80_FR_46754 80 FR 46604 - Manufacturer of Controlled Substances Registration: Patheon Pharmaceuticals, Inc.

80 FR 46604 - Manufacturer of Controlled Substances Registration: Patheon Pharmaceuticals, Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 80, Issue 150 (August 5, 2015)

Page Range46604-46604
FR Document2015-19173

Patheon Pharmaceuticals, Inc. applied to be registered as a manufacturer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Patheon Pharmaceuticals, Inc. registration as a manufacturer of this controlled substance.

Federal Register, Volume 80 Issue 150 (Wednesday, August 5, 2015) 
[Federal Register Volume 80, Number 150 (Wednesday, August 5, 2015)]
[Notices]
[Page 46604]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-19173]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Manufacturer of Controlled Substances Registration: Patheon 
Pharmaceuticals, Inc.

ACTION: Notice of registration.

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SUMMARY: Patheon Pharmaceuticals, Inc. applied to be registered as a 
manufacturer of a certain basic class of controlled substance. The Drug 
Enforcement Administration (DEA) grants Patheon Pharmaceuticals, Inc. 
registration as a manufacturer of this controlled substance.

SUPPLEMENTARY INFORMATION: By notice dated March 9, 2015, and published 
in the Federal Register on March 24, 2015, 80 FR 15632, Patheon 
Pharmaceuticals, Inc., 2110 E. Galbraith Road, Cincinnati, Ohio 45237 
applied to be registered as a manufacturer 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(a) and 
determined that the registration of Patheon Pharmaceuticals, Inc. to 
manufacture 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. 823(a), and in accordance with 21 
CFR 1301.33, the above-named company is granted registration as a bulk 
manufacturer of gamma hydroxybutyric acid (2010), a basic class of 
controlled substance listed in schedule I.
    The company plans to manufacturer the listed controlled substance 
for distribution to its customers.

    Dated: July 29, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-19173 Filed 8-4-15; 8:45 am]
 BILLING CODE P

46604 Federal Register / Vol. 80, No. 150 / Wednesday, August 5, 2015 / Notices Background compliance with state and local laws, Attn: OMB Desk Officer for DOL–WHD, The Commission, pursuant to section and reviewing the company’s Office of Management and Budget, 751(c) of the Tariff Act of 1930 (19 background and history. Room 10235, 725 17th Street, NW., U.S.C. 1675(c)), instituted this review Therefore, pursuant to 21 U.S.C. Washington, DC 20503; by Fax: 202– on March 2, 2015 (80 FR 11226) and 823(a), and in accordance with 21 CFR 395–5806 (this is not a toll-free determined on June 5, 2015 that it 1301.33, the above-named company is number); or by email: OIRA_ would conduct an expedited review (80 granted registration as a bulk submission@omb.eop.gov. Commenters FR 37661, July 1, 2015). manufacturer of gamma hydroxybutyric are encouraged, but not required, to The Commission completed and filed acid (2010), a basic class of controlled send a courtesy copy of any comments its determination in this review on July substance listed in schedule I. by mail or courier to the U.S. 30, 2015. The views of the Commission The company plans to manufacturer Department of Labor-OASAM, Office of are contained in USITC Publication the listed controlled substance for the Chief Information Officer, Attn: 4546 (July 2015), entitled Hand Trucks distribution to its customers. Departmental Information Compliance and Certain Parts Thereof from China: Dated: July 29, 2015. Management Program, Room N1301, Investigation No. 731–TA–1059 (Second Joseph T. Rannazzisi, 200 Constitution Avenue NW., Review). Washington, DC 20210; or by email: Deputy Assistant Administrator. DOL_PRA_PUBLIC@dol.gov. By order of the Commission. [FR Doc. 2015–19173 Filed 8–4–15; 8:45 am] FOR FURTHER INFORMATION CONTACT: Issued: July 30, 2015. BILLING CODE P Contact Michel Smyth by telephone at Lisa R. Barton, 202–693–4129, TTY 202–693–8064, Secretary to the Commission. (these are not toll-free numbers) or [FR Doc. 2015–19080 Filed 8–4–15; 8:45 am] DEPARTMENT OF LABOR sending an email to DOL_PRA_ BILLING CODE 7020–02–P Office of the Secretary PUBLIC@dol.gov. SUPPLEMENTARY INFORMATION: This ICR Agency Information Collection seeks approval under the PRA for DEPARTMENT OF JUSTICE Activities; Submission for OMB revisions to the Application for a Farm Review; Comment Request; Labor Contractor or Farm Labor Drug Enforcement Administration Application for a Farm Labor Contractor Employee Certificate of [Docket No. DEA–392] Contractor or Farm Labor Contractor Registration information collection. Employee Certificate of Registration Migrant and Seasonal Agricultural Manufacturer of Controlled Worker Protection Act (MSPA) section Substances Registration: Patheon ACTION: Notice. 101 provides that no individual may Pharmaceuticals, Inc. perform farm labor contracting activities SUMMARY: The Department of Labor without a certificate of registration. See ACTION: Notice of registration. (DOL) is submitting the Wage and Hour 29 U.S.C. 1811. Form WH–530 is the Division (WHD) sponsored information application form that provides the DOL SUMMARY: Patheon Pharmaceuticals, Inc. collection request (ICR) revision titled, with the information necessary to issue applied to be registered as a ‘‘Application for a Farm Labor certificates specifying the farm labor manufacturer of a certain basic class of Contractor or Farm Labor Contractor contracting activities authorized. In controlled substance. The Drug Employee Certificate of Registration,’’ to addition, certain vehicle and safety Enforcement Administration (DEA) the Office of Management and Budget standards are required of a farm labor grants Patheon Pharmaceuticals, Inc. (OMB) for review and approval for use contractor applicant and such data is registration as a manufacturer of this in accordance with the Paperwork collected via forms WH–514, WH–514a, controlled substance. Reduction Act (PRA) of 1995 (44 U.S.C. and WH–515. This information SUPPLEMENTARY INFORMATION: By notice 3501 et seq.). Public comments on the collection has been classified as a dated March 9, 2015, and published in ICR are invited. revision, because DOL proposes to the Federal Register on March 24, 2015, DATES: The OMB will consider all implement minor changes to Forms 80 FR 15632, Patheon Pharmaceuticals, written comments that agency receives WH–514, WH–514a, WH–515 and WH– Inc., 2110 E. Galbraith Road, Cincinnati, on or before September 4, 2015. 530. Most of the alterations are to make Ohio 45237 applied to be registered as ADDRESSES: A copy of this ICR with the forms clearer for the regulated a manufacturer of a certain basic class applicable supporting documentation; community and to highlight certain of controlled substance. No comments including a description of the likely instructions. MSPA sections 102, 105, or objections were submitted for this respondents, proposed frequency of and 511 authorize this information notice. response, and estimated total burden collection. See 29 U.S.C. 1812, 1815, The DEA has considered the factors in may be obtained free of charge from the and 1861. 21 U.S.C. 823(a) and determined that RegInfo.gov Web site at http:// This information collection is subject the registration of Patheon www.reginfo.gov/public/do/ to the PRA. A Federal agency generally Pharmaceuticals, Inc. to manufacture PRAViewICR?ref_nbr=201505-1235-001 cannot conduct or sponsor a collection the basic class of controlled substance is (this link will only become active on the of information, and the public is consistent with the public interest and day following publication of this notice) generally not required to respond to an asabaliauskas on DSK5VPTVN1PROD with NOTICES with United States obligations under or by contacting Michel Smyth by information collection, unless it is international treaties, conventions, or telephone at 202–693–4129, TTY 202– approved by the OMB under the PRA protocols in effect on May 1, 1971. The 693–8064, (these are not toll-free and displays a currently valid OMB DEA investigated the company’s numbers) or sending an email to DOL_ Control Number. In addition, maintenance of effective controls PRA_PUBLIC@dol.gov. notwithstanding any other provisions of against diversion by inspecting and Submit comments about this request law, no person shall generally be subject testing the company’s physical security by mail or courier to the Office of to penalty for failing to comply with a systems, verifying the company’s Information and Regulatory Affairs, collection of information that does not VerDate Sep<11>2014 16:54 Aug 04, 2015 Jkt 235001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 E:\FR\FM\05AUN1.SGM 05AUN1


Document Created: 2018-02-23 10:53:38
Document Modified: 2018-02-23 10:53:38
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of registration.
FR Citation80 FR 46604 
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