Agency Information Collection Activities: Proposed Collection; Comments Requested: Application for Registration; Application for Registration Renewal; Affidavit for Chain Renewal; Application for Modification of Registration for Online Pharmacies DEA Forms 224, 224a, 224b, 224c, 47095-47096 [2012-19228]
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Federal Register / Vol. 77, No. 152 / Tuesday, August 7, 2012 / Notices
per page reproduction cost) payable to
the U.S. Treasury.
Maureen Katz,
Assistant Chief, Environmental Enforcement
Section, Environment and Natural Resources
Division.
[FR Doc. 2012–19250 Filed 8–6–12; 8:45 am]
BILLING CODE 4410–15–P
DEPARTMENT OF JUSTICE
mstockstill on DSK4VPTVN1PROD with NOTICES
Notice of Proposed Settlement
Agreement Under the Park System
Resource Protection Act
Notice is hereby given that the U.S.
Department of Justice, on behalf of the
U.S. Department of Interior, National
Park Service has reached a settlement
with University of Miami, on behalf of
itself and the R/V F.G. Walton Smith
regarding claims for response costs and
damages under the Park System
Resource Protection Act, 16 U.S.C. 19jj.
The United States’ claims arise from
the grounding of the vessel F.G. Walton
Smith in Biscayne National Park on
October 13, 2007. The grounding
injured Park resources. Pursuant to the
Agreement, the United States will
recover a total of $508,708.
The U.S. Department of Justice will
receive for a period of thirty (30) days
from the date of this publication
comments relating to the Settlement
Agreement. Comments should be
addressed to the Assistant Attorney
General, Environment and Natural
Resources Division, and either emailed
to pubcomment-ees.enrd@usdoj.gov or
mailed to P.O. Box 7611, U.S.
Department of Justice, Washington, DC
20044–7611 and should refer to the
Settlement Agreement between the
United States and University of Miami
and the R/V F.G. Walton Smith, DJ No.
90–5–1–1–10168.
The proposed settlement agreement
may be examined at Biscayne National
Park, at 9700 SW 328 Street, Homestead,
Florida 33033, and at the Department of
the Interior, Office of the Solicitor,
Southeast Regional Office, Richard B.
Russell Federal Building, 75 Spring
Street SW., Atlanta, Georgia 30303.
During the public comment period, the
Settlement Agreement may also be
examined on the following Department
of Justice Web site: https://
www.usdoj.gov/enrd/
Consent_Decrees.html. A copy of the
Settlement Agreement may also be
obtained by mail from the Consent
Decree Library, P.O. Box 7611, U.S.
Department of Justice, Washington, DC
20044–7611, or by faxing or emailing a
request to ‘‘Consent Decree Copy’’
(EESCDCopy.enrd@usdoj.gov), fax
VerDate Mar<15>2010
16:52 Aug 06, 2012
Jkt 226001
number (202) 514–0097, phone
confirmation number (202) 514–5271. In
requesting a copy from the Consent
Decree Library, please refer to the
Settlement Agreement between the
United States and University of Miami
and the R/V F.G. Walton Smith
(proposed Settlement Agreement, DOJ
Ref. No. 90–5–1–1–10168), and enclose
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per page reproduction cost) payable to
the U.S. Treasury or, if by email or fax,
forward a check in that amount to the
Consent Decree Library at the stated
address.
Maureen Katz,
Assistant Section Chief, Environmental
Enforcement Section, Environment and
Natural Resources Division.
[FR Doc. 2012–19251 Filed 8–6–12; 8:45 am]
BILLING CODE 4410–15–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[OMB Number 1117–0014]
Agency Information Collection
Activities: Proposed Collection;
Comments Requested: Application for
Registration; Application for
Registration Renewal; Affidavit for
Chain Renewal; Application for
Modification of Registration for Online
Pharmacies DEA Forms 224, 224a,
224b, 224c
60-Day Notice of Information
Collection Under Review.
ACTION:
The Department of Justice (DOJ), Drug
Enforcement Administration (DEA), will
be submitting the following information
collection request to the Office of
Management and Budget (OMB) for
review and approval in accordance with
the Paperwork Reduction Act of 1995.
The proposed information collection is
published to obtain comments from the
public and affected agencies. Comments
are encouraged and will be accepted
until October 9, 2012. This process is
conducted in accordance with 5 CFR
1320.10.
