Maria Anne Kirkman Campbell; Denial of Hearing; Debarment Order, 51305-51306 [E8-20295]
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Federal Register / Vol. 73, No. 170 / Tuesday, September 2, 2008 / Notices
Dated: August 20, 2008.
Mary M. McGeein,
Principal Deputy Assistant Secretary for
Planning and Evaluation.
[FR Doc. E8–20225 Filed 8–29–08; 8:45 am]
BILLING CODE 4154–05–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2006–N–0166] (formerly
Docket No. 2006N–0238)
Maria Anne Kirkman Campbell; Denial
of Hearing; Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
erowe on PROD1PC64 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (the act) permanently
debarring Dr. Maria Anne Kirkman
Campbell (Dr. Campbell) 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. Campbell was
convicted of a felony under Federal law
for conduct relating to the development
or approval, including the process for
development or approval, of a drug
product, and conduct otherwise relating
to the regulation of a drug product
under the act. Dr. Campbell failed to
request a hearing and, therefore, has
waived her opportunity for a hearing
concerning this action. Even assuming
that any statement in Dr. Campbell’s
correspondence with FDA were to be
construed as requesting a hearing, Dr.
Campbell has failed to file with the
agency information and analyses
sufficient to create a basis for a hearing
concerning this action. Therefore, we
are, in the alternative, issuing an order
denying any such assumed request for a
hearing because we find that there is no
genuine and substantial issue of fact to
grant a hearing on the debarment, if a
hearing were requested.
DATES: This order is effective September
2, 2008.
ADDRESSES: Submit applications for
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:
Brian Pendleton, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6304,
VerDate Aug<31>2005
14:40 Aug 29, 2008
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Silver Spring, MD, 20993–0002, 301–
796–3504.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(a)(2)(A) of the act (21
U.S.C. 335a(a)(2)(A)) 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 development or approval,
including the process for development
or approval, of any drug product.
Section 306(a)(2)(B) of the act 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 act.
On March 25, 2004, the U.S. District
Court for the Northern District of
Alabama accepted Dr. Campbell’s plea
of guilty and convicted her of one count
of mail fraud, a felony under 18 U.S.C.
1341 and 2. Specifically, Dr. Campbell
admitted to submitting a fraudulent case
report form (reflecting enrollment of a
nonexistent person) while serving as a
clinical investigator in a clinical study
designed to test the safety and
effectiveness of an antibacterial drug
product, Ketek (telithromycin), for the
treatment of respiratory tract infections.
The clinical study was to be submitted
to FDA in support of approval of Ketek.
Accordingly, in a letter dated
February 28, 2007, and hand delivered
on March 5, 2007, FDA served Dr.
Campbell a notice proposing to
permanently debar her from providing
services in any capacity to a person
having an approved or pending drug
product application. The proposal was
based on a finding, under section
306(a)(2)(A) and (a)(2)(B) of the act, that
Dr. Campbell was convicted of a felony
under Federal law for conduct relating
to the development or approval,
including the process for development
or approval, of a drug product, and
conduct otherwise relating to the
regulation of a drug product. The letter
offered Dr. Campbell an opportunity to
request a hearing on the proposal,
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 letter also informed Dr. Campbell
that her request for a hearing could not
rest upon mere allegations or denials,
but must present specific facts showing
that there is a genuine and substantial
issue of fact requiring a hearing. In
addition, the letter informed Dr.
Campbell that the only material issue of
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51305
fact was whether she was convicted as
alleged in the letter, and that the facts
underlying her conviction are not at
issue in this proceeding. The letter also
informed Dr. Campbell that if it
conclusively appeared from the face of
the information and factual analyses in
her request for a hearing that there was
no genuine and substantial issue of fact
that precluded the order of debarment,
we would deny her request for a hearing
and enter a final order of debarment.
Finally, the letter informed Dr.
Campbell that if she were to file a
request for a hearing, she was required
to file, on or before 60 days from the
date of receipt of the letter, the
information on which she relied to
justify a hearing.
Dr. Campbell has responded to the
proposal to debar her but has not
requested a hearing.1 Her failure to
request a hearing constitutes a waiver of
her opportunity for a hearing and a
waiver of any contentions concerning
her debarment.
Even assuming that any statement in
Dr. Campbell’s correspondence with
FDA were to be construed as requesting
a hearing, Dr. Campbell has not
submitted information that would
justify granting a hearing. Therefore, we
are, in the alternative, hereby denying
any such assumed request for a hearing
because Dr. Campbell has failed to show
that there is a genuine and substantial
issue of fact requiring a hearing. Dr.
