Information Collection Request

Adverse Experience/Events with Approved New Animal Drugs

ICR 202306-0910-009 · OMB 0910-0284 · Received in OIRA

Forms and Documents

Document Name	Status
Form FDA 1932 Animal Drug Adverse Event Information Collection Activities Form and Instruction	Modified
Form 2301 Drug experience reports; advertisements and promotional labeling; distributor statements Form and Instruction	Removed
Form 1932a Voluntary adverse event reporting Form and Instruction	Removed
0284 CVM AER SSA 2023 REV.docx Supporting Statement A	2023-06-30

IC Document Collections

IC ID	Document Title	Status
37624	Animal Drug Adverse Event Information Collection Activities Form and Instruction	Modified
239296	One time recordkeeping resulting from implementation of new requirements (New SOPs and training)	Removed
239295	Request for waiver from electronic reporting requirement	Removed
230017	Medicated feed reports	Removed
197284	Recordkeeping requirements under 510.301 and 514.80	Modified
197280	Drug experience reports; advertisements and promotional labeling; distributor statements Form and Instruction	Removed
197279	Voluntary adverse event reporting Form and Instruction	Removed

ICR Details

Status	Received in OIRA
Agency/Subagency	HHS/FDA
OMB Control No	0910-0284
Type of Information Collection	Extension without change of a currently approved collection
Previous ICR Reference No	202001-0910-009
Agency Tracking No	CVM
Date Submitted to OIRA	1969-12-31
Requested Expiration Date	1969-12-31