Export Notification and Recordkeeping Requirements

OMB 0910-0482

OMB 0910-0482

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).

The latest form for Export Notification and Recordkeeping Requirements expires 2022-07-31 and can be found here.

OMB Details

CBER, CDER, CDRH Notification Requirements

Federal Enterprise Architecture: Health - Consumer Health and Safety

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