Information Collection

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

IC 192360 under ICR 202109-0910-006 · OMB 0910-0645.

Documents and Forms

Documents and forms in this information collection
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

IC Title:

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Unchanged

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

table that charts list of 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 %

table that charts list of burden
	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

table that charts IC Documents
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.