Manufacturer of Controlled Substances Registration: Cambrex Charles City, 46336-46337 [2015-19111]

Download as PDF 46336 Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Notices Controlled substance Fentanyl (9801) ............................ II The company plans to import small quantities of the listed controlled substances in dosage form to conduct clinical trials. Dated: July 29, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015–19109 Filed 8–3–15; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Registration: Meridian Medical Technologies ACTION: The company plans to manufacture the listed controlled substance as an active pharmaceutical ingredient (API) for clinical trials. Dated: July 29, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015–19164 Filed 8–3–15; 8:45 am] Meridian Medical Technologies applied to be registered as an importer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Meridian Medical Technologies registration as an importer of this controlled substance. SUPPLEMENTARY INFORMATION: By notice dated April 14, 2015, and published in the Federal Register on April 22, 2015, 80 FR 22553, Meridian Medical Technologies, 2555 Hermelin Drive, St. Louis, Missouri 63144 applied to be registered as an importer of a certain basic class of controlled substance. No comments or objections were submitted for this notice. The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of Meridian Medical Technologies to import the basic class of controlled substance 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. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the above-named company is granted registration as an importer of morphine (9300), a basic class controlled substance listed in schedule II. VerDate Sep<11>2014 18:45 Aug 03, 2015 Jkt 235001 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 Oxymorphone (9652) ................... Noroxymorphone (9668) .............. Schedule II II [FR Doc. 2015–19099 Filed 8–3–15; 8:45 am] BILLING CODE 4410–09–P BILLING CODE 4410–09–P Notice of registration. SUMMARY: tkelley on DSK3SPTVN1PROD with NOTICES The company manufactures a product containing morphine in the United States. The company exports this product to customers around the world. The company has been asked to ensure that its product, which is sold to European customers, meets the standards established by the European Pharmacopeia, administered by the Directorate for the Quality of Medicines (EDQM). In order to ensure that its product will meet European specifications, the company seeks to import morphine supplied by EDQM for use as reference standards. This is the sole purpose for which the company will be authorized by the DEA to import morphine. Dated: July 29, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. Schedule DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE Drug Enforcement Administration Drug Enforcement Administration [Docket No. DEA–392] [Docket No. DEA–392] Manufacturer of Controlled Substances Registration: Pharmacore, Inc. Manufacturer of Controlled Substances Registration: Cambrex Charles City ACTION: ACTION: Notice of registration. Pharmacore, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Pharmacore, Inc. registration as a manufacturer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated April 14, 2015, and published in the Federal Register on April 22, 2015, 80 FR 22554, Pharmacore, Inc., 4180 Mendenhall Oaks Parkway, High Point, North Carolina 27265 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 Pharmacore, Inc. 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 SUMMARY: PO 00000 Frm 00103 Fmt 4703 Sfmt 4703 Notice of registration. Cambrex Charles City applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Cambrex Charles City registration as a manufacturer of those controlled substances. SUMMARY: By notice dated April 14, 2015, and published in the Federal Register on April 22, 2015, 80 FR 22555, Cambrex Charles City, 1205 11th Street, Charles City, Iowa 50616 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 Cambrex Charles City 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 SUPPLEMENTARY INFORMATION: E:\FR\FM\04AUN1.SGM 04AUN1 Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Notices 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 listed: Controlled substance Schedule Amphetamine (1100) .................... Lisdexamfetamine (1205) ............. Methylphenidate (1724) ................ 4-Anilino-N-phenethyl-4-piperidine (ANPP) (8333). Phenylacetone (8501) .................. Cocaine (9041) ............................. Codeine (9050) ............................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Hydrocodone (9193) ..................... Morphine (9300) ........................... Oripavine (9330) ........................... Thebaine (9333) ........................... Opium, raw (9600) ....................... Opium extracts (9610) .................. Opium fluid extract (9620) ............ Opium tincture (9630) .................. Opium, powdered (9639) ............. Opium, granulated (9640) ............ Oxymorphone (9652) ................... Noroxymorphone (9668) .............. Poppy Straw Concentrate (9670) Alfentanil (9737) ........................... Remifentanil (9739) ...................... Sufentanil (9740) .......................... Fentanyl (9801) ............................ II II II 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 the listed controlled substances in bulk for sale to its customers, for dosage form development, for clinical trials, and for use in stability qualification studies. Dated: July 29, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015–19111 Filed 8–3–15; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF LABOR Employment and Training Administration Comment Request for Proposed Information Collection for Employment and Training Administration Financial Report Form #9130 (OMB Control No. 1205–0461), Extension With Changes Employment and Training Administration (ETA), Labor. ACTION: Notice. tkelley on DSK3SPTVN1PROD with NOTICES AGENCY: The Department of Labor, 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 SUMMARY: VerDate Sep<11>2014 18:45 Aug 03, 2015 Jkt 235001 opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) [44 U.S.C. 3506(c)(2)(A)]. 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 Employment and Training Administration is soliciting comments concerning the collection of data for quarterly financial reporting on federally funded programs, on Form ETA–9130 (currently due to expire December 31, 2015). A copy of the proposed information collection request (ICR) can be obtained by contacting the office listed below in the addressee section of this notice. DATES: Submit written comments to the office listed in the addresses section below on or before October 5, 2015. ADDRESSES: Send written comments to Maggie Ewell, Division of Policy, Review, and Resolution, Office of Grants Management, Room N–4716, Employment and Training Administration, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210. Telephone number: 202–693–3160 (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: 202–693– 2705. Email: Ewell.Maggie@dol.gov. To obtain a copy of the proposed information collection request (ICR), please contact the person listed above. SUPPLEMENTARY INFORMATION: I. Background ETA awards approximately $8 billion in formula and discretionary grants each year to an average of 1,000 recipients. Financial reports for each of these grants must be submitted quarterly on the financial report form ETA–9130. Recipients include but are not limited to: State Employment Security Agencies which are comprised of three components: Wagner Peyser Employment Service, Unemployment Insurance program, and Trade Program Grant Agreements; as well as Workforce Innovation and Opportunity Act (WIOA) Youth, Adult, and Dislocated Worker programs; National Dislocated Worker Grants; National Farmworker Jobs Program (NFJP); Indian and Native American programs; the Senior PO 00000 Frm 00104 Fmt 4703 Sfmt 4703 46337 Community Service Employment Program; Workforce Innovation and Opportunity Act discretionary grants; and H–1B Job Training Grants. Financial reporting requirements for Federal programs prescribed by the Office of Management and Budget (OMB) have changed with the implementation of the Uniform Guidance, which went into effect on December 26, 2014, replacing numerous previously applicable Circulars. These changes affect both the ETA–9130 reporting form and its instructions. However, they do not affect the collection burden, but instead only update certain key terms and definitions. Additionally, with the passage of WIOA, there are numerous new statutory requirements that impact financial reporting, including but not limited to new and/or revised limitations and baselines that require the addition of new and modification of existing reporting line items on ETA– 9130 Financial Reports, as outlined in this TEGL. Other reporting line items have been added and removed in an effort to streamline Federal financial reporting and make form ETA–9130 more closely resemble the SF–425 (OMB 0348–0061), which is the standard financial reporting form for Federal grant recipients. ETA has utilized the data collected to assess the effectiveness of ETA programs and to monitor and analyze the financial activity of its grantees. Grantees are provided with predesigned software to reflect the requirements of ETA Form 9130 so that the required data will be reported electronically. ETA strives to reduce reporting time for our recipients. Several sections of the 9130 have prefilled line items or automatically calculated line items, which is convenient and time saving for our recipients. This data collection format permits ETA to evaluate program effectiveness and to monitor and analyze financial activity, while complying with OMB efforts to streamline Federal financial reporting. II. Review Focus The Department is particularly interested in comments which: • 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, E:\FR\FM\04AUN1.SGM 04AUN1

Agencies

[Federal Register Volume 80, Number 149 (Tuesday, August 4, 2015)]
[Notices]
[Pages 46336-46337]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19111]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Manufacturer of Controlled Substances Registration: Cambrex 
Charles City

ACTION: Notice of registration.

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

SUMMARY: Cambrex Charles City applied to be registered as a 
manufacturer of certain basic classes of controlled substances. The 
Drug Enforcement Administration (DEA) grants Cambrex Charles City 
registration as a manufacturer of those controlled substances.

SUPPLEMENTARY INFORMATION:  By notice dated April 14, 2015, and 
published in the Federal Register on April 22, 2015, 80 FR 22555, 
Cambrex Charles City, 1205 11th Street, Charles City, Iowa 50616 
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 Cambrex Charles City 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

[[Page 46337]]

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 listed:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Amphetamine (1100).........................  II
Lisdexamfetamine (1205)....................  II
Methylphenidate (1724).....................  II
4-Anilino-N-phenethyl-4-piperidine (ANPP)    II
 (8333).
Phenylacetone (8501).......................  II
Cocaine (9041).............................  II
Codeine (9050).............................  II
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  II
Hydrocodone (9193).........................  II
Morphine (9300)............................  II
Oripavine (9330)...........................  II
Thebaine (9333)............................  II
Opium, raw (9600)..........................  II
Opium extracts (9610)......................  II
Opium fluid extract (9620).................  II
Opium tincture (9630)......................  II
Opium, powdered (9639).....................  II
Opium, granulated (9640)...................  II
Oxymorphone (9652).........................  II
Noroxymorphone (9668)......................  II
Poppy Straw Concentrate (9670).............  II
Alfentanil (9737)..........................  II
Remifentanil (9739)........................  II
Sufentanil (9740)..........................  II
Fentanyl (9801)............................  II
------------------------------------------------------------------------

    The company plans to manufacture the listed controlled substances 
in bulk for sale to its customers, for dosage form development, for 
clinical trials, and for use in stability qualification studies.

    Dated: July 29, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-19111 Filed 8-3-15; 8:45 am]
BILLING CODE 4410-09-P
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