Maja S. Ruetschi: Debarment Order, 18556-18557 [2011-7782]
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Federal Register / Vol. 76, No. 64 / Monday, April 4, 2011 / Notices
administrative, provider, and customer
services process.
• Facilitate plans for IT Integration of
data resources and data services.
• Coordinate policy analysis,
development and execution for CMS.
• Build and maintain agency capacity
to perform analysis of regional variation
in the quality and cost of care.
• Conduct and manage surveys to
capture information about beneficiary
populations that our programs serve that
is not available in the administrative
data. This includes the Medicare
Current Beneficiary Survey (MCBS) and
the Medicare Health Outcomes Survey
(HOS).
• Conduct and manage the Research
Data Assistance Center (RESDAC),
Research Data Distribution Center
(RDDC) and Chronic Condition
Warehouse (CCW) activities.
• Operationalize research-usable files
for Medicare, Medicaid, and CHIP
administrative data.
Dated: March 24, 2011.
Marilyn Tavenner,
Principal Deputy Administrator and Chief
Operating Officer, Centers for Medicare &
Medicaid Services.
[FR Doc. 2011–7903 Filed 4–1–11; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Reunification Procedures for
Unaccompanied Alien Children.
OMB No.: 0970–0278.
Description: Following the passage of
the 2002 Homeland Security Act (Pub.
L. 107–296), the Administration for
Children and Families (ACF), Office of
Refugee Resettlement (ORR), is charged
with the care and placement of
unaccompanied alien children in
Federal custody, and implementing a
policy for the release of these children,
when appropriate, upon the request of
suitable sponsors while awaiting
immigration proceedings. In order for
ORR to make determinations regarding
the release of these children, the
potential sponsors must meet certain
conditions pursuant to section 462 of
the Homeland Security Act and the
Flores v. Reno Settlement Agreement
No. CV85 4544–RJK (C.D. Cal. 1997).
The proposed information collection
requests information to be utilized by
ORR for determining the suitability of a
sponsor/respondent for the release of a
minor from ORR custody. The proposed
instruments are the Sponsors Agreement
to Conditions of Release, Verification of
Release, Family Reunification Packet,
and the Authorization for Release of
Information.
Respondents: Sponsors requesting
release of unaccompanied alien.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Emcdonald on DSK2BSOYB1PROD with NOTICES
Verification of Release (UAC) ..........................................................................
Authorization for Release of Information (Sponsor) ........................................
Family Reunification Packet (Sponsor) ...........................................................
Sponsors Agreement to Conditions of Release (Sponsor) .............................
Verification of Release (Case Worker) ............................................................
Authorization for Release of Information (Case Worker) ................................
Family Reunification Packet (Case Worker) ....................................................
Sponsors Agreement to conditions of Release (Case Worker) ......................
Estimated Total Annual Burden
Hours: 16,082.50.
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
VerDate Mar<15>2010
18:47 Apr 01, 2011
Jkt 223001
4,595
4,595
4,595
4,595
4,595
4,595
4,595
4,595
Reduction Project, Fax: 202–395–7285,
E-mail:
OIRA_SUBMISSION@OMB.EOP.GOV,
Attn: Desk Officer for the
Administration for Children and
Families.
Dated: March 29, 2011.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011–7823 Filed 4–1–11; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0474]
Maja S. Ruetschi: Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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Average
burden hours
per response
0.25
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Total burden
hours
1,148.75
1,148.75
4,595
1,148.75
1,148.75
4,595
1,148.75
order under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) debarring
Maja S. Ruetschi, MD for 5 years from
providing services in any capacity to a
person that has an approved or pending
drug product application. FDA bases
this order on findings that Dr. Ruetschi
was convicted of a misdemeanor under
Federal law for conduct relating to the
regulation of a drug product under the
FD&C Act and that the type of conduct
underlying the conviction undermines
the process for the regulation of drugs.
Dr. Ruetschi was given notice of the
proposed debarment and an opportunity
to request a hearing within the
timeframe prescribed by regulation. Dr.
Ruetschi failed to respond. Dr.
Ruetschi’s failure to respond constitutes
a waiver of her right to a hearing
concerning this action.
DATES: This order is effective April 4,
2011.
Submit applications for
termination of debarment to the
Division of Dockets Management (HFA–
ADDRESSES:
The Food and Drug
Administration (FDA) is issuing an
SUMMARY:
PO 00000
Number of
responses per
respondent
E:\FR\FM\04APN1.SGM
04APN1
Federal Register / Vol. 76, No. 64 / Monday, April 4, 2011 / Notices
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
Enforcement, Office of Regulatory
Affairs, Food and Drug Administration,
5600 Fishers Lane, Rockville, MD
20857, 301–796–4640.
