Importer of Controlled Substances Application: Catalent CTS, LLC, 48564 [2020-17435]
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48564
Federal Register / Vol. 85, No. 155 / Tuesday, August 11, 2020 / Notices
In
accordance with 21 CFR 1301.34(a), this
is notice that on July 20, 2020, GE
Healthcare, 3350 North Ridge Avenue,
Arlington Heights, Illinois 60004–1412,
applied to be registered as an importer
of the following basic class(es) of a
controlled substance:
SUPPLEMENTARY INFORMATION:
Controlled substance
Cocaine .........................
Drug
code
9041
Schedule
II
The company plans to import small
quantities of Ioflupane, in the form of
three separate analogues of cocaine, to
validate production and quality control
systems, for a reference standard, and
for producing material for a future
investigational new drug submission.
Supplies of this particular controlled
substances are not available in the form
needed within the current domestic
supply of the United States.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–17437 Filed 8–10–20; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–696]
Importer of Controlled Substances
Application: Catalent CTS, LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Catalent, CTS LLC applied to
be registered as an importer of the
following basic class(es) of controlled
substances: Gamma Hydroxybutyric
Acid, Marihuana Extract, Marihuana,
and Tetrahydrocannabinols.
DATES: Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before September 10, 2020. Such
persons may also file a written request
for a hearing on the application on or
before September 10, 2020.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing must
be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for a
hearing should also be sent to: (1) Drug
SUMMARY:
VerDate Sep<11>2014
17:02 Aug 10, 2020
Jkt 250001
Enforcement Administration, Attn:
Hearing Clerk/OALJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/DPW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on July 17, 2020, Catalent,
CTS LLC, 10245 Hickman Mills Drive,
Kansas City, Missouri 64137, applied to
be registered as an importer of the
following basic class(es) of controlled
substances:
Controlled substance
Gamma Hydroxybutyric
Acid.
Marihuana Extract ........
Marihuana .....................
Tetrahydrocannabinols
Drug
code
Schedule
2010
I
7350
7360
7370
I
I
I
The company plans to import finished
dosage unit products containing
Gamma-Hydroxybutyric Acid and
Marihuana Extracts for clinical trial
studies. These Marihuana Extracts
compounds are listed under drug code
7350. No other activity for these drug
codes is authorized for this registration.
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).
Authorization will not extend to the
import of FDA-approved or nonapproved finished dosage forms for
commercial sale.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–17435 Filed 8–10–20; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Mark D. Beale, M.D.; Decision and
Order
On May 14, 2019, the Assistant
Administrator, Diversion Control
Division, Drug Enforcement
Administration (hereinafter, DEA or
Government), issued an Order to Show
Cause (hereinafter, OSC) to Mark D.
Beale, M.D. (hereinafter, Registrant) of
Las Cruces, New Mexico. OSC, at 1. The
OSC proposed the revocation of
Registrant’s Certificate of Registration
No. FB0178194. Id. It alleged that
Registrant has ‘‘no state authority to
handle controlled substances.’’ Id.
(citing 21 U.S.C. 824(a)(3)).
Specifically, the OSC alleged that,
‘‘[o]n April 17, 2019, the New Mexico
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
Medical Board (hereinafter, NMMB)
summarily suspended . . . [Registrant’s]
medical license.’’ OSC, at 2. The OSC
concluded that ‘‘DEA must revoke . . .
[Registrant’s] registration based on . . .
[his] lack of authority to handle
controlled substances in the State of
New Mexico.’’ Id.
The OSC notified Registrant of the
right to request a hearing on the
allegations or to submit a written
statement, while waiving the right to a
hearing, the procedures for electing each
option, and the consequences for failing
to elect either option. Id. (citing 21 CFR
1301.43). The OSC also notified
Registrant of the opportunity to submit
a corrective action plan. OSC, at 3
(citing 21 U.S.C. 824(c)(2)(C)).
Adequacy of Service
In a sworn Declaration dated January
17, 2020, a DEA Diversion Investigator
assigned to the El Paso Division
(hereinafter, EPDI) stated that she
attempted personal service of the OSC
on Registrant at his medical practice
and at his residence on multiple
occasions. Request for Final Agency
Action, dated January 17, 2020
(hereinafter, RFAA), Exhibit
(hereinafter, EX) 5 (Declaration of
Attempted Service of Order to Show
Cause, dated January 17, 2020), at 1–3.
For the last attempt, EPDI was
accompanied by two DEA Special
Agents. Id. at 3. None of the attempts
was successful. Id.
EPDI’s Declaration also describes her
attempts to reach Registrant by
telephone. Id. at 2. Due to these
attempts, EPDI succeeded in speaking
with Registrant’s wife. Id. Registrant’s
wife told EPDI that their attorney was
handling the matter. Id. EPDI contacted
the attorney whose name Registrant’s
wife gave her. Id. This attorney,
however, stated that ‘‘he is only
handling Registrant’s criminal matter.’’
Id.
EPDI’s Declaration details multiple
instances of her transmitting the OSC to
Registrant by mail. Id. at 2–3. Two of the
mailings, one to Registrant’s registered
address and one to his residential
address, were transmitted through the
United States Postal Service
(hereinafter, USPS) by prepaid postage
and return receipt requested. Id. at 2.
The mailing to Registrant’s registered
address was returned ‘‘with a label
stating ‘RETURN TO SENDER
UNCLAIMED UNABLE TO
FORWARD.’ ’’ Id. Neither the mailing to
Registrant’s residence, nor the return
receipt request attached to it, was
returned. Id.
EPDI’s Declaration states that she
attempted to serve the OSC on
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]]>Agencies
[Federal Register Volume 85, Number 155 (Tuesday, August 11, 2020)]
[Notices]
[Page 48564]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17435]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-696]
Importer of Controlled Substances Application: Catalent CTS, LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Catalent, CTS LLC applied to be registered as an importer of
the following basic class(es) of controlled substances: Gamma
Hydroxybutyric Acid, Marihuana Extract, Marihuana, and
Tetrahydrocannabinols.
DATES: Registered bulk manufacturers of the affected basic class(es),
and applicants therefore, may file written comments on or objections to
the issuance of the proposed registration on or before September 10,
2020. Such persons may also file a written request for a hearing on the
application on or before September 10, 2020.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DPW,
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a
hearing must be sent to: Drug Enforcement Administration, Attn:
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All
requests for a hearing should also be sent to: (1) Drug Enforcement
Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive,
Springfield, Virginia 22152; and (2) Drug Enforcement Administration,
Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive,
Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this
is notice that on July 17, 2020, Catalent, CTS LLC, 10245 Hickman Mills
Drive, Kansas City, Missouri 64137, applied to be registered as an
importer of the following basic class(es) of controlled substances:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid.............. 2010 I
Marihuana Extract...................... 7350 I
Marihuana.............................. 7360 I
Tetrahydrocannabinols.................. 7370 I
------------------------------------------------------------------------
The company plans to import finished dosage unit products
containing Gamma-Hydroxybutyric Acid and Marihuana Extracts for
clinical trial studies. These Marihuana Extracts compounds are listed
under drug code 7350. No other activity for these drug codes is
authorized for this registration.
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). Authorization will not extend to the import
of FDA-approved or non-approved finished dosage forms for commercial
sale.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-17435 Filed 8-10-20; 8:45 am]
BILLING CODE 4410-09-P
