Reportable Food (human and animal) Voluntary View

Electronic Data Collection Using MedWatchPlus Portal and Rational Questionnaire--21 CFR 310.305, 314.80, 314.98, 514.80, 600.80, 1271.350 and Part 803

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0645 can be found here:

Documents and Forms

Document Name Document Type
Confidential 1005_Mandatory-Initial-Part_4-Adulteration_Origination_Site-040109 (2).pdf Other-system screenshot
Confidential 1005 Mandatory-Initial-Subview Questions Explanatory Notes-040109.doc Other-system screenshot
Confidential 1005_Mandatory-Initial-Part_3-Problem_Summary-040109.pdf Other-system screenshot
guidance 3-11-2010.doc Other-guidance document
FDA 1932a Veterinary Adverse Drug Reaction, Lack of Effectiveness Form FDA 1932a 3-11-2010.pdf Form

Information Collection (IC) Details

IC Title:	Reportable Food (human and animal) Voluntary View	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-system screenshot			Confidential 1005_Mandatory-Initial-Part_4-Adulteration_Origination_Site-040109 (2).pdf	Yes	Yes	Paper Only
Other-system screenshot			Confidential 1005 Mandatory-Initial-Subview Questions Explanatory Notes-040109.doc	Yes	Yes	Paper Only
Other-system screenshot			Confidential 1005_Mandatory-Initial-Part_3-Problem_Summary-040109.pdf	Yes	Yes	Paper Only
Other-guidance document			guidance 3-11-2010.doc	No	No	Printable Only
Form	FDA 1932a	Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product Defect Report	Form FDA 1932a 3-11-2010.pdf	Yes	No	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 1,200	Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	1,200	1,200
Annual IC Time Burden (Hours)	720	720
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
No associated records found

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.