80 FR 57387 - Manufacturer of Controlled Substances Registration: AMRI Rensselaer Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 80, Issue 184 (September 23, 2015)
Drug Enforcement Administration
Federal Register Volume 80, Issue 184 (September 23, 2015)
| Page Range | 57387-57388 | |
| FR Document | 2015-24122 |
[Federal Register Volume 80, Number 184 (Wednesday, September 23, 2015)] [Notices] [Pages 57387-57388] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-24122] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Manufacturer of Controlled Substances Registration: AMRI Rensselaer Inc. ACTION: Notice of registration. ----------------------------------------------------------------------- SUMMARY: AMRI Rensselaer, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants AMRI Rensselaer, Inc. registration as a manufacturer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated April 14, 2015, and published in the Federal Register on April 22, 2015, 80 FR 22560, AMRI Rensselaer, Inc., 33 Riverside Avenue, Rensselaer, New York 12144 applied to be registered as a manufacturer of certain basic classes of controlled substances. No comments or objections were submitted for this notice. The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of AMRI Rensselaer, Inc. to manufacture the 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. [[Page 57388]] Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the above-named company is granted registration as a bulk manufacturer of the basic classes of controlled substances: ------------------------------------------------------------------------ Controlled substance Schedule ------------------------------------------------------------------------ Marihuana (7360).......................... I Tetrahydrocannabinols (7370).............. I Amphetamine (1100)........................ II Lisdexamfetamine (1205)................... II Methylphenidate (1724).................... II Pentobarbital (2270)...................... II 4-Anilino-N-phenethyl-4-piperidine (8333). II Meperidine (9230)......................... II Fentanyl (9801)........................... II ------------------------------------------------------------------------ The company plans to manufacture bulk controlled substances for use in product development and for distribution to its customers. In reference to drug code 7360 (marihuana), and 7370 (THC), the company plans to bulk manufacture these drugs as synthetic. No other activity for this drug code is authorized for this registration. Dated: September 16, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015-24122 Filed 9-22-15; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 80, No. 184 / Wednesday, September 23, 2015 / Notices 57387
INTERNATIONAL TRADE pursuant to section 751(c)(3) of the Commission’s Web site at http://
COMMISSION Tariff Act of 1930 (19 U.S.C. 1675(c)(3)). edis.usitc.gov.
For further information concerning In accordance with sections 201.16(c)
[Investigation Nos. 701–TA–465 and 731– the conduct of this review and rules of and 207.3 of the rules, each document
TA–1161 (Review)] general application, consult the filed by a party to the review must be
Commission’s Rules of Practice and served on all other parties to the review
Certain Steel Grating From China; Procedure, part 201, subparts A and B (as identified by either the public or BPI
Scheduling of an Expedited Five-Year (19 CFR part 201), and part 207, service list), and a certificate of service
Review subparts A, D, E, and F (19 CFR part must be timely filed. The Secretary will
207). not accept a document for filing without
AGENCY: United States International a certificate of service.
Trade Commission. Staff Report
Authority: This review is being conducted
ACTION: Notice. A staff report containing information under authority of title VII of the Tariff Act
concerning the subject matter of the of 1930; this notice is published pursuant to
SUMMARY: The Commission hereby gives review will be placed in the nonpublic section 207.62 of the Commission’s rules.
notice of the scheduling of an expedited record on September 30, 2015, and Issued: September 17, 2015.
review pursuant to the Tariff Act of made available to persons on the By order of the Commission.
1930 (‘‘the Act’’) to determine whether Administrative Protective Order service
Lisa R. Barton,
revocation of the antidumping duty and list for this review. A public version
Secretary the Commission.
countervailing duty orders on certain will be issued thereafter, pursuant to
section 207.62(d)(4) of the [FR Doc. 2015–24081 Filed 9–22–15; 8:45 am]
steel grating from China would be likely
to lead to continuation or recurrence of Commission’s rules. BILLING CODE 7020–02–P
material injury within a reasonably
Written Submissions
foreseeable time.
As provided in section 207.62(d) of DEPARTMENT OF JUSTICE
DATES: Effective date: September 4,
the Commission’s rules, interested
2015. Drug Enforcement Administration
parties that are parties to the review and
FOR FURTHER INFORMATION CONTACT: that have provided individually [Docket No. DEA–392]
Charles Yost ((202) 205–3432), Office of adequate responses to the notice of
Investigations, U.S. International Trade institution,2 and any party other than an Manufacturer of Controlled
Commission, 500 E Street SW., interested party to the review may file Substances Registration: AMRI
Washington, DC 20436. Hearing- written comments with the Secretary on Rensselaer Inc.
impaired persons can obtain what determination the Commission
information on this matter by contacting should reach in the review. Comments ACTION: Notice of registration.
