[Federal Register Volume 74, Number 109 (Tuesday, June 9, 2009)]
[Notices]
[Page 27335]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-13419]


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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.

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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 [email protected] 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 http://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