83 FR 45468 - Bulk Manufacturer of Controlled Substances Registration
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 174 (September 7, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 174 (September 7, 2018)
| Page Range | 45468-45468 | |
| FR Document | 2018-19444 |
[Federal Register Volume 83, Number 174 (Friday, September 7, 2018)] [Notices] [Page 45468] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-19444] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Bulk Manufacturer of Controlled Substances Registration ACTION: Notice of registration. ----------------------------------------------------------------------- SUMMARY: Registrant listed below has applied for and been granted registration by the Drug Enforcement Administration (DEA) as a bulk manufacturer of various classes of schedule I and II controlled substances. SUPPLEMENTARY INFORMATION: The company listed below applied to be registered as a bulk manufacturer of various basic classes of controlled substances. Information on the previously published notice is listed in the table below. No comments or objections were submitted for this notice. ------------------------------------------------------------------------ Company FR docket Published ------------------------------------------------------------------------ Patheon API Manufacturing, Inc.. 83 FR 22516 May 15, 2018. ------------------------------------------------------------------------ The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of this registrant to manufacture the applicable basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company's maintenance of effective controls against diversion by inspecting and testing the company's physical security systems, verifying the company's compliance with state and local laws, and reviewing the company's background and history. Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the DEA has granted a registration as a bulk manufacturer to the above listed company. Dated: August 23, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018-19444 Filed 9-6-18; 8:45 am] BILLING CODE 4410-09-P
![45468 Federal Register / Vol. 83, No. 174 / Friday, September 7, 2018 / Notices
public are invited to file comments, not and Procedure (19 CFR 210.4(f)). Issued: August 31, 2018.
to exceed five (5) pages in length, Submissions should refer to the docket Katherine Hiner,
inclusive of attachments, on any public number (‘‘Docket No. 3336’’) in a Supervisory Attorney.
interest issues raised by the complaint prominent place on the cover page and/ [FR Doc. 2018–19386 Filed 9–6–18; 8:45 am]
or § 210.8(b) filing. Comments should or the first page. (See Handbook for BILLING CODE 7020–02–P
address whether issuance of the relief Electronic Filing Procedures, Electronic
specifically requested by the Filing Procedures.1) Persons with
complainant in this investigation would questions regarding filing should
affect the public health and welfare in contact the Secretary (202–205–2000).
the United States, competitive DEPARTMENT OF JUSTICE
conditions in the United States Any person desiring to submit a
document to the Commission in Drug Enforcement Administration
economy, the production of like or
directly competitive articles in the confidence must request confidential
United States, or United States treatment. All such requests should be [Docket No. DEA–392]
consumers. directed to the Secretary to the
In particular, the Commission is Commission and must include a full Bulk Manufacturer of Controlled
interested in comments that: statement of the reasons why the Substances Registration
(i) Explain how the articles Commission should grant such
potentially subject to the requested treatment. See 19 CFR 201.6. Documents ACTION: Notice of registration.
remedial orders are used in the United for which confidential treatment by the
States; Commission is properly sought will be SUMMARY: Registrant listed below has
(ii) identify any public health, safety, applied for and been granted
treated accordingly. All such requests
or welfare concerns in the United States registration by the Drug Enforcement
should be directed to the Secretary to
relating to the requested remedial Administration (DEA) as a bulk
orders; the Commission and must include a full
statement of the reasons why the manufacturer of various classes of
(iii) identify like or directly schedule I and II controlled substances.
competitive articles that complainant, Commission should grant such
its licensees, or third parties make in the treatment. See 19 CFR 201.6. Documents SUPPLEMENTARY INFORMATION: The
United States which could replace the for which confidential treatment by the company listed below applied to be
subject articles if they were to be Commission is properly sought will be registered as a bulk manufacturer of
excluded; treated accordingly. All information, various basic classes of controlled
(iv) indicate whether complainant, including confidential business substances. Information on the
complainant’s licensees, and/or third information and documents for which previously published notice is listed in
party suppliers have the capacity to confidential treatment is properly the table below. No comments or
replace the volume of articles sought, submitted to the Commission for objections were submitted for this
potentially subject to the requested purposes of this Investigation may be notice.
exclusion order and/or a cease and disclosed to and used: (i) By the
desist order within a commercially Company FR docket Published
Commission, its employees and Offices,
reasonable time; and and contract personnel (a) for Patheon API Man- 83 FR 22516 May 15, 2018.
(v) explain how the requested developing or maintaining the records ufacturing, Inc.
remedial orders would impact United of this or a related proceeding, or (b) in
States consumers. The DEA has considered the factors in
Written submissions on the public internal investigations, audits, reviews,
and evaluations relating to the 21 U.S.C. 823(a) and determined that
interest must be filed no later than by
programs, personnel, and operations of the registration of this registrant to
close of business, eight calendar days
the Commission including under 5 manufacture the applicable basic classes
after the date of publication of this
U.S.C. Appendix 3; or (ii) by U.S. of controlled substances is consistent
notice in the Federal Register. There
government employees and contract with the public interest and with United
will be further opportunities for
personnel,2 solely for cybersecurity States obligations under international
comment on the public interest after the
purposes. All nonconfidential written treaties, conventions, or protocols in
issuance of any final initial
submissions will be available for public effect on May 1, 1971. The DEA
determination in this investigation. Any
inspection at the Office of the Secretary investigated the company’s maintenance
written submissions on other issues
and on EDIS.3 of effective controls against diversion by
should be filed no later than by close of
inspecting and testing the company’s
business nine calendar days after the This action is taken under the physical security systems, verifying the
date of publication of this notice in the authority of section 337 of the Tariff Act company’s compliance with state and
Federal Register. Complainant may file of 1930, as amended (19 U.S.C. 1337), local laws, and reviewing the company’s
a reply to any written submission no and of §§ 201.10 and 210.8(c) of the background and history.
later than the date on which Commission’s Rules of Practice and
complainant’s reply would be due Therefore, pursuant to 21 U.S.C.
Procedure (19 CFR 201.10, 210.8(c)). 823(a), and in accordance with 21 CFR
under § 210.8(c)(2) of the Commission’s
Rules of Practice and Procedure (19 CFR By order of the Commission. 1301.33, the DEA has granted a
210.8(c)(2)). registration as a bulk manufacturer to
daltland on DSKBBV9HB2PROD with NOTICES
Persons filing written submissions 1 Handbook for Electronic Filing Procedures:
the above listed company.
must file the original document https://www.usitc.gov/documents/handbook_on_ Dated: August 23, 2018.
electronically on or before the deadlines filing_procedures.pdf. John J. Martin,
stated above and submit 8 true paper 2 All contract personnel will sign appropriate
copies to the Office of the Secretary by Assistant Administrator.
nondisclosure agreements.
noon the next day pursuant to § 210.4(f) 3 Electronic Document Information System [FR Doc. 2018–19444 Filed 9–6–18; 8:45 am]
of the Commission’s Rules of Practice (EDIS): https://edis.usitc.gov. BILLING CODE 4410–09–P
VerDate Sep<11>2014 17:55 Sep 06, 2018 Jkt 244001 PO 00000 Frm 00058 Fmt 4703 Sfmt 9990 E:\FR\FM\07SEN1.SGM 07SEN1](https://thefederalregister.org/doc/83_FR_45642/page/1.svg)
Document Created: 2018-09-07 00:15:51
Document Modified: 2018-09-07 00:15:51
| 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 registration. | |
| FR Citation | 83 FR 45468 |
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR