Voluntary Adverse Event Reporting via the SRP (other than RFR reports)

FDA Adverse Event Reports; Electronic Submissions

⚠️ Notice: This information collection may be referencing outdated material.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
0645 IC 1 CTP Wireframe TPRv2.pdf Other-eForm Submission
0645 IC 1 CTP Wireframe TIR.pdf Other-eForm Submission
0645 IC 1 Voluntary DSR Wireframes.pdf Other-eForm Submission
0645 RQ for Foods.xlsx Other-eForm Submission
0645 RQ for Infant Formula.xlsx Other-eForm Submission

Information Collection (IC) Details

IC Title:	Voluntary Adverse Event Reporting via the SRP (other than RFR reports)	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-eForm Submission	0645 IC 1 CTP Wireframe TPRv2.pdf	Yes	Yes	Fillable Fileable
Other-eForm Submission	0645 IC 1 CTP Wireframe TIR.pdf	Yes	Yes	Fillable Fileable
Other-eForm Submission	0645 IC 1 Voluntary DSR Wireframes.pdf	Yes	Yes	Fillable Fileable
Other-eForm Submission	0645 RQ for Foods.xlsx	Yes	Yes	Fillable Fileable
Other-eForm Submission	0645 RQ for Infant Formula.xlsx	Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 1,786	Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	1,786	273	1,513
Annual IC Time Burden (Hours)	1,072	164	908
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.