James T. Kimball; Denial of Hearing; Final Debarment Order, 4269-4270 [E7-1416]
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4269
Federal Register / Vol. 72, No. 19 / Tuesday, January 30, 2007 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR Section
FDA Form
Number
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Responses
Total Hours
600.14
3486
147
2.73
401
2.0
802
606.171 2
3486
194
169.89
32,958
2.0
65,916
606.171 3
3486
6,210
1.50
9,311
2.0
18,622
3486A 4
6,551
0.33
2,133
0.5
1,067
Total
86,407
1 There
are no capital costs or maintenance costs associated with this collection of information.
manufacturers of human blood and blood components, including Source Plasma.
registered blood establishments and transfusion services (1,230 + 4,980 = 6,210).
4 Five percent of the total annual responses to CBER (42,653 x 0.05 = 2,133).
2 Licensed
3 Unlicensed
Dated: January 24, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–1415 Filed 1–29–07; 8:45 am]
Lane, Rockville, MD 20857, 301–594–
2041.
SUPPLEMENTARY INFORMATION:
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0105]
James T. Kimball; Denial of Hearing;
Final Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ycherry on PROD1PC64 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is denying Mr.
James T. Kimball’s request for a hearing
and is issuing a final order under the
Federal Food, Drug, and Cosmetic Act
(the act) permanently debarring Mr.
James T. Kimball from providing
services in any capacity to a person that
has an approved or pending drug
product application. FDA bases this
order on a finding that Mr. Kimball was
convicted of felonies under Federal law
for conduct relating to the regulation of
a drug product under the act. In
addition, Mr. Kimball has failed to file
with the agency information and
analyses sufficient to create a basis for
a hearing concerning this action.
DATES: This order is effective January
30, 2007.
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:
Mary Catchings, Center for Drug
Evaluation and Research (HFD–7), Food
and Drug Administration, 5600 Fishers
VerDate Aug<31>2005
15:36 Jan 29, 2007
Jkt 211001
I. Background
On May 24, 2000, a jury found Mr.
Kimball guilty of one count of
conspiring to commit offenses against
the United States and the Florida
Department of Health, a Federal felony
offense under 18 U.S.C. 371; six counts
of distributing a misbranded drug into
interstate commerce, a Federal felony
offense under 21 U.S.C. 331(a); and one
count of making a false statement in a
matter within the jurisdiction of a
Federal agency, a Federal felony offense
under 18 U.S.C. 1001. On October 19,
2000, the U.S. District Court for the
Middle District of Florida entered
judgment and sentenced Mr. Kimball for
these offenses.
The bases for these convictions were
Mr. Kimball’s knowing and willful
participation, including conspiring, to
violate Federal laws in connection with
the distribution of a misbranded drug,
deprenyl, into interstate commerce, and
false statements he made to the U.S.
Customs Service about shipments of
deprenyl for export. The drug deprenyl
was misbranded because it contained
selegiline, the active ingredient of a
prescription drug Eldepryl, but was
dispensed without a prescription issued
by a licensed practitioner.
As a result of these convictions, FDA
served Mr. Kimball by certified letter on
April 25, 2005,1 a proposal to
permanently debar him from providing
services in any capacity to a person that
has an approved or pending drug
1 The certified letter was mailed to the prison
facility where records indicated that Mr. Kimball
was incarcerated, and the return receipt was signed
on April 25, 2005, by an employee at the facility.
In his request for hearing, Mr. Kimball stated that
he received the letter on May 5, 2005. The delivery
dates do not alter the nature of Mr. Kimball’s
request for a hearing or our application of summary
judgement in this matter.
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
product application. The notice also
offered Mr. Kimball an opportunity to
request a hearing on the debarment
proposal. The debarment proposal was
based on a finding, under section
306(a)(2)(B) of the act (21 U.S.C.
335a(a)(2)(B)), that Mr. Kimball was
convicted of felonies under Federal law
for conduct relating to the regulation of
a drug product under the act.
