Stephen L. Marks: Debarment Order, 10533-10534 [2012-4064]
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10533
Federal Register / Vol. 77, No. 35 / Wednesday, February 22, 2012 / Notices
ANNUAL BURDEN ESTIMATES—Continued
Number of
responses per
respondent
Number of
respondents
Instrument
Protection and Advocacy (P&A) Voting Access Annual Report ......
Estimated Total Annual Burden
Hours: 1,980.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 370
L’Enfant Promenade SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. Email address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Fax: 202–395–7285,
Email:
OIRA_SUBMISSION@OMB.EOP.GOV.
Attn: Desk Officer for the
55
Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2012–3986 Filed 2–21–12; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Title: Understanding the Dynamics of
Disconnection from Employment and
Assistance.
OMB No.: New Collection.
Description: The Administration for
Children and Families (ACF), U.S.
Department of Health and Human
Services (HHS), is proposing a data
collection activity as part of the
‘‘Understanding the Dynamics of
Disconnection from Employment and
Assistance’’ research project. The
purpose of this study is to improve
understanding of low-income
Average burden
hours per
response
1
Total burden
hours
16
880
individuals and families who are
disconnected from employment and
from public assistance and particularly
those not receiving cash assistance
through the Temporary Assistance for
Needy Families (TANF) program. ACF
is proposing to use a discussion guide
to collect qualitative information from
respondents who are low-income and
disconnected from employment and
public assistance. The guide will be
used to interview respondents in order
to learn about their experiences with
disconnection. Topics will include
recent employment and reasons for not
working; use of public benefit programs
and reasons for using or not using
specific benefits; their financial
circumstances and material well-being
including the stability and sources of
income, housing and living
arrangements; their coping strategies for
addressing their circumstances; and
their views on potential pathways out of
disconnectedness.
Respondents: Individuals who are
low-income, disconnected from
employment and public assistance, and
living in low-income areas targeted by
the study.
ANNUAL BURDEN ESTIMATES
Annual
number of
respondents
Number of
responses
per
respondent
Average
burden hours
per response
Total annual
burden hours
Discussion Guide .............................................................................................
srobinson on DSK4SPTVN1PROD with NOTICES
Instrument
72
1
1.5
108
Estimated Total Annual Burden
Hours: 108.
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade, SW., Washington, DC
20447, Attn: OPRE Reports Clearance
Officer. Email address:
OPREinfocollection@acf.hhs.gov. All
VerDate Mar<15>2010
17:19 Feb 21, 2012
Jkt 226001
requests should be identified by the title
of the information collection.
The Department specifically requests
comments on (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
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 through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
PO 00000
Frm 00062
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Sfmt 4703
comments and suggestions submitted
within 60 days of this publication.
Dated: February 14, 2012.
Steven M. Hanmer,
Reports Clearance Officer.
[FR Doc. 2012–3945 Filed 2–21–12; 8:45 am]
BILLING CODE 4184–09–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0585]
Stephen L. Marks: Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
E:\FR\FM\22FEN1.SGM
22FEN1
10534
ACTION:
Federal Register / Vol. 77, No. 35 / Wednesday, February 22, 2012 / Notices
Notice.
The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act)
permanently debarring Stephen L.
Marks from providing services in any
capacity to a person that has an
approved or pending drug product
application. We base this order on a
finding that Mr. Marks was convicted of
felonies under Federal law for conduct
relating to the regulation of a drug
product under the FD&C Act. Mr. Marks
was given notice of the proposed
permanent debarment and an
opportunity to request a hearing within
the timeframe prescribed by regulation.
Mr. Marks failed to respond. Mr. Marks’
failure to respond constitutes a waiver
of his right to a hearing concerning this
action.
DATES: This order is effective February
22, 2012.
ADDRESSES: Submit applications for
special termination of debarment to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Kenny Shade, Office of Regulatory
Affairs, Food and Drug Administration,
12420 Parklawn Dr., Element Bldg., rm.
4144, Rockville, MD 20857, 301–796–
4640.
SUMMARY:
srobinson on DSK4SPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(a)(2)(B) of the FD&C Act
(21 U.S.C. 335a(a)(2)(B)) requires
debarment of an individual if FDA finds
that the individual has been convicted
of a felony under Federal law for
conduct relating to the regulation of any
drug product under the FD&C Act.
On June 23, 2011, the U.S. District
Court for the Middle District of
Pennsylvania entered judgment against
Mr. Marks for: Conspiracy to distribute
misbranded controlled substances in
violation of 21 U.S.C. 846; causing the
misbranding of a drug product by
dispensing a prescription drug product
without a valid prescription in violation
of 21 U.S.C. 331(k); and aiding and
abetting in a monetary transaction in
criminally derived property of a value
greater than $10,000 in violation of 18
U.S.C. 1957 and 2.
