Maria Carmen Palazzo: Debarment Order, 19100-19101 [2011-8152]
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Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Notices
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[FR Doc. 2011–8164 Filed 4–5–11; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0450]
Maria Carmen Palazzo: 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 Maria Carmen
Palazzo, M.D. 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. Palazzo was convicted
of felonies under Federal law for
conduct relating to the development or
approval, including the process for
development or approval, of any drug
product or otherwise relating to the
regulation of any drug product under
the FD&C Act. Dr. Palazzo was given
notice of the proposed permanent
debarment and an opportunity to
request a hearing within the timeframe
prescribed by regulation. Dr. Palazzo
failed to respond. Dr. Palazzo’s failure to
respond constitutes a waiver of her right
to a hearing concerning this action.
DATES: This order is effective April 6,
2011.
mstockstill on DSKH9S0YB1PROD with NOTICES
SUMMARY:
Submit applications for
special termination of debarment to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
ADDRESSES:
VerDate Mar<15>2010
17:57 Apr 05, 2011
Jkt 223001
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)(A) and (B) of the
FD&C Act (21 U.S.C. 335a(a)(2)(A) and
(B)) require debarment of an individual
if FDA finds that the individual has
been convicted of a felony under
Federal law for conduct relating to the
development or approval, including the
process for development or approval, of
any drug product or otherwise relating
to the regulation of any drug product
under the FD&C Act.
On August 19, 2010, the United States
District Court for the Eastern District of
Louisiana accepted Dr. Palazzo’s plea of
guilty, and entered judgment against her
for 15 counts of failure to prepare and
maintain records with intent to defraud
or mislead in violation of 21 U.S.C.
331(e), 333(a)(2), and 18 U.S.C. 2.
FDA’s finding that debarment is
appropriate is based on the felony
convictions referenced herein for
conduct relating to the development or
approval, including the process for
development or approval, of any drug
product and otherwise relating to the
regulation of any drug product under
the FD&C Act. The factual basis for
those convictions is as follows: Dr.
Palazzo was a licensed medical doctor
with offices located in New Orleans,
Louisiana. SmithKline Beecham,
Corporation, d.b.a. GlaxoSmithKline
(SKB) was a pharmaceutical company
engaged in developing, testing, and
marketing pharmaceutical products
including Paroxetine, also known as
‘‘Paxil.’’ Under the FD&C Act and its
implementing regulations, SKB had to
apply to FDA for approval to market
Paxil. SKB was required to demonstrate,
through clinical investigations in which
Paxil was given to human subjects, the
safety and effectiveness of the drug in
order to receive approval from FDA.
SKB hired Dr. Palazzo to be a clinical
investigator for the Paxil study. As a
participating investigator, Dr. Palazzo
signed, on multiple occasions, an FDA
Form 1572 committing to conduct the
study in accordance with the study
protocol, to personally conduct or
supervise the investigation, and to
comply with FDA regulations. Dr.
Palazzo agreed to conduct the study in
strict compliance with the criteria set
forth in the study protocol, to personally
review all Case Report Forms, and, in
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
return, SKB agreed to pay for each
subject who completed the study.
FDA regulations require that a clinical
investigator on a drug study prepare and
maintain adequate and accurate case
histories that record all observations
and other data pertinent to the
investigation on each study subject and
provide that information to the drug
sponsor. From on or about October 23,
2000, through May 24, 2001, Dr.
Palazzo, with intent to defraud and
mislead, failed to prepare and maintain
records required under 21 U.S.C. 355(i)
and 21 CFR 312.62(b), all in violation of
21 U.S.C. 331(e), 333(a)(2), and 18
U.S.C. 2.
As a result of her convictions, on
January 11, 2011, FDA sent Dr. Palazzo
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)(A) and (B) of the FD&C Act,
that Dr. Palazzo was convicted of
felonies under Federal law for conduct
relating to the development or approval,
including the process for development
or approval, of any drug product and
otherwise relating to the regulation of
any drug product under the FD&C Act.
The proposal also offered Dr. Palazzo 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.
Palazzo 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(a)(2)(A)
and(B) of the FD&C Act, under authority
delegated to the Acting Director (Staff
Manual Guide 1410.35), finds that Maria
Carmen Palazzo has been convicted of
felonies under Federal law for conduct
relating to the development or approval,
including the process for development
or approval, of any drug product and
otherwise relating to the regulation of
any drug product under the FD&C Act.
