Importer of Controlled Substances Application: Almac Clinical Services Incorp (ACSI), 37114-37115 [2017-16699]
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37114
Federal Register / Vol. 82, No. 151 / Tuesday, August 8, 2017 / Notices
asabaliauskas on DSKBBXCHB2PROD with NOTICES
registration. Id. (citing 21 U.S.C.
824(a)(3); 21 CFR 1301.37(b)).
The Show Cause Order notified
Registrant of her right to request a
hearing on the allegations or to submit
a written statement in lieu of a hearing,
the procedure for electing either option,
and the consequence for failing to elect
either option. Id. (citing 21 CFR
1301.43). The Show Cause Order also
notified Registrant of her right to submit
a corrective action plan. Id. at 2–3
(citing 21 U.S.C. 824(c)(2)(C)).
The Government states that on March
16, 2017, ‘‘[p]ersonnel from DEA’s New
Orleans Field Division served the Order
on Registrant.’’ Government Request for
Final Agency Action (RFFA), at 1 (citing
Government Exhibit (GX) 5).
Specifically, a DEA Diversion
Investigator (DI) and DEA Task Force
Officer traveled to a medical center in
Louisiana on March 16, 2017, where the
nursing staff escorted them to her room
where they found the Registrant. GX5, at
1. The DI advised Registrant that he had
a Show Cause Order to serve on her. Id.
According to the DI’s affidavit, the
Registrant then responded ‘‘ ‘You will
not take my DEA number’ and she
refused to take the [Show Cause Order]
document.’’ Id. The DI ‘‘then placed the
[Order] on the night stand next to
[Registrant’s] bed.’’ Id.
On May 19, 2017, the Government
forwarded its Request for Final Agency
Action and an evidentiary record to my
Office. Therein, the Government
represents that Registrant has neither
requested a hearing nor ‘‘otherwise
corresponded or communicated with
DEA regarding’’ the Show Cause Order.
RFFA, at 2. Based on the Government’s
representation and the record, I find that
more than 30 days have passed since the
Order to Show Cause was served on
Registrant, and she has neither
requested a hearing nor submitted a
written statement in lieu of a hearing.
Id. at 2 (citing 21 CFR 1301.43(d)).
Accordingly, I find that Registrant has
waived her right to a hearing or to
submit a written statement and issue
this Decision and Order based on
relevant evidence submitted by the
Government. I make the following
findings.
Findings of Fact
Registrant is a physician who is
registered as a practitioner in schedules
II–V pursuant to Certificate of
Registration BF5029574, at the address
of 3312 South I–10 Service Road,
Metairie, Louisiana. GX 1, at 1. The
registration does not expire until
September 30, 2017. Id.
On May 6, 2016, the Louisiana State
Board of Medical Examiners summarily
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21:16 Aug 07, 2017
Jkt 241001
suspended Registrant’s medical license
and stated that the suspension was
‘‘effective immediately.’’ GX 3, at 1. On
November 16, 2016, the Louisiana State
Board of Pharmacy ‘‘indefinitely
suspended’’ Registrant’s controlled
substance license ‘‘in accordance with
the suspension of her medical license by
the Louisiana State Board of Medical
Examiners on May 6, 2016.’’ GX 4, at 1.
Based on the above, I find that
Registrant does not currently have
authority under the laws of Louisiana to
dispense controlled substances.
Discussion
Pursuant to 21 U.S.C. 824(a)(3), the
Attorney General is authorized to
suspend or revoke a registration issued
under section 823 of Title 21, ‘‘upon a
finding that the registrant . . . has had
[her] State license . . . suspended [or]
revoked . . . by competent State
authority and is no longer authorized by
State law to engage in the . . .
dispensing of controlled substances.’’
With respect to a practitioner, DEA has
long held that the possession of
authority to dispense controlled
substances under the laws of the State
in which a practitioner engages in
professional practice is a fundamental
condition for obtaining and maintaining
a registration. See, e.g., James L. Hooper,
76 FR 71371 (2011), pet. for rev. denied,
481 Fed. Appx. 826 (4th Cir. 2012); see
also Frederick Marsh Blanton, 43 FR
27616 (1978) (‘‘State authorization to
dispense or otherwise handle controlled
substances is a prerequisite to the
issuance and maintenance of a Federal
controlled substances registration.’’).
