80 FR 76709 - Bulk Manufacturer of Controlled Substances Application: Cody Laboratories, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 80, Issue 237 (December 10, 2015)
Drug Enforcement Administration
Federal Register Volume 80, Issue 237 (December 10, 2015)
| Page Range | 76709-76709 | |
| FR Document | 2015-31074 |
[Federal Register Volume 80, Number 237 (Thursday, December 10, 2015)] [Notices] [Page 76709] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-31074] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Bulk Manufacturer of Controlled Substances Application: Cody Laboratories, 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 8, 2016. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. Request for hearings should be sent to: Drug Enforcement Administration, Attention: Hearing Clerk/LJ, 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 September 3, 2015, Cody Laboratories, Inc., 601 Yellowstone Avenue, Cody, Wyoming 82414 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: ------------------------------------------------------------------------ Controlled substance Schedule ------------------------------------------------------------------------ Dihydromorphine (9145)..................... I Amphetamine (1100)......................... II Methamphetamine (1105)..................... II Methylphenidate (1724)..................... II Amobarbital (2125)......................... II Pentobarbital (2270)....................... II Secobarbital (2315)........................ II 4-Anilino-N-phenethyl-4-piperidine (ANPP) II (8333). Phenylacetone (8501)....................... II Cocaine (9041)............................. II Codeine (9050)............................. II Dihydrocodeine (9120)...................... II Oxycodone (9143)........................... II Hydromorphone (9150)....................... II Diphenoxylate (9170)....................... II Ecgonine (9180)............................ II Hydrocodone (9193)......................... II Meperidine (9230).......................... II Methadone (9250)........................... II Methadone intermediate (9254).............. II Morphine (9300)............................ II Thebaine (9333)............................ II Oxymorphone (9652)......................... II Alfentanil (9737).......................... II Remifentanil (9739)........................ II Sufentanil (9740).......................... II Tapentadol (9780).......................... II Fentanyl (9801)............................ II ------------------------------------------------------------------------ The company plans to manufacture the listed controlled substances in bulk for sale to its customers. Dated: December 4, 2015. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2015-31074 Filed 12-9-15; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 80, No. 237 / Thursday, December 10, 2015 / Notices 76709
Filing Procedures 4). Persons with authority under the Controlled DEPARTMENT OF JUSTICE
questions regarding filing should Substances Act to the Administrator of
contact the Secretary (202–205–2000). the Drug Enforcement Administration Drug Enforcement Administration
Any person desiring to submit a (DEA), 28 CFR 0.100(b). Authority to [Docket No. DEA–392]
document to the Commission in exercise all necessary functions with
confidence must request confidential respect to the promulgation and Importer of Controlled Substances
treatment. All such requests should be implementation of 21 CFR part 1301, Application: Mylan Pharmaceuticals,
directed to the Secretary to the incident to the registration of Inc.
Commission and must include a full
manufacturers, distributors, dispensers,
statement of the reasons why the ACTION: Notice of application.
importers, and exporters of controlled
Commission should grant such
treatment. See 19 CFR. 201.6. substances (other than final orders in DATES: Registered bulk manufacturers of
Documents for which confidential connection with suspension, denial, or the affected basic classes, and
treatment by the Commission is revocation of registration) has been applicants therefore, may file written
properly sought will be treated redelegated to the Deputy Assistant comments on or objections to the
accordingly. All nonconfidential written Administrator of the DEA Office of issuance of the proposed registration in
submissions will be available for public Diversion Control (‘‘Deputy Assistant accordance with 21 CFR 1301.34(a) on
inspection at the Office of the Secretary Administrator’’) pursuant to section 7 of or before January 11, 2016. Such
and on EDIS.5 28 CFR part 0, appendix to subpart R. persons may also file a written request
This action is taken under the In accordance with 21 CFR for a hearing on the application
authority of section 337 of the Tariff Act 1301.33(a), this is notice that on pursuant to 21 CFR 1301.43 on or before
of 1930, as amended (19 U.S.C. 1337), September 3, 2015, Cody Laboratories, January 11, 2016.
and of sections 201.10 and 210.8(c) of ADDRESSES: Written comments should
Inc., 601 Yellowstone Avenue, Cody,
the Commission’s Rules of Practice and be sent to: Drug Enforcement
Wyoming 82414 applied to be registered
Procedure (19 CFR 201.10, 210.8(c)). Administration, Attention: DEA Federal
as a bulk manufacturer of the following
By order of the Commission. basic classes of controlled substances: Register Representative/ODW, 8701
Issued: December 7, 2015. Morrissette Drive, Springfield, Virginia
Lisa R. Barton, Controlled substance Schedule 22152. Request for hearings should be
Secretary to the Commission. sent to: Drug Enforcement
[FR Doc. 2015–31151 Filed 12–9–15; 8:45 am] Dihydromorphine (9145) ............... I Administration, Attention: Hearing
BILLING CODE 7020–02–P
Amphetamine (1100) .................... II Clerk/LJ, 8701 Morrissette Drive,
Methamphetamine (1105) ............ II Springfield, Virginia 22152.
