Design of Clinical Trials for Systemic Antibacterial Drugs for the Treatment of Acute Otitis Media; Public Workshop, 39883-39884 [2011-16962]
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Federal Register / Vol. 76, No. 130 / Thursday, July 7, 2011 / Notices
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39883
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Design of Clinical Trials for Systemic
Antibacterial Drugs for the Treatment
of Acute Otitis Media; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA) is announcing a
public workshop regarding the design of
Clinical Trials for Systemic
Antibacterial Agents for the Treatment
of Acute Otitis Media. This public
workshop is intended to provide
information for and gain perspective
from health care providers, patients and
patient advocacy organizations,
academia, and industry on various
aspects of the design of clinical trials.
The input from this public workshop
will help in developing topics for
further discussion.
Dates and Times: The public
workshop will be held on September 7,
2011 from 8:30 a.m. to 5 p.m.
Location: The public workshop will
be held at the Crowne Plaza, 8777
Georgia Ave., Silver Spring, MD 20910,
301–589–0800. Seating is limited and
available only on a first-come, firstserved basis.
Contact Persons: Christine Moser or
Ramou Mauer, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6193,
Silver Spring, MD 20993–0002, 301–
796–1300.
Registration: Registration is free for
the public workshop. Interested parties
are encouraged to register early. Seating
will be available on a first-come, firstserved basis. To register electronically,
e-mail registration information
(including name, title, firm name,
address, telephone, and fax number) to
Otitisworkshop@fda.hhs.gov. Persons
without access to the Internet may call
301–796–1300 to register. Persons
needing a sign language interpreter or
other special accommodations should
notify Christine Moser or Lori Benner
(see Contact Persons) at least 7 days in
advance.
SUPPLEMENTARY INFORMATION: FDA is
announcing a public workshop
regarding scientific considerations in
the design of clinical trials of
antibacterial agents for the treatment of
acute otitis media (middle ear
infection). Discussions will focus on
SUMMARY:
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Federal Register / Vol. 76, No. 130 / Thursday, July 7, 2011 / Notices
appropriate endpoints for informative
clinical trials, the role and effect of
tympanocentesis (drainage of fluid from
the middle chamber of the ear) in
clinical trials, and the feasibility and
acceptability of different kinds of
clinical trial designs including
superiority trial designs, the data
available that might scientifically
support feasible non-inferiority trial
designs, and what additional data may
be useful to scientifically support noninferiority trial designs.
The Agency encourages individuals,
patient advocates, industry, consumer
groups, health care professionals,
researchers, and other interested
persons to attend this public workshop.
Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD. A transcript will
also be available in either hardcopy or
on CD–ROM, after submission of a
Freedom of Information request. Written
requests are to be sent to Division of
Freedom of Information (ELEM–1029),
Food and Drug Administration, 12420
Parklawn Dr., Element Bldg., Rockville,
MD 20857. Transcripts will also be
available on the Internet https://
www.fda.gov/Drugs/NewsEvents/
ucm205809.htm approximately 45 days
after the workshop.
Dated: June 30, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
Name of Committee: National Cancer
Institute Board of Scientific Advisors;
caBIG® Oversight Ad hoc Subcommittee.
Date: July 25, 2011.
Time: 12 p.m. to 4 p.m.
Agenda: Evaluation of Scientific Merit of
caBIG® program, ongoing and planned
initiatives.
Place: Hilton Chicago O’Hare, Hilton
Chicago O’Hare International Airport,
Terminal 3, Access Road 5, Room 2051,
Chicago, IL 60666.
Contact Person: John Czajkowski, MPA,
Deputy Director for Management, Office of
the Director, National Cancer Institute,
National Institutes of Health, 31 Center Drive,
Rm. 11A48, Bethesda, MD 20892, 301–435–
2455, john.czajkowski@nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
Information is also available on the
Institute’s/Center’s home page: https://
deainfo.nci.nih.gov/advisory/bsa.htm, where
an agenda and any additional information for
the meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: June 30, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–17075 Filed 7–6–11; 8:45 am]
Name of Committee: National Institute of
Mental Health Special Emphasis Panel;
Fellowships and Dissertation Grants.
Date: July 20, 2011.
