Ivyl W. Wells: Debarment Order, 21910-21911 [2011-9431]
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Federal Register / Vol. 76, No. 75 / Tuesday, April 19, 2011 / Notices
Estimated Total Annual Burden
Hours: 3,187,804.80.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Administration, Office of Information
Services, 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. E-mail 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,
E-mail:
OIRA_SUBMISSION@OMB.EOP.GOV,
Attn: Desk Officer for the
Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011–9423 Filed 4–18–11; 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: University Centers for
Excellence in Developmental
Disabilities Education, Research, and
Service—Annual Report.
OMB No.: 0970–0289.
Description: Section 104 (42 U.S.C.
15004) of the Developmental Disabilities
Assistance and Bill of Rights Act of
2000 (DD Act of 2000) directs the
Secretary of Health and Human Services
to develop and implement a system of
program accountability to monitor the
grantees funded under the DD Act of
2000. The program accountability
system shall include the National
Network of University Centers for
Excellence in Developmental
Disabilities Education, Research, and
Service (UCEDDs) authorized under Part
D of the DD Act of 2000. In addition
tothe accountability system, Section
154(e) (42 U.S.C. 15064) of the DD Act
of 2000 includes requirements for a
UCEDD Annual Report.
Respondents: University Centers.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average burden
hours per
response
Total burden
hours
UCEDD Annual Report Template ............................................
mstockstill on DSKH9S0YB1PROD with NOTICES
Instrument
67
1
500
33,500
Estimated Total Annual Burden
Hours: 33,500.
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 Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All 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
VerDate Mar<15>2010
16:19 Apr 18, 2011
Jkt 223001
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011–9393 Filed 4–18–11; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0407]
Ivyl W. Wells: 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 Ivyl W. Wells,
MD 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 Dr. Wells was convicted of
multiple felonies under Federal law for
conduct relating to the regulation of a
SUMMARY:
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
drug product under the FD&C Act. Dr.
Wells was given notice of the proposed
permanent debarment and an
opportunity to request a hearing within
the timeframe prescribed by regulation.
Dr. Wells failed to respond. Dr. Well’s
failure to respond constitutes a waiver
of his right to a hearing concerning this
action.
DATES: This order is effective April 19,
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, Office of Regulatory
Affairs (HFC–230), 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 otherwise relating to the
regulation of any drug product under
the FD&C Act.
On July 12, 2006, Dr. Wells pleaded
guilty to, among other things, mail fraud
E:\FR\FM\19APN1.SGM
19APN1
mstockstill on DSKH9S0YB1PROD with NOTICES
Federal Register / Vol. 76, No. 75 / Tuesday, April 19, 2011 / Notices
in violation of 18 U.S.C. 1341 and 1346,
adulterating a drug while held for sale,
in violation of 21 U.S.C. 331(k) and
333(a)(2), and misbranding a drug while
held for sale, in violation of 21 U.S.C.
331(k) and 333(a)(2). On December 11,
2006, the U.S. District Court for the
District of Idaho entered judgment
against him.
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: Dr. Wells was
a physician licensed by the Idaho State
Board of Medicine and he owned and
operated the Skinovative Laser Center.
Between late 2003 and early 2004, Dr.
Wells attended training sponsored by
TRI-toxin International (TRI), an
Arizona corporation. During the TRI
seminar he learned that the TRI
Botulinum Toxin Type A (TRI-toxin)
was not approved for use in humans.
Beginning in February 2004, Wells
began ordering TRI-toxin for use in
treatments in human patients at his
office. The TRI-toxin came with
invoices and labels on the vials of toxin
that stated the product was ‘‘for research
purposes only, not for human use.’’ Dr.
Wells mixed the TRI-toxin with
BOTOX/BOTOX Cosmetic, causing the
drug to become adulterated in violation
of 21 U.S.C. 331(k) and 333(a)(2), and
then he injected the mixture into
patients, representing the injection as
BOTOX/BOTOX Cosmetic.
