Manufacturer of Controlled Substances; Notice of Application, 17474-17475 [05-6796]

Download as PDF 17474 Federal Register / Vol. 70, No. 65 / Wednesday, April 6, 2005 / Notices Drug Schedule Glutethimide (2550) ...................... Phencyclidine (7471) .................... Cocaine (9041) ............................. Codeine (9050) ............................. Diprenorphine (9058) ................... Oxycodone (9143) ........................ Hydromorphone (9150) ................ Ecgonine (9180) ........................... Ethylmorphine (9190) ................... Hydrocodone (9193) ..................... Levorphanol (9220) ...................... Meperidine (9230) ........................ Methadone (9250) ........................ Dextropropoxyphene, bulk (nondosage forms) (9273). Morphine (9300) ........................... Thebaine (9333) ........................... Opium powdered (9649) .............. Oxymorphone (9652) ................... Fentanyl (9801) ............................ II II II II II II II II II II II II II II BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application II II II II II The company plans to import the listed controlled substances for drug testing and analysis. Any manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic classes of controlled substances may file comments or objections to the issuance of the proposed registration and may, at the same time, file a written request for a hearing on such application pursuant to 21 CFR 1301.43 and in such form as prescribed by 21 CFR 1316.47. Any such written comments or objections being sent via regular mail may be addressed, in quintuplicate, to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Attention: DEA Federal Register Representative, Liaison and Policy Section (ODL); or any being sent via express mail should be sent to DEA Headquarters, Attention: DEA Federal Register Representative/ODL, 2401 Jefferson-Davis Highway, Alexandria, Virginia 22301; and must be filed no later than May 6, 2005. This procedure is to be conducted simultaneously with and independent of the procedures described in 21 CFR 1301.34(b), (c), (d), (e) and (f). As noted in a previous notice published in the Federal Register on September 23, 1975 (40 FR 43745–46), all applicants for registration to import a basic class of any controlled substance in Schedule I or II are and will continue to be required to demonstrate to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, that the requirements for such registration pursuant to 21 U.S.C. 958(a), 21 U.S.C. 823(a), and 21 CFR 1301.34(b), (c),(d),(e) and (f) are satisfied. VerDate jul<14>2003 18:17 Apr 05, 2005 Jkt 205001 Dated: March 29, 2005. William J. Walker, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 05–6792 Filed 4–5–05; 8:45 am] Pursuant to 21 U.S.C. 958(i), the Attorney General shall, prior to issuing a registration under this Section to a bulk manufacturer of a controlled substance in Schedule I or II and prior to issuing a regulation under 21 U.S.C. 952(a)(2)(B) authorizing the importation of such a substance, provide manufacturers holding registrations for the bulk manufacture of the substance an opportunity for a hearing. Therefore, in accordance with 21 CFR 1301.34(a), this is notice that on January 26, 2005, Stepan Company, Natural Products Department, 100 W. Hunter Avenue, Maywood, New Jersey 07607, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of Coca Leaves (9040), a basic class of controlled substance listed in Schedule II. The company plans to import the listed controlled substance for the manufacture of bulk controlled substances and distribution to its customers. Any manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic classes of controlled substances may file comments or objections to the issuance of the proposed registration and may, at the same time, file a written request for a hearing on such application pursuant to 21 CFR 1301.43 and in such form as prescribed by 21 CFR 1316.47. Any such written comments or objections being sent via regular mail may be addressed, in quintuplicate, to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Attention: DEA Federal Register Representative, Liaison and Policy Section (ODL); or any being sent via express mail should be sent to DEA Headquarters, Attention: DEA Federal Register Representative/ODL, 2401 Jefferson-Davis Highway, Alexandria, Virginia 22301; and must be filed no later than (30 days from publication). PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 This procedure is to be conducted simultaneously with and independent of the procedures described in 21 CFR 1301.34(b), (c), (d), (e) and (f). As noted in a previous notice published in the Federal Register on September 23, 1975, (40 FR 43745–46), all applicants for registration to import a basic class of any controlled substance listed in Schedule I or II are, and will continue to be required to demonstrate to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, that the requirements for such registration pursuant to 21 U.S.C. 958(a), 21 U.S.C. 823(a), and 21 CFR 1301.34(b), (c), (d), (e) and (f) are satisfied. Dated: March 29, 2005. William J. Walker, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 05–6801 Filed 4–5–05; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application Pursuant to Section 1301.33(a) of Title 21 of the Code of Federal Regulations (CFR), this is notice that on February 16, 2005, Varian, Inc., Lake Forest, 25200 Commercentre Drive, Lake Forest, California 92630–8810, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the basic classes of controlled substances listed in Schedules II: Drug Phencyclidine (7471) .................... 