81 FR 61250 - Bulk Manufacturer of Controlled Substances Application: AMRI Rensselaer, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 81, Issue 172 (September 6, 2016)
Drug Enforcement Administration
Federal Register Volume 81, Issue 172 (September 6, 2016)
| Page Range | 61250-61251 | |
| FR Document | 2016-21242 |
[Federal Register Volume 81, Number 172 (Tuesday, September 6, 2016)] [Notices] [Pages 61250-61251] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-21242] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Bulk Manufacturer of Controlled Substances Application: AMRI Rensselaer, Inc. 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 November 7, 2016. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: The Attorney General has delegated her 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 Deputy Assistant Administrator of the DEA Office of Diversion Control (``Deputy Assistant 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 May 19, 2016, AMRI Rensselaer, Inc., 33 Riverside Avenue, Rensselaer, New York 12144 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: ------------------------------------------------------------------------ Controlled substance Schedule ------------------------------------------------------------------------ Marihuana (7360)........................... I [[Page 61251]] Tetrahydrocannabinols (7370)............... I Amphetamine (1100)......................... II Lisdexamfetamine (1205).................... II Methylphenidate (1724)..................... II Pentobarbital (2270)....................... II 4-Anilino-N-phenethyl-4-piperidine......... II (ANPP) (8333).............................. 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 codes 7360 (marihuana) and 7370 (THC), the company plans to bulk manufacture these drugs as synthetics. No other activities for these drug codes are authorized for this registration. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016-21242 Filed 9-2-16; 8:45 am] BILLING CODE 4410-09-P
![61250 Federal Register / Vol. 81, No. 172 / Tuesday, September 6, 2016 / Notices
Register Representative/ODW, 8701 DEPARTMENT OF JUSTICE The company plans to import the
Morrissette Drive, Springfield, Virginia listed substance solely for updated
22152. Drug Enforcement Administration analytical testing purposes for EU
[Docket No. DEA–392] customer requirements.
SUPPLEMENTARY INFORMATION: The This analysis is required to allow the
Attorney General has delegated her Importer of Controlled Substances company to export domestically-
authority under the Controlled Application: Unither Manufacturing, manufactured FDF to foreign markets.
Substances Act to the Administrator of LLC Louis J. Milione,
the Drug Enforcement Administration
ACTION: Notice of application. Deputy Assistant Administrator.
(DEA), 28 CFR 0.100(b). Authority to
[FR Doc. 2016–21239 Filed 9–2–16; 8:45 am]
exercise all necessary functions with
respect to the promulgation and DATES: Registered bulk manufacturers of BILLING CODE 4410–09–P
implementation of 21 CFR part 1301, the affected basic classes, and
incident to the registration of applicants therefore, may file written
comments on or objections to the DEPARTMENT OF JUSTICE
manufacturers, distributors, dispensers,
importers, and exporters of controlled issuance of the proposed registration in
Drug Enforcement Administration
substances (other than final orders in accordance with 21 CFR 1301.34(a) on
or before October 6, 2016. Such persons [Docket No. DEA–392]
connection with suspension, denial, or
may also file a written request for a
revocation of registration) has been Bulk Manufacturer of Controlled
hearing on the application pursuant to
redelegated to the Deputy Assistant 21 CFR 1301.43 on or before October 6, Substances Application: AMRI
Administrator of the DEA Office of 2016. Rensselaer, Inc.
Diversion Control (‘‘Deputy Assistant
ADDRESSES: Written comments should ACTION: Notice of application.
Administrator’’) pursuant to section 7 of
be sent to: Drug Enforcement
28 CFR part 0, appendix to subpart R.
Administration, Attention: DEA Federal DATES: Registered bulk manufacturers of
In accordance with 21 CFR Register Representative/ODW, 8701 the affected basic classes, and
1301.33(a), this is notice that on May 3, Morrissette Drive, Springfield, Virginia applicants therefore, may file written
2016, Isosciences, LLC, 1017 West Ninth 22152. All requests for hearing must be comments on or objections to the
Avenue, Building 10, Suite B, King of sent to: Drug Enforcement issuance of the proposed registration in
Prussia, Pennsylvania 19406 applied to Administration, Attn: Administrator, accordance with 21 CFR 1301.33(a) on
be registered as a bulk manufacturer of 8701 Morrissette Drive, Springfield, or before November 7, 2016.
the following basic classes of controlled Virginia 22152. All requests for hearing ADDRESSES: Written comments should
substances: should also be sent to: (1) Drug be sent to: Drug Enforcement
Enforcement Administration, Attn: Administration, Attention: DEA Federal
Controlled substance Schedule Hearing Clerk/LJ, 8701 Morrissette Register Representative/ODW, 8701
Drive, Springfield, Virginia 22152; and Morrissette Drive, Springfield, Virginia
Cathinone (1235) .......................... I (2) Drug Enforcement Administration, 22152.
