Manufacturer of Controlled Substances; Notice of Application; Apertus Pharmaceuticals, LLC, 35058 [2012-14165]

Download as PDF 35058 Federal Register / Vol. 77, No. 113 / Tuesday, June 12, 2012 / Notices importer of the basic classes of controlled substances listed. DEPARTMENT OF LABOR Office of the Secretary Dated: June 5, 2012. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. Agency Information Collection Activities; Submission for OMB Review; Comment Request; Pilot Surveys of Employee Voice in the Coal Mining Industry [FR Doc. 2012–14163 Filed 6–11–12; 8:45 am] BILLING CODE 4410–09–P ACTION: Notice. The Department of Labor (DOL) is submitting the Mine Safety and Health Administration (MSHA) sponsored new information collection request (ICR) titled, ‘‘Pilot Surveys of Employee Voice in the Coal Mining Industry,’’ to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501 et seq.). DATES: Submit comments on or before July 12, 2012. ADDRESSES: A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained from the RegInfo.gov Web site, https://www.reginfo.gov/ public/do/PRAMain, on the day following publication of this notice or by contacting Michel Smyth by telephone at 202–693–4129 (this is not a toll-free number) or sending an email to DOL_PRA_PUBLIC@dol.gov. Submit comments about this request to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL–MSHA, Office of Management and Budget, Room 10235, New Executive Office Building, Washington, DC 20503, Telephone: 202–395–6929/Fax: 202–395–6881 (these are not toll-free numbers), email: OIRA_submission@omb.eop.gov. FOR FURTHER INFORMATION CONTACT: Michel Smyth by telephone at 202–693– 4129 (this is not a toll-free number) or by email at DOL_PRA_PUBLIC@dol.gov. SUPPLEMENTARY INFORMATION: The DOL seeks OMB approval to conduct an information collection as part of a pilot study to determine how to measure workers’ voice in mining workplaces under the jurisdiction of the MSHA. The DOL working definition for voice in the workplace is workers’ ability to access information on their rights in the workplace, their understanding of those rights, and their ability to exercise these rights without fear of discrimination or retaliation. Voice in the workplace is a key outcome goal for the Secretary of Labor and part of her vision of good jobs for everyone. A separate concurrent effort will measure workers’ voice in SUMMARY: DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application; Apertus Pharmaceuticals, LLC Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on March 27, 2012, Apertus Pharmaceuticals, LLC, 331 Consort Drive, St Louis, Missouri 63011, made application to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the following basic classes of controlled substances: Drug Schedule Alfentanil (9737) ........................... Remifentanil (9739) ...................... Sufentanil (9740) .......................... Fentanyl (9801) ............................ II II II II srobinson on DSK4SPTVN1PROD with NOTICES The company plans to manufacture small quantities of the listed controlled substances to make reference standards which will be distributed to their customers. Any other such applicant, and any person who is presently registered with DEA to manufacture such substances, 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 should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than August 13, 2012. Dated: June 4, 2012. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2012–14165 Filed 6–11–12; 8:45 am] BILLING CODE 4410–09–P VerDate Mar<15>2010 22:42 Jun 11, 2012 Jkt 226001 PO 00000 Frm 00126 Fmt 4703 Sfmt 4703 workplaces under the jurisdiction of the Wage and Hour Division and Occupational Safety and Health Administration. Measuring voice among miners, however, poses unique data collection challenges, including implementing a survey in a setting that feels non-threatening to mine workers, and asking questions in a format that reflects mining community cultures and practices. The DOL seeks to perform a pilot study to investigate the efficacy of different data collection methods and to develop a survey instrument that is appropriate for the mining community. The primary research question is what measures of voice and perceived noncompliance, combined with what modes of data collection, could be best used to track MSHA’s worker-protection outreach activity? This ICR covers a set two or three small-scale pilot data collections. Data collection for this effort will employ two or three strategies: (1) Submission of paper questionnaires to be filled out by individual mine workers during offsite mining-related training sessions, (2) recruitment of miners by using radio and paper advertisements, and (3) a mail or phone survey. The DOL is currently assessing the feasibility of each method prior to implementation. For example, implementation of a phone or mail survey will depend on the availability of a valid list of miners. A maximum of 125 respondents will be surveyed under each collection mode for 375 maximum respondents for the overall effort. This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information if the collection of information does not display a valid OMB Control Number. See 5 CFR 1320.5(a) and 1320.6. For additional information, see the related notice published in the Federal Register on January 19, 2012 (77 FR 2760). Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the ADDRESSES section within 30 days of publication of this notice in the Federal Register. In order to help ensure appropriate consideration, comments should reference OMB ICR Reference Number 201205–1219–001. The OMB is E:\FR\FM\12JNN1.SGM 12JNN1

Agencies

[Federal Register Volume 77, Number 113 (Tuesday, June 12, 2012)]
[Notices]
[Page 35058]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14165]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances; Notice of Application; 
Apertus Pharmaceuticals, LLC

    Pursuant to Sec.  1301.33(a), Title 21 of the Code of Federal 
Regulations (CFR), this is notice that on March 27, 2012, Apertus 
Pharmaceuticals, LLC, 331 Consort Drive, St Louis, Missouri 63011, made 
application to the Drug Enforcement Administration (DEA) to be 
registered as a bulk manufacturer of the following basic classes of 
controlled substances:

------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
Alfentanil (9737)..........................  II
Remifentanil (9739)........................  II
Sufentanil (9740)..........................  II
Fentanyl (9801)............................  II
------------------------------------------------------------------------

    The company plans to manufacture small quantities of the listed 
controlled substances to make reference standards which will be 
distributed to their customers.
    Any other such applicant, and any person who is presently 
registered with DEA to manufacture such substances, 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 should be addressed, in 
quintuplicate, to the Drug Enforcement Administration, Office of 
Diversion Control, Federal Register Representative (ODL), 8701 
Morrissette Drive, Springfield, Virginia 22152; and must be filed no 
later than August 13, 2012.

    Dated: June 4, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2012-14165 Filed 6-11-12; 8:45 am]
BILLING CODE 4410-09-P
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