If you have comments, especially on
the estimated public burden or
associated response time, suggestions,
or need a copy of the proposed
information collection instrument with
instructions or additional information,
please contact John W. Partridge, Chief,
Liaison and Policy Section, Office of
Diversion Control, Drug Enforcement
Administration, 8701 Morrissette Drive,
Springfield, VA 22152; (202) 307–7297.
Written comments and suggestions
from the public and affected agencies
PO 00000
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Fmt 4703
Sfmt 4703
47095
concerning the proposed collection of
information are encouraged. Your
comments should address one or more
of the following four points:
• Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
• Evaluate the accuracy of the
agencies’ estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
• Enhance the quality, utility, and
clarity of the information to be
collected; and
• Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses.
Overview of Information Collection
1117–0014
(1) Type of Information Collection:
Extension of a currently approved
collection.
(2) Title of the Form/Collection:
Application for Registration;
Application for Registration Renewal;
Affidavit for Chain Renewal;
Application for Modification of
Registration for Online Pharmacies.
(3) Agency form number, if any, and
the applicable component of the
Department of Justice sponsoring the
collection: DEA Forms 224, 224a, 224b,
224c. Component: Office of Diversion
Control, Drug Enforcement
Administration, U.S. Department of
Justice.
(4) Affected public who will be asked
or required to respond, as well as a brief
abstract: Primary: Business or other forprofit.
Other: Not-for-profit institutions;
State, local, or tribal government.
Abstract: All firms and individuals
who dispense controlled substances
must register with the DEA under the
Controlled Substances Act. Pharmacies
wishing to be online pharmacies must
apply to modify their registrations. Such
registration is mandatory under the law
and needed for control measures over
legal handlers of controlled substances
and to monitor their activities.
(4) An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
respond:
E:\FR\FM\07AUN1.SGM
07AUN1
47096
Federal Register / Vol. 77, No. 152 / Tuesday, August 7, 2012 / Notices
Number of
annual
respondents
Average time per response
Total
annual hours
DEA–224 (paper) .........................................................
DEA–224 (electronic) ...................................................
DEA–224a (paper) .......................................................
DEA–224a (electronic) .................................................
DEA–224b (chain renewal)* .........................................
DEA–224c ....................................................................
5,867
79,057
66,200
323,758
32
0
0.2 hours (12 minutes) ...............................................
0.13 hours (8 minutes) ...............................................
0.2 hours (12 minutes) ...............................................
0.07 hours (4 minutes) ...............................................
5 hours ........................................................................
0.25 hours (15 minutes) .............................................
1,173.4
10,540.9
13,240
21,583.8
160
0
Total ......................................................................
474,914
.....................................................................................
46,698.1
* In total, 64 chain pharmacies represent 36,660 individual pharmacy registrants. Pharmacies register for a three-year registration period. In
calendar year 2011, the year for which estimates are calculated, 32 chains registered 6,472 individual pharmacies.
(6) An estimate of the total public
burden (in hours) associated with the
collection: It is estimated that there are
46,698 annual burden hours associated
with this collection.
If additional information is required
contact: Jerri Murray, Department
Clearance Officer, Policy and Planning
Staff, Justice Management Division,
Department of Justice, Two Constitution
Square, 145 N Street NE., Suite 2E–508,
Washington, DC 20530.
Dated: August 1, 2012.
Jerri Murray,
Department Clearance Officer, PRA, U.S.
Department of Justice.
[FR Doc. 2012–19228 Filed 8–6–12; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 11–52]
Physicians Pharmacy, L.L.C.; Decision
and Order
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On December 15, 2011,
Administrative Law Judge Timothy D.
Wing issued the attached recommended
decision.1 Thereafter, the Government
filed Exceptions to the ALJ’s decision.
Having carefully considered the ALJ’s
recommended decision and the record
in light of the Government’s Exceptions,
I have decided to adopt the ALJ’s
rulings, findings of fact, and
conclusions of law except as discussed
below.2 Accordingly, I will order that
Respondent’s application be granted.
1 All citations to the ALJ’s opinion are to the slip
opinion as originally issued.
2 I do not, however, adopt footnote 20 of the ALJ’s
opinion. See Kwan Bo Jin, 77 FR 35021, 35021 n.2
(2012). Moreover, to the extent the ALJ’s decision
suggests that a practitioner does not have an
obligation to maintain effective controls against
diversion of controlled substances because this is
not a statutory factor under the public interest
standard of section 823(f), see ALJ at 25–26, it
should be noted that factor four authorizes the
Agency to consider an applicant’s compliance with
applicable federal and state laws ‘‘relating to
controlled substances’’ and DEA regulations require
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16:52 Aug 06, 2012
Jkt 226001
The Government’s Exceptions
The Government’s principal
contention is that Mr. Lawrence James,
Respondent’s pharmacist-in-charge,
‘‘will not adequately fulfill his
corresponding responsibility to prevent
drug diversion.’’ Exceptions at 1.