Campbell has not offered any
information or factual analyses to refute
that she was convicted of mail fraud for
conduct relating to the development or
approval of a drug product, or otherwise
relating to the regulation of a drug
product under the act.
II. Findings and Order
Therefore, the Associate
Commissioner for Regulatory Affairs,
under section 306(a)(2)(A) and (a)(2)(B)
of the act and under authority delegated
to her, finds that Dr. Maria Anne
Kirkman Campbell has been convicted
of a felony under Federal law for
conduct relating to the development or
approval, including the process for
1After we served Dr. Campbell on March 5, 2007,
with notice of the agency’s proposal to debar her,
Dr. Campbell sent a series of letters to the agency—
dated March 9, 2007, April 6, 2007, May 23, 2007,
July 17, 2007, August 21, 2007, and January 13,
2008,—and participated in a teleconference with
FDA on April 9, 2007. Although some of Dr.
Campbell’s correspondence refers to another
proceeding the agency initiated against Dr.
Campbell (investigator disqualification under 21
CFR 312.70), instead of, or in addition to, the
proposal to debar her, for the purposes of this order,
we have taken into account all of Dr. Campbell’s
correspondence with the agency after March 5,
2007, as well as the transcript from the April 9,
2007, teleconference.
E:\FR\FM\02SEN1.SGM
02SEN1
51306
Federal Register / Vol. 73, No. 170 / Tuesday, September 2, 2008 / Notices
development or approval, of a drug
product, and conduct otherwise relating
to the regulation of a drug product
under the act.
As a result of the foregoing finding,
Dr. Maria Anne Kirkman Campbell 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 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 as stated in the DATES section
of this document (see section
306(c)(1)(B) and (c)(2)(A)(ii) and 201(dd)
of the act (21 U.S.C. 321(dd))). Any
person with an approved or pending
drug product application who
knowingly uses the services of Dr.
Campbell in any capacity, during her
period of debarment, will be subject to
civil money penalties (section 307(a)(6)
of the act (21 U.S.C. 335b(a)(6))). If Dr.
Campbell, during her period of
debarment, provides services in any
capacity to a person with an approved
or pending drug product application,
she will be subject to civil money
penalties (section 307(a)(7) of the act).
In addition, FDA will not accept or
review any abbreviated new drug
application submitted by or with the
assistance of Dr. Campbell during her
period of debarment (section
306(c)(1)(B) of the act).
Any application by Dr. Campbell for
special termination of debarment under
section 306(d)(4) of the act should be
identified with Docket No. FDA–2006–
N–0166 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: August 22, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–20295 Filed 8–29–08; 8:45 am]
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BILLING CODE 4160–01–S
VerDate Aug<31>2005
14:40 Aug 29, 2008
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0455]
Guide to Minimize Microbial Food
Safety Hazards for Fresh Fruits and
Vegetables; Request for Comments
and for Scientific Data and Information
AGENCY:
Food and Drug Administration,
HHS.
Notice; request for comments
and for scientific data and information.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is requesting
comments and scientific data and
information that may assist the agency
to improve the guidance to industry set
forth in the ‘‘Guide to Minimize
Microbial Food Safety Hazards for Fresh
Fruits and Vegetables,’’ issued in 1998.
Specifically, FDA is seeking information
about current agricultural practices and
conditions used to grow, harvest, pack,
cool, and transport fresh produce; risk
factors for contamination of fresh
produce associated with these practices;
and possible measures that FDA could
implement that would enhance the
safety of fresh produce.
DATES: Submit written comments and
scientific data and information or
electronic comments by December 31,
2008.
Submit written comments
and scientific data and information to
the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments and scientific data
and information to https://
www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to this document.
FOR FURTHER INFORMATION CONTACT:
Michelle A. Smith, Center for Food
Safety and Applied Nutrition (HFS–
317), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740–3835, 301–436–2024.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
I. Background
A. Food Safety and Fresh Produce
FDA is responsible for ensuring the
safety of all domestic and imported
fresh fruits and vegetables consumed in
the United States. Fresh fruits and
vegetables are those that are likely to be
sold to consumers in an unprocessed or
minimally processed (i.e., raw) form.