the Commission’s TDD terminal on 202– are due on or before October 5, 2015 and SUMMARY: AMRI Rensselaer, Inc. applied
205–1810. Persons with mobility may not contain new factual to be registered as a manufacturer of
impairments who will need special information. Any person that is neither certain basic classes of controlled
assistance in gaining access to the a party to the five-year review nor an substances. The Drug Enforcement
Commission should contact the Office interested party may submit a brief Administration (DEA) grants AMRI
of the Secretary at 202–205–2000. written statement (which shall not Rensselaer, Inc. registration as a
General information concerning the contain any new factual information) manufacturer of those controlled
Commission may also be obtained by pertinent to the review by October 5, substances.
accessing its internet server (http:// 2015. However, should the Department
www.usitc.gov). The public record for of Commerce extend the time limit for SUPPLEMENTARY INFORMATION: By notice
this review may be viewed on the its completion of the final results of its dated April 14, 2015, and published in
Commission’s electronic docket (EDIS) review, the deadline for comments the Federal Register on April 22, 2015,
at http://edis.usitc.gov. (which may not contain new factual 80 FR 22560, AMRI Rensselaer, Inc., 33
information) on Commerce’s final Riverside Avenue, Rensselaer, New
SUPPLEMENTARY INFORMATION: York 12144 applied to be registered as
results is three business days after the
Background issuance of Commerce’s results. If a manufacturer of certain basic classes
comments contain business proprietary of controlled substances. No comments
On September 4, 2015, the or objections were submitted for this
Commission determined that the information (BPI), they must conform
with the requirements of sections 201.6, notice.
domestic interested party group The DEA has considered the factors in
response to its notice of institution (80 207.3, and 207.7 of the Commission’s
rules. Please be aware that the 21 U.S.C. 823(a) and determined that
FR 31071, June 1, 2015) of the subject the registration of AMRI Rensselaer, Inc.
five-year review was adequate and that Commission’s rules with respect to
filing have changed. The most recent to manufacture the basic classes of
the respondent interested party group controlled substances is consistent with
response was inadequate. The amendments took effect on July 25,
2014. See 79 FR 35920 (June 25, 2014), the public interest and with United
Commission did not find any other States obligations under international
circumstances that would warrant and the revised Commission Handbook
on E-filing, available from the treaties, conventions, or protocols in
conducting a full review.1 Accordingly,
mstockstill on DSK4VPTVN1PROD with NOTICES
effect on May 1, 1971. The DEA
the Commission determined that it investigated the company’s maintenance
2 The Commission has found the responses
would conduct an expedited review of effective controls against diversion by
submitted by the Metal Grating Coalition and its
individual member, Alabama Metal Industries inspecting and testing the company’s
1 A record of the Commissioners’ votes, the Corporation, fisher & Ludlow, Inc., Harsco physical security systems, verifying the
Commission’s statement on adequacy, and any Industrial IKG, Interstate Gratings, LLC, and Ohio
individual Commissioner’s statements will be Gratings, Inc. to be individually adequate.
company’s compliance with state and
available from the Office of the Secretary and at the Comments from other interested parties will not be local laws, and reviewing the company’s
Commission’s Web site. accepted (see 19 CFR 207.62(d)(2)). background and history.
VerDate Sep<11>2014 18:00 Sep 22, 2015 Jkt 235001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\23SEN1.SGM 23SEN1](https://thefederalregister.org/doc/80_FR_57571/page/1.svg)
![57388 Federal Register / Vol. 80, No. 184 / Wednesday, September 23, 2015 / Notices
Therefore, pursuant to 21 U.S.C. Substances Act to the Administrator of The company plans to manufacturer
823(a), and in accordance with 21 CFR the Drug Enforcement Administration bulk active pharmaceutical ingredients
1301.33, the above-named company is (DEA), 28 CFR 0.100(b). Authority to (API) for distribution its customers.
granted registration as a bulk exercise all necessary functions with Dated: September 16, 2015.
manufacturer of the basic classes of respect to the promulgation and Joseph T. Rannazzisi,
controlled substances: implementation of 21 CFR part 1301,
Deputy Assistant Administrator.
incident to the registration of
[FR Doc. 2015–24125 Filed 9–22–15; 8:45 am]
manufacturers, distributors, dispensers,
importers, and exporters of controlled BILLING CODE 4410–09–P
Controlled substance Schedule
substances (other than final orders in
Marihuana (7360) ....................... I connection with suspension, denial, or
Tetrahydrocannabinols (7370) .... I DEPARTMENT OF JUSTICE
revocation of registration) has been
Amphetamine (1100) .................. II redelegated to the Deputy Assistant
Lisdexamfetamine (1205) ........... II Drug Enforcement Administration
Methylphenidate (1724) .............. II
Administrator of the DEA Office of
Diversion Control (‘‘Deputy Assistant [Docket No. DEA–392]
Pentobarbital (2270) ................... II
4-Anilino-N-phenethyl-4-piper- II Administrator’’) pursuant to section 7 of
28 CFR part 0, appendix to subpart R. Importer of Controlled Substances
idine (8333).
Registration: Fisher Clinical Services,
Meperidine (9230) ...................... II In accordance with 21 CFR
Fentanyl (9801) .......................... II Inc.
1301.33(a), this is notice that on July 21,
2015, Mallinckrodt LLC, 3600 North ACTION: Notice of registration.
