North Dakota; Amendment No. 1 to Notice of an Emergency Declaration, 21911-21912 [2011-9427]
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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).
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16:19 Apr 18, 2011
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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
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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,
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21912
Federal Register / Vol. 76, No. 75 / Tuesday, April 19, 2011 / Notices
Disaster Unemployment Assistance (DUA);
97.046, Fire Management Assistance Grant;
97.048, Disaster Housing Assistance to
Individuals and Households In Presidentially
Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance—
Disaster Housing Operations for Individuals
and Households; 97.050 Presidentially
Declared Disaster Assistance to Individuals
and Households—Other Needs; 97.036,
Disaster Grants—Public Assistance
(Presidentially Declared Disasters); 97.039,
Hazard Mitigation Grant.
W. Craig Fugate,
Administrator, Federal Emergency
Management Agency.
[FR Doc. 2011–9427 Filed 4–18–11; 8:45 am]
BILLING CODE 9111–23–P
DEPARTMENT OF HOMELAND
SECURITY
U.S. Citizenship and Immigration
Services
Agency Information Collection
Activities: Form I–363; Extension of an
Existing Information Collection;
Comment Request
60-Day Notice of Information
Collection Under Review: Form I–363,
Request to Enforce Affidavit of
Financial Support and Intent To
Petition for Custody for Public Law 97–
359 Amerasian; OMB Control No. 1615–
0022.
mstockstill on DSKH9S0YB1PROD with NOTICES
ACTION:
The Department of Homeland
Security, U.S. Citizenship and
Immigration Services (USCIS) will be
submitting the following information
collection request for review and
clearance in accordance with the
Paperwork Reduction Act of 1995. The
information collection is published to
obtain comments from the public and
affected agencies. Comments are
encouraged and will be accepted for 60
days until June 20, 2011.
During this 60-day period, USCIS will
be evaluating whether to revise the
Form I–363. Should USCIS decide to
revise Form I–363 we will advise the
public when we publish the 30-day
notice in the Federal Register in
accordance with the Paperwork
Reduction Act. The public will then
have 30 days to comment on any
revisions to the Form I–363.
Written comments and suggestions
regarding items contained in this notice,
and especially with regard to the
estimated public burden and associated
response time should be directed to the
Department of Homeland Security
(DHS), USCIS, Chief, Regulatory
Products Division, Office of the
Executive Secretariat, Clearance Officer,
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16:19 Apr 18, 2011
Jkt 223001
20 Massachusetts Avenue, NW.,
Washington, DC 20529–2020.
Comments may also be submitted to
DHS via facsimile to 202–272–0997 or
via e-mail at rfs.regs@dhs.gov. When
submitting comments by e-mail please
add the OMB Control Number 1615–
0022 in the subject box.
Note: The address listed in this notice
should only be used to submit comments
concerning this information collection.
Please do not submit requests for individual
case status inquiries to this address. If you
are seeking information about the status of
your individual case, please check ‘‘My Case
Status’’ online at: https://egov.uscis.gov/cris/
Dashboard.do, or call the USCIS National
Customer Service Center at 1–800–375–5283.
Written comments and suggestions
from the public and affected agencies
concerning the collection of information
should address one or more of the
following four points:
(1) 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;
(2) 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;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) 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 This Information
Collection
(1) Type of Information Collection:
Extension of an existing information
collection.
(2) Title of the Form/Collection:
Request to Enforce Affidavit of
Financial Support and Intent to Petition
for Custody for Public Law 97–359
Amerasian.
(3) Agency form number, if any, and
the applicable component of the
Department of Homeland Security
sponsoring the collection: Form I–363,
U.S. Citizenship and Immigration
Services (USCIS).
(4) Affected public who will be asked
or required to respond, as well as a brief
abstract: Primary: Individuals or
households. Form I–363 is used by
applicants to ensure the financial
support of a U.S. citizen. Without the
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Sfmt 4703
use of Form I–363, the USCIS is not able
to ensure the child does not become a
public charge.
(5) An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
respond: 50 responses at 30 minutes
(0.50 hours) per response.
(6) An estimate of the total public
burden (in hours) associated with the
collection: 25 annual burden hours.
If you need a copy of the information
collection instrument, please visit the
Web site at: https://
www.regulations.gov/.
We may also be contacted at: USCIS,
Regulatory Products Division, Office of
the Executive Secretariat, 20
Massachusetts Avenue, NW., Room
5012, Washington, DC 20529–2020,
Telephone number 202–272–8377.
Dated: April 14, 2011.
Sunday A. Aigbe,
Chief, Regulatory Products Division, Office
of the Executive Secretariat, U.S. Citizenship
and Immigration Services, Department of
Homeland Security.
[FR Doc. 2011–9437 Filed 4–18–11; 8:45 am]
BILLING CODE 9111–97–P
DEPARTMENT OF HOMELAND
SECURITY
U.S. Citizenship and Immigration
Services
Agency Information Collection
Activities: Form I–765, Extension of an
Existing Information Collection;
Comment Request
60-Day Notice of Information
Collection Under Review: Form I–765,
Application for Employment
Authorization; OMB Control No. 1615–
0040.
ACTION:
The Department of Homeland
Security, U.S. Citizenship and
Immigration Services (USCIS) will be
submitting the following information
collection request for review and
clearance in accordance with the
Paperwork Reduction Act of 1995. The
information collection is published to
obtain comments from the public and
affected agencies. Comments are
encouraged and will be accepted for
sixty days until June 20, 2011.
During this 60 day period, USCIS will
be evaluating whether to revise the
Form I–765. Should USCIS decide to
revise Form I–765 we will advise the
public when we publish the 30-day
notice in the Federal Register in
accordance with the Paperwork
Reduction Act. The public will then
have 30 days to comment on any
revisions to the Form I–765.
E:\FR\FM\19APN1.SGM
19APN1
]]>Agencies
[Federal Register Volume 76, Number 75 (Tuesday, April 19, 2011)]
[Notices]
[Pages 21911-21912]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-9427]
=======================================================================
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DEPARTMENT OF HOMELAND SECURITY
Federal Emergency Management Agency
[Internal Agency Docket No. FEMA-3318-EM; Docket ID FEMA-2011-0001]
North Dakota; Amendment No. 1 to Notice of an Emergency
Declaration
AGENCY: Federal Emergency Management Agency, DHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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.
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,
[[Page 21912]]
Disaster Unemployment Assistance (DUA); 97.046, Fire Management
Assistance Grant; 97.048, Disaster Housing Assistance to Individuals
and Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050 Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.
W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-9427 Filed 4-18-11; 8:45 am]
BILLING CODE 9111-23-P