FDA’s finding that debarment is
appropriate is based on the felony
convictions referenced herein for
conduct relating to the regulation of a
drug product. The factual basis for this
conviction is as follows: Mr. Marks was
a pharmacist licensed to practice as a
VerDate Mar<15>2010
16:37 Feb 21, 2012
Jkt 226001
pharmacist in Pennsylvania. Mr. Marks
managed and operated Pharmacy
Services, Inc. (PSI, Inc.), a pharmacy
registered with the Drug Enforcement
Administration. This registration
permitted Mr. Marks to fill prescriptions
for and dispense certain controlled
substances. From on or about June 2004,
through January 2006, Mr. Marks and
other employees of PSI, Inc. dispensed
and distributed controlled substances
for businesses that used telemarketers
and Web sites to market, sell, and
distribute controlled substances,
including pain medications and
stimulants, to individuals throughout
the United States. From on or about
June 2004, through on or about January
2006, in the Middle District of
Pennsylvania, with intent to defraud
and mislead, Mr. Marks did an act that
caused drugs to be misbranded after
they moved in interstate commerce and
while they were held for sale, in that he
dispensed the prescription drugs
hydrocodone and Didrex, both of which
are Schedule III controlled substances,
without a valid prescription of a
practitioner licensed by law to
administer such drugs.
As a result of his convictions, on
September 30, 2011, FDA sent Mr.
Marks a notice by certified mail
proposing to permanently debar him
from providing services in any capacity
to a person that has an approved or
pending drug product application. The
proposal was based on a finding, under
section 306(a)(2)(B) of the FD&C Act,
that Mr. Marks was convicted of felonies
under Federal law for conduct relating
to the regulation of a drug product
under the FD&C Act. The proposal also
offered Mr. Marks an opportunity to
request a hearing, providing him 30
days from the date of receipt of the letter
in which to file the request, and advised
him that failure to request a hearing
constituted a waiver of the opportunity
for a hearing and of any contentions
concerning this action. The proposal
was received on October 6, 2011. Mr.
Marks failed to respond within the
timeframe prescribed by regulation and
has, therefore, waived his opportunity
for a hearing and has waived any
contentions concerning his debarment
(21 CFR part 12).
regulation of a drug product under the
FD&C Act.
As a result of the foregoing finding,
Mr. Marks is permanently debarred from
providing services in any capacity to a
person with an approved or pending
drug product application under sections
505, 512, or 802 of the FD&C Act (21
U.S.C. 355, 360b, or 382), or under
section 351 of the Public Health Service
Act (42 U.S.C. 262), effective (see DATES)
(see sections 306(c)(1)(B), (c)(2)(A)(ii),
and 201(dd) of the FD&C Act (21 U.S.C.
335a(c)(1)(B), (c)(2)(A)(ii), and 321(dd))).
Any person with an approved or
pending drug product application who
knowingly employs or retains as a
consultant or contractor, or otherwise
uses the services of Mr. Marks, in any
capacity during Mr. Marks’ debarment,
will be subject to civil money penalties
(section 307(a)(6) of the FD&C Act (21
U.S.C. 335b(a)(6))). If Mr. Marks
provides services in any capacity to a
person with an approved or pending
drug product application during his
period of debarment he will be subject
to civil money penalties (section
307(a)(7) of the FD&C Act (21 U.S.C.
335b(a)(7)). In addition, FDA will not
accept or review any abbreviated new
drug applications submitted by or with
the assistance of Mr. Marks during his
period of debarment (section
306(c)(1)(A) of the FD&C Act (21 U.S.C.
335a(c)(1)(A))).
Any application by Mr. Marks for
special termination of debarment under
section 306(d)(4) of the FD&C Act (21
U.S.C. 335a(d)(4)) should be identified
with Docket No. FDA–2011–N–0585
and sent to the Division of Dockets
Management (see ADDRESSES). All such
submissions are to be filed in four
copies. The public availability of
information in these submissions is
governed by 21 CFR 10.20(j).
Publicly available submissions may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
II. Findings and Order
[FR Doc. 2012–4064 Filed 2–21–12; 8:45 am]
Therefore, the Director, Office of
Enforcement, Office of Regulatory
Affairs, under section 306(a)(2)(B) of the
FD&C Act, under authority delegated to
the Director (Staff Manual Guide
1410.35), finds that Stephen L. Marks
has been convicted of felonies under
Federal law for conduct relating to the
BILLING CODE 4160–01–P
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Fmt 4703
Sfmt 9990
Dated: February 7, 2012.
Armando Zamora,
Acting Director, Office of Enforcement, Office
of Regulatory Affairs.
E:\FR\FM\22FEN1.SGM
22FEN1
]]>Agencies
[Federal Register Volume 77, Number 35 (Wednesday, February 22, 2012)]
[Notices]
[Pages 10533-10534]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-4064]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0585]
Stephen L. Marks: Debarment Order
AGENCY: Food and Drug Administration, HHS.
[[Page 10534]]
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
permanently debarring Stephen L. Marks from providing services in any
capacity to a person that has an approved or pending drug product
application. We base this order on a finding that Mr. Marks was
convicted of felonies under Federal law for conduct relating to the
regulation of a drug product under the FD&C Act. Mr. Marks was given
notice of the proposed permanent debarment and an opportunity to
request a hearing within the timeframe prescribed by regulation. Mr.
Marks failed to respond. Mr. Marks' failure to respond constitutes a
waiver of his right to a hearing concerning this action.
