Reporting - ICH E2C(R2) Guidance: Providing periodic safety updates (applicants with and without waiver for an approved application)

Postmarketing Adverse Drug Experience Reporting

Documents and Forms

Document Name Document Type
0230 Providing Postmarketing Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report).pdf Other-Agency Guidance
0230 Providing Submissions in Electronic Format—Postmarketing Safety Reports.pdf Other-Agency Guidance

Information Collection (IC) Details

IC Title:	Reporting - ICH E2C(R2) Guidance: Providing periodic safety updates (applicants with and without waiver for an approved application)	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

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			0230 Providing Postmarketing Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report).pdf		Yes	Yes	Fillable Fileable
Other-Agency Guidance			0230 Providing Submissions in Electronic Format—Postmarketing Safety Reports.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: 1,586	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

	Requested	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	22,308	22,054	254
Annual IC Time Burden (Hours)	40,431	40,110	321
Annual IC Cost Burden (Dollars)	5,000	5,000	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.