1–Piperidinocyclohexanecarbonitrile (8603). Benzoylecgonine (9180) ............... Schedule II II II The company plans to manufacture small quantities of the listed controlled substances for use in diagnostic products. Any other such applicant and any person who is presently registered with DEA to manufacture such a substance may file comments or objections to the issuance of the proposed registration pursuant to 21 CFR 1301.33(a). Any such written comments or objections being sent via regular mail may be addressed, in quintuplicate, to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Attention: DEA E:\FR\FM\06APN1.SGM 06APN1 Federal Register / Vol. 70, No. 65 / Wednesday, April 6, 2005 / Notices Federal Register Representative, Liaison and Policy Section (ODL); or any being sent via express mail should be sent to DEA Headquarters, Attention: DEA Federal Register Representative/ODL, 2401 Jefferson-Davis Highway, Alexandria, Virginia 22301; and must be filed no later than (60 days from publication). Send comments to Mr. Gerald B. Lindrew, Office of Policy and Research, U.S. Department of Labor, Employee Benefits Security Administration, 200 Constitution Avenue, NW., Room N– 5647, Washington, DC 20210. Telephone: (202) 693–8410. Fax: (202) 693–4745 (These are not toll-free numbers). Dated: March 29, 2005. William J. Walker, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 05–6796 Filed 4–5–05; 8:45 am] SUPPLEMENTARY INFORMATION: I. Background BILLING CODE 4410–09–P DEPARTMENT OF LABOR Employee Benefits Security Administration Proposed Extension of Information Collection Request Submitted for Public Comment and Recommendations; PTE 86–128 ACTION: Notice. SUMMARY: The Department of Labor (Department), as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA 95). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Employee Benefits Security Administration is soliciting comments concerning the proposed extension of a currently approved collection of information, Prohibited Transaction Class Exemption 86–128 for certain transactions involving employee benefit plans and securities brokerdealers. A copy of the proposed information collection request (ICR) can be obtained by contacting the office listed below in the ADDRESSES section of this notice. DATES: Written comments must be submitted to the office listed in the ADDRESSES section below on or before June 6, 2005. ADDRESSES: Interested parties are invited to submit written comments regarding the collection of information. VerDate jul<14>2003 18:17 Apr 05, 2005 Jkt 205001 Prohibited Transaction Class Exemption 86–128 permits persons who serve as fiduciaries for employee benefit plans to effect or execute securities transactions on behalf of employee benefit plans. The exemption also allows sponsors of pooled separate accounts and other pooled investment funds to use their affiliates to effect or execute securities transactions for such accounts in order to recapture brokerage commissions for benefit of employee benefit plans whose assets are maintained in pooled separate accounts managed by the insurance companies. This exemption provides relief from certain prohibitions in section 406(b) of the Employee Retirement Income Security Act of 1974 (ERISA) and from the taxes imposed by section 4975(a) and (b) of the Internal Revenue Code of 1986 (the Code) by reason of Code section 4975(c)(1)(E) or (F). In order to insure that the exemption is not abused, that the rights of participants and beneficiaries are protected, and that the exemption’s conditions are being complied with, the Department has included in the exemption five information collection requirements. The first requirement is written authorization executed in advance by an independent fiduciary of the plan whose assets are involved in the transaction with the brokerfiduciary. The second requirement is, within three months of the authorization, the broker-fiduciary furnish the independent fiduciary with any reasonably available information necessary for the independent fiduciary to determine whether an authorization should be made. The information must include a copy of the exemption, a form for termination, and a description of the broker-fiduciary’s brokerage placement practices. The third requirement is that the broker-fiduciary must provide a termination form to the independent fiduciary annually so that the independent fiduciary may terminate the authorization without penalty to the plan; failure to return the form constitutes continuing authorization. The fourth requirement is for the brokerfiduciary to report all transactions to the PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 17475 independent fiduciary, either by confirmation slips or through quarterly reports. The fifth requirement calls for the broker-fiduciary to provide an annual summary of the transactions. The annual summary must contain all security transaction-related charges incurred by the plan, the brokerage placement practices, and a portfolio turnover ratio. II. Review Focus The Department is particularly interested in comments that: • 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; • Enhance the quality, utility, and clarity of the information to be collected; 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 submissions of responses. III. Current Actions The Department is requesting an extension of the currently approved ICR pertaining to Prohibited Transaction Class Exemption 86–128 for certain transactions involving employee benefit plans and securities broker-dealers. The Department is not proposing or implementing changes to the existing ICR at this time. Agency: Department of Labor, Employee Benefits Security Administration. Title: PTE 86–128 for Certain Transactions Involving Employee Benefit Plans and Securities BrokerDealers. Type of Review: Extension of a currently approved collection. OMB Numbers: 1210–0059. Affected Public: Individuals or households; Business or other for-profit; Not-for-profit institutions. Total Respondents: 4,200. Total Responses: 284,000. Frequency of Response: Quarterly; Annually. Total Annual Burden: 93,530 hours. Total Annual Cost (Operating & Maintenance): $183,550. Comments submitted in response to this request will be summarized and/or E:\FR\FM\06APN1.SGM 06APN1

