Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting, 80948-80949 [2011-33059]
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80948
Federal Register / Vol. 76, No. 248 / Tuesday, December 27, 2011 / Notices
Dated: December 21, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
action to allow interested persons
additional time to submit comments.
Submit either electronic or
written comments and information by
March 9, 2012.
DATES:
[FR Doc. 2011–33142 Filed 12–23–11; 8:45 am]
BILLING CODE 4160–01–P
Submit electronic
comments on the draft guidance to
https://www.regulations.gov. Submit
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Identify comments with the docket
number found in brackets in the
heading of this document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Dorothy Abel, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 1204, Silver Spring,
MD 20993–0002, (301) 796–6366.
In the Federal Register of November
10, 2011 (76 FR 70150), FDA published
a notice announcing the availability of
the draft guidance entitled
‘‘Investigational Device Exemptions
(IDE) for Early Feasibility Medical
Device Clinical Studies, Including
Certain First in Human (FIH) Studies’’
and the opening of a public docket to
receive comments on the key principles
unique to the justification for, and
design of, early feasibility studies, as
well as outlines the general principles
for preparing and reviewing early
feasibility study IDE applications that
are discussed in the guidance. Interested
persons were invited to submit
comments by February 8, 2012. At this
time, the Agency is extending the
comment period until March 9, 2012, to
continue to receive public comments.
Comments submitted to the docket will
enhance the development and review of
IDE applications for early feasibility
studies of significant risk for the
industry and the Center for Devices and
Radiological Health.
sroberts on DSK5SPTVN1PROD with NOTICES
II. Request for Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to submit one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in the brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
22:00 Dec 23, 2011
Food and Drug Administration
[Docket No. FDA–2011–D–0790]
Draft Guidance for Industry, Clinical
Investigators, Institutional Review
Boards, and Food and Drug
Administration Staff; Food and Drug
Administration Decisions for
Investigational Device Exemption (IDE)
Clinical Investigations; Extension of
Comment Period
AGENCY:
Food and Drug Administration,
HHS.
I. Background
VerDate Mar<15>2010
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Jkt 226001
ACTION:
Notice; extension of comment
I. Background
In the Federal Register of November
10, 2011 (76 FR 70151), FDA published
a notice announcing the availability of
the draft guidance entitled ‘‘FDA
Decisions for Investigational Device
Exemption (IDE) Clinical
Investigations’’ and the opening of a
public docket to receive comments on
the development of methods to allow a
clinical investigation to begin under
certain circumstances, even when there
are outstanding issues regarding the IDE
submission. Interested persons were
invited to submit comments by February
8, 2012. At this time, the Agency is
extending the comment period until
March 9, 2012, to continue to receive
public comments. Comments submitted
to the docket will assist in promoting
timely clinical investigations actions
that the Center for Devices and
Radiological Health and Center for
Biologics Evaluation and Research can
consider taking for IDE submissions.
period.
II. Comments
The Food and Drug
Administration (FDA) is extending the
comment period for the notice that
appeared in the Federal Register of
Thursday, November, 10, 2011 (76 FR
70151). In the notice, FDA requested
comments on the draft guidance that has
been developed to promote the
initiation of clinical investigations to
evaluate the medical devices under
FDA’s Investigational Device
Exemptions (IDE) regulations. The
Agency is taking this action to allow
interested persons additional time to
submit comments.
DATES: Submit written or electronic
comments and information by March 9,
2012.
ADDRESSES: Submit electronic
comments on the draft guidance to
https://www.regulations.gov. Submit
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Identify comments with the docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Owen Faris, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 1108, Silver Spring,
MD 20993–0002, (301) 796–6356.
Stephen Ripley, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852, (301) 827–6210.
SUPPLEMENTARY INFORMATION:
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to submit one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in the brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
SUMMARY:
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Dated: December 21, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–33141 Filed 12–23–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
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.
E:\FR\FM\27DEN1.SGM
27DEN1
Federal Register / Vol. 76, No. 248 / Tuesday, December 27, 2011 / Notices
sroberts on DSK5SPTVN1PROD with NOTICES
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 February 22, 2012, from 8 a.m. to 5 p.m.
Location: FDA White Oak Campus, 10903
New Hampshire Ave., Bldg. 31 Conference
Center, the Great Room (rm. 1503), 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 Bldg.
1.
Contact Person: Paul Tran, 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,
email: EMDAC@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 upto-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: The committee will discuss the
safety and efficacy of new drug application
(NDA) 22–580, proposed trade name QNEXA
(phentermine/topiramate) Controlled-Release
Capsules, manufactured by VIVUS, Inc., as
an adjunct to diet and exercise for weight
management in patients with a body mass
index (BMI) equal to or greater than 30
kilograms (kg) per square meter or a BMI
equal to or greater than 27 kg per square
meter if accompanied by weight-related
comorbidities.
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
VerDate Mar<15>2010
22:00 Dec 23, 2011
Jkt 226001
writing, on issues pending before the
committee. Written submissions may be
made to the contact person on or before
February 7, 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
January 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 January 31, 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: December 20, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–33059 Filed 12–23–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting
nominations for voting members to
serve on the Device Good
Manufacturing Practice Advisory
Committee, certain device panels of the
Medical Devices Advisory Committee,
and the National Mammography Quality
Assurance Advisory Committee in the
Center for Devices and Radiological
Health. Nominations will be accepted
for current vacancies and those that will
or may occur through December 31,
2012.
FDA has a special interest in ensuring
that women, minority groups, and
individuals with disabilities are
adequately represented on advisory
committees and, therefore, encourages
nominations of qualified candidates
from these groups.
SUMMARY:
Because scheduled vacancies
occur on various dates throughout each
year, no cutoff date is established for the
receipt of nominations. However, when
possible, nominations should be
received at least 6 months before the
date of scheduled vacancies for each
year, as indicated in this notice.
DATES:
All nominations for
membership should be sent
electronically to cv@oc.fda.gov, or by
mail to Advisory Committee Oversight
and Management Staff, 10903 New
Hampshire Ave., Bldg. 32, rm. 5103,
Silver Spring, MD 20993–0002.
Information about becoming a
member on a FDA advisory committee
can also be obtained by visiting FDA’s
Web site at https://www.fda.gov/
AdvisoryCommittees/default.htm.
ADDRESSES:
For
specific Committee/Panel questions,
contact the following persons listed in
table 1 of this document.
FOR FURTHER INFORMATION CONTACT:
[Docket No. FDA–2011–N–0002]
Request for Nominations for Voting
Members on Public Advisory Panels or
Committees
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
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80949
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]]>Agencies
[Federal Register Volume 76, Number 248 (Tuesday, December 27, 2011)]
[Notices]
[Pages 80948-80949]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-33059]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
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.
[[Page 80949]]
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 February 22, 2012,
from 8 a.m. to 5 p.m.
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg.
31 Conference Center, the Great Room (rm. 1503), 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 Bldg. 1.
Contact Person: Paul Tran, 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, email: EMDAC@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: The committee will discuss the safety and efficacy of
new drug application (NDA) 22-580, proposed trade name QNEXA
(phentermine/topiramate) Controlled-Release Capsules, manufactured
by VIVUS, Inc., as an adjunct to diet and exercise for weight
management in patients with a body mass index (BMI) equal to or
greater than 30 kilograms (kg) per square meter or a BMI equal to or
greater than 27 kg per square meter if accompanied by weight-related
comorbidities.
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
February 7, 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
January 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
January 31, 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: December 20, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-33059 Filed 12-23-11; 8:45 am]
BILLING CODE 4160-01-P
