83 FR 54612 - Importer of Controlled Substances Application: Sharp (Bethlehem), LLC
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 210 (October 30, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 210 (October 30, 2018)
| Page Range | 54612-54612 | |
| FR Document | 2018-23705 |
[Federal Register Volume 83, Number 210 (Tuesday, October 30, 2018)] [Notices] [Page 54612] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-23705] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Application: Sharp (Bethlehem), LLC 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 on or before November 29, 2018. Such persons may also file a written request for a hearing on the application on or before November 29, 2018. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 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 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 1301.34(a), this is notice that on August 30, 2018, Sharp (Bethlehem), LLC, 2400 Baglyos Circle, Bethlehem, Pennsylvania 18020, applied to be registered as an importer of the following basic class of controlled substances: ------------------------------------------------------------------------ Controlled substance Drug code Schedule ------------------------------------------------------------------------ Gamma Hydroxybutyric Acid.......... 2010 I ------------------------------------------------------------------------ The company plans to import dosage forms of the listed controlled substances to conduct clinical trials. Approval of permit applications will occur only when the registrant's 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: October 22, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018-23705 Filed 10-29-18; 8:45 am] BILLING CODE 4410-09-P
![54612 Federal Register / Vol. 83, No. 210 / Tuesday, October 30, 2018 / Notices
Convention, 12601 Twinbrook Parkway, respect to the promulgation and Administration, Attention: DEA Federal
Rockville, Maryland 20852–1717, implementation of 21 CFR part 1301, Register Representative/DPW, 8701
applied to be registered as an importer incident to the registration of Morrissette Drive, Springfield, Virginia
of the following basic class of the manufacturers, distributors, dispensers, 22152. All requests for hearing must be
controlled substance: importers, and exporters of controlled sent to: Drug Enforcement
substances (other than final orders in Administration, Attn: Administrator,
Controlled Drug code Schedule connection with suspension, denial, or 8701 Morrissette Drive, Springfield,
substance revocation of registration) has been Virginia 22152. All requests for hearing
redelegated to the Assistant should also be sent to: (1) Drug
Oxymorphone ......... 9652 II
Administrator of the DEA Diversion
Enforcement Administration, Attn:
Control Division (‘‘Assistant
The company plans to import the bulk Hearing Clerk/OALJ, 8701 Morrissette
Administrator’’) pursuant to section 7 of
controlled substance for distribution of Drive, Springfield, Virginia 22152; and
28 CFR part 0, appendix to subpart R.
analytical reference standards to its (2) Drug Enforcement Administration,
In accordance with 21 CFR
customers for research and analytical Attn: DEA Federal Register
1301.34(a), this is notice that on August
purposes. 30, 2018, Sharp (Bethlehem), LLC, 2400 Representative/DPW, 8701 Morrissette
Dated: October 22, 2018. Baglyos Circle, Bethlehem, Drive, Springfield, Virginia 22152.
John J. Martin, Pennsylvania 18020, applied to be SUPPLEMENTARY INFORMATION: The
Assistant Administrator. registered as an importer of the Attorney General has delegated his
[FR Doc. 2018–23701 Filed 10–29–18; 8:45 am] following basic class of controlled authority under the Controlled
substances:
BILLING CODE 4410–09–P Substances Act to the Administrator of
Controlled the Drug Enforcement Administration
Drug code Schedule (DEA), 28 CFR 0.100(b). Authority to
substance
DEPARTMENT OF JUSTICE
exercise all necessary functions with
Gamma Hydrox- 2010 I respect to the promulgation and
Drug Enforcement Administration ybutyric Acid. implementation of 21 CFR part 1301,
[Docket No. DEA–392] incident to the registration of
The company plans to import dosage
manufacturers, distributors, dispensers,
Importer of Controlled Substances forms of the listed controlled substances
to conduct clinical trials. importers, and exporters of controlled
Application: Sharp (Bethlehem), LLC
Approval of permit applications will substances (other than final orders in
ACTION: Notice of application. occur only when the registrant’s activity connection with suspension, denial, or
is consistent with what is authorized revocation of registration) has been
DATES: Registered bulk manufacturers of under to 21 U.S.C. 952 (a)(2). redelegated to the Assistant
the affected basic classes, and Authorization will not extend to the Administrator of the DEA Diversion
applicants therefore, may file written import of FDA approved or non- Control Division (‘‘Assistant
comments on or objections to the approved finished dosage forms for Administrator’’) pursuant to section 7 of
issuance of the proposed registration on commercial sale. 28 CFR part 0, appendix to subpart R.
or before November 29, 2018. Such Dated: October 22, 2018. In accordance with 21 CFR
persons may also file a written request 1301.34(a), this is notice that on August
John J. Martin,
for a hearing on the application on or
Assistant Administrator. 17, 2018, Fisher Clinical Services Inc.,
before November 29, 2018.
[FR Doc. 2018–23705 Filed 10–29–18; 8:45 am] 7554 Schantz Road, Allentown,
ADDRESSES: Written comments should Pennsylvania 18106, applied to be
BILLING CODE 4410–09–P
be sent to: Drug Enforcement registered as an importer of the
Administration, Attention: DEA Federal following basic classes of controlled
Register Representative/DPW, 8701 DEPARTMENT OF JUSTICE substances:
Morrissette Drive, Springfield, Virginia
22152. All requests for hearing must be Drug Enforcement Administration Controlled
sent to: Drug Enforcement Drug code Schedule
substance
Administration, Attn: Administrator, [Docket No. DEA–392]
8701 Morrissette Drive, Springfield, Importer of Controlled Substances Psilocybin ......... 7437 I
Virginia 22152. All requests for hearing Application: Fisher Clinical Services,
Methylphenidate 1724 II
should also be sent to: (1) Drug Inc.
Levorphanol ...... 9220 II
Enforcement Administration, Attn: Noroxymorphon- 9668 II
Hearing Clerk/OALJ, 8701 Morrissette ACTION: Notice of application. e.
Drive, Springfield, Virginia 22152; and Tapentadol ........ 9780 II
(2) Drug Enforcement Administration, DATES: Registered bulk manufacturers of
Attn: DEA Federal Register the affected basic classes, and The company plans to import the
Representative/DPW, 8701 Morrissette applicants therefore, may file written listed controlled substances for clinical
Drive, Springfield, Virginia 22152. comments on or objections to the trials.
khammond on DSK30JT082PROD with NOTICES
SUPPLEMENTARY INFORMATION: issuance of the proposed registration on
Dated: October 22, 2018.
The Attorney General has delegated or before November 29, 2018. Such
persons may also file a written request John J. Martin,
his authority under the Controlled
Substances Act to the Administrator of for a hearing on the application on or Assistant Administrator.
the Drug Enforcement Administration before November 29, 2018. [FR Doc. 2018–23702 Filed 10–29–18; 8:45 am]
(DEA), 28 CFR 0.100(b). Authority to ADDRESSES: Written comments should BILLING CODE 4410–09–P
exercise all necessary functions with be sent to: Drug Enforcement
VerDate Sep<11>2014 19:27 Oct 29, 2018 Jkt 247001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\30OCN1.SGM 30OCN1](https://thefederalregister.org/doc/83_FR_54822/page/1.svg)
Document Created: 2018-10-30 00:43:29
Document Modified: 2018-10-30 00:43:29
| 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 on or before November 29, 2018. Such persons may also file a written request for a hearing on the application on or before November 29, 2018. | |
| FR Citation | 83 FR 54612 |
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