80 FR 54327 - Manufacturer of Controlled Substances Registration: PCAS-Nanosyn, LLC
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 80, Issue 174 (September 9, 2015)
Drug Enforcement Administration
Federal Register Volume 80, Issue 174 (September 9, 2015)
| Page Range | 54327-54328 | |
| FR Document | 2015-22626 |
[Federal Register Volume 80, Number 174 (Wednesday, September 9, 2015)] [Notices] [Pages 54327-54328] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-22626] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Manufacturer of Controlled Substances Registration: PCAS-Nanosyn, LLC ACTION: Notice of registration. ----------------------------------------------------------------------- SUMMARY: PCAS-Nanosyn, LLC applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants PCAS-Nanosyn, LLC registration as a manufacturer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated May 15, 2015, and published in the Federal Register on May 21, 2015, 80 FR 29336, PCAS-Nanosyn, LLC, 3331-B Industrial Drive, Santa Rosa, California 95403 applied to be registered as a manufacturer of certain basic classes of controlled substances. 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 PCAS-Nanosyn, LLC to manufacture the basic classes of controlled substances 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 the basic classes of controlled substances: ------------------------------------------------------------------------ Controlled substance Schedule ------------------------------------------------------------------------ Oxycodone (9143)........................... II Oripavine (9330)........................... II Oxymorphone (9652)......................... II Fentanyl (9801)............................ II ------------------------------------------------------------------------ The company is a contract manufacturer. At the request of the company's customers, it manufacturers [[Page 54328]] derivatives of controlled substances in bulk form. Dated: September 1, 2015 Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015-22626 Filed 9-8-15; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Notices 54327
21 CFR 1301.43 on or before October 9, Dated: September 1, 2015. Dated: September 1, 2015.
2015. Joseph T. Rannazzisi, Joseph T. Rannazzisi,
Deputy Assistant Administrator. Deputy Assistant Administrator.
ADDRESS: Written comments should be
[FR Doc. 2015–22624 Filed 9–8–15; 8:45 am] [FR Doc. 2015–22625 Filed 9–8–15; 8:45 am]
sent to: Drug Enforcement
Administration, Attention: DEA Federal BILLING CODE 4410–09–P BILLING CODE 4410–09–P
Register Representative/ODXL, 8701
Morrissette Drive, Springfield, Virginia
DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE
22152. Request for hearings should be
sent to: Drug Enforcement Drug Enforcement Administration Drug Enforcement Administration
Administration, Attention: Hearing
Clerk/LJ, 8701 Morrissette Drive, [Docket No. DEA–392] [Docket No. DEA–392]
Springfield, Virginia 22152. Comments
Importer of Controlled Substances Manufacturer of Controlled
and requests for hearings on Application: Akorn, Inc. Substances Registration: PCAS-
applications to import narcotic raw Nanosyn, LLC
material are not appropriate. 72 FR 3417 ACTION: Notice of application.
(January 25, 2007). ACTION: Notice of registration.
DATES: Registered bulk manufacturers of
SUPPLEMENTARY INFORMATION: The SUMMARY: PCAS-Nanosyn, LLC applied
the affected basic class, and applicants
Attorney General has delegated her to be registered as a manufacturer of
therefore, may file written comments on
authority under the Controlled certain basic classes of controlled
or objections to the issuance of the
Substances Act to the Administrator of substances. The Drug Enforcement
proposed registration in accordance
the Drug Enforcement Administration Administration (DEA) grants PCAS-
with 21 CFR 1301.34(a) on or before
(DEA), 28 CFR 0.100(b). Authority to October 9, 2015. Such persons may also Nanosyn, LLC registration as a
exercise all necessary functions with file a written request for a hearing on manufacturer of those controlled
respect to the promulgation and the application pursuant to 21 CFR substances.
implementation of 21 CFR part 1301, 1301.43 on or before October 9, 2015. SUPPLEMENTARY INFORMATION:
incident to the registration of
ADDRESSES: Written comments should By notice dated May 15, 2015, and
manufacturers, distributors, dispensers,
be sent to: Drug Enforcement published in the Federal Register on
importers, and exporters of controlled May 21, 2015, 80 FR 29336, PCAS-
Administration, Attention: DEA Federal
substances (other than final orders in Nanosyn, LLC, 3331–B Industrial Drive,
Register Representative/ODXL, 8701
connection with suspension, denial, or Santa Rosa, California 95403 applied to
Morrissette Drive, Springfield, Virginia
revocation of registration) has been 22152. Request for hearings should be be registered as a manufacturer of
redelegated to the Deputy Assistant sent to: Drug Enforcement certain basic classes of controlled
Administrator of the DEA Office of Administration, Attention: Hearing substances. No comments or objections
Diversion Control (‘‘Deputy Assistant Clerk/LJ, 8701 Morrissette Drive, were submitted for this notice.
Administrator’’) pursuant to section. 7 Springfield, Virginia 22152. The DEA has considered the factors in
of 28 CFR part 0, appendix to subpart 21 U.S.C. 823(a) and determined that
SUPPLEMENTARY INFORMATION: The
R. the registration of PCAS-Nanosyn, LLC
Attorney General has delegated her
In accordance with 21 CFR authority under the Controlled to manufacture the basic classes of
1301.34(a), this is notice that on July 22, Substances Act to the Administrator of controlled substances is consistent with
2015, Chattem Chemicals, Inc., 3801 St. the Drug Enforcement Administration the public interest and with United
Elmo Avenue, Chattanooga, Tennessee (DEA), 28 CFR 0.100(b). Authority to States obligations under international
37409 applied to be registered as an exercise all necessary functions with treaties, conventions, or protocols in
importer of the following basic classes respect to the promulgation and effect on May 1, 1971. The DEA
of controlled substances: implementation of 21 CFR part 1301, investigated the company’s maintenance
incident to the registration of of effective controls against diversion by
Controlled substance Schedule manufacturers, distributors, dispensers, inspecting and testing the company’s
importers, and exporters of controlled physical security systems, verifying the
Methamphetamine (1105) ............ II substances (other than final orders in company’s compliance with state and
4-Anilino-N-phenethyl-4-piperidine II connection with suspension, denial, or local laws, and reviewing the company’s
(8333). revocation of registration) has been background and history.
