[Federal Register Volume 77, Number 159 (Thursday, August 16, 2012)]
[Notices]
[Page 49450]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-20106]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
Issues in the Design of Clinical Trials of Antibacterial Drugs
for the Treatment of Non-Cystic Fibrosis Bronchiectasis; 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 focusing on the design of clinical trials of antibacterial
drugs for the treatment of non-cystic fibrosis (non-CF) bronchiectasis.
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 useful in
developing topics for further discussion.
Date and Time: The public workshop will be held on September 7,
2012, from 8 a.m. to 3:30 p.m.
Location: The public workshop will be held at the Sheraton Silver
Spring Hotel, 8777 Georgia Ave., Silver Spring, MD 20910. The hotel's
phone number is 301-589-0800. Seating is limited and available on a
first-come, first-served basis.
CONTACT PERSON FOR MORE INFORMATION: Christine Moser or Lori Benner,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 22, rm. 6204, 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, email your registration information (including name,
title, firm name, address, telephone, and fax number) to
[email protected]. Those 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 PERSON FOR MORE
INFORMATION) at least 7 days in advance.
Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://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 should
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 (http://www.fda.gov/Drugs/NewsEvents/ucm305463.htm) approximately 45 days after
the workshop.
SUPPLEMENTARY INFORMATION: FDA is announcing a public workshop focusing
on scientific considerations in the design of clinical trials of
antibacterial agents for the treatment of non-CF bronchiectasis.
Discussions will focus on natural history; patient populations for
enrollment in clinical trials; current standard of care and unmet need;
clinical trial endpoints, including exacerbation and patient-reported
outcomes; and clinical trial design elements, including duration of
treatment and patient followup.
FDA encourages individuals, patient advocates, industry, consumer
groups, health care professionals, researchers, and other interested
persons to attend this public workshop.
Dated: August 10, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-20106 Filed 8-15-12; 8:45 am]
BILLING CODE 4160-01-P