Methcathinone (1237) .................. I Attn: DEA Federal Register
Lysergic acid diethylamide (7315) I Representative/ODW, 8701 Morrissette SUPPLEMENTARY INFORMATION:
3,4-Methylenedioxyamphetamine I Drive, Springfield, Virginia 22152. The Attorney General has delegated
(7400). her authority under the Controlled
SUPPLEMENTARY INFORMATION: The
3,4-Methylenedioxy-N- I Substances Act to the Administrator of
Attorney General has delegated her the Drug Enforcement Administration
ethylamphetamine (7404).
3,4- I
authority under the Controlled (DEA), 28 CFR 0.100(b). Authority to
Methylenedioxymethamphetam- Substances Act to the Administrator of exercise all necessary functions with
ine (7405). the Drug Enforcement Administration respect to the promulgation and
Amphetamine (1100) .................... II (DEA), 28 CFR 0.100(b). Authority to implementation of 21 CFR part 1301,
Methamphetamine (1105) ............ II exercise all necessary functions with incident to the registration of
Codeine (9050) ............................. II respect to the promulgation and manufacturers, distributors, dispensers,
Morphine (9300) ........................... II implementation of 21 CFR part 1301, importers, and exporters of controlled
incident to the registration of substances (other than final orders in
The company plans to manufacture manufacturers, distributors, dispensers connection with suspension, denial, or
importers, and exporters of controlled revocation of registration) has been
small quantities of the listed controlled
substances (other than final orders in redelegated to the Deputy Assistant
substances to make reference standards
connection with suspension, denial, or Administrator of the DEA Office of
which will be distributed to their revocation of registration) has been
customers. Diversion Control (‘‘Deputy Assistant
redelegated to the Deputy Assistant Administrator’’) pursuant to section 7 of
Louis J. Milione, Administrator of the DEA Office of 28 CFR part 0, appendix to subpart R.
Deputy Assistant Administrator. Diversion Control (‘‘Deputy Assistant In accordance with 21 CFR
Administrator’’) pursuant to section 7 of 1301.33(a), this is notice that on May 19,
[FR Doc. 2016–21241 Filed 9–2–16; 8:45 am]
28 CFR part 0, appendix to subpart R. 2016, AMRI Rensselaer, Inc., 33
BILLING CODE 4410–09–P
In accordance with 21 CFR
mstockstill on DSK3G9T082PROD with NOTICES
Riverside Avenue, Rensselaer, New
1301.34(a), this is notice that on May 6, York 12144 applied to be registered as
2016, Unither Manufacturing, LLC., 331 a bulk manufacturer of the following
Clay Road, Rochester, New York 14623 basic classes of controlled substances:
applied to be registered as an importer
of methylphenidate (1724), a basic class Controlled substance Schedule
of controlled substance listed in
schedule II. Marihuana (7360) ......................... I
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![Federal Register / Vol. 81, No. 172 / Tuesday, September 6, 2016 / Notices 61251
Controlled substance Schedule 22152; Telephone: (202) 598–6812 or states it ‘‘shall be unlawful for any
sent to OIRA_submissions@ person to distribute a controlled
Tetrahydrocannabinols (7370) ..... I omb.eop.gov. substance in schedules I or II to another
Amphetamine (1100) .................... II except in pursuance of a written order
Lisdexamfetamine (1205) ............. II SUPPLEMENTARY INFORMATION: Written
comments and suggestions from the of the person to whom such substance
Methylphenidate (1724) ................ II
public and affected agencies concerning is distributed, made on a form to be
Pentobarbital (2270) ..................... II
4-Anilino-N-phenethyl-4-piperidine II the proposed collection of information issued by the Attorney General in blank
(ANPP) (8333) .............................. are encouraged. Your comments should in accordance with subsection (d) of this
Meperidine (9230) ........................ II address one or more of the following section..’’ 21 U.S.C. 828(a).
