Importation of Prescription Drugs

OMB 0910-0888

This ICR collects information from Section 804 Importation Programs (SIPs), which would be authorized by FDA and overseen by States or certain other governmental entities (SIP Sponsors) that seek to import certain prescription drugs from Canada.

The latest form for Importation of Prescription Drugs expires 2023-10-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
0888 Importation of Rx drugs SSA 2020 Final Rule.docx Supporting Statement A
Importation of Prescription Drugs FRIA Sept 2020.pdf Supplementary Document
3rd Party DISCLOSURE: Manuracturer
RECORDKEEPING: SIP sponsor; importer, manufactuer
REPORTING: SIP sponsor; importer; manufacturer

All Historical Document Collections

202010-0910-005 Approved without change	New collection (Request for a new OMB Control Number)	2020-10-01
202006-0910-007 Comment filed on proposed rule	New collection (Request for a new OMB Control Number)	2020-06-11

OMB Details

REPORTING: SIP sponsor; importer; manufacturer

Federal Enterprise Architecture: Health - Consumer Health and Safety