83 FR 55205 - Bulk Manufacturer of Controlled Substances Application: Janssen Pharmaceuticals, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 213 (November 2, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 213 (November 2, 2018)
| Page Range | 55205-55206 | |
| FR Document | 2018-24006 |
[Federal Register Volume 83, Number 213 (Friday, November 2, 2018)] [Notices] [Pages 55205-55206] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-24006] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Bulk Manufacturer of Controlled Substances Application: Janssen Pharmaceuticals, Inc. 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 on or before January 2, 2019. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: The Attorney General has delegated his 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 Assistant Administrator of the DEA Diversion Control Division (``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 September 13, 2018, Janssen Pharmaceuticals, Inc., Buildings 1-5 & 7- 14, 1440 Olympic Drive, Athens, Georgia 30601 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: ------------------------------------------------------------------------ Drug Controlled substance code Schedule ------------------------------------------------------------------------ Methylphenidate......................... 1724 II Hydromorphone........................... 9150 II Hydrocodone............................. 9193 II Oripavine............................... 9330 II Thebaine................................ 9333 II Tapentadol.............................. 9780 II ------------------------------------------------------------------------ [[Page 55206]] The company plans to manufacture the above-listed controlled substances in bulk for distribution to its customers. Dated: October 24, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018-24006 Filed 11-1-18; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 83, No. 213 / Friday, November 2, 2018 / Notices 55205
Cambridge, UK; Clear Scientific, LLC, Register pursuant to Section 6(b) of the Dated: October 24, 2018.
Cambridge, MA; Cornerstone Act on June 19, 2018 (83 FR 28448). John J. Martin,
Government Affairs, Inc., Washington, Assistant Administrator.
Suzanne Morris,
DC; DePuy Synthes Products, Inc., [FR Doc. 2018–24005 Filed 11–1–18; 8:45 am]
Chief, Premerger and Division Statistics Unit
Raynham, MA; Dignitas Technologies, Antitrust Division. BILLING CODE 4410–09–P
Orlando, FL; ECM Therapeutics, Inc.,
[FR Doc. 2018–23989 Filed 11–1–18; 8:45 am]
Warrendale, PA; ElMindA Ltd.,
BILLING CODE 4410–11–P DEPARTMENT OF JUSTICE
Herzliya, Israel; Family Health
International DBA FHI 360, Durham,
NC; Hypatia Project, Reston, VA; Drug Enforcement Administration
DEPARTMENT OF JUSTICE
Institutes for Behavior Resources, Inc. [Docket No. DEA–392]
(IBR), Baltimore, MD; Integrated Drug Enforcement Administration
MicroSciences, LLC, Frederick, MD; J. Bulk Manufacturer of Controlled
Craig Venter Institute (JCVI), Rockville, Substances Application: Janssen
[Docket No. DEA–392]
MD; KaloCyte, Inc., St. Louis, MO; Pharmaceuticals, Inc.
Lieber Institute, Inc., Baltimore, MD; Bulk Manufacturer of Controlled
ACTION: Notice of application.
NanoDirect, LLC, Baltimore, MD; Substances Registration
OXYVITA, Inc., Middletown, NY; DATES: Registered bulk manufacturers of
Parsons Government Services, Inc., ACTION: Notice of registration. the affected basic classes, and
Pasadena, CA; Protocentral, Inc., applicants therefore, may file written
Woburn, MA; Q2Pharma, Haifa, Israel; SUMMARY: The registrants listed below comments on or objections to the
RAIN Scientific, Inc., Asheville, NC; have applied for and been granted issuance of the proposed registration on
Rehat, LLC, Pittsburgh, PA; Research registration by the Drug Enforcement or before January 2, 2019.
Foundation for Mental Hygiene, Inc. Administration (DEA) as bulk ADDRESSES: Written comments should
(NYSPI), New York, NY; Responde2 manufacturers of various classes of be sent to: Drug Enforcement
Corporation, Mountain View, CA; Saint schedule I and II controlled substances. Administration, Attention: DEA Federal
Barnabas Medical Center (SBMC), SUPPLEMENTARY INFORMATION: The Register Representative/DPW, 8701
Livingston, NJ; San Diego Blood Bank, companies listed below applied to be Morrissette Drive, Springfield, Virginia
San Diego, CA; SmartMD Systems, Inc., registered as bulk manufacturers of 22152.
Manchester Center, VT; Sonica LLC, various basic classes of controlled SUPPLEMENTARY INFORMATION: The
Evanston, IL; Spire, San Francisco, CA; substances. Information on previously Attorney General has delegated his
Syracuse University, Syracuse, NY; The published notices is listed in the table authority under the Controlled
Charles Stark Draper Laboratory, Inc. below. No comments or objections were Substances Act to the Administrator of
(Draper), Cambridge, MA; The submitted for these notices. the Drug Enforcement Administration
University of Arizona, Defense and (DEA), 28 CFR 0.100(b). Authority to
Security Research Institute (DSRI), Company FR citation Published exercise all necessary functions with
Tucson, AZ; Trauma Insight, LLC, San respect to the promulgation and
Chemtos, 83 FR 37520 August 1,
Antonio, TX; Trustees of Boston implementation of 21 CFR part 1301,
LLC. 2018.
University, Boston, MA; University of Johnson 83 FR 34880 July 23, incident to the registration of
Central Florida Research Foundation, Matthey Inc. 2018. manufacturers, distributors, dispensers,
Inc., Orlando, FL; University of AMRI 83 FR 38179 August 3, importers, and exporters of controlled
Houston—Cullen College of Rensselaer, 2018. substances (other than final orders in
Engineering, Houston, TX; Vivonics, Inc. connection with suspension, denial, or
Inc., Bedford, MA; and Washington revocation of registration) has been
State University, Pullman, WA; have The DEA has considered the factors in redelegated to the Assistant
been added as parties to this venture. 21 U.S.C. 823(a) and determined that Administrator of the DEA Diversion
the registration of these registrants to Control Division (‘‘Assistant
No other changes have been made in
manufacture the applicable basic classes Administrator’’) pursuant to section 7 of
either the membership or planned
of controlled substances is consistent 28 CFR part 0, appendix to subpart R.
activity of the group research project.
with the public interest and with United In accordance with 21 CFR
Membership in this group research 1301.33(a), this is notice that on
States obligations under international
project remains open, and MTEC September 13, 2018, Janssen
treaties, conventions, or protocols in
intends to file additional written Pharmaceuticals, Inc., Buildings 1–5 &
effect on May 1, 1971. The DEA
notifications disclosing all changes in 7–14, 1440 Olympic Drive, Athens,
investigated each of the company’s
membership. maintenance of effective controls Georgia 30601 applied to be registered
On May 9, 2014, MTEC filed its against diversion by inspecting and as a bulk manufacturer of the following
original notification pursuant to Section testing each company’s physical basic classes of controlled substances:
6(a) of the Act. The Department of security systems, verifying each
Justice published a notice in the Federal company’s compliance with state and Drug
Controlled substance Schedule
code
Register pursuant to Section 6(b) of the local laws, and reviewing each
Act on June 9, 2014 (79 FR 32999). company’s background and history. Methylphenidate ............... 1724 II
The last notification was filed with Therefore, pursuant to 21 U.S.C. Hydromorphone ................ 9150 II
823(a), and in accordance with 21 CFR Hydrocodone .................... 9193 II
the Department on May 3, 2018. A
1301.33, the DEA has granted a Oripavine .......................... 9330 II
notice was published in the Federal Thebaine ........................... 9333 II
registration as a bulk manufacturer to Tapentadol ........................ 9780 II
the above listed companies.
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![55206 Federal Register / Vol. 83, No. 213 / Friday, November 2, 2018 / Notices
The company plans to manufacture Consent Decree also required a DEPARTMENT OF JUSTICE
the above-listed controlled substances $1,300,000 penalty, which VIWAPA has
in bulk for distribution to its customers. paid. The proposed Amended Consent U.S. Marshals Service
Dated: October 24, 2018. Decree makes certain changes to the [OMB Number 1105–0096]
John J. Martin, Consent Decree, including: Updating
Assistant Administrator. references to current operating units; Agency Information Collection
adding new units called reciprocating Activities; Proposed eCollection
[FR Doc. 2018–24006 Filed 11–1–18; 8:45 am]
internal combustion engines to the eComments Requested; Extension
BILLING CODE 4410–09–P
requirements of Paragraph 13 and any With No Changes, of a Previously
requirements associated with the Approved Collection; Sequestered
DEPARTMENT OF JUSTICE requirements of Paragraph 13; updating Juror Information Form
aspects of the Consent Decree that have
become outdated and are no longer AGENCY: U.S. Marshals Service,
Notice of Lodging of Proposed
relevant to its enforcement; addressing Department of Justice.
