[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