83 FR 39130 - Importer of Controlled Substances Application: Myoderm
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 153 (August 8, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 153 (August 8, 2018)
| Page Range | 39130-39130 | |
| FR Document | 2018-16938 |
[Federal Register Volume 83, Number 153 (Wednesday, August 8, 2018)] [Notices] [Page 39130] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-16938] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Application: Myoderm 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 September 7, 2018. Such persons may also file a written request for a hearing on the application on or before September 7, 2018. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 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 request for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. Comments and requests for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417, (January 25, 2007) 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 October 5, 2017, Myoderm, 48 East Main St., Norristown, Pennsylvania 19401 applied to be registered as an importer of the following basic classes of controlled substances: ------------------------------------------------------------------------ Drug Controlled substance code Schedule ------------------------------------------------------------------------ Amphetamine............................ 1100 II Lisdexamfetamine....................... 1205 II Methylphenidate........................ 1724 II Nabilone............................... 7379 II Oxycodone.............................. 9143 II Hydromorphone.......................... 9150 II Hydrocodone............................ 9193 II Morphine............................... 9300 II Oxymorphone............................ 9652 II Fentanyl............................... 9801 II ------------------------------------------------------------------------ The company plans to import controlled substances commercially packaged in dosage form only for clinical trials purposes, research, and analytical purposes only. Dated: July 31, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018-16938 Filed 8-7-18; 8:45 am] BILLING CODE 4410-09-P
![39130 Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Notices
Controlled Drug the Drug Enforcement Administration Research Study.’’ This comment request
Schedule
substance code (DEA), 28 CFR 0.100(b). Authority to is part of continuing Departmental
exercise all necessary functions with efforts to reduce paperwork and
Opium, raw ................... 9600 II respect to the promulgation and respondent burden in accordance with
Poppy Straw Con- 9670 II implementation of 21 CFR part 1301, the Paperwork Reduction Act of 1995
centrate.
Tapentadol .................... 9780 II
incident to the registration of (PRA).
manufacturers, distributors, dispensers, DATES: Consideration will be given to all
The company plans to import the importers, and exporters of controlled written comments received by October
listed controlled substances to substances (other than final orders in 9, 2018.
manufacture bulk controlled substances connection with suspension, denial, or
ADDRESSES: A copy of this ICR with
for sale to its customers. The company revocation of registration) has been
applicable supporting documentation;
plans to import an intermediate form of redelegated to the Assistant
including a description of the likely
tapentadol (9780), to bulk manufacture Administrator of the DEA Diversion
respondents, proposed frequency of
tapentadol for distribution to its Control Division (‘‘Assistant
response, and estimated total burden
customers. Administrator’’) pursuant to section 7 of
may be obtained free by contacting
28 CFR part 0, appendix to subpart R.
Dated: July 31, 2018. In accordance with 21 CFR Gloribel Nieves-Cartagena by telephone
John J. Martin, 1301.34(a), this is notice that on October at (202) 693–2771, TTY 1–877–889–
Assistant Administrator. 5, 2017, Myoderm, 48 East Main St., 5627 (these are not toll free numbers),
Norristown, Pennsylvania 19401 or by email at Nieves-
[FR Doc. 2018–16940 Filed 8–7–18; 8:45 am]
applied to be registered as an importer Cartagena.Gloribel@dol.gov.
BILLING CODE 4410–09–P
Submit written comments about, or
of the following basic classes of
requests for a copy of, this ICR by mail
controlled substances:
or courier to the U.S. Department of
DEPARTMENT OF JUSTICE
Controlled Drug Labor, Employment and Training
Schedule Administration, Office of Policy
Drug Enforcement Administration substance code
Development and Research, Room N–
[Docket No. DEA–392] Amphetamine ............... 1100 II 5641, 200 Constitution Avenue NW,
Lisdexamfetamine ........ 1205 II Washington, DC 20210; by email:
Importer of Controlled Substances Methylphenidate ........... 1724 II Nieves-Cartagena.Gloribel@dol.gov; or
Application: Myoderm Nabilone ....................... 7379 II by Fax at (202) 693–2766.
