Bulk Manufacturer of Controlled Substances Application: Cambrex Charles City, 33358-33359 [2021-13252]

Download as PDF 33358 Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Notices Bureau of Alcohol, Tobacco, Firearms and Explosives, Department of Justice. ACTION: 60-Day notice. form. The proposed IC is also being published to obtain comments from the public and affected agencies. DATES: Comments are encouraged and will be accepted for 60 days until August 23, 2021. FOR FURTHER INFORMATION CONTACT: If you have additional comments regarding the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions, or additional information, please contact: Neil Troppman, Law Enforcement Support Branch, National Tracing Center Division, either by mail at 244 Needy Road, Martinsburg, WV 25405, by email at neil.troppman@atf.gov, or by telephone at 304–260–3643. SUPPLEMENTARY INFORMATION: Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points: —Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; —Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; —Evaluate whether and if so how the quality, utility, and clarity of the information to be collected can be enhanced; and —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 responses. The Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), Department of Justice (DOJ), will submit the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection (IC) OMB 1140–0003 (Report of Multiple Sale or Other Disposition of Pistols and Revolvers—ATF Form 3310.4) is being revised due to an increase in the total respondents, responses, and burden hours. A minor change to update the firearms description columns was made to the Overview of This Information Collection 1. Type of Information Collection (check justification or form 83): Revision of a currently approved collection. 2. The Title of the Form/Collection: Report of Multiple Sale or Other Disposition of Pistols and Revolvers. 3. The agency form number, if any, and the applicable component of the Department sponsoring the collection: Form number (if applicable): ATF Form 3310.4. Component: Bureau of Alcohol, Tobacco, Firearms and Explosives, U.S. Department of Justice. INTERNATIONAL TRADE COMMISSION [Investigation Nos. 731–TA–1546–1549 (Final)] Thermal Paper From Germany, Japan, Korea, and Spain; Notice of Correction Concerning Scheduling of Record Closing and Final Comments United States International Trade Commission. ACTION: Correction of notice. AGENCY: Correction is made to the October 20, 2021 date of record closing, and the October 22, 2021 deadline for filing final comments, in the Written Submissions section of the notice which was published on June 9, 2021 (86 FR 30627). The correct deadline dates are as follows: The record closing is October 19, 2021; and deadline for final comments is October 21, 2021. SUMMARY: By order of the Commission. Issued: June 14, 2021. Lisa Barton, Secretary to the Commission. [FR Doc. 2021–13345 Filed 6–23–21; 8:45 am] BILLING CODE 7020–02–P DEPARTMENT OF JUSTICE Bureau of Alcohol, Tobacco, Firearms and Explosives [OMB Number 1140–0003] Agency Information Collection Activities; Proposed eCollection of eComments Requested; Revision of a Currently Approved Collection; Report of Multiple Sale or Other Disposition of Pistols and Revolvers—ATF Form 3310.4 AGENCY: khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 19:19 Jun 23, 2021 Jkt 253001 PO 00000 Frm 00153 Fmt 4703 Sfmt 4703 4. Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Business or other for-profit. Other (if applicable): Federal Government and State, Local, or Tribal Government. Abstract: The Report of Multiple Sale or Other Disposition of Pistols and Revolvers—ATF Form 3310.4 is used to report multiple sale or other disposition of two or more pistols, revolvers, or any combination of pistols or revolvers to an unlicensed person, whether it occurs one time or within five consecutive business days. 5. An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: An estimated 82,011 respondents will complete this form approximately 6.33365 times annually, and it will take each respondent approximately 15 minutes to complete their responses. 6. An estimate of the total public burden (in hours) associated with the collection: The estimated annual public burden associated with this collection is 129,857 hours, which is equal to 82,011 (# of respondents) * 6.33365 (# of responses per respondent) * .25 (15 mins). 7. An Explanation of the Change in Estimates: The increase in total respondents, responses, and burden hours, by 4,106, 63,495, and 15,873 hours respectively, is due to the revision of agency estimates, and a general increase in the number of respondents since the last renewal in 2018. If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, 3E.405A, Washington, DC 20530. Dated: June 21, 2021. Melody Braswell, Department Clearance Officer for PRA, U.S. Department of Justice. [FR Doc. 2021–13419 Filed 6–23–21; 8:45 am] BILLING CODE 4410–FY–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–857] Bulk Manufacturer of Controlled Substances Application: Cambrex Charles City Drug Enforcement Administration, Justice. AGENCY: E:\FR\FM\24JNN1.SGM 24JNN1 33359 Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Notices ACTION: Notice of application. Cambrex Charles City 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 August 23, 2021. Such persons may also file a written request for a hearing on the application on or before August 23, 2021. ADDRESSES: 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 May 6, 2021, Cambrex Charles City, 1205 11th Street, Charles City, Iowa 50616–3466, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): SUMMARY: Controlled substance khammond on DSKJM1Z7X2PROD with NOTICES Gamma Hydroxybutyric Acid ............................. Tetrahydrocannabinols ... Amphetamine .................. Lisdexamfetamine ........... Methylphenidate ............. ANPP (4-Anilino-Nphenethyl-4-piperidine) Phenylacetone ................ Codeine .......................... Oxycodone ...................... Hydromorphone .............. Hydrocodone .................. Methadone ...................... Morphine ......................... Oripavine ........................ Thebaine ......................... Opium extracts ............... Opium fluid extract ......... Opium tincture ................ Opium, powdered ........... Oxymorphone ................. Noroxymorphone ............ Fentanyl .......................... Drug code Schedule 2010 7370 1100 1205 1724 I I II II II 8333 8501 9050 9143 9150 9193 9250 9300 9330 9333 9610 9620 9630 9639 9652 9668 9801 II II II II II II II II II II II II II II II II II 19:19 Jun 23, 2021 Jkt 253001 William T. McDermott, Assistant Administrator. [FR Doc. 2021–13252 Filed 6–23–21; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–858] Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Annac Medical Center LC 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 23, 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–858 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 DATES: The company plans to manufacture the above-listed controlled substances in bulk for conversion to other controlled substances and sales to its customers for dosage form development, clinical trials and use in stability qualification studies. In reference to drug code 7370 (Tetrahydrocannabinols), the company plans to bulk manufacture this drug as synthetic. No other activities for these VerDate Sep<11>2014 drug codes are authorized for this registration. PO 00000 Frm 00154 Fmt 4703 Sfmt 4703 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 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 April 14, 2021, Annac Medical Center, LC, 5172 West Patrick Lane, Suite 100, Las Vegas, Nevada 89117– 8911, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substances: Controlled substance Tetrahydrocannabinols ... Drug code Schedule I 7370 II William T. McDermott, Assistant Administrator. [FR Doc. 2021–13249 Filed 6–23–21; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Oil Pollution Act On June 17, 2021, the Department of Justice lodged a proposed Consent Decree with the United States District Court for the Western District of Louisiana in the lawsuit entitled United States of America and Louisiana v. CITGO Petroleum Corp., Civil Action No. 2:21–cv–1705. The United States is E:\FR\FM\24JNN1.SGM 24JNN1

