Export Notification and Recordkeeping Requirements

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.

Latest Forms, Documents, and Supporting Material

Document Name
0482ExportNotificationsandRecordsSSA 5-3-22.docx Supporting Statement A
CBER, CDER, CDRH Notification Requirements
CTP (currently regulated tobacco products) Recordkeeping Requirements
Office of International Programs Recordkeeping Requirements
CBER, CDER, CDRH Recordkeeping Requirements

All Historical Document Collections

202201-0910-009 Approved without change	Extension without change of a currently approved collection	2022-05-03
201811-0910-004 Approved without change	Extension without change of a currently approved collection	2019-06-05
201601-0910-011 Approved without change	Revision of a currently approved collection	2016-05-12
201410-0910-001 Approved with change	Extension without change of a currently approved collection	2014-10-17
201107-0910-004 Approved without change	Extension without change of a currently approved collection	2011-07-08
200805-0910-003 Approved without change	Extension without change of a currently approved collection	2008-05-13
200504-0910-003 Approved without change	Extension without change of a currently approved collection	2005-04-15
200112-0910-003 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