Attachment K. Determination: No IRB Review Required

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Centers for Disease Control

and Prevention (CDC)

_____________________________________________________________________________________________________

December 18, 2006

To whom it may concern:

CDC is proposing to conduct an evaluation of the occupational exposure management programs to determine the extent that occupational exposures management policies and practices are consistent with national guidelines. The results of this survey may inform updates of guidelines and educational materials on management of occupational exposures to bloodborne viruses.

The National Center for Preparedness, Detection, and Control of Infectious Diseases (NCPDCID), proposed, has determined that these activities are defined as program evaluation, not research. As such, IRB regulations do not apply.

Sincerely,

Rita Helfand, M.D.

Acting Associate Director for Epidemiologic Science

National Center for Preparedness, Detection, and Control of Infectious Diseases, proposed