80 FR 78766 - Importer of Controlled Substances Application: Fisher Clinical Services, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 80, Issue 242 (December 17, 2015)
Drug Enforcement Administration
Federal Register Volume 80, Issue 242 (December 17, 2015)
| Page Range | 78766-78766 | |
| FR Document | 2015-31672 |
[Federal Register Volume 80, Number 242 (Thursday, December 17, 2015)] [Notices] [Page 78766] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-31672] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Application: Fisher Clinical Services, 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 January 19, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before January 19, 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 1301.34(a), this is notice that on August 26, 2015, Fisher Clinical Services, Inc. 7554 Schantz Road, Allentown, Pennsylvania 18106 applied to be registered as an importer of the following basic classes of controlled substances: ------------------------------------------------------------------------ Controlled substance Schedule ------------------------------------------------------------------------ Methylphenidate (1724)..................... II Levorphanol (9220)......................... II Noroxymorphone (9668)...................... II Tapentadol (9780).......................... II ------------------------------------------------------------------------ The company plans to import the listed substances for analytical research, testing, and clinical trials. This authorization does not extend to the import of a finished FDA approved or non-approved dosage form for commercial distribution in the United States. The company plans to import an intermediate form of tapentadol (9780) to bulk manufacture tapentadol for distribution to its customers. Placement of these (this) drug code (s) onto the company's registration does not translate into automatic approval of subsequent permit applications to import controlled substances. Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under to 21 U.S.C. 952(a)(2). Authorization will not extend to the import of FDA approved or non- approved finished dosage forms for commercial sale. Dated: December 9, 2015. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2015-31672 Filed 12-16-15; 8:45 am] BILLING CODE 4410-09-P
![78766 Federal Register / Vol. 80, No. 242 / Thursday, December 17, 2015 / Notices
Administrator of the DEA Office of DEPARTMENT OF JUSTICE The company plans to import the
Diversion Control (‘‘Deputy Assistant listed substances for analytical research,
Administrator’’) pursuant to section 7 of Drug Enforcement Administration testing, and clinical trials. This
28 CFR part 0, appendix to subpart R. authorization does not extend to the
In accordance with 21 CFR [Docket No. DEA–392] import of a finished FDA approved or
non-approved dosage form for
1301.33(a), this is notice that on
Importer of Controlled Substances commercial distribution in the United
September 3, 2015, Johnson Matthey, Application: Fisher Clinical Services, States.
Inc., Custom Pharmaceuticals Inc. The company plans to import an
Department, 2003 Nolte Drive, West intermediate form of tapentadol (9780)
Deptford, New Jersey 08066–1742 ACTION: Notice of application. to bulk manufacture tapentadol for
applied to be registered as a bulk distribution to its customers. Placement
manufacturer of the following basic DATES: Registered bulk manufacturers of of these (this) drug code (s) onto the
classes of controlled substances: the affected basic classes, and company’s registration does not
applicants therefore, may file written translate into automatic approval of
Controlled substance Schedule comments on or objections to the subsequent permit applications to
issuance of the proposed registration in import controlled substances. Approval
Gamma Hydroxybutyric Acid I accordance with 21 CFR 1301.34(a) on of permit applications will occur only
(2010). or before January 19, 2016. Such when the registrant’s business activity is
Marihuana (7360) ......................... I persons may also file a written request consistent with what is authorized
Tetrahydrocannabinols (7370) ..... I for a hearing on the application under to 21 U.S.C. 952(a)(2).
Dihydromorphine (9145) ............... I pursuant to 21 CFR 1301.43 on or before
Difenoxin (9168) ........................... I
Authorization will not extend to the
January 19, 2016. import of FDA approved or non-
Propiram (9649) ........................... I
Amphetamine (1100) .................... II ADDRESSES: Written comments should approved finished dosage forms for
Methamphetamine (1105) ............ II be sent to: Drug Enforcement commercial sale.
Lisdexamfetamine (1205) ............. II Administration, Attention: DEA Federal Dated: December 9, 2015.