Fentanyl (9801) ............................ II four points: 5. An estimate of the total number of
respondents and the amount of time
The company plans to manufacture —Evaluate whether the proposed estimated for an average respondent to
bulk controlled substances for use in collection of information is necessary respond: The DEA estimates that
product development and for for the proper performance of the 125,435 registrants participate in this
distribution to its customers. functions of the agency, including information collection, taking an
In reference to drug codes 7360 whether the information will have estimated 11.6 hours per registrant
(marihuana) and 7370 (THC), the practical utility; annually.
company plans to bulk manufacture —Evaluate the accuracy of the agency’s 6. An estimate of the total public
these drugs as synthetics. No other estimate of the burden of the burden (in hours) associated with the
activities for these drug codes are proposed collection of information, proposed collection: The DEA estimates
authorized for this registration. including the validity of the that this collection takes 1,453,348
methodology and assumptions used; annual burden hours.
Louis J. Milione, —Evaluate whether and if so how the If additional information is required
Deputy Assistant Administrator. quality, utility, and clarity of the please contact: Jerri Murray, Department
[FR Doc. 2016–21242 Filed 9–2–16; 8:45 am] information proposed to be collected Clearance Officer, United States
BILLING CODE 4410–09–P can be enhanced; and Department of Justice, Justice
—Minimize the burden of the collection
Management Division, Policy and
of information on those who are to
Planning Staff, Two Constitution
DEPARTMENT OF JUSTICE respond, including through the use of
Square, 145 N Street NE., Suite 3E.405B,
appropriate automated, electronic,
[OMB Number 1117–0010] Washington, DC 20530.
mechanical, or other forms of
information technology, e.g., Dated: August 31, 2016.
Agency Information Collection
Activities; Proposed eCollection, permitting electronic submission of Jerri Murray,
eComments Requested; Extension responses. Department Clearance Officer for PRA, U.S.
Without Change of a Previously Department of Justice.
Overview of This Information
Approved Collection U.S. Official Order [FR Doc. 2016–21297 Filed 9–2–16; 8:45 am]
Collection
Forms for Schedules I and II Controlled BILLING CODE 4410–09–P
Substances DEA Form 222 1. Type of Information Collection:
Extension of a currently approved
AGENCY: Drug Enforcement collection. DEPARTMENT OF JUSTICE
Administration, Department of Justice. 2. Title of the Form/Collection: U.S.
[OMB Number 1190–NEW]
ACTION: 30-day notice. Official Order Forms for Schedules I
and II Controlled Substances. Agency Information Collection
SUMMARY: The Department of Justice 3. The agency form number, if any,
(DOJ), Drug Enforcement Activities; Proposed eCollection;
and the applicable component of the eComments Requested; Approval of a
Administration (DEA), will submit the Department sponsoring the collection:
following information collection request New Collection; Assessing Potential
DEA Form: 222. The applicable Benefits of Accessible Web Content
to the Office of Management and Budget component within the Department of
(OMB) for review and approval in for Individuals Who Are Blind
Justice is the Drug Enforcement
accordance with the Paperwork Administration, Office of Diversion AGENCY: Civil Rights Division,
Reduction Act of 1995. This proposed Control. Department of Justice.
information collection was previously 4. Affected public who will be asked ACTION: 30-day notice.
published in the Federal Register at 81 or required to respond, as well as a brief
FR 42726, June 30, 2016, allowing for a abstract: SUMMARY: The Department of Justice
60 day comment period. Affected public (Primary): Business or (DOJ), Civil Rights Division, Disability
DATES: Comments are encouraged and other for-profit. Rights Section, will submit the
will be accepted for an additional 30 Affected public (Other): Not-for-profit following information collection request
days until October 6, 2016. institutions; Federal, State, local, and to the Office of Management and Budget
FOR FURTHER INFORMATION CONTACT: If tribal governments. (OMB) for review and approval in
you have comments on the estimated Abstract: The Controlled Substances accordance with the Paperwork
public burden or associated response Act (CSA) (21 U.S.C. 801–971) Reduction Act of 1995 (PRA). This
time, suggestions, or need a copy of the establishes a closed system of proposed information collection was
mstockstill on DSK3G9T082PROD with NOTICES
proposed information collection distribution for controlled substances. previously published in the Federal
instrument with instructions or To this end, controlled substances are Register on June 30, 2016 at 81 FR
additional information, please contact closely monitored and tightly regulated 43249, on July 1, 2016, allowing for a 60
Michael J. Lewis, Office of Diversion as they are distributed through the day public comment period.
Control, Drug Enforcement supply chain. One tool that helps to DATES: Comments are encouraged and
Administration; Mailing Address: 8701 maintain the closed system of will be accepted for an additional 30
Morrissette Drive, Springfield, Virginia distribution is the CSA provision that days until October 6, 2016.
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Document Created: 2018-02-09 12:04:08
Document Modified: 2018-02-09 12:04:08
| 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 November 7, 2016. | |
| FR Citation | 81 FR 61250 |
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