81 FR 96045 - Bulk Manufacturer of Controlled Substances Application: Janssen Pharmaceutical, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 81, Issue 250 (December 29, 2016)
Drug Enforcement Administration
Federal Register Volume 81, Issue 250 (December 29, 2016)
| Page Range | 96045-96046 | |
| FR Document | 2016-31641 |
[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)] [Notices] [Pages 96045-96046] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-31641] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Bulk Manufacturer of Controlled Substances Application: Janssen Pharmaceutical, 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 in accordance with 21 CFR 1301.33(a) on or before February 27, 2017. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 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 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 9, 2016, Janssen Pharmaceutical, 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: ------------------------------------------------------------------------ Controlled substance Drug code Schedule ------------------------------------------------------------------------ Methylphenidate................................... 1724 II Oxycodone......................................... 9143 II Hydromorphone..................................... 9150 II Hydrocodone....................................... 9193 II Oripavine......................................... 9330 II Thebaine.......................................... 9333 II Oxymorphone....................................... 9652 II Tapentadol........................................ 9780 II Fentanyl.......................................... 9801 II ------------------------------------------------------------------------ The company plans to manufacture the above-listed controlled substances in bulk for distribution to its customers. [[Page 96046]] Dated: December 21, 2016. Louis J. Milione, Assistant Administrator. [FR Doc. 2016-31641 Filed 12-28-16; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices 96045
of Cupertino, CA. The complainant Filing Procedures.1) Persons with DEPARTMENT OF JUSTICE
requests that the Commission issue an questions regarding filing should
exclusion order and a cease and desist contact the Secretary (202–205–2000). Drug Enforcement Administration
order. Any person desiring to submit a [Docket No. DEA–392]
Proposed respondents, other
interested parties, and members of the document to the Commission in
confidence must request confidential Bulk Manufacturer of Controlled
public are invited to file comments, not Substances Application: Janssen
to exceed five (5) pages in length, treatment. All such requests should be
directed to the Secretary to the Pharmaceutical, Inc.
inclusive of attachments, on any public
interest issues raised by the complaint Commission and must include a full ACTION: Notice of application.
or § 210.8(b) filing. Comments should statement of the reasons why the
address whether issuance of the relief Commission should grant such DATES: Registered bulk manufacturers of
specifically requested by the treatment. See 19 CFR 201.6. Documents the affected basic classes, and
complainant in this investigation would for which confidential treatment by the applicants therefore, may file written
affect the public health and welfare in Commission is properly sought will be comments on or objections to the
the United States, competitive treated accordingly. All such requests issuance of the proposed registration in
conditions in the United States should be directed to the Secretary to accordance with 21 CFR 1301.33(a) on
economy, the production of like or the Commission and must include a full or before February 27, 2017.
directly competitive articles in the statement of the reasons why the ADDRESSES: Written comments should
United States, or United States Commission should grant such be sent to: Drug Enforcement
consumers. treatment. See 19 CFR 201.6. Documents Administration, Attention: DEA Federal
In particular, the Commission is for which confidential treatment by the Register Representative/DRW, 8701
interested in comments that: Commission is properly sought will be Morrissette Drive, Springfield, Virginia
(i) explain how the articles potentially
treated accordingly. All information, 22152.
subject to the requested remedial orders
including confidential business SUPPLEMENTARY INFORMATION: The
are used in the United States;
(ii) identify any public health, safety, information and documents for which Attorney General has delegated her
or welfare concerns in the United States confidential treatment is properly authority under the Controlled
relating to the requested remedial sought, submitted to the Commission for Substances Act to the Administrator of
orders; purposes of this Investigation may be the Drug Enforcement Administration
(iii) identify like or directly disclosed to and used: (i) by the (DEA), 28 CFR 0.100(b). Authority to
competitive articles that complainant, Commission, its employees and Offices, exercise all necessary functions with
its licensees, or third parties make in the and contract personnel (a) for respect to the promulgation and
United States which could replace the developing or maintaining the records implementation of 21 CFR part 1301,
subject articles if they were to be of this or a related proceeding, or (b) in incident to the registration of
excluded; internal investigations, audits, reviews, manufacturers, distributors, dispensers,
(iv) indicate whether complainant, and evaluations relating to the importers, and exporters of controlled
complainant’s licensees, and/or third programs, personnel, and operations of substances (other than final orders in
party suppliers have the capacity to the Commission including under 5 connection with suspension, denial, or
replace the volume of articles U.S.C. Appendix 3; or (ii) by U.S. revocation of registration) has been
potentially subject to the requested government employees and contract redelegated to the Assistant
exclusion order and/or a cease and personnel,2 solely for cybersecurity Administrator of the DEA Diversion
desist order within a commercially purposes. All nonconfidential written Control Division (‘‘Assistant
reasonable time; and Administrator’’) pursuant to section 7 of
(v) explain how the requested submissions will be available for public
inspection at the Office of the Secretary 28 CFR part 0, appendix to subpart R.
