Agency Forms Undergoing Paperwork Reduction Act Review, 13191-13192 [2011-5460]
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13191
Federal Register / Vol. 76, No. 47 / Thursday, March 10, 2011 / Notices
FEDERAL RESERVE SYSTEM
Formations of, Acquisitions by, and
Mergers of Bank Holding Companies
The companies listed in this notice
have applied to the Board for approval,
pursuant to the Bank Holding Company
Act of 1956 (12 U.S.C. 1841 et seq.)
(BHC Act), Regulation Y (12 CFR part
225), and all other applicable statutes
and regulations to become a bank
holding company and/or to acquire the
assets or the ownership of, control of, or
the power to vote shares of a bank or
bank holding company and all of the
banks and nonbanking companies
owned by the bank holding company,
including the companies listed below.
The applications listed below, as well
as other related filings required by the
Board, are available for immediate
inspection at the Federal Reserve Bank
indicated. The application also will be
available for inspection at the offices of
the Board of Governors. Interested
persons may express their views in
writing on the standards enumerated in
the BHC Act (12 U.S.C. 1842(c)). If the
proposal also involves the acquisition of
a nonbanking company, the review also
includes whether the acquisition of the
nonbanking company complies with the
standards in section 4 of the BHC Act
(12 U.S.C. 1843). Unless otherwise
noted, nonbanking activities will be
conducted throughout the United States.
Unless otherwise noted, comments
regarding each of these applications
must be received at the Reserve Bank
indicated or the offices of the Board of
Governors not later than April 4, 2011.
A. Federal Reserve Bank of Atlanta
(Clifford Stanford, Vice President) 1000
Peachtree Street, NE., Atlanta, Georgia
30309:
1. Teche Holding Company, New
Iberia, Louisiana; to become a bank
holding company by acquiring 100
percent of the outstanding shares of
Teche Federal Bank, New Iberia,
Louisiana.
Board of Governors of the Federal Reserve
System, March 7, 2011.
Robert deV. Frierson,
Deputy Secretary of the Board.
[FR Doc. 2011–5458 Filed 3–9–11; 8:45 am]
BILLING CODE 6210–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30-Day–11–11BI]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC 20503 or by fax to (202) 395–5806.
Written comments should be received
within 30 days of this notice.
Proposed Project
FoodNet Non-O157 Shiga toxinProducing E. coli Study: Assessment of
Risk Factors for Laboratory-Confirmed
Infections and Characterization of
Illnesses by Microbiological
Characteristics—New—National Center
for Emerging and Zoonotic Infectious
Diseases, Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Each year many Shiga toxinproducing E. coli (STEC) infections
occur in the United States, ranging in
severity from mild diarrhea, to
hemorrhagic colitis and in some cases,
life-threatening hemolytic uremic
syndrome (HUS). HUS occurs most
frequently following infection with
serogroup O157; 6% of patients with
this type of STEC infection develop
HUS, with highest occurrence in
children aged < 5 years. HUS has a
fatality rate of approximately 5%; up to
25% of HUS survivors are left with
chronic kidney damage. STEC are
broadly categorized into two groups by
their O antigens, STEC O157 and nonO157 STEC. The serogroup O157 is
most frequently isolated and most
strongly associated with HUS. Risk
factors for STEC O157 infections in the
United States and internationally have
been intensely studied. Non-O157 STEC
are a diverse group that includes all
Shiga toxin-producing E. coli of
serogroups other than O157. Over 50
STEC serogroups are known to have
caused human illness. Numerous nonO157 outbreaks have been reported from
throughout the world and clinical
outcomes in some patients can be as
severe as those seen with STEC O157
infections, however, little is known
about the specific risk factors for
infections due to non-O157 STEC
serogroups. More comprehensive
understanding of risk factors for
sporadic non-O157 STEC infections is
needed to inform prevention and
control efforts. The FoodNet casecontrol study will be the first multistate
investigation of non-outbreak-associated
non-O157 STEC infections in the United
States. It will investigate risk factors for
non-O157 STEC infections, both as a
group and individually for the most
common non-O157 STEC serogroups. In
addition, the study will characterize the
major known virulence factors of nonO157 STEC to assess how risk factors
and clinical features vary by virulence
factor profiles. As the largest, most
comprehensive, and most powerful
study of its kind, it could make an
important contribution towards better
understanding of non-O157 STEC
infections and to providing sciencebased recommendations for
interventions to prevent these
infections.
