Information Collection

GFI: Providing PSURs

IC 250441 under ICR 202110-0910-003 · OMB 0910-0230.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0230 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
GFI Postmarket Safety Reports in ICH-E2C(R2)-Format-(Periodic-Benefit-Risk-Evaluation-Report) NOV 2016.pdf	Other-Agency Guidance
GFI Postmarket Safety Reports in ICH-E2C(R2)-Format-(Periodic-Benefit-Risk-Evaluation-Report) NOV 2016.pdf	Other-Agency Guidance

IC Title:

GFI: Providing PSURs

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: New

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

table that charts list of instruments
Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Guidance			GFI Postmarket Safety Reports in ICH-E2C(R2)-Format-(Periodic-Benefit-Risk-Evaluation-Report) NOV 2016.pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 84

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	254	254
Annual IC Time Burden (Hours)	321	321
Annual IC Cost Burden (Dollars)	0	0

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.