Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting, 49447 [2012-20104]
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Federal Register / Vol. 77, No. 159 / Thursday, August 16, 2012 / Notices
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 Cindy Hong
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: August 10, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–20103 Filed 8–15–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Endocrinologic and Metabolic Drugs
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSK4VPTVN1PROD 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: Endocrinologic
and Metabolic Drugs Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
DATES: Date and Time: The meeting will
be held on October 18, 2012, from 8 a.m.
to 5 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/Advisory
Committees/default.htm; under the
heading ‘‘Resources for You,’’ click on
‘‘Public Meetings at the FDA White Oak
Campus.’’ Please note that visitors to the
White Oak Campus must enter through
Building 1.
VerDate Mar<15>2010
16:38 Aug 15, 2012
Jkt 226001
Contact Person: Paul Tran, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., WO31–2417, Silver
Spring, MD 20993–0002, (301) 796–
9001, Fax: (301) 847–8533, email:
EMDAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), to find out
further information regarding FDA
advisory committee information. 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 at
https://www.fda.gov/Advisory
Committees/Calendar/default.htm and
scroll down to the appropriate advisory
committee meeting link, or call the
advisory committee information line to
learn about possible modifications
before coming to the meeting.
Agenda: The committee will discuss
new drug application (NDA) 203568,
mipomersen injection, by Genzyme
Corporation. The proposed indication
(use) is as an adjunct to maximally
tolerated lipid-lowering medications
and diet to reduce low-density
lipoprotein (LDL) cholesterol,
apolipoprotein B, total cholesterol, nonhigh density lipoprotein-cholesterol and
lipoprotein (a) in patients with
homozygous familial
hypercholesterolemia.
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 October 2, 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
PO 00000
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49447
participants, and an indication of the
approximate time requested to make
their presentation on or before
September 24, 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 September 25, 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 Paul Tran 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: August 10, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–20104 Filed 8–15–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Endpoints for Clinical Trials in Kidney
Transplantation; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
to discuss the endpoints for clinical
trials of drugs and therapeutic biologics
in kidney transplantation. This public
workshop is intended to provide
information and gain perspective from
health care providers, academia, and
industry on the role of various clinical,
laboratory, histologic, genomic/
proteomic, safety, and other endpoints
E:\FR\FM\16AUN1.SGM
16AUN1
]]>Agencies
[Federal Register Volume 77, Number 159 (Thursday, August 16, 2012)]
[Notices]
[Page 49447]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20104]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
Endocrinologic and Metabolic 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: Endocrinologic and Metabolic Drugs Advisory
Committee.
General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
DATES: Date and Time: The meeting will be held on October 18, 2012,
from 8 a.m. to 5 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 ``Public Meetings at the FDA
White Oak Campus.'' Please note that visitors to the White Oak Campus
must enter through Building 1.
Contact Person: Paul Tran, Center for Drug Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., WO31-2417,
Silver Spring, MD 20993-0002, (301) 796-9001, Fax: (301) 847-8533,
email: EMDAC@fda.hhs.gov, or FDA Advisory Committee Information Line,
1-800-741-8138 (301-443-0572 in the Washington, DC area), to find out
further information regarding FDA advisory committee information. 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 at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm and scroll down to the
appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
coming to the meeting.
Agenda: The committee will discuss new drug application (NDA)
203568, mipomersen injection, by Genzyme Corporation. The proposed
indication (use) is as an adjunct to maximally tolerated lipid-lowering
medications and diet to reduce low-density lipoprotein (LDL)
cholesterol, apolipoprotein B, total cholesterol, non-high density
lipoprotein-cholesterol and lipoprotein (a) in patients with homozygous
familial hypercholesterolemia.
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
October 2, 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 September 24, 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 September 25, 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 Paul Tran 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: August 10, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-20104 Filed 8-15-12; 8:45 am]
BILLING CODE 4160-01-P