This rule derives from the text of two
provisions of the CSA. First, Congress
defined ‘‘the term ‘practitioner’ [to]
mean[] a . . . physician . . . or other
person licensed, registered or otherwise
permitted, by . . . the jurisdiction in
which he practices . . . to distribute,
dispense, [or] administer . . . a
controlled substance in the course of
professional practice.’’ 21 U.S.C.
802(21). Second, in setting the
requirements for obtaining a
practitioner’s registration, Congress
directed that ‘‘[t]he Attorney General
shall register practitioners . . . if the
applicant is authorized to dispense . . .
controlled substances under the laws of
the State in which [s]he practices.’’ 21
U.S.C. 823(f). Because Congress has
clearly mandated that a practitioner
possess state authority in order to be
deemed a practitioner under the Act,
DEA has held repeatedly that revocation
of a practitioner’s registration is the
appropriate sanction whenever she is no
longer authorized to dispense controlled
substances under the laws of the State
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in which she engages in professional
practice. See, e.g., Calvin Ramsey, 76 FR
20034, 20036 (2011); Sheran Arden
Yeates, M.D., 71 FR 39130, 39131
(2006); Dominick A. Ricci, 58 FR 51104,
51105 (1993); Bobby Watts, 53 FR
11919, 11920 (1988); Blanton, 43 FR
27616 (1978).
Moreover, because ‘‘the controlling
question’’ in a proceeding brought
under 21 U.S.C. 824(a)(3) is whether the
holder of a practitioner’s registration ‘‘is
currently authorized to handle
controlled substances in the [S]tate,’’
Hooper, 76 FR at 71371 (quoting Anne
Lazar Thorn, 62 FR 12847, 12848
(1997)), the Agency has also long held
that revocation is warranted even where
a practitioner has lost her state authority
by virtue of the State’s use of summary
process and the State has yet to provide
a hearing to challenge the suspension.
Bourne Pharmacy, 72 FR 18273, 18274
(2007); Wingfield Drugs, 52 FR 27070,
27071 (1987). Thus, it is of no
consequence that the Louisiana State
Board of Medical Examiners has
employed summary process in
suspending Registrant’s state medical
license. What is consequential is that
Registrant is no longer currently
authorized to dispense controlled
substances in Louisiana, the State in
which she is registered. I will therefore
order that her registration be revoked.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f) and 824(a), as well
as 28 CFR 0.100(b), I order that DEA
Certificate of Registration No.
BF5029574, issued to Leia A. Frickey,
M.D., be, and it hereby is, revoked. I
further order that any pending
application of Leia A. Frickey to renew
or modify the above registration, or any
pending application of Leia A. Frickey
for any other registration, be, and it
hereby is, denied. This Order is effective
immediately.
Dated: July 31, 2017.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2017–16700 Filed 8–7–17; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Almac Clinical Services
Incorp (ACSI)
ACTION:
E:\FR\FM\08AUN1.SGM
Notice of application.
08AUN1
Federal Register / Vol. 82, No. 151 / Tuesday, August 8, 2017 / Notices
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 in
accordance with 21 CFR 1301.34(a) on
or before September 7, 2017. Such
persons may also file a written request
for a hearing on the application
pursuant to 21 CFR 1301.43 on or before
September 7, 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 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 March
7, 2017, Almac Clinical Services Incorp
(ACSI), 25 Fretz Road, Souderton,
Pennsylvania 18964 applied to be
registered as an importer of the
following basic classes of controlled
substances:
asabaliauskas on DSKBBXCHB2PROD with NOTICES
DATES:
Controlled substance
Oxycodone ...............
Hydromorphone ........
Morphine ...................
Tapentadol ................
Fentanyl ....................
Drug
code
Schedule
9143
9150
9300
9780
9801
II
II
II
II
II
The company plans to import small
quantities of the listed controlled
VerDate Sep<11>2014
21:16 Aug 07, 2017
Jkt 241001
substances in dosage form to conduct
clinical trials.
Dated: August 2, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017–16699 Filed 8–7–17; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Notice of Lodging of Proposed
Consent Decree Under the
Comprehensive Environmental
Response, Compensation, and Liability
Act
On August 1, 2017, the Department of
Justice lodged a proposed consent
decree with the United States District
Court for the Central District of
California in the lawsuit entitled United
States v. The Bionetics Corporation,
Civil Action No. 17–5677.
