81 FR 45306 - Importer of Controlled Substances Application: Janssen Pharmaceutical, Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 81, Issue 134 (July 13, 2016)

Page Range		45306-45307
FR Document		2016-16551

Federal Register, Volume 81 Issue 134 (Wednesday, July 13, 2016)

[Federal Register Volume 81, Number 134 (Wednesday, July 13, 2016)]
[Notices]
[Pages 45306-45307]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-16551]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Janssen 
Pharmaceutical, Inc.

ACTION: Notice of application.

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DATES: Registered bulk manufacturers of the affected basic classes, 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 August 12, 2016. Such persons may also file a 
written request for a hearing on the application pursuant to 21 CFR 
1301.43 on or before August 12, 2016.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
requests for hearing should also be sent to: (1) Drug Enforcement 
Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, 
Springfield, Virginia 22152; and (2) Drug Enforcement Administration, 
Attn: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, 
Springfield, Virginia 22152. Comments and requests for hearings on 
applications to import narcotic raw material are not appropriate. 72 FR 
3417 (January 25, 2007).

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 April 
11, 2016, Janssen Pharmaceutical, Inc., 1440 Olympic Drive, Athens, 
Georgia 30601 applied to be registered as an importer of the following 
basic classes of controlled substances:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Phenylacetone (8501).......................  II
Thebaine (9333)............................  II
Poppy Straw Concentrate (9670).............  II
Tapentadol (9780)..........................  II
------------------------------------------------------------------------

    The company plans to import thebaine derivatives (9333) as 
reference standards. The company plans to import an intermediate form 
of tapentadol (9780) to bulk manufacture tapentadol for distribution to 
its customers. The

[[Page 45307]]

company plans to import phenylacetone (8501) and poppy straw 
concentrate (9670) to manufacture other controlled substances.

    Dated: July 5, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-16551 Filed 7-12-16; 8:45 am]
 BILLING CODE 4410-09-P

45306 Federal Register / Vol. 81, No. 134 / Wednesday, July 13, 2016 / Notices

On June 10, 2016, Complainants www.usitc.gov). The public record for accordance with 21 CFR 1301.34(a) on
moved to terminate the investigation this review may be viewed on the or before August 12, 2016. Such persons
based on their withdrawal of the Commission’s electronic docket (EDIS) may also file a written request for a
complaint. No party responded to the at http://edis.usitc.gov. hearing on the application pursuant to
motion. For further information concerning 21 CFR 1301.43 on or before August 12,
On June 14, 2016, the ALJ issued the the conduct of this review and rules of 2016.
subject ID, granting Complainants’ general application, consult the ADDRESSES: Written comments should
motion and terminating the Commission’s Rules of Practice and be sent to: Drug Enforcement
investigation. No petitions for review Procedure, part 201, subparts A through Administration, Attention: DEA Federal
were filed. E (19 CFR part 201), and part 207, Register Representative/ODW, 8701
The Commission has determined not subparts A, D, E, and F (19 CFR part Morrissette Drive, Springfield, Virginia
to review the subject ID. 207). 22152. All requests for hearing must be
The authority for the Commission’s SUPPLEMENTARY INFORMATION: On July 5, sent to: Drug Enforcement
determination is contained in section 2016, the Commission determined that Administration, Attn: Administrator,
337 of the Tariff Act of 1930, as it should proceed to a full review in the 8701 Morrissette Drive, Springfield,
amended (19 U.S.C. 1337), and in Part subject five-year review pursuant to Virginia 22152. All requests for hearing