Time: 1:30 p.m. to 2:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call)
Contact Person: David W Miller, PhD,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center,
6001 Executive BLVD, Room 6140, MSC
9608, Bethesda, MD 20892–9608, 301–443–
9734, millerda@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.242, Mental Health Research
Grants; 93.281, Scientist Development
Award, Scientist Development Award for
Clinicians, and Research Scientist Award;
93.282, Mental Health National Research
Service Awards for Research Training,
National Institutes of Health, HHS)
Dated: June 30, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–17073 Filed 7–6–11; 8:45 am]
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Aviation Security Advisory Committee
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AGENCY:
DEPARTMENT OF HEALTH AND
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ACTION:
Transportation Security
Administration, DHS.
[FR Doc. 2011–16962 Filed 7–6–11; 8:45 am]
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National Institutes of Health
National Institutes of Health
National Institute of Mental Health
Notice of Closed Meeting
National Cancer Institute Notice of
Meeting
sroberts on DSK5SPTVN1PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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 meeting.
The meeting 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.
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Cancer Institute Board of
Scientific Advisors.
The meeting will be open to the
public, with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
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Committee Management; Notice
of Federal Advisory Committee ReEstablishment.
The Transportation Security
Administration (TSA) announces the reestablishment of the Aviation Security
Advisory Committee (ASAC). The
Secretary of Homeland Security has
determined that the re-establishment of
ASAC is necessary and is in the public
interest in connection with the
performance of duties of TSA. This
determination follows consultation with
the Committee Management Secretariat,
General Services Administration.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Dean Walter, ASAC Designated Federal
Official, Transportation Security
Administration (TSA–28), 601 12th St.
South, Arlington, VA 20598–4028,
Dean.Walter@dhs.gov, 571–227–2645.
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 76, Number 130 (Thursday, July 7, 2011)]
[Notices]
[Pages 39883-39884]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-16962]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Design of Clinical Trials for Systemic Antibacterial Drugs for
the Treatment of Acute Otitis Media; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop regarding the design of Clinical Trials for Systemic
Antibacterial Agents for the Treatment of Acute Otitis Media. This
public workshop is intended to provide information for and gain
perspective from health care providers, patients and patient advocacy
organizations, academia, and industry on various aspects of the design
of clinical trials. The input from this public workshop will help in
developing topics for further discussion.
Dates and Times: The public workshop will be held on September 7,
2011 from 8:30 a.m. to 5 p.m.
Location: The public workshop will be held at the Crowne Plaza,
8777 Georgia Ave., Silver Spring, MD 20910, 301-589-0800. Seating is
limited and available only on a first-come, first-served basis.
Contact Persons: Christine Moser or Ramou Mauer, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6193, Silver Spring, MD 20993-0002, 301-
796-1300.
Registration: Registration is free for the public workshop.
Interested parties are encouraged to register early. Seating will be
available on a first-come, first-served basis. To register
electronically, e-mail registration information (including name, title,
firm name, address, telephone, and fax number) to
Otitisworkshop@fda.hhs.gov. Persons without access to the Internet may
call 301-796-1300 to register. Persons needing a sign language
interpreter or other special accommodations should notify Christine
Moser or Lori Benner (see Contact Persons) at least 7 days in advance.
SUPPLEMENTARY INFORMATION: FDA is announcing a public workshop
regarding scientific considerations in the design of clinical trials of
antibacterial agents for the treatment of acute otitis media (middle
ear infection). Discussions will focus on
[[Page 39884]]
appropriate endpoints for informative clinical trials, the role and
effect of tympanocentesis (drainage of fluid from the middle chamber of
the ear) in clinical trials, and the feasibility and acceptability of
different kinds of clinical trial designs including superiority trial
designs, the data available that might scientifically support feasible
non-inferiority trial designs, and what additional data may be useful
to scientifically support non-inferiority trial designs.
The Agency encourages individuals, patient advocates, industry,
consumer groups, health care professionals, researchers, and other
interested persons to attend this public workshop. Transcripts: Please
be advised that as soon as a transcript is available, it will be
accessible at https://www.regulations.gov. It may be viewed at the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD. A transcript will also be
available in either hardcopy or on CD-ROM, after submission of a
Freedom of Information request. Written requests are to be sent to
Division of Freedom of Information (ELEM-1029), Food and Drug
Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.
Transcripts will also be available on the Internet https://www.fda.gov/Drugs/NewsEvents/ucm205809.htm approximately 45 days after the
workshop.
Dated: June 30, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-16962 Filed 7-6-11; 8:45 am]
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