Fresh fruits and vegetables may be
intact and whole, such as whole apples,
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or cut in the act of harvest, such as
heads of lettuce and bunches of
broccoli.
Because most fresh produce is grown
in a natural environment, it is
vulnerable to contamination with
pathogens (i.e., bacteria or other
organisms that can cause disease).
Factors that may affect the occurrence of
such contamination include agricultural
and/or post-harvest water quality, the
use of manure as fertilizer, the presence
of wild or domestic animals in or near
fields or packing areas, worker health
and hygiene, environmental conditions,
production activities, and equipment
and facility sanitation. Consequently,
the manner in which fresh produce is
grown, harvested, packed, cooled, and
transported is crucial to minimizing the
risk of microbial contamination. (We
use the term ‘‘microbial contamination’’
to refer to contamination with any
microorganism.)
Data reported to the U.S. Centers for
Disease Control and Prevention (CDC)
indicate that between 1973 and 1997
reported outbreaks of foodborne illness
in the United States associated with
fresh produce increased in absolute
numbers and as a proportion of all
reported foodborne outbreaks (Ref. 1).
(By ‘‘outbreak,’’ we mean the occurrence
of two or more cases of a similar illness
resulting from the ingestion of a
common food.) Unpublished data
compiled by FDA indicate that from
1996 to 2007 there were approximately
72 reported outbreaks of foodborne
illness associated with approximately
20 fresh produce commodities. Of this
total, 13 outbreaks were associated with
tomatoes, 11 outbreaks were associated
with melons, and 24 outbreaks were
associated with leafy greens such as
lettuce and spinach (Ref. 2). These
outbreaks involved a number of
pathogens, including Escherichia coli
(E. coli) O157:H7 and Salmonella
species, and involved both domestic
and imported produce. These totals
include only those outbreaks in which
our investigation has indicated that the
contamination of the produce was not a
result of exposure to an infected food
handler or other unsafe food handling
practice at the place of preparation and
consumption (i.e., home or restaurant).
There have also been a number of
reported outbreaks associated with fresh
produce in 2008.
B. FDA’s GAPs/GMPs Guide
FDA places a high priority on
identifying and promoting measures
that can reduce the incidence of
foodborne illness associated with fresh
produce. In 1998, FDA and the U.S.
Department of Agriculture issued
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]]>Agencies
[Federal Register Volume 73, Number 170 (Tuesday, September 2, 2008)]
[Notices]
[Pages 51305-51306]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-20295]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2006-N-0166] (formerly Docket No. 2006N-0238)
Maria Anne Kirkman Campbell; Denial of Hearing; 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 act) permanently
debarring Dr. Maria Anne Kirkman Campbell (Dr. Campbell) 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.
Campbell was convicted of a felony under Federal law for conduct
relating to the development or approval, including the process for
development or approval, of a drug product, and conduct otherwise
relating to the regulation of a drug product under the act. Dr.
Campbell failed to request a hearing and, therefore, has waived her
opportunity for a hearing concerning this action. Even assuming that
any statement in Dr. Campbell's correspondence with FDA were to be
construed as requesting a hearing, Dr. Campbell has failed to file with
the agency information and analyses sufficient to create a basis for a
hearing concerning this action. Therefore, we are, in the alternative,
issuing an order denying any such assumed request for a hearing because
we find that there is no genuine and substantial issue of fact to grant
a hearing on the debarment, if a hearing were requested.
DATES: This order is effective September 2, 2008.
ADDRESSES: Submit applications for 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: Brian Pendleton, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6304, Silver Spring, MD, 20993-0002, 301-
796-3504.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(a)(2)(A) of the act (21 U.S.C. 335a(a)(2)(A)) 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
development or approval, including the process for development or
approval, of any drug product. Section 306(a)(2)(B) of the act 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 act.
On March 25, 2004, the U.S. District Court for the Northern
District of Alabama accepted Dr. Campbell's plea of guilty and
convicted her of one count of mail fraud, a felony under 18 U.S.C. 1341
and 2. Specifically, Dr. Campbell admitted to submitting a fraudulent
case report form (reflecting enrollment of a nonexistent person) while
serving as a clinical investigator in a clinical study designed to test
the safety and effectiveness of an antibacterial drug product, Ketek
(telithromycin), for the treatment of respiratory tract infections. The
clinical study was to be submitted to FDA in support of approval of
Ketek.