Oxycodone ................... 9143 II
ACTION: Notice of application. Hydromorphone ............ 9150 II FOR FURTHER INFORMATION CONTACT:
Hydrocodone ................ 9193 II Gloribel Nieves-Cartagena by telephone
DATES: Registered bulk manufacturers of Morphine ....................... 9300 II at (202) 693–2771, TYY 1–877–889–
the affected basic classes, and Oxymorphone ............... 9652 II 5627 (these are not toll-free numbers) or
applicants therefore, may file written Fentanyl ........................ 9801 II by email at Nieves-Cartagena.Gloribel@
comments on or objections to the dol.gov.
issuance of the proposed registration on The company plans to import
Authority: 44 U.S.C. 3506(c)(2)(A).
or before September 7, 2018. Such controlled substances commercially
packaged in dosage form only for SUPPLEMENTARY INFORMATION: The DOL,
persons may also file a written request
clinical trials purposes, research, and as part of its continuing effort to reduce
for a hearing on the application on or
analytical purposes only. paperwork and respondent burden,
before September 7, 2018.
Dated: July 31, 2018. conducts a pre-clearance consultation
ADDRESSES: Written comments should program to provide the general public
be sent to: Drug Enforcement John J. Martin,
and Federal agencies with an
Administration, Attention: DEA Federal Assistant Administrator.
opportunity to comment on proposed
Register Representative/DRW, 8701 [FR Doc. 2018–16938 Filed 8–7–18; 8:45 am] and/or continuing collections of
Morrissette Drive, Springfield, Virginia BILLING CODE 4410–09–P information before submitting them to
22152. All requests for hearing must be the OMB for final approval. This
sent to: Drug Enforcement program helps to ensure that requested
Administration, Attn: Administrator, DEPARTMENT OF LABOR data can be provided in the desired
8701 Morrissette Drive, Springfield, format, reporting burden (time and
Virginia 22152. All request for hearing Employment and Training financial resources) is minimized,
should also be sent to: (1) Drug Administration collection instruments are clearly
Enforcement Administration, Attn: understood, and the impact of collection
Hearing Clerk/LJ, 8701 Morrissette Agency Information Collection
requirements on respondents is properly
Drive, Springfield, Virginia 22152; and Activities; Comment Request; State
assessed.
(2) Drug Enforcement Administration, Apprenticeship Expansion (SAE)
The information collection activities
Attn: DEA Federal Register Grants Research Study
described in this notice will provide
Representative/DRW, 8701 Morrissette data for a qualitative study of
ACTION: Notice of information collection;
Drive, Springfield, Virginia 22152. Apprenticeship SAE grants and related
request for comment.
Comments and requests for hearings on
sradovich on DSK3GMQ082PROD with NOTICES
apprenticeship expansion activities.
applications to import narcotic raw SUMMARY: The Department of Labor Through grant and contract vehicles,
material are not appropriate. 72 FR (DOL), Employment and Training DOL is seeking to expand opportunities
3417, (January 25, 2007) Administration (ETA) is soliciting related to Registered Apprenticeships,
SUPPLEMENTARY INFORMATION: The comments concerning a new request for expand programs to new industries and
Attorney General has delegated his the authority to conduct the information occupations, increase the number of
authority under the Controlled collection request (ICR) titled, ‘‘State apprentices, and to promote the
Substances Act to the Administrator of Apprenticeship Expansion (SAE) Grants diversity and inclusion of apprentices.
VerDate Sep<11>2014 22:37 Aug 07, 2018 Jkt 244001 PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 E:\FR\FM\08AUN1.SGM 08AUN1](https://thefederalregister.org/doc/83_FR_39283/page/1.svg)
Document Created: 2018-08-08 02:06:15
Document Modified: 2018-08-08 02:06:15
| 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 September 7, 2018. Such persons may also file a written request for a hearing on the application on or before September 7, 2018. | |
| FR Citation | 83 FR 39130 |
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