Bulk Manufacturer of Controlled Substances Application: Apertus Pharmaceuticals, 61470-61471 [2015-25880]

Download as PDF 61470 Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Notices 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 1301.33(a), this is notice that on August 10, 2015, American Radiolabeled Chemicals, Inc., 101 Arc Drive, St. Louis, Missouri 63146 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: mstockstill on DSK4VPTVN1PROD with NOTICES Controlled substance Schedule Gamma Hydroxybutyric Acid (2010) ........................................ Ibogaine (7260) ............................ Lysergic Acid diethylamide (7315) Tetrahydrocannabinols (7370) ...... Dimethyltryptamine (7435) ........... 1-[1-(2Thienyl)cyclohexyl]piperidine (7470) ........................................ Dihydromorphine (9145) ............... Heroin (9200) ................................ Normorphine (9313) ..................... Amphetamine (1100) .................... Methamphetamine (1105) ............ Amobarbital (2125) ....................... Phencyclidine (7471) .................... Phenylacetone (8501) .................. Cocaine (9041) ............................. Codeine (9050) ............................. Dihydrocodeine (9120) ................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Ecgonine (9180) ........................... Hydrocodone (9193) ..................... Meperidine (9230) ........................ Metazocine (9240) ........................ Methadone (9250) ........................ Dextropropoxyphene, bulk (nondosage forms) (9273) ............... Morphine (9300) ........................... Oripavine (9330) ........................... Thebaine (9333) ........................... Oxymorphone (9652) .................... Phenazocine (9715) ..................... Carfentanil (9743) ......................... Fentanyl (9801) ............................ I I I 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 The company plans to manufacture small quantities of the listed controlled substances as radiolabeled compounds for biochemical research. VerDate Sep<11>2014 21:23 Oct 09, 2015 Jkt 238001 Dated: October 2, 2015. Louis J. Milione, Deputy Assistant Administrator. Dated: October 2, 2015. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2015–25882 Filed 10–9–15; 8:45 am] [FR Doc. 2015–25879 Filed 10–9–15; 8:45 am] BILLING CODE 4410–09–P BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE Drug Enforcement Administration Drug Enforcement Administration [Docket No. DEA–392] [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Cambridge Isotope Lab ACTION: Bulk Manufacturer of Controlled Substances Application: Apertus Pharmaceuticals ACTION: Notice of application. 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 December 14, 2015. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODXL, 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 1301.33(a), this is notice that on August 6, 2015, Apertus Pharmaceuticals, 331 Consort Drive, St. Louis, Missouri 63011 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: DATES: Registered bulk manufacturers of the affected basic class, 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 December 14, 2015. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODXL, 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 1301.33(a), this is notice that on August 7, 2015, Cambridge Isotope Lab, 50 Frontage Road, Andover, Massachusetts 01810 applied to be registered as a bulk manufacturer of morphine (9300), a basic class of controlled substance listed in schedule II. The company plans to utilize small quantities of the listed controlled substance in the preparation of analytical standards. DATES: PO 00000 Frm 00137 Fmt 4703 Sfmt 4703 Controlled Substance Marihuana (7360) ......................... Tetrahydrocannabinols (7370) ..... Remifentanil (9739) ...................... E:\FR\FM\13OCN1.SGM 13OCN1 Schedule I I II Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Notices The company plans to manufacture the above-listed controlled substances in bulk for distribution to its customers. In reference to drug codes 7360 marihuana and 7370 tetrahydrocannabinols the company plans to bulk manufacture both as synthetic substances. No other activity for these drug codes is authorized for this registration. Dated: October 2, 2015. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2015–25880 Filed 10–9–15; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE [OMB Numbers 1121–0341] Agency Information Collection Activities; Proposed Collection; Comments Requested; Revision of a Currently Approved Collection: Office for Victims of Crime Training and Technical Assistance Center (OVC TTAC) Feedback Form Package Office for Victims of Crime, Department of Justice. ACTION: 60-Day notice. AGENCY: The Department of Justice (DOJ), Office of Justice Programs, Office for Victims of Crime, 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 following collections (1121–0336 and 1121–0342) will be discontinued and combined with this revision of 1121–0341. DATES: Comments are encouraged and will be accepted for 60 days until December 14, 2015. FOR FURTHER INFORMATION CONTACT: If you have 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 Shelby Jones Crawford, Program Manager, Office for Victims of Crime, Office of Justice Programs, Department of Justice, 810 7th Street NW., Washington, DC 20530. 