Importer of Controlled Substances Application: Alcami Carolinas Corporation, 46758-46759 [2018-20001]
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46758
Federal Register / Vol. 83, No. 179 / Friday, September 14, 2018 / Notices
these reviews may be viewed on the
Commission’s electronic docket (EDIS)
at https://edis.usitc.gov.
SUPPLEMENTARY INFORMATION:
Background.—On April 9, 2018, the
Commission determined that responses
to its notice of institution of the subject
five-year reviews were such that full
reviews should proceed (83 FR 18347,
April 26, 2018); accordingly, full
reviews are being scheduled pursuant to
section 751(c)(5) of the Tariff Act of
1930 (19 U.S.C. 1675(c)(5)). A record of
the Commissioners’ votes, the
Commission’s statement on adequacy,
and any individual Commissioner’s
statements are available from the Office
of the Secretary and at the
Commission’s website.
Participation in the reviews and
public service list.—Persons, including
industrial users of the subject
merchandise and, if the merchandise is
sold at the retail level, representative
consumer organizations, wishing to
participate in these reviews as parties
must file an entry of appearance with
the Secretary to the Commission, as
provided in section 201.11 of the
Commission’s rules, by 45 days after
publication of this notice. A party that
filed a notice of appearance following
publication of the Commission’s notice
of institution of the reviews need not
file an additional notice of appearance.
The Secretary will maintain a public
service list containing the names and
addresses of all persons, or their
representatives, who are parties to the
reviews.
For further information concerning
the conduct of these reviews and rules
of general application, consult the
Commission’s Rules of Practice and
Procedure, part 201, subparts A and B
(19 CFR part 201), and part 207,
subparts A, D, E, and F (19 CFR part
207).
Limited disclosure of business
proprietary information (BPI) under an
administrative protective order (APO)
and BPI service list.—Pursuant to
section 207.7(a) of the Commission’s
rules, the Secretary will make BPI
gathered in these reviews available to
authorized applicants under the APO
issued in the reviews, provided that the
application is made by 45 days after
publication of this notice. Authorized
applicants must represent interested
parties, as defined by 19 U.S.C. 1677(9),
who are parties to the reviews. A party
granted access to BPI following
publication of the Commission’s notice
of institution of the reviews need not
reapply for such access. A separate
service list will be maintained by the
Secretary for those parties authorized to
receive BPI under the APO.
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Staff report.—The prehearing staff
report in the reviews will be placed in
the nonpublic record on December 20,
2018, and a public version will be
issued thereafter, pursuant to section
207.64 of the Commission’s rules.
Hearing.—The Commission will hold
a hearing in connection with the
reviews beginning at 9:30 a.m. on
Thursday, January 17, 2019, at the U.S.
International Trade Commission
Building. Requests to appear at the
hearing should be filed in writing with
the Secretary to the Commission on or
before January 10, 2019. A nonparty
who has testimony that may aid the
Commission’s deliberations may request
permission to present a short statement
at the hearing. All parties and
nonparties desiring to appear at the
hearing and make oral presentations
should participate in a prehearing
conference to be held on January 16,
2019, at the U.S. International Trade
Commission Building, if deemed
necessary. Oral testimony and written
materials to be submitted at the public
hearing are governed by sections
201.6(b)(2), 201.13(f), 207.24, and
207.66 of the Commission’s rules.
Parties must submit any request to
present a portion of their hearing
testimony in camera no later than 7
business days prior to the date of the
hearing.
Written submissions.—Each party to
the reviews may submit a prehearing
brief to the Commission. Prehearing
briefs must conform with the provisions
of section 207.65 of the Commission’s
rules; the deadline for filing is January
8, 2019. Parties may also file written
testimony in connection with their
presentation at the hearing, as provided
in section 207.24 of the Commission’s
rules, and posthearing briefs, which
must conform with the provisions of
section 207.67 of the Commission’s
rules. The deadline for filing
posthearing briefs is January 25, 2019.
In addition, any person who has not
entered an appearance as a party to the
reviews may submit a written statement
of information pertinent to the subject of
the reviews on or before January 25,
2019. On February 15, 2019, the
Commission will make available to
parties all information on which they
have not had an opportunity to
comment. Parties may submit final
comments on this information on or
before February 19, 2019, but such final
comments must not contain new factual
information and must otherwise comply
with section 207.68 of the Commission’s
rules. All written submissions must
conform with the provisions of section
201.8 of the Commission’s rules; any
submissions that contain BPI must also
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conform with the requirements of
sections 201.6, 207.3, and 207.7 of the
Commission’s rules. The Commission’s
Handbook on E-Filing, available on the
Commission’s website at https://
edis.usitc.gov, elaborates upon the
Commission’s rules with respect to
electronic filing.
Additional written submissions to the
Commission, including requests
pursuant to section 201.12 of the
Commission’s rules, shall not be
accepted unless good cause is shown for
accepting such submissions, or unless
the submission is pursuant to a specific
request by a Commissioner or
Commission staff.
In accordance with sections 201.16(c)
and 207.3 of the Commission’s rules,
each document filed by a party to the
reviews must be served on all other
parties to the reviews (as identified by
either the public or BPI service list), and
a certificate of service must be timely
filed. The Secretary will not accept a
document for filing without a certificate
of service.
The Commission has determined that
these reviews are extraordinarily
complicated and therefore has
determined to exercise its authority to
extend the review period by up to 90
days pursuant to 19 U.S.C.
1675(c)(5)(B).
Authority: These reviews are being
conducted under authority of title VII of the
Tariff Act of 1930; this notice is published
pursuant to section 207.62 of the
Commission’s rules.
By order of the Commission.
Issued: September 10, 2018.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2018–19987 Filed 9–13–18; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Alcami Carolinas
Corporation
ACTION:
Notice of application.
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.
DATES:
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Federal Register / Vol. 83, No. 179 / Friday, September 14, 2018 / Notices
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.
ADDRESSES:
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:
SUPPLEMENTARY INFORMATION:
Controlled substance
daltland on DSKBBV9HB2PROD with NOTICES
Psilocybin ......................
Psilocyn .........................
Drug
code
7437
7438
Schedule
I
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 nonapproved finished dosage forms for
commercial sale.
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Jkt 244001
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
DEPARTMENT OF JUSTICE
Federal Bureau of Investigation
[OMB Number: 1110–0068]
Agency Information Collection
Activities; Proposed eCollection
eComments Requested; Revision of a
Currently Approved Collection:
Records Modification Form (FD–1115)
Criminal Justice Information
Services Division, Federal Bureau of
Investigation, Department of Justice.
ACTION: 60-Day notice.
AGENCY:
The Department of Justice
(DOJ), Federal Bureau of Investigation
(FBI), Criminal Justice Information
Services (CJIS) Division, will be
submitting the following information
collection request to the Office of
Management and Budget (OMB) for
review and approval in accordance with
the Paperwork Reduction Act of 1995.
The proposed information collection is
published to obtain comments from the
public and affected agencies.
DATES: Comments are encouraged and
will be accepted for 60 days until
November 13, 2018.
FOR FURTHER INFORMATION CONTACT: If
you have additional comments
especially on the estimated public
burden or associated response time,
suggestions, or need a copy of the
proposed information collection
instrument with instructions or
additional information, please contact
Gerry Lynn Brovey, Supervisory
Information Liaison Specialist, FBI,
CJIS, Resources Management Section,
Administrative Unit, Module C–2, 1000
Custer Hollow Road, Clarksburg, West
Virginia, 26306 (facsimile: 304–625–
5093) or email glbrovey@ic.fbi.gov.
Written comments and/or suggestions
can also be sent to the Office of
Management and Budget, Office of
Information and Regulatory Affairs,
Attention Department of Justice Desk
Officer, Washington, DC 20503.
Additionally, comments may be
submitted via email to OIRA_
submission@omb.eop.gov.
SUPPLEMENTARY INFORMATION: This
process is conducted in accordance with
5 CFR 1320.10. Written comments and
suggestions from the public and affected
agencies concerning the proposed
collection of information are
SUMMARY:
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46759
encouraged. Your comments should
address one or more of the following
four points:
—Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
—Evaluate the accuracy of the agency’s
estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
—Evaluate whether and if so how the
quality, utility, and clarity of the
information to be collected can be
enhanced; and
—Minimize the burden of the collection
of information on those who are to
respond, including through the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms
of information technology, e.g.,
permitting electronic submission of
responses.
Overview of this information
collection:
(1) Type of Information Collection:
Revision of a currently approved
collection.
(2) Title of the Form/Collection:
Records Modification Form.
(3) Agency form number: FD–1115.
(4) Affected public who will be asked
or required to respond, as well as a brief
abstract: Primary: This form is utilized
by criminal justice and affiliated
judicial agencies to request appropriate
modification of criminal history
information from an individual’s record.
(5) An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
respond: It is estimated that 43,584
respondents are authorized to complete
the form which would require
approximately 10 minutes.
(6) An estimate of the total public
burden (in hours) associated with the
collection: There are an estimated
19,882 total annual burden hours
associated with this collection.
If additional information is required
contact: Melody Braswell, Department
Clearance Officer, United States
Department of Justice, Justice
Management Division, Policy and
Planning Staff, Two Constitution
Square, 145 N Street NE, 3E.405A,
Washington, DC 20530.
Dated: September 11, 2018.
Melody Braswell,
Department Clearance Officer for PRA, U.S.
Department of Justice.
[FR Doc. 2018–20003 Filed 9–13–18; 8:45 am]
BILLING CODE 4410–02–P
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]]>Agencies
[Federal Register Volume 83, Number 179 (Friday, September 14, 2018)]
[Notices]
[Pages 46758-46759]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20001]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Alcami Carolinas
Corporation
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.
[[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