SUPPLEMENTARY INFORMATION:
Emcdonald on DSK2BSOYB1PROD with NOTICES
I. Background
Section 306(b)(2)(B)(i)(I) of the FD&C
Act (21 U.S.C. 335a(b)(2)(B)(i)(I))
permits FDA to debar an individual if it
finds that the individual has been
convicted of a misdemeanor under
Federal law for conduct relating to the
regulation of drug products under the
FD&C Act, and if FDA finds that the
type of conduct that served as the basis
for the conviction undermines the
process for the regulation of drugs.
On June 18, 2008, Dr. Ruetschi
pleaded guilty to a misdemeanor offense
of receipt and delivery of a misbranded
drug in interstate commerce in violation
of 21 U.S.C. 331(c), 333(a)(1), and 352(f).
On July 2, 2008, the U.S. District Court
for the Central District of California
entered judgment against Dr. Ruetschi
for receipt in interstate commerce of
misbranded drug and delivery thereof.
FDA’s finding that debarment is
appropriate is based on the
misdemeanor conviction referenced
herein. The factual basis for the
conviction is as follows: Dr. Ruetschi
was a licensed medical doctor in the
State of California and maintained an
office in Palm Desert, CA. Beginning on
or about January 20, 2004, and
continuing until on or about October 20,
2004, Dr. Ruetschi began ordering from
Toxin International, Inc., (TRI) an
unapproved drug product represented to
be a Botulinum Toxin Type A product
(TRI-toxin). Specifically, Dr. Ruetschi
placed 11 orders for a total of 11 vials
of TRI-toxin, which was shipped in
interstate commerce from Tucson, AZ to
her office in Palm Desert, CA. Dr.
Ruetschi subsequently administered the
TRI-toxin to her patients for the
treatment of facial wrinkles. The TRItoxin bore warnings that it was not for
human use and did not bear any
directions for human use, and was
misbranded under 21 U.S.C. 352(f) in
that it lacked adequate directions for
use.
As a result of her convictions, on
January 5, 2011, FDA sent Dr. Ruetschi
a notice by certified mail proposing to
debar her for 5 years from providing
services in any capacity to a person that
has an approved or pending drug
VerDate Mar<15>2010
18:47 Apr 01, 2011
Jkt 223001
product application. The proposal was
based on a finding, under section
306(b)(2)(B)(i)(I) of the FD&C Act (21
U.S.C. 335a(b)(2)(B)(i)(I)), that Dr.
Ruetschi was convicted of a
misdemeanor under Federal law for
conduct relating to the regulation of
drug products under the FD&C Act, and
the conduct that served as a basis for the
conviction undermines the process for
the regulation of drugs. The proposal
also offered Dr. Ruetschi 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 request a hearing
constituted a waiver of the opportunity
for a hearing and of any contentions
concerning this action. Dr. Ruetschi
failed to respond within the timeframe
prescribed by regulation and has,
therefore, waived her opportunity for a
hearing and waived 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(b)(2)(B)(i)(I)
of the FD&C Act under authority
delegated to him (Staff Manual Guide
1410.35), finds that Maja S. Ruetschi has
been convicted of a misdemeanor under
Federal law for conduct relating to the
regulation of a drug product under the
FD&C Act, and that the type of conduct
that served as a basis for the conviction
undermines the process for the
regulation of drugs.
As a result of the foregoing finding,
Dr. Ruetschi is debarred for 5 years 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)(iii), and 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. Ruetschi, in any capacity
during Dr. Ruetschi’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. Ruetschi 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). In addition, FDA will not
accept or review any abbreviated new
drug applications submitted by or with
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
18557
the assistance of Dr. Ruetschi during her
period of debarment (section
306(c)(1)(B) of the FD&C Act).
Any application by Dr. Ruetschi for
termination of debarment under section
306(d)(1) of the FD&C Act should be
identified with Docket No. FDA–2010–
N–0474 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 23, 2011.
Howard Sklamberg,
Director, Office of Enforcement, Office of
Regulatory Affairs.
[FR Doc. 2011–7782 Filed 4–1–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0476]
Marilyn A. Mehlmauer: 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) debarring
Marilyn Mehlmauer, MD for 4 years
from providing services in any capacity
to a person that has an approved or
pending drug product application. FDA
bases this order on findings that Dr.
Mehlmauer was convicted of a
misdemeanor under Federal Law for
conduct relating to the regulation of a
drug product under the FD&C Act and
that the type of conduct underlying the
conviction undermines the process for
the regulation of drugs. Dr. Mehlmauer
was given notice of the proposed
debarment and an opportunity to
request a hearing within the timeframe
prescribed by regulation. Dr. Mehlmauer
failed to respond. Dr. Mehlmauer’s
failure to respond constitutes a waiver
of her right to a hearing concerning this
action.