210 of the Commission’s Rules of section 751(c) of the Tariff Act of 1930 should also be sent to: (1) Drug
Practice and Procedure (19 CFR part (19 U.S.C. 1675(c)). The Commission Enforcement Administration, Attn:
210). found that the domestic interested party Hearing Clerk/LJ, 8701 Morrissette
By order of the Commission. group response to its notice of Drive, Springfield, Virginia 22152; and
Issued: July 7, 2016. institution (81 FR 18882, April 1, 2016) (2) Drug Enforcement Administration,
Lisa R. Barton, was adequate. Although the Attn: DEA Federal Register
Secretary to the Commission. Commission received a response to its Representative/ODW, 8701 Morrissette
notice of institution from respondent Drive, Springfield, Virginia 22152.
[FR Doc. 2016–16523 Filed 7–12–16; 8:45 am]
interested parties, the Commission Comments and requests for hearings on
BILLING CODE 7020–02–P
found that the respondent interested applications to import narcotic raw
party group response with respect to the material are not appropriate. 72 FR 3417
INTERNATIONAL TRADE reviews on subject imports from Iran (January 25, 2007).
COMMISSION was inadequate.1 The Commission also SUPPLEMENTARY INFORMATION: The
found that other circumstances Attorney General has delegated her
[Investigation No. 731–TA–287 (Second warranted conducting a full review. A authority under the Controlled
Review)] Substances Act to the Administrator of
record of the Commissioners’ votes, the
Raw In-Shell Pistachios From Iran; Commission’s statement on adequacy, the Drug Enforcement Administration
Notice of Commission Determination and any individual Commissioner’s (DEA), 28 CFR 0.100(b). Authority to
To Conduct a Full Five-Year Review statements will be available from the exercise all necessary functions with
Office of the Secretary and at the respect to the promulgation and
AGENCY: United States International Commission’s Web site. implementation of 21 CFR part 1301,
Trade Commission. Authority: This review is being conducted incident to the registration of
ACTION: Notice. under authority of title VII of the Tariff Act manufacturers, distributors, dispensers
of 1930; this notice is published pursuant to importers, and exporters of, controlled
SUMMARY: The Commission hereby gives section 207.62 of the Commission’s rules. substances (other than final orders in
notice that it will proceed with a full connection with suspension, denial, or
By order of the Commission.
review pursuant to the Tariff Act of revocation of registration) has been
Issued: July 7, 2016.
1930 to determine whether revocation of redelegated to the Deputy Assistant
the antidumping duty order on raw in- Lisa R. Barton,
Administrator of the DEA Office of
shell pistachios from Iran would be Secretary to the Commission.
Diversion Control (‘‘Deputy Assistant
likely to lead to continuation or [FR Doc. 2016–16525 Filed 7–12–16; 8:45 am]
Administrator’’) pursuant to section 7 of
recurrence of material injury within a BILLING CODE 7020–02–P
28 CFR part 0, appendix to subpart R.
reasonably foreseeable time. A schedule In accordance with 21 CFR
for the review will be established and 1301.34(a), this is notice that on April
announced at a later date. DEPARTMENT OF JUSTICE 11, 2016, Janssen Pharmaceutical, Inc.,
DATES: Effective Date: July 5, 2016. 1440 Olympic Drive, Athens, Georgia
Drug Enforcement Administration 30601 applied to be registered as an
FOR FURTHER INFORMATION CONTACT:
Chris Cassise (202) 708–5408, Office of [Docket No. DEA–392] importer of the following basic classes
Investigations, U.S. International Trade of controlled substances:
Commission, 500 E Street SW., Importer of Controlled Substances
Washington, DC 20436. Hearing- Application: Janssen Pharmaceutical, Controlled substance Schedule
impaired persons can obtain Inc.
Phenylacetone (8501) .................. II
information on this matter by contacting ACTION: Notice of application. Thebaine (9333) ........................... II
the Commission’s TDD terminal on 202– Poppy Straw Concentrate (9670) II
205–1810. Persons with mobility
jstallworth on DSK7TPTVN1PROD with NOTICES

