Information Collection Activities: Proposed Collection; Comment Request, 66165-66166 [2010-27153]
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Federal Register / Vol. 75, No. 207 / Wednesday, October 27, 2010 / Notices
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depression. Accordingly, even if
Volkman told Mr. Fletcher that he did
blood tests and MRIs, this would not
make the prescriptions any more
legitimate.54
This alone supports the conclusion
that Mr. Fletcher violated Federal law in
dispensing the Volkman prescriptions.
21 CFR 1306.04(a). The other
evidence—such as that related to the
quantities of the various drugs being
prescribed, the dosing, and lack of
individualization of therapy; the
distances the patients were travelling
and the typical method of payment; the
fact that Mr. Fletcher knew that other
pharmacists had refused to fill
Volkman’s prescriptions; the percentage
and number of Volkman’s prescriptions
that were for controlled substances—is
simply icing on the cake.
Moreover, even after a DEA
Investigator had interviewed Mr.
Fletcher and asked him if he found it
suspicious that Volkman’s patients were
travelling long distances to fill their
prescriptions, Mr. Fletcher proceeded to
fill numerous oxycodone and
alprazolam prescriptions for residents of
Kentucky who had travelled to South
Florida to obtain the prescriptions.
Indeed, even one of Respondent’s
employees was ‘‘skeptical’’ as to whether
these were legitimate prescriptions.
While Respondent contends that Mr.
Fletcher stopped filling prescriptions
issued by Florida pain-clinic physicians
after he received the Ohio Board of
Pharmacy’s Notice, Mr. Fletcher did not
testify in this proceeding and so has
failed to offer any explanation as to why
he filled the prescriptions in the first
place. Furthermore, a responsible DEA
registrant should be able to make these
determinations without the authorities
having to provide the information to
him on a silver platter.
54 Respondent also elicited the testimony of Mr.
Aalyson, a lawyer who practiced workers
compensation law in Portsmouth and who knew
most of the local doctors, that Mr. Fletcher had
called and asked him if knew whether Dr. Volkman
was a legitimate doctor. Tr. 1159. Mr. Aalyson
testified that the phone call occurred in October
2006, more than a year after Mr. Fletcher started
filling Volkman’s prescriptions and eight months
after DEA suspended Volkman’s registration and
thus could no longer prescribe.
To the extent this testimony was offered to
support the contention that Mr. Fletcher tried to do
due diligence, it provides no comfort to him as the
conversation occurred more than a year after he
started filling Volkman’s prescriptions. Moreover,
even if the conversation had occurred shortly after
Mr. Fletcher started filling Volkman’s prescriptions
(the apparent point of Respondent’s repeated
questioning of Mr. Aalyson regarding when the
conversation occurred), his testimony that Mr.
Fletcher stated that he was ‘‘getting a lot of people
coming in, and I’m beginning to wonder if the guy
is legitimate,’’ Tr. 1159, would actually support the
Government’s case that Mr. Fletcher knew
Volkman’s prescriptions were not legitimate.
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Nor was this the end of Respondent’s
abysmal experience in dispensing
controlled substances. On November 4,
2009, Respondent dispensed to B.A., a
recovering drug addict who lived in
Morehead, Kentucky, four controlledsubstance prescriptions issued by a
Portsmouth physician, including two for
Roxicodone 30 mg. (totaling 240
tablets), one for 120 oxycodone 15 mg.,
and one for 30 alprazolam; B.A. had
been directed by the doctor’s staff to fill
his prescriptions at Respondent. Later
that day, B.A. got high, and the next
morning, he was found dead; the
detective who found the prescription
vials noted that there were only
nineteen tablets left out of the total of
240 Roxicodone 30 mg., there were only
fifty-two tablets left out of the 120
oxycodone 15 mg., and only eight
tablets out of the 30 alprazolam. The
quantity of oxycodone provided by
these prescriptions totaled 300 mg. per
day, an amount which was five to ten
times the normal daily dose of
oxycodone (5 to 10 mg. every four
hours) as testified to by the
Government’s Expert. Moreover, on this
single day, Respondent dispensed three
prescriptions for the same schedule II
narcotic. According to the Government’s
Expert, both the multiple prescriptions
which B.A. presented and the large
quantities prescribed were ‘‘red flags’’
which are suggestive of abuse and ‘‘no
reasonable pharmacist would fill’’ the
prescriptions. Here again, however, Mr.
