OMB.report

Federal forms, ICRs, and supporting documents

OMB control number

Export Notification and Recordkeeping Requirements

OMB 0910-0482 · HHS/FDA.

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 2028-09-30 and can be found here.

Latest Forms, Documents, and Supporting Material
Document
Name
Supporting Statement A
Supporting Statement A
All Historical Document Collections
 Reinstatement with change of a previously approved collection 2025-07-30
Approved without change
 Extension without change of a currently approved collection 2022-05-03
Approved without change
 Extension without change of a currently approved collection 2019-06-05
Approved without change
 Revision of a currently approved collection 2016-05-12
Approved with change
 Extension without change of a currently approved collection 2014-10-17
Approved without change
 Extension without change of a currently approved collection 2011-07-08
Approved without change
 Extension without change of a currently approved collection 2008-05-13
Approved without change
 Extension without change of a currently approved collection 2005-04-15
Approved without change
 New collection (Request for a new OMB Control Number) 2001-12-18
OMB Details

CBER, CDER, CDRH Notification Requirements

Federal Enterprise Architecture: Health - Consumer Health and Safety