Justification for No Material/Nonsubstantive Change

0687 83-C increase in hours and responses request 12-15-14.docx

Testing Communications on Biological Products

Justification for No Material/Nonsubstantive Change

OMB: 0910-0687

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Testing Communications on Biological Products

(OMB Control Number 0910-0687)



Change Request (83-C)


December 15, 2014



The Food and Drug Administration is submitting this nonmaterial/non-substantive change request (83-C) to add 2,724 burden hours and 9,280 annual responses.


This generic clearance was originally thought to include projects originating in only the Center for Biological Evaluation and Research but because various programs within FDA deal with biological products we experienced more use of this generic approval then anticipated and, therefore, require an increase in hours until the expiration date in 2017.


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