83 FR 15633 - Bulk Manufacturer of Controlled Substances Registration
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 70 (April 11, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 70 (April 11, 2018)
| Page Range | 15633-15634 | |
| FR Document | 2018-07455 |
[Federal Register Volume 83, Number 70 (Wednesday, April 11, 2018)] [Notices] [Pages 15633-15634] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-07455] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Bulk Manufacturer of Controlled Substances Registration ACTION: Notice of registration. ----------------------------------------------------------------------- SUMMARY: Registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as bulk manufacturers of various classes of schedule I and II controlled substances. SUPPLEMENTARY INFORMATION: The companies listed below applied to be registered as bulk manufacturers of various basic classes of controlled substances. Information on previously published notices is listed in the table below. No comments or objections were submitted for these notices. ---------------------------------------------------------------------------------------------------------------- Company FR docket Published ---------------------------------------------------------------------------------------------------------------- Nanosyn, Inc.......................... 82 FR 56993................... December 1, 2017. Janssen Pharmaceutical, Inc........... 82 FR 58027................... December 8, 2017. Cambrex High Point, Inc............... 82 FR 61795................... December 29, 2017. AMPAC Fine Chemicals LLC.............. 82 FR 61795................... December 29, 2017. Organix, Inc.......................... 83 FR 150..................... January 2, 2018. Johnson Matthey Inc................... 83 FR 2215.................... January 16, 2018. Chemtos, LLC.......................... 83 FR 2671.................... January 18, 2018. Alcami Wisconsin Corporation.......... 83 FR 2675.................... January 18, 2018. ---------------------------------------------------------------------------------------------------------------- [[Page 15634]] The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of these registrants 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 each of the company's maintenance of effective controls against diversion by inspecting and testing each company's physical security systems, verifying each company's compliance with state and local laws, and reviewing each 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 companies. Dated: April 3, 2018. Susan A. Gibson, Deputy Assistant Administrator. [FR Doc. 2018-07455 Filed 4-10-18; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 83, No. 70 / Wednesday, April 11, 2018 / Notices 15633
authority is contingent on Respondent registration in the State of Illinois, be, SUMMARY: Registrants listed below have
being a practitioner with a valid DEA and it hereby is, denied. This Order is applied for and been granted
registration, see 21 U.S.C. 823(g)(2)(A); effective immediately.4 registration by the Drug Enforcement
21 CFR 1301.28(a), I will revoke his Dated: April 4, 2018. Administration (DEA) as importers of
DATA-Waiver authority as well. Robert W. Patterson, various classes of schedule I or II
Order Acting Administrator. controlled substances.
Pursuant to the authority vested in me [FR Doc. 2018–07454 Filed 4–10–18; 8:45 am] SUPPLEMENTARY INFORMATION:
by 21 U.S.C. 823(f) and 824(a), as well BILLING CODE 4410–09–P
The companies listed below applied
as 28 CFR 0.100(b), I order that DEA to be registered as importers of various
Certificate of Registration No. basic classes of controlled substances.
BZ5641419 and DATA-Waiver DEPARTMENT OF JUSTICE
Information on previously published
Identification Number XZ5641419,
Drug Enforcement Administration notices is listed in the table below. No
issued to Witold Marek Zajewski, M.D.,
comments or objections were submitted
be, and they hereby are, revoked. I [Docket No. DEA–392]
further order that any pending and no requests for hearing were
application of Witold Marek Zajewski to Importer of Controlled Substances submitted for these notices.
renew or modify the above registration, Registration
or any pending application of Witold
ACTION: Notice of registration.
Marek Zajewski for any other
Company FR docket Published
Sharp (Bethlehem), LLC ..................................................... 83 FR 539 .......................................................................... January 4, 2018.
Catalent Pharma Solutions, LLC ........................................ 83 FR 2215 ........................................................................ January 16, 2018.
Janssen Pharmaceuticals, Inc ............................................ 83 FR 2214 ........................................................................ January 16, 2018.
Mylan Pharmaceuticals, Inc ............................................... 83 FR 5809 ........................................................................ February 9, 2018.
Meridian Medical Technologies, Inc ................................... 83 FR 5810 ........................................................................ February 9, 2018.
Noramco, Inc ...................................................................... 83 FR 5810 ........................................................................ February 9, 2018.
Johnson Matthey, Inc ......................................................... 83 FR 5811 ........................................................................ February 9, 2018.
