83 FR 46758 - Importer of Controlled Substances Application: Alcami Carolinas Corporation

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 179 (September 14, 2018)

Page Range		46758-46759
FR Document		2018-20001

Federal Register, Volume 83 Issue 179 (Friday, September 14, 2018)

[Federal Register Volume 83, Number 179 (Friday, September 14, 2018)]
[Notices]
[Pages 46758-46759]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-20001]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Alcami Carolinas 
Corporation

ACTION: Notice of application.

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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 on or before October 15, 2018. 
Such persons may also file a written request for a hearing on the 
application on or before October 15, 2018.

[[Page 46759]]


ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DRW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
request for hearing should also be sent to: (1) Drug Enforcement 
Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, 
Springfield, Virginia 22152; and (2) Drug Enforcement Administration, 
Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, 
Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: The Attorney General has delegated his 
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 Assistant Administrator of the DEA Diversion Control Division 
(``Assistant Administrator'') pursuant to section 7 of 28 CFR part 0, 
appendix to subpart R.
    In accordance with 21 CFR 1301.34(a), this is notice that on July 
2, 2018, Alcami Carolinas Corporation, 1726 North 23rd Street, 
Wilmington, North Carolina 28405-1822 applied to be registered as an 
importer of the following basic classes of controlled substances:

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Psilocybin.............................     7437  I
Psilocyn...............................     7438  I
------------------------------------------------------------------------

    The company plans to import the listed controlled substances in 
bulk form for the manufacturing of capsules/tablets for Phase II 
clinical trials.
    Approval of permit applications will occur only when the 
registrant's activity is consistent with what is authorized under 21 
U.S.C. 952(a)(2).
    Authorization will not extend to the import of FDA approved or non-
approved finished dosage forms for commercial sale.

    Dated: September 5, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-20001 Filed 9-13-18; 8:45 am]
 BILLING CODE 4410-09-P

46758 Federal Register / Vol. 83, No. 179 / Friday, September 14, 2018 / Notices

these reviews may be viewed on the Staff report.—The prehearing staff conform with the requirements of
Commission’s electronic docket (EDIS) report in the reviews will be placed in sections 201.6, 207.3, and 207.7 of the
at https://edis.usitc.gov. the nonpublic record on December 20, Commission’s rules. The Commission’s
SUPPLEMENTARY INFORMATION: 2018, and a public version will be Handbook on E-Filing, available on the
Background.—On April 9, 2018, the issued thereafter, pursuant to section Commission’s website at https://
Commission determined that responses 207.64 of the Commission’s rules. edis.usitc.gov, elaborates upon the
to its notice of institution of the subject Hearing.—The Commission will hold Commission’s rules with respect to
five-year reviews were such that full a hearing in connection with the electronic filing.
reviews should proceed (83 FR 18347, reviews beginning at 9:30 a.m. on Additional written submissions to the
April 26, 2018); accordingly, full Thursday, January 17, 2019, at the U.S. Commission, including requests
reviews are being scheduled pursuant to International Trade Commission pursuant to section 201.12 of the
section 751(c)(5) of the Tariff Act of Building. Requests to appear at the Commission’s rules, shall not be
1930 (19 U.S.C. 1675(c)(5)). A record of hearing should be filed in writing with accepted unless good cause is shown for
the Commissioners’ votes, the the Secretary to the Commission on or accepting such submissions, or unless
Commission’s statement on adequacy, before January 10, 2019. A nonparty the submission is pursuant to a specific
and any individual Commissioner’s who has testimony that may aid the request by a Commissioner or
statements are available from the Office Commission’s deliberations may request Commission staff.
of the Secretary and at the permission to present a short statement In accordance with sections 201.16(c)
Commission’s website. at the hearing. All parties and and 207.3 of the Commission’s rules,
Participation in the reviews and nonparties desiring to appear at the each document filed by a party to the
public service list.—Persons, including hearing and make oral presentations reviews must be served on all other
industrial users of the subject should participate in a prehearing parties to the reviews (as identified by
merchandise and, if the merchandise is conference to be held on January 16, either the public or BPI service list), and
sold at the retail level, representative 2019, at the U.S. International Trade a certificate of service must be timely
consumer organizations, wishing to Commission Building, if deemed filed. The Secretary will not accept a
participate in these reviews as parties necessary. Oral testimony and written document for filing without a certificate
must file an entry of appearance with materials to be submitted at the public of service.
the Secretary to the Commission, as hearing are governed by sections The Commission has determined that
provided in section 201.11 of the 201.6(b)(2), 201.13(f), 207.24, and these reviews are extraordinarily
Commission’s rules, by 45 days after 207.66 of the Commission’s rules. complicated and therefore has
publication of this notice. A party that Parties must submit any request to determined to exercise its authority to
filed a notice of appearance following present a portion of their hearing extend the review period by up to 90
publication of the Commission’s notice testimony in camera no later than 7 days pursuant to 19 U.S.C.
of institution of the reviews need not business days prior to the date of the 1675(c)(5)(B).
file an additional notice of appearance. hearing.
The Secretary will maintain a public Written submissions.—Each party to Authority: These reviews are being
the reviews may submit a prehearing conducted under authority of title VII of the
service list containing the names and
brief to the Commission. Prehearing Tariff Act of 1930; this notice is published
addresses of all persons, or their pursuant to section 207.62 of the
representatives, who are parties to the briefs must conform with the provisions Commission’s rules.
reviews. of section 207.65 of the Commission’s
For further information concerning rules; the deadline for filing is January By order of the Commission.
8, 2019. Parties may also file written Issued: September 10, 2018.
the conduct of these reviews and rules
of general application, consult the testimony in connection with their Lisa Barton,
Commission’s Rules of Practice and presentation at the hearing, as provided Secretary to the Commission.
Procedure, part 201, subparts A and B in section 207.24 of the Commission’s [FR Doc. 2018–19987 Filed 9–13–18; 8:45 am]
(19 CFR part 201), and part 207, rules, and posthearing briefs, which BILLING CODE 7020–02–P
subparts A, D, E, and F (19 CFR part must conform with the provisions of
207). section 207.67 of the Commission’s
Limited disclosure of business rules. The deadline for filing
proprietary information (BPI) under an posthearing briefs is January 25, 2019. DEPARTMENT OF JUSTICE
administrative protective order (APO) In addition, any person who has not
Drug Enforcement Administration
and BPI service list.—Pursuant to entered an appearance as a party to the
section 207.7(a) of the Commission’s reviews may submit a written statement [Docket No. DEA–392]
rules, the Secretary will make BPI of information pertinent to the subject of
gathered in these reviews available to the reviews on or before January 25, Importer of Controlled Substances
authorized applicants under the APO 2019. On February 15, 2019, the Application: Alcami Carolinas
issued in the reviews, provided that the Commission will make available to Corporation
application is made by 45 days after parties all information on which they
publication of this notice. Authorized have not had an opportunity to ACTION: Notice of application.
applicants must represent interested comment. Parties may submit final
parties, as defined by 19 U.S.C. 1677(9), comments on this information on or DATES: Registered bulk manufacturers of
who are parties to the reviews. A party before February 19, 2019, but such final the affected basic classes, and
daltland on DSKBBV9HB2PROD with NOTICES

