Importer of Controlled Substances Application: Almac Clinical Services Incorp (ACSI), 80387 [2015-32367]

Download as PDF Federal Register / Vol. 80, No. 247 / Thursday, December 24, 2015 / Notices Controlled substance Schedule Lysergic acid diethylamide (7315) Heroin (9200) ............................... Meperidine (9230) ........................ I I II The company plans to import these controlled substances for the manufacture of reference standards. Dated: December 15, 2015. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2015–32370 Filed 12–23–15; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Dated: December 15, 2015. Louis J. Milione, Deputy Assistant Administrator. [Docket No. DEA–392] Importer of Controlled Substances Application: Almac Clinical Services Incorp (ACSI) ACTION: mstockstill on DSK4VPTVN1PROD with NOTICES [FR Doc. 2015–32367 Filed 12–23–15; 8:45 am] BILLING CODE 4410–09–P Notice of application. DEPARTMENT OF LABOR 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 January 25, 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 25, 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. DATES: VerDate Sep<11>2014 17:57 Dec 23, 2015 Jkt 238001 In accordance with 21 CFR 1301.34(a), this is notice that on September 1, 2015, Almac Clinical Services Incorp (ACSI), 25 Fretz Road, Souderton, Pennsylvania 18964 applied to be registered as an importer of Morphine (9300), a basic class of controlled substance listed in schedule II. The company plans to import the listed controlled substance in dosage form, for clinical trial only. Approval of permit applications will occur only when the registrant’s business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of FDA approved or non-approved finished dosage forms for commercial sale. Employment and Training Administration Comment Request for Information Collection for Form ETA–9142A, H–2A Application for Temporary Employment Certification, and Appendix A (OMB Control Number 1205–0466), Revision Employment and Training Administration (ETA), Labor. ACTION: Notice. AGENCY: The Department of Labor (Department or DOL), as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3506(c)(2)(A)). This program helps 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 Employment and Training Administration (ETA) is soliciting comments concerning the collection of data on the Form ETA– 9142A, H–2A Application for Temporary Employment Certification, and Appendix A (OMB Control Number 1205–0466), which expire on March 31, 2016. A copy of the proposed SUMMARY: PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 80387 information collection request can be obtained free of charge by contacting the office listed below in the addressee section of this notice. The forms are used by employers in the H–2A temporary agricultural employment-based program to collect information that demonstrates compliance with program requirements. DATES: Written comments must be submitted to the office listed in the addresses section below on or before February 22, 2016. ADDRESSES: Submit written comments to Brian Pasternak, National Director of Temporary Programs, Office of Foreign Labor Certification, Employment & Training Administration, U.S. Department of Labor, 200 Constitution Avenue, Box 12–200 NW., Washington, DC 20210; Telephone: (202) 513–7350 (this is not a toll-free number). Individuals with hearing or speech impairments may access the telephone number above via TTY by calling the toll-free Federal Information Relay Service at 1–877–889–5627 (TTY/TDD). Fax: 202–513–7495. Email: ETA.OFLC.Forms@dol.gov subject line: ETA–9141A. A copy of the proposed information collection request (ICR) can be obtained free of charge by contacting the office listed above. SUPPLEMENTARY INFORMATION: I. Background The information collection (IC) is required by sections 101(a)(15)(H)(ii)(a); 214(c); and 218 of the Immigration and Nationality Act (INA) (8 U.S.C. 1011(a)(15)(H)(ii)(a), 1184(c), and 1188) and 8 CFR 214.2(h). Before an employer may petition for any temporary foreign workers, it must submit a request for certification to the Secretary of Labor containing the elements prescribed by the INA and the Department’s implementing regulations, which differ depending on the visa program under which the foreign workers are sought. The H–2A program enables employers to bring nonimmigrant foreign workers to the U.S. to perform agricultural work of a temporary or seasonal nature as defined in 8 U.S.C. 1101(a)(15)(H)(ii)(a). For purposes of the H–2A program, the INA and governing federal regulations require the Secretary of Labor to certify, among other things, that any foreign worker seeking to enter the United States (U.S.) temporarily for the purpose of performing certain unskilled labor will not, by doing so, adversely affect wages and working conditions of U.S. workers similarly employed. The Secretary must also certify that there are not sufficient U.S. workers available to E:\FR\FM\24DEN1.SGM 24DEN1

Agencies

[Federal Register Volume 80, Number 247 (Thursday, December 24, 2015)]
[Notices]
[Page 80387]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32367]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Almac Clinical 
Services Incorp (ACSI)

ACTION: Notice of application.

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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 
1301.34(a) on or before January 25, 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 25, 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 
September 1, 2015, Almac Clinical Services Incorp (ACSI), 25 Fretz 
Road, Souderton, Pennsylvania 18964 applied to be registered as an 
importer of Morphine (9300), a basic class of controlled substance 
listed in schedule II.
    The company plans to import the listed controlled substance in 
dosage form, for clinical trial only. Approval of permit applications 
will occur only when the registrant's business activity is consistent 
with what is authorized under 21 U.S.C. 952(a)(2). Authorization will 
not extend to the import of FDA approved or non-approved finished 
dosage forms for commercial sale.

    Dated: December 15, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015-32367 Filed 12-23-15; 8:45 am]
 BILLING CODE 4410-09-P
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