Mandatory and Voluntary RFR Reports via the SRP

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⚠️ Notice: This information collection may be referencing outdated material.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
FSMA-Notification-04-30-2012+16_21[1].pdf Other-Screenshot
RFR proposed SRP modifications_12April12.doc Other-Reportable Registry Fields Tab

Information Collection (IC) Details

IC Title:	Mandatory and Voluntary RFR Reports via the SRP	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Screenshot			FSMA-Notification-04-30-2012+16_21[1].pdf		Yes	No	Fillable Fileable
Other-Reportable Registry Fields Table			RFR proposed SRP modifications_12April12.doc		Yes	No	Paper Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 1,413	Number of Respondents for Small Entity: 1,130

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 100 %

	Requested	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	1,413	213	1,200
Annual IC Time Burden (Hours)	848	128	720
Annual IC Cost Burden (Dollars)	0	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.