Bulk Manufacturer of Controlled Substances Application: Chattem Chemicals, 64564-64565 [2019-25400]

Download as PDF 64564 Federal Register / Vol. 84, No. 226 / Friday, November 22, 2019 / Notices is notice that on October 4, 2019, S & B Pharma, Inc., DBA Norac Pharma, 405 South Motor Avenue, Azusa, California 91702–3232 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: Controlled substance Drug code Gamma Hydroxybutyric Acid ................................................................................................................................... Telrahydrocannabinois ............................................................................................................................................. Amphetamine ........................................................................................................................................................... Methamphetamine ................................................................................................................................................... Lisdexamfetamine .................................................................................................................................................... Methylphenidate ....................................................................................................................................................... Pentobarbital ............................................................................................................................................................ 4-Anilino-N-phenethyl-4-piperidine (ANPP) ............................................................................................................. Tapentadol ............................................................................................................................................................... Fentanyl ................................................................................................................................................................... The company plans to manufacture the listed controlled substances in bulk for use in product development and for commercial sales to its customers. In reference to drug code 7360 (marihuana) and 7370 (tetrahydrocannabinois), the company plans to bulk manufacture both as synthetic substances. No other activity for these dug codes is authorized for this registration. Dated: November 5, 2019. William T. McDermott, Assistant Administrator. [FR Doc. 2019–25402 Filed 11–21–19; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–549] Importer of Controlled Substances Application: Mylan Technologies 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 23, 2019. Such persons may also file a written request for a hearing on the application on or before December 23, 2019. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 DATES: In accordance with 21 CFR 1301.34(a), this is notice that on October 16, 2019, Mylan Technologies Inc., 110 Lake Street, Saint Albans, Vermont 054780 applied to be registered as an importer of the following basic classes of controlled substances: Drug code khammond on DSKJM1Z7X2PROD with NOTICES DEPARTMENT OF JUSTICE Dated: November 8, 2019. William T. McDermott, Assistant Administrator. DATES: [FR Doc. 2019–25405 Filed 11–21–19; 8:45 am] BILLING CODE 4410–09–P Jkt 250001 Drug Enforcement Administration [Docket No. DEA–540] Bulk Manufacturer of Controlled Substances Application: Chattem Chemicals 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 January 21, 2020. PO 00000 Frm 00112 Fmt 4703 1724 9801 In accordance with 21 CFR 1301.33(a), this is notice that on May 17, 2019, Chattem Chemicals, 3801 Saint Elmo Avenue, Chattanooga, Tennessee 37409 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Drug code Sfmt 4703 II II Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. Gamma Hydroxybutyric Acid ................................................................................................................................... Marihuana ................................................................................................................................................................ Tetrahydrocannabinols ............................................................................................................................................ 16:57 Nov 21, 2019 Schedule ADDRESSES: Controlled substance VerDate Sep<11>2014 I I II II II II II II II II SUPPLEMENTARY INFORMATION: Methylphenidate ....................................................................................................................................................... Fentanyl ................................................................................................................................................................... ACTION: 7360 7370 1100 1105 1205 1724 2270 8333 9780 9801 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. Controlled substance The company plans to import the listed controlled substances in finished dosage form (FDF) from foreign sources for analytical testing and clinical trials in which the foreign FDF will be compared to the company’s own domestically-manufactured FDF. This analysis is required to allow the company to export domestically manufactured FDF to foreign markets. Schedule E:\FR\FM\22NON1.SGM 22NON1 2010 7360 7370 Schedule I I I 64565 Federal Register / Vol. 84, No. 226 / Friday, November 22, 2019 / Notices Controlled substance Drug code 4-Methoxyamphetamine .......................................................................................................................................... Dihydromorphine ...................................................................................................................................................... Amphetamine ........................................................................................................................................................... Methamphetamine ................................................................................................................................................... Lisdexamfetamine .................................................................................................................................................... Methylphenidate ....................................................................................................................................................... Cocaine .................................................................................................................................................................... Codeine .................................................................................................................................................................... Dihydrocodeine ........................................................................................................................................................ Oxycodone ............................................................................................................................................................... Hydromorphone ....................................................................................................................................................... Ecgonine .................................................................................................................................................................. Hydrocodone ............................................................................................................................................................ Levorphanol ............................................................................................................................................................. Methadone ............................................................................................................................................................... Methadone intermediate .......................................................................................................................................... Morphine .................................................................................................................................................................. Oripavine .................................................................................................................................................................. Thebaine .................................................................................................................................................................. Oxymorphone .......................................................................................................................................................... Noroxymorphone ..................................................................................................................................................... Tapentadol ............................................................................................................................................................... Fentanyl ................................................................................................................................................................... The company plans to manufacturer the listed controlled substances in bulk for distribution and sale to its customers. In reference to drug codes 7360 (marihuana) and 7370 (tetrahydrocannabinols), the company plans to bulk manufacture these drugs as synthetics. No other activities for these drug codes are authorized for this registration. Dated: November 5, 2019. William T. McDermott, Assistant Administrator. [FR Doc. 2019–25400 Filed 11–21–19; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE [OMB Number 1117–0053] Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension of a Previously Approved Collection: Leadership Engagement Survey Department of Justice, Drug Enforcement Administration. ACTION: 30-Day notice. AGENCY: The Department of Justice (DOJ), Drug Enforcement Administration (DEA), will be submitting 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 was previously published in the Federal Register allowing for a 60 day comment period. khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:57 Nov 21, 2019 Jkt 250001 Comments are encouraged and will be accepted for 30 days until December 23, 2019. DATES: If you have additional comments especially on 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 Chiwoniso S. Gurira (Choni), Senior Personnel Psychologist, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 22152. Written comments and/or suggestions may also be directed to the Office of Management and Budget, Office of Information and Regulatory Affairs, Attention Department of Justice Desk Officer, Washington, DC 20530 or send to OIRA_submission@omb.eop.gov. FOR FURTHER INFORMATION CONTACT: This process is conducted in accordance with 5 CFR 1320.10. 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 Bureau of Justice Statistics, 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; SUPPLEMENTARY INFORMATION: PO 00000 Frm 00113 Fmt 4703 Sfmt 4703 7411 9145 1100 1105 1205 1724 9041 9050 9120 9143 9150 9180 9193 9220 9250 9254 9300 9330 9333 9652 9668 9780 9801 Schedule I I II II II II II II II II II II II II II II II II II II II II II —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. Overview of This Information Collection 1. Type of Information Collection: Extension of a previously approved collection for which approval has expired. 2. The Title of the Form/Collection: Leadership Engagement Survey. 3. The agency form number, if any and the applicable component of the Department sponsoring the collection: Online survey. 4. Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Drug Enforcement Administration contractors and Task Force Officers. Other: None. 5. An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: It is estimated that 5000 respondents will complete the survey in approximately 20 minutes. 6. An estimate of the total public burden (in hours) associated with the collection: The estimated public burden associated with this collection is 1667 hours. It is estimated that applicants E:\FR\FM\22NON1.SGM 22NON1

