Bulk Manufacturer of Controlled Substances Application: AMRI Rensselaer, Inc., 41517 [2021-16337]

Download as PDF 41517 khammond on DSKJM1Z7X2PROD with NOTICES Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices (11) If you are a producer, an exporter, or a trade/business association of producers or exporters of the Subject Merchandise in any Subject Country, provide the following information on your firm’s(s’) operations on that product during calendar year 2020 (report quantity data in square yards and value data in U.S. dollars, landed and duty-paid at the U.S. port but not including antidumping or countervailing duties). If you are a trade/business association, provide the information, on an aggregate basis, for the firms which are members of your association. (a) Production (quantity) and, if known, an estimate of the percentage of total production of Subject Merchandise in each Subject Country accounted for by your firm’s(s’) production; (b) Capacity (quantity) of your firm(s) to produce the Subject Merchandise in each Subject Country (that is, the level of production that your establishment(s) could reasonably have expected to attain during the year, assuming normal operating conditions (using equipment and machinery in place and ready to operate), normal operating levels (hours per week/weeks per year), time for downtime, maintenance, repair, and cleanup, and a typical or representative product mix); and (c) the quantity and value of your firm’s(s’) exports to the United States of Subject Merchandise and, if known, an estimate of the percentage of total exports to the United States of Subject Merchandise from each Subject Country accounted for by your firm’s(s’) exports. (12) Identify significant changes, if any, in the supply and demand conditions or business cycle for the Domestic Like Product that have occurred in the United States or in the market for the Subject Merchandise in each Subject Country after 2015, and significant changes, if any, that are likely to occur within a reasonably foreseeable time. Supply conditions to consider include technology; production methods; development efforts; ability to increase production (including the shift of production facilities used for other products and the use, cost, or availability of major inputs into production); and factors related to the ability to shift supply among different national markets (including barriers to importation in foreign markets or changes in market demand abroad). Demand conditions to consider include end uses and applications; the existence and availability of substitute products; and the level of competition among the Domestic Like Product produced in the United States, Subject Merchandise produced in each Subject VerDate Sep<11>2014 17:21 Jul 30, 2021 Jkt 253001 Country, and such merchandise from other countries. (13) (OPTIONAL) A statement of whether you agree with the above definitions of the Domestic Like Product and Domestic Industry; if you disagree with either or both of these definitions, please explain why and provide alternative definitions. Authority: This proceeding is being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to § 207.61 of the Commission’s rules. By order of the Commission. Issued: July 26, 2021. Lisa Barton, Secretary to the Commission. [FR Doc. 2021–16239 Filed 7–30–21; 8:45 am] BILLING CODE 7020–02–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Bulk Manufacturer of Controlled Substances Application: AMRI Rensselaer, Inc. Drug Enforcement Administration, Justice. AGENCY: AMRI Rensselaer, Inc., has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information. Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before October 1, 2021. Such persons may also file a written request for a hearing on the application on or before October 1, 2021. DATES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. ADDRESSES: In accordance with 21 CFR 1301.33(a), this is notice that on May 31, 2021, AMRI Rensselaer Inc., 33 Riverside Avenue, Rensselaer, New York 12144–2951, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Fmt 4703 7360 7370 1100 1205 2270 8333 I I II II II II 9050 9143 9150 9193 9300 9801 II II II II II II The company plans to manufacture the above controlled substances as bulk active pharmaceutical ingredients (API) for use in product development and for distribution to its customers. In reference to drug codes 7360 (Marihuana), and 7370 (Tetrahydrocannabinols), the company plans to bulk manufacture these drugs as synthetic. No other activities for these drug codes are authorized for this registration. Sfmt 4703 [FR Doc. 2021–16337 Filed 7–30–21; 8:45 am] BILLING CODE P [OMB Number 1122–0027] Notice of application. Frm 00085 Schedule DEPARTMENT OF JUSTICE SUMMARY: PO 00000 Marihuana ........................ Tetrahydrocannabinols .... Amphetamine .................. Lisdexamfetamine ........... Pentobarbital ................... ANPP (4-Anilino-Nphenethyl-4-piperidine). Codeine ........................... Oxycodone ...................... Hydromorphone ............... Hydrocodone ................... Morphine .......................... Fentanyl ........................... Drug code William T. McDermott, Assistant Administrator. [Docket No. DEA–877] ACTION: Controlled substance Agency Information Collection Activities; Proposed eCollection Requested; Extension of a Currently Approved Collection Office on Violence Against Women, Department of Justice. ACTION: 60-Day notice. AGENCY: The Office on Violence Against Women (OVW), Department of Justice, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. DATES: Comments are encouraged and will be accepted for 60 days until October 1, 2021. FOR FURTHER INFORMATION CONTACT: Written comments and/or suggestion regarding the items contained in this notice, especially the estimated public burden and associated response time, should be directed to Cathy Poston, Office on Violence Against Women, at 202–514–5430 or Catherine.poston@ usdoj.gov. SUPPLEMENTARY INFORMATION: Written comments and suggestions from the SUMMARY: E:\FR\FM\02AUN1.SGM 02AUN1

Agencies

[Federal Register Volume 86, Number 145 (Monday, August 2, 2021)]
[Notices]
[Page 41517]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16337]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-877]


Bulk Manufacturer of Controlled Substances Application: AMRI 
Rensselaer, Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: AMRI Rensselaer, Inc., has applied to be registered as a bulk 
manufacturer of basic class(es) of controlled substance(s). Refer to 
Supplemental Information listed below for further drug information.

DATES: Registered bulk manufacturers of the affected basic class(es), 
and applicants therefore, may file written comments on or objections to 
the issuance of the proposed registration on or before October 1, 2021. 
Such persons may also file a written request for a hearing on the 
application on or before October 1, 2021.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this 
is notice that on May 31, 2021, AMRI Rensselaer Inc., 33 Riverside 
Avenue, Rensselaer, New York 12144-2951, applied to be registered as a 
bulk manufacturer of the following basic class(es) of controlled 
substance(s):

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Marihuana...............................    7360  I
Tetrahydrocannabinols...................    7370  I
Amphetamine.............................    1100  II
Lisdexamfetamine........................    1205  II
Pentobarbital...........................    2270  II
ANPP (4-Anilino-N-phenethyl-4-              8333  II
 piperidine).
Codeine.................................    9050  II
Oxycodone...............................    9143  II
Hydromorphone...........................    9150  II
Hydrocodone.............................    9193  II
Morphine................................    9300  II
Fentanyl................................    9801  II
------------------------------------------------------------------------

    The company plans to manufacture the above controlled substances as 
bulk active pharmaceutical ingredients (API) for use in product 
development and for distribution to its customers. In reference to drug 
codes 7360 (Marihuana), and 7370 (Tetrahydrocannabinols), the company 
plans to bulk manufacture these drugs as synthetic. No other activities 
for these drug codes are authorized for this registration.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-16337 Filed 7-30-21; 8:45 am]
BILLING CODE P
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