Gayle Rothenberg: Debarment Order, 69272-69273 [2011-28877]
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mstockstill on DSK4VPTVN1PROD with NOTICES
69272
Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Notices
Rick Larsen, Jay Inslee, Norm Dicks,
Adam Smith, Dave Reichert, Jaime
Herrera Beutler and Jim McDermott (all
of Washington), and Congresswoman
Laura Richardson (California), to study
the impacts and the extent to which the
U.S. Harbor Maintenance Tax (HMT),
other U.S. policies, and other factors
may incentivize container cargo to shift
from U.S. West Coast ports to those
located in Canada and Mexico. These
requests also asked the Commission to
make legislative and regulatory
recommendations to address this
concern.
In recent years, there has been a
steadily observed increase in the
amount of U.S.-destined cargo moving
through newly established west coast
Canadian port Prince Rupert and the
´
expanded Mexican port Lazaro
´
Cardenas. These same years saw
investment in and promotion of
Canadian and Mexican port and
intermodal rail infrastructure, as well as
changes to environmental requirements,
security considerations, and customs
inspection procedures.
The HMT has also been the subject of
recent congressional interest. Originally
enacted as part of the Comprehensive
Water Resources Development Act of
1986, the HMT was devised to help
fund harbor and channel maintenance
by charging users of U.S. seaports at an
ad valorem rate of 0.125%. See 26
U.S.C. 4461. The HMT is currently
imposed only on imports and is payable
at the time of unloading of the cargo in
the U.S. port. Id. Cargo ultimately
destined for U.S. inland points but
entering at Canadian or Mexican
seaports is not subject to the HMT.
In order to prepare the fullest
response possible, the Commission now
invites comment and information from
all members of the interested public
(whether they be located in the United
States or elsewhere), including public
port authorities, private marine terminal
operators, ocean common carriers,
ocean transportation intermediaries,
supply chain experts, providers of rail
and trucking services, state, local,
provincial or national governments,
importers, exporters and beneficial
cargo owners. Comments that are
specific and provide supporting data are
most helpful.
1. Describe the differences, if any, in
taxes, fees, laws, regulations, cargo
handling, customs processes, related
terminal/port procedure, infrastructure,
or intermodal services between U.S. and
Canadian or Mexican ports that may
come into consideration when
determining how to route cargo destined
for U.S. inland points. Please be as
specific as possible.
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16:29 Nov 07, 2011
Jkt 226001
2. Provide your opinion and
supporting data regarding the reasons
vessel-operating common carriers
serving the U.S., Canada and Mexico
may prefer to make Mexican or
Canadian ports their first North
American ports of call.
3. Describe why ocean transportation
intermediaries or importers may prefer
to route their customers’ inland U.S.destined cargo via a Mexican or
Canadian port.
4. Describe and, if possible, quantify
the advantages and disadvantages a
beneficial cargo owner may face when
considering whether to route inland
U.S.-destined cargo via a Mexican or
Canadian port. Specifically, what role, if
any, does the assessment of the Harbor
Maintenance Tax (HMT) have on that
determination? What are the other
considerations? If there is a cost
advantage due to lower total
transportation costs (ocean, truck, rail),
please quantify those differences and
describe the source of any such cost
differentials.
5. Please quantify the effect, if any,
the change in cargo routing has had on
employment in the United States.
6. Describe what volume or other
incentives, bonuses or discounts, if any,
are offered by ports, common carriers,
terminal operators, or other entities for
cargo moved through Canadian or
Mexican ports and where these may be
available to the shipping public.
7. Describe the advantages and/or
disadvantages current transportation
services via Canadian or Mexican ports
may offer to U.S. exporters.
8. State your view on actions that the
U.S. Government can take to improve
competitiveness of U.S. ports. Of those
actions, what are the most important or
pressing?
Submit Comments:
Non-confidential filings may be
submitted in hard copy or by email as
an attachment (preferably in Microsoft
Word or PDF) addressed to
secretary@fmc.gov on or before
December 22, 2011. Include in the
subject line: ‘‘U.S. Containerized Cargo
Flows—Response to NOI.’’ Confidential
filings must be submitted in the
traditional manner on paper, rather than
by email. Comments submitted that seek
confidential treatment must be
submitted in hard copy by U.S. mail or
courier. Confidential filings must be
accompanied by a transmittal letter that
identifies the filing as ‘‘confidential’’
and describes the nature and extent of
the confidential treatment requested.
When submitting comments in response
to the Notice of Inquiry that contain
confidential information, the
confidential copy of the filing must
PO 00000
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Fmt 4703
Sfmt 4703
consist of the complete filing and be
marked by the filer as ‘‘ConfidentialRestricted,’’ with the confidential
material clearly marked on each page.
When a confidential filing is submitted,
an original and one additional copy of
the public version of the filing must be
submitted. The public version of the
filing should exclude confidential
materials, and be clearly marked on
each affected page, ‘‘confidential
materials excluded.’’ The Commission
will provide confidential treatment to
the extent allowed by law for those
submissions, or parts of submissions, for
which confidential treatment is
requested. Questions regarding filing or
treatment of confidential responses to
this Notice of Inquiry should be directed
to the Commission’s Secretary, Karen V.
Gregory, at the telephone number or
email provided above.
By the Commission.
Karen V. Gregory,
Secretary.
[FR Doc. 2011–28878 Filed 11–7–11; 8:45 am]
BILLING CODE 6730–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0444]
Gayle Rothenberg: 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 Gayle
Rothenberg, 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. Rothenberg was
convicted of felonies under Federal law
for conduct relating to the regulation of
a drug product under the FD&C Act.
Dr. Rothenberg was given notice of the
proposed permanent debarment and an
opportunity to request a hearing within
the timeframe prescribed by regulation.
Dr. Rothenberg failed to respond.
Dr. Rothenberg’s failure to respond
constitutes a waiver of her right to a
hearing concerning this action.
DATES: This order is effective November
8, 2011.
ADDRESSES: Submit applications for
special termination of debarment to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
SUMMARY:
E:\FR\FM\08NON1.SGM
08NON1
Federal Register / Vol. 76, No. 216 / Tuesday, November 8, 2011 / Notices
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:
mstockstill on DSK4VPTVN1PROD 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 relating to the regulation of any
drug product under the FD&C Act.
On April 20, 2010, the U.S. District
Court for the Southern District of Texas
entered judgment against Dr.
Rothenberg for one felony count of, with
intent to defraud and mislead,
misbranding a drug while held for sale
after shipment in interstate commerce in
violation of 21 U.S.C. 331(k), 333(a)(2),
352(i)(3) and 18 U.S.C. 2, and one felony
count of intentionally and knowingly, in
a matter within the jurisdiction of FDA,
making a false statement to an agent of
FDA in violation of 18 U.S.C. 1001.
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 this
conviction is as follows: Dr. Rothenberg
was a physician licensed by the State of
Texas as a medical doctor with a
specialty in the area of anesthesiology.
Dr. Rothenberg served as the medical
director and operated a medical clinic
in the Southern District of Texas. The
medical clinic provided and performed
services related to the enhancement of
the physical appearance of clients and
included BOTOX injections.
From February to September 2004,
Dr. Rothenberg and her office manager
caused staff members to order a
botulinum toxin type A (TRI-toxin)
product from Toxin Research
International, Inc. (TRI) that was not
approved by FDA. Dr. Rothenberg
informed staff members that a new
BOTOX product would be used to treat
patients. When the orders from TRI
were received, the invoice
accompanying the order as well as
packaging and labeling on each vial
indicated that the TRI-toxin was for
research purposes only and not for
human use. Dr. Rothenberg was aware
that the product was not intended for
human use; however, she performed
injections and used the TRI-toxin on
patients at her medical practice from
February through September 2004.