From February through November
2004, Dr. Wells defrauded
approximately 200 patients who
received injection treatments intended
to reduce wrinkles. Dr. Wells defrauded
patients by representing and selling the
Botulinum toxin mixture as BOTOX/
BOTOX Cosmetic. Patients injected with
the Botulinum toxin mixture received
pre-treatment consultations during
which they were informed that they
were receiving BOTOX/BOTOX
Cosmetic and during which they were
never informed that they would be
injected with a Botulinum toxin mixture
not approved for use in humans.
Patients injected also signed a consent
form entitled ‘‘Botox Consent form’’ and
were told by Skinovative employees that
they were receiving BOTOX/BOTOX
Cosmetic. Patients who received the
Botulinum toxin mixture were charged
prices for treatments that were the same
as, or similar to, patients who had
received BOTOX/BOTOX Cosmetic. Dr.
Wells misrepresentation of the
Botulinum toxin mixture as BOTOX/
BOTOX Cosmetic resulted in the drug
being misbranded in violation of 21
U.S.C. 331(k) and 333(a)(2).
VerDate Mar<15>2010
16:19 Apr 18, 2011
Jkt 223001
21911
As a result of his convictions, on
November 22, 2010, FDA sent Dr. Wells
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 Dr.
Wells 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 Dr.
Wells 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. Dr. Wells failed to respond
within the timeframe prescribed by
regulation and has, therefore, waived
his opportunity for a hearing and
waived any contentions concerning his
debarment (21 CFR part 12).
Any application by Dr. Wells for
special termination of debarment under
section 306(d)(4) of the FD&C Act
should be identified with Docket No.
FDA–2010–N–0407 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
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
him (Staff Manual Guide 1410.35), finds
that Ivyl W. Wells 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,
Dr. Wells 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), (c)(2)(B), and section
201(dd) of the FD&C Act (21 U.S.C.
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 Dr. Wells in any
capacity during Dr. Well’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 Dr. Wells 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). In addition, FDA will not
accept or review any abbreviated new
drug applications submitted by or with
the assistance of Dr. Wells during his
period of debarment (section
306(c)(1)(B) of the FD&C Act).
Federal Emergency Management
Agency
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
Dated: March 28, 2011.
Howard Sklamberg,
Director, Office of Enforcement, Office of
Regulatory Affairs.
[FR Doc. 2011–9431 Filed 4–18–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HOMELAND
SECURITY
[Internal Agency Docket No. FEMA–3318–
EM; Docket ID FEMA–2011–0001]
North Dakota; Amendment No. 1 to
Notice of an Emergency Declaration
Federal Emergency
Management Agency, DHS.
ACTION: Notice.
AGENCY:
This notice amends the notice
of an emergency declaration for the
State of North Dakota (FEMA–3318–
EM), dated April 7, 2011, and related
determinations.
SUMMARY:
DATES:
Effective Date: April 13, 2011.
FOR FURTHER INFORMATION CONTACT:
Peggy Miller, Office of Response and
Recovery, Federal Emergency
Management Agency, 500 C Street, SW.,
Washington, DC 20472, (202) 646–3886.
SUPPLEMENTARY INFORMATION: The notice
of an emergency declaration for the
State of North Dakota is hereby
amended to include the following areas
among those areas determined to have
been adversely affected by the event
declared an emergency by the President
in his declaration of April 7, 2011.
Grand Forks, Pembina, Walsh, and Ward
Counties for emergency protective measures
(Category B), limited to direct Federal
assistance, under the Public Assistance
program.
The following Catalog of Federal Domestic
Assistance Numbers (CFDA) are to be used
for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora
Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034,
E:\FR\FM\19APN1.SGM
19APN1
]]>Agencies
[Federal Register Volume 76, Number 75 (Tuesday, April 19, 2011)]
[Notices]
[Pages 21910-21911]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-9431]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0407]
Ivyl W. Wells: 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 Ivyl W. Wells, MD 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 Dr. Wells was
convicted of multiple felonies under Federal law for conduct relating
to the regulation of a drug product under the FD&C Act. Dr. Wells was
given notice of the proposed permanent debarment and an opportunity to
request a hearing within the timeframe prescribed by regulation. Dr.
