[Federal Register Volume 71, Number 30 (Tuesday, February 14, 2006)]
[Notices]
[Pages 7778-7779]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-1371]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0065]


Emerging Clostridial Disease; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA), on behalf of the 
Centers for Disease Control and Prevention (CDC) and the National 
Institute of Allergy and Infectious Diseases (NIAID) are announcing a 
public workshop entitled ``Emerging Clostridial Disease.'' This public 
workshop is intended to develop a draft research agenda to better 
understand the virulence, pathogenesis, host factors, and 
nonantimicrobial risk factors contributing to reports of morbidity and 
mortality associated with Clostridium sordellii (C. sordellii) and 
Clostridium difficile (C. difficile). Additionally, our goals are to 
identify research needs and priorities that will enable rapid progress 
as well as to develop and provide recommendations for detecting cases 
and conducting surveillance of diseases and organisms.
    DATES: The public workshop will be held on May 11, 2006, from 8:30 
a.m. to 4:30 p.m. See section III of this document for information on 
how to

[[Page 7779]]

register to attend or present at the workshop. You must register by 
close of business on April 15, 2006, to attend or participate.
    We are opening a docket to receive your written or electronic 
comments (see ADDRESSES). Written or electronic comments must be 
submitted to the docket by June 15, 2006.

ADDRESSES: The public workshop will be held at the Centers for Disease 
Control and Prevention, 1600 Clifton Rd., NE., CDC Roybal Campus, Bldg. 
19, Auditorium A, Atlanta, GA 30333.
    Submit written comments to Division of Dockets Management (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 FURTHER INFORMATION CONTACT: Workshop Coordinator, Center for Drug 
Evaluation and Research (HFD-006), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-6779, FAX: 301-827-4312, e-
mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Why Are We Holding a Public Workshop?

    This workshop has been developed in response to reports of 
morbidity and mortality associated with C. sordellii and C. difficile. 
These reports include cases and clusters of C. sordellii toxic shock 
syndrome following treatment with mifepristone, C. sordellii sepsis 
associated with tissue grafts, and rapidly fatal toxin-mediated cases 
of community-associated C. difficile infection. The primary goal of the 
workshop is to bring together scientific and public health experts to 
develop a draft research agenda. This research agenda is expected to 
lead to better understanding of the virulence, pathogenesis, host 
factors, and nonantimicrobial risk factors contributing to these 
reports and to identify research needs and priorities in these areas. 
As part of a research agenda, the workshop will assist in the 
development of recommendations for detecting cases and conducting 
surveillance. The meeting focus will be on increasing our understanding 
of severe community associated C. difficile and C. sordellii disease 
and of disease in otherwise healthy populations previously thought to 
be at low risk.

II. What Are the Issues We Intend to Address at the Workshop?

    1. What clinical and laboratory surveillance data are needed to 
help guide infection prevention?
    2. Are there characteristics of the clinical presentations of these 
infections that suggest measures that could prevent or mitigate them?
    3. How does our current understanding of the pathophysiology and 
risk factors associated with these infections inform future research 
and public health actions?
    4. What are the gaps in basic research that are critical to a 
better understanding of the pathogenesis of C. sordellii and C. 
difficile?

III. How Do You Register?

    Registration is required to attend or participate in the workshop. 
Your registration must be received by the close of business on April 
15, 2006. Registration is free. Seats are limited, so please register 
as soon as possible. Space will be filled in order of receipt of 
registration. Those registered will receive confirmation on April 18, 
2006. Registration will close after available space fills. You will not 
be notified if registration has closed before your registration is 
received. There will be no on-site registration the day of the 
workshop.
    Time will be allowed during the scheduled agenda for attendees to 
ask questions of panelists, to participate in the discussion, and to 
provide input to the sponsoring agencies on future research, 
surveillance, and case detection. In addition, we strongly encourage 
written submissions to the docket.
    If you need special accommodations due to disability, please 
contact the Workshop Coordinator (see FOR FURTHER INFORMATION CONTACT) 
at least 7 days in advance of the workshop.
    Registration Form Instructions: To register to attend the workshop, 
complete the following registration form and submit via:
     E-mail: [email protected];
     FAX: 301-827-4312; or
     Mail to: Food and Drug Administration, Center for Drug 
Evaluation and Research, Office of Executive Programs, Executive 
Operations Staff (HFD-006), 5600 Fishers Lane, Rockville, MD 20857, 
Attn: Workshop Coordinator.
Name: --------------------------------------------------------
Company Name: --------------------------------------
Mailing Address: ------------------------------------
City: ---------------------------------- State: ------------
Zip Code: ----------------
Phone: ( ) --------------------------------
Fax: ( ) --------------------------------------
E-mail: ( ) --------------------------------
U.S. Citizen Yes/No (Required by CDC Security)

IV. How Should You Send Comments on the Issues?

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments should be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday. To ensure consideration of your comments, we must 
receive any written or electronic comments by the date indicated (see 
DATES).

V. Will Meeting Transcripts Be Available?

    You can examine a transcript of the May 11, 2006, public workshop 
on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cq 
approximately 30 days after the workshop or at the Division of Dockets 
Management (see ADDRESSES), Monday through Friday between 9 a.m. and 4 
p.m. You may also request a copy of the transcript from the Freedom of 
Information Office (HFI-35), Food and Drug Administration, 5600 Fishers 
Lane, rm. 12A-16, Rockville, MD 20857, approximately 15 working days 
after the public workshop at a cost of 10 cents per page.

    Dated: February 9, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-1371 Filed 2-10-06; 11:33 am]
BILLING CODE 4160-01-S