The United States filed this lawsuit
under the Comprehensive
Environmental Response,
Compensation, and Liability Act
(CERCLA) for the recovery of costs that
the United States incurred responding
to releases of hazardous substances at
certain Installation Restoration Program
(IRP) Sites at Vandenberg Air Force Base
in Santa Barbara County, California. The
consent decree requires the defendant
The Bionetics Corporation to pay
$219,000 to the United States. In return,
the United States agrees not to sue the
defendant under sections 106 and 107 of
CERCLA at certain IRP Sites at
Vandenberg Air Force Base.
The publication of this notice opens
a period for public comment on the
consent decree. Comments should be
addressed to the Assistant Attorney
General, Environment and Natural
Resources Division, and should refer to
United States v. The Bionetics
Corporation, D.J. Ref. No. 90–11–3–
10477/4. All comments must be
submitted no later than thirty (30) days
after the publication date of this notice.
Comments may be submitted either by
email or by mail:
To submit
comments:
Send them to:
By email .........
pubcomment-ees.enrd@
usdoj.gov.
Assistant Attorney General,
U.S. DOJ–ENRD, P.O.
Box 7611, Washington,
D.C. 20044–7611.
By mail ...........
During the public comment period,
the consent decree may be examined
and downloaded at this Justice
Department Web site: https://
www.justice.gov/enrd/consent-decrees.
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37115
We will provide a paper copy of the
consent decree upon written request
and payment of reproduction costs.
Please mail your request and payment
to: Consent Decree Library, U.S. DOJ–
ENRD, P.O. Box 7611, Washington, DC
20044–7611.
Please enclose a check or money order
for $5.25 (25 cents per page
reproduction cost) payable to the United
States Treasury.
Henry S. Friedman,
Assistant Section Chief, Environmental
Enforcement Section, Environment and
Natural Resources Division.
[FR Doc. 2017–16695 Filed 8–7–17; 8:45 am]
BILLING CODE P
DEPARTMENT OF LABOR
Bureau of Labor Statistics
Information Collection Activities,
Comment Request
Bureau of Labor Statistics,
Department of Labor.
ACTION: Notice of information collection,
request for comment.
AGENCY:
The Department of Labor, as
part of its continuing effort to reduce
paperwork and respondent burden,
conducts a pre-clearance consultation
program to provide the general public
and Federal agencies with an
opportunity to comment on proposed
and/or continuing collections of
information in accordance with the
Paperwork Reduction Act of 1995. This
program helps to ensure that requested
data can be provided in the desired
format, reporting burden (time and
financial resources) is minimized,
collection instruments are clearly
understood, and the impact of collection
requirements on respondents can be
properly assessed. The Bureau of Labor
Statistics (BLS) is soliciting comments
concerning the proposed revision of the
‘‘The Consumer Expenditure Surveys:
The Quarterly Interview and the Diary.’’
A copy of the proposed information
collection request can be obtained by
contacting the individual listed below
in the ADDRESSES section of this notice.
DATES: Written comments must be
submitted to the office listed in the
ADDRESSES section of this notice on or
before October 10, 2017.
ADDRESSES: Send comments to Nora
Kincaid, BLS Clearance Officer,
Division of Management Systems,
Bureau of Labor Statistics, Room 4080,
2 Massachusetts Avenue NE.,
Washington, DC 20212. Written
comments also may be transmitted by
SUMMARY:
E:\FR\FM\08AUN1.SGM
08AUN1
]]>Agencies
[Federal Register Volume 82, Number 151 (Tuesday, August 8, 2017)]
[Notices]
[Pages 37114-37115]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16699]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Almac Clinical
Services Incorp (ACSI)
ACTION: Notice of application.
-----------------------------------------------------------------------
[[Page 37115]]
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 in accordance with 21 CFR
1301.34(a) on or before September 7, 2017. Such persons may also file a
written request for a hearing on the application pursuant to 21 CFR
1301.43 on or before September 7, 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
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 March
7, 2017, Almac Clinical Services Incorp (ACSI), 25 Fretz Road,
Souderton, Pennsylvania 18964 applied to be registered as an importer
of the following basic classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Oxycodone............................. 9143 II
Hydromorphone......................... 9150 II
Morphine.............................. 9300 II
Tapentadol............................ 9780 II
Fentanyl.............................. 9801 II
------------------------------------------------------------------------
The company plans to import small quantities of the listed
controlled substances in dosage form to conduct clinical trials.
Dated: August 2, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017-16699 Filed 8-7-17; 8:45 am]
BILLING CODE 4410-09-P
