Document ID: FDA-2008-N-0521-0003
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2009-07-22T04:00Z

[Federal Register: July 22, 2009 (Volume 74, Number 139)]
[Notices]               
[Page 36228-36229]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22jy09-82]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0521]

 
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 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3794.

SUPPLEMENTARY INFORMATION: In the Federal Register of March 10, 2009 
(74 FR 10253), the agency announced that the proposed information 
collection had been submitted to OMB for review and

[[Page 36229]]

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 June 30, 2012. A copy of the 
supporting statement for this information collection is available on 
the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: July 15, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-17330 Filed 7-21-09; 8:45 am]

BILLING CODE 4160-01-S