The certified letter also informed Mr.
Kimball that his request for a hearing
could not rest upon mere allegations or
denials, but must present specific facts
showing that there was a genuine and
substantial issue of fact requiring a
hearing. The letter also informed Mr.
Kimball that the only material issue of
fact was whether he was convicted as
alleged in the letter, and that the facts
underlying his conviction are not at
issue in this proceeding. Finally, the
letter informed Mr. Kimball that if it
conclusively appeared from the face of
the information and factual analyses in
his request for a hearing that there was
no genuine and substantial issue of fact
that precluded the order of debarment,
FDA would enter summary judgment
against him and deny his request for a
hearing.
In a letter dated May 16, 2005, Mr.
Kimball responded to the certified letter
by requesting a hearing.
II. Denial of Hearing
In his May 16, 2005, request for a
hearing, Mr. Kimball does not present
any arguments or information to show
why he should not be debarred. Mr.
Kimball merely states that: (1) He ‘‘was
not convicted pursuant to the
statements set forth in FDA’s alleged
notice’’, (2) the allegations of his
convictions are incorrect, and (3) his
conviction does not mandate his
debarment. Such statements do not
create a basis for a hearing because
hearings will not be granted on mere
allegations, denials, or general
E:\FR\FM\30JAN1.SGM
30JAN1
4270
Federal Register / Vol. 72, No. 19 / Tuesday, January 30, 2007 / Notices
ycherry on PROD1PC64 with NOTICES
descriptions of positions (see 21 CFR
12.24(b)(2)). Although FDA’s proposal
to debar Mr. Kimball explained that he
had the opportunity to file a request for
a hearing and then submit factual
information within 60 days from receipt
of the letter, Mr. Kimball did not submit
any factual information. Mr. Kimball
has failed to present any arguments or
information to show why he should not
be debarred. Therefore, FDA finds that
Mr. Kimball has failed to identify any
genuine and substantial issue of fact
requiring a hearing. Accordingly, FDA
denies Mr. Kimball’s request for a
hearing.
III. Findings and Order
Therefore, the Associate
Commissioner for Regulatory Affairs,
under section 306(a) of the act and
under authority delegated to him, finds
that Mr. James T. Kimball has been
convicted of felonies under Federal law
for conduct relating to the regulation of
a drug product under the act (section
306(a)(2)(B) of the act).
As a result of the foregoing findings,
Mr. James T. Kimball 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
(see DATES) (sections 306(c)(1)(B) and
(c)(2)(A)(iii) 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 Mr. Kimball in any capacity,
during his 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 Mr. Kimball, during his
period of debarment, provides services
in any capacity to a person with an
approved or pending drug product
application, he 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
applications submitted by or with the
assistance of Mr. Kimball during his
period of debarment.
Any application by Mr. Kimball for
termination of debarment under section
306(d)(4) of the act should be identified
with Docket No. 2005N–0105 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.
VerDate Aug<31>2005
15:36 Jan 29, 2007
Jkt 211001
Dated: January 22, 2007.
Margaret O’K. Glavin,
Associate Commissioner for Regulatory
Affairs.
[FR Doc. E7–1416 Filed 1–29–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0029]
Indevus Pharmaceuticals, Inc.;
Withdrawal of Approval of a New Drug
Application
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is withdrawing
approval of a new drug application
(NDA) for REDUX (dexfenfluramine
hydrochloride (HCl)) Capsules held by
Indevus Pharmaceuticals, Inc. (Indevus),
33 Hayden Ave., Lexington, MA 02421–
7971. Indevus has requested that
approval of this application be
withdrawn because the product is no
longer marketed, thereby waiving its
opportunity for a hearing.
DATES: Effective January 30, 2007.
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug
Evaluation and Research (HFD–7), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–594–
2041.
