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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug

Administration

Memorandum

Date	August 30, 2006
From	Director, Division of Management Systems, DMS Paperwork Reduction Act and Records Management Branch, HFA-250
Subject	Request for OMB Approval of "Guidance for Industry Submitting and Reviewing Complete Responses to Clinical Holds”
To	Chief, Human Resources and Housing Branch Office of Information and Regulatory Affairs, OMB Through: Reports Clearance Officer, HHS_______

The purpose of this memorandum is to request OMB approval of the collection of information requirements for “Guidance for Industry Submitting and Reviewing Complete Responses to Clinical Holds.” The annual burden estimate imposed by this collection of information will be 51,120 hours.

Paul Jones