Deborah Martinez Seldon: Debarment Order, 61712-61713 [2011-25680]
Download as PDF
<![CDATA[
61712
Federal Register / Vol. 76, No. 193 / Wednesday, October 5, 2011 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
21 CFR Section
Average
burden per
response
(in hours)
Total annual
responses
Total hours
315.4, 315.5, and 315.6 .......................................................
2
1
2
2,000
4,000
Total ..............................................................................
........................
........................
........................
........................
4,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 30, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–25685 Filed 10–4–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0165]
Deborah Martinez Seldon: Debarment
Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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 Deborah
Martinez Seldon from providing
services in any capacity to a person that
has an approved or pending drug
product application. FDA bases this
order on a finding that Ms. Seldon was
convicted of multiple felonies under
Federal law for conduct relating to the
regulation of a drug product under the
FD&C Act. Ms. Seldon was given notice
of the proposed permanent debarment
and an opportunity to request a hearing
within the timeframe prescribed by
regulation. Ms. Seldon failed to
respond. Ms. Seldon’s failure to respond
constitutes a waiver of her right to a
hearing concerning this action.
DATES: This order is effective October 5,
2011.
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, Division of Compliance
Policy (HFC–230), Office of Regulatory
Affairs, Food and Drug Administration,
5600 Fishers Lane, Rockville, MD
20857, 301–796–4640.
SUPPLEMENTARY INFORMATION:
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
19:11 Oct 04, 2011
Jkt 226001
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 March 27, 2009, judgment was
entered against Ms. Seldon in the
United States District Court for the
District of Nevada for mail fraud, in
violation of 18 U.S.C. 1341, aiding and
abetting, in violation of 18 U.S.C. 2, and
misbranding a drug while held for sale,
in violation of 21 U.S.C. 331(k) and
333(a)(2).
The 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 those
convictions is as follows: Ms. Seldon
was the manager of her husband’s
medical practice called A New You
Medical Aesthetics (A New You) in Las
Vegas, Nevada. As the office manager of
A New You, Ms. Seldon was responsible
for ordering supplies, paying bills,
managing personnel, and managing the
bank accounts.
From, on or about, October 15, 2003,
until on or about September 16, 2005, in
the State and Federal District of Nevada,
Ms. Seldon and her husband, aided and
abetted by each other, devised a scheme
and artifice to fraudulently obtain
money from patients by substituting the
cheaper, non-FDA approved product
marketed by Toxin Research
International that purported to be
Botulinum Neurotoxin Type A (TRItoxin) in treatments provided to patients
at A New You, while falsely and
fraudulently representing to the patients
that they were receiving injections of
the FDA-approved BOTOX product
marketed by Allergan, Inc..
As part of the scheme Ms. Seldon
ordered and caused to be ordered 38
vials of TRI-toxin between October 2003
and September 2004 while at the same
time the practice stopped purchasing
the approved BOTOX in October 2003.
In January 2005, as part of the scheme
and artifice, Ms. Seldon arranged for a
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
secret purchase of, and received 132
vials of TRI-toxin for use at A New You.
Ms. Seldon and her husband
defrauded patients by misleading them
to believe that they were receiving the
FDA-approved drug BOTOX, when, in
fact, the patients were receiving TRItoxin, which was not approved, thereby
exposing patients to severe health risk.
On or about January 12, 2005, Ms.
Seldon caused to be falsified
computerized medical records by
deleting references to BOTOX and
changing these entries to the generic
notation ‘‘Cosmetic Procedure.’’ In
furtherance of their scheme, Ms. Seldon
and Dr. Seldon caused 28 vials of TRItoxin to be returned to the FDA, seeking
to create the misleading impression that
they were returning 28 of the original 38
vials they had purchased. In fact, all of
the original TRI-toxin had been used on
patients at A New You, and Ms. Seldon
was returning vials that were part of the
secret 132 vial purchase.
Ms. Seldon and her husband also
caused advertisements to be placed in
local magazines offering BOTOX,
creating the false impression that the
office was using approved BOTOX
when, in fact, patients were being
injected with unapproved TRI-toxin.
Ms. Seldon also caused patients to sign
consent forms that fraudulently
represented that Dr. Seldon would be
injecting approved BOTOX when she
knew her husband was injecting them
with TRI-toxin.
As a result of her convictions, on May
23, 2011, FDA sent Ms. Seldon a notice
by certified mail proposing to
permanently debar her 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 (21 U.S.C.
