81 FR 15571 - Bulk Manufacturer of Controlled Substances Application: Patheon Pharmaceuticals, Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 81, Issue 56 (March 23, 2016)

Page Range		15571-15571
FR Document		2016-06539

Federal Register, Volume 81 Issue 56 (Wednesday, March 23, 2016)

[Federal Register Volume 81, Number 56 (Wednesday, March 23, 2016)]
[Notices]
[Page 15571]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-06539]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Patheon 
Pharmaceuticals, Inc.

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 
1301.33(a) on or before May 23, 2016.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODW, 
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 1301.33(a), this is notice that on 
December 10, 2015, Patheon Pharmaceuticals, Inc., 2110 E. Galbraith 
Road, Cincinnati, Ohio 45237 applied to be registered as a bulk 
manufacturer of gamma hydroxybutyric acid (2010) a basic class of 
controlled substance listed in schedule I.
    The company plans to manufacture the listed controlled substance 
for product development.

    Dated: March 14, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-06539 Filed 3-22-16; 8:45 am]
 BILLING CODE 4410-09-P

Federal Register / Vol. 81, No. 56 / Wednesday, March 23, 2016 / Notices 15571

Dated: March 14, 2016. DEPARTMENT OF LABOR Constitution Avenue NW., Washington,
Louis J. Milione, DC 20210; telephone (202) 693–1999;
Deputy Assistant Administrator. Occupational Safety and Health email jameson.grettah@dol.gov.
[FR Doc. 2016–06548 Filed 3–22–16; 8:45 am] Administration Instructions: Your submissions must
BILLING CODE 4410–09–P
include the agency name and docket
[Docket No. OSHA–2016–0008]
number for this Federal Register notice
Whistleblower Protection Advisory (Docket No. OSHA–2016–0008). Due to
DEPARTMENT OF JUSTICE Committee (WPAC) security-related procedures,
submissions by regular mail may
Drug Enforcement Administration AGENCY: Occupational Safety and Health experience significant delays. Please
[Docket No. DEA–392]
Administration (OSHA), Labor. contact the OSHA Docket Office for
ACTION: Announcement of a meeting of information about security procedures
Bulk Manufacturer of Controlled WPAC. for making submissions. For additional
Substances Application: Patheon information on submitting comments,
Pharmaceuticals, Inc. SUMMARY: WPAC will meet April 26, requests to speak, and speaker
2016, in Washington, DC. presentations, see the SUPPLEMENTARY
ACTION: Notice of application. DATES: WPAC meeting: WPAC will meet INFORMATION section of this notice.
from 9:00 a.m. to 4:00 p.m., E.T., FOR FURTHER INFORMATION CONTACT:
DATES: Registered bulk manufacturers of Tuesday, April 26, 2015. For press inquiries: Mr. Frank
the affected basic class, and applicants Written comments, requests to speak, Meilinger, Director, OSHA Office of
therefore, may file written comments on speaker presentations, and requests for Communications, Room N–3647, U.S.
or objections to the issuance of the special accommodation: You must Department of Labor, 200 Constitution
proposed registration in accordance Avenue NW., Washington, DC 20210;
submit (postmark, send, transmit)
with 21 CFR 1301.33(a) on or before telephone (202) 693–1999; email
comments, requests to address the
May 23, 2016. meilinger.francis2@dol.gov.
WPAC meeting, speaker presentations
ADDRESSES: Written comments should (written or electronic), and requests for For general information about WPAC
be sent to: Drug Enforcement special accommodations for the WPAC and WPAC meetings: Mr. Anthony Rosa,
Administration, Attention: DEA Federal meeting by April 12, 2016. OSHA, Directorate of Whistleblower
Register Representative/ODW, 8701 Protection Programs, Room N–4618,
ADDRESSES: WPAC meeting: WPAC will
Morrissette Drive, Springfield, Virginia U.S. Department of Labor, 200
22152. meet in Room N–4437 A–C, U.S.
Department of Labor, Francis Perkins Constitution Avenue NW., Washington,
SUPPLEMENTARY INFORMATION: The Building, 200 Constitution Avenue NW., DC 20210; telephone (202) 693–2199;