As a result of the foregoing finding,
Dr. Palazzo 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
E:\FR\FM\06APN1.SGM
06APN1
Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Notices
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)(ii), and 201(dd) of the FD&C
Act (21 U.S.C. 335a(c)(1)(B), (c)(2)(A)(ii),
and 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.
Palazzo, in any capacity during Dr.
Palazzo’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. Palazzo 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. Palazzo during her period of
debarment (section 306(c)(1)(B) of the
FD&C Act.
Any application by Dr. Palazzo for
special termination of debarment under
section 306(d)(4) of the FD&C Act
should be identified with Docket No.
FDA–2010–N–0450 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. 2011–8152 Filed 4–5–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on DSKH9S0YB1PROD with NOTICES
[Docket No. FDA–2011–N–0002]
Request for Notification From Industry
Organizations Interested in
Participating in the Selection Process
for a Nonvoting Industry
Representative and Request for
Nominations for a Nonvoting Industry
Representative on an FDA Advisory
Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Mar<15>2010
16:52 Apr 05, 2011
Jkt 223001
The Food and Drug
Administration (FDA) is requesting that
any industry organizations interested in
participating in the selection of a
nonvoting industry representative to
serve on its Allergenic Products
Advisory Committee notify FDA in
writing. A nominee may either be selfnominated or nominated by an
organization to serve as a nonvoting
industry representative. Nomination
will be accepted for current vacancies
effective with this notice.
DATES: Any industry organization
interested in participating in the
selection of an appropriate nonvoting
member to represent industry interests
must send a letter stating the interest to
FDA by May 6, 2011 for vacancies listed
in the notice. Concurrently, nomination
material for prospective candidates
should be sent to FDA by May 6, 2011.
ADDRESSES: All letters of interest and
nominations should be submitted in
writing to Gail Dapolito (see FOR
FURTHER INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT: Gail
Dapolito, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 1401 Rockville
Pike, Rockville, MD 20852–1448, 301–
827–1289, FAX: 301–827–0294, e-mail:
gail.dapolito@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
The Agency requests nominations for
a nonvoting industry representative on
the Allergenic Products Advisory
Committee. The Allergenic Products
Advisory Committee advises the
Commissioner or designee in
discharging responsibilities as they
relate to the regulation of allergenic
products. This Committee has nine
voting members. Members are asked to
provide their expert scientific and
technical advice to FDA to help make
sound decisions on the safety,
effectiveness, appropriate use, and
labeling of allergenic biological
products.
II. Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent industry interests should send
a letter stating that interest to the FDA
contact (see FOR FURTHER INFORMATION
CONTACT) within 30 days of publication
of this document. Within the
subsequent 30 days, FDA will send a
letter to each organization that has
expressed an interest, attaching a
complete list of all such organizations,
and a list of all nominees along with
their current resumes. The letter will
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Fmt 4703
Sfmt 4703
19101
also state that it is the responsibility of
the interested organizations to confer
with one another and to select a
candidate, within 60 days after the
receipt of the FDA letter, to serve as the
nonvoting member to represent industry
interests for the Allergenic Products
Advisory Committee.
The interested organizations are not
bound by the list of nominees in
selecting a candidate. However, if no
individual is selected within 60 days,
the Commissioner of Food and Drugs
will select the nonvoting member to
represent industry interests.
III. Application Procedure
Individuals may self-nominate and/or
an organization may nominate one or
more individuals to serve as a nonvoting
industry representative. A current
curriculum vitae and the name of the
committee of interest should be sent to
the FDA contact person within the 30
days following nomination. FDA will
forward all nominations to the
organizations expressing interest in
participating in the selection process for
the committee. (Persons who nominate
themselves as nonvoting industry
representatives will not participate in
the selection process).
FDA has a special interest in ensuring
that women, minority groups,
individuals with physical disabilities,
and small businesses are adequately
represented on its advisory committees
and, therefore, encourages nominations
for appropriately qualified candidates
from these groups. Specifically, in this
document, nominations for nonvoting
representatives of industry interests are
encouraged from the allergenic product
manufacturing industry.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: March 31, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–8125 Filed 4–5–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Council on Blood Stem Cell
Transplantation; Notice of Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
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]]>Agencies
[Federal Register Volume 76, Number 66 (Wednesday, April 6, 2011)]
[Notices]
[Pages 19100-19101]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-8152]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0450]
Maria Carmen Palazzo: 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 Maria Carmen Palazzo, M.D. 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.