remedial orders would impact United In accordance with 21 CFR
States consumers. and on EDIS.3
1301.33(a), this is notice that on
Written submissions must be filed no This action is taken under the September 9, 2016, Janssen
later than by close of business, eight authority of section 337 of the Tariff Act Pharmaceutical, Inc., Buildings 1–5 & 7–
calendar days after the date of of 1930, as amended (19 U.S.C. 1337), 14, 1440 Olympic Drive, Athens,
publication of this notice in the Federal and of §§ 201.10 and 210.8(c) of the Georgia 30601 applied to be registered
Register. There will be further Commission’s Rules of Practice and as a bulk manufacturer of the following
opportunities for comment on the Procedure (19 CFR 201.10, 210.8(c)). basic classes of controlled substances:
public interest after the issuance of any
final initial determination in this By order of the Commission.
Drug
Issued: December 22, 2016. Controlled substance Schedule
investigation. code
Persons filing written submissions Lisa R. Barton,
must file the original document Methylphenidate ....... 1724 II
Secretary to the Commission.
electronically on or before the deadlines Oxycodone ................ 9143 II
[FR Doc. 2016–31435 Filed 12–28–16; 8:45 am] Hydromorphone ........ 9150 II
stated above and submit 8 true paper
BILLING CODE 7020–02–P Hydrocodone ............ 9193 II
copies to the Office of the Secretary by
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Oripavine .................. 9330 II
noon the next day pursuant to § 210.4(f) Thebaine ................... 9333 II
of the Commission’s Rules of Practice 1 Handbook for Electronic Filing Procedures: Oxymorphone ........... 9652 II
and Procedure (19 CFR 210.4(f)). https://www.usitc.gov/documents/handbook_on_ Tapentadol ................ 9780 II
Submissions should refer to the docket filing_procedures.pdf. Fentanyl .................... 9801 II
number (‘‘Docket No. 3190’’) in a 2 All contract personnel will sign appropriate
prominent place on the cover page and/ nondisclosure agreements. The company plans to manufacture
or the first page. (See Handbook for 3 Electronic Document Information System the above-listed controlled substances
Electronic Filing Procedures, Electronic (EDIS): https://edis.usitc.gov in bulk for distribution to its customers.
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![96046 Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices
Dated: December 21, 2016. On June 27, 2016, People of the State Appendix A of the Decree (Buyback,
Louis J. Milione, of California (‘‘California’’), by and Lease Termination, Vehicle
Assistant Administrator. through the California Air Resources Modification, and Emissions Compliant
[FR Doc. 2016–31641 Filed 12–28–16; 8:45 am] Board (‘‘CARB’’) and the California Recall Program):
BILLING CODE 4410–09–P Attorney General filed a complaint First, for Generation 1.x 3.0 Liter
against defendants alleging that Subject Vehicles, Volkswagen must offer
defendants violated Cal. Health & Safety all Eligible Owners and Lessees of these
DEPARTMENT OF JUSTICE Code §§ 43016, 43017, 43151, 43152, vehicles the Buyback or the Lease
43153, 43205, 43211, and 43212; Cal. Termination under terms described in
Notice of Lodging of Proposed Second Code Regs. tit. 13, §§ 1903, 1961, 1961.2, Appendix A. In addition, if approved by
Partial Consent Decree Under the 1965, 1968.2, and 2037, and 40 CFR EPA/CARB, Volkswagen may, in
Clean Air Act Sections incorporated by reference in accordance with the requirements
those California regulations; Cal. Bus. & specified in Appendix B of the Decree
On December 20, 2016, the
Prof. Code §§ 17200 et seq., 17500 et (Vehicle Recall and Emissions
Department of Justice lodged a proposed
seq., and 17580.5; Cal. Civ. Code § 3494; Modification Program for 3.0 Liter
Second Partial Consent Decree with the
and 12 U.S.C. 5531 et seq., with regard Subject Vehicles), offer for Eligible
United States District Court for the
to approximately 71,000 model year Vehicles the option of a modification to
Northern District of California in the
2009 to 2015 motor vehicles containing substantially reduce NOX emissions in
lawsuit entitled In re: Volkswagen
2.0 liter diesel engines and accordance with standards established
‘‘Clean Diesel’’ Marketing, Sales
approximately 16,000 model year 2009 by EPA/CARB in the Decree.