SUPPLEMENTARY INFORMATION:
In 1997,
FDA asked that REDUX
(dexfenfluramine HCl) be withdrawn
from the market because of safety
concerns; Indevus (formerly Interneuron
Pharmaceuticals, Inc.) discontinued
marketing this product. REDUX
(dexfenfluramine HCl)Capsules, a
treatment for obesity, was withdrawn
from the market after review of safety
data showed that the product is
associated with valvular heart disease
(see FDA press releases on ‘‘Health
Advisory on Fenfluramine/Phentermine
for Obesity,’’ dated July 8, 1997, (https://
www.fda.gov/opacom/hpnews.html),
and ‘‘FDA Announces Withdrawal of
Fenfluramine and Dexfenfluramine,’’
dated September 15, 1997, (https://
www.fda.gov/opacom/hpnews.html)).
In a letter dated January 16, 2006,
Indevus requested that FDA withdraw
approval, under § 314.150(d) (21 CFR
314.150(d)), of NDA 20–344 for REDUX
(dexfenfluramine HCl) Capsules, stating
that it had discontinued marketing the
product. The letter also stated that
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
Indevus believes that the risk/benefit
ratio for the use of dexfenfluramine is
unfavorable and that withdrawal of
approval of NDA 20–344 is in the best
interest of public health. Indevus
voluntarily waived its opportunity for a
hearing, provided under § 314.150(a)
and (b).
Therefore, under section 505(e) of
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 355(e)), § 314.150(d),
and under authority delegated to the
Director, Center for Drug Evaluation and
Research, by the Commissioner of Food
and Drugs, approval of NDA 20–544,
and all amendments and supplements
thereto, is withdrawn, effective January
30, 2007. Distribution of this product in
interstate commerce without an
approved application is illegal and
subject to regulatory action (see sections
505(a) and 301(d) of the act (21 U.S.C.
331(d)).
Dated: January 12, 2007.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation
and Research.
[FR Doc. E7–1414 Filed 1–29–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995,
Public Law 104–13), the Health
Resources and Services Administration
(HRSA) publishes periodic summaries
of proposed projects being developed
for submission to the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
To request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, call the HRSA Reports
Clearance Officer on (301) 443–1129.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
E:\FR\FM\30JAN1.SGM
30JAN1
]]>Agencies
[Federal Register Volume 72, Number 19 (Tuesday, January 30, 2007)]
[Notices]
[Pages 4269-4270]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-1416]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0105]
James T. Kimball; Denial of Hearing; Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is denying Mr. James T.
Kimball's request for a hearing and is issuing a final order under the
Federal Food, Drug, and Cosmetic Act (the act) permanently debarring
Mr. James T. Kimball from providing services in any capacity to a
person that has an approved or pending drug product application. FDA
bases this order on a finding that Mr. Kimball was convicted of
felonies under Federal law for conduct relating to the regulation of a
drug product under the act. In addition, Mr. Kimball has failed to file
with the agency information and analyses sufficient to create a basis
for a hearing concerning this action.
DATES: This order is effective January 30, 2007.
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: Mary Catchings, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2041.
SUPPLEMENTARY INFORMATION:
I. Background
On May 24, 2000, a jury found Mr. Kimball guilty of one count of
conspiring to commit offenses against the United States and the Florida
Department of Health, a Federal felony offense under 18 U.S.C. 371; six
counts of distributing a misbranded drug into interstate commerce, a
Federal felony offense under 21 U.S.C. 331(a); and one count of making
a false statement in a matter within the jurisdiction of a Federal
agency, a Federal felony offense under 18 U.S.C. 1001. On October 19,
2000, the U.S. District Court for the Middle District of Florida
entered judgment and sentenced Mr. Kimball for these offenses.
The bases for these convictions were Mr. Kimball's knowing and
willful participation, including conspiring, to violate Federal laws in
connection with the distribution of a misbranded drug, deprenyl, into
interstate commerce, and false statements he made to the U.S. Customs
Service about shipments of deprenyl for export. The drug deprenyl was
misbranded because it contained selegiline, the active ingredient of a
prescription drug Eldepryl, but was dispensed without a prescription
issued by a licensed practitioner.
As a result of these convictions, FDA served Mr. Kimball by
certified letter on April 25, 2005,\1\ a proposal to permanently debar
him from providing services in any capacity to a person that has an
approved or pending drug product application. The notice also offered
Mr. Kimball an opportunity to request a hearing on the debarment
proposal. The debarment proposal was based on a finding, under section
306(a)(2)(B) of the act (21 U.S.C. 335a(a)(2)(B)), that Mr. Kimball was
convicted of felonies under Federal law for conduct relating to the
regulation of a drug product under the act.
---------------------------------------------------------------------------
\1\ The certified letter was mailed to the prison facility where
records indicated that Mr. Kimball was incarcerated, and the return
receipt was signed on April 25, 2005, by an employee at the
facility. In his request for hearing, Mr. Kimball stated that he
received the letter on May 5, 2005. The delivery dates do not alter
the nature of Mr. Kimball's request for a hearing or our application
of summary judgement in this matter.
---------------------------------------------------------------------------
The certified letter also informed Mr. Kimball that his request for
a hearing could not rest upon mere allegations or denials, but must
present specific facts showing that there was a genuine and substantial
issue of fact requiring a hearing. The letter also informed Mr. Kimball
that the only material issue of fact was whether he was convicted as
alleged in the letter, and that the facts underlying his conviction are
not at issue in this proceeding. Finally, the letter informed Mr.
Kimball that if it conclusively appeared from the face of the
information and factual analyses in his request for a hearing that
there was no genuine and substantial issue of fact that precluded the
order of debarment, FDA would enter summary judgment against him and
deny his request for a hearing.
In a letter dated May 16, 2005, Mr. Kimball responded to the
certified letter by requesting a hearing.
II. Denial of Hearing
In his May 16, 2005, request for a hearing, Mr. Kimball does not
present any arguments or information to show why he should not be
debarred. Mr. Kimball merely states that: (1) He ``was not convicted
pursuant to the statements set forth in FDA's alleged notice'', (2) the
allegations of his convictions are incorrect, and (3) his conviction
does not mandate his debarment. Such statements do not create a basis
for a hearing because hearings will not be granted on mere allegations,
denials, or general
[[Page 4270]]
descriptions of positions (see 21 CFR 12.24(b)(2)). Although FDA's
proposal to debar Mr. Kimball explained that he had the opportunity to
file a request for a hearing and then submit factual information within
60 days from receipt of the letter, Mr. Kimball did not submit any
factual information. Mr. Kimball has failed to present any arguments or
information to show why he should not be debarred. Therefore, FDA finds
that Mr. Kimball has failed to identify any genuine and substantial
issue of fact requiring a hearing. Accordingly, FDA denies Mr.
Kimball's request for a hearing.
III. Findings and Order
Therefore, the Associate Commissioner for Regulatory Affairs, under
section 306(a) of the act and under authority delegated to him, finds
that Mr. James T. Kimball has been convicted of felonies under Federal
law for conduct relating to the regulation of a drug product under the
act (section 306(a)(2)(B) of the act).
As a result of the foregoing findings, Mr. James T. Kimball 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 (see DATES) (sections 306(c)(1)(B) and (c)(2)(A)(iii) 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 Mr.
Kimball in any capacity, during his 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 Mr. Kimball, during his period of debarment,
provides services in any capacity to a person with an approved or
pending drug product application, he 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 applications submitted by or
with the assistance of Mr. Kimball during his period of debarment.
Any application by Mr. Kimball for termination of debarment under
section 306(d)(4) of the act should be identified with Docket No.
2005N-0105 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: January 22, 2007.
Margaret O'K. Glavin,
Associate Commissioner for Regulatory Affairs.
[FR Doc. E7-1416 Filed 1-29-07; 8:45 am]
BILLING CODE 4160-01-S
