0338 CoverMemotoOMB 1-2007

DEPARTMENT OF HEALTH AND HUMAN SERVICES

____________________________________________________________________________________________________________________________

Memorandum

Date January 23, 2007

From Deputy Chief Information Officer

Office of the Chief Information Officer

Office of Management, FDA

Subject Request for OMB Approval for “General Licensing Provisions: Biologics License Application,
Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing

Studies Status Reports, and Forms FDA 356h and 2567” (OMB No. 0910-0338) --

EXTENSION

To Chief, Human Resources and Housing Branch

Office of Information and Regulatory Affairs, OMB

Through: Reports Clearance Officer, HHS _________

This memorandum is to request approval of the information collection requirements for
“General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Forms FDA 356h and 2567.” The estimate of the burden imposed by this information collection will be 335,808 hours.

E. Glenn Rogers Sr.

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