Manufacturer of Controlled Substances Registration: PCAS-Nanosyn, LLC, 54327-54328 [2015-22626]

Download as PDF 54327 Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Notices 21 CFR 1301.43 on or before October 9, 2015. 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. Comments and requests for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417 (January 25, 2007). ADDRESS: 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 July 22, 2015, Chattem Chemicals, Inc., 3801 St. Elmo Avenue, Chattanooga, Tennessee 37409 applied to be registered as an importer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Controlled substance Schedule Lhorne on DSK5TPTVN1PROD with NOTICES Methamphetamine (1105) ............ 4-Anilino-N-phenethyl-4-piperidine (8333). Phenylacetone (8501) .................. Opium, raw (9600) ....................... Poppy Straw Concentrate (9670) Tapentadol (9780) ........................ II II II II II II The company plans to import the listed controlled substances to bulk manufacture other controlled substances for distribution to its customers. The company plans to import an intermediate form of tapentadol (9780), to bulk manufacturer tapentadol (9780) for distribution to its customers. The company plans to import Phenylacetone (8501) in bulk for the manufacture of a controlled substance. VerDate Sep<11>2014 14:19 Sep 08, 2015 Jkt 235001 Dated: September 1, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. Dated: September 1, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015–22624 Filed 9–8–15; 8:45 am] [FR Doc. 2015–22625 Filed 9–8–15; 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] Importer of Controlled Substances Application: Akorn, Inc. Manufacturer of Controlled Substances Registration: PCASNanosyn, LLC ACTION: Notice of application. ACTION: 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 1301.34(a) on or before October 9, 2015. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before October 9, 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 1301.34(a), this is notice that on May 14, 2015, Akorn, Inc., 1222 W. Grand Avenue, Decatur, Illinois 62522 applied to be registered as an importer of remifentanil (9739), a basic class of controlled substance listed in schedule II. The company plans to import remifentanil in dosage form for distribution. DATES: PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 Notice of registration. PCAS-Nanosyn, LLC applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants PCASNanosyn, LLC registration as a manufacturer of those controlled substances. SUMMARY: SUPPLEMENTARY INFORMATION: By notice dated May 15, 2015, and published in the Federal Register on May 21, 2015, 80 FR 29336, PCASNanosyn, LLC, 3331–B Industrial Drive, Santa Rosa, California 95403 applied to be registered as a manufacturer of certain basic classes of controlled substances. No comments or objections were submitted for this notice. The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of PCAS-Nanosyn, LLC to manufacture the 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 the company’s physical security systems, verifying the 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 above-named company is granted registration as a bulk manufacturer of the basic classes of controlled substances: Controlled substance Oxycodone (9143) ........................ Oripavine (9330) ........................... Oxymorphone (9652) ................... Fentanyl (9801) ............................ Schedule II II II II The company is a contract manufacturer. At the request of the company’s customers, it manufacturers E:\FR\FM\09SEN1.SGM 09SEN1 54328 Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Notices derivatives of controlled substances in bulk form. Dated: September 1, 2015 Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015–22626 Filed 9–8–15; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF LABOR Employee Benefits Security Administration Lhorne on DSK5TPTVN1PROD with NOTICES 178th Meeting of the Advisory Council on Employee Welfare and Pension Benefit Plans; Notice of Teleconference Meeting Pursuant to the authority contained in Section 512 of the Employee Retirement Income Security Act of 1974 (ERISA), 29 U.S.C. 1142, the 178th open meeting of the Advisory Council on Employee Welfare and Pension Benefit Plans (also known as the ERISA Advisory Council) will be held as a teleconference on September 30, 2015. The meeting will take place in C5320 room 6, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210. Public access is available only in this room (i.e. not by telephone). The meeting will run from 9:00 a.m. to approximately 4:00 p.m. The purpose of the open meeting is to discuss reports/ recommendations for the Secretary of Labor on the issues of (1) Model Notices and Plan Sponsor Education on Lifetime Plan Participation and (2) Model Notices and Disclosures for Pension Risk Transfers. Descriptions of these topics are available on the Advisory Council page of the EBSA Web site at http://www.dol.gov/ebsa/aboutebsa/ erisa_advisory_council.html. Organizations or members of the public wishing to submit a written statement may do so by submitting 30 copies on or before September 23, 2015 to Larry Good, Executive Secretary, ERISA Advisory Council, U.S. Department of Labor, Suite N–5623, 200 Constitution Avenue NW., Washington, DC 20210. Statements also may be submitted as email attachments in rich text, Word, or pdf format transmitted to good.larry@dol.gov. It is requested that statements not be included in the body of an email. Statements deemed relevant by the Advisory Council and received on or before September 23 will be included in the record of the meeting and will be available to anyone by contacting the EBSA Public Disclosure Room. Do not include any personally identifiable information (such as name, address, or other contact information) or VerDate Sep<11>2014 14:19 Sep 08, 2015 Jkt 235001 confidential business information that you do not want publicly disclosed. Individuals or representatives of organizations wishing to address the Advisory Council should forward their requests to the Executive Secretary or telephone (202) 693–8668. Oral presentations will be limited to ten minutes, time permitting, but an extended statement may be submitted for the record. Individuals with disabilities who need special accommodations should contact the Executive Secretary by September 23, 2015 at the address indicated. Signed at Washington, DC, this 2nd day of September, 2015. Judith Mares, Deputy Assistant Secretary, Employee Benefits Security Administration. [FR Doc. 2015–22643 Filed 9–8–15; 8:45 am] BILLING CODE 4510–29–P NATIONAL SCIENCE FOUNDATION National Science Board; Sunshine Act Meetings; Notice The National Science Board’s ad hoc Task Force on NEON Performance and Plans, pursuant to NSF regulations (45 CFR part 614), the National Science Foundation Act, as amended (42 U.S.C. 1862n–5), and the Government in the Sunshine Act (5 U.S.C. 552b), hereby gives notice in regard to the scheduling of a meeting for the transaction of National Science Board business, as follows: Friday, September 4, 2015 at 4–5 p.m. EDT. TIME AND DATE: This meeting will be held by teleconference originating at the National Science Board Office, National Science Foundation, 4201 Wilson Blvd., Arlington, VA 22230. PLACE: STATUS: Closed. Task Force Chair’s opening remarks; review and discussion of the Task Force charge, and discussion of the status of the NEON project. MATTERS TO BE CONSIDERED: CONTACT PERSON FOR MORE INFORMATION: Please refer to the National Science Board Web site (www.nsf.gov/nsb) for information or schedule updates, or contact: John Veysey (jveysey@nsf.gov), National Science Foundation, 4201 Wilson Blvd., Arlington, VA 22230. Nadene Kennedy, Polar Coordination Specialist. [FR Doc. 2015–22727 Filed 9–4–15; 11:15 am] BILLING CODE 7555–01–P PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 OFFICE OF PERSONNEL MANAGEMENT Submission for Review: Representative Payee Application, RI 20–007 and Information Necessary for a Competency Determination, RI 30–3, 3206–0140 U.S. Office of Personnel Management. ACTION: 60-Day notice and request for comments. AGENCY: The Retirement Services, Office of Personnel Management (OPM) offers the general public and other Federal agencies the opportunity to comment on a revised information collection request (ICR) 3206–0140, Representative Payee Application, RI 20–7; Information necessary for a competency determination, collects medical information regarding the annuitant’s competency in evaluating the annuitant’s condition, RI 30–3. As required by the Paperwork Reduction Act of 1995 (Pub. Law 104–13, 44 U.S.C. chapter 35) as amended by the ClingerCohen Act (Pub. L. 104–106), OPM is soliciting comments for this collection. DATES: Comments are encouraged and will be accepted until November 9, 2015. This process is conducted in accordance with 5 CFR 1320.1. ADDRESSES: Interested persons are invited to submit written comments on the proposed information collection to Retirement Services, U.S. Office of Personnel Management, 1900 E Street NW., Washington, DC 20415, Attention: Alberta Butler, Room 2349, or sent via electronic mail to Alberta.Butler@ opm.gov. FOR FURTHER INFORMATION CONTACT: A copy of this ICR, with applicable supporting documentation, may be obtained by contacting the Retirement Services Publications Team, Office of Personnel Management, 1900 E Street NW., Room 3316–AC, Washington, DC 20415, Attention: Cyrus S. Benson or sent via electronic mail to Cyrus.Benson@opm.gov or faxed to (202) 606–0910. SUPPLEMENTARY INFORMATION: The Office of Management and Budget is particularly interested in comments that: 1. Evaluate whether the proposed collection of information is necessary for the proper performance of functions of OPM, including whether the information will have practical utility; 2. Evaluate the accuracy of OPM’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; SUMMARY: E:\FR\FM\09SEN1.SGM 09SEN1

