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

FDA Adverse Event and Products Experience 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⚠️ Notice: This information collection may be referencing outdated material.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
0645 83C April 2019 CFSAN RQ Screenshots for SRP.pdf www.safetyreporting.hhs.gov/SRP2/en/Home.aspx?sid=a461d596-9ac1-4df0-b780-48feb90d4f09 Other-E-form Screenshots

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	URL	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
Other-E-form Screenshots	0645 83C April 2019 CFSAN RQ Screenshots for SRP.pdf	https://www.safetyreporting.hhs.gov/SRP2/en/Home.aspx?sid=a461d596-9ac1-4df0-b780-48feb90d4f09	Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 1,800	Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	1,800	14	1,786
Annual IC Time Burden (Hours)	1,080	8	1,072
Annual IC Cost Burden (Dollars)	84,454	84,454	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.