80 FR 52509 - Importer of Controlled Substances Application: Alltech Associates, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 80, Issue 168 (August 31, 2015)
Drug Enforcement Administration
Federal Register Volume 80, Issue 168 (August 31, 2015)
| Page Range | 52509-52510 | |
| FR Document | 2015-21470 |
[Federal Register Volume 80, Number 168 (Monday, August 31, 2015)] [Notices] [Pages 52509-52510] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-21470] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Application: Alltech Associates, 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 1301.34(a) on or before September 30, 2015. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before September 30, 2015. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODXL, 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 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 Deputy Assistant Administrator of the DEA Office of Diversion Control (``Deputy Assistant [[Page 52510]] 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 24, 2015, Alltech Associates, Inc., 2051 Waukegan Road, Deerfield, Illinois 60015 applied to be registered as an importer of the following basic classes of controlled substances: ------------------------------------------------------------------------ Controlled substance Schedule ------------------------------------------------------------------------ Gamma Hydroxybutyric Acid (2010)........... I Lysergic acid diethylamide (7315).......... I Heroin (9200).............................. I Meperidine (9230).......................... II ------------------------------------------------------------------------ The company plans to import these controlled substances for the manufacture of reference standards. Dated: August 21, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015-21470 Filed 8-28-15; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 80, No. 168 / Monday, August 31, 2015 / Notices 52509
to which the United States is a party DEPARTMENT OF JUSTICE This compound is listed under drug
(including grand jury proceedings), or code 7360. No other activity for this
for the purpose of securing compliance Drug Enforcement Administration drug code is authorized for this
with this Final Judgment, or as registration. Approval of permits
otherwise required by law. [Docket No. DEA–392] applications will occur only when the
registrant’s business activity is
(D) If, at the time information or Importer of Controlled Substances consistent with what is authorized
documents are furnished by Defendants Application: Catalent CTS, LLC under to 21 U.S.C. 952(a)(2).
to Plaintiff, Defendants represent and Authorization will not extend to the
identify in writing the material in any ACTION: Notice of application. import of FDA approved or non-
such information or documents to approved finished dosage forms for
which a claim of protection may be DATES: Registered bulk manufacturers of commercial sale.
asserted under Rule 26(c)(1) of the the affected basic class, and applicants
therefore, may file written comments on Dated: August 21, 2015.
Federal Rules of Civil Procedure, and
or objections to the issuance of the Joseph T. Rannazzisi,
Defendants mark each pertinent page of
proposed registration in accordance Deputy Assistant Administrator.
such material, ‘‘Subject to claim of
protection under Rule 26(c)(1) of the with 21 CFR 1301.34(a) on or before [FR Doc. 2015–21464 Filed 8–28–15; 8:45 am]
Federal Rules of Civil Procedure,’’ then September 30, 2015. Such persons may BILLING CODE 4410–09–P
the United States shall give ten (10) also file a written request for a hearing
calendar days’ notice prior to divulging on the application pursuant to 21 CFR
1301.43 on or before September 30, DEPARTMENT OF JUSTICE
such material in any legal proceeding
2015.
(other than a grand jury proceeding) to Drug Enforcement Administration
which Defendants are not a party. ADDRESSES: Written comments should
be sent to: Drug Enforcement [Docket No. DEA–392]
VII. RETENTION OF JURISDICTION Administration, Attention: DEA Federal Importer of Controlled Substances
This Court retains jurisdiction to Register Representative/ODXL, 8701 Application: Alltech Associates, Inc.
Morrissette Drive, Springfield, Virginia
enable any party to this Final Judgment
22152. Request for hearings should be ACTION: Notice of application.
to apply to this Court at any time for
sent to: Drug Enforcement
such further orders and directions as Administration, Attention: Hearing DATES: Registered bulk manufacturers of
may be necessary or appropriate to carry Clerk/LJ, 8701 Morrissette Drive, the affected basic classes, and
out or construe this Final Judgment, to Springfield, Virginia 22152. Comments applicants therefore, may file written
modify or terminate any of its and requests for hearings on comments on or objections to the
provisions, to enforce compliance, and applications to import narcotic raw issuance of the proposed registration in
to punish any violations of its material are not appropriate. 72 FR 3417 accordance with 21 CFR 1301.34(a) on
provisions. (January 25, 2007). or before September 30, 2015. Such
VIII. EXPIRATION OF FINAL SUPPLEMENTARY INFORMATION: The persons may also file a written request
Attorney General has delegated her for a hearing on the application
JUDGMENT
authority under the Controlled pursuant to 21 CFR 1301.43 on or before
This Final Judgment shall expire five Substances Act to the Administrator of September 30, 2015.
(5) years from the date of its entry, the Drug Enforcement Administration ADDRESSES: Written comments should
except that, if, during the term of this (DEA), 28 CFR 0.100(b). Authority to be sent to: Drug Enforcement
Final Judgment, the Exemption is exercise all necessary functions with Administration, Attention: DEA Federal
replaced by a Flat Exemption, then the respect to the promulgation and Register Representative/ODXL, 8701
Final Judgment shall expire on the date implementation of 21 CFR part 1301, Morrissette Drive, Springfield, Virginia
that the Flat Exemption is effective. incident to the registration of 22152. Request for hearings should be
manufacturers, distributors, dispensers, sent to: Drug Enforcement
IX. COSTS importers, and exporters of controlled Administration, Attention: Hearing
substances (other than final orders in Clerk/LJ, 8701 Morrissette Drive,
Each party shall bear its own costs. Springfield, Virginia 22152.
connection with suspension, denial, or
X. PUBLIC INTEREST revocation of registration) has been SUPPLEMENTARY INFORMATION: The
DETERMINATION redelegated to the Deputy Assistant Attorney General has delegated his
Administrator of the DEA Office of authority under the Controlled
The entry of this Final Judgment is in Diversion Control (‘‘Deputy Assistant Substances Act to the Administrator of
the public interest. Administrator’’) pursuant to section 7 of the Drug Enforcement Administration
DATED: 28 CFR part 0, appendix to subpart R. (DEA), 28 CFR 0.100(b). Authority to
In accordance with 21 CFR exercise all necessary functions with
Court approval subject to the 1301.34(a), this is notice that on May 7, respect to the promulgation and
Antitrust Procedures and Penalties Act, 2015, Catalent CTS, LLC, 10245 implementation of 21 CFR part 1301,
Hickman Mills Drive, Kansas City, incident to the registration of
15 U.S.C. 16
Missouri 64137 applied to be registered manufacturers, distributors, dispensers,
tkelley on DSK3SPTVN1PROD with NOTICES
United States District Judge as an importer of Marihuana (7360), a importers, and exporters of controlled
[FR Doc. 2015–21534 Filed 8–28–15; 8:45 am] basic class of controlled substance listed substances (other than final orders in
BILLING CODE P
in schedule I. connection with suspension, denial, or
The company plans to import finished revocation of registration) has been
pharmaceutical products containing redelegated to the Deputy Assistant
cannabis extracts in dosage form for Administrator of the DEA Office of
clinical trial studies. Diversion Control (‘‘Deputy Assistant
VerDate Sep<11>2014 16:19 Aug 28, 2015 Jkt 235001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 E:\FR\FM\31AUN1.SGM 31AUN1](https://thefederalregister.org/doc/80_FR_52677/page/1.svg)
![52510 Federal Register / Vol. 80, No. 168 / Monday, August 31, 2015 / Notices
Administrator’’) pursuant to section 7 of implementation of 21 CFR part 1301, Clerk/LJ, 8701 Morrissette Drive,
28 CFR part 0, appendix to subpart R. incident to the registration of Springfield, Virginia 22152. Comments
In accordance with 21 CFR manufacturers, distributors, dispensers, and requests for hearings on
1301.34(a), this is notice that on April importers, and exporters of controlled applications to import narcotic raw
24, 2015, Alltech Associates, Inc., 2051 substances (other than final orders in material are not appropriate. 72 FR 3417
Waukegan Road, Deerfield, Illinois connection with suspension, denial, or (January 25, 2007).
60015 applied to be registered as an revocation of registration) has been SUPPLEMENTARY INFORMATION: The
importer of the following basic classes redelegated to the Deputy Assistant Attorney General has delegated her
of controlled substances: Administrator of the DEA Office of authority under the Controlled
Diversion Control (‘‘Deputy Assistant Substances Act to the Administrator of
Controlled substance Schedule Administrator’’) pursuant to section 7 of the Drug Enforcement Administration
28 CFR part 0, appendix to subpart R. (DEA), 28 CFR 0.100(b). Authority to
Gamma Hydroxybutyric Acid I In accordance with 21 CFR
(2010). exercise all necessary functions with
1301.34(a), this is notice that on July 27, respect to the promulgation and
Lysergic acid diethylamide (7315) I
Heroin (9200) ............................... I 2015, Catalent Pharma Solutions, LLC, implementation of 21 CFR part 1301,
Meperidine (9230) ........................ II 10381 Decatur Road, Philadelphia, incident to the registration of
Pennsylvania 19114 applied to be manufacturers, distributors, dispensers
The company plans to import these registered as an importer of importers, and exporters of, controlled
controlled substances for the hydromorphone (9150), a basic class of substances (other than final orders in
manufacture of reference standards. controlled substance listed in schedule connection with suspension, denial, or
II. revocation of registration) has been
Dated: August 21, 2015. The company plans to import the
Joseph T. Rannazzisi,
redelegated to the Deputy Assistant
above listed controlled substance for a Administrator of the DEA Office of
Deputy Assistant Administrator. clinical trial study. Approval of permit Diversion Control (‘‘Deputy Assistant
[FR Doc. 2015–21470 Filed 8–28–15; 8:45 am] applications will occur only when the Administrator’’) pursuant to section 7 of
BILLING CODE 4410–09–P registrant’s business activity is 28 CFR part 0, appendix to subpart R.
