82 FR 23066 - Bulk Manufacturer of Controlled Substances Application: Insys Manufacturing, LLC
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 82, Issue 96 (May 19, 2017)
Drug Enforcement Administration
Federal Register Volume 82, Issue 96 (May 19, 2017)
| Page Range | 23066-23067 | |
| FR Document | 2017-10230 |
[Federal Register Volume 82, Number 96 (Friday, May 19, 2017)] [Notices] [Pages 23066-23067] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-10230] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Bulk Manufacturer of Controlled Substances Application: Insys Manufacturing, 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 in accordance with 21 CFR 1301.33(a) on or before July 18, 2017. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: 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 [[Page 23067]] Administrator'') pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.33(a), this is notice that on March 21, 2017, Insys Manufacturing, LLC, 2700 Oakmont Drive, Round Rock, Texas 78665 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: ------------------------------------------------------------------------ Controlled substance Schedule ------------------------------------------------------------------------ Marihuana (7360)........................... I Tetrahydrocannabinols (7370)............... I ------------------------------------------------------------------------ The company plans to manufacture bulk synthetic active pharmaceutical ingredients (APIs) for product development and distribution to its customers. No other activity for these drug codes is authorized for this registration. Dated: May 15, 2017. Louis J. Milione, Assistant Administrator. [FR Doc. 2017-10230 Filed 5-18-17; 8:45 am] BILLING CODE 4410-09-P
![23066 Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Notices
21, 2005. 70 FR 43251 (July 26, 2005). directed to the Secretary to the rules-policies/records-and-archives-
During this period, the subject articles Commission and must include a full rules-committees/agenda-books.
would be entitled to enter the United statement of the reasons why the DATES: June 12–13, 2017.
States under bond, in an amount Commission should grant such TIME:
determined by the Commission and treatment. See 19 CFR 201.6. Documents June 12—1:30 p.m.–5:00 p.m.
prescribed by the Secretary of the for which confidential treatment by the June 13—8:30 a.m.–3:00 p.m.
Treasury. The Commission is therefore Commission is properly sought will be
interested in receiving submissions ADDRESSES: Thurgood Marshall Federal
treated accordingly. All information,
concerning the amount of the bond that including confidential business Judiciary Building, Mecham Conference
should be imposed if a remedy is information and documents for which Center, Administrative Office of the
ordered. confidential treatment is properly United States Courts, One Columbus
Written Submissions: The parties to sought, submitted to the Commission for Circle NE., Washington, DC 20544.
the investigation are requested to file purposes of this Investigation may be FOR FURTHER INFORMATION CONTACT:
written submissions on the issues disclosed to and used: (i) By the Rebecca A. Womeldorf, Rules
identified in this notice. Parties to the Commission, its employees and Offices, Committee Secretary, Rules Committee
investigation, interested government and contract personnel (a) for Support Office, Administrative Office of
agencies, and any other interested developing or maintaining the records the United States Courts, Washington,
parties are encouraged to file written of this or a related proceeding, or (b) in DC 20544, telephone (202) 502–1820.
submissions on the issues of remedy, internal investigations, audits, reviews, Dated: May 15, 2017.
the public interest, and bonding. Such and evaluations relating to the Rebecca A. Womeldorf,
submissions should address the programs, personnel, and operations of Rules Committee Secretary.
recommended determination by the ALJ the Commission including under 5
on remedy and bonding. Complainants [FR Doc. 2017–10151 Filed 5–18–17; 8:45 am]
U.S.C. Appendix 3; or (ii) by U.S.
are requested to submit proposed government employees and contract
BILLING CODE 2210–55–P
remedial orders for the Commission’s personnel,1 solely for cybersecurity
consideration. Complainants are also purposes. All nonconfidential written
requested to state the date that the submissions will be available for public DEPARTMENT OF JUSTICE
patent expires and the HTSUS numbers inspection at the Office of the Secretary
under which the accused products are Drug Enforcement Administration
and on EDIS.
imported. Complainants are further The authority for the Commission’s [Docket No. DEA–392]
requested to supply the names of known determination is contained in section
importers of the Nautilus products at 337 of the Tariff Act of 1930, as Bulk Manufacturer of Controlled
issue in this investigation. The written amended (19 U.S.C. 1337), and in Part Substances Application: Insys
submissions and proposed remedial 210 of the Commission’s Rules of Manufacturing, LLC
orders must be filed no later than close Practice and Procedure (19 CFR part
of business on May 25, 2017. Reply 210). ACTION: Notice of application.