Accordingly, in a letter dated February 28, 2007, and hand
delivered on March 5, 2007, FDA served Dr. Campbell a notice proposing
to permanently debar her from providing services in any capacity to a
person having an approved or pending drug product application. The
proposal was based on a finding, under section 306(a)(2)(A) and
(a)(2)(B) of the act, that Dr. Campbell was convicted of a felony under
Federal law for conduct relating to the development or approval,
including the process for development or approval, of a drug product,
and conduct otherwise relating to the regulation of a drug product. The
letter offered Dr. Campbell an opportunity to request a hearing on the
proposal, 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 letter also informed Dr. Campbell that her request for a
hearing could not rest upon mere allegations or denials, but must
present specific facts showing that there is a genuine and substantial
issue of fact requiring a hearing. In addition, the letter informed Dr.
Campbell that the only material issue of fact was whether she was
convicted as alleged in the letter, and that the facts underlying her
conviction are not at issue in this proceeding. The letter also
informed Dr. Campbell that if it conclusively appeared from the face of
the information and factual analyses in her request for a hearing that
there was no genuine and substantial issue of fact that precluded the
order of debarment, we would deny her request for a hearing and enter a
final order of debarment. Finally, the letter informed Dr. Campbell
that if she were to file a request for a hearing, she was required to
file, on or before 60 days from the date of receipt of the letter, the
information on which she relied to justify a hearing.
Dr. Campbell has responded to the proposal to debar her but has not
requested a hearing.\1\ Her failure to request a hearing constitutes a
waiver of her opportunity for a hearing and a waiver of any contentions
concerning her debarment.
---------------------------------------------------------------------------
\1\After we served Dr. Campbell on March 5, 2007, with notice of
the agency's proposal to debar her, Dr. Campbell sent a series of
letters to the agency--dated March 9, 2007, April 6, 2007, May 23,
2007, July 17, 2007, August 21, 2007, and January 13, 2008,--and
participated in a teleconference with FDA on April 9, 2007. Although
some of Dr. Campbell's correspondence refers to another proceeding
the agency initiated against Dr. Campbell (investigator
disqualification under 21 CFR 312.70), instead of, or in addition
to, the proposal to debar her, for the purposes of this order, we
have taken into account all of Dr. Campbell's correspondence with
the agency after March 5, 2007, as well as the transcript from the
April 9, 2007, teleconference.
---------------------------------------------------------------------------
Even assuming that any statement in Dr. Campbell's correspondence
with FDA were to be construed as requesting a hearing, Dr. Campbell has
not submitted information that would justify granting a hearing.
Therefore, we are, in the alternative, hereby denying any such assumed
request for a hearing because Dr. Campbell has failed to show that
there is a genuine and substantial issue of fact requiring a hearing.
Dr. Campbell has not offered any information or factual analyses to
refute that she was convicted of mail fraud for conduct relating to the
development or approval of a drug product, or otherwise relating to the
regulation of a drug product under the act.
II. Findings and Order
Therefore, the Associate Commissioner for Regulatory Affairs, under
section 306(a)(2)(A) and (a)(2)(B) of the act and under authority
delegated to her, finds that Dr. Maria Anne Kirkman Campbell has been
convicted of a felony under Federal law for conduct relating to the
development or approval, including the process for
[[Page 51306]]
development or approval, of a drug product, and conduct otherwise
relating to the regulation of a drug product under the act.
As a result of the foregoing finding, Dr. Maria Anne Kirkman
Campbell 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 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 as stated in the DATES section of this
document (see section 306(c)(1)(B) and (c)(2)(A)(ii) and 201(dd) of the
act (21 U.S.C. 321(dd))). Any person with an approved or pending drug
product application who knowingly uses the services of Dr. Campbell in
any capacity, during her period of debarment, will be subject to civil
money penalties (section 307(a)(6) of the act (21 U.S.C. 335b(a)(6))).
If Dr. Campbell, during her period of debarment, provides services in
any capacity to a person with an approved or pending drug product
application, she will be subject to civil money penalties (section
307(a)(7) of the act). In addition, FDA will not accept or review any
abbreviated new drug application submitted by or with the assistance of
Dr. Campbell during her period of debarment (section 306(c)(1)(B) of
the act).
Any application by Dr. Campbell for special termination of
debarment under section 306(d)(4) of the act should be identified with
Docket No. FDA-2006-N-0166 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: August 22, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-20295 Filed 8-29-08; 8:45 am]
BILLING CODE 4160-01-S