Ignoring that Mr. James has nearly forty
years of experience as a registered
pharmacist and has never been cited for
any violation of state or federal laws, the
Government argues that various
portions of Mr. James’ testimony
support its contention.
First, the Government’s argues that
‘‘[i]n testifying how he would prevent
diversion and fraud, [its pharmacist-incharge’s] testimony focused on
fraudulent prescriptions, including
prescriptions that had been altered,
that an applicant or registrant ‘‘provide effective
controls and procedures to guard against theft and
diversion of controlled substances.’’ 21 CFR
1301.71(a).
However, I agree with the ALJ’s rejection of the
Government’s contention that ‘‘in assessing the
public interest, the nature and amount of diversion
of controlled substances in a geographical area is a
legitimate area of inquiry and concern when
determining whether an applicant should be
granted a DEA registration.’’ ALJ at 25 (quoting Gov.
Br. 4). Contrary to the Government’s understanding,
DEA has held that the public interest inquiry is not
a free-wheeling inquiry but is guided by the specific
factors set forth by Congress for the applicable
category of registration. Gregory D. Owens, 74 FR
36751, 36757 (2009). With respect to a practitioner
(which includes a pharmacy), see 21 U.S.C. 823(f),
these factors primarily focus on an applicant’s past
conduct and the likelihood of future compliance.
Nothing in the texts of any of the five factors set
forth in section 823(f) remotely suggests that
Congress granted the Agency the authority to deny
an application based on its assessment of ‘‘the
nature and amount of diversion of controlled
substances in a geographical area.’’ Gov. Br. 4.
Indeed, this is simply the other side of the
community impact coin. However, in multiple
cases, DEA has held that such evidence is not
relevant to any of the public interest factors and
further noted that a rule which takes into account
the impact on the community caused by not
registering (or de-registering through a revocation
proceeding) a particular practitioner is completely
unworkable. See Linda Sue Cheek, 76 FR 66972,
66973 n.4 (2011) (quoting Owens, 74 FR at 36757)
(‘‘‘the ALJ’s reasoning begs the question of how
many patients from underserved areas would a
practitioner have to treat to claim the benefit of the
rule’’’).
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
stolen or forged by the prospective
patient.’’ Id. at 1–2 (citing Tr. 51).
Continuing, the Government argues that
‘‘Mr. James did not address the
significant diversion problem that exists
with pill-pushing physicians and
[which] is the exact type of pernicious
drug diversion that plagues southern
Ohio and surrounding areas.’’ Id. at 2.
The Government based this contention
on the following colloquy:
Q [by Government Counsel]: Are you aware
of any diversion schemes where the doctor
was in cahoots with the patient to issue a
prescription that wasn’t for a legitimate
medical purpose?
A That question is also very tough because
it relies upon basically the equivalent of
hearsay evidence. I have heard of and been
told of some of those things, but at the same
difference—and I am sure somewhere in
Ohio, somewhere in the United States, there
probably are doctors, like down in Florida,
that will have an arrangement with a patient
where they will supposedly—the doctor will
write them a prescription, they’ll get it filled,
and the doctor either gets a cut of the pills
or whatever. Have I ever actually seen any of
that or am I totally aware of like any
specifics? No, I am not.
Tr. 52.
While the Government finds this
testimony remarkable in light of Mr.
James’ extensive experience as a
Registered Pharmacist and the scope of
the diversion problem in southern Ohio,
it did not ask Mr. James any further
questions regarding his awareness of
doctors writing unlawful prescriptions.
Nor did the Government pose to Mr.
James any hypothetical questions
regarding how he would handle
prescriptions which raise red flags due
to the quantity and strength of the drug
or combination of drugs prescribed, as
well as other relevant circumstances.
Thus, to the extent Mr. James did not
address to the Government’s satisfaction
the problems posed by prescriptions
issued by pill-pushing physicians, the
Government ignores that it (and not
Respondent) had the burden of proof in
this proceeding, see 21 CFR 1301.44(d),
and that Mr. James was only required to
E:\FR\FM\07AUN1.SGM
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]]>Agencies
[Federal Register Volume 77, Number 152 (Tuesday, August 7, 2012)]
[Notices]
[Pages 47095-47096]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-19228]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[OMB Number 1117-0014]
Agency Information Collection Activities: Proposed Collection;
Comments Requested: Application for Registration; Application for
Registration Renewal; Affidavit for Chain Renewal; Application for
Modification of Registration for Online Pharmacies DEA Forms 224, 224a,
224b, 224c
ACTION: 60-Day Notice of Information Collection Under Review.
