[Federal Register Volume 71, Number 146 (Monday, July 31, 2006)]
[Notices]
[Page 43198]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-12157]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2001D-0489] (formerly Docket No. 01D-0489)


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Guidance for Clinical Trial 
Sponsors: Establishment and Operation of Clinical Trial Data Monitoring 
Committees

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Guidance for Clinical Trial 
Sponsors: Establishment and Operation of Clinical Trial Data Monitoring 
Committees'' has been approved by the Office of Management and Budget 
(OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-4659.

SUPPLEMENTARY INFORMATION: In the Federal Register of December 30, 2005 
(70 FR 77403), the agency announced that the proposed information 
collection had been submitted to OMB for review and clearance under 44 
U.S.C. 3507. An agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
a currently valid OMB control number. OMB has now approved the 
information collection and has assigned OMB control number 0910-0581. 
The approval expires on March 31, 2009. A copy of the supporting 
statement for this information collection is available on the Internet 
at http://www.fda.gov/ohrms/dockets.

    Dated: July 21, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-12157 Filed 7-28-06; 8:45 am]
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