[Federal Register Volume 67, Number 25 (Wednesday, February 6, 2002)]
[Notices]
[Pages 5603-5604]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-2752]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 02N-0027 ]
Swine Mycoplasmal Pneumonia Technical Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
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The Food and Drug Administration (FDA) is announcing the following
public workshop: Swine Mycoplasmal Pneumonia Technical Workshop. The
topic to be discussed is how to evaluate drug effectiveness against
swine mycoplasmal respiratory disease.
Date and Time: The public workshop will be held on March 6 and 7,
2002, 8:30 a.m. to 4:30 p.m. Submit written or electronic comments by
May 6, 2002.
Addresses: The public workshop will be held at the DoubleTree Hotel
Kansas City, 1301 Wyandotte St., Kansas City, MO 64105, 816-474-6664.
Submit written comments to the Dockets Management Branch (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.
For General Information Contact: Gillian A. Comyn, Center for
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7568, FAX 301-594-2298.
For Information About Registration Contact: Irma Carpenter, Center
for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7580, FAX 301-594-2298.
Registration: Registration is required. There is no registration
fee for the meeting. Space is limited. Registration will be on a first
come, first served basis. Information about the workshop is available
on the Internet at the Center for Veterinary Medicine (CVM) Web site at
http://www.fda.gov/cvm. Electronic registration for the workshop is
available at http://www.accessdata.fda.gov/scripts/oc/dockets/meetings/meetingdocket.cfm. Alternatively, please send registration information
(including name, title, firm name, address, telephone, and fax number)
to Irma Carpenter (address above). If you need special accommodations
due to a disability, please contact the DoubleTree Hotel Kansas City at
least 7 days in advance at 816-474-6664, and Irma Carpenter at 301-827-
7580.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is seeking scientific input from a broad public forum to help
the agency determine an acceptable method, in light of the current
state of scientific knowledge, for evaluating drug effectiveness
against swine mycoplasmal respiratory disease. Mycoplasma hyopneumoniae
is a major pathogen in ``porcine respiratory disease complex'' (PRDC).
PRDC is a significant problem in the swine industry in the
[[Page 5604]]
United States and abroad. This workshop will provide a necessary forum
for leveraging scientific resources, including top experts in swine
mycoplasmal pneumonia. The workshop is part of CVM's leveraging
initiative aimed at increasing interaction with industry, academia,
practitioners, and other government agencies.
II. Agenda
The preliminary agenda is as follows:
Session 1: The disease--history, clinical presentation,
epidemiology, and economics;
Session 2: Cutting edge--new findings on the organism;
Session 3: Perspectives from industry, producers, veterinarians,
and government regulators;
Session 4: Breakout exercise;
Panel discussion;
Adjourn.
Proposed core items for discussion include:
1. Define swine mycoplasmal pneumonia.
M. hyopneumoniae as a pathogen in PRDC, enzootic
pneumonia.
The disease(s) in clinical and field settings.
Epidemiology: Disease determinants, risk factors, and
confounders.
Methods for diagnosing pneumonia associated with M.
hyopneumoniae.
The disease contribution of M. hyopneumoniae in PRDC.
2. Methods of detection of M. hyopneumoniae in body tissues and
fluids.
Proper sampling for different methods.
Comparison of detection methods for sensitivity,
specificity, and positive and negative predictive test values.
3. What is the best study design for demonstrating effectiveness of
treatments against pneumonia associated with M. hyopneumoniae
infection?
What is a ``cure'' in swine mycoplasmal pneumonia, and
what are the best clinical and laboratory indicators?
Study designs.
Perspectives on designing studies to demonstrate
effectiveness of therapeutic modalities against pneumonia in swine
associated with M. hyopneumoniae infection.
Substantial evidence.
III. Submission of Comments
Interested persons may submit to the Dockets Management Branch
(address above) written or electronic comments regarding this workshop
until May 6, 2002. Comments are to be identified with the docket number
found in the brackets in the heading of this document.
Dated: January 30, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-2752 Filed 2-6-02; 8:45 am]
BILLING CODE 4160-01-S