Practices, and Products Liability Second, for Generation 2.x 3.0 Liter
to 2016 motor vehicles containing 3.0
Litigation, Case No: MDL No. 2672 CRB Subject Vehicles, if proposed by
liter diesel engines, for a total of
(JSC), partially resolving Clean Air Act Volkswagen and approved by EPA/
approximately 87,000 motor vehicles.
and various California claims (including CARB, Volkswagen must offer an
The California complaint alleges, in
under the California Health and Safety Emissions Compliant Recall as set forth
relevant part, that the motor vehicles
Code) against Volkswagen AG and in Appendix A to bring these vehicles
contain prohibited defeat devices and
others, concerning certain noncompliant into compliance with their Certified
have resulted in, and continue to result
3.0 liter diesel vehicles. Exhaust Emission Standards in
in, increased NOx emissions from each
On January 4, 2016, the United States, accordance with the requirements
such vehicle significantly in excess of
on behalf of the Environmental specified in Appendix B. If Volkswagen
CARB requirements, that these vehicles
Protection Agency (‘‘EPA’’) filed a is unable to effect a recall that meets
have resulted in the creation of a public
complaint against Volkswagen AG, Certified Exhaust Emission Standards
nuisance, and that defendants engaged
Volkswagen Group of America, Inc., for a particular Test Group or Groups of
in related conduct that violated unfair
Volkswagen Group of America Generation 2.x 3.0 Liter Subject
competition, false advertising, and
Chattanooga Operations, LLC, Audi AG, Vehicles in accordance with the
consumer protection laws.
Dr. Ing. h.c. F. Porsche AG, and Porsche On June 28, 2016, the United States requirements specified in Appendix B,
Cars North America, Inc. alleging that lodged a Partial Consent Decree, Dkt. Volkswagen must offer all Eligible
the defendants violated Sections No. 1605–1 (‘‘First Partial Consent Owners and Lessees of such vehicles the
203(a)(1), (2), (3)(A), and (3)(B) of the Decree’’), concerning the 2.0 Liter Buyback or Lease Termination, under
Clean Air Act (‘‘Act’’), 42 U.S.C. Subject Vehicles, which was entered terms described in Appendix A, and
7522(a)(1), (2), (3)(A), and (3)(B), with into by the United States, California, may, if proposed by Volkswagen and
regard to approximately 500,000 model and certain defendants (Volkswagen approved by EPA/CARB, consistent
year 2009 to 2015 motor vehicles AG, Audi AG, Volkswagen Group of with the provisions in Appendix B, offer
containing 2.0 liter diesel engines (2.0 America, Inc., and Volkswagen Group of to modify such vehicles to substantially
Liter Subject Vehicles) and America Chattanooga Operations, LLC). reduce their NOX emissions in
approximately 80,000 model year 2009 The First Partial Consent Decree was accordance with standards established
to 2016 motor vehicles containing 3.0 entered by this Court on October 25, by EPA/CARB in this Consent Decree.
liter diesel engines (3.0 Liter Subject 2016, Dkt. No. 2103, and may be viewed See Decree ¶¶ 9–15; Appendices A and
Vehicles). An amended complaint was here: http://www.cand.uscourts.gov/crb/ B.
filed on October 7, 2016. The United vwmdl. Volkswagen must achieve a recall rate
States’ complaint (initial and as This Second Partial Consent Decree (through the buyback, lease termination,
amended) alleges that each 2.0 and 3.0 (‘‘Decree’’) is entered into between the scrapped vehicles, the Emissions
Liter Subject Vehicle contains computer United States, California, and all Compliant Recall, and any other
algorithms that are prohibited defeat defendants (collectively, approved vehicle modification options)
devices that cause the emissions control ‘‘Volkswagen’’). The Decree partially of 85% by November 30, 2019 for the
system of those vehicles to perform resolves the governments’ claims for Generation 1.x 3.0 Liter Subject
differently during normal vehicle injunctive relief with respect to the 3.0 Vehicles, and by May 31, 2020 for the
operation and use than during Liter Subject Vehicles, by providing Generation 2.x 3.0 Liter Subject
emissions testing. The complaint alleges remedies for the cars on the road and Vehicles. If it fails to do so, Volkswagen
that the defeat devices cause the the environmental harm from the must augment the mitigation trust fund
vehicles, during normal vehicle violations. It does not address plaintiffs’ discussed below by $5.5 million for
asabaliauskas on DSK3SPTVN1PROD with NOTICES
operation and use, to emit levels of claims, inter alia, for prospective each 1% that it falls short of the 85%
oxides of nitrogen (‘‘NOX’’) significantly injunctive relief to prevent future rate for the Generation 1.x 3.0 Liter
in excess of EPA-compliant levels. The violations of the same type that are Subject Vehicles, and by $21 million for
complaint seeks, among other things, alleged in the complaints or claims for each 1% that it falls short of the 85%
injunctive relief to remedy the civil penalties. rate for the Generation 2.x 3.0 Liter
violations, including mitigation of Under the Decree, Volkswagen must Subject Vehicles. Volkswagen must also
excess NOX emissions, and civil perform two vehicle recalls as follows achieve a separate 85% recall rate for
penalties. (with all capitalized terms as defined in vehicles in California, and must pay to
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Document Created: 2016-12-29 01:58:11
Document Modified: 2016-12-29 01:58:11
| 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 1301.33(a) on or before February 27, 2017. | |
| FR Citation | 81 FR 96045 |
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