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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service Food and Drug Administration Rockville MD 20857

August 9, 2011

In reply to: 2011-5576 Anne L. Weismann Citizen for Responsibility and Ethics in Washington (CREW) 1400 Eye Street, N.W., Suite 450 Washington, DC 20005

Dear Ms. Weismann: This is in response to your request for records from the Food and Drug Administration (FDA) pursuant to the Freedom of Information Act. Enclosed are the records you requested: Refrain From Approving Investigational Radioactive Sentinel Lymph Node Detection Agents Without Accompanying Data From Successful Controlled Trials of Such Agents, docket FDA-2011-P-0450-0003, comment. Another office will respond to the other portion of your request. You will receive an invoice from the Freedom of Information Staff. The charges listed below may not reflect the final charges for this request. Please do not send payment until you receive an invoice.

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If you have any questions, please contact Ms. Michelle Bigesby at 301-827-6857. Sincerely yours,

Karen Kennard Director, Division of Dockets Management Office of Public Information and Library Services Office of Shared Services Office of Management Enclosure

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