Methylphenidate (1724) ................ II Register Representative/ODW, 8701 Louis J. Milione,
Nabilone (7379) ............................ II Morrissette Drive, Springfield, Virginia Deputy Assistant Administrator.
Cocaine (9041) ............................. II 22152. Request for hearings should be
[FR Doc. 2015–31672 Filed 12–16–15; 8:45 am]
Codeine (9050) ............................. II sent to: Drug Enforcement
BILLING CODE 4410–09–P
Dihydrocodeine (9120) ................. II Administration, Attention: Hearing
Oxycodone (9143) ........................ II Clerk/LJ, 8701 Morrissette Drive,
Hydromorphone (9150) ................ II Springfield, Virginia 22152. DEPARTMENT OF JUSTICE
Diphenoxylate (9170) ................... II SUPPLEMENTARY INFORMATION: The
Ecgonine (9180) ........................... II Attorney General has delegated her Drug Enforcement Administration
Hydrocodone (9193) ..................... II authority under the Controlled [Docket No. DEA–392]
Meperidine (9230) ........................ II Substances Act to the Administrator of
Methadone (9250) ........................ II the Drug Enforcement Administration Bulk Manufacturer of Controlled
Methadone intermediate (9254) ... II (DEA), 28 CFR 0.100(b). Authority to Substances Application: National
Morphine (9300) ........................... II exercise all necessary functions with Center for Natural Products Research
Thebaine (9333) ........................... II respect to the promulgation and (NIDA MPROJECT)
Oxymorphone (9652) ................... II implementation of 21 CFR part 1301,
Noroxymorphone (9668) .............. II incident to the registration of ACTION: Notice of application.
Alfentanil (9737) ........................... II manufacturers, distributors, dispensers,
Remifentanil (9739) ...................... II importers, and exporters of controlled DATES: Registered bulk manufacturers of
Sufentanil (9740) .......................... II substances (other than final orders in the affected basic classes, and
Tapentadol (9780) ........................ II connection with suspension, denial, or applicants therefore, may file written
Fentanyl (9801) ............................ II revocation of registration) has been comments on or objections to the
redelegated to the Deputy Assistant issuance of the proposed registration in
The company plans to manufacture Administrator of the DEA Office of accordance with 21 CFR 1301.33(a) on
the listed controlled substances in bulk Diversion Control (‘‘Deputy Assistant or before February 16, 2016.
for sale to its customers. Administrator’’) pursuant to section 7 of ADDRESSES: Written comments should
In reference to drug codes 7360 28 CFR part 0, appendix to subpart R. be sent to: Drug Enforcement
In accordance with 21 CFR Administration, Attention: DEA Federal
(marihuana) and 7370 (THC), the
1301.34(a), this is notice that on August Register Representative/ODW, 8701
company plans to bulk manufacture
26, 2015, Fisher Clinical Services, Inc. Morrissette Drive, Springfield, Virginia
these drugs as synthetic. No other 22152. Request for hearing should be
activities for these drug codes are 7554 Schantz Road, Allentown,
Pennsylvania 18106 applied to be sent to: Drug Enforcement
authorized for this registration. Administration, Attention: Hearing
registered as an importer of the
Dated: December 9, 2015. following basic classes of controlled Clerk/LJ, 8701 Morrissette Drive,
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Louis J. Milione, substances: Springfield, Virginia 22152.
Deputy Assistant Administrator. SUPPLEMENTARY INFORMATION: The
[FR Doc. 2015–31665 Filed 12–16–15; 8:45 am]
Controlled substance Schedule Attorney General has delegated her
authority under the Controlled
BILLING CODE 4410–09–P Methylphenidate (1724) ................ II Substances Act to the Administrator of
Levorphanol (9220) ...................... II the Drug Enforcement Administration
Noroxymorphone (9668) .............. II
Tapentadol (9780) ........................ II
(DEA), 28 CFR 0.100(b). Authority to
exercise all necessary functions with
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Document Created: 2018-03-02 09:18:17
Document Modified: 2018-03-02 09:18:17
| 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 January 19, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before January 19, 2016. | |
| FR Citation | 80 FR 78766 |
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