Importer of Controlled Substances Application: Galephar Pharmaceutical Research, Inc., 49663 [2017-23328]
Download as PDF
<![CDATA[
Federal Register / Vol. 82, No. 206 / Thursday, October 26, 2017 / Notices
ethrower on DSK3G9T082PROD with NOTICES
noon the next day pursuant to § 210.4(f)
of the Commission’s Rules of Practice
and Procedure (19 CFR 210.4(f)).
Submissions should refer to the docket
number (‘‘Docket No. 3266’’) in a
prominent place on the cover page and/
or the first page. (See Handbook for
Electronic Filing Procedures, Electronic
Filing Procedures 1). Persons with
questions regarding filing should
contact the Secretary (202–205–2000).
Any person desiring to submit a
document to the Commission in
confidence must request confidential
treatment. All such requests should be
directed to the Secretary to the
Commission and must include a full
statement of the reasons why the
Commission should grant such
treatment. See 19 CFR 201.6. Documents
for which confidential treatment by the
Commission is properly sought will be
treated accordingly. All such requests
should be directed to the Secretary to
the Commission and must include a full
statement of the reasons why the
Commission should grant such
treatment. See 19 CFR 201.6. Documents
for which confidential treatment by the
Commission is properly sought will be
treated accordingly. All information,
including confidential business
information and documents for which
confidential treatment is properly
sought, submitted to the Commission for
purposes of this Investigation may be
disclosed to and used: (i) By the
Commission, its employees and Offices,
and contract personnel (a) for
developing or maintaining the records
of this or a related proceeding, or (b) in
internal investigations, audits, reviews,
and evaluations relating to the
programs, personnel, and operations of
the Commission including under 5
U.S.C. Appendix 3; or (ii) by U.S.
government employees and contract
personnel,2 solely for cybersecurity
purposes. All nonconfidential written
submissions will be available for public
inspection at the Office of the Secretary
and on EDIS.3
This action is taken under the
authority of section 337 of the Tariff Act
of 1930, as amended (19 U.S.C. 1337),
and of §§ 201.10 and 210.8(c) of the
Commission’s Rules of Practice and
Procedure (19 CFR 201.10, 210.8(c)).
By order of the Commission.
1 Handbook for Electronic Filing Procedures:
https://www.usitc.gov/documents/handbook_on_
filing_procedures.pdf.
2 All contract personnel will sign appropriate
nondisclosure agreements.
3 Electronic Document Information System
(EDIS): https://edis.usitc.gov.
VerDate Sep<11>2014
17:29 Oct 25, 2017
Jkt 244001
Issued: October 20, 2017.
Lisa R. Barton,
Secretary to the Commission.
[FR Doc. 2017–23233 Filed 10–25–17; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Galephar Pharmaceutical
Research, Inc.
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 November 27, 2017. Such
persons may also file a written request
for a hearing on the application on or
before November 27, 2017.
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 requests 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 August
2, 2017, Galephar Pharmaceutical
DATES:
PO 00000
Frm 00078
Fmt 4703
Sfmt 4703
49663
Research, Inc., #100 Carr 198, Industrial
Park, Juncos, Puerto Rico 00777–3873
applied to be registered as an importer
of hydromorphone (9150), a basic class
of controlled substance in schedule II.
The company plans to import the
listed controlled substance in finished
dosage form for clinical trials, research
and analytical purposes.
The import of this class of controlled
substance will be granted only for
analytical testing, research, and clinical
trials. This authorization does not
extend to the import of a finished FDA
approved or non-approved dosage form
for commercial sale.
Dated: October 18, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017–23328 Filed 10–25–17; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 17–28]
Yoon H. Choi, M.D.; Decision and
Order
On April 4, 2017, the Assistant
Administrator, Division of Diversion
Control, issued an Order to Show Cause
to Yoon H. Choi, M.D. (Respondent), of
Brockton, Massachusetts. The Show
Cause Order proposed the revocation of
Respondent’s DEA Certificate of
Registration as a practitioner, on the
ground that he does not have authority
to dispense controlled substances in
Massachusetts, the State in which he is
registered with the Agency. Show Cause
Order, at 1.
As to the Agency’s jurisdiction, the
Show Cause Order alleged that
Respondent holds DEA Certificate of
Registration No. BC6966381, which
authorizes him to dispense controlled
substances in schedules II through V as
a practitioner, at the registered address
of Steward Medical Group, One Pearl
Street, Suite 2200, Brockton,
Massachusetts. Id. The Show Cause
Order alleged that this registration does
not expire until August 31, 2018. Id.
As to the substantive ground for the
proceeding, the Show Cause Order
alleged that ‘‘[o]n January 5, 2017, the
Commonwealth of Massachusetts Board
of Registration in Medicine indefinitely
suspended [his] medical license’’ and
that ‘‘[t]his order remains in effect.’’ Id.
The Order thus alleged that Respondent
is ‘‘without authority to handle
controlled substances in . . .
Massachusetts, the [S]tate in which [he
is] registered,’’ that he is ‘‘required to
E:\FR\FM\26OCN1.SGM
26OCN1
]]>Agencies
[Federal Register Volume 82, Number 206 (Thursday, October 26, 2017)]
[Notices]
[Page 49663]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23328]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Galephar
Pharmaceutical Research, Inc.
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 November 27, 2017.
Such persons may also file a written request for a hearing on the
application on or before November 27, 2017.
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
requests 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 August
2, 2017, Galephar Pharmaceutical Research, Inc., #100 Carr 198,
Industrial Park, Juncos, Puerto Rico 00777-3873 applied to be
registered as an importer of hydromorphone (9150), a basic class of
controlled substance in schedule II.
The company plans to import the listed controlled substance in
finished dosage form for clinical trials, research and analytical
purposes.
The import of this class of controlled substance will be granted
only for analytical testing, research, and clinical trials. This
authorization does not extend to the import of a finished FDA approved
or non-approved dosage form for commercial sale.
Dated: October 18, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017-23328 Filed 10-25-17; 8:45 am]
BILLING CODE 4410-09-P
