Gastrointestinal Drugs Advisory Committee; Notice of Meeting, 59732 [2010-24252]
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Federal Register / Vol. 75, No. 187 / Tuesday, September 28, 2010 / Notices
Matters to be Discussed: The meeting
will include the initial review,
discussion, and evaluation of ‘‘Member
Conflict Review, PA 07–318.’’
CONTACT PERSON FOR MORE INFORMATION:
M. Chris Langub, PhD., Scientific
Review Administrator, Office of
Extramural Programs, National Institute
for Occupational Safety and Health,
CDC, 1600 Clifton Road, NE., Mailstop
E74, Atlanta Georgia 30333; Telephone:
(404)498–2543.
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 CDC
and the Agency for Toxic Substances
and Disease Registry.
Dated: September 20, 2010.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2010–24258 Filed 9–27–10; 8:45 am]
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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.
srobinson on DSKHWCL6B1PROD 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: 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 5, 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:
VerDate Mar<15>2010
15:22 Sep 27, 2010
Jkt 220001
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 5, 2010, the
committee will discuss the results from
clinical trials of proton pump inhibitors
in gastroespohageal reflux disease
(GERD) in patients less than 1 year of
age, performed in response to a
Pediatric Written Request under the
Best Pharmaceuticals for Children Act
(Nexium, esomeprazole by AstraZeneca
LP; Prevacid, lansoprazole by Takeda
Pharmaceuticals North America, Inc;
Protonix, pantoprazole by Pfizer, Inc.)
and Pediatric Research Equity Act
commitment (Prilosec, omeprazole by
AstraZeneca LP). The pathophysiology
(disease process) of GERD, its diagnosis
and management, and issues related to
the design of clinical trials in this age
group will be considered.
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
1:30 p.m. to 2:30 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
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
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.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: September 22, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2010–24252 Filed 9–27–10; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Docket ID: FEMA–2010–0041]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request, OMB No.
1660–0036; Federal Emergency
Management Agency Individual
Assistance Customer Satisfaction
Surveys
Federal Emergency
Management Agency, DHS.
ACTION: Notice; 30-day notice and
request for comments; revision of a
currently approved information
collection; OMB No. 1660–0036; Caller
Services Registration Intake Survey,
FEMA Form 007–0–3 (currently 90–
147); Caller Services Helpline Survey,
FEMA Form 007–0–5 (currently 90–
AGENCY:
E:\FR\FM\28SEN1.SGM
28SEN1
]]>Agencies
[Federal Register Volume 75, Number 187 (Tuesday, September 28, 2010)]
[Notices]
[Page 59732]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-24252]
-----------------------------------------------------------------------
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 5, 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 5, 2010, the committee will discuss the results
from clinical trials of proton pump inhibitors in gastroespohageal
reflux disease (GERD) in patients less than 1 year of age, performed in
response to a Pediatric Written Request under the Best Pharmaceuticals
for Children Act (Nexium, esomeprazole by AstraZeneca LP; Prevacid,
lansoprazole by Takeda Pharmaceuticals North America, Inc; Protonix,
pantoprazole by Pfizer, Inc.) and Pediatric Research Equity Act
commitment (Prilosec, omeprazole by AstraZeneca LP). The
pathophysiology (disease process) of GERD, its diagnosis and
management, and issues related to the design of clinical trials in this
age group will be considered.
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 1:30 p.m. to 2:30 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.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: September 22, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-24252 Filed 9-27-10; 8:45 am]
BILLING CODE 4160-01-S
