Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturers of Marihuana: Agronomed Pharmaceuticals, 71001-71002 [2019-27781]

Download as PDF 71001 Federal Register / Vol. 84, No. 247 / Thursday, December 26, 2019 / Notices Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before February 24, 2020. 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 October 25, 2019, Kinetochem LLC, 111 W Cooperative Way, Suite 310–B, Georgetown, Texas 78626 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: DATES: Controlled substance Drug code Marihuana ............... Tetrahydrocannabinols. 7360 7370 Schedule I I The company plans to synthetically manufacture drug codes 7360 (marihuana) and 7370 (tetrahydrocannabinols), in bulk for distribution and sale to its customers. No other activities for these drug codes are authorized for this registration. Dated: December 6, 2019. William T. McDermott, Assistant Administrator. [FR Doc. 2019–27784 Filed 12–23–19; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–559] Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturers of Marihuana: Royal Emerald Pharmaceuticals Research and Development 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 classes of controlled substances listed in schedule I. Prior to making decisions on this and other pending applications, DEA intends to promulgate regulations that govern the program of growing marihuana for scientific and medical research under DEA registration. DATES: Registered bulk manufacturers of the affected basic classes, and khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:53 Dec 23, 2019 Jkt 250001 applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before February 24, 2020. 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–559 in all correspondence, including attachments. ADDRESSES: 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 classes, and applicants therefore, 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 its 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) as described in 84 FR 44920, published on August 27, 2019. In accordance with 21 CFR 1301.33(a), DEA is providing notice that on September 24, 2019, Royal Emerald Pharmaceuticals Research and Development, 7220 Trade Street, Suite 340, San Diego, California 92121–2324 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 Controlled substance Drug code Marihuana Extract Marihuana ............. Tetrahydrocannabinols .................... Schedule 7350 7360 1 I 7370 I The applicant noticed above applied to become registered with DEA to grow marihuana as a bulk manufacturer subsequent to a 2016 DEA policy statement that provided information on how it intended to expand the number of registrations, and described in general terms the way it would oversee those additional growers. Before DEA completes the evaluation and registration process for applicants to grow marihuana, DEA intends to propose regulations in the near future that would supersede the 2016 policy statement and govern persons seeking to become registered with DEA to grow marihuana as bulk manufacturers, consistent with applicable law, as described in 84 FR 44920. Dated: December 6, 2019. William T. McDermott, Assistant Administrator. [FR Doc. 2019–27783 Filed 12–23–19; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–563] Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturers of Marihuana: Agronomed Pharmaceuticals 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 classes of controlled substances listed in schedule I. Prior to making decisions on this and other pending applications, DEA intends to promulgate regulations that govern the program of growing marihuana for scientific and medical research under DEA registration. DATES: Registered bulk manufacturers of the affected basic classes, and applicants therefor, may file written comments on or objections to the issuance of the proposed registration on or before February 24, 2020. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW 8701 Morrissette Drive, Springfield, Virginia SUMMARY: E:\FR\FM\26DEN1.SGM 26DEN1 71002 Federal Register / Vol. 84, No. 247 / Thursday, December 26, 2019 / Notices 22152. To ensure proper handling of comments, please reference ‘‘Docket No. DEA–563’’ 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 classes, 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 its 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) as described in 84 FR 44920, published on August 27, 2019. In accordance with 21 CFR 1301.33(a), DEA is providing notice that on November 1, 2019, Agronomed Pharmaceuticals, 740 Springdale Drive, Suite 130, Exton, Pennsylvania 19341– 2876 applied to be registered as a bulk manufacturer of the following basic class of controlled substances: khammond on DSKJM1Z7X2PROD with NOTICES Controlled substance Marihuana ............... Tetrahydrocannabinols. Drug code 7360 7370 Schedule I I The applicant noticed above applied to become registered with DEA to grow marihuana as bulk manufacturer subsequent to a 2016 DEA policy statement that provided information on VerDate Sep<11>2014 16:53 Dec 23, 2019 Jkt 250001 how it intended to expand the number of registrations, and described in general terms the way it would oversee those additional growers. Before DEA completes the evaluation and registration process for applicants to grow marihuana, DEA intends to propose regulations in the near future that would supersede the 2016 policy statement and govern persons seeking to become registered with DEA to grow marihuana as bulk manufacturers, consistent with applicable law, as described in 84 FR 44920. Dated: December 6, 2019. William T. McDermott, Assistant Administrator. [FR Doc. 2019–27781 Filed 12–23–19; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE [OMB Number 1140–0020] Agency Information Collection Activities; Proposed eCollection eComments Requested; Revision of a Currently Approved Collection; Firearms Transaction Record/Registro de Transaccio´n de Armas de Fuego— ATF Form 4473 (5300.9) Bureau of Alcohol, Tobacco, Firearms and Explosives, Department of Justice. ACTION: 60-Day notice. AGENCY: The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), 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 collection is being revised to include a Continuation Sheet, as well as changes to the content and layout of the form. There is also a decrease in the total respondents and burden hours associated with this information collection (IC). 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 February 24, 2020. 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: Helen Koppe, ATF Firearms & Explosives Industry Division either by mail at 99 New York Avenue NE, 6 N– SUMMARY: PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 652, Washington, DC 20226, by email at FederalRegisterNoticeATFF4473@ atf.gov, or by telephone at 202–648– 7173. 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. SUPPLEMENTARY INFORMATION: 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: Firearms Transaction Record/Registro de Transaccio´n de Armas de Fuego. (3) The agency form number, if any, and the applicable component of the Department sponsoring the collection: Form number (if applicable): ATF Form 4473 (5300.9). Component: Bureau of Alcohol, Tobacco, Firearms and Explosives, U.S. Department of Justice. (4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Individuals or households. Other (if applicable): Business or other for-profit. Abstract: The Firearms Transaction Record/Registro de Transaccio´n de Armas de Fuego allows Federal firearms licensees to determine the eligibility of persons purchasing firearms. It also alerts buyers to certain restrictions on the receipt and possession of firearms. (5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to E:\FR\FM\26DEN1.SGM 26DEN1

