Joint Meeting of the Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting, 19374-19375 [2011-8284]
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Federal Register / Vol. 76, No. 67 / Thursday, April 7, 2011 / Notices
mstockstill on DSKH9S0YB1PROD with NOTICES
Cathryn Lyn Chatman (also known as
Cathryn Lyn Garcia) 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 Ms. Chatman
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.
Ms. Chatman was given notice of the
proposed debarment and an opportunity
to request a hearing within the
timeframe prescribed by regulation. Ms.
Chatman failed to respond. Ms.
Chatman’s failure to respond constitutes
a waiver of her right to a hearing
concerning this action.
DATES: This order is effective April 7,
2011.
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:
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(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 March 14, 2006, Cathryn Lyn
Chatman (also known as Cathryn Lyn
Garcia) pleaded guilty to a misdemeanor
offense of misbranding a drug. On
August 14, 2006, the United States
District Court for the District of Oregon
entered judgment against Ms. Chatman
for misdemeanor misbranding a drug, in
violation of 21 U.S.C. 331(k) and
333(a)(1).
FDA’s finding that debarment is
appropriate is based on the
misdemeanor conviction referenced
herein. The factual basis for the
conviction is as follows: Ms. Chatman
was a registered nurse licensed by the
Oregon Board of Nursing. Throughout
2004, she assisted a codefendant in
operating two clinics that offered
treatments they claimed could combat
the effects of aging, including injection
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with BOTOX. From August 2004
through December 2004, Ms. Chatman
offered a botulinum toxin called
‘‘Refinex’’ for sale for injection to
patients under the name of another
drug, BOTOX. Refinex is manufactured
by the Shandong Bioresearch Institute
in the People’s Republic of China and
has never been approved or licensed by
FDA for any use. Ms. Chatman
misbranded a drug, namely botulinum
toxin type A manufactured by Shandong
Bioresearch Institute and known as
Refinex, while it was held for sale and
after shipment in interstate commerce,
in that she offered Refinex for sale by
injection to patients under the name of
another drug that is approved, namely
BOTOX, all in violation of 21 U.S.C.
331(k) and 333(a)(1).
As a result of her conviction, on
January 5, 2011, FDA sent Ms. Chatman
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, that
Ms. Chatman was convicted of a
misdemeanor under Federal law for
conduct relating to the regulation of
drug products under the FD&C Act, and
that the conduct that served as a basis
for the conviction undermines the
process for the regulation of drugs. The
proposal also offered Ms. Chatman 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. Ms.
Chatman 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 Cathryn Lyn
Chatman 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,
Ms. Chatman is debarred for 5 years
from providing services in any capacity
to a person with an approved or
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Frm 00068
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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 Ms. Chatman, in any
capacity during Ms. Chatman’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 Ms.
Chatman 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
Ms. Chatman during her period of
debarment (section 306(c)(1)(B) of the
FD&C Act (21 U.S.C. 335a(c)(1)(B)). Any
application by Ms. Chatman for
termination of debarment under section
306(d)(1) of the FD&C Act should be
identified with Docket No. FDA–2010–
N–0443 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 22, 2011.
Howard Sklamberg,
Director, Office of Enforcement, Office of
Regulatory Affairs.
[FR Doc. 2011–8218 Filed 4–6–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Joint Meeting of the Cardiovascular
and Renal Drugs Advisory Committee
and the Drug Safety and Risk
Management Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
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07APN1
mstockstill on DSKH9S0YB1PROD with NOTICES
Federal Register / Vol. 76, No. 67 / Thursday, April 7, 2011 / Notices
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committees: Cardiovascular
and Renal Drugs Advisory Committee
and the Drug Safety and Risk
Management Advisory Committee.
General Function of the Committees:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on May 2, 2011, from 8 a.m. to 4
p.m.
Location: FDA White Oak Campus,
Building 31, the Great Room, White Oak
Conference Center, rm. 1503, 10903
New Hampshire Ave., Silver Spring, MD
20993–0002. Information regarding
special accommodations due to a
disability, visitor parking and
transportation may be accessed at: http:
//www.fda.gov/AdvisoryCommittees/
default.htm; under the heading
‘‘Resources for You’’, click on ‘‘White
Oak Conference Center Parking and
Transportation Information for FDA
Advisory Committee Meetings’’. Please
note that visitors to the White Oak
Campus must enter through Building 1.
Contact Person: Nicole Vesely,
Pharm.D., Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Avenue, WO31–2417, Silver Spring, MD
20993–0002, 301–796–9001, Fax: 301–
847–8533, e-mail:
nicole.vesely@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
area. Please call the Information Line for
up-to-date information on this meeting.
A notice in the Federal Register about
last minute modifications that impact a
previously announced advisory
committee meeting cannot always be
published quickly enough to provide
timely notice. Therefore, you should
always check the Agency’s Web site and
call the appropriate advisory committee
hot line/phone line to learn about
possible modifications before coming to
the meeting.
Agenda: On May 2, 2011, the
committees will discuss safety
considerations of ultrasound contrast
agents (materials intended to improve
the clarity of ultrasound imaging),
particularly related to new information
and developments since the prior
Advisory Committee meeting on the
same topic on June 24, 2008. The
discussion will include the results of
required postmarketing safety studies
and data from postmarketing
surveillance. Specific drugs to be
discussed include: (1) New drug
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19:53 Apr 06, 2011
Jkt 223001
application (NDA) 21–064, perflutren
lipid microsphere injectable suspension,
Lantheus Medical Imaging, Inc.; (2)
NDA 20–899, perflutren protein-type A
microspheres injectable suspension, GE
Healthcare; and (3) the investigational
new drug (IND) application for sulfur
hexafluoride microbubble injection,
Bracco Diagnostics, Inc. Perflutren lipid
microsphere injectable suspension and
perflutren protein-type A microspheres
injectable suspension are indicated for
use in patients with suboptimal
echocardiograms to opacify the left
ventricular chamber and to improve the
delineation of the left ventricular
endocardial border (improve the clarity
of imaging of specific areas of the left
lower side of the heart).
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committees. Written
submissions may be made to the contact
person on or before April 18, 2011. Oral
presentations from the public will be
scheduled between approximately 1
p.m. and 2 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before April 8,
2011. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by April 11, 2011.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
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19375
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Nicole
Vesely at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated March 22, 2011.
Leslie Kux,
Acting Associate Commissioner for Policy.
[FR Doc. 2011–8284 Filed 4–6–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Safety and Efficacy of Hypnotic Drugs;
Public Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public meeting.
The Food and Drug Administration
(FDA) is announcing a public meeting to
discuss the safety and efficacy of drugs
for the treatment of insomnia. The
Division of Neurology Products (DNP)
in FDA’s Center for Drug Evaluation and
Research and the Pharmaceutical
Education and Research Institute (PERI)
are cosponsoring the 2-day meeting,
with the first day centered on issues of
efficacy and the second day on safety.
Date and Time: The public meeting
will be held on Tuesday, May 10, and
Wednesday, May 11, 2011, from 8 a.m.
to 5 p.m.
Location: The public meeting will be
held at the Bethesda Marriott, 5151
Pooks Hill Rd., Bethesda, MD 20814.
Contact: Margaret Bogie, 703–276–
0178, ext. 115, Fax: 703–276–0069; or
Cathleen Michaloski, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 4342,
Silver Spring, MD 20993, 301–796–
1123, e-mail:
Cathleen.michaloski@fda.hhs.gov.
Accommodations: Attendees are
responsible for their own
accommodations. Reservations can be
E:\FR\FM\07APN1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 67 (Thursday, April 7, 2011)]
[Notices]
[Pages 19374-19375]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-8284]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Joint Meeting of the Cardiovascular and Renal Drugs Advisory
Committee and the Drug Safety and Risk Management Advisory Committee;
Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a public advisory
committee
[[Page 19375]]
of the Food and Drug Administration (FDA). The meeting will be open to
the public.
Name of Committees: Cardiovascular and Renal Drugs Advisory
Committee and the Drug Safety and Risk Management Advisory Committee.
General Function of the Committees: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
Date and Time: The meeting will be held on May 2, 2011, from 8 a.m.
to 4 p.m.
Location: FDA White Oak Campus, Building 31, the Great Room, White
Oak Conference Center, rm. 1503, 10903 New Hampshire Ave., Silver
Spring, MD 20993-0002. Information regarding special accommodations due
to a disability, visitor parking and transportation may be accessed at:
https://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You'', click on ``White Oak Conference Center Parking
and Transportation Information for FDA Advisory Committee Meetings''.
Please note that visitors to the White Oak Campus must enter through
Building 1.
Contact Person: Nicole Vesely, Pharm.D., Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Avenue,
WO31-2417, Silver Spring, MD 20993-0002, 301-796-9001, Fax: 301-847-
8533, e-mail: nicole.vesely@fda.hhs.gov, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), and follow the prompts to the desired center or product area.
Please call the Information Line for up-to-date information on this
meeting. A notice in the Federal Register about last minute
modifications that impact a previously announced advisory committee
meeting cannot always be published quickly enough to provide timely
notice. Therefore, you should always check the Agency's Web site and
call the appropriate advisory committee hot line/phone line to learn
about possible modifications before coming to the meeting.
Agenda: On May 2, 2011, the committees will discuss safety
considerations of ultrasound contrast agents (materials intended to
improve the clarity of ultrasound imaging), particularly related to new
information and developments since the prior Advisory Committee meeting
on the same topic on June 24, 2008. The discussion will include the
results of required postmarketing safety studies and data from
postmarketing surveillance. Specific drugs to be discussed include: (1)
New drug application (NDA) 21-064, perflutren lipid microsphere
injectable suspension, Lantheus Medical Imaging, Inc.; (2) NDA 20-899,
perflutren protein-type A microspheres injectable suspension, GE
Healthcare; and (3) the investigational new drug (IND) application for
sulfur hexafluoride microbubble injection, Bracco Diagnostics, Inc.
Perflutren lipid microsphere injectable suspension and perflutren
protein-type A microspheres injectable suspension are indicated for use
in patients with suboptimal echocardiograms to opacify the left
ventricular chamber and to improve the delineation of the left
ventricular endocardial border (improve the clarity of imaging of
specific areas of the left lower side of the heart).
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committees.
Written submissions may be made to the contact person on or before
April 18, 2011. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before April 8, 2011. Time allotted for
each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by April 11, 2011.
Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Nicole Vesely at
least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated March 22, 2011.
Leslie Kux,
Acting Associate Commissioner for Policy.
[FR Doc. 2011-8284 Filed 4-6-11; 8:45 am]
BILLING CODE 4160-01-P