consistent with what is authorized In accordance with 21 CFR
under to 21 U.S.C. 952(a)(2). 1301.34(a), this is notice that on July 16,
DEPARTMENT OF JUSTICE Authorization will not extend to the 2014, Noramco, Inc., 1440 Olympic
import of FDA approved or non- Drive, Athens, Georgia 30601, applied to
Drug Enforcement Administration approved finished dosage forms for be registered as an importer of the
[Docket No. DEA–392] commercial sale. following basic classes of controlled
Dated: August 21, 2015. substances:
Importer of Controlled Substances Joseph T. Rannazzisi,
Application: Catalent Pharma Controlled substance Schedule
Deputy Assistant Administrator.
Solutions, LLC
[FR Doc. 2015–21520 Filed 8–28–15; 8:45 am] Phenylacetone (8501) .................. II
ACTION: Notice of application. BILLING CODE 4410–09–P Thebaine (9333) ........................... II
Poppy Straw Concentrate (9670) II
DATES: Registered bulk manufacturers of Tapentadol (9780) ........................ II
the affected basic class, and applicants DEPARTMENT OF JUSTICE
therefore, may file written comments on The company plans to import
or objections to the issuance of the Drug Enforcement Administration thebaine (9333) analytical reference
proposed registration in accordance [Docket No. DEA–392] standards for distribution to its
with 21 CFR 1301.34(a) on or before customers. The company plans to
September 30, 2015. Such persons may Importer of Controlled Substances import an intermediate form of
also file a written request for a hearing Application: Noramco, Inc. tapentadol (9780) to bulk manufacture
on the application pursuant to 21 CFR tapentadol for distribution to its
1301.43 on or before September 30, ACTION: Notice of application. customers. The company plans to
2015. import phenylacetone (8501) and poppy
DATES: Registered bulk manufacturers of straw concentrate (9670) to manufacture
ADDRESSES: Written comments should the affected basic classes, and other controlled substances.
be sent to: Drug Enforcement applicants therefore, may file written
Administration, Attention: DEA Federal Dated: August 21, 2015.
comments on or objections to the
Register Representative/ODXL, 8701 issuance of the proposed registration in Joseph T. Rannazzisi,
Morrissette Drive, Springfield, Virginia accordance with 21 CFR 1301.34(a) on Deputy Assistant Administrator.
22152. Request for hearings should be or before September 30, 2015. Such [FR Doc. 2015–21545 Filed 8–28–15; 8:45 am]
sent to: Drug Enforcement persons may also file a written request BILLING CODE 4410–09–P
Administration, Attention: Hearing for a hearing on the application
Clerk/LJ, 8701 Morrissette Drive, pursuant to 21 CFR 1301.43 on or before
Springfield, Virginia 22152. September 30, 2015. DEPARTMENT OF JUSTICE
SUPPLEMENTARY INFORMATION: The ADDRESSES: Written comments should
Drug Enforcement Administration
tkelley on DSK3SPTVN1PROD with NOTICES
Attorney General has delegated her be sent to: Drug Enforcement
authority under the Controlled Administration, Attention: DEA Federal [Docket No. DEA–392]
Substances Act to the Administrator of Register Representative/ODXL, 8701
the Drug Enforcement Administration Morrissette Drive, Springfield, Virginia Importer of Controlled Substances
(DEA), 28 CFR 0.100(b). Authority to 22152. Request for hearings should be Application: Cambrex Charles City
exercise all necessary functions with sent to: Drug Enforcement ACTION: Notice of application.
respect to the promulgation and Administration, Attention: Hearing
VerDate Sep<11>2014 16:19 Aug 28, 2015 Jkt 235001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 E:\FR\FM\31AUN1.SGM 31AUN1](https://thefederalregister.org/doc/80_FR_52677/page/2.svg)
Document Created: 2018-02-23 11:04:17
Document Modified: 2018-02-23 11:04:17
| 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 September 30, 2015. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before September 30, 2015. | |
| FR Citation | 80 FR 52509 |
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR