OMB.report

Federal forms, ICRs, and supporting documents

OMB control number

Export Notification and Recordkeeping Requirements

OMB 0910-0482 ยท 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 is listed under ICR 202507-0910-003.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
DocumentType
0482_Supporting Statement A_2025.docxSupporting Statement A
0482_Supporting Statement A_2025.docxSupporting Statement A
CBER, CDER, CDRH Notification Requirements Information collection
CTP (currently regulated tobacco products) Recordkeeping Requirements Information collection
Office of International Programs Recordkeeping Requirements Information collection
CBER, CDER, CDRH, CVM Recordkeeping Requirements Information collection

All Historical Document Collections

Historical document collections
ReferenceFilingReceivedConcludedAction
202507-0910-003 Reinstatement with change of a previously approved collection 2025-07-30
202201-0910-009 Extension without change of a currently approved collection 2022-05-03 Approved without change
201811-0910-004 Extension without change of a currently approved collection 2019-06-05 Approved without change
201601-0910-011 Revision of a currently approved collection 2016-05-12 Approved without change
201410-0910-001 Extension without change of a currently approved collection 2014-10-17 Approved with change
201107-0910-004 Extension without change of a currently approved collection 2011-07-08 Approved without change
200805-0910-003 Extension without change of a currently approved collection 2008-05-13 Approved without change
200504-0910-003 Extension without change of a currently approved collection 2005-04-15 Approved without change
200112-0910-003 New collection (Request for a new OMB Control Number) 2001-12-18 Approved without change

OMB Details

CBER, CDER, CDRH Notification Requirements

Federal Enterprise Architecture: Health - Consumer Health and Safety