Agencies

[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Pages 33358-33359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13252]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-857]


Bulk Manufacturer of Controlled Substances Application: Cambrex 
Charles City

AGENCY: Drug Enforcement Administration, Justice.

[[Page 33359]]


ACTION: Notice of application.

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SUMMARY: Cambrex Charles City 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 August 23, 2021. 
Such persons may also file a written request for a hearing on the 
application on or before August 23, 2021.

ADDRESSES: 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 May 6, 2021, Cambrex Charles City, 1205 11th Street, 
Charles City, Iowa 50616-3466, applied to be registered as a bulk 
manufacturer of the following basic class(es) of controlled 
substance(s):

------------------------------------------------------------------------
                                                       Drug
                Controlled substance                   code    Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid...........................    2010          I
Tetrahydrocannabinols...............................    7370          I
Amphetamine.........................................    1100         II
Lisdexamfetamine....................................    1205         II
Methylphenidate.....................................    1724         II
ANPP (4-Anilino-N-phenethyl-4-piperidine)...........    8333         II
Phenylacetone.......................................    8501         II
Codeine.............................................    9050         II
Oxycodone...........................................    9143         II
Hydromorphone.......................................    9150         II
Hydrocodone.........................................    9193         II
Methadone...........................................    9250         II
Morphine............................................    9300         II
Oripavine...........................................    9330         II
Thebaine............................................    9333         II
Opium extracts......................................    9610         II
Opium fluid extract.................................    9620         II
Opium tincture......................................    9630         II
Opium, powdered.....................................    9639         II
Oxymorphone.........................................    9652         II
Noroxymorphone......................................    9668         II
Fentanyl............................................    9801         II
------------------------------------------------------------------------

    The company plans to manufacture the above-listed controlled 
substances in bulk for conversion to other controlled substances and 
sales to its customers for dosage form development, clinical trials and 
use in stability qualification studies. In reference to drug code 7370 
(Tetrahydrocannabinols), the company plans to bulk manufacture this 
drug as synthetic. No other activities for these drug codes are 
authorized for this registration.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-13252 Filed 6-23-21; 8:45 am]
BILLING CODE P
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