Dr. Rothenberg misrepresented to
VerDate Mar<15>2010
16:29 Nov 07, 2011
Jkt 226001
patients that they were receiving
injections of authentic BOTOX and
BOTOX Cosmetic when in fact she
knew the patients were receiving
injections of non-FDA approved TRItoxin.
On January 20, 2005, agents of FDA
traveled to Dr. Rothenberg’s clinic and
spoke to her about whether any TRItoxin had been ordered and used on
patients of the medical clinic.
Dr. Rothenberg confirmed that the
nonapproved product had been ordered
but stated that it had only been
administered to friends and family. On
February 28, 2005, agents of FDA again
traveled to Dr. Rothenberg’s clinic and
presented 10 invoices showing that the
clinic had ordered the TRI-toxin. This
time Dr. Rothenberg stated that the
product had been used on patients
without her knowledge and approval.
Dr. Rothenberg indicated that
approximately 210 patients received
injections of the TRI-toxin during the
period of February 4 and September 8,
2004. Agents of FDA reviewed billing
statements from Dr. Rothenberg’s clinic
and determined that the clinic received
approximately $98,000 from patients
who received injections of the non-FDA
approved TRI-toxin.
Dr. Rothenberg pleaded guilty to, with
intent to defraud or mislead,
misbranding a drug while held for sale
after shipment in interstate commerce,
in violation of Title 21 U.S.C. 331(k),
333(a)(2), 352(i)(3) and 18 U.S.C. 2, and
to making a false statement to an agent
of FDA in violation of 18 U.S.C. 1001.
As a result of her convictions, on
August 22, 2011, FDA sent Dr.
Rothenberg 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,
that Dr. Rothenberg 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. Rothenberg 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. The
proposal was received on August 30,
2011. Dr. Rothenberg failed to respond
within the timeframe prescribed by
regulation and has, therefore, waived
her opportunity for a hearing and has
waived any contentions concerning her
debarment (21 CFR part 12).
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Fmt 4703
Sfmt 9990
69273
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 Gayle Rothenberg
has been convicted of felonies 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. Rothenberg 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) and
(c)(2)(A)(ii) 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. Rothenberg, in
any capacity during Dr. Rothenberg’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.
Rothenberg 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. Rothenberg during her period of
debarment (section 306(c)(1)(B) of the
FD&C Act).
Any application by Dr. Rothenberg for
special termination of debarment under
section 306(d)(4) of the FD&C Act
should be identified with Docket
No. FDA–2011–N–0444 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: October 25, 2011.
Armando Zamora,
Acting Director, Office of Enforcement, Office
of Regulatory Affairs.
[FR Doc. 2011–28877 Filed 11–7–11; 8:45 am]
BILLING CODE 4160–01–P
E:\FR\FM\08NON1.SGM
08NON1
]]>Agencies
[Federal Register Volume 76, Number 216 (Tuesday, November 8, 2011)]
[Notices]
[Pages 69272-69273]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-28877]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0444]
Gayle Rothenberg: 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 Gayle Rothenberg, 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. Rothenberg was
convicted of felonies under Federal law for conduct relating to the
regulation of a drug product under the FD&C Act. Dr. Rothenberg was
given notice of the proposed permanent debarment and an opportunity to
request a hearing within the timeframe prescribed by regulation. Dr.
Rothenberg failed to respond. Dr. Rothenberg's failure to respond
constitutes a waiver of her right to a hearing concerning this action.
DATES: This order is effective November 8, 2011.
ADDRESSES: Submit applications for special termination of debarment to
the Division of Dockets Management (HFA-305), Food and Drug
Administration,
[[Page 69273]]
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 relating
to the regulation of any drug product under the FD&C Act.
