Cover memo 0910-0582

Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration

Memorandum

Date	April 25,2006
From	Director, Division of Management Systems, Paperwork reduction Act and Records Management Branch, FDA
Subject	Request for OMB Approval for “Guidance on Informed Consent for In Vitro Diagnostic Studies Using Leftover Human Specimens That Are Not Individually Identifiable.”
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 approval of the collection of information

requirements for "Guidance on Informed Consent for IN Vitro Diagnostic Studies Using Leftover Human Specimens That Are Not Individually Identifiable.” The estimate of the burden for this collection of information will be 2,800 hours.

.

Paul Jones

Attachment