335a(a)(2)(B)), that Ms. Seldon 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 Ms. Seldon an
opportunity to request a hearing,
providing her 30 days from the date of
receipt of the letter in which to file the
request, and advised her that failure to
E:\FR\FM\05OCN1.SGM
05OCN1
Federal Register / Vol. 76, No. 193 / Wednesday, October 5, 2011 / Notices
request a hearing constituted a waiver of
the opportunity for a hearing and of any
contentions concerning this action. Ms.
Seldon received the proposal on May
27, 2011, and failed to respond within
the timeframe prescribed by regulation.
She therefore has waived her
opportunity for a hearing and any
contentions concerning her debarment
(21 CFR part 12).
Publicly available submissions may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: September 6, 2011.
Armando Zamora,
Acting Director, Office of Enforcement, Office
of Regulatory Affairs.
[FR Doc. 2011–25680 Filed 10–4–11; 8:45 am]
BILLING CODE 4160–01–P
mstockstill on DSK4VPTVN1PROD with NOTICES
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 (21 U.S.C. 335a(a)(2)(B)),
under authority delegated to him (Staff
Manual Guide 1410.35), finds that
Deborah Martinez Seldon has been
convicted of a felony 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,
Ms. Seldon 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 section 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 Ms.
Seldon in any capacity during Ms.
Seldon’s 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 Ms. Seldon provides services in any
capacity to a person with an approved
or pending drug product application
during her period of debarment she 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 Deborah Martinez
Seldon during her period of debarment
(section 306(c)(1)(A) of the FD&C Act
(21 U.S.C. 335a(c)(1)(A)).
Any application by Deborah Martinez
Seldon 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–0165 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).
VerDate Mar<15>2010
19:11 Oct 04, 2011
Jkt 226001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Pediatric Oncology Subcommittee of
the Oncologic Drugs Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Pediatric
Oncology Subcommittee of the
Oncologic Drugs Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on November 1, 2011, from 8 a.m.
to 5:30 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(rm. 1503), Silver Spring, MD 20993–
0002. Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You’’, click
on ‘‘Public Meetings at the FDA White
Oak Campus’’. Please note that visitors
to the White Oak Campus must enter
through Building 1.
Contact Person: Caleb Briggs, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, Fax: 301–847–8533, e-mail:
ODAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
area. Please call the Information Line for
up-to-date information on this meeting.
A notice in the Federal Register about
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
61713
last minute modifications that impact a
previously announced advisory
committee meeting cannot always be
published quickly enough to provide
timely notice. Therefore, you should
always check the Agency’s Web site and
call the appropriate advisory committee
hot line/phone line to learn about
possible modifications before coming to
the meeting.
Agenda: On November 1, 2011,
information will be presented regarding
pediatric development plans for four
products that were either recently
approved by FDA, are in late stage
development for an adult oncology
indication, or in late stage development
in pediatric patients with cancer. The
subcommittee will consider and discuss
issues relating to the development of
each product for pediatric use and
provide guidance to facilitate the
formulation of Written Requests for
pediatric studies, if appropriate. The
four products under consideration are:
(1) Sodium thiosulfate injection,
application submitted by Adherex
Technologies, Inc.; (2) vismodegib
(GDC–0449), application submitted by
Genentech, Inc.; (3) pazopanib,
application submitted by Glaxo
Wellcome Manufacturing Pte Ltd.,
Singapore doing business as
GlaxoSmithKline; and (4) Medi-573
(fully human antibody to IGF–I and
IGF–II), application submitted by
MedImmune, LLC.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before October 18, 2011.
Oral presentations from the public will
be scheduled between approximately
9:15 a.m. to 9:30 a.m., 11:15 a.m. to
11:30 a.m., 2:05 p.m. to 2:20 p.m., and
4:10 p.m. to 4:25 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
E:\FR\FM\05OCN1.SGM
05OCN1
]]>Agencies
[Federal Register Volume 76, Number 193 (Wednesday, October 5, 2011)]
[Notices]
[Pages 61712-61713]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25680]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0165]
Deborah Martinez Seldon: Debarment Order
AGENCY: Food and Drug Administration, HHS.
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 Deborah Martinez Seldon from providing services
in any capacity to a person that has an approved or pending drug
product application. FDA bases this order on a finding that Ms. Seldon
was convicted of multiple felonies under Federal law for conduct
relating to the regulation of a drug product under the FD&C Act. Ms.