Agencies

[Federal Register Volume 84, Number 247 (Thursday, December 26, 2019)]
[Notices]
[Pages 71001-71002]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27781]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-563]


Bulk Manufacturer of Controlled Substances Application: Bulk 
Manufacturers of Marihuana: Agronomed Pharmaceuticals

ACTION: Notice of application.

-----------------------------------------------------------------------

SUMMARY: 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 classes of controlled 
substances listed in schedule I. Prior to making decisions on this and 
other pending applications, DEA intends to promulgate regulations that 
govern the program of growing marihuana for scientific and medical 
research under DEA registration.

DATES: Registered bulk manufacturers of the affected basic classes, and 
applicants therefor, may file written comments on or objections to the 
issuance of the proposed registration on or before February 24, 2020.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW 8701 
Morrissette Drive, Springfield, Virginia

[[Page 71002]]

22152. To ensure proper handling of comments, please reference ``Docket 
No. DEA-563'' 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 classes, 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 its 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) as described in 84 FR 44920, published on 
August 27, 2019.
    In accordance with 21 CFR 1301.33(a), DEA is providing notice that 
on November 1, 2019, Agronomed Pharmaceuticals, 740 Springdale Drive, 
Suite 130, Exton, Pennsylvania 19341-2876 applied to be registered as a 
bulk manufacturer of the following basic class of controlled 
substances:

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

    The applicant noticed above applied to become registered with DEA 
to grow marihuana as bulk manufacturer subsequent to a 2016 DEA policy 
statement that provided information on how it intended to expand the 
number of registrations, and described in general terms the way it 
would oversee those additional growers. Before DEA completes the 
evaluation and registration process for applicants to grow marihuana, 
DEA intends to propose regulations in the near future that would 
supersede the 2016 policy statement and govern persons seeking to 
become registered with DEA to grow marihuana as bulk manufacturers, 
consistent with applicable law, as described in 84 FR 44920.

    Dated: December 6, 2019.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2019-27781 Filed 12-23-19; 8:45 am]
 BILLING CODE 4410-09-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.