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

FDA Adverse Event and Products Experience Reports; Electronic Submissions

Documents and Forms

Document Name Document Type
0645 IC 1 CTP Wireframe TPRv2.pdf Other-eForm Submission
0645 IC 1 CTP Wireframe TPRv2.pdf Other-eForm Submission
0645 IC 1 CTP Wireframe TIR.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 IC 1 Voluntary DSR Wireframes.pdf Other-eForm Submission
0645 RQ for Foods.xlsx Other-eForm Submission
0645 RQ for Foods.xlsx Other-eForm Submission
0645 RQ for Infant Formula.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
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: Unchanged

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	Previously Approved
Annual Number of Responses for this IC	1,800	1,800
Annual IC Time Burden (Hours)	1,080	1,080
Annual IC Cost Burden (Dollars)	84,454	84,454

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.