Bulk Manufacturer of Controlled Substances Application: National Center for Natural Products Research (NIDA MPROJECT), 78766-78767 [2015-31669]

Download as PDF 78766 Federal Register / Vol. 80, No. 242 / Thursday, December 17, 2015 / Notices Administrator of the DEA Office of Diversion Control (‘‘Deputy Assistant Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.33(a), this is notice that on September 3, 2015, Johnson Matthey, Inc., Custom Pharmaceuticals Department, 2003 Nolte Drive, West Deptford, New Jersey 08066–1742 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: Controlled substance Schedule Gamma Hydroxybutyric Acid (2010). Marihuana (7360) ......................... Tetrahydrocannabinols (7370) ..... Dihydromorphine (9145) ............... Difenoxin (9168) ........................... Propiram (9649) ........................... Amphetamine (1100) .................... Methamphetamine (1105) ............ Lisdexamfetamine (1205) ............. Methylphenidate (1724) ................ Nabilone (7379) ............................ Cocaine (9041) ............................. Codeine (9050) ............................. Dihydrocodeine (9120) ................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Diphenoxylate (9170) ................... Ecgonine (9180) ........................... Hydrocodone (9193) ..................... Meperidine (9230) ........................ Methadone (9250) ........................ Methadone intermediate (9254) ... Morphine (9300) ........................... Thebaine (9333) ........................... Oxymorphone (9652) ................... Noroxymorphone (9668) .............. Alfentanil (9737) ........................... Remifentanil (9739) ...................... Sufentanil (9740) .......................... Tapentadol (9780) ........................ Fentanyl (9801) ............................ I I I I I I II II II II II II II II II II II II II II II II II II II II II II II II II asabaliauskas on DSK5VPTVN1PROD with NOTICES The company plans to manufacture the listed controlled substances in bulk for sale to its customers. In reference to drug codes 7360 (marihuana) and 7370 (THC), the company plans to bulk manufacture these drugs as synthetic. No other activities for these drug codes are authorized for this registration. Dated: December 9, 2015. Louis J. Milione, Deputy Assistant Administrator. DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Fisher Clinical Services, Inc. ACTION: 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 in accordance with 21 CFR 1301.34(a) on or before January 19, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before January 19, 2016. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. Request for hearings should be sent to: Drug Enforcement Administration, Attention: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: The Attorney General has delegated her authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (‘‘Deputy Assistant Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.34(a), this is notice that on August 26, 2015, Fisher Clinical Services, Inc. 7554 Schantz Road, Allentown, Pennsylvania 18106 applied to be registered as an importer of the following basic classes of controlled substances: DATES: Controlled substance [FR Doc. 2015–31665 Filed 12–16–15; 8:45 am] BILLING CODE 4410–09–P VerDate Sep<11>2014 16:53 Dec 16, 2015 Notice of application. Methylphenidate (1724) ................ Levorphanol (9220) ...................... Noroxymorphone (9668) .............. Tapentadol (9780) ........................ Jkt 238001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 Schedule II II II II The company plans to import the listed substances for analytical research, testing, and clinical trials. This authorization does not extend to the import of a finished FDA approved or non-approved dosage form for commercial distribution in the United States. The company plans to import an intermediate form of tapentadol (9780) to bulk manufacture tapentadol for distribution to its customers. Placement of these (this) drug code (s) onto the company’s registration does not translate into automatic approval of subsequent permit applications to import controlled substances. Approval of permit applications will occur only when the registrant’s business activity is consistent with what is authorized under to 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. Dated: December 9, 2015. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2015–31672 Filed 12–16–15; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: National Center for Natural Products Research (NIDA MPROJECT) 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 in accordance with 21 CFR 1301.33(a) on or before February 16, 2016. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. Request for hearing should be sent to: Drug Enforcement Administration, Attention: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: The Attorney General has delegated her authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with DATES: E:\FR\FM\17DEN1.SGM 17DEN1 Federal Register / Vol. 80, No. 242 / Thursday, December 17, 2015 / Notices respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (‘‘Deputy Assistant Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.33(a), this is notice that on October 27, 2015, National Center for Natural Products Research (NIDA MPROJECT), University of Mississippi, 135 Coy Waller Complex, P.O. Box 1848, University, Mississippi 38677–1848 applied to be registered as a bulk manufacturer of the following basic classes controlled substances: Controlled substance Schedule Marihuana (7360) ......................... Tetrahydrocannabinols (7370) ..... I I The company plans to cultivate marihuana in support of the National Institute on Drug Abuse for research approved by the Department of Health and Human Services. Dated: December 9, 2015. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2015–31669 Filed 12–16–15; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE [OMB Number 1140–0092] Agency Information Collection Activities; Proposed eCollection eComments Requested; Voluntary Magazine Questionnaire for Agencies/ Entities Who Store Explosive Materials 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. DATES: Comments are encouraged and will be accepted for 60 days until February 16, 2016. FOR FURTHER INFORMATION CONTACT: If you have additional comments asabaliauskas on DSK5VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:53 Dec 16, 2015 Jkt 238001 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 Anita Scheddel, Program Analyst, Explosives Industry Programs Branch, 99 New York Ave. NE., Washington, DC 20226 at email: Anita.Scheddel@atf.gov. 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. Overview of this information collection 1140–0092: 1. Type of Information Collection (check justification or form 83): Extension of a currently approved collection. 2. The Title of the Form/Collection: Voluntary Magazine Questionnaire for Agencies/Entities Who Store Explosive Materials. 3. The agency form number, if any, and the applicable component of the Department sponsoring the collection: Form number (if applicable): Not Applicable. 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: Agencies/Entities Who Store Explosive Materials. Other (if applicable): None. Abstract: Primary: Agencies/Entities Who Store Explosive Materials. Other: None. The purpose of the form is to PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 78767 identify the number and locations of public explosives storage facilities (magazines), including those facilities used by State and local law enforcement. 5. An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: An estimated 1,000 respondents will take 30 minutes to complete the survey. 6. An estimate of the total public burden (in hours) associated with the collection: The estimated annual public burden associated with this collection is 500 hours. If additional information is required contact: Jerri Murray, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., Room 3E– 405B, Washington, DC 20530. Dated: December 14, 2015. Jerri Murray, Department Clearance Officer for PRA, U.S. Department of Justice. [FR Doc. 2015–31705 Filed 12–16–15; 8:45 am] BILLING CODE 4410–FY–P DEPARTMENT OF JUSTICE [OMB Number 1121–NEW] Agency Information Collection Activities; Proposed eCollection eComments Requested; New Collection: Body Worn Camera Supplement (BWCS) to the Law Enforcement Management and Administrative Statistics (LEMAS) Survey Bureau of Justice Statistics, Department of Justice. ACTION: 30-day notice. AGENCY: The Department of Justice (DOJ), Office of Justice Programs, Bureau of Justice Statistics, 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. This proposed information collection was previously published in the Federal Register at 80 FR 52512, on August 31, 2015, allowing for a 60 day comment period. SUMMARY: Comments are encouraged and will be accepted for an additional 30 days until January 19, 2016. FOR FURTHER INFORMATION CONTACT: If you have additional comments especially on the estimated public DATES: E:\FR\FM\17DEN1.SGM 17DEN1

