81 FR 31960 - Bulk Manufacturer of Controlled Substances Application: American Radiolabeled Chemicals
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 81, Issue 98 (May 20, 2016)
Drug Enforcement Administration
Federal Register Volume 81, Issue 98 (May 20, 2016)
| Page Range | 31960-31961 | |
| FR Document | 2016-11938 |
[Federal Register Volume 81, Number 98 (Friday, May 20, 2016)] [Notices] [Pages 31960-31961] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-11938] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Bulk Manufacturer of Controlled Substances Application: American Radiolabeled Chemicals 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 19, 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 March 3, 2016, American Radiolabeled Chemicals, 101 Arc Drive, Saint Louis, Missouri 63146 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: ------------------------------------------------------------------------ Controlled substance Schedule ------------------------------------------------------------------------ Gamma Hydroxybutyric Acid (2010)............ I Ibogaine (7260)............................. I Lysergic Acid Diethylamide (7315)........... I Tetrahydrocannabinols (7370)................ I Dimethyltryptamine (7435)................... I 1-[1-(2-Thienyl)cyclohexyl]piperidine (7470) I Dihydromorphine (9145)...................... I Heroin (9200)............................... I Normorphine (9313).......................... I Amphetamine (1100).......................... II Methamphetamine (1105)...................... II [[Page 31961]] Amobarbital (2125).......................... II Phencyclidine (7471)........................ II Phenylacetone (8501)........................ II Cocaine (9041).............................. II Codeine (9050).............................. II Dihydrocodeine (9120)....................... II Oxycodone (9143)............................ II Hydromorphone (9150)........................ II Ecgonine (9180)............................. II Hydrocodone (9193).......................... II Meperidine (9230)........................... II Metazocine (9240)........................... II Methadone (9250)............................ II Dextropropoxyphene, bulk (non-dosage forms) II (9273). Morphine (9300)............................. II Oripavine (9330)............................ II Thebaine (9333)............................. II Oxymorphone (9652).......................... II Phenazocine (9715).......................... II Carfentanil (9743).......................... II Fentanyl (9801)............................. II ------------------------------------------------------------------------ The company plans to manufacture small quantities of the listed controlled substances as radiolabeled compounds for biochemical research. Dated: May 16, 2016. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016-11938 Filed 5-19-16; 8:45 am] BILLING CODE 4410-09-P
![31960 Federal Register / Vol. 81, No. 98 / Friday, May 20, 2016 / Notices
Controlled substance Schedule
Morphine-N-oxide (9307) ............................................................................................................................................................................. I
Normorphine (9313) .................................................................................................................................................................................... I
Norlevorphanol (9634) ................................................................................................................................................................................. I
Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) (9821) ............................................................................................... I
Amphetamine (1100) ................................................................................................................................................................................... II
Methamphetamine (1105) ........................................................................................................................................................................... II
Lisdexamfetamine (1205) ............................................................................................................................................................................ II
Methylphenidate (1724) ............................................................................................................................................................................... II
Nabilone (7379) ........................................................................................................................................................................................... II
4-Anilino-N-phenethyl-4-piperidine (ANPP) (8333) ..................................................................................................................................... II
Codeine (9050) ............................................................................................................................................................................................ II
Dihydrocodeine (9120) ................................................................................................................................................................................ II
Oxycodone (9143) ....................................................................................................................................................................................... II
Hydromorphone (9150) ............................................................................................................................................................................... II
Diphenoxylate (9170) .................................................................................................................................................................................. II
Ecgonine (9180) .......................................................................................................................................................................................... II
Hydrocodone (9193) .................................................................................................................................................................................... II
Levorphanol (9220) ..................................................................................................................................................................................... II
Meperidine (9230) ....................................................................................................................................................................................... II
Methadone (9250) ....................................................................................................................................................................................... II
Methadone intermediate (9254) .................................................................................................................................................................. II
Dextropropoxyphene, bulk (non-dosage forms) (9273) .............................................................................................................................. II
Morphine (9300) .......................................................................................................................................................................................... II
Oripavine (9330) .......................................................................................................................................................................................... II
Thebaine (9333) .......................................................................................................................................................................................... II
Opium tincture (9630) .................................................................................................................................................................................. II
Opium, powdered (9639) ............................................................................................................................................................................. II
Oxymorphone (9652) ................................................................................................................................................................................... II
Noroxymorphone (9668) .............................................................................................................................................................................. II
Alfentanil (9737) .......................................................................................................................................................................................... II
Remifentanil (9739) ..................................................................................................................................................................................... II
Sufentanil (9740) ......................................................................................................................................................................................... II
Tapentadol (9780) ....................................................................................................................................................................................... II
Fentanyl (9801) ........................................................................................................................................................................................... II
The company plans to manufacturer DATES: Registered bulk manufacturers of respect to the promulgation and
bulk active pharmaceutical ingredients the affected basic classes, and implementation of 21 CFR part 1301,
(APIs) for distribution to its customers. applicants therefore, may file written incident to the registration of
Dated: May 16, 2016. comments on or objections to the manufacturers, distributors, dispensers,
Louis J. Milione, issuance of the proposed registration in importers, and exporters of controlled
accordance with 21 CFR 1301.33(a) on substances (other than final orders in
Deputy Assistant Administrator.