Wells failed to respond. Dr. Well's failure to respond constitutes a
waiver of his right to a hearing concerning this action.
DATES: This order is effective April 19, 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, Office of Regulatory
Affairs (HFC-230), 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 otherwise
relating to the regulation of any drug product under the FD&C Act.
On July 12, 2006, Dr. Wells pleaded guilty to, among other things,
mail fraud
[[Page 21911]]
in violation of 18 U.S.C. 1341 and 1346, adulterating a drug while held
for sale, in violation of 21 U.S.C. 331(k) and 333(a)(2), and
misbranding a drug while held for sale, in violation of 21 U.S.C.
331(k) and 333(a)(2). On December 11, 2006, the U.S. District Court for
the District of Idaho entered judgment against him.
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:
Dr. Wells was a physician licensed by the Idaho State Board of Medicine
and he owned and operated the Skinovative Laser Center. Between late
2003 and early 2004, Dr. Wells attended training sponsored by TRI-toxin
International (TRI), an Arizona corporation. During the TRI seminar he
learned that the TRI Botulinum Toxin Type A (TRI-toxin) was not
approved for use in humans. Beginning in February 2004, Wells began
ordering TRI-toxin for use in treatments in human patients at his
office. The TRI-toxin came with invoices and labels on the vials of
toxin that stated the product was ``for research purposes only, not for
human use.'' Dr. Wells mixed the TRI-toxin with BOTOX/BOTOX Cosmetic,
causing the drug to become adulterated in violation of 21 U.S.C. 331(k)
and 333(a)(2), and then he injected the mixture into patients,
representing the injection as BOTOX/BOTOX Cosmetic.
From February through November 2004, Dr. Wells defrauded
approximately 200 patients who received injection treatments intended
to reduce wrinkles. Dr. Wells defrauded patients by representing and
selling the Botulinum toxin mixture as BOTOX/BOTOX Cosmetic. Patients
injected with the Botulinum toxin mixture received pre-treatment
consultations during which they were informed that they were receiving
BOTOX/BOTOX Cosmetic and during which they were never informed that
they would be injected with a Botulinum toxin mixture not approved for
use in humans. Patients injected also signed a consent form entitled
``Botox Consent form'' and were told by Skinovative employees that they
were receiving BOTOX/BOTOX Cosmetic. Patients who received the
Botulinum toxin mixture were charged prices for treatments that were
the same as, or similar to, patients who had received BOTOX/BOTOX
Cosmetic. Dr. Wells misrepresentation of the Botulinum toxin mixture as
BOTOX/BOTOX Cosmetic resulted in the drug being misbranded in violation
of 21 U.S.C. 331(k) and 333(a)(2).
As a result of his convictions, on November 22, 2010, FDA sent Dr.
Wells 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 Dr. Wells
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 Dr. Wells 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. Dr. Wells failed to respond within the
timeframe prescribed by regulation and has, therefore, waived his
opportunity for a hearing and 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 him (Staff Manual Guide 1410.35), finds that
Ivyl W. Wells 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, Dr. Wells 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), (c)(2)(B), and
section 201(dd) of the FD&C Act (21 U.S.C. 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 Dr. Wells in any capacity during Dr. Well'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 Dr. Wells 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). In addition, FDA will not accept
or review any abbreviated new drug applications submitted by or with
the assistance of Dr. Wells during his period of debarment (section
306(c)(1)(B) of the FD&C Act).
Any application by Dr. Wells for special termination of debarment
under section 306(d)(4) of the FD&C Act should be identified with
Docket No. FDA-2010-N-0407 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: March 28, 2011.
Howard Sklamberg,
Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2011-9431 Filed 4-18-11; 8:45 am]
BILLING CODE 4160-01-P
