81 FR 15560 - Importer of Controlled Substances Application: Meda Pharmaceuticals, Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 81, Issue 56 (March 23, 2016)

Page Range		15560-15560
FR Document		2016-06544

Federal Register, Volume 81 Issue 56 (Wednesday, March 23, 2016)

[Federal Register Volume 81, Number 56 (Wednesday, March 23, 2016)]
[Notices]
[Page 15560]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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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

15560 Federal Register / Vol. 81, No. 56 / Wednesday, March 23, 2016 / Notices

parties to the investigations. A party comments on this information on or the application pursuant to 21 CFR
granted access to BPI in the preliminary before June 17, 2016, but such final 1301.43 on or before April 22, 2016.
phase of the investigations need not comments must not contain new factual
reapply for such access. A separate information and must otherwise comply ADDRESSES: Written comments should
service list will be maintained by the with section 207.30 of the Commission’s be sent to: Drug Enforcement
Secretary for those parties authorized to rules. All written submissions must Administration, Attention: DEA Federal
receive BPI under the APO. conform with the provisions of section Register Representative/ODW, 8701
Staff report.—The prehearing staff 201.8 of the Commission’s rules; any Morrissette Drive, Springfield, Virginia
report in the final phase of these submissions that contain BPI must also 22152. All request for hearing must be
investigations will be placed in the conform with the requirements of sent to: Drug Enforcement
nonpublic record on May 10, 2016, and sections 201.6, 207.3, and 207.7 of the Administration, Attn: Administrator,
a public version will be issued Commission’s rules. The Commission’s 8701 Morrissette Drive, Springfield,
thereafter, pursuant to section 207.22 of Handbook on E-Filing, available on the Virginia 22152. All request for hearing
the Commission’s rules. Commission’s Web site at http:// should also be sent to: (1) Drug
Hearing.—The Commission will hold edis.usitc.gov, elaborates upon the Enforcement Administration, Attn:
a hearing in connection with the final Commission’s rules with respect to Hearing Clerk/LJ, 8701 Morrissette
phase of these investigations beginning electronic filing. Drive, Springfield, Virginia 22152; and
at 9:30 a.m. on Tuesday, May 24, 2016, Additional written submissions to the (2) Drug Enforcement Administration,
at the U.S. International Trade Commission, including requests Attn: DEA Federal Register
Commission Building. Requests to pursuant to section 201.12 of the Representative/ODW, 8701 Morrissette
appear at the hearing should be filed in Commission’s rules, shall not be
writing with the Secretary to the Drive, Springfield, Virginia 22152.
accepted unless good cause is shown for
Commission on or before May 18, 2016. accepting such submissions, or unless SUPPLEMENTARY INFORMATION: The
A nonparty who has testimony that may the submission is pursuant to a specific Attorney General has delegated her
aid the Commission’s deliberations may request by a Commissioner or authority under the Controlled
request permission to present a short Commission staff. Substances Act to the Administrator of
statement at the hearing. All parties and In accordance with sections 201.16(c) the Drug Enforcement Administration
nonparties desiring to appear at the and 207.3 of the Commission’s rules, (DEA), 28 CFR 0.100(b). Authority to
hearing and make oral presentations each document filed by a party to the exercise all necessary functions with
should participate in a prehearing investigations must be served on all respect to the promulgation and
conference to be held on May 23, 2016, other parties to the investigations (as implementation of 21 CFR part 1301,
at the U.S. International Trade identified by either the public or BPI
Commission Building, if deemed incident to the registration of
service list), and a certificate of service manufacturers, distributors, dispensers,
necessary. Oral testimony and written must be timely filed. The Secretary will
materials to be submitted at the public importers, and exporters of controlled
not accept a document for filing without substances (other than final orders in
hearing are governed by sections a certificate of service.
201.6(b)(2), 201.13(f), and 207.24 of the connection with suspension, denial, or
Commission’s rules. Parties must submit Authority: These investigations are being revocation of registration) has been
conducted under authority of title VII of the redelegated to the Deputy Assistant
any request to present a portion of their Tariff Act of 1930; this notice is published
hearing testimony in camera no later pursuant to section 207.21 of the Administrator of the DEA Office of
than 7 business days prior to the date of Commission’s rules. Diversion Control (‘‘Deputy Assistant
the hearing. Administrator’’) pursuant to section 7 of
Written submissions.—Each party By order of the Commission.
28 CFR part 0, appendix of subpart R.
who is an interested party shall submit Issued: March 17, 2016.
Lisa R. Barton, In accordance with 21 CFR
a prehearing brief to the Commission.
1301.34(a), this is notice that on January
Prehearing briefs must conform with the Secretary to the Commission.
provisions of section 207.23 of the 11, 2016, Meda Pharmaceuticals, Inc.,
[FR Doc. 2016–06527 Filed 3–22–16; 8:45 am]
Commission’s rules; the deadline for 705 Eldorado Street, Decatur, Illinois
BILLING CODE 7020–02–P
filing is May 17, 2016. Parties may also 62523 applied to be registered as an
file written testimony in connection importer of nabilone (7379), a basic
with their presentation at the hearing, as class of controlled substance listed in
DEPARTMENT OF JUSTICE
provided in section 207.24 of the schedule II.
Commission’s rules, and posthearing Drug Enforcement Administration The company plans to import the
briefs, which must conform with the FDA approved drug product in finished
[Docket No. DEA–392]
provisions of section 207.25 of the dosage form for distribution to its
Commission’s rules. The deadline for Importer of Controlled Substances customers. Approval of permit
filing posthearing briefs is June 1, 2016. Application: Meda Pharmaceuticals, applications will occur only when the
In addition, any person who has not Inc. registrant’s business activity is
entered an appearance as a party to the
consistent with what is authorized
investigations may submit a written ACTION: Notice of application. under 21 U.S.C. 952(a)(2).
statement of information pertinent to
the subject of the investigations, DATES: Registered bulk manufacturers of Dated: March 14, 2016.
jstallworth on DSK7TPTVN1PROD with NOTICES

including statements of support or the affected basic class, and applicants Louis J. Milione,
opposition to the petition, on or before therefore, may file written comments on Deputy Assistant Administrator.
June 1, 2016. On June 15, 2016, the or objections to the issuance of the [FR Doc. 2016–06544 Filed 3–22–16; 8:45 am]
Commission will make available to proposed registration in accordance
BILLING CODE 4410–09–P
parties all information on which they with 21 CFR 1301.34(a) on or before
have not had an opportunity to April 22, 2016. Such persons may also
comment. Parties may submit final file a written request for a hearing on

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Document Created: 2016-03-23 00:03:52
Document Modified: 2016-03-23 00:03:52

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 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.
FR Citation		81 FR 15560

81 FR 15560 - Importer of Controlled Substances Application: Meda Pharmaceuticals, Inc.

DEPARTMENT OF JUSTICEDrug Enforcement Administration

Federal Register Volume 81, Issue 56 (March 23, 2016)

DEPARTMENT OF JUSTICE
Drug Enforcement Administration