Fletcher failed to testify and thus
offered no explanation as to why he did
so.
DEA Investigators also obtained an
OARRS report which showed that on
eighteen different occasions between
November 6, 2007 and October 30, 2009,
Respondent had dispensed oxycodone
to S.P. based on prescriptions she
obtained from seven different doctors;
most of the doctors practiced in
different cities (Waverly, Beavercreek,
Dayton and Wheelersburg), and while
three of the doctors practiced in
Portsmouth, two of them practiced at
different clinics. Notwithstanding that
its own dispensing records should have
shown that S.P. was a doctor shopper
(indeed, there was no need for Mr.
Fletcher to check the OARRS to make
this determination), Respondent
repeatedly dispensed this highly abused
schedule II controlled substance to her.
Here again, Mr. Fletcher did not testify
and thus has failed to explain why he
ignored the information in his own
records.
Respondent and Mr. Fletcher also
violated the CSA and DEA regulations
because during the November 6, 2009
inspection, it could not produce the
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66165
biennial inventory of controlled
substances which it is required to
maintain. See 21 U.S.C. 827(a)(1) (‘‘every
registrant * * * shall * * * as soon
* * * as such registrant first engages in
the * * * dispensing of controlled
substances, and every second year
thereafter, make a complete and
accurate record of all stocks thereof on
hand’’); see also 21 CFR 1304.11.
Moreover, Mr. Fletcher was unaware
that there is such a requirement. Finally,
as found by the Ohio Board of
Pharmacy, Mr. Fletcher and Respondent
violated Ohio law on three occasions
because Mr. Fletcher, as ‘‘the
responsible pharmacist[,] failed to
maintain supervision and control over
the custody and possession of
dangerous drugs’’ which had been
delivered to the pharmacy.
I therefore conclude that the evidence
relevant to Respondent’s experience in
dispensing controlled substances and its
record of compliance with applicable
Federal and State laws related to
controlled substances shows that it has
committed acts which render its
continued registration inconsistent with
the public interest and which justified
the suspension of its registration.
Notably, Mr. Fletcher failed to testify in
this proceeding; Respondent therefore
has not rebutted the Government’s
prima facie case. While there is only the
suspension order to review (because
Respondent allowed its registration to
expire), which I affirm, had Respondent
filed a renewal application, I would
have denied it.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 824, as well as by 28 CFR
0.100(b) and 0.104, I hereby affirm my
order which immediately suspended the
now-expired DEA Certificate of
Registration, BE5902615, issued to East
Main Street Pharmacy. This Order is
effective immediately.
Dated: October 15, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010–27096 Filed 10–26–10; 8:45 am]
BILLING CODE 4410–09–P
OFFICE OF MANAGEMENT AND
BUDGET
Information Collection Activities:
Proposed Collection; Comment
Request
Office of Management and
Budget, Office of Federal Financial
Management.
ACTION: Notice; request for comments.
AGENCY:
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66166
Federal Register / Vol. 75, No. 207 / Wednesday, October 27, 2010 / Notices
In accordance with the
Paperwork Reduction Act (44 U.S.C.
3501 et seq.), the Office of Management
and Budget (OMB) invites the general
public and Federal agencies to comment
on the renewal of the SF–LLL,
Disclosure of Lobbying Activities.
Although OMB proposes no changes to
the SF–LLL as part of this notice, we are
seeking public comments on whether
changes are warranted. We are
particularly interested in comments on
whether the information collected in the
forms could be more consistent with
other similar governmentwide
information collections or whether
additional information should be
collected to further the aims of
government transparency.
DATES: Comments must be received by
November 26, 2010. Due to potential
delays in OMB’s receipt and processing
of mail sent through the U.S. Postal
Service, we encourage respondents to
submit comments electronically to
ensure timely receipt. We cannot
guarantee that comments mailed will be
received before the comment closing
date.
SUMMARY:
Comments may be sent to
regulations.gov, a Federal E-Government
Web site that allows the public to find,
review, and submit comments on
documents that agencies have published
in the Federal Register and that are
open for comment. Simply type ‘‘SF–
LLL renewal-10’’ (in quotes) in the
Comment or Submission search box,
click Go, and follow the instructions for
submitting comments. Comments
received by the date specified above
will be included as part of the official
record.
