: 24. Estimated Completion Time per Response: ONRR estimates that each response will take 15 minutes for the payor to complete. Total Estimated Number of Annual Burden Hours: 6 hours. Respondent’s Obligation: Voluntary. Frequency of Collection: Annual. Total Estimated Annual Non-hour Burden Cost: ONRR did not identify any ‘‘non-hour cost’’ burden associated with this collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The authority for this action is the PRA (44 U.S.C. 3501 et seq). Kimbra G. Davis, Director, Office of Natural Resources Revenue. [FR Doc. 2021–21893 Filed 10–6–21; 8:45 am] BILLING CODE 4335–30–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–905] Importer of Controlled Substances Application: AndersonBrecon, Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: AndersonBrecon, Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental 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 November 8, 2021. Such persons may also file a written request for a hearing on the application on or before November 8, 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 SUMMARY: E:\FR\FM\07OCN1.SGM 07OCN1 55860 Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Notices 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 May 19, 2021, AndersonBrecon, Inc., 4545 Assembly Drive, Rockford, Illonois 61109, applied to be registered as an importer of the following basic class(es) of controlled substance(s): Controlled substance Tetrahydrocannabinols ... Drug code Schedule 7370 I The company plans to import the listed controlled substance for clinical trials only. 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. 2021–21876 Filed 10–6–21; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–906] Importer of Controlled Substances Application: Caligor Coghlan Pharma Services Drug code Controlled substance Tapentadol ...................... I 9780 Schedule III The company plans to import the listed controlled substance in finished dosage form to be used in pediatric clinical trials. 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. Brian S. Besser, Acting Assistant Administrator. Drug Enforcement Administration, Justice. ACTION: Notice of application. [FR Doc. 2021–21878 Filed 10–6–21; 8:45 am] Caligor Coghlan Pharma Services has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental 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 November 8, 2021. Such persons may also file a written request for a hearing on the application on or before November 8, 2021. ADDRESSES: Written comments should be sent to: Drug Enforcement DEPARTMENT OF JUSTICE AGENCY: SUMMARY: lotter on DSK11XQN23PROD with NOTICES1 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 August 16, 2021, Caligor Coghlan Pharma Services, 1500 Business Park Drive, Unit B, Bastrop, Texas 78602, applied to be registered as an importer of the following basic class(es) of controlled substance(s): VerDate Sep<11>2014 17:46 Oct 06, 2021 Jkt 256001 BILLING CODE P Drug Enforcement Administration [Docket No. DEA–907] Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: New Mexico Top Organics-Ultra Health 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 SUMMARY: PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 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 December 6, 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–907 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 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 E:\FR\FM\07OCN1.SGM 07OCN1

Agencies

[Federal Register Volume 86, Number 192 (Thursday, October 7, 2021)]
[Notices]
[Pages 55859-55860]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21876]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-905]


Importer of Controlled Substances Application: AndersonBrecon, 
Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: AndersonBrecon, Inc. has applied to be registered as an 
importer of basic class(es) of controlled substance(s). Refer to 
Supplemental 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 November 8, 
2021. Such persons may also file a written request for a hearing on the 
application on or before November 8, 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

[[Page 55860]]

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 May 19, 2021, AndersonBrecon, Inc., 4545 Assembly 
Drive, Rockford, Illonois 61109, applied to be registered as an 
importer of the following basic class(es) of controlled substance(s):

------------------------------------------------------------------------
                                          Drug
          Controlled substance            code           Schedule
------------------------------------------------------------------------
Tetrahydrocannabinols..................    7370  I
------------------------------------------------------------------------

    The company plans to import the listed controlled substance for 
clinical trials only. 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. 2021-21876 Filed 10-6-21; 8:45 am]
BILLING CODE 4410-09-P
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