Public reporting burden for this collection of information is estimated as follows:

The time required to complete registration and listing for existing establishments is estimated to average 30 minutes per response, for new establishments it is estimated to average 45 minutes per response, and updates to a list are estimated to average 30 minutes per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information.

Send comments regarding this burden estimate or any other aspects of this collection of information, including suggestions for reducing burden, to PRAStaff@fda.hhs.gov.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.