[Federal Register Volume 71, Number 128 (Wednesday, July 5, 2006)]
[Notices]
[Page 38171]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-10409]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0065]


Emerging Clostridial Disease; Public Workshop; Reopening of the 
Administrative Record

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments; reopening of 
the administrative record.

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SUMMARY: The Food and Drug Administration (FDA) is reopening until July 
31, 2006, the administrative record to accept comments concerning the 
public workshop entitled ``Emerging Clostridial Disease,'' as the 
administrative record officially closed on June 15, 2006.

DATES: Submit written or electronic comments by July 31, 2006.

ADDRESSES: Submit written comments to the 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: Lee Lemley, Center for Drug Evaluation 
and Research (HFD-006), Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, 301-443-5392.

SUPPLEMENTARY INFORMATION: In the Federal Register of February 14, 2006 
(71 FR 7778), FDA published a notice announcing a public workshop 
entitled ``Emerging Clostridial Disease,'' to be held on May 11, 2006. 
This workshop was developed in response to reports of morbidity and 
mortality associated with Clostridium sordellii (C. sordellii) and 
Clostridium difficile (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-medicated cases of community acquired C. difficile 
infection. The goal of the workshop was to bring together scientific 
and public health experts to develop a draft research agenda. 
Additionally, the goals were to identify research needs and priorities 
that will enable rapid progress in detecting cases and conducting 
surveillance of disease and organisms. Interested persons were asked to 
submit written comments by June 15, 2006. In the interest of allowing 
additional comments to be received, FDA has decided to reopen the 
comment period until July 31, 2006.
    Interested persons may, on or before July 31, 2006, submit to the 
Division of Dockets Management (see ADDRESSES) written or electronic 
comments regarding this public workshop. 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.

    Dated: June 28, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-10409 Filed 7-3-06; 8:45 am]
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