Agencies

[Federal Register Volume 70, Number 65 (Wednesday, April 6, 2005)]
[Notices]
[Pages 17474-17475]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-6796]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances; Notice of Application

    Pursuant to Section 1301.33(a) of Title 21 of the Code of Federal 
Regulations (CFR), this is notice that on February 16, 2005, Varian, 
Inc., Lake Forest, 25200 Commercentre Drive, Lake Forest, California 
92630-8810, made application by renewal to the Drug Enforcement 
Administration (DEA) to be registered as a bulk manufacturer of the 
basic classes of controlled substances listed in Schedules II:

------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
Phencyclidine (7471).......................  II
1-Piperidinocyclohexane-carbonitrile (8603)  II
Benzoylecgonine (9180).....................  II
------------------------------------------------------------------------

    The company plans to manufacture small quantities of the listed 
controlled substances for use in diagnostic products.
    Any other such applicant and any person who is presently registered 
with DEA to manufacture such a substance may file comments or 
objections to the issuance of the proposed registration pursuant to 21 
CFR 1301.33(a).
    Any such written comments or objections being sent via regular mail 
may be addressed, in quintuplicate, to the Deputy Assistant 
Administrator, Office of Diversion Control, Drug Enforcement 
Administration, Washington, DC 20537, Attention: DEA

[[Page 17475]]

Federal Register Representative, Liaison and Policy Section (ODL); or 
any being sent via express mail should be sent to DEA Headquarters, 
Attention: DEA Federal Register Representative/ODL, 2401 Jefferson-
Davis Highway, Alexandria, Virginia 22301; and must be filed no later 
than (60 days from publication).

    Dated: March 29, 2005.
William J. Walker,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 05-6796 Filed 4-5-05; 8:45 am]
BILLING CODE 4410-09-P
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