Agencies

[Federal Register Volume 80, Number 174 (Wednesday, September 9, 2015)]
[Notices]
[Pages 54327-54328]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-22626]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Manufacturer of Controlled Substances Registration: PCAS-Nanosyn, 
LLC

ACTION: Notice of registration.

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SUMMARY: PCAS-Nanosyn, LLC applied to be registered as a manufacturer 
of certain basic classes of controlled substances. The Drug Enforcement 
Administration (DEA) grants PCAS-Nanosyn, LLC registration as a 
manufacturer of those controlled substances.

SUPPLEMENTARY INFORMATION: 
    By notice dated May 15, 2015, and published in the Federal Register 
on May 21, 2015, 80 FR 29336, PCAS-Nanosyn, LLC, 3331-B Industrial 
Drive, Santa Rosa, California 95403 applied to be registered as a 
manufacturer of certain basic classes of controlled substances. No 
comments or objections were submitted for this notice.
    The DEA has considered the factors in 21 U.S.C. 823(a) and 
determined that the registration of PCAS-Nanosyn, LLC to manufacture 
the 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 the company's physical security 
systems, verifying the 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 above-named company is granted registration as a bulk 
manufacturer of the basic classes of controlled substances:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Oxycodone (9143)...........................  II
Oripavine (9330)...........................  II
Oxymorphone (9652).........................  II
Fentanyl (9801)............................  II
------------------------------------------------------------------------

    The company is a contract manufacturer. At the request of the 
company's customers, it manufacturers

[[Page 54328]]

derivatives of controlled substances in bulk form.

    Dated: September 1, 2015
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-22626 Filed 9-8-15; 8:45 am]
 BILLING CODE 4410-09-P