Persons with non-O157 STEC
infections who are identified as part of
routine public health surveillance and
randomly selected healthy persons in
the patients’ communities (to serve as
controls) will be contacted and offered
enrollment into this study. Participation
is completely voluntary and there is no
cost for enrollment. The total estimated
annualized burden is 268 hours.
jdjones on DSK8KYBLC1PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Respondents
Patients ........................................................................................................................................
Controls ........................................................................................................................................
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14:43 Mar 09, 2011
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161
483
10MRN1
Number of responses per
respondent
1
1
Average
burden per
response
(in hours)
25/60
25/60
13192
Federal Register / Vol. 76, No. 47 / Thursday, March 10, 2011 / Notices
Catina Conner,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevent.
[FR Doc. 2011–5460 Filed 3–9–11; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0479]
Mark E. Van Wormer: 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 Mark E. Van
Wormer, MD, 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 Dr. Van Wormer was
convicted of a felony under Federal law
for conduct relating to the regulation of
a drug product under the FD&C Act. Dr.
Van Wormer was given notice of the
proposed permanent debarment and an
opportunity to request a hearing within
the timeframe prescribed by regulation.
In a January 1, 2011, letter to FDA, Dr.
Van Wormer notified FDA that he did
not plan to seek a hearing and therefore
has waived his right to a hearing
concerning this action.
DATES: This order is effective March 10,
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:
SUMMARY:
jdjones on DSK8KYBLC1PROD with NOTICES
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 December 13, 2007, the U.S.
District Court, District of New Mexico,
entered judgment against Dr. Van
VerDate Mar<15>2010
14:43 Mar 09, 2011
Jkt 223001
Wormer for felony misbranding a drug
while held for sale in violation of 21
U.S.C. 333(a)(2), 331(k) and 352(i)(3).
FDA’s finding that debarment is
appropriate is based on the felony
conviction referenced herein for
conduct relating to the regulation of a
drug product. The factual basis for the
conviction is as follows: Dr. Van
Wormer is a physician licensed by the
New Mexico State Board of Medicine,
and he owned and operated the Union
County Medical Center, also known as
the Union County Medical, Diagnostic
Imaging and Laser Surgery Center, PC,
and the Physicians GreatSkin® Clinic.
From on or about January 13, 2004,
through on or about November 9, 2004,
Dr. Van Wormer advertised the use of
Allergan’s approved BOTOX for use in
treatment of forehead wrinkles.
However, during that time he knowingly
used TRI-toxin, an unapproved
botulinum toxin type A product, that he
purchased from Toxin Research
International, Inc. (TRI), a company in
Tucson, AZ.
Dr. Van Wormer purchased
approximately 20 vials of the TRI-toxin,
which he injected into his patients. He
did not inform his patients that they
were being injected with an unapproved
substance, and patients were charged as
if they were receiving the approved drug
product. Dr. Van Wormer injected
approximately 120 patients with the
unapproved TRI-toxin.
As a result of his convictions, on
December 17, 2010, FDA sent Dr. Van
Wormer 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. Van Wormer was convicted of
a felony under Federal law for conduct
relating to the regulation of a drug
product under the FD&C Act. The
proposal also offered Dr. Van Wormer
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.
Van Wormer submitted a letter dated
January 1, 2011, acknowledging receipt
of the proposal to debar and noting that
he did not plan to seek a further hearing
regarding the matter and thereby has
waived his opportunity for a hearing
and any contentions concerning his
debarment (21 CFR part 12).