Methylphenidate (1724) ................ II SUPPLEMENTARY INFORMATION: The
Amobarbital (2125) ....................... II Attorney General has delegated her
DEPARTMENT OF JUSTICE
Pentobarbital (2270) ..................... II authority under the Controlled
Drug Enforcement Administration Secobarbital (2315) ...................... II Substances Act to the Administrator of
4-Anilino-N-phenethyl-4-piperidine II the Drug Enforcement Administration
[Docket No. DEA–392] (ANPP) (8333). (DEA), 28 CFR 0.100(b). Authority to
Phenylacetone (8501) .................. II exercise all necessary functions with
Bulk Manufacturer of Controlled Cocaine (9041) ............................. II
Substances Application: Cody respect to the promulgation and
Codeine (9050) ............................. II implementation of 21 CFR part 1301,
Laboratories, Inc. Dihydrocodeine (9120) ................. II incident to the registration of
Oxycodone (9143) ........................ II manufacturers, distributors, dispensers,
ACTION: Notice of application.
Hydromorphone (9150) ................ II
importers, and exporters of controlled
DATES: Registered bulk manufacturers of Diphenoxylate (9170) ................... II
substances (other than final orders in
the affected basic classes, and Ecgonine (9180) ........................... II
connection with suspension, denial, or
applicants therefore, may file written Hydrocodone (9193) ..................... II
revocation of registration) has been
comments on or objections to the Meperidine (9230) ........................ II
redelegated to the Deputy Assistant
issuance of the proposed registration in Methadone (9250) ........................ II
Administrator of the DEA Office of
accordance with 21 CFR 1301.33(a) on Methadone intermediate (9254) ... II
Morphine (9300) ........................... II
Diversion Control (‘‘Deputy Assistant
or before February 8, 2016. Administrator’’) pursuant to section 7 of
Thebaine (9333) ........................... II
ADDRESSES: Written comments should 28 CFR part 0, appendix to subpart R.
Oxymorphone (9652) ................... II
be sent to: Drug Enforcement In accordance with 21 CFR
Alfentanil (9737) ........................... II
Administration, Attention: DEA Federal 1301.34(a), this is notice that on October
Remifentanil (9739) ...................... II
Register Representative/ODW, 8701 19, 2015, Mylan Pharmaceuticals, Inc.,
Sufentanil (9740) .......................... II
Morrissette Drive, Springfield, Virginia 3711 Collins Ferry Road, Morgantown,
Tapentadol (9780) ........................ II
22152. Request for hearings should be Fentanyl (9801) ............................ II West Virginia 26505 applied to be
sent to: Drug Enforcement registered as an importer of the
Administration, Attention: Hearing following basic classes of controlled
Clerk/LJ, 8701 Morrissette Drive, The company plans to manufacture substances:
Springfield, Virginia 22152. the listed controlled substances in bulk
mstockstill on DSK4VPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION: The for sale to its customers. Controlled substance Schedule
Attorney General has delegated her Dated: December 4, 2015.
Amphetamine (1100) .................... II
Louis J. Milione, Lisdexamfetamine (1205) ............. II
4 Handbook for Electronic Filing Procedures:
http://www.usitc.gov/secretary/fed_reg_notices/ Deputy Assistant Administrator. Methylphenidate (1724) ................ II
rules/handbook_on_electronic_filing.pdf. [FR Doc. 2015–31074 Filed 12–9–15; 8:45 am] Pentobarbital (2270) ..................... II
5 Electronic Document Information System Oxycodone (9143) ........................ II
BILLING CODE 4410–09–P
(EDIS): http://edis.usitc.gov. Hydromorphone (9150) ................ II
VerDate Sep<11>2014 19:33 Dec 09, 2015 Jkt 238001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\10DEN1.SGM 10DEN1](https://thefederalregister.org/doc/80_FR_76946/page/1.svg)
Document Created: 2015-12-14 13:28:45
Document Modified: 2015-12-14 13:28:45
| 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 8, 2016. | |
| FR Citation | 80 FR 76709 |
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