DATES: This order is effective February 22, 2012.
ADDRESSES: Submit applications for special termination of debarment to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Kenny Shade, Office of Regulatory
Affairs, Food and Drug Administration, 12420 Parklawn Dr., Element
Bldg., rm. 4144, Rockville, MD 20857, 301-796-4640.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B))
requires debarment of an individual if FDA finds that the individual
has been convicted of a felony under Federal law for conduct relating
to the regulation of any drug product under the FD&C Act.
On June 23, 2011, the U.S. District Court for the Middle District
of Pennsylvania entered judgment against Mr. Marks for: Conspiracy to
distribute misbranded controlled substances in violation of 21 U.S.C.
846; causing the misbranding of a drug product by dispensing a
prescription drug product without a valid prescription in violation of
21 U.S.C. 331(k); and aiding and abetting in a monetary transaction in
criminally derived property of a value greater than $10,000 in
violation of 18 U.S.C. 1957 and 2.
FDA's finding that debarment is appropriate is based on the felony
convictions referenced herein for conduct relating to the regulation of
a drug product. The factual basis for this conviction is as follows:
Mr. Marks was a pharmacist licensed to practice as a pharmacist in
Pennsylvania. Mr. Marks managed and operated Pharmacy Services, Inc.
(PSI, Inc.), a pharmacy registered with the Drug Enforcement
Administration. This registration permitted Mr. Marks to fill
prescriptions for and dispense certain controlled substances. From on
or about June 2004, through January 2006, Mr. Marks and other employees
of PSI, Inc. dispensed and distributed controlled substances for
businesses that used telemarketers and Web sites to market, sell, and
distribute controlled substances, including pain medications and
stimulants, to individuals throughout the United States. From on or
about June 2004, through on or about January 2006, in the Middle
District of Pennsylvania, with intent to defraud and mislead, Mr. Marks
did an act that caused drugs to be misbranded after they moved in
interstate commerce and while they were held for sale, in that he
dispensed the prescription drugs hydrocodone and Didrex, both of which
are Schedule III controlled substances, without a valid prescription of
a practitioner licensed by law to administer such drugs.
As a result of his convictions, on September 30, 2011, FDA sent Mr.
Marks a notice by certified mail proposing to permanently debar him
from providing services in any capacity to a person that has an
approved or pending drug product application. The proposal was based on
a finding, under section 306(a)(2)(B) of the FD&C Act, that Mr. Marks
was convicted of felonies under Federal law for conduct relating to the
regulation of a drug product under the FD&C Act. The proposal also
offered Mr. Marks an opportunity to request a hearing, providing him 30
days from the date of receipt of the letter in which to file the
request, and advised him that failure to request a hearing constituted
a waiver of the opportunity for a hearing and of any contentions
concerning this action. The proposal was received on October 6, 2011.
Mr. Marks failed to respond within the timeframe prescribed by
regulation and has, therefore, waived his opportunity for a hearing and
has waived any contentions concerning his debarment (21 CFR part 12).
II. Findings and Order
Therefore, the Director, Office of Enforcement, Office of
Regulatory Affairs, under section 306(a)(2)(B) of the FD&C Act, under
authority delegated to the Director (Staff Manual Guide 1410.35), finds
that Stephen L. Marks has been convicted of felonies under Federal law
for conduct relating to the regulation of a drug product under the FD&C
Act.
As a result of the foregoing finding, Mr. Marks is permanently
debarred from providing services in any capacity to a person with an
approved or pending drug product application under sections 505, 512,
or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 382), or under section
351 of the Public Health Service Act (42 U.S.C. 262), effective (see
DATES) (see sections 306(c)(1)(B), (c)(2)(A)(ii), and 201(dd) of the
FD&C Act (21 U.S.C. 335a(c)(1)(B), (c)(2)(A)(ii), and 321(dd))). Any
person with an approved or pending drug product application who
knowingly employs or retains as a consultant or contractor, or
otherwise uses the services of Mr. Marks, in any capacity during Mr.
Marks' debarment, will be subject to civil money penalties (section
307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))). If Mr. Marks
provides services in any capacity to a person with an approved or
pending drug product application during his period of debarment he will
be subject to civil money penalties (section 307(a)(7) of the FD&C Act
(21 U.S.C. 335b(a)(7)). In addition, FDA will not accept or review any
abbreviated new drug applications submitted by or with the assistance
of Mr. Marks during his period of debarment (section 306(c)(1)(A) of
the FD&C Act (21 U.S.C. 335a(c)(1)(A))).
Any application by Mr. Marks for special termination of debarment
under section 306(d)(4) of the FD&C Act (21 U.S.C. 335a(d)(4)) should
be identified with Docket No. FDA-2011-N-0585 and sent to the Division
of Dockets Management (see ADDRESSES). All such submissions are to be
filed in four copies. The public availability of information in these
submissions is governed by 21 CFR 10.20(j).
Publicly available submissions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: February 7, 2012.
Armando Zamora,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2012-4064 Filed 2-21-12; 8:45 am]
BILLING CODE 4160-01-P