Palazzo was convicted of felonies under Federal law for conduct
relating to the development or approval, including the process for
development or approval, of any drug product or otherwise relating to
the regulation of any drug product under the FD&C Act. Dr. Palazzo was
given notice of the proposed permanent debarment and an opportunity to
request a hearing within the timeframe prescribed by regulation. Dr.
Palazzo failed to respond. Dr. Palazzo's failure to respond constitutes
a waiver of her right to a hearing concerning this action.
DATES: This order is effective April 6, 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)(A) and (B) of the FD&C Act (21 U.S.C.
335a(a)(2)(A) and (B)) require debarment of an individual if FDA finds
that the individual has been convicted of a felony under Federal law
for conduct relating to the development or approval, including the
process for development or approval, of any drug product or otherwise
relating to the regulation of any drug product under the FD&C Act.
On August 19, 2010, the United States District Court for the
Eastern District of Louisiana accepted Dr. Palazzo's plea of guilty,
and entered judgment against her for 15 counts of failure to prepare
and maintain records with intent to defraud or mislead in violation of
21 U.S.C. 331(e), 333(a)(2), and 18 U.S.C. 2.
FDA's finding that debarment is appropriate is based on the felony
convictions referenced herein for conduct relating to the development
or approval, including the process for development or approval, of any
drug product and otherwise relating to the regulation of any drug
product under the FD&C Act. The factual basis for those convictions is
as follows: Dr. Palazzo was a licensed medical doctor with offices
located in New Orleans, Louisiana. SmithKline Beecham, Corporation,
d.b.a. GlaxoSmithKline (SKB) was a pharmaceutical company engaged in
developing, testing, and marketing pharmaceutical products including
Paroxetine, also known as ``Paxil.'' Under the FD&C Act and its
implementing regulations, SKB had to apply to FDA for approval to
market Paxil. SKB was required to demonstrate, through clinical
investigations in which Paxil was given to human subjects, the safety
and effectiveness of the drug in order to receive approval from FDA.
SKB hired Dr. Palazzo to be a clinical investigator for the Paxil
study. As a participating investigator, Dr. Palazzo signed, on multiple
occasions, an FDA Form 1572 committing to conduct the study in
accordance with the study protocol, to personally conduct or supervise
the investigation, and to comply with FDA regulations. Dr. Palazzo
agreed to conduct the study in strict compliance with the criteria set
forth in the study protocol, to personally review all Case Report
Forms, and, in return, SKB agreed to pay for each subject who completed
the study.
FDA regulations require that a clinical investigator on a drug
study prepare and maintain adequate and accurate case histories that
record all observations and other data pertinent to the investigation
on each study subject and provide that information to the drug sponsor.
From on or about October 23, 2000, through May 24, 2001, Dr. Palazzo,
with intent to defraud and mislead, failed to prepare and maintain
records required under 21 U.S.C. 355(i) and 21 CFR 312.62(b), all in
violation of 21 U.S.C. 331(e), 333(a)(2), and 18 U.S.C. 2.
As a result of her convictions, on January 11, 2011, FDA sent Dr.
Palazzo 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)(A) and (B) of the FD&C Act, that Dr.
Palazzo was convicted of felonies under Federal law for conduct
relating to the development or approval, including the process for
development or approval, of any drug product and otherwise relating to
the regulation of any drug product under the FD&C Act. The proposal
also offered Dr. Palazzo 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. Palazzo 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(a)(2)(A) and(B) of the FD&C Act,
under authority delegated to the Acting Director (Staff Manual Guide
1410.35), finds that Maria Carmen Palazzo has been convicted of
felonies under Federal law for conduct relating to the development or
approval, including the process for development or approval, of any
drug product and otherwise relating to the regulation of any drug
product under the FD&C Act.
As a result of the foregoing finding, Dr. Palazzo 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
[[Page 19101]]
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)(ii), and 201(dd) of the FD&C Act (21
U.S.C. 335a(c)(1)(B), (c)(2)(A)(ii), and 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. Palazzo, in any capacity during Dr. Palazzo'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. Palazzo 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. Palazzo during her period of debarment (section
306(c)(1)(B) of the FD&C Act.
Any application by Dr. Palazzo for special termination of debarment
under section 306(d)(4) of the FD&C Act should be identified with
Docket No. FDA-2010-N-0450 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. 2011-8152 Filed 4-5-11; 8:45 am]
BILLING CODE 4160-01-P
