GFI: Providing PSURs

Postmarketing Adverse Drug Experience Reporting

Documents and Forms

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

Information Collection (IC) Details

IC Title:	GFI: Providing PSURs	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Unchanged

Obligation to Respond: Mandatory

CFR Citation:

Information Collection 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 %

	Approved	Previously Approved
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

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.