Seldon was given notice of the proposed permanent debarment and an
opportunity to request a hearing within the timeframe prescribed by
regulation. Ms. Seldon failed to respond. Ms. Seldon's failure to
respond constitutes a waiver of her right to a hearing concerning this
action.
DATES: This order is effective October 5, 2011.
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, Division of Compliance
Policy (HFC-230), Office of Regulatory Affairs, Food and Drug
Administration, 5600 Fishers Lane, 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 March 27, 2009, judgment was entered against Ms. Seldon in the
United States District Court for the District of Nevada for mail fraud,
in violation of 18 U.S.C. 1341, aiding and abetting, in violation of 18
U.S.C. 2, and misbranding a drug while held for sale, in violation of
21 U.S.C. 331(k) and 333(a)(2).
The 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 those convictions
is as follows: Ms. Seldon was the manager of her husband's medical
practice called A New You Medical Aesthetics (A New You) in Las Vegas,
Nevada. As the office manager of A New You, Ms. Seldon was responsible
for ordering supplies, paying bills, managing personnel, and managing
the bank accounts.
From, on or about, October 15, 2003, until on or about September
16, 2005, in the State and Federal District of Nevada, Ms. Seldon and
her husband, aided and abetted by each other, devised a scheme and
artifice to fraudulently obtain money from patients by substituting the
cheaper, non-FDA approved product marketed by Toxin Research
International that purported to be Botulinum Neurotoxin Type A (TRI-
toxin) in treatments provided to patients at A New You, while falsely
and fraudulently representing to the patients that they were receiving
injections of the FDA-approved BOTOX product marketed by Allergan,
Inc..
As part of the scheme Ms. Seldon ordered and caused to be ordered
38 vials of TRI-toxin between October 2003 and September 2004 while at
the same time the practice stopped purchasing the approved BOTOX in
October 2003. In January 2005, as part of the scheme and artifice, Ms.
Seldon arranged for a secret purchase of, and received 132 vials of
TRI-toxin for use at A New You.
Ms. Seldon and her husband defrauded patients by misleading them to
believe that they were receiving the FDA-approved drug BOTOX, when, in
fact, the patients were receiving TRI-toxin, which was not approved,
thereby exposing patients to severe health risk. On or about January
12, 2005, Ms. Seldon caused to be falsified computerized medical
records by deleting references to BOTOX and changing these entries to
the generic notation ``Cosmetic Procedure.'' In furtherance of their
scheme, Ms. Seldon and Dr. Seldon caused 28 vials of TRI-toxin to be
returned to the FDA, seeking to create the misleading impression that
they were returning 28 of the original 38 vials they had purchased. In
fact, all of the original TRI-toxin had been used on patients at A New
You, and Ms. Seldon was returning vials that were part of the secret
132 vial purchase.
Ms. Seldon and her husband also caused advertisements to be placed
in local magazines offering BOTOX, creating the false impression that
the office was using approved BOTOX when, in fact, patients were being
injected with unapproved TRI-toxin. Ms. Seldon also caused patients to
sign consent forms that fraudulently represented that Dr. Seldon would
be injecting approved BOTOX when she knew her husband was injecting
them with TRI-toxin.
As a result of her convictions, on May 23, 2011, FDA sent Ms.
Seldon a notice by certified mail proposing to permanently debar her
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 (21 U.S.C.
335a(a)(2)(B)), that Ms. Seldon 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 Ms. Seldon an opportunity to
request a hearing, providing her 30 days from the date of receipt of
the letter in which to file the request, and advised her that failure
to
[[Page 61713]]
request a hearing constituted a waiver of the opportunity for a hearing
and of any contentions concerning this action. Ms. Seldon received the
proposal on May 27, 2011, and failed to respond within the timeframe
prescribed by regulation. She therefore has waived her opportunity for
a hearing and any contentions concerning her 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 (21
U.S.C. 335a(a)(2)(B)), under authority delegated to him (Staff Manual
Guide 1410.35), finds that Deborah Martinez Seldon has been convicted
of a felony 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, Ms. Seldon 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 section 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 Ms. Seldon in any capacity during Ms.
Seldon's 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 Ms. Seldon
provides services in any capacity to a person with an approved or
pending drug product application during her period of debarment she
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 Deborah Martinez Seldon during her period of debarment
(section 306(c)(1)(A) of the FD&C Act (21 U.S.C. 335a(c)(1)(A)).
Any application by Deborah Martinez Seldon 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-0165 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: September 6, 2011.
Armando Zamora,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2011-25680 Filed 10-4-11; 8:45 am]
BILLING CODE 4160-01-P
