Export Notification and
Extension without change of a currently approved collection
36 Months From Approved
The information collection supports
FDA regulations at 21 CFR 1.101 and pertains to the notifications
and records required for human drug, biological product, device,
animal drug, food, cosmetic, and tobacco product exports under
sections 801 or 802 of the Federal Food, Drug, and Cosmetic Act or
(21 U.S.C. 381 and 382) or section 351 of the Public Health Service
Act (42 U.S.C. 262).
Based on a review of Agency
data, we decreased our estimate by 24,251 burden hours. This
decrease reflects an overall downward trend in the number of export
certification requests across programs and commodities. The
estimate for tobacco products remains steady.