Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting, 39404-39405 [2011-16862]
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Federal Register / Vol. 76, No. 129 / Wednesday, July 6, 2011 / Notices
1448, 301–827–1289; Fax: 301–827–
0294; E-mail: gail.dapolito@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Cellular, Tissue, and Gene Therapies
Advisory Committee
The Agency requests nominations for
a nonvoting industry representative on
the Cellular, Tissue, and Gene Therapies
Advisory Committee. The Cellular,
Tissue, and Gene Therapies Advisory
Committee advises the Commissioner of
Food and Drugs (the Commissioner) or
designee in discharging responsibilities
as they relate to the regulation of
cellular and gene therapy products.
This committee has 13 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 cellular
and gene therapy products.
sroberts on DSK5SPTVN1PROD with NOTICES
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 (see DATES). 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
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 Cellular, Tissue, and
Gene Therapies 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 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 (see FOR
FURTHER INFORMATION CONTACT) within
the 30 days (see DATES). FDA will
forward all nominations to the
organizations expressing interest in
participating in the selection process for
the committee. (Persons who nominate
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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 cellular and gene
therapy products biotech industry.
This notice is issued under the
Federal Advisory Committee Act
(5 U.S.C. app. 2) and 21 CFR part 14,
relating to the advisory committees.
Dated: June 29, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2011–16828 Filed 7–5–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Cardiovascular and Renal Drugs
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: Cardiovascular
and Renal Drugs 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 September 8, 2011, from 8 a.m.
to 5 p.m.
Location: The Marriott Inn and
Conference Center, University of
Maryland University College (UMUC),
The Ballroom, 3501 University Blvd.
East, Adelphi, MD 20783–7998. The
conference center’s telephone number is
301–985–7300.
Contact Person: Kristina Toliver,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, rm. 2417, Silver Spring,
MD 20993–0002, 301–796–9001, FAX:
301–847–8533, e-mail:
CRDAC@fda.hhs.gov, or FDA Advisory
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
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 September 8, 2011, the
committee will discuss new drug
application (NDA) 202439, rivaroxaban
tablets, submitted by Johnson & Johnson
Pharmaceutical Research and
Development, L.L.C., on behalf of OrthoMcNeil-Janssen-Pharmaceuticals, for the
prevention of stroke and systemic
embolism (blood clots other than in the
head) in patients with nonvalvular atrial
fibrillation (abnormally rapid
contractions of the atria, the upper
chambers 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 committee. Written
submissions may be made to the contact
person on or before August 24, 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 August
16, 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
E:\FR\FM\06JYN1.SGM
06JYN1
Federal Register / Vol. 76, No. 129 / Wednesday, July 6, 2011 / Notices
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 August 17, 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 Kristina
Toliver 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: June 30, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2011–16862 Filed 7–5–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Blood Products Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
sroberts on DSK5SPTVN1PROD 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.
Date and Time: The meeting will be
held on August 2, 2011, from 1:30 p.m.
to 5 p.m. and on August 3, 2011, from
8 a.m. to 2:30 p.m.
Location: Hilton Hotel, Washington,
DC North Gaithersburg, 620 Perry
Pkwy., Gaithersburg, MD 20877, 301–
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18:17 Jul 05, 2011
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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
Day 1: https://fda.yorkcast.com/webcast/
Viewer/?peid=b6ce0d080a
594ddf9d362a0b1815b4491d.
Blood Products Advisory Committee
Day 2: https://fda.yorkcast.com/webcast/
Viewer/?peid=68d4630cf50847c5aaec
06b1720f205f1d.
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,
301–827–0314, 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 August 2, 2011, the
committee will discuss a study on the
incidence of Trypanosoma cruzi
infection in blood donors and its
implications for selective testing of
blood donors. On August 3, 2011, the
committee will discuss measures to
preserve the blood supply during a
severe emergency. In the afternoon, the
committee will hear the following
updates: Summary of the June 7–8,
2011, Health and Human Services
Advisory Committee on Blood Safety
and Availability meeting; summary of
the May 17–18, 2011, public workshop
on risk mitigation strategies to address
procoagulant activity in immune
globulin products; and summary of the
August 1–2, 2011, Transmissible
Spongiform Encephalopathies Advisory
Committee meeting.
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/
PO 00000
Frm 00030
Fmt 4703
Sfmt 9990
39405
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 July 26, 2011. Oral
presentations from the public will be
scheduled on August 2, 2011, between
approximately 3:30 and 4 p.m. and on
August 3, 2011, between approximately
11 and 11:30 a.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 July 18,
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 July 19, 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 Bryan Emery
or Rosanna Harvey 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: June 30, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2011–16859 Filed 7–5–11; 8:45 am]
BILLING CODE 4160–01–P
E:\FR\FM\06JYN1.SGM
06JYN1
]]>Agencies
[Federal Register Volume 76, Number 129 (Wednesday, July 6, 2011)]
[Notices]
[Pages 39404-39405]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-16862]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Cardiovascular and Renal Drugs 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: Cardiovascular and Renal Drugs 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 September 8, 2011, from
8 a.m. to 5 p.m.
Location: The Marriott Inn and Conference Center, University of
Maryland University College (UMUC), The Ballroom, 3501 University Blvd.
East, Adelphi, MD 20783-7998. The conference center's telephone number
is 301-985-7300.
Contact Person: Kristina Toliver, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-
8533, e-mail: CRDAC@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 September 8, 2011, the committee will discuss new drug
application (NDA) 202439, rivaroxaban tablets, submitted by Johnson &
Johnson Pharmaceutical Research and Development, L.L.C., on behalf of
Ortho-McNeil-Janssen-Pharmaceuticals, for the prevention of stroke and
systemic embolism (blood clots other than in the head) in patients with
nonvalvular atrial fibrillation (abnormally rapid contractions of the
atria, the upper chambers 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 committee.
Written submissions may be made to the contact person on or before
August 24, 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 August 16, 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
[[Page 39405]]
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 August 17, 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 Kristina Toliver 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: June 30, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-16862 Filed 7-5-11; 8:45 am]
BILLING CODE 4160-01-P
