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DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

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 "Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs – Proposed Rule”
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 “Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated under a Biologics License Application, and Animal Drugs – Proposed Rule.” The annual burden estimate imposed by this collection of information will be 181,145 hours.

Paul Jones