82 FR 13134 - Importer of Controlled Substances Application: Myoderm
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 82, Issue 45 (March 9, 2017)
Drug Enforcement Administration
Federal Register Volume 82, Issue 45 (March 9, 2017)
| Page Range | 13134-13135 | |
| FR Document | 2017-04646 |
[Federal Register Volume 82, Number 45 (Thursday, March 9, 2017)] [Notices] [Pages 13134-13135] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-04646] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Application: Myoderm ACTION: Notice of application. ----------------------------------------------------------------------- [[Page 13135]] 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 April 10, 2017. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before April 10, 2017. 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 requests 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. 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 November 11, 2016, Myoderm, 48 East Main Street, Norristown, Pennsylvania 19401 applied to be registered as an importer of the following basic classes of controlled substances: ------------------------------------------------------------------------ Controlled substance Drug 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 the listed controlled substances in finished dosage form for clinical trials, research, and analytical purposes. The import of the above listed basic classes of controlled substances will be granted only for analytical testing, research, and clinical trials. This authorization does not extend to the import of a finished FDA approved or non-approved dosage form for commercial sale. Louis J. Milione, Assistant Administrator. [FR Doc. 2017-04646 Filed 3-8-17; 8:45 am] BILLING CODE 4410-09-P
![13134 Federal Register / Vol. 82, No. 45 / Thursday, March 9, 2017 / Notices
3. Please explain how ‘‘antitrust may not exceed 20 pages in length, (Room 101), 500 E Street SW.,
injury’’ standing, as required for private exclusive of any exhibits, and shall be Washington, DC 20436, beginning at
litigants in federal district courts double-spaced. No further submissions 9:30 a.m. While any member of the
asserting antitrust claims, see, e.g., Atl. on any of these issues will be permitted public may attend the oral argument,
Richfield Co. v. USA Petroleum Co., 495 unless otherwise ordered by the only counsel for the parties to the
U.S. 328, 335 (1990), compares to, or Commission. investigation, including the Office of
differs from, the injury requirement Persons filing written submissions Unfair Import Investigations, and
under Section 337(a)(1)(A). Please must file the original document representatives of interested government
include an analysis of any relevant electronically on or before the deadlines agencies may participate and/or argue at
statutory language, legislative history, stated above and submit eight (8) true the oral argument.
Commission determinations, case law, paper copies to the Office of the At the oral argument, counsel for each
or other authority. In discussing this Secretary by noon the next day pursuant party and representatives of interested
question, please explain the chronology to section 210.4(f) of the Commission’s government agencies will be given an
of the adoption of the ‘‘antitrust injury’’ Rules of Practice and Procedure (19 CFR opportunity to comment in opening
standing requirement in relation to the 210.4(f)). Submissions should refer to remarks for no more than 10 minutes,
injury requirement under Section the investigation number (‘‘Inv. No. and the Commissioners may ask
337(a)(1)(A). 337–TA–1002’’) in a prominent place on questions of those appearing. Details as
4. Please explain whether ‘‘antitrust the cover page and/or the first page. (See to the format of the hearing will be
injury’’ standing is, or should be, Handbook for Electronic Filing provided at a later date. This is a public
required for establishing a Section 337 Procedures, https://www.usitc.gov/ proceeding; confidential business
violation based on a claim alleging a secretary/documents/handbook_on_ information (‘‘CBI’’) shall not be
conspiracy to fix prices and control filing_procedures.pdf). Persons with discussed. A party, however, can draw
output and export volumes as a matter questions regarding filing should the Commission’s attention to CBI, if
of law and/or policy. Please include an contact the Secretary (202–205–2000). necessary, by pointing to where in the
analysis of any relevant statutory Any person desiring to submit a record the information can be found.
language, legislative history, document to the Commission in The oral argument will be limited in
Commission determinations, case law, confidence must request confidential scope to the issues identified in the ID
or other authority. treatment. All such requests should be (Order No. 38); the Commission’s
The parties to this investigation, directed to the Secretary to the December 19, 2016, Notice; the present
including the Office of Unfair Import Commission and must include a full Notice; and any related petition, written
Investigations, may file submissions in statement of the reasons why the submissions, and responses thereto.