DATES: Registered bulk manufacturers of Tapentadol (9780) ........................ II
impairments who will need special the affected basic classes, and
assistance in gaining access to the applicants therefore, may file written The company plans to import
Commission should contact the Office comments on or objections to the thebaine derivatives (9333) as reference
of the Secretary at 202–205–2000. issuance of the proposed registration in standards. The company plans to import
General information concerning the an intermediate form of tapentadol
Commission may also be obtained by 1 Commissioner Broadbent determined that the (9780) to bulk manufacture tapentadol
accessing its Internet server (http:// respondent group response was adequate. for distribution to its customers. The

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Federal Register / Vol. 81, No. 134 / Wednesday, July 13, 2016 / Notices 45307

company plans to import phenylacetone revocation of registration) has been This meeting is also available
(8501) and poppy straw concentrate redelegated to the Deputy Assistant telephonically and by WebEx. You must
(9670) to manufacture other controlled Administrator of the DEA Office of use a touch-tone phone to participate in
substances. Diversion Control (‘‘Deputy Assistant this meeting. Any interested person may
Dated: July 5, 2016. Administrator’’) pursuant to section 7 of dial the USA toll number 1–630–395–
Louis J. Milione, 28 CFR part 0, appendix to subpart R. 0279 or toll free number 1–888–989–
In accordance with 21 CFR 4389, Passcode: 3927350 followed by
Deputy Assistant Administrator.
1301.34(a), this is notice that on April the # sign for both days. To join via
[FR Doc. 2016–16551 Filed 7–12–16; 8:45 am]
4, 2016, Noramco, Inc., 1440 Olympic WebEx, the link is https://
BILLING CODE 4410–09–P
Drive, Athens, Georgia 30601 applied to nasa.webex.com/, the meeting number
be registered as an importer of the for July 28 is 991 445 749 and the
following basic classes of controlled password is nacgrc0728* (case
DEPARTMENT OF JUSTICE
substances: sensitive). The meeting number for July
Drug Enforcement Administration 29 is 998 630 315 and the password is
Controlled substance Schedule nacgrc0729+ (case sensitive).
[Docket No. DEA–392] The agenda for the meeting will
Phenylacetone (8501) .................. II
Importer of Controlled Substances include reports from the following:
Thebaine (9333) ........................... II
Application: Noramco, Inc. Poppy Straw Concentrate (9670) II —Aeronautics Committee
Tapentadol (9780) ........................ II —Human Exploration and Operations
ACTION: Notice of application. Committee
The company plans to import —Institutional Committee
DATES: Registered bulk manufacturers of thebaine derivatives (9333) as reference —Science Committee
the affected basic classes, and standards. The company plans to import —Technology, Innovation and
applicants therefore, may file written an intermediate form of tapentadol Engineering Committee
comments on or objections to the (9780) to bulk manufacture tapentadol —Ad Hoc Task Force on STEM
issuance of the proposed registration in for distribution to its customers. The Education
accordance with 21 CFR 1301.34(a) on company plans to import phenylacetone Attendees will be required to sign a
or before August 12, 2016. Such persons (8501) and poppy straw concentrate register. It is imperative that the meeting
may also file a written request for a (9670) to manufacture other controlled be held on this date to accommodate the
hearing on the application pursuant to substances. scheduling priorities of the key
21 CFR 1301.43 on or before August 12, participants.
Dated: July 5, 2016.
2016.
Louis J. Milione, Patricia D. Rausch,
ADDRESSES: Written comments should
Deputy Assistant Administrator. Advisory Committee Management Officer,
be sent to: Drug Enforcement
Administration, Attention: DEA Federal [FR Doc. 2016–16550 Filed 7–12–16; 8:45 am] National Aeronautics and Space
Register Representative/ODW, 8701 BILLING CODE 4410–09–P Administration.
Morrissette Drive, Springfield, Virginia [FR Doc. 2016–16548 Filed 7–12–16; 8:45 am]
22152. All requests for hearing must be BILLING CODE 7510–13–P
sent to: Drug Enforcement NATIONAL AERONAUTICS AND
Administration, Attn: Administrator, SPACE ADMINISTRATION
8701 Morrissette Drive, Springfield, [Notice: 16–053]
Virginia 22152. All requests for hearing NATIONAL FOUNDATION ON THE
should also be sent to: (1) Drug NASA Advisory Council; Meeting ARTS AND THE HUMANITIES
Enforcement Administration, Attn:
Hearing Clerk/LJ, 8701 Morrissette AGENCY: National Aeronautics and National Endowment for the
Drive, Springfield, Virginia 22152; and Space Administration. Humanities
(2) Drug Enforcement Administration, ACTION: Notice of meeting.
Meetings of Humanities Panel
Attn: DEA Federal Register
SUMMARY: In accordance with the
Representative/ODW, 8701 Morrissette AGENCY: National Endowment for the
Federal Advisory Committee Act, Public
Drive, Springfield, Virginia 22152. Humanities, National Foundation on the
Law 92–463, as amended, the National
Comments and requests for hearings on Arts and the Humanities.
Aeronautics and Space Administration
applications to import narcotic raw ACTION: Notice of meetings.
(NASA) announces a meeting of the
material are not appropriate. 72 FR 3417
NASA Advisory Council. SUMMARY: The National Endowment for
(January 25, 2007).
DATES: Thursday, July 28, 2016, 9:00 the Humanities will hold twenty-four
SUPPLEMENTARY INFORMATION: The
a.m.–5:00 p.m., Local Time; and Friday, meetings of the Humanities Panel, a
Attorney General has delegated her
July 29, 2016, 9:00 a.m.–12:00 p.m., federal advisory committee, during
authority under the Controlled
Local Time. August, 2016. The purpose of the
Substances Act to the Administrator of
the Drug Enforcement Administration ADDRESSES: Ohio Aerospace Institute, meetings is for panel review, discussion,
(DEA), 28 CFR 0.100(b). Authority to President’s Room, 22800 Cedar Point evaluation, and recommendation of
exercise all necessary functions with Road, Cleveland, Ohio 44142. applications for financial assistance
jstallworth on DSK7TPTVN1PROD with NOTICES

respect to the promulgation and FOR FURTHER INFORMATION CONTACT: Ms. under the National Foundation on the
implementation of 21 CFR part 1301, Marla King, NAC Administrative Arts and Humanities Act of 1965.
incident to the registration of Officer, NASA Headquarters, DATES: See SUPPLEMENTARY INFORMATION
manufacturers, distributors, dispensers Washington, DC 20546, (202) 358–1148. section for meeting dates. The meetings
importers, and exporters of, controlled SUPPLEMENTARY INFORMATION: This will open at 8:30 a.m. and will adjourn
substances (other than final orders in meeting will be open to the public up by 5:00 p.m. on the dates specified
connection with suspension, denial, or to the capacity of the meeting room. below.

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Document Created: 2016-07-13 01:43:50
Document Modified: 2016-07-13 01:43:50

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 classes, 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 August 12, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before August 12, 2016.
FR Citation		81 FR 45306

81 FR 45306 - Importer of Controlled Substances Application: Janssen Pharmaceutical, Inc.

DEPARTMENT OF JUSTICEDrug Enforcement Administration

Federal Register Volume 81, Issue 134 (July 13, 2016)

DEPARTMENT OF JUSTICE
Drug Enforcement Administration