Issues in the Design of Clinical Trials of Antimycobacterial Drugs for Treatment of Tuberculosis; Public Workshop, 27335 [E9-13419]
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Federal Register / Vol. 74, No. 109 / Tuesday, June 9, 2009 / Notices
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Cancer
Diagnostic and Treatment SBIR/STTR.
Date: June 29–30, 2009.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
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Contact Person: Bonnie L. Burgess-Beusse,
PhD, Scientific Review Officer, Center for
Scientific Review, National Institutes of
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MSC 7818, Bethesda, MD 20892, 301–435–
1783, beusseb@mail.nih.gov.
Name of Committee: Center for Scientific
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Date: June 30, 2009.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
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Place: Ritz Carlton Hotel, 1150 22nd Street,
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Contact Person: George Ann McKie, DVM,
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Date: June 30, 2009.
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Agenda: To review and evaluate grant
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Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Lawrence Ka-Yun Ng,
PhD, Scientific Review Officer, Center for
Scientific Review, National Institutues of
Health, 6701 Rockledge Drive, Room 6152,
MSC 7804, Bethesda, MD 20892, 301–435–
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Dated: June 1, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–13428 Filed 6–8–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Issues in the Design of Clinical Trials
of Antimycobacterial Drugs for
Treatment of Tuberculosis; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
VerDate Nov<24>2008
14:45 Jun 08, 2009
Jkt 217001
ACTION:
Notice of public workshop.
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
public workshop regarding scientific
issues in clinical trial design for the
treatment of tuberculosis. This public
workshop is intended to bring together
public health experts, health care
providers, academia, and industry to
share perspectives on scientific aspects
of antimicrobial drug development for
tuberculosis. Topics will include
considerations in the development of
clinical trials to study treatments for
tuberculosis, including enrollment of
patients, the effect of antimicrobial
treatment, study endpoints, and
statistical issues in analysis of results.
The input from this public workshop
will help in developing topics for
further public discussion.
Date and Time: The public workshop
will be held on July 30, 2009, from 8
a.m. to 5:30 p.m. and on July 31, 2009,
from 8 a.m. to 5 p.m.
Location: The public workshop will
be held at the Crowne Plaza Silver
Spring, 8777 Georgia Ave., Silver
Spring, MD 20910. Seating is limited
and available only on a first-come, firstserved basis.
Contact: Christine Moser or Ramou
Mauer, Center for Drug Evaluation and
Research, Food and Drug
Administration, Office of Antimicrobial
Products, 10903 New Hampshire Ave.,
Bldg. 22, rm. 6209, Silver Spring, MD
20993–0002, 301–796–1300.
Registration: To register
electronically, e-mail registration
information (including name, title, firm
name, address, telephone, and fax
number) to TBwkshp@fda.hhs.gov by
July 22, 2009. Persons without access to
the Internet can call 301–796–1300 to
register. Registration is free for the
public workshop. Interested parties are
encouraged to register early because
spaced is limited. Seating will be
available on a first-come, first-served
basis. Persons needing a sign language
interpreter or other special
accommodations should notify
Christine Moser or Ramou Mauer (see
Contact) at least 7 days in advance.
SUPPLEMENTARY INFORMATION: FDA is
announcing a public workshop
regarding antimicrobial drug
development for tuberculosis. This
public workshop will focus on scientific
considerations in designing clinical
trials for tuberculosis. Topics for
discussion include the enrollment of
patient populations with tuberculosis,
the effect size of antimicrobial treatment
for tuberculosis, assessing effect size of
a new drug in a multi-drug regimen,
various endpoints that might be
PO 00000
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27335
considered to assess drug efficacy for
trials of tuberculosis, the timing of
assessment for efficacy, extrapolation of
safety and efficacy to other
subpopulations, and statistical issues in
analysis of results from trials in
tuberculosis. The input from this public
workshop will help in developing topics
for further discussion.
The agency encourages individuals,
patient advocates, industry, consumer
groups, health care professionals,
researchers, and other interested
persons to attend this public workshop.