Agencies

[Federal Register Volume 80, Number 242 (Thursday, December 17, 2015)]
[Notices]
[Pages 78766-78767]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31669]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: National 
Center for Natural Products Research (NIDA MPROJECT)

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 in accordance with 21 CFR 
1301.33(a) on or before February 16, 2016.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODW, 
8701 Morrissette Drive, Springfield, Virginia 22152. Request for 
hearing should be sent to: Drug Enforcement Administration, Attention: 
Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: The Attorney General has delegated her 
authority under the Controlled Substances Act to the Administrator of 
the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority 
to exercise all necessary functions with

[[Page 78767]]

respect to the promulgation and implementation of 21 CFR part 1301, 
incident to the registration of manufacturers, distributors, 
dispensers, importers, and exporters of controlled substances (other 
than final orders in connection with suspension, denial, or revocation 
of registration) has been redelegated to the Deputy Assistant 
Administrator of the DEA Office of Diversion Control (``Deputy 
Assistant Administrator'') pursuant to section 7 of 28 CFR part 0, 
appendix to subpart R.
    In accordance with 21 CFR 1301.33(a), this is notice that on 
October 27, 2015, National Center for Natural Products Research (NIDA 
MPROJECT), University of Mississippi, 135 Coy Waller Complex, P.O. Box 
1848, University, Mississippi 38677-1848 applied to be registered as a 
bulk manufacturer of the following basic classes controlled substances:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Marihuana (7360)...........................  I
Tetrahydrocannabinols (7370)...............  I
------------------------------------------------------------------------

    The company plans to cultivate marihuana in support of the National 
Institute on Drug Abuse for research approved by the Department of 
Health and Human Services.

    Dated: December 9, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015-31669 Filed 12-16-15; 8:45 am]
 BILLING CODE 4410-09-P
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