Agencies

[Federal Register Volume 84, Number 226 (Friday, November 22, 2019)]
[Notices]
[Pages 64564-64565]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25400]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-540]


Bulk Manufacturer of Controlled Substances Application: Chattem 
Chemicals

ACTION: Notice of application.

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

DATES: 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 January 21, 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 May 17, 2019, Chattem Chemicals, 3801 Saint Elmo 
Avenue, Chattanooga, Tennessee 37409 applied to be registered as a bulk 
manufacturer of the following basic classes of controlled substances:

------------------------------------------------------------------------
          Controlled substance               Drug code       Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid...............            2010               I
Marihuana...............................            7360               I
Tetrahydrocannabinols...................            7370               I

[[Page 64565]]

 
4-Methoxyamphetamine....................            7411               I
Dihydromorphine.........................            9145               I
Amphetamine.............................            1100              II
Methamphetamine.........................            1105              II
Lisdexamfetamine........................            1205              II
Methylphenidate.........................            1724              II
Cocaine.................................            9041              II
Codeine.................................            9050              II
Dihydrocodeine..........................            9120              II
Oxycodone...............................            9143              II
Hydromorphone...........................            9150              II
Ecgonine................................            9180              II
Hydrocodone.............................            9193              II
Levorphanol.............................            9220              II
Methadone...............................            9250              II
Methadone intermediate..................            9254              II
Morphine................................            9300              II
Oripavine...............................            9330              II
Thebaine................................            9333              II
Oxymorphone.............................            9652              II
Noroxymorphone..........................            9668              II
Tapentadol..............................            9780              II
Fentanyl................................            9801              II
------------------------------------------------------------------------

    The company plans to manufacturer the listed controlled substances 
in bulk for distribution and sale to its customers.
    In reference to drug codes 7360 (marihuana) and 7370 
(tetrahydrocannabinols), the company plans to bulk manufacture these 
drugs as synthetics. No other activities for these drug codes are 
authorized for this registration.

    Dated: November 5, 2019.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2019-25400 Filed 11-21-19; 8:45 am]
 BILLING CODE 4410-09-P
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