-----------------------------------------------------------------------
The Department of Justice (DOJ), Drug Enforcement Administration
(DEA), will be submitting the following information collection request
to the Office of Management and Budget (OMB) for review and approval in
accordance with the Paperwork Reduction Act of 1995. The proposed
information collection is published to obtain comments from the public
and affected agencies. Comments are encouraged and will be accepted
until October 9, 2012. This process is conducted in accordance with 5
CFR 1320.10.
If you have comments, especially on the estimated public burden or
associated response time, suggestions, or need a copy of the proposed
information collection instrument with instructions or additional
information, please contact John W. Partridge, Chief, Liaison and
Policy Section, Office of Diversion Control, Drug Enforcement
Administration, 8701 Morrissette Drive, Springfield, VA 22152; (202)
307-7297.
Written comments and suggestions from the public and affected
agencies concerning the proposed collection of information are
encouraged. Your comments should address one or more of the following
four points:
Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the agency,
including whether the information will have practical utility;
Evaluate the accuracy of the agencies' estimate of the
burden of the proposed collection of information, including the
validity of the methodology and assumptions used;
Enhance the quality, utility, and clarity of the
information to be collected; and
Minimize the burden of the collection of information on
those who are to respond, including through the use of appropriate
automated, electronic, mechanical, or other technological collection
techniques or other forms of information technology, e.g., permitting
electronic submission of responses.
Overview of Information Collection 1117-0014
(1) Type of Information Collection: Extension of a currently
approved collection.
(2) Title of the Form/Collection: Application for Registration;
Application for Registration Renewal; Affidavit for Chain Renewal;
Application for Modification of Registration for Online Pharmacies.
(3) Agency form number, if any, and the applicable component of the
Department of Justice sponsoring the collection: DEA Forms 224, 224a,
224b, 224c. Component: Office of Diversion Control, Drug Enforcement
Administration, U.S. Department of Justice.
(4) Affected public who will be asked or required to respond, as
well as a brief abstract: Primary: Business or other for-profit.
Other: Not-for-profit institutions; State, local, or tribal
government.
Abstract: All firms and individuals who dispense controlled
substances must register with the DEA under the Controlled Substances
Act. Pharmacies wishing to be online pharmacies must apply to modify
their registrations. Such registration is mandatory under the law and
needed for control measures over legal handlers of controlled
substances and to monitor their activities.
(4) An estimate of the total number of respondents and the amount
of time estimated for an average respondent to respond:
[[Page 47096]]
----------------------------------------------------------------------------------------------------------------
Number of
annual Average time per response Total annual
respondents hours
----------------------------------------------------------------------------------------------------------------
DEA-224 (paper)......................... 5,867 0.2 hours (12 minutes)............... 1,173.4
DEA-224 (electronic).................... 79,057 0.13 hours (8 minutes)............... 10,540.9
DEA-224a (paper)........................ 66,200 0.2 hours (12 minutes)............... 13,240
DEA-224a (electronic)................... 323,758 0.07 hours (4 minutes)............... 21,583.8
DEA-224b (chain renewal)*............... 32 5 hours.............................. 160
DEA-224c................................ 0 0.25 hours (15 minutes).............. 0
-----------------------------------------------------------------------
Total............................... 474,914 ..................................... 46,698.1
----------------------------------------------------------------------------------------------------------------
* In total, 64 chain pharmacies represent 36,660 individual pharmacy registrants. Pharmacies register for a
three-year registration period. In calendar year 2011, the year for which estimates are calculated, 32 chains
registered 6,472 individual pharmacies.
(6) An estimate of the total public burden (in hours) associated
with the collection: It is estimated that there are 46,698 annual
burden hours associated with this collection.
If additional information is required contact: Jerri Murray,
Department Clearance Officer, Policy and Planning Staff, Justice
Management Division, Department of Justice, Two Constitution Square,
145 N Street NE., Suite 2E-508, Washington, DC 20530.
Dated: August 1, 2012.
Jerri Murray,
Department Clearance Officer, PRA, U.S. Department of Justice.
[FR Doc. 2012-19228 Filed 8-6-12; 8:45 am]
BILLING CODE 4410-09-P