or before July 19, 2016. connection with suspension, denial, or
[FR Doc. 2016–11940 Filed 5–19–16; 8:45 am]
ADDRESSES: Written comments should revocation of registration) has been
BILLING CODE 4410–09–P
be sent to: Drug Enforcement redelegated to the Deputy Assistant
Administration, Attention: DEA Federal Administrator of the DEA Office of
DEPARTMENT OF JUSTICE Register Representative/ODW, 8701 Diversion Control (‘‘Deputy Assistant
Morrissette Drive, Springfield, Virginia Administrator’’) pursuant to section 7 of
Drug Enforcement Administration 22152. 28 CFR part 0, appendix to subpart R.
[Docket No. DEA–392] SUPPLEMENTARY INFORMATION: The In accordance with 21 CFR
Attorney General has delegated her 1301.33(a), this is notice that on March
Bulk Manufacturer of Controlled authority under the Controlled 3, 2016, American Radiolabeled
Substances Application: American Substances Act to the Administrator of Chemicals, 101 Arc Drive, Saint Louis,
Radiolabeled Chemicals the Drug Enforcement Administration Missouri 63146 applied to be registered
(DEA), 28 CFR 0.100(b). Authority to as a bulk manufacturer of the following
ACTION: Notice of application.
exercise all necessary functions with basic classes of controlled substances:
Controlled substance Schedule
Gamma Hydroxybutyric Acid (2010) ........................................................................................................................................................... I
Ibogaine (7260) ........................................................................................................................................................................................... I
Lysergic Acid Diethylamide (7315) .............................................................................................................................................................. I
mstockstill on DSK3G9T082PROD with NOTICES
Tetrahydrocannabinols (7370) ..................................................................................................................................................................... I
Dimethyltryptamine (7435) .......................................................................................................................................................................... I
1-[1-(2-Thienyl)cyclohexyl]piperidine (7470) ............................................................................................................................................... I
Dihydromorphine (9145) .............................................................................................................................................................................. I
Heroin (9200) ............................................................................................................................................................................................... I
Normorphine (9313) .................................................................................................................................................................................... I
Amphetamine (1100) ................................................................................................................................................................................... II
Methamphetamine (1105) ........................................................................................................................................................................... II
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![Federal Register / Vol. 81, No. 98 / Friday, May 20, 2016 / Notices 31961
Controlled substance Schedule
Amobarbital (2125) ...................................................................................................................................................................................... II
Phencyclidine (7471) ................................................................................................................................................................................... II
Phenylacetone (8501) ................................................................................................................................................................................. II
Cocaine (9041) ............................................................................................................................................................................................ II
Codeine (9050) ............................................................................................................................................................................................ II
Dihydrocodeine (9120) ................................................................................................................................................................................ II
Oxycodone (9143) ....................................................................................................................................................................................... II
Hydromorphone (9150) ............................................................................................................................................................................... II
Ecgonine (9180) .......................................................................................................................................................................................... II
Hydrocodone (9193) .................................................................................................................................................................................... II
Meperidine (9230) ....................................................................................................................................................................................... II
Metazocine (9240) ....................................................................................................................................................................................... II
Methadone (9250) ....................................................................................................................................................................................... II
Dextropropoxyphene, bulk (non-dosage forms) (9273) .............................................................................................................................. II
Morphine (9300) .......................................................................................................................................................................................... II
Oripavine (9330) .......................................................................................................................................................................................... II
Thebaine (9333) .......................................................................................................................................................................................... II
Oxymorphone (9652) ................................................................................................................................................................................... II
Phenazocine (9715) .................................................................................................................................................................................... II
Carfentanil (9743) ........................................................................................................................................................................................ II
Fentanyl (9801) ........................................................................................................................................................................................... II
The company plans to manufacture including any attachments. The Drug www.regulations.gov and in the DEA’s
small quantities of the listed controlled Enforcement Administration (DEA) public docket. Such information
substances as radiolabeled compounds encourages that all comments be includes personal identifying
for biochemical research. submitted through the Federal information (such as your name,
Dated: May 16, 2016. eRulemaking Portal, which provides the address, etc.) voluntarily submitted by
Louis J. Milione,
ability to type short comments directly the commenter.
