0458 CoverMemotoOMB 2007

DEPARTMENT OF HEALTH AND HUMAN SERVICES

____________________________________________________________________________________________________________________________

Memorandum

Date

From Deputy Chief Information Officer

Office of the Chief Information Officer

Office of Management, FDA

Subject Request for OMB Approval for “Biological Products: Reporting of Biological Product
Deviations in Manufacturing; Forms FDA 3486 and 3486A” (OMB No. 0910-####) --
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
“Biological Products: Reporting of Biological Product Deviations in Manufacturing; Forms

FDA 3486 and 3486A”. The estimate of the burden imposed by this information collection

will be 86,407 hours.

E. Glenn Rogers Sr.

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