Amended Consent Decree Under the
Clean Air Act the current status of the St. John Unit; ACTION: 30-Day notice.
edits to Paragraph 21 regarding the SUMMARY: The Department of Justice
On October 25, 2018, the Department
Atomizer on Unit 14; and adding a date (DOJ), U.S. Marshals Service (USMS),
of Justice lodged a proposed Amended
certain for the performance of a stack will submit the following information
Consent Decree with the United States
test. collection request to the Office of
District Court of the Virgin Islands in
the lawsuit entitled United States of The Department of Justice will Management and Budget (OMB) for
America v. Virgin Islands Water and receive, for a period of thirty (30) days review and approval in accordance with
Power Authority, Civil Action No. 3:14– from the date of this publication, the Paperwork Reduction Act of 1995.
cv–00086. comments relating to the Consent The proposed information collection
The original Consent Decree resolved Decree. Comments should be addressed was previously published in the Federal
the Clean Air Act violations as alleged to the Assistant Attorney General for the Register on August 29, 2018, allowing
in the Complaint filed by the United Environmental and Natural Resources for a 60-day comment period.
States on October 30, 2014. The Division, and should refer to United DATES: Comments are encouraged and
violations alleged in the Complaint with States v. Virgin Islands Water and will be accepted for an additional 30
respect to VIWAPA’s St. Thomas facility Power Authority, DOJ Ref. # 90–5–2–1– days until December 3, 2018.
include VIWAPA’s failure to properly 10424. All comments must be submitted FOR FURTHER INFORMATION CONTACT: If
operate and/or maintain its water no later than thirty days after the you have additional comments,
injection systems on its gas turbine publication date of this notice. particularly with respect to the
units, failure to operate in compliance Comments may be submitted either by estimated public burden or associated
with NOX, sulfuric acid mist, particulate email or by mail: response time, have suggestions, need a
matter and VOC emission limits, failure
copy of the proposed information
to operate in compliance with opacity To submit Send them to: collection instrument with instructions,
limits, failure to perform required audits comments:
or desire any other additional
and maintain required quality data
By e-mail ...... pubcomment-ees.enrd@ information, please contact Nicole
availability, failure to properly operate
usdoj.gov. Timmons either by mail at CG–3, 10th
and calibrate the continuous emission
By mail ......... Assistant Attorney General, Floor, Washington, DC 20530–0001, by
monitoring systems (CEMS) for NOX
U.S. DOJ—ENRD, P.O. email at Nicole.Timmons@usdoj.gov, or
and CO, failure to conduct stack testing
Box 7611, Washington, DC by telephone at 202–236–2646. Written
every 30 months, and failure to properly 20044–7611. comments and/or suggestions can also
report non-compliance. The violations
alleged in the Complaint with respect to be directed to the Office of Management
VIWAPA’s St. John facility concern During the public comment period, and Budget, Office of Information and
VIWAPA’s failure to comply with the the Consent Decree may be examined Regulatory Affairs, Attention
RICE NESHAP regulations, failure to and downloaded at this Justice Department of Justice Desk Officer,
timely submit a Title V renewal Department website: http:// Washington, DC 20503 or sent to OIRA_
application and operation without a www.justice.gov/enrd/consent-decrees. submissions@omb.eop.gov.
Title V permit, and failure to conduct We will provide a paper copy of the SUPPLEMENTARY INFORMATION: Written
stack testing every 30 months. Consent Decree upon written request comments and suggestions from the
The Consent Decree, entered by the and payment of reproduction costs. public and affected agencies concerning
Court on September 30, 2016, requires Please mail your request and payment the proposed collection of information
VIWAPA to generate a high percentage to: Consent Decree Library, U.S. DOJ— are encouraged. Your comments should
of its KWh from liquid propane gas or ENRD, P.O. Box 7611, Washington, DC address one or more of the following
liquid natural gas and renewables, to 20044–7611. four points:
implement a spare parts inventory Please enclose a check or money order —Evaluate whether the proposed
program, to control NOX emissions for $22.75 (25 cents per page collection of information is necessary
through improved operation of its water reproduction cost) payable to the United for the proper performance of the
injection system, to maintain and States Treasury. functions of the agency, including
operate continuous emissions whether the information will have
monitoring systems on specified units, Robert Maher, practical utility;
to operate a video camera system for Assistant Section Chief, Environmental —Evaluate the accuracy of the agency’s
visible emissions, to perform stack Enforcement Section, Environment & Natural estimate of the burden of the
testing, and to conduct targeted self- Resources Division. proposed collection of information,
audits and third party audits given its [FR Doc. 2018–23985 Filed 11–1–18; 8:45 am] including the validity of the
long term compliance problems. The BILLING CODE 4410–15–P methodology and assumptions used;
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Document Created: 2018-11-02 01:10:03
Document Modified: 2018-11-02 01:10:03
| 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 on or before January 2, 2019. | |
| FR Citation | 83 FR 55205 |
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