Emerging Clostridial Disease; Public Workshop; Reopening of the Administrative Record, 38171 [E6-10409]

Download as PDF Federal Register / Vol. 71, No. 128 / Wednesday, July 5, 2006 / Notices submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments and ask for a redetermination by September 5, 2006. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by January 2, 2006. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: June 13, 2006. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E6–10408 Filed 7–3–06; 8:45 am] BILLING CODE 4160–01–S 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. Notice of public workshop; request for comments; reopening of the administrative record. ACTION: 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 https:// www.fda.gov/dockets/ecomments. rwilkins on PROD1PC63 with NOTICES SUMMARY: VerDate Aug<31>2005 19:34 Jul 03, 2006 Jkt 205001 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. FOR FURTHER INFORMATION CONTACT: Dated: June 28, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–10409 Filed 7–3–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF THE INTERIOR Office of the Secretary Exxon Valdez Oil Spill Trustee Council; Request for Nominations Office of the Secretary, Interior. Notice. AGENCY: ACTION: SUMMARY: The Exxon Valdez Oil Spill Trustee Council is soliciting PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 38171 nominations for the Public Advisory Committee, which advises the Trustee Council on decisions related to the planning, evaluation, and conduct of injury assessment, restoration, long-term monitoring, and research activities using funds obtained as part of the civil settlement pursuant to the T/V Exxon Valdez oil spill of 1989. Public Advisory Committee members will be selected to serve a 24-month term beginning in October 2006. DATES: All nominations should be received on or before August 4, 2006. ADDRESSES: Nominations should be sent to Executive Director, Exxon Valdez Oil Spill Trustee Council, 441 West 5th Avenue, Suite 500, Anchorage, Alaska 99501–2340 or by email to PAC Nominations, Executive Director, c/o Cherri Womac, cherri_womac@evostc.state.ak.us. FOR FURTHER INFORMATION CONTACT: Douglas Mutter, Designated Federal Officer, Department of the Interior, Office of Environmental Policy and Compliance, 1689 ‘‘C’’ Street, Suite 119, Anchorage, Alaska, 99501, 907–271– 5011; or Cherri Womac, Exxon Valdez Oil Spill Trustee Council, 441 West 5th Avenue, Suite 500, Anchorage, Alaska, 99501–2340, 907–278–8012 or 800– 478–7745. A copy of the charter for the Public Advisory Committee is available upon request. SUPPLEMENTARY INFORMATION: The Public Advisory Committee was created by Paragraph V.A.4 of the Memorandum of Agreement and Consent Decree entered into by the United States of America and the State of Alaska on August 27, 1991, and approved by the United States District Court for the District of Alaska in settlement of United States of America v. State of Alaska, Civil Action No. A91–081 CV. The Public Advisory Committee was created to advise the Trustee Council on matters relating to decisions on injury assessment, restoration activities or other use of natural resources damage recoveries obtained by the governments. The Trustee Council consists of representatives of the State of Alaska Attorney General; Commissioner of the Alaska Department of Fish and Game; Commissioner of the Alaska Department of Environmental Conservation; the Secretary of the Interior; the Secretary of Agriculture; and the Administrator of the National Oceanic and Atmospheric Administration, U.S. Department of Commerce. Appointment to the Public Advisory Committee will be made by the Secretary of the Interior with unanimous approval of the Trustees. The Public Advisory Committee consists of 15 members representing the E:\FR\FM\05JYN1.SGM 05JYN1

Agencies

[Federal Register Volume 71, Number 128 (Wednesday, July 5, 2006)]
[Notices]
[Page 38171]
From the Federal Register Online via the Government Printing 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.

-----------------------------------------------------------------------

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 https://
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]
BILLING CODE 4160-01-S

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