submissions must be filed no later than
the close of business on June 1, 2017. By order of the Commission. DATES: Registered bulk manufacturers of
Opening submissions are limited to 50 Issued: May 15, 2017. the affected basic classes, and
pages. Reply submissions are limited to William R. Bishop, applicants therefore, may file written
25 pages. Such submissions should Supervisory Hearings and Information comments on or objections to the
address the ALJ’s recommended Officer. issuance of the proposed registration in
determinations on remedy and bonding. [FR Doc. 2017–10144 Filed 5–18–17; 8:45 am] accordance with 21 CFR 1301.33(a) on
No further submissions on any of these BILLING CODE 7020–02–P or before July 18, 2017.
issues will be permitted unless ADDRESSES: Written comments should
otherwise ordered by the Commission. be sent to: Drug Enforcement
Persons filing written submissions Administration, Attention: DEA Federal
must file the original document JUDICIAL CONFERENCE OF THE
UNITED STATES Register Representative/DRW, 8701
electronically on or before the deadlines Morrissette Drive, Springfield, Virginia
stated above and submit eight true paper Meeting of the Judicial Conference; 22152.
copies to the Office of the Secretary by Committee on Rules of Practice and
noon the next day pursuant to section SUPPLEMENTARY INFORMATION: The
Procedure Attorney General has delegated his
210.4(f) of the Commission’s Rules of
Practice and Procedure (19 CFR AGENCY: Committee on Rules of Practice authority under the Controlled
210.4(f)). Submissions should refer to and Procedure, Judicial Conference of Substances Act to the Administrator of
the investigation number (‘‘Inv. No. the United States. the Drug Enforcement Administration
337–TA–989’’) in a prominent place on ACTION: Notice of open meeting. (DEA), 28 CFR 0.100(b). Authority to
the cover page and/or the first page. (See exercise all necessary functions with
Handbook for Electronic Filing SUMMARY: The Committee on Rules of respect to the promulgation and
Procedures, http://www.usitc.gov/ Practice and Procedure will hold a implementation of 21 CFR part 1301,
secretary/fed_reg_notices/rules/ incident to the registration of
asabaliauskas on DSK3SPTVN1PROD with NOTICES
meeting on June 12–13, 2017. The
handbook_on_electronic_filing.pdf). meeting will be open to public manufacturers, distributors, dispensers,
Persons with questions regarding filing observation but not participation. An importers, and exporters of controlled
should contact the Secretary (202–205– agenda and supporting materials will be substances (other than final orders in
2000). posted at least 7 days in advance of the connection with suspension, denial, or
Any person desiring to submit a meeting at: http://www.uscourts.gov/ revocation of registration) has been
document to the Commission in redelegated to the Assistant
confidence must request confidential 1 All contract personnel will sign appropriate Administrator of the DEA Diversion
treatment. All such requests should be nondisclosure agreements. Control Division (‘‘Assistant
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![Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Notices 23067
Administrator’’) pursuant to section 7 of Morrissette Drive, Springfield, Virginia DATES: Registered bulk manufacturers of
28 CFR part 0, appendix to subpart R. 22152. the affected basic class, and applicants
In accordance with 21 CFR SUPPLEMENTARY INFORMATION: The therefore, may file written comments on
1301.33(a), this is notice that on March Attorney General has delegated his or objections to the issuance of the
21, 2017, Insys Manufacturing, LLC, authority under the Controlled proposed registration in accordance
2700 Oakmont Drive, Round Rock, Substances Act to the Administrator of with 21 CFR 1301.33(a) on or before July
Texas 78665 applied to be registered as the Drug Enforcement Administration 18, 2017.
a bulk manufacturer of the following (DEA), 28 CFR 0.100(b). Authority to
basic classes of controlled substances: ADDRESSES: Written comments should
exercise all necessary functions with
respect to the promulgation and be sent to: Drug Enforcement
Controlled substance Schedule implementation of 21 CFR part 1301, Administration, Attention: DEA Federal
incident to the registration of Register Representative/DRW, 8701
Marihuana (7360) ......................... I Morrissette Drive, Springfield, Virginia
Tetrahydrocannabinols (7370) ..... I manufacturers, distributors, dispensers,
importers, and exporters of controlled 22152.
The company plans to manufacture substances (other than final orders in
SUPPLEMENTARY INFORMATION: The
bulk synthetic active pharmaceutical connection with suspension, denial, or
Attorney General has delegated his
ingredients (APIs) for product revocation of registration) has been
redelegated to the Assistant authority under the Controlled
development and distribution to its Substances Act to the Administrator of
customers. No other activity for these Administrator of the DEA Diversion
Control Division (‘‘Assistant the Drug Enforcement Administration
drug codes is authorized for this (DEA), 28 CFR 0.100(b). Authority to
registration. Administrator’’) pursuant to section 7 of
28 CFR part 0, appendix to subpart R. exercise all necessary functions with
Dated: May 15, 2017. In accordance with 21 CFR respect to the promulgation and
Louis J. Milione, 1301.33(a), this is notice that on implementation of 21 CFR part 1301,
Assistant Administrator. December 2, 2016, Patheon incident to the registration of
[FR Doc. 2017–10230 Filed 5–18–17; 8:45 am] Pharmaceuticals, Inc., 2110 E. Galbraith manufacturers, distributors, dispensers,
BILLING CODE 4410–09–P Road, Cincinnati, Ohio 45237 applied to importers, and exporters of controlled
be registered as a bulk manufacturer of substances (other than final orders in
gamma hydroxybutyric acid (2010) a connection with suspension, denial, or
DEPARTMENT OF JUSTICE basic class of controlled substance listed revocation of registration) has been
in schedule I. redelegated to the Assistant
Drug Enforcement Administration The company plans to manufacture Administrator of the DEA Diversion
the listed controlled substance for Control Division (‘‘Assistant
[Docket No. DEA–392] product development.
Administrator’’) pursuant to section 7 of
Dated: May 15, 2017. 28 CFR part 0, appendix to subpart R.
Bulk Manufacturer of Controlled
Substances Application: Patheon Louis J. Milione,
In accordance with 21 CFR
Pharmaceuticals, Inc. Assistant Administrator.
1301.33(a), this is notice that on March
[FR Doc. 2017–10238 Filed 5–18–17; 8:45 am]
3, 2017, Eli-Elsohly Laboratories,
ACTION: Notice of application. BILLING CODE 4410–09–P
Mahmoud A. Elsohly Ph. D., 5
DATES: Registered bulk manufacturers of Industrial Park Drive, Oxford,
the affected basic class, and applicants DEPARTMENT OF JUSTICE Mississippi 38655 applied to be
therefore, may file written comments on registered as a bulk manufacturer of the
or objections to the issuance of the Drug Enforcement Administration following basic classes of controlled
proposed registration in accordance substances:
[Docket No. DEA–392]
with 21 CFR 1301.33(a) on or before July
18, 2017. Bulk Manufacturer of Controlled
ADDRESSES: Written comments should Substances Application: Eli-Elsohly
be sent to: Drug Enforcement Laboratories
Administration, Attention: DEA Federal
ACTION: Notice of application.
Register Representative/DRW 8701
Controlled substance Drug code Schedule
Marihuana Extract ........................................................................................................................................................... 7350 I
Marihuana ........................................................................................................................................................................ 7360 I
Tetrahydrocannabinols .................................................................................................................................................... 7370 I
Dihydromorphine ............................................................................................................................................................. 9145 I
Amphetamine ................................................................................................................................................................... 1100 II
Methamphetamine ........................................................................................................................................................... 1105 II
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Cocaine ............................................................................................................................................................................ 9041 II
Codeine ........................................................................................................................................................................... 9050 II
Dihydrocodeine ................................................................................................................................................................ 9120 II
Oxycodone ....................................................................................................................................................................... 9143 II
Hydromorphone ............................................................................................................................................................... 9150 II
Ecgonine .......................................................................................................................................................................... 9180 II
Hydrocodone ................................................................................................................................................................... 9193 II
Morphine .......................................................................................................................................................................... 9300 II
Thebaine .......................................................................................................................................................................... 9333 II
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Document Created: 2018-11-08 08:48:23
Document Modified: 2018-11-08 08:48:23
| 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 1301.33(a) on or before July 18, 2017. | |
| FR Citation | 82 FR 23066 |
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