DATES: This order is effective April 4,
2011.
SUMMARY:
Submit applications for
termination of debarment to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
ADDRESSES:
E:\FR\FM\04APN1.SGM
04APN1
]]>Agencies
[Federal Register Volume 76, Number 64 (Monday, April 4, 2011)]
[Notices]
[Pages 18556-18557]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-7782]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0474]
Maja S. Ruetschi: 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) debarring
Maja S. Ruetschi, MD for 5 years from providing services in any
capacity to a person that has an approved or pending drug product
application. FDA bases this order on findings that Dr. Ruetschi was
convicted of a misdemeanor under Federal law for conduct relating to
the regulation of a drug product under the FD&C Act and that the type
of conduct underlying the conviction undermines the process for the
regulation of drugs. Dr. Ruetschi was given notice of the proposed
debarment and an opportunity to request a hearing within the timeframe
prescribed by regulation. Dr. Ruetschi failed to respond. Dr.
Ruetschi's failure to respond constitutes a waiver of her right to a
hearing concerning this action.
DATES: This order is effective April 4, 2011.
ADDRESSES: Submit applications for termination of debarment to the
Division of Dockets Management (HFA-
[[Page 18557]]
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 Enforcement, Office of Regulatory Affairs,
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,
301-796-4640.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(2)(B)(i)(I) of the FD&C Act (21 U.S.C.
335a(b)(2)(B)(i)(I)) permits FDA to debar an individual if it finds
that the individual has been convicted of a misdemeanor under Federal
law for conduct relating to the regulation of drug products under the
FD&C Act, and if FDA finds that the type of conduct that served as the
basis for the conviction undermines the process for the regulation of
drugs.
On June 18, 2008, Dr. Ruetschi pleaded guilty to a misdemeanor
offense of receipt and delivery of a misbranded drug in interstate
commerce in violation of 21 U.S.C. 331(c), 333(a)(1), and 352(f). On
July 2, 2008, the U.S. District Court for the Central District of
California entered judgment against Dr. Ruetschi for receipt in
interstate commerce of misbranded drug and delivery thereof.
FDA's finding that debarment is appropriate is based on the
misdemeanor conviction referenced herein. The factual basis for the
conviction is as follows: Dr. Ruetschi was a licensed medical doctor in
the State of California and maintained an office in Palm Desert, CA.
Beginning on or about January 20, 2004, and continuing until on or
about October 20, 2004, Dr. Ruetschi began ordering from Toxin
International, Inc., (TRI) an unapproved drug product represented to be
a Botulinum Toxin Type A product (TRI-toxin). Specifically, Dr.
Ruetschi placed 11 orders for a total of 11 vials of TRI-toxin, which
was shipped in interstate commerce from Tucson, AZ to her office in
Palm Desert, CA. Dr. Ruetschi subsequently administered the TRI-toxin
to her patients for the treatment of facial wrinkles. The TRI-toxin
bore warnings that it was not for human use and did not bear any
directions for human use, and was misbranded under 21 U.S.C. 352(f) in
that it lacked adequate directions for use.
As a result of her convictions, on January 5, 2011, FDA sent Dr.
Ruetschi a notice by certified mail proposing to debar her for 5 years
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(b)(2)(B)(i)(I) of the FD&C Act (21 U.S.C.
335a(b)(2)(B)(i)(I)), that Dr. Ruetschi was convicted of a misdemeanor
under Federal law for conduct relating to the regulation of drug
products under the FD&C Act, and the conduct that served as a basis for
the conviction undermines the process for the regulation of drugs. The
proposal also offered Dr. Ruetschi 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 request a hearing
constituted a waiver of the opportunity for a hearing and of any
contentions concerning this action. Dr. Ruetschi failed to respond
within the timeframe prescribed by regulation and has, therefore,
waived her opportunity for a hearing and waived 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(b)(2)(B)(i)(I) of the FD&C Act
under authority delegated to him (Staff Manual Guide 1410.35), finds
that Maja S. Ruetschi has been convicted of a misdemeanor under Federal
law for conduct relating to the regulation of a drug product under the
FD&C Act, and that the type of conduct that served as a basis for the
conviction undermines the process for the regulation of drugs.
As a result of the foregoing finding, Dr. Ruetschi is debarred for
5 years 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)(iii), and 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.
Ruetschi, in any capacity during Dr. Ruetschi'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. Ruetschi 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). In addition, FDA will not accept
or review any abbreviated new drug applications submitted by or with
the assistance of Dr. Ruetschi during her period of debarment (section
306(c)(1)(B) of the FD&C Act).
Any application by Dr. Ruetschi for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2010-N-0474 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 23, 2011.
Howard Sklamberg,
Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2011-7782 Filed 4-1-11; 8:45 am]
BILLING CODE 4160-01-P