granted access to BPI following comments must not contain new factual applicants therefore, may file written
publication of the Commission’s notice information and must otherwise comply comments on or objections to the
of institution of the reviews need not with section 207.68 of the Commission’s issuance of the proposed registration on
reapply for such access. A separate rules. All written submissions must or before October 15, 2018. Such
service list will be maintained by the conform with the provisions of section persons may also file a written request
Secretary for those parties authorized to 201.8 of the Commission’s rules; any for a hearing on the application on or
receive BPI under the APO. submissions that contain BPI must also before October 15, 2018.

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Federal Register / Vol. 83, No. 179 / Friday, September 14, 2018 / Notices 46759

ADDRESSES: Written comments should Dated: September 5, 2018. encouraged. Your comments should
be sent to: Drug Enforcement John J. Martin, address one or more of the following
Administration, Attention: DEA Federal Assistant Administrator. four points:
Register Representative/DRW, 8701 [FR Doc. 2018–20001 Filed 9–13–18; 8:45 am] —Evaluate whether the proposed
Morrissette Drive, Springfield, Virginia BILLING CODE 4410–09–P collection of information is necessary
22152. All requests for hearing must be for the proper performance of the
sent to: Drug Enforcement functions of the agency, including
Administration, Attn: Administrator, DEPARTMENT OF JUSTICE whether the information will have
8701 Morrissette Drive, Springfield, practical utility;
Virginia 22152. All request for hearing Federal Bureau of Investigation —Evaluate the accuracy of the agency’s
should also be sent to: (1) Drug [OMB Number: 1110–0068] estimate of the burden of the
Enforcement Administration, Attn: proposed collection of information,
Hearing Clerk/LJ, 8701 Morrissette Agency Information Collection including the validity of the
Activities; Proposed eCollection methodology and assumptions used;
Drive, Springfield, Virginia 22152; and —Evaluate whether and if so how the
(2) Drug Enforcement Administration, eComments Requested; Revision of a
Currently Approved Collection: quality, utility, and clarity of the
Attn: DEA Federal Register information to be collected can be
Records Modification Form (FD–1115)
Representative/DRW, 8701 Morrissette enhanced; and
Drive, Springfield, Virginia 22152. AGENCY: Criminal Justice Information —Minimize the burden of the collection
Services Division, Federal Bureau of of information on those who are to
SUPPLEMENTARY INFORMATION: The
Investigation, Department of Justice. respond, including through the use of
Attorney General has delegated his
authority under the Controlled ACTION: 60-Day notice. appropriate automated, electronic,
Substances Act to the Administrator of mechanical, or other technological
SUMMARY: The Department of Justice collection techniques or other forms
the Drug Enforcement Administration (DOJ), Federal Bureau of Investigation of information technology, e.g.,
(DEA), 28 CFR 0.100(b). Authority to (FBI), Criminal Justice Information permitting electronic submission of
exercise all necessary functions with Services (CJIS) Division, will be responses.
respect to the promulgation and submitting the following information
implementation of 21 CFR part 1301, collection request to the Office of Overview of this information
incident to the registration of Management and Budget (OMB) for collection:
(1) Type of Information Collection:
manufacturers, distributors, dispensers, review and approval in accordance with
Revision of a currently approved
importers, and exporters of controlled the Paperwork Reduction Act of 1995.
collection.
substances (other than final orders in The proposed information collection is (2) Title of the Form/Collection:
connection with suspension, denial, or published to obtain comments from the Records Modification Form.
revocation of registration) has been public and affected agencies. (3) Agency form number: FD–1115.
redelegated to the Assistant DATES: Comments are encouraged and (4) Affected public who will be asked
Administrator of the DEA Diversion will be accepted for 60 days until or required to respond, as well as a brief
Control Division (‘‘Assistant November 13, 2018. abstract: Primary: This form is utilized
Administrator’’) pursuant to section 7 of FOR FURTHER INFORMATION CONTACT: If by criminal justice and affiliated
28 CFR part 0, appendix to subpart R. you have additional comments judicial agencies to request appropriate
In accordance with 21 CFR especially on the estimated public modification of criminal history
1301.34(a), this is notice that on July 2, burden or associated response time, information from an individual’s record.
suggestions, or need a copy of the (5) An estimate of the total number of
2018, Alcami Carolinas Corporation,
proposed information collection respondents and the amount of time
1726 North 23rd Street, Wilmington,
instrument with instructions or estimated for an average respondent to
North Carolina 28405–1822 applied to
additional information, please contact respond: It is estimated that 43,584
be registered as an importer of the respondents are authorized to complete
following basic classes of controlled Gerry Lynn Brovey, Supervisory
Information Liaison Specialist, FBI, the form which would require
substances: approximately 10 minutes.
CJIS, Resources Management Section,
Administrative Unit, Module C–2, 1000 (6) An estimate of the total public
Drug burden (in hours) associated with the
Controlled substance Schedule Custer Hollow Road, Clarksburg, West
code
Virginia, 26306 (facsimile: 304–625– collection: There are an estimated
Psilocybin ...................... 7437 I 5093) or email glbrovey@ic.fbi.gov. 19,882 total annual burden hours
Psilocyn ......................... 7438 I Written comments and/or suggestions associated with this collection.
can also be sent to the Office of If additional information is required
Management and Budget, Office of contact: Melody Braswell, Department
The company plans to import the Clearance Officer, United States
listed controlled substances in bulk Information and Regulatory Affairs,
Attention Department of Justice Desk Department of Justice, Justice
form for the manufacturing of capsules/ Management Division, Policy and
tablets for Phase II clinical trials. Officer, Washington, DC 20503.
Additionally, comments may be Planning Staff, Two Constitution
Approval of permit applications will submitted via email to OIRA_ Square, 145 N Street NE, 3E.405A,
Washington, DC 20530.
daltland on DSKBBV9HB2PROD with NOTICES

occur only when the registrant’s activity submission@omb.eop.gov.
is consistent with what is authorized Dated: September 11, 2018.
SUPPLEMENTARY INFORMATION: This
under 21 U.S.C. 952(a)(2). Melody Braswell,
process is conducted in accordance with
Authorization will not extend to the 5 CFR 1320.10. Written comments and Department Clearance Officer for PRA, U.S.
import of FDA approved or non- suggestions from the public and affected Department of Justice.
approved finished dosage forms for agencies concerning the proposed [FR Doc. 2018–20003 Filed 9–13–18; 8:45 am]
commercial sale. collection of information are BILLING CODE 4410–02–P

VerDate Sep<11>2014 17:06 Sep 13, 2018 Jkt 244001 PO 00000 Frm 00062 Fmt 4703 Sfmt 9990 E:\FR\FM\14SEN1.SGM 14SEN1

Document Created: 2018-09-14 03:03:22
Document Modified: 2018-09-14 03:03:22

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 on or before October 15, 2018. Such persons may also file a written request for a hearing on the application on or before October 15, 2018.
FR Citation		83 FR 46758

83 FR 46758 - Importer of Controlled Substances Application: Alcami Carolinas Corporation

DEPARTMENT OF JUSTICEDrug Enforcement Administration

Federal Register Volume 83, Issue 179 (September 14, 2018)

DEPARTMENT OF JUSTICE
Drug Enforcement Administration