response to any written submission(s) Commission should grant such After the conclusion of the oral
that are submitted by the public or any treatment. See 19 CFR 201.6. Documents argument, no additional written
interested government agencies. No for which confidential treatment by the submissions or arguments will be
further submissions on any of these Commission is properly sought will be permitted.
issues will be permitted unless treated accordingly. All information, Notice of Appearance: Counsel for the
otherwise ordered by the Commission. including confidential business parties to the investigation or any
Written Submissions: Written information and documents for which representatives of interested government
submissions from entities other than the confidential treatment is properly agencies who wish to participate in the
parties and/or government agencies sought, submitted to the Commission for oral argument must file a written
shall include a Statement of Interest purposes of this Investigation may be request to appear at the Commission
including: (1) A concise statement of the disclosed to and used: (i) By the oral argument by April 6, 2017 and must
identity of the entity filing the written Commission, its employees and Offices, provide their email addresses as part of
submission, its interest in the case, and and contract personnel (a) for their contact information.
the reasons why the written submission developing or maintaining the records The authority for the Commission’s
is relevant to the disposition of the of this or a related proceeding, or (b) in determination is contained in section
issues in dispute; and (2) a statement internal investigations, audits, reviews, 337 of the Tariff Act of 1930, as
indicating whether: (i) A party’s counsel and evaluations relating to the amended (19 U.S.C. 1337), and in part
authored the written submission in programs, personnel, and operations of 210 of the Commission’s Rules of
whole or in part; (ii) a party or party’s the Commission including under 5 Practice and Procedure (19 CFR part
counsel contributed money that was U.S.C. Appendix 3; or (ii) by U.S. 210).
intended to fund preparing or government employees and contract By order of the Commission.
submitting the written submission; and personnel,1 solely for cybersecurity Issued: March 3, 2017.
(iii) a person—other than the entity, its purposes. All nonconfidential written Lisa R. Barton,
members, or its counsel—contributed submissions will be available for public Secretary to the Commission.
money that was specifically intended to inspection at the Office of the Secretary [FR Doc. 2017–04597 Filed 3–8–17; 8:45 am]
fund preparing or submitting the written and on EDIS. BILLING CODE 7020–02–P
submission and, if so, each such person Commission Oral Argument: The
shall be identified. Written submissions Commission has also determined to
from individuals shall also include a reschedule the oral argument to April
curriculum vitae (‘‘CV’’). Written DEPARTMENT OF JUSTICE
asabaliauskas on DSK3SPTVN1PROD with NOTICES
20, 2017, in order to provide sufficient
submissions must be filed no later than time for the Commission to receive and
close of business on March 27, 2017, Drug Enforcement Administration
review any written submissions and any
may not exceed 20 pages in length, responses thereto. The Commission will [Docket No. DEA–392]
exclusive of any exhibits, Statement of hold the public oral argument in the
Interest, and CV, and shall be double- Importer of Controlled Substances
Commission’s Main Hearing Room
spaced. Responsive submissions from Application: Myoderm
the parties must be filed no later than 1 All contract personnel will sign appropriate
ACTION: Notice of application.
the close of business on April 3, 2017, nondisclosure agreements.
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![Federal Register / Vol. 82, No. 45 / Thursday, March 9, 2017 / Notices 13135
DATES: Registered bulk manufacturers of 8701 Morrissette Drive, Springfield, incident to the registration of
the affected basic classes, and Virginia 22152. All requests for hearing manufacturers, distributors, dispensers,
applicants therefore, may file written should also be sent to: (1) Drug importers, and exporters of controlled
comments on or objections to the Enforcement Administration, Attn: substances (other than final orders in
issuance of the proposed registration in Hearing Clerk/LJ, 8701 Morrissette connection with suspension, denial, or
accordance with 21 CFR 1301.34(a) on Drive, Springfield, Virginia 22152; and revocation of registration) has been
or before April 10, 2017. Such persons (2) Drug Enforcement Administration, redelegated to the Assistant
may also file a written request for a Attn: DEA Federal Register Administrator of the DEA Diversion
hearing on the application pursuant to Representative/DRW, 8701 Morrissette Control Division (‘‘Assistant
21 CFR 1301.43 on or before April 10, Drive, Springfield, Virginia 22152.
Administrator’’) pursuant to section 7 of
2017. SUPPLEMENTARY INFORMATION: The
28 CFR part 0, appendix to subpart R.
ADDRESSES: Written comments should Attorney General has delegated his
be sent to: Drug Enforcement authority under the Controlled In accordance with 21 CFR
Administration, Attention: DEA Federal Substances Act to the Administrator of 1301.34(a), this is notice that on
Register Representative/DRW, 8701 the Drug Enforcement Administration November 11, 2016, Myoderm, 48 East
Morrissette Drive, Springfield, Virginia (DEA), 28 CFR 0.100(b). Authority to Main Street, Norristown, Pennsylvania
22152. All requests for hearing must be exercise all necessary functions with 19401 applied to be registered as an
sent to: Drug Enforcement respect to the promulgation and importer of the following basic classes
Administration, Attn: Administrator, implementation of 21 CFR part 1301, of controlled substances:
Controlled substance Drug 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 the or before April 10, 2017. Such persons substances (other than final orders in
listed controlled substances in finished may also file a written request for a connection with suspension, denial, or
dosage form for clinical trials, research, hearing on the application pursuant to revocation of registration) has been
and analytical purposes. 21 CFR 1301.43 on or before April 10, redelegated to the Assistant
The import of the above listed basic 2017. Administrator of the DEA Diversion
classes of controlled substances will be ADDRESSES: Written comments should Control Division (‘‘Assistant
granted only for analytical testing, be sent to: Drug Enforcement Administrator’’) pursuant to section 7 of
research, and clinical trials. This Administration, Attention: DEA Federal 28 CFR part 0, appendix to subpart R.
authorization does not extend to the Register Representative/DRW, 8701
import of a finished FDA approved or In accordance with 21 CFR
Morrissette Drive, Springfield, Virginia
non-approved dosage form for 1301.34(a), this is notice that on
22152. All requests for hearing must be
commercial sale. sent to: Drug Enforcement December 29, 2016, Meridian Medical
Administration, Attn: Administrator, Technologies, 2555 Hermelin Drive,
Louis J. Milione, Saint Louis, Missouri 63144 applied to
Assistant Administrator.
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for hearing be registered as an importer of morphine
[FR Doc. 2017–04646 Filed 3–8–17; 8:45 am] (9300), a basic class of controlled
should also be sent to: (1) Drug
BILLING CODE 4410–09–P
Enforcement Administration, Attn: substance listed in schedule II.
Hearing Clerk/LJ, 8701 Morrissette The company manufactures a product
Drive, Springfield, Virginia 22152; and containing morphine in the United
DEPARTMENT OF JUSTICE
(2) Drug Enforcement Administration, States. The company exports this
Drug Enforcement Administration Attn: DEA Federal Register product to customers around the world.
Representative/DRW, 8701 Morrissette The company has been asked to ensure
[Docket No. DEA–392] Drive, Springfield, Virginia 22152. that its product, which is sold to
SUPPLEMENTARY INFORMATION: The European customers, meets the
Importer of Controlled Substances
Application: Meridian Medical Attorney General has delegated his standards established by the European
Technologies authority under the Controlled Pharmacopeia, administered by the
Substances Act to the Administrator of
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Directorate for the Quality of Medicines
ACTION: Notice of application. the Drug Enforcement Administration (EDQM). In order to ensure that its
(DEA), 28 CFR 0.100(b). Authority to product will meet European
DATES: Registered bulk manufacturers of exercise all necessary functions with
specifications, the company seeks to
the affected basic classes, and respect to the promulgation and
import morphine supplied by EDQM for
applicants therefore, may file written implementation of 21 CFR part 1301,
comments on or objections to the incident to the registration of use as reference standards.
issuance of the proposed registration in manufacturers, distributors, dispensers,
accordance with 21 CFR 1301.34(a) on importers, and exporters of controlled
VerDate Sep<11>2014 18:42 Mar 08, 2017 Jkt 241001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\09MRN1.SGM 09MRN1](https://thefederalregister.org/doc/82_FR_13179/page/2.svg)
Document Created: 2017-03-09 04:58:40
Document Modified: 2017-03-09 04:58:40
| 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 April 10, 2017. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before April 10, 2017. | |
| FR Citation | 82 FR 13134 |
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