PO 00000
Frm 00069
Fmt 4703
Sfmt 9990
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 Mark E. Van
Wormer 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
and based on his notification of
acquiescence, Dr. Van Wormer 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) of the
FD&C Act 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. Van Wormer, in
any capacity during Dr. Van Wormer’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.
Van Wormer 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. Van Wormer during his period of
debarment (section 306(c)(1)(B) of the
FD&C Act).
Any application by Dr. Van Wormer
for special termination of debarment
under section 306(d)(4) of the FD&C Act
should be identified with Docket No.
FDA–2010–N–0479 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 16, 2011.
Howard Sklamberg,
Director, Office of Enforcement, Office of
Regulatory Affairs.
[FR Doc. 2011–5498 Filed 3–9–11; 8:45 am]
BILLING CODE 4160–01–P
E:\FR\FM\10MRN1.SGM
10MRN1
]]>Agencies
[Federal Register Volume 76, Number 47 (Thursday, March 10, 2011)]
[Notices]
[Pages 13191-13192]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-5460]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30-Day-11-11BI]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call
the CDC Reports Clearance Officer at (404) 639-5960 or send an e-mail
to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of
Management and Budget, Washington, DC 20503 or by fax to (202) 395-
5806. Written comments should be received within 30 days of this
notice.
Proposed Project
FoodNet Non-O157 Shiga toxin-Producing E. coli Study: Assessment of
Risk Factors for Laboratory-Confirmed Infections and Characterization
of Illnesses by Microbiological Characteristics--New--National Center
for Emerging and Zoonotic Infectious Diseases, Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
Each year many Shiga toxin-producing E. coli (STEC) infections
occur in the United States, ranging in severity from mild diarrhea, to
hemorrhagic colitis and in some cases, life-threatening hemolytic
uremic syndrome (HUS). HUS occurs most frequently following infection
with serogroup O157; 6% of patients with this type of STEC infection
develop HUS, with highest occurrence in children aged < 5 years. HUS
has a fatality rate of approximately 5%; up to 25% of HUS survivors are
left with chronic kidney damage. STEC are broadly categorized into two
groups by their O antigens, STEC O157 and non-O157 STEC. The serogroup
O157 is most frequently isolated and most strongly associated with HUS.
Risk factors for STEC O157 infections in the United States and
internationally have been intensely studied. Non-O157 STEC are a
diverse group that includes all Shiga toxin-producing E. coli of
serogroups other than O157. Over 50 STEC serogroups are known to have
caused human illness. Numerous non-O157 outbreaks have been reported
from throughout the world and clinical outcomes in some patients can be
as severe as those seen with STEC O157 infections, however, little is
known about the specific risk factors for infections due to non-O157
STEC serogroups. More comprehensive understanding of risk factors for
sporadic non-O157 STEC infections is needed to inform prevention and
control efforts. The FoodNet case-control study will be the first
multistate investigation of non-outbreak-associated non-O157 STEC
infections in the United States. It will investigate risk factors for
non-O157 STEC infections, both as a group and individually for the most
common non-O157 STEC serogroups. In addition, the study will
characterize the major known virulence factors of non-O157 STEC to
assess how risk factors and clinical features vary by virulence factor
profiles. As the largest, most comprehensive, and most powerful study
of its kind, it could make an important contribution towards better
understanding of non-O157 STEC infections and to providing science-
based recommendations for interventions to prevent these infections.
Persons with non-O157 STEC infections who are identified as part of
routine public health surveillance and randomly selected healthy
persons in the patients' communities (to serve as controls) will be
contacted and offered enrollment into this study. Participation is
completely voluntary and there is no cost for enrollment. The total
estimated annualized burden is 268 hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Respondents Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Patients........................................................ 161 1 25/60
Controls........................................................ 483 1 25/60
----------------------------------------------------------------------------------------------------------------
[[Page 13192]]
Catina Conner,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevent.
[FR Doc. 2011-5460 Filed 3-9-11; 8:45 am]
BILLING CODE 4163-18-P
