The Paperwork Reduction Act (PRA) of 1995 requires agencies to estimate the time andresource burdens that compliance with our regulations impose on private businesses and citizens. The PRA also requires agencies to obtain the Office of Management and Budget (OMB) approval before requesting most types of information from the public, including information collected through forms, interviews, and recordkeeping requirements. FDA (like other Federal agencies) is required to publish a notice in the Federal Register about each collection of information.