Marguerite Pridgen, Office of Federal
Financial Management, Office of
Management and Budget, 725 17th
Street, NW., Washington, DC 20503;
telephone 202–395–7844; fax 202–395–
3952; e-mail mpridgen@omb.eop.gov.
FOR FURTHER INFORMATION CONTACT:
Marguerite Pridgen at the addresses
noted above.
OMB Control No.: 0348–0046.
Title: Disclosure of Lobbying
Activities.
Form No.: SF–LLL.
Type of Review: Extension of a
currently approved collection.
Respondents: Contractors, States,
Local Governments, Universities, NonProfit Organizations, For-Profit
Organizations, Individuals.
Number of Responses: 1,000.
Estimated Time per Response: 10
minutes.
Needs and Uses: The SF–LLL is the
standard disclosure form for lobbying
paid for with non-Federal funds, as
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ADDRESSES:
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17:00 Oct 26, 2010
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required by the Byrd Amendment and
amended by the Lobbying Disclosure
Act of 1995. The Federal awarding
agencies use information reported on
this form for the award and general
management of Federal contracts and
assistance program awards.
NATIONAL ARCHIVES AND RECORDS
ADMINISTRATION
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Debra J. Bond,
Deputy Controller.
National Archives and Records
Administration (NARA).
ACTION: Notice.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Summary of Comments and
Responses
On June 22, 2010, OMB published in
the Federal Register a notice seeking
comments on the Standard form LLL,
Disclosure of Lobbying Activities (SF–
LLL) in accordance with the Paperwork
Reduction Act [75 FR 35507]. OMB
Watch, Project on Government
Oversight, Sunlight Foundation, and
Thomas M. Susman submitted their
combined comments in a single letter
(‘‘proposal’’) dated August 19, 2010.
Their comments were the only
comments received in response to the
June 22 notice and included
recommendations for major changes to
the system of disclosing lobbying
activities. In summary, the August 19
proposal recommends expanding the
information collected by the SF–LLL;
raising the thresholds for reporting from
$100,000 and $150,000 to $250,000;
adding a form and process for
government employees to report
contacts with lobbyists; posting SF–LLL
content from electronic submissions on
a centralized, public, searchable Web
site within three days of receiving it;
and creating a system to ensure
enforcement of the new reporting
requirements.
II. Next Steps
The August 19 proposal, which can be
viewed at regulations.gov, includes
several recommendations that would
require changes in policy and the
process of lobbying disclosure that
cannot be implemented before the SF–
LLL expires. Therefore, the SF–LLL will
be renewed without change to prevent
any disruption in collecting lobbying
disclosure information by Executive
Branch agencies. Concurrent with the
renewal without change, the August 19
proposal will be carefully reviewed and
assessed for further action separate from
this renewal process.
[FR Doc. 2010–27153 Filed 10–26–10; 8:45 am]
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AGENCY:
NARA is giving public notice
that the agency has submitted to OMB
for approval the information collection
described in this notice. The public is
invited to comment on the proposed
information collection pursuant to the
Paperwork Reduction Act of 1995.
DATES: Written comments must be
submitted to OMB at the address below
on or before November 26, 2010 to be
assured of consideration.
ADDRESSES: Send comments to Mr.
Nicholas A. Fraser, Desk Officer for
NARA, Office of Management and
Budget, New Executive Office Building,
Washington, DC 20503; fax: 202–395–
5167; or electronically mailed to
Nicholas_A._Fraser@omb.eop.gov.
FOR FURTHER INFORMATION CONTACT:
Requests for additional information or
copies of the proposed information
collection and supporting statement
should be directed to Tamee Fechhelm
at telephone number 301–837–1694 or
fax number 301–713–7409.
SUPPLEMENTARY INFORMATION: Pursuant
to the Paperwork Reduction Act of 1995
(Pub. L. 104–13), NARA invites the
general public and other Federal
agencies to comment on proposed
information collections. NARA
published a notice of proposed
collection for this information collection
on August 4, 2010 (75 FR 47029 and
47030). No comments were received.
NARA has submitted the described
information collection to OMB for
approval.