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 mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 21:23 Oct 09, 2015 Jkt 238001 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: 1. Type of Information Collection: Revision of Existing Collection. 2. The Title of the Form/Collection: OVC TTAC Feedback Form Package. 3. The agency form number, if any, and the applicable component of the Department sponsoring the collection: N/A. Office for Victims of Crime, Office of Justice Programs, Department of Justice. 4. Affected public who will be asked or required to respond, as well as a brief abstract: Primary: State, Local, or Tribal agencies/organizations. Other: Federal Government; Individuals or households; Not-for-profit institutions; Businesses or other for-profit. Abstract: The Office for Victims of Crime Training and Technical Assistance Center (OVC TTAC) Feedback Form Package is designed to collect the data necessary to continuously assess the satisfaction and outcomes of assistance provided through OVC TTAC for both monitoring and accountability purposes to continuously meet the needs of the victim services field. OVC TTAC will give these forms to recipients of training and technical assistance, scholarship applicants, users of the Web site and call center, consultants/instructors providing training, agencies requesting services, and other professionals receiving assistance from OVC TTAC. The purpose of this data collection will be to capture important feedback on the respondents’ satisfaction and outcomes of the resources provided. The data will then be used to advise OVC on ways to improve the support that it provides to the victim services field at-large. 5. An estimate of the total number of respondents and the amount of time estimated for an average respondent to PO 00000 Frm 00138 Fmt 4703 Sfmt 4703 61471 respond: There are approximately 27,225 respondents who will require an average of 10 minutes (ranging from 5 to 15 minutes across all forms) to respond to a single form each year. 6. An estimate of the total public burden (in hours) associated with the collection: The total annual public burden hours for this information collection are estimated to be 5,075 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., 3E.405B, Washington, DC 20530. Dated: October 6, 2015. Jerri Murray, Department Clearance Officer for PRA, U.S. Department of Justice. [FR Doc. 2015–25873 Filed 10–9–15; 8:45 am] BILLING CODE 4410–18–P DEPARTMENT OF LABOR Employment and Training Administration Renewal of the Native American Employment and Training Council (NAETC) Charter Employment and Training Administration, Labor. ACTION: Renewal of the Native American Employment and Training Council (NAETC) Charter. AGENCY: Notice is hereby given of the renewal of the Workforce Innovation and Opportunity Act (WIOA), section 166 Indian and Native American Programs Charter that is necessary and in the public interest. Accordingly, the U.S. Department of Labor (the Department), Employment and Training Administration (ETA) has renewed the NAETC Charter for two years with revisions. The revisions are not intended to change the purpose or the Council’s original intent. The revisions include language regarding the use of proxies and changes to the membership balance plan. The Council Charter expired on September 9, 2015. SUPPLEMENTARY INFORMATION: Background: Pursuant to WIOA section 166(i)(4)(C), the NAETC advises the Secretary on the operation and administration of the Native American programs authorized under section 166 of WIOA. In addition, the Council advises the Secretary on matters that promote the employment and training needs of Indian and Native Americans, SUMMARY: E:\FR\FM\13OCN1.SGM 13OCN1

Agencies

[Federal Register Volume 80, Number 197 (Tuesday, October 13, 2015)]
[Notices]
[Pages 61470-61471]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25880]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Apertus 
Pharmaceuticals

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 December 14, 2015.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODXL, 
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 1301.33(a), this is notice that on August 
6, 2015, Apertus Pharmaceuticals, 331 Consort Drive, St. Louis, 
Missouri 63011 applied to be registered as a bulk manufacturer of the 
following basic classes of controlled substances:

------------------------------------------------------------------------
            Controlled Substance                       Schedule
------------------------------------------------------------------------
Marihuana (7360)...........................  I
Tetrahydrocannabinols (7370)...............  I
Remifentanil (9739)........................  II
------------------------------------------------------------------------


[[Page 61471]]

    The company plans to manufacture the above-listed controlled 
substances in bulk for distribution to its customers. In reference to 
drug codes 7360 marihuana and 7370 tetrahydrocannabinols the company 
plans to bulk manufacture both as synthetic substances.
    No other activity for these drug codes is authorized for this 
registration.

    Dated: October 2, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015-25880 Filed 10-9-15; 8:45 am]
BILLING CODE 4410-09-P

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