Bulk Manufacturer of Controlled Substances Registration, 57747-57748 [2019-23501]

Download as PDF 57747 Federal Register / Vol. 84, No. 208 / Monday, October 28, 2019 / Notices khammond on DSKJM1Z7X2PROD with NOTICES system for payment of the associated permit application fee. We anticipate including the following Service forms in the ePermits initiative: 3–186, 3–186a, 3–200–6 through 3–200– 9, 3–200–10a through 3–200–10f, 3– 200–12 through 3–200–13, 3–200–67, 3– 200–79, 3–200–81, 3–202–1 through 3– 202–10, 3–202–12, and 3–202–17. Falconry Program Requirements Additionally, we will request are proposing to incorporate the information collection requirements associated with the Service’s falconry program into this collection (OMB Control No. 1018–0022). Beginning in 2014, the Service passed the authority to issue permits for the practice of falconry to individual States (50 CFR 21.29; 78 FR 72830, December 4, 2013). As part of this change in authority, we required States to maintain databases of falconers authorized to conduct falconry in their States and required falconers to report transfers of falconry birds using the paper version of FWS Form 3–186A. We require each State that maintains its own database to ensure that it is compatible with the Service’s database. To date, 47 States utilize the system provided by the Service. The Service’s database continues to track take of birds from the wild by falconers and to maintain records of persons permitted by the States to practice falconry, as required by 50 CFR 21.29(k)(1). The primary purpose of this database is to allow the Service to track take of raptors from the wild by falconers to ensure take does not exceed levels established in the Service’s 2008 environmental assessment of the impacts of the falconry regulations on wild raptor populations. The ability to track and document the effects of the wild take of raptors by falconers remains a responsibility of the Service. The database also: (1) Provides falconers and States with the information necessary to allow the efficient movement of falconers and raptors held under falconry permits among States; and (2) ensures that falconers can formally document their experience regardless of the States in which they have resided, which is required to advance from the apprentice—to general—to master-class permit levels. In 2018, the Service requested and received OMB approval under the Department of the Interior Fast Track generic clearance (OMB Control No. 1090–0011) to conduct usability testing of the revised/repaired application and database functionality. The revised/ repairs falconry database (database) replaced a legacy system based on outdated programming. It reduced the cost to the government by eliminating the need for Service personnel to enter data for each new falconer, and simply required the entry of data for State administrators. In addition, this new database enhances the user experience by allowing them to enter data from any device that has internet access, including PCs, tablets, and smart phones. The usability testing helped the Service to address problems and recommendations prior to the database going live. We are now ready to request full OMB approval of the falconry database and the information collection requirements associated with the falconry program. Goose Requirements OMB previously approved the information collection requirements associated with the management of geese under two OMB control numbers: 1018–0103, ‘‘Conservation Order for Light Geese, 50 CFR 21.60’’ (exp. 03/31/ 2021) and 1018–0133, ‘‘Control and Management of Resident Canada Geese, 50 CFR 20.21, 21.49, 21.50, 21.51, 21.52 and 21.61’’ (exp. 06/30/2022). Since both collections follow the requirements of the Migratory Bird Treaty Act, we are proposing to transfer the information collections into 1018–0022. We are not proposing any changes to the currently approved requirements for either collection and are merely transferring the requirements into 1018–0022. The annual burden associated with 1018– 0103 is 21,577 responses, 7,318 burden hours, and $78,000 non-hour cost burden for overhead costs (materials, printing, postage, etc.). The annual burden associated with 1018–0133 is 8,698 responses, 3,360 burden hours, and zero non-hour burden costs. There are no forms associated with either of these two collections. Title of Collection: Federal Fish and Wildlife Permit Applications and Reports—Migratory Birds; 50 CFR 10, 13, 21. OMB Control Number: 1018–0022. Form Number: FWS Forms 3–186, 3– 186a, 3–200–6 through 3–200–9, 3–200– 10a through 3–200–10f, 3–200–12 through 3–200–13, 3–200–67, 3–200–79, 3–200–81, 3–202–1 through 3–202–10, 3–202–12, and 3–202–17. Type of Review: Revision of an existing information collection. Respondents/Affected Public: Individuals; zoological parks; museums; universities; scientists; taxidermists; businesses; utilities; and Federal, State, local, and Tribal governments. Total Estimated Number of Annual Respondents: 56,984. Total Estimated Number of Annual Responses: 56,984. Estimated Completion Time per Response: Varies from 15 minutes to 240 hours, depending on activity. Total Estimated Number of Annual Burden Hours: 213,365. Respondent’s Obligation: Required to obtain or retain a benefit. Frequency of Collection: On occasion for applications; annually or on occasion for reports. Total Estimated Annual Nonhour Burden Cost: $571,975 (primarily associated with application processing fees). 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 Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Dated: October 23, 2019. Madonna L. Baucum, Information Collection Clearance Officer, U.S. Fish and Wildlife Service. [FR Doc. 2019–23459 Filed 10–25–19; 8:45 am] BILLING CODE 4333–15–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Registration ACTION: Notice of registration. The registrants listed below have applied for and been granted a registration by the Drug Enforcement Administration (DEA) as a bulk manufacturer of a various classes of schedule I and II controlled substances. SUPPLEMENTARY INFORMATION: The companies listed below applied to be registered as a bulk manufacturer of various classes of scheduled I and II controlled substances. Information on previously published notices is listed below. No comments or objections were submitted for these notices. SUMMARY: Company FR docket American Radiolabeled Chem ................................................................... 84 FR 26446 ....................................................... VerDate Sep<11>2014 16:58 Oct 25, 2019 Jkt 250001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\28OCN1.SGM Published 28OCN1 June 6, 2019. 57748 Federal Register / Vol. 84, No. 208 / Monday, October 28, 2019 / Notices Company FR docket Eli-Elsohly Laboratories ............................................................................. 84 FR 27661 ....................................................... The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of these registrants to manufacture the applicable basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company’s maintenance of effective controls against diversion by inspecting and testing each company’s physical security systems, verifying each company’s compliance with state and local laws, and reviewing the company’s background and history. Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the DEA has granted a registration as a bulk manufacturer to the above listed companies. Dated: October 18, 2019. William T. McDermott, Assistant Administrator. [FR Doc. 2019–23501 Filed 10–25–19; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Catalent CTS, LLC ACTION: Notice of application. 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 November 27, 2019. Such persons may also file a written request for a hearing on the application on or before November 27, 2019. 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 khammond on DSKJM1Z7X2PROD with NOTICES DATES: VerDate Sep<11>2014 16:58 Oct 25, 2019 Jkt 250001 Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this is notice that on July 16, 2019, Catalent CTS, LLC, 10245 Hickman Mills Drive, Kansas City, Missouri 64137–1418 applied to be registered as an importer of the following basic classes of controlled substances: Controlled substance Gamma Hydroxybutyric Acid. Marihuana Extract .......... Marihuana ....................... Tetrahydrocannabinols ... Drug code Schedule 2010 I 7350 7360 7370 I I I Published June 13, 2019. Morrissette Drive, Springfield, Virginia 22152. In accordance with 21 CFR 1301.33(a), this is notice that on June 27, 2019, Euticals Inc., 2460 W Bennett Street, Springfield, Missouri 65807–1229 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Controlled substance Gamma Hydroxybutyric Acid. Amphetamine ............... Lisdexamfetamine ........ Methylphenidate ........... Phenylacetone .............. Methadone .................... Methadone intermediate Oripavine ...................... Tapentadol .................... Drug code Schedule 2010 I 1100 1205 1724 8501 9250 9254 9330 9780 II II II II II II II II The company plans to import finished dosage unit products containing gammahydroxybutryic acid and marihuana extracts for clinical trial studies. These marihuana extracts compounds are listed under drug code 7350. 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 nonapproved finished dosage forms for commercial sale. The company plans to manufacture the above-listed controlled substances in bulk for distribution to its customers. Dated: October 18, 2019. William T. McDermott, Assistant Administrator. DEPARTMENT OF JUSTICE [FR Doc. 2019–23502 Filed 10–25–19; 8:45 am] Drug Enforcement Administration Dated: October 18, 2019. William T. McDermott, Assistant Administrator. [FR Doc. 2019–23499 Filed 10–25–19; 8:45 am] BILLING CODE 4410–09–P BILLING CODE 4410–09–P [Docket No. DEA–392] DEPARTMENT OF JUSTICE Drug Enforcement Administration ACTION: [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Euticals Inc. ACTION: Notice of application. 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 December 27, 2019. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 DATES: PO 00000 Frm 00061 Fmt 4703 [Bulk Manufacturer of Controlled Substances Registration Sfmt 4703 Notice of registration. The registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as bulk manufacturers of various classes of schedule I and II controlled substances. SUMMARY: The companies listed below applied to be registered as a bulk manufacturers of various classes of scheduled I and II controlled substances. Information on previously published notices is listed below. No comments or objections were submitted for these notices. SUPPLEMENTARY INFORMATION: E:\FR\FM\28OCN1.SGM 28OCN1

