Importer of Controlled Substances Application: Meda Pharmaceuticals, Inc., 15560 [2016-06544]
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15560
Federal Register / Vol. 81, No. 56 / Wednesday, March 23, 2016 / Notices
parties to the investigations. A party
granted access to BPI in the preliminary
phase of the investigations need not
reapply for such access. A separate
service list will be maintained by the
Secretary for those parties authorized to
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Staff report.—The prehearing staff
report in the final phase of these
investigations will be placed in the
nonpublic record on May 10, 2016, and
a public version will be issued
thereafter, pursuant to section 207.22 of
the Commission’s rules.
Hearing.—The Commission will hold
a hearing in connection with the final
phase of these investigations beginning
at 9:30 a.m. on Tuesday, May 24, 2016,
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 May 18, 2016.
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 May 23, 2016,
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), and 207.24 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
who is an interested party shall submit
a prehearing brief to the Commission.
Prehearing briefs must conform with the
provisions of section 207.23 of the
Commission’s rules; the deadline for
filing is May 17, 2016. 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 207.25 of the
Commission’s rules. The deadline for
filing posthearing briefs is June 1, 2016.
In addition, any person who has not
entered an appearance as a party to the
investigations may submit a written
statement of information pertinent to
the subject of the investigations,
including statements of support or
opposition to the petition, on or before
June 1, 2016. On June 15, 2016, the
Commission will make available to
parties all information on which they
have not had an opportunity to
comment. Parties may submit final
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comments on this information on or
before June 17, 2016, but such final
comments must not contain new factual
information and must otherwise comply
with section 207.30 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
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 Web site 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
investigations must be served on all
other parties to the investigations (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.
Authority: These investigations are being
conducted under authority of title VII of the
Tariff Act of 1930; this notice is published
pursuant to section 207.21 of the
Commission’s rules.
By order of the Commission.
Issued: March 17, 2016.
Lisa R. Barton,
Secretary to the Commission.
[FR Doc. 2016–06527 Filed 3–22–16; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Meda Pharmaceuticals,
Inc.
ACTION:
Notice of application.
Registered bulk manufacturers of
the affected basic class, and applicants
therefore, may file written comments on
or objections to the issuance of the
proposed registration in accordance
with 21 CFR 1301.34(a) on or before
April 22, 2016. Such persons may also
file a written request for a hearing on
DATES:
PO 00000
Frm 00063
Fmt 4703
Sfmt 9990
the application pursuant to 21 CFR
1301.43 on or before April 22, 2016.
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia
22152. All request 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/ODW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
ADDRESSES:
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 of subpart R.
In accordance with 21 CFR
1301.34(a), this is notice that on January
11, 2016, Meda Pharmaceuticals, Inc.,
705 Eldorado Street, Decatur, Illinois
62523 applied to be registered as an
importer of nabilone (7379), a basic
class of controlled substance listed in
schedule II.
The company plans to import the
FDA approved drug product in finished
dosage form for distribution to its
customers. Approval of permit
applications will occur only when the
registrant’s business activity is
consistent with what is authorized
under 21 U.S.C. 952(a)(2).
SUPPLEMENTARY INFORMATION:
Dated: March 14, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–06544 Filed 3–22–16; 8:45 am]
BILLING CODE 4410–09–P
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[Federal Register Volume 81, Number 56 (Wednesday, March 23, 2016)]
[Notices]
[Page 15560]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-06544]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Meda
Pharmaceuticals, Inc.
ACTION: Notice of application.
-----------------------------------------------------------------------
DATES: Registered bulk manufacturers of the affected basic class, and
applicants therefore, may file written comments on or objections to the
issuance of the proposed registration in accordance with 21 CFR
1301.34(a) on or before April 22, 2016. Such persons may also file a
written request for a hearing on the application pursuant to 21 CFR
1301.43 on or before April 22, 2016.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/ODW,
8701 Morrissette Drive, Springfield, Virginia 22152. All request 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/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 of subpart R.
In accordance with 21 CFR 1301.34(a), this is notice that on
January 11, 2016, Meda Pharmaceuticals, Inc., 705 Eldorado Street,
Decatur, Illinois 62523 applied to be registered as an importer of
nabilone (7379), a basic class of controlled substance listed in
schedule II.
The company plans to import the FDA approved drug product in
finished dosage form for distribution to its customers. Approval of
permit applications will occur only when the registrant's business
activity is consistent with what is authorized under 21 U.S.C.
952(a)(2).
Dated: March 14, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-06544 Filed 3-22-16; 8:45 am]
BILLING CODE 4410-09-P