into the comment field on the Web page If you want to submit personal
Deputy Assistant Administrator.
or to attach a file for lengthier identifying information (such as your
[FR Doc. 2016–11938 Filed 5–19–16; 8:45 am]
comments. Please go to http:// name, address, etc.) as part of your
BILLING CODE 4410–09–P www.regulations.gov and follow the comment, but do not want it to be
online instructions at that site for posted online or made available in the
submitting comments. Upon completion public docket, you must include the
DEPARTMENT OF JUSTICE of your submission you will receive a phrase ‘‘PERSONAL IDENTIFYING
Drug Enforcement Administration Comment Tracking Number for your INFORMATION’’ in the first paragraph
comment. Please be aware that of your comment. You must also place
[Docket No. DEA–372] submitted comments are not all the personal identifying information
instantaneously available for public you do not want posted online or made
Exempt Chemical Preparations Under view on Regulations.gov. If you have available in the public docket in the first
the Controlled Substances Act received a comment tracking number, paragraph of your comment and identify
AGENCY: Drug Enforcement your comment has been successfully what information you want redacted.
Administration, Department of Justice. submitted and there is no need to If you want to submit confidential
ACTION: Order with opportunity for resubmit the same comment. Paper business information as part of your
comment. comments that duplicate the electronic comment, but do not want it to be
submission are not necessary and are posted online or made available in the
SUMMARY: The applications for exempt discouraged. Should you wish to mail a public docket, you must include the
chemical preparations received by the comment in lieu of an electronic phrase ‘‘CONFIDENTIAL BUSINESS
Drug Enforcement Administration comment, it should be sent via regular INFORMATION’’ in the first paragraph
(DEA) between January 1, 2016, and or express mail to: Drug Enforcement of your comment. You must also
March 31, 2016, as listed below, were Administration, Attention: DEA Federal prominently identify confidential
accepted for filing and have been Register Representative/ODW, 8701 business information to be redacted
approved or denied as indicated. Morrissette Drive, Springfield, Virginia within the comment.
DATES: Interested persons may file 22152. Comments containing personal
written comments on this order in FOR FURTHER INFORMATION CONTACT: identifying information and confidential
accordance with 21 CFR 1308.23(e). Barbara J. Boockholdt, Office of business information identified as
Electronic comments must be Diversion Control, Drug Enforcement directed above will generally be made
submitted, and written comments must Administration; Mailing Address: 8701 publicly available in redacted form. If a
be postmarked, on or before July 19, Morrissette Drive, Springfield, Virginia comment has so much confidential
2016. Commenters should be aware that 22152; Telephone: (202) 598–6812. business information that it cannot be
mstockstill on DSK3G9T082PROD with NOTICES
the electronic Federal Docket SUPPLEMENTARY INFORMATION: effectively redacted, all or part of that
Management System will not accept comment may not be made publicly
comments after 11:59 p.m. Eastern Time Posting of Public Comments available. Comments posted to http://
on the last day of the comment period. Please note that all comments www.regulations.gov may include any
ADDRESSES: To ensure proper handling received are considered part of the personal identifying information (such
of comments, please reference ‘‘Docket public record and made available for as name, address, and phone number)
No. DEA–372’’ on all correspondence, public inspection online at http:// included in the text of your electronic
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Document Created: 2016-05-20 02:00:19
Document Modified: 2016-05-20 02:00:19
| 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 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 19, 2016. | |
| FR Citation | 81 FR 31960 |
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