The company plans to manufacture
Second Street, Saint. Louis, Missouri
bulk controlled substances for use in SUMMARY: Fisher Clinical Services, Inc.
63147 applied to be registered as a bulk
product development and for applied to be registered as an importer
manufacturer of the following basic
distribution to its customers. of certain basic classes of controlled
In reference to drug code 7360 classes of controlled substances:
substances. The Drug Enforcement
(marihuana), and 7370 (THC), the Administration (DEA) grants Fisher
Controlled substance Schedule
company plans to bulk manufacture Clinical Services, Inc. registration as an
these drugs as synthetic. No other Gamma Hydroxybutyric Acid I importer of those controlled substances.
activity for this drug code is authorized (2010). SUPPLEMENTARY INFORMATION: By notice
for this registration. Tetrahydrocannabinols (7370) ..... I
dated August 27, 2014, and published in
Dated: September 16, 2015. Codeine-N-oxide (9053) ............... I
Dihydromorphine (9145) ............... I
the Federal Register on September 4,
Joseph T. Rannazzisi, 2014, 79 FR 52762, Fisher Clinical
Difenoxin (9168) ........................... I
Deputy Assistant Administrator. Morphine-N-oxide (9307) ............. I Services, Inc., 700A–C Nestle Way,
[FR Doc. 2015–24122 Filed 9–22–15; 8:45 am] Normorphine (9313) ..................... I Breinigsville, Pennsylvania 18031–1522
BILLING CODE 4410–09–P Norlevorphanol (9634) .................. I applied to be registered as an importer
Acetyl Fentanyl (N-(1- I of certain basic classes of controlled
phenethylpiperidin-4-yl)-N- substances. No comments or objections
DEPARTMENT OF JUSTICE phenylacetamide) (9821). were submitted for this notice.
Amphetamine (1100) .................... II The DEA has considered the factors in
Drug Enforcement Administration Methamphetamine (1105) ............ II 21 U.S.C. 823, 952(a) and 958(a) and
Lisdexamfetamine (1205) ............. II determined that the registration of
[Docket No. DEA–392] Methylphenidate (1724) ................ II
Fisher Clinical Services, Inc. to import
Nabilone (7379) ............................ II
Bulk Manufacturer of Controlled 4-Anilino-N-phenethyl-4-piperidine II
the basic classes of controlled
Substances Application: Mallinckrodt (8333). substances is consistent with the public
LLC Codeine (9050) ............................. II interest and with United States
Dihydrocodeine (9120) ................. II obligations under international treaties,
ACTION: Notice of application. Oxycodone (9143) ........................ II conventions, or protocols in effect on
Hydromorphone (9150) ................ II May 1, 1971. The DEA investigated the
DATES: Registered bulk manufacturers of Diphenoxylate (9170) ................... II company’s maintenance of effective
the affected basic classes, and Ecgonine (9180) ........................... II controls against diversion by inspecting
applicants therefore, may file written Hydrocodone (9193) ..................... II and testing the company’s physical
comments on or objections to the Levorphanol (9220) ...................... II security systems, verifying the
issuance of the proposed registration in Meperidine (9230) ........................ II company’s compliance with state and
accordance with 21 CFR 1301.33(a) on Methadone (9250) ........................ II
local laws, and reviewing the company’s
or before November 23, 2015. Methadone intermediate (9254) ... II
Dextropropoxyphene, bulk (non- II background and history.
ADDRESSES: Written comments should Therefore, pursuant to 21 U.S.C.
dosage forms) (9273).
be sent to: Drug Enforcement 952(a) and 958(a), and in accordance
Morphine (9300) ........................... II
Administration, Attention: DEA Federal Oripavine (9330) ........................... II with 21 CFR 1301.34, the above-named
Register Representative/ODXL, 8701 Thebaine (9333) ........................... II company is granted registration as an
Morrissette Drive, Springfield, Virginia Opium tincture (9630) .................. II importer of the basic classes of
22152. Request for hearings should be
mstockstill on DSK4VPTVN1PROD with NOTICES
Opium, powdered (9639) ............. II controlled substances:
sent to: Drug Enforcement Oxymorphone (9652) ................... II
Administration, Attention: Hearing Noroxymorphone (9668) .............. II Controlled substance Schedule
Clerk/LJ, 8701 Morrissette Drive, Alfentanil (9737) ........................... II
Springfield, Virginia 22152. Remifentanil (9739) ...................... II Methylphenidate (1724) ................ II
SUPPLEMENTARY INFORMATION: The
Sufentanil (9740) .......................... II Levorphanol (9220) ...................... II
Tapentadol (9780) ........................ II Noroxymorphone (9668) .............. II
Attorney General has delegated her Fentanyl (9801) ............................ II Tapentadol (9780) ........................ II
authority under the Controlled
VerDate Sep<11>2014 18:00 Sep 22, 2015 Jkt 235001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\23SEN1.SGM 23SEN1](https://thefederalregister.org/doc/80_FR_57571/page/2.svg)
Document Created: 2015-12-15 09:45:19
Document Modified: 2015-12-15 09:45:19
| 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 | 80 FR 57387 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR