General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 20642-20643 [2012-8166]
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Federal Register / Vol. 77, No. 66 / Thursday, April 5, 2012 / Notices
Tkelley on DSK3SPTVN1PROD with NOTICES
person that has an approved or pending
drug product application. The proposal
was based on a finding, under section
306(b)(2)(B)(i)(II) of the FD&C Act, that
Mr. Concepcion was convicted of
conspiracy to commit an offense against
the United States, that the conduct that
served as the basis for the felony
conspiracy conviction relates to the
development or approval, including the
process for development or approval, of
any drug product and relates 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 Mr. Concepcion an opportunity
to request a hearing, providing him 30
days from the date of receipt of the letter
in which to file the request, and advised
him that failure to request a hearing
constituted a waiver of the opportunity
for a hearing and of any contentions
concerning this action. Mr. Concepcion
failed to request a hearing within the
timeframe prescribed by regulation and
has, therefore, waived his opportunity
for a hearing and waived any
contentions concerning his 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)(II)
of the FD&C Act under authority
delegated to him (Staff Manual Guide
1410.35), finds that Jose Concepcion has
been convicted of a felony 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,
Mr. Concepcion is debarred for 5 years
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),
(c)(2)(A)(iii), and 201(dd) of the FD&C
Act (21 U.S.C. 335a(c)(1)(B),
(c)(2)(A)(iii), 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 Mr. Concepcion, in any
capacity during Mr. Concepcion’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 Mr.
Concepcion provides services in any
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16:20 Apr 04, 2012
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capacity to a person with an approved
or pending drug product application
during his period of debarment he 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
Mr. Concepcion during his period of
debarment (section 306(c)(1)(B) of the
FD&C Act).
Any application by Mr. Concepcion
for termination of debarment under
section 306(d)(1) of the FD&C Act (21
U.S.C. 355a(d)(1)) should be identified
with Docket No. FDA–2009–N–0331
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 27, 2012.
Armando Zamora,
Acting Director, Office of Enforcement, Office
of Regulatory Affairs.
[FR Doc. 2012–8249 Filed 4–4–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
General and Plastic Surgery Devices
Panel of the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: General and
Plastic Surgery Devices Panel of the
Medical Devices Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on June 21, 2012, from 8 a.m. to 6
p.m.
Location: Hilton Washington DC
North/Gaithersburg, salons A, B, C, and
D, 620 Perry Pkwy., Gaithersburg, MD
20877. The hotel telephone number is
301–977–8900.
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Contact Person: Avena Russell, Center
for Devices and Radiological Health,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm.
1535, Silver Spring, MD 20993–0002,
Avena.Russell@fda.hhs.gov, 301–796–
3805, 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 June 21, 2012, the
committee will discuss, make
recommendations, and vote on
information related to the premarket
approval application, sponsored by
Dune Medical Devices, Inc., for the
MarginProbe System, that utilizes
electromagnetic waves to characterize
human tissue in real time and provides
intraoperative information on the
malignancy of the surface of the ex vivo
lumpectomy specimen.
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 committee. Written
submissions may be made to the contact
person on or before June 11, 2012. 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
E:\FR\FM\05APN1.SGM
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Federal Register / Vol. 77, No. 66 / Thursday, April 5, 2012 / Notices
June 1, 2012. 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 June 4, 2012.
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 Ann Marie
Williams, at
AnnMarie.Williams@fda.hhs.gov or
301–796–5966, 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 30, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2012–8166 Filed 4–4–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Blood Products Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
Tkelley on DSK3SPTVN1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Blood Products
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
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Date and Time: The meeting will be
held on May 15, 2012, from 8:30 a.m. to
5 p.m. and May 16, 2012 from 8 a.m. to
4 p.m.
Location: Hilton Washington DC/
North Gaithersburg, 620 Perry Pkwy.,
Gaithersburg, MD 20877, 301–977–8900.
For those unable to attend in person, the
meeting will also be Web cast. The Web
cast will be available at the following
links.
Blood Products Advisory Committee
Web Cast Link
May 15
https://fda.yorkcast.com/webcast/
Viewer/?peid=ba104b31fe4c4c0995
68bacda9a4e5401d.
May 16
https://fda.yorkcast.com/webcast/
Viewer/?peid=19caf3c8c1624acdaab
205ddde9c48581d.
Contact Person: Bryan Emery or
Rosanna Harvey, Center for Biologics
Evaluation and Research (HFM–71),
Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852,
301–827–1297, 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 15, 2012, the
committee will discuss as a device
panel the evaluation of the safety and
effectiveness of the OraQuick In-Home
HIV Test. On May 16, 2012, the
committee will discuss the evaluation of
possible new plasma products frozen
following in-process storage at room
temperature for up to 24 hours, namely
plasma for transfusion prepared from
Whole Blood held at room temperature
for up to 24 hours prior to separation
and freezing, or from apheresis plasma
held at room temperature for up to 24
hours before freezing. In the afternoon,
the committee will hear update
presentations on the following topics:
HHS activities related to the evaluation
of the donor deferral policy for men
who have had sex with other men; a
summary of the November 8–9, 2011,
public workshop on hemoglobin
standards and maintaining an adequate
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20643
blood supply; and a summary of the
November 29, 2011, public workshop on
data and data needs to advance risk
assessment for emerging infectious
diseases for blood and blood products.
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 committee. Written
submissions may be made to the contact
person on or before May 8, 2012. Oral
presentations from the public will be
scheduled between approximately 1:30
p.m. and 3:15 p.m. on May 15, 2012,
and between approximately 11:30 a.m.
and 12:45 p.m. on May 16, 2012. 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 30, 2012. 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 May 1, 2012.
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 Bryan Emery,
301–827–1277, or Rosanna Harvey, 301–
827–1297, 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
E:\FR\FM\05APN1.SGM
05APN1
]]>Agencies
[Federal Register Volume 77, Number 66 (Thursday, April 5, 2012)]
[Notices]
[Pages 20642-20643]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-8166]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
General and Plastic Surgery Devices Panel of the Medical Devices
Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: General and Plastic Surgery Devices Panel of the
Medical Devices Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
Date and Time: The meeting will be held on June 21, 2012, from 8
a.m. to 6 p.m.
Location: Hilton Washington DC North/Gaithersburg, salons A, B, C,
and D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel telephone
number is 301-977-8900.
Contact Person: Avena Russell, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 1535, Silver Spring, MD 20993-0002, Avena.Russell@fda.hhs.gov,
301-796-3805, 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 June 21, 2012, the committee will discuss, make
recommendations, and vote on information related to the premarket
approval application, sponsored by Dune Medical Devices, Inc., for the
MarginProbe System, that utilizes electromagnetic waves to characterize
human tissue in real time and provides intraoperative information on
the malignancy of the surface of the ex vivo lumpectomy specimen.
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 committee.
Written submissions may be made to the contact person on or before June
11, 2012. 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
[[Page 20643]]
June 1, 2012. 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 June 4, 2012.
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 Ann Marie Williams,
at AnnMarie.Williams@fda.hhs.gov or 301-796-5966, 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 30, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-8166 Filed 4-4-12; 8:45 am]
BILLING CODE 4160-01-P
