Gastrointestinal Drugs Advisory Committee; Notice of Meeting, 61506-61507 [2010-24984]
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Federal Register / Vol. 75, No. 192 / Tuesday, October 5, 2010 / Notices
Dated: September 27, 2010.
Elaine Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[FR Doc. 2010–25012 Filed 10–4–10; 8:45 am]
mstockstill on DSKH9S0YB1PROD with NOTICES
Advisory Committee on Immunization
Practices (ACIP)
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC),
announces the following meeting of the
aforementioned committee:
Times and Dates: 8 a.m.–6 p.m.,
October 27, 2010; 8 a.m.–5 p.m., October
28, 2010.
Place: CDC, Tom Harkin Global
Communications Center, 1600 Clifton
Road, NE., Building 19, Kent ‘‘Oz’’
Nelson Auditorium, Atlanta, Georgia
30333.
Status: Open to the public, limited
only by the space available.
Purpose: The committee is charged
with advising the Director, CDC, on the
appropriate uses of immunizing agents.
In addition, under 42 U.S.C. 1396s, the
committee is mandated to establish and
periodically review and, as appropriate,
revise the list of vaccines for
administration to vaccine-eligible
children through the Vaccines for
Children (VFC) program, along with
schedules regarding the appropriate
periodicity, dosage, and
contraindications applicable to the
vaccines.
Matters To Be Discussed: The agenda
will include discussions on: Evidence
based recommendations; Human
Papillomavirus (HPV) vaccines;
Meningococcal vaccine; Hepatitis
vaccines; vaccine supply update; RSV
Immunoprophylaxis; Rotavirus
vaccines; Pertussis vaccine; Influenza
vaccines; the 2011 Immunization
Schedule for adults, children &
adolescents; and the Herpes Zoster
vaccine. Agenda items are subject to
change as priorities dictate.
Contact Person for More Information:
Leola Mitchell, National Center for
Immunization and Respiratory Diseases,
CDC, 1600 Clifton Road, NE., Mailstop
E–05, Atlanta, Georgia 30333,
Telephone (404) 639–8836, Fax (404)
639–8905. The Director, Management
Analysis and Services Office, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities for
both the CDC and Agency for Toxic
Substances and Disease Registry.
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18:36 Oct 04, 2010
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
Gastrointestinal 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: Gastrointestinal
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 November 4, 2010, from 8 a.m.
to 5 p.m.
Location: Hilton Washington DC
North/Gaithersburg, The Ballroom, 620
Perry Pkwy., Gaithersburg, MD. The
hotel telephone number is 301–977–
8900.
Contact Person: Kristine T. Khuc,
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:
kristine.khuc@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512538. 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 November 4, 2010, the
committee will discuss the adequacy of
endoscopically documented gastric
ulcers as an outcome measure to
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evaluate drugs intended to prevent
gastrointestinal complications of
nonsteroidal anti-inflammatory drugs
including aspirin.
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 21, 2010.
Oral presentations from the public will
be scheduled between approximately 1
p.m. to 2 p.m. Those desiring to make
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 October 13, 2010. 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
October 14, 2010.
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 Kristine T.
Khuc 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.
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Federal Register / Vol. 75, No. 192 / Tuesday, October 5, 2010 / Notices
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: September 30, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2010–24984 Filed 10–4–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
General and Plastic Surgery Devices
Panel of the Medical Devices Advisory
Committee; Amendment of Notice
AGENCY:
Food and Drug Administration,
HHS.
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ACTION:
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The Food and Drug Administration
(FDA) is announcing an amendment to
the notice of meeting of the General and
Plastic Surgery Devices Panel of the
Medical Devices Advisory Committee.
This meeting was announced in the
Federal Register of August 16, 2010 (75
FR 49940). The amendment is being
made to reflect a change in the Agenda
portion of the document. There are no
other changes.
FOR FURTHER INFORMATION CONTACT:
Margaret McCabe-Janicki, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 1535,
Silver Spring, MD 20993–0002, 301–
796–7029, or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area), code 3014512519. Please call the
Information Line for up-to-date
information on this meeting.