On April 20, 2010, the U.S. District Court for the Southern
District of Texas entered judgment against Dr. Rothenberg for one
felony count of, with intent to defraud and mislead, misbranding a drug
while held for sale after shipment in interstate commerce in violation
of 21 U.S.C. 331(k), 333(a)(2), 352(i)(3) and 18 U.S.C. 2, and one
felony count of intentionally and knowingly, in a matter within the
jurisdiction of FDA, making a false statement to an agent of FDA in
violation of 18 U.S.C. 1001.
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 this conviction is as follows:
Dr. Rothenberg was a physician licensed by the State of Texas as a
medical doctor with a specialty in the area of anesthesiology. Dr.
Rothenberg served as the medical director and operated a medical clinic
in the Southern District of Texas. The medical clinic provided and
performed services related to the enhancement of the physical
appearance of clients and included BOTOX injections.
From February to September 2004, Dr. Rothenberg and her office
manager caused staff members to order a botulinum toxin type A (TRI-
toxin) product from Toxin Research International, Inc. (TRI) that was
not approved by FDA. Dr. Rothenberg informed staff members that a new
BOTOX product would be used to treat patients. When the orders from TRI
were received, the invoice accompanying the order as well as packaging
and labeling on each vial indicated that the TRI-toxin was for research
purposes only and not for human use. Dr. Rothenberg was aware that the
product was not intended for human use; however, she performed
injections and used the TRI-toxin on patients at her medical practice
from February through September 2004. Dr. Rothenberg misrepresented to
patients that they were receiving injections of authentic BOTOX and
BOTOX Cosmetic when in fact she knew the patients were receiving
injections of non-FDA approved TRI-toxin.
On January 20, 2005, agents of FDA traveled to Dr. Rothenberg's
clinic and spoke to her about whether any TRI-toxin had been ordered
and used on patients of the medical clinic. Dr. Rothenberg confirmed
that the nonapproved product had been ordered but stated that it had
only been administered to friends and family. On February 28, 2005,
agents of FDA again traveled to Dr. Rothenberg's clinic and presented
10 invoices showing that the clinic had ordered the TRI-toxin. This
time Dr. Rothenberg stated that the product had been used on patients
without her knowledge and approval. Dr. Rothenberg indicated that
approximately 210 patients received injections of the TRI-toxin during
the period of February 4 and September 8, 2004. Agents of FDA reviewed
billing statements from Dr. Rothenberg's clinic and determined that the
clinic received approximately $98,000 from patients who received
injections of the non-FDA approved TRI-toxin.
Dr. Rothenberg pleaded guilty to, with intent to defraud or
mislead, misbranding a drug while held for sale after shipment in
interstate commerce, in violation of Title 21 U.S.C. 331(k), 333(a)(2),
352(i)(3) and 18 U.S.C. 2, and to making a false statement to an agent
of FDA in violation of 18 U.S.C. 1001.
As a result of her convictions, on August 22, 2011, FDA sent Dr.
Rothenberg 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, that Dr.
Rothenberg 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. Rothenberg 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. The proposal was received on
August 30, 2011. Dr. Rothenberg failed to respond within the timeframe
prescribed by regulation and has, therefore, waived her opportunity for
a hearing and has 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(a)(2)(B) of the FD&C Act, under
authority delegated to the Director (Staff Manual Guide 1410.35), finds
that Gayle Rothenberg has been convicted of felonies 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. Rothenberg 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) and (c)(2)(A)(ii) 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. Rothenberg, in any capacity during Dr. Rothenberg'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. Rothenberg 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. Rothenberg
during her period of debarment (section 306(c)(1)(B) of the FD&C Act).
Any application by Dr. Rothenberg for special termination of
debarment under section 306(d)(4) of the FD&C Act should be identified
with Docket No. FDA-2011-N-0444 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: October 25, 2011.
Armando Zamora,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2011-28877 Filed 11-7-11; 8:45 am]
BILLING CODE 4160-01-P