Attorney General has delegated her Washington, DC 20210. email osha.dwpp@dol.gov.
authority under the Controlled Submission of comments, requests to SUPPLEMENTARY INFORMATION:
Substances Act to the Administrator of speak, and speaker presentations: You
the Drug Enforcement Administration WPAC Meeting
may submit comments, requests to
(DEA), 28 CFR 0.100(b). Authority to speak at the WPAC meeting, and WPAC will meet Tuesday, April 26,
exercise all necessary functions with speaker presentations using one of the 2015, in Washington, DC. WPAC
respect to the promulgation and following methods: meetings are open to the public.
implementation of 21 CFR part 1301, The tentative agenda of the WPAC
Electronically: You may submit
incident to the registration of meeting includes:
materials, including attachments,
manufacturers, distributors, dispensers, electronically at http:// Remarks from the Assistant Secretary of
importers, and exporters of controlled www.regulations.gov, which is the Labor for Occupational Safety and Health
substances (other than final orders in Federal eRulemaking Portal. Follow the (OSHA);
connection with suspension, denial, or on-line instructions for submissions.
Remarks from the Director of the Directorate
revocation of registration) has been of Whistleblower Protection Programs;
Facsimile (Fax): If your submission, Presentations from other federal agencies
redelegated to the Deputy Assistant including attachments, does not exceed
Administrator of the DEA Office of with whistleblower programs;
10 pages, you may fax it to the OSHA Railroad worker whistleblower presentation;
Diversion Control (‘‘Deputy Assistant
Docket Office at (202) 693–1648. Public comments;
Administrator’’) pursuant to section 7 of
Regular mail, express mail, hand Work Group presentations; and,
28 CFR part 0, appendix to subpart R. Old business.
delivery, or messenger (courier) service:
In accordance with 21 CFR
You may submit your materials to the OSHA transcribes WPAC meetings and
1301.33(a), this is notice that on
OSHA Docket Office, Docket No. prepares detailed minutes of the
December 10, 2015, Patheon
OSHA–2016–0008, Room N–2625, U.S. meetings. OSHA places the meeting
Pharmaceuticals, Inc., 2110 E. Galbraith
Department of Labor, 200 Constitution transcripts and minutes in the public
Road, Cincinnati, Ohio 45237 applied to
Avenue NW., Washington, DC 20210; record of the WPAC meeting. The public
be registered as a bulk manufacturer of
telephone (202) 693–2350 (TTY (877) record also includes Work Group
gamma hydroxybutyric acid (2010) a
889–5627). OSHA’s Docket Office reports, speaker presentations,
basic class of controlled substance listed
accepts deliveries (hand deliveries, comments and other materials
in schedule I.
The company plans to manufacture express mail, and messenger service) submitted to WPAC.
during normal business hours, 8:15
jstallworth on DSK7TPTVN1PROD with NOTICES

the listed controlled substance for WPAC Work Groups
product development. a.m.–4:45 p.m., E.T., weekdays.
Requests for special accommodations: The WPAC work groups (Outreach
Dated: March 14, 2016. Please submit any requests for special and Training) will meet on April 25,
Louis J. Milione, accommodations to attend the WPAC 2016. These work group meetings will
Deputy Assistant Administrator. meeting to Ms. Gretta Jameson, OSHA, be open to the public. The purpose of
[FR Doc. 2016–06539 Filed 3–22–16; 8:45 am] Office of Communications, Room N– the work groups is to provide
BILLING CODE 4410–09–P 3647, U.S. Department of Labor, 200 recommendations to the full WPAC

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Document Created: 2016-03-23 00:04:10
Document Modified: 2016-03-23 00:04:10

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of application.
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 1301.33(a) on or before May 23, 2016.
FR Citation		81 FR 15571

81 FR 15571 - Bulk Manufacturer of Controlled Substances Application: Patheon Pharmaceuticals, Inc.

DEPARTMENT OF JUSTICEDrug Enforcement Administration

Federal Register Volume 81, Issue 56 (March 23, 2016)

DEPARTMENT OF JUSTICE
Drug Enforcement Administration