Mylan Technologies, Inc ..................................................... 83 FR 5811 ........................................................................ February 9, 2018.
Mylan Pharmaceuticals, Inc ............................................... 83 FR 8107 ........................................................................ February 23, 2018.
The Drug Enforcement with 21 CFR 1301.34, the DEA has SUMMARY: Registrants listed below have
Administration (DEA) has considered granted a registration as an importer for applied for and been granted
the factors in 21 U.S.C. 823, 952(a) and schedule I or II controlled substances to registration by the Drug Enforcement
958(a) and determined that the the above listed companies. Administration (DEA) as bulk
registration of the listed registrants to Dated: April 4, 2018. manufacturers of various classes of
import the applicable basic classes of Susan A. Gibson, schedule I and II controlled substances.
schedule I or II controlled substances is
Deputy Assistant Administrator. SUPPLEMENTARY INFORMATION:
consistent with the public interest and
with United States obligations under [FR Doc. 2018–07444 Filed 4–10–18; 8:45 am]
The companies listed below applied
international treaties, conventions, or BILLING CODE 4410–09–P
to be registered as bulk manufacturers of
protocols in effect on May 1, 1971. The various basic classes of controlled
DEA investigated each company’s substances. Information on previously
maintenance of effective controls DEPARTMENT OF JUSTICE
published notices is listed in the table
against diversion by inspecting and Drug Enforcement Administration below. No comments or objections were
testing each company’s physical submitted for these notices.
security systems, verifying each [Docket No. DEA–392]
company’s compliance with state and
local laws, and reviewing each Bulk Manufacturer of Controlled
company’s background and history. Substances Registration
Therefore, pursuant to 21 U.S.C.
ACTION: Notice of registration.
952(a) and 958(a), and in accordance
Company FR docket Published
Nanosyn, Inc ....................................................................... 82 FR 56993 ...................................................................... December 1, 2017.
Janssen Pharmaceutical, Inc ............................................. 82 FR 58027 ...................................................................... December 8, 2017.
Cambrex High Point, Inc .................................................... 82 FR 61795 ...................................................................... December 29, 2017.
AMPAC Fine Chemicals LLC ............................................. 82 FR 61795 ...................................................................... December 29, 2017.
Organix, Inc ........................................................................ 83 FR 150 .......................................................................... January 2, 2018.
amozie on DSK30RV082PROD with NOTICES
Johnson Matthey Inc .......................................................... 83 FR 2215 ........................................................................ January 16, 2018.
Chemtos, LLC ..................................................................... 83 FR 2671 ........................................................................ January 18, 2018.
Alcami Wisconsin Corporation ........................................... 83 FR 2675 ........................................................................ January 18, 2018.
4 For the same reasons which led the IDFPR to conclude that the public interest necessitates that this Order be effective immediately. 21 CFR
revoke Respondent’s controlled substance license, I 1316.67.
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![15634 Federal Register / Vol. 83, No. 70 / Wednesday, April 11, 2018 / Notices
The DEA has considered the factors in SUPPLEMENTARY INFORMATION: The DEPARTMENT OF JUSTICE
21 U.S.C. 823(a) and determined that Attorney General has delegated his
the registration of these registrants to authority under the Controlled [OMB Number 1121–0111]
manufacture the applicable basic classes Substances Act to the Administrator of
of controlled substances is consistent the Drug Enforcement Administration Agency Information Collection
with the public interest and with United (DEA), 28 CFR 0.100(b). Authority to Activities: Proposed eCollection
States obligations under international exercise all necessary functions with eComments Requested; Revision of a
treaties, conventions, or protocols in respect to the promulgation and Currently Approved Collection;
effect on May 1, 1971. The DEA Comments Requested: National Crime
implementation of 21 CFR part 1301,
investigated each of the company’s Victimization Survey (NCVS)
incident to the registration of
maintenance of effective controls manufacturers, distributors, dispensers, AGENCY: Bureau of Justice Statistics,
against diversion by inspecting and importers, and exporters of controlled Department of Justice.
testing each company’s physical
substances (other than final orders in ACTION: 30-day notice.
security systems, verifying each
connection with suspension, denial, or
company’s compliance with state and SUMMARY: The Department of Justice
local laws, and reviewing each revocation of registration) has been
redelegated to the Assistant (DOJ), Office of Justice Programs,
company’s background and history. Bureau of Justice Statistics, will be
Therefore, pursuant to 21 U.S.C. Administrator of the DEA Diversion
Control Division (‘‘Assistant submitting a request to the Office of
823(a), and in accordance with 21 CFR Management and Budget (OMB) for
1301.33, the DEA has granted a Administrator’’) pursuant to section 7 of
28 CFR part 0, appendix to subpart R. review and approval of a revision to the
registration as a bulk manufacturer to National Crime Victimization Survey
the above listed companies. In accordance with 21 CFR information collection in accordance
Dated: April 3, 2018. 1301.34(a), this is notice that on March with the Paperwork Reduction Act of
Susan A. Gibson, 7, 2018, Almac Clinical Services Incorp 1995. The proposed information
Deputy Assistant Administrator. (ACSI) 25 Fretz Road, Souderton, PA collection, which is currently under
[FR Doc. 2018–07455 Filed 4–10–18; 8:45 am]
18964 applied to be registered as an OMB review, was previously published
BILLING CODE 4410–09–P
importer of the following basic classes in the Federal Register on Monday,
of controlled substances: March 19, 2018, allowing a 30-day
comment period. The requested revision
DEPARTMENT OF JUSTICE impacts the minimum age at which
respondents will be administered
Drug Enforcement Administration Controlled substance Drug Schedule questions on their sexual orientation
code and gender identity, raising the
[Docket No. DEA–392] minimum age from 16 to 18. This
Oxycodone ............... 9143 II
revision, which will be implemented
Importer of Controlled Substances Hydromorphone ........ 9150 II
within 6 months of OMB approval, will
Application: Almac Clinical Services Morphine ................... 9300 II
not impact the burden hours associated
Incorp (ACSI) Tapentadol ................ 9780 II
with the previous 30-day request.
Fentanyl .................... 9801 II
DATES: Comments are encouraged and
ACTION: Notice of application.
will be accepted for 30 days until May
The company plans to import the 11, 2018.
DATES: Registered bulk manufacturers of listed controlled substances in dosage
the affected basic classes, and FOR FURTHER INFORMATION CONTACT:
form to conduct clinical trials.
applicants therefore, may file written If you have additional comments
comments on or objections to the Approval of permit applications will especially on the estimated public
issuance of the proposed registration on occur only when the registrant’s burden or associated response time,
or before May 11, 2018. Such persons business activity is consistent with what suggestions, or need a copy of the
may also file a written request for a is authorized under to 21 U.S.C. 952 proposed information collection
hearing on the application on or before (a)(2). instrument with instructions or
May 11, 2018. Authorization will not extend to the additional information, please contact
ADDRESSES: Written comments should import of FDA approved or non- Jennifer Truman, Statistician, Bureau of
be sent to: Drug Enforcement approved finished dosage forms for Justice Statistics, 810 Seventh Street
Administration, Attention: DEA Federal commercial sale. NW, Washington, DC 20531 (email:
Register Representative/DRW, 8701 Jennifer.Truman@ojp.usdoj.gov;
Dated: April 3, 2018 telephone: 202–514–5083).
Morrissette Drive, Springfield, Virginia
Susan A. Gibson, SUPPLEMENTARY INFORMATION: Written
22152. All requests for hearing must be
sent to: Drug Enforcement Deputy Assistant Administrator. comments and suggestions from the
Administration, Attn: Administrator, [FR Doc. 2018–07441 Filed 4–10–18; 8:45 am] public and affected agencies concerning
8701 Morrissette Drive, Springfield, BILLING CODE 4410–09–P the proposed collection of information
Virginia 22152. All request for hearing are encouraged. Your comments should
should also be sent to: (1) Drug address one or more of the following
amozie on DSK30RV082PROD with NOTICES
Enforcement Administration, Attn: four points:
Hearing Clerk/LJ, 8701 Morrissette —Evaluate the impact of the change on
Drive, Springfield, Virginia 22152; and the functioning of the Bureau of
(2) Drug Enforcement Administration, Justice Statistics;
Attn: DEA Federal Register —Evaluate the accuracy of the agency’s
Representative/DRW, 8701 Morrissette estimate of the burden of the
Drive, Springfield, Virginia 22152. proposed collection of information,
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Document Created: 2018-04-10 23:59:38
Document Modified: 2018-04-10 23:59:38
| 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 15633 |
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