Transcripts: Transcripts of the public
workshop may be requested in writing
from the Freedom of Information Office
(HFI–35), Food and Drug
Administration, 5600 Fishers Lane, rm.
6–30, Rockville, MD 20857,
approximately 20 working days after the
public workshop, at a cost of 10 cents
per page. Transcripts will also be
available on the Internet at https://
internet-dev/cder/meeting/tb.htm
approximately 45 days after the
workshop.
Dated: June 2, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–13419 Filed 6–8–09; 8:45 am]
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Notice of Meeting; National
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AGENCY: Administration for Children
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Human Services.
ACTION: Notice of meeting.
DATES: The meeting will be held on
Thursday, June 25, 2009, from 9 a.m. to
5:30 p.m.
ADDRESSES: The meeting will be held at
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require a sign language interpreter or
other special assistance, please call
Jacqueline Haye at (202) 205–9560 as
E:\FR\FM\09JNN1.SGM
09JNN1
]]>Agencies
[Federal Register Volume 74, Number 109 (Tuesday, June 9, 2009)]
[Notices]
[Page 27335]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-13419]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0664]
Issues in the Design of Clinical Trials of Antimycobacterial
Drugs for Treatment of Tuberculosis; 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 scientific issues in clinical trial design for the
treatment of tuberculosis. This public workshop is intended to bring
together public health experts, health care providers, academia, and
industry to share perspectives on scientific aspects of antimicrobial
drug development for tuberculosis. Topics will include considerations
in the development of clinical trials to study treatments for
tuberculosis, including enrollment of patients, the effect of
antimicrobial treatment, study endpoints, and statistical issues in
analysis of results. The input from this public workshop will help in
developing topics for further public discussion.
Date and Time: The public workshop will be held on July 30, 2009,
from 8 a.m. to 5:30 p.m. and on July 31, 2009, from 8 a.m. to 5 p.m.
Location: The public workshop will be held at the Crowne Plaza
Silver Spring, 8777 Georgia Ave., Silver Spring, MD 20910. Seating is
limited and available only on a first-come, first-served basis.
Contact: Christine Moser or Ramou Mauer, Center for Drug Evaluation
and Research, Food and Drug Administration, Office of Antimicrobial
Products, 10903 New Hampshire Ave., Bldg. 22, rm. 6209, Silver Spring,
MD 20993-0002, 301-796-1300.
Registration: To register electronically, e-mail registration
information (including name, title, firm name, address, telephone, and
fax number) to TBwkshp@fda.hhs.gov by July 22, 2009. Persons without
access to the Internet can call 301-796-1300 to register. Registration
is free for the public workshop. Interested parties are encouraged to
register early because spaced is limited. Seating will be available on
a first-come, first-served basis. Persons needing a sign language
interpreter or other special accommodations should notify Christine
Moser or Ramou Mauer (see Contact) at least 7 days in advance.
SUPPLEMENTARY INFORMATION: FDA is announcing a public workshop
regarding antimicrobial drug development for tuberculosis. This public
workshop will focus on scientific considerations in designing clinical
trials for tuberculosis. Topics for discussion include the enrollment
of patient populations with tuberculosis, the effect size of
antimicrobial treatment for tuberculosis, assessing effect size of a
new drug in a multi-drug regimen, various endpoints that might be
considered to assess drug efficacy for trials of tuberculosis, the
timing of assessment for efficacy, extrapolation of safety and efficacy
to other subpopulations, and statistical issues in analysis of results
from trials in tuberculosis. The input from this public workshop will
help in developing topics for further discussion.
The agency encourages individuals, patient advocates, industry,
consumer groups, health care professionals, researchers, and other
interested persons to attend this public workshop.
Transcripts: Transcripts of the public workshop may be requested in
writing from the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857,
approximately 20 working days after the public workshop, at a cost of
10 cents per page. Transcripts will also be available on the Internet
at https://internet-dev/cder/meeting/tb.htm approximately 45 days after
the workshop.
Dated: June 2, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-13419 Filed 6-8-09; 8:45 am]
BILLING CODE 4160-01-S