Phenylacetone (8501) .................. II Therefore, pursuant to 21 U.S.C.
redelegated to the Deputy Assistant
Opium, raw (9600) ....................... II 823(a), and in accordance with 21 CFR
Administrator of the DEA Office of
Poppy Straw Concentrate (9670) II 1301.33, the above-named company is
Diversion Control (‘‘Deputy Assistant
Tapentadol (9780) ........................ II granted registration as a bulk
Administrator’’) pursuant to section 7 of
28 CFR part 0, appendix to subpart R. manufacturer of the basic classes of
The company plans to import the In accordance with 21 CFR controlled substances:
listed controlled substances to bulk 1301.34(a), this is notice that on May 14,
manufacture other controlled substances Controlled substance Schedule
2015, Akorn, Inc., 1222 W. Grand
for distribution to its customers. The Avenue, Decatur, Illinois 62522 applied Oxycodone (9143) ........................ II
Lhorne on DSK5TPTVN1PROD with NOTICES
company plans to import an to be registered as an importer of Oripavine (9330) ........................... II
intermediate form of tapentadol (9780), remifentanil (9739), a basic class of Oxymorphone (9652) ................... II
to bulk manufacturer tapentadol (9780) controlled substance listed in schedule Fentanyl (9801) ............................ II
for distribution to its customers. The II.
company plans to import Phenylacetone The company plans to import The company is a contract
(8501) in bulk for the manufacture of a remifentanil in dosage form for manufacturer. At the request of the
controlled substance. distribution. company’s customers, it manufacturers
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![54328 Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Notices
derivatives of controlled substances in confidential business information that OFFICE OF PERSONNEL
bulk form. you do not want publicly disclosed. MANAGEMENT
Dated: September 1, 2015 Individuals or representatives of
organizations wishing to address the Submission for Review:
Joseph T. Rannazzisi,
Advisory Council should forward their Representative Payee Application, RI
Deputy Assistant Administrator. 20–007 and Information Necessary for
[FR Doc. 2015–22626 Filed 9–8–15; 8:45 am]
requests to the Executive Secretary or
telephone (202) 693–8668. Oral a Competency Determination, RI 30–3,
BILLING CODE 4410–09–P
presentations will be limited to ten 3206–0140
minutes, time permitting, but an AGENCY: U.S. Office of Personnel
extended statement may be submitted Management.
DEPARTMENT OF LABOR for the record. Individuals with ACTION: 60-Day notice and request for
disabilities who need special comments.
Employee Benefits Security accommodations should contact the
Administration Executive Secretary by September 23, SUMMARY: The Retirement Services,
2015 at the address indicated. Office of Personnel Management (OPM)
178th Meeting of the Advisory Council
Signed at Washington, DC, this 2nd day of
offers the general public and other
on Employee Welfare and Pension
September, 2015. Federal agencies the opportunity to
Benefit Plans; Notice of comment on a revised information
Teleconference Meeting Judith Mares,
collection request (ICR) 3206–0140,
Deputy Assistant Secretary, Employee
Pursuant to the authority contained in Representative Payee Application, RI
Benefits Security Administration.
Section 512 of the Employee Retirement 20–7; Information necessary for a
[FR Doc. 2015–22643 Filed 9–8–15; 8:45 am]
Income Security Act of 1974 (ERISA), 29 competency determination, collects
BILLING CODE 4510–29–P medical information regarding the
U.S.C. 1142, the 178th open meeting of
the Advisory Council on Employee annuitant’s competency in evaluating
Welfare and Pension Benefit Plans (also the annuitant’s condition, RI 30–3. As
known as the ERISA Advisory Council) required by the Paperwork Reduction
NATIONAL SCIENCE FOUNDATION Act of 1995 (Pub. Law 104–13, 44 U.S.C.
will be held as a teleconference on
September 30, 2015. chapter 35) as amended by the Clinger-
National Science Board; Sunshine Act
The meeting will take place in C5320 Cohen Act (Pub. L. 104–106), OPM is
Meetings; Notice
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DC 20210. Public access is available Task Force on NEON Performance and will be accepted until November 9,
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Council page of the EBSA Web site at 2015 at 4–5 p.m. EDT.
FOR FURTHER INFORMATION CONTACT: A
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erisa_advisory_council.html. teleconference originating at the supporting documentation, may be
Organizations or members of the National Science Board Office, National obtained by contacting the Retirement
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Lhorne on DSK5TPTVN1PROD with NOTICES
on or before September 23 will be National Science Foundation, 4201 of OPM, including whether the
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contacting the EBSA Public Disclosure Nadene Kennedy, estimate of the burden of the proposed
Room. Do not include any personally Polar Coordination Specialist. collection of information, including the
identifiable information (such as name, [FR Doc. 2015–22727 Filed 9–4–15; 11:15 am] validity of the methodology and
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Document Created: 2015-12-15 09:53:12
Document Modified: 2015-12-15 09:53:12
| 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 registration. | |
| FR Citation | 80 FR 54327 |
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