SUPPLEMENTARY INFORMATION: In the
Federal Register of August 16, 2010,
FDA announced that a meeting of the
General and Plastic Surgery Devices
Panel of the Medical Devices Advisory
Committee would be held on November
18, 2010. On page 49940, in the second
column, in the Agenda portion of the
document, the first full paragraph is
changed to read as follows:
Agenda: On November 18, 2010, the
committee will discuss, make
recommendations, and vote on
information related to the premarket
approval application for MelaFind,
sponsored by MELA Sciences.
MelaFind(R) is a non-invasive and
objective multi-spectral computer vision
system designed to aid physicians in the
detection of early melanoma from
18:36 Oct 04, 2010
Dated: September 30, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2010–24983 Filed 10–4–10; 8:45 am]
Notice.
VerDate Mar<15>2010
among clinically atypical (those having
one or more clinical or historical
characteristics of melanoma, such as
asymmetry, border irregularity, color
variegation, diameter greater than 6
millimeters, evolving, patient concern,
regression, and ‘‘ugly duckling’’)
cutaneous pigmented lesions that are
non-ulcerated, not bleeding, and less
than 2.2 centimeters in diameter, when
a physician chooses to obtain additional
information before making a final
decision to biopsy to rule out
melanoma.
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.
Jkt 223001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
NHLBI Research Centers at Minority-Serving
Institutions.
Date: October 20, 2010.
Time: 8 a.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Chang Sook Kim, PhD,
Scientific Review Officer, Review Branch,
DERA, National Heart, Lung, and Blood
Institute, 6701 Rockledge Drive, Room 7190,
Bethesda, MD 20892, 301–435–0287,
carolko@mail.nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
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61507
Mentored Patient Oriented Research Career
Development Awards.
Date: October 21, 2010.
Time: 8 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 8120 Military Road, NW.,
Washington, DC 20015.
Contact Person: Stephanie J. Webb, PhD,
Scientific Review Officer, Review Branch/
DERA, National Heart, Lung, and Blood
Institute, 6701 Rockledge Drive, Room 7196,
Bethesda, MD 20892, 301–435–0291,
stephanie.webb@nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Programs of Excellence in Glycosciences.
Date: October 25–26, 2010.
Time: 8 a.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: YingYing Li-Smerin, MD,
PhD, Scientific Review Officer, Office of
Scientific Review, National Heart, Lung, and
Blood Institute, National Institutes of Health,
6701 Rockledge Drive, Room 7184, Bethesda,
MD 20892–7924, 301–435–0277,
lismerin@nhlbi.nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Program Project in Cardiac Fibrillation.
Date: October 28, 2010.
Time: 10 a.m. to 2 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: William J Johnson, PhD,
Scientific Review Officer, Review Branch/
DERA, National Heart, Lung, and Blood
Institute, 6701 Rockledge Drive, Room 7178,
Bethesda, MD 20892–7924, 301–435–0725,
johnsonwj@nhlbi.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: September 28, 2010.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–24932 Filed 10–4–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
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]]>Agencies
[Federal Register Volume 75, Number 192 (Tuesday, October 5, 2010)]
[Notices]
[Pages 61506-61507]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-24984]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
Gastrointestinal 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: Gastrointestinal 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 November 4, 2010, from 8
a.m. to 5 p.m.
Location: Hilton Washington DC North/Gaithersburg, The Ballroom,
620 Perry Pkwy., Gaithersburg, MD. The hotel telephone number is 301-
977-8900.
Contact Person: Kristine T. Khuc, 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: kristine.khuc@fda.hhs.gov, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), code 3014512538. 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 November 4, 2010, the committee will discuss the
adequacy of endoscopically documented gastric ulcers as an outcome
measure to evaluate drugs intended to prevent gastrointestinal
complications of nonsteroidal anti-inflammatory drugs including
aspirin.
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 21, 2010. Oral presentations from the public will be scheduled
between approximately 1 p.m. to 2 p.m. Those desiring to make 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 October 13, 2010. 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 October
14, 2010.
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 Kristine T. Khuc 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.
[[Page 61507]]
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: September 30, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-24984 Filed 10-4-10; 8:45 am]
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