In response to this notice, comments
and suggestions should address one or
more of the following points: (a)
Whether the proposed information
collection is necessary for the proper
performance of the functions of NARA;
(b) the accuracy of NARA’s estimate of
the burden of the proposed information
collection; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including the use of
information technology; and (e) whether
small businesses are affected by this
collection. In this notice, NARA is
soliciting comments concerning the
following information collections:
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Agencies
[Federal Register Volume 75, Number 207 (Wednesday, October 27, 2010)]
[Notices]
[Pages 66165-66166]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-27153]
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OFFICE OF MANAGEMENT AND BUDGET
Information Collection Activities: Proposed Collection; Comment
Request
AGENCY: Office of Management and Budget, Office of Federal Financial
Management.
ACTION: Notice; request for comments.
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[[Page 66166]]
SUMMARY: In accordance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), the Office of Management and Budget (OMB) invites the general
public and Federal agencies to comment on the renewal of the SF-LLL,
Disclosure of Lobbying Activities. Although OMB proposes no changes to
the SF-LLL as part of this notice, we are seeking public comments on
whether changes are warranted. We are particularly interested in
comments on whether the information collected in the forms could be
more consistent with other similar governmentwide information
collections or whether additional information should be collected to
further the aims of government transparency.
DATES: Comments must be received by November 26, 2010. Due to potential
delays in OMB's receipt and processing of mail sent through the U.S.
Postal Service, we encourage respondents to submit comments
electronically to ensure timely receipt. We cannot guarantee that
comments mailed will be received before the comment closing date.
ADDRESSES: Comments may be sent to regulations.gov, a Federal E-
Government Web site that allows the public to find, review, and submit
comments on documents that agencies have published in the Federal
Register and that are open for comment. Simply type ``SF-LLL renewal-
10'' (in quotes) in the Comment or Submission search box, click Go, and
follow the instructions for submitting comments. Comments received by
the date specified above will be included as part of the official
record.
Marguerite Pridgen, Office of Federal Financial Management, Office
of Management and Budget, 725 17th Street, NW., Washington, DC 20503;
telephone 202-395-7844; fax 202-395-3952; e-mail mpridgen@omb.eop.gov.
FOR FURTHER INFORMATION CONTACT: Marguerite Pridgen at the addresses
noted above.
OMB Control No.: 0348-0046.
Title: Disclosure of Lobbying Activities.
Form No.: SF-LLL.
Type of Review: Extension of a currently approved collection.
Respondents: Contractors, States, Local Governments, Universities,
Non-Profit Organizations, For-Profit Organizations, Individuals.
Number of Responses: 1,000.
Estimated Time per Response: 10 minutes.
Needs and Uses: The SF-LLL is the standard disclosure form for
lobbying paid for with non-Federal funds, as required by the Byrd
Amendment and amended by the Lobbying Disclosure Act of 1995. The
Federal awarding agencies use information reported on this form for the
award and general management of Federal contracts and assistance
program awards.
Debra J. Bond,
Deputy Controller.
SUPPLEMENTARY INFORMATION:
I. Summary of Comments and Responses
On June 22, 2010, OMB published in the Federal Register a notice
seeking comments on the Standard form LLL, Disclosure of Lobbying
Activities (SF-LLL) in accordance with the Paperwork Reduction Act [75
FR 35507]. OMB Watch, Project on Government Oversight, Sunlight
Foundation, and Thomas M. Susman submitted their combined comments in a
single letter (``proposal'') dated August 19, 2010. Their comments were
the only comments received in response to the June 22 notice and
included recommendations for major changes to the system of disclosing
lobbying activities. In summary, the August 19 proposal recommends
expanding the information collected by the SF-LLL; raising the
thresholds for reporting from $100,000 and $150,000 to $250,000; adding
a form and process for government employees to report contacts with
lobbyists; posting SF-LLL content from electronic submissions on a
centralized, public, searchable Web site within three days of receiving
it; and creating a system to ensure enforcement of the new reporting
requirements.
II. Next Steps
The August 19 proposal, which can be viewed at regulations.gov,
includes several recommendations that would require changes in policy
and the process of lobbying disclosure that cannot be implemented
before the SF-LLL expires. Therefore, the SF-LLL will be renewed
without change to prevent any disruption in collecting lobbying
disclosure information by Executive Branch agencies. Concurrent with
the renewal without change, the August 19 proposal will be carefully
reviewed and assessed for further action separate from this renewal
process.
[FR Doc. 2010-27153 Filed 10-26-10; 8:45 am]
BILLING CODE P