Agencies

[Federal Register Volume 84, Number 208 (Monday, October 28, 2019)]
[Notices]
[Pages 57747-57748]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23501]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Registration

ACTION: Notice of registration.

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SUMMARY: The registrants listed below have applied for and been granted 
a registration by the Drug Enforcement Administration (DEA) as a bulk 
manufacturer of a various classes of schedule I and II controlled 
substances.

SUPPLEMENTARY INFORMATION: The companies listed below applied to be 
registered as a bulk manufacturer of various classes of scheduled I and 
II controlled substances. Information on previously published notices 
is listed below. No comments or objections were submitted for these 
notices.

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           Company                FR docket             Published
------------------------------------------------------------------------
American Radiolabeled Chem...  84 FR 26446....  June 6, 2019.

[[Page 57748]]

 
Eli-Elsohly Laboratories.....  84 FR 27661....  June 13, 2019.
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    The DEA has considered the factors in 21 U.S.C. 823(a) and 
determined that the registration of these registrants to manufacture 
the applicable basic classes of controlled substances is consistent 
with the public interest and with United States obligations under 
international treaties, conventions, or protocols in effect on May 1, 
1971. The DEA investigated the company's maintenance of effective 
controls against diversion by inspecting and testing each company's 
physical security systems, verifying each company's compliance with 
state and local laws, and reviewing the company's background and 
history.
    Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 
CFR 1301.33, the DEA has granted a registration as a bulk manufacturer 
to the above listed companies.

    Dated: October 18, 2019.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2019-23501 Filed 